WorldWideScience

Sample records for rdea806 study drug

  1. 21 CFR 806.40 - Public availability of reports.

    Science.gov (United States)

    2010-04-01

    ... report: (1) Any information that constitutes trade secret or confidential commercial or financial... report all the information in the report concerning that patient. ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Public availability of reports. 806.40 Section 806...

  2. 15 CFR 806.13 - Miscellaneous.

    Science.gov (United States)

    2010-01-01

    ... 15 Commerce and Foreign Trade 3 2010-01-01 2010-01-01 false Miscellaneous. 806.13 Section 806.13 Commerce and Foreign Trade Regulations Relating to Commerce and Foreign Trade (Continued) BUREAU OF ECONOMIC ANALYSIS, DEPARTMENT OF COMMERCE DIRECT INVESTMENT SURVEYS § 806.13 Miscellaneous. (a) Accounting...

  3. 15 CFR 806.5 - Confidentiality.

    Science.gov (United States)

    2010-01-01

    ... 15 Commerce and Foreign Trade 3 2010-01-01 2010-01-01 false Confidentiality. 806.5 Section 806.5 Commerce and Foreign Trade Regulations Relating to Commerce and Foreign Trade (Continued) BUREAU OF ECONOMIC ANALYSIS, DEPARTMENT OF COMMERCE DIRECT INVESTMENT SURVEYS § 806.5 Confidentiality. Information...

  4. 15 CFR 806.6 - Penalties.

    Science.gov (United States)

    2010-01-01

    ... 15 Commerce and Foreign Trade 3 2010-01-01 2010-01-01 false Penalties. 806.6 Section 806.6 Commerce and Foreign Trade Regulations Relating to Commerce and Foreign Trade (Continued) BUREAU OF ECONOMIC ANALYSIS, DEPARTMENT OF COMMERCE DIRECT INVESTMENT SURVEYS § 806.6 Penalties. (a) Whoever fails to...

  5. 7 CFR 52.806 - Color.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 2 2010-01-01 2010-01-01 false Color. 52.806 Section 52.806 Agriculture Regulations... United States Standards for Grades of Frozen Red Tart Pitted Cherries Factors of Quality § 52.806 Color. (a) (A) Classification. Frozen red tart pitted cherries that possess a good red color may be given a...

  6. 15 CFR 806.2 - Recordkeeping requirements.

    Science.gov (United States)

    2010-01-01

    ... 15 Commerce and Foreign Trade 3 2010-01-01 2010-01-01 false Recordkeeping requirements. 806.2 Section 806.2 Commerce and Foreign Trade Regulations Relating to Commerce and Foreign Trade (Continued) BUREAU OF ECONOMIC ANALYSIS, DEPARTMENT OF COMMERCE DIRECT INVESTMENT SURVEYS § 806.2 Recordkeeping...

  7. 32 CFR 806.10 - Records management.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 6 2010-07-01 2010-07-01 false Records management. 806.10 Section 806.10 National Defense Department of Defense (Continued) DEPARTMENT OF THE AIR FORCE ADMINISTRATION AIR FORCE FREEDOM OF INFORMATION ACT PROGRAM § 806.10 Records management. Keep records that were fully released for...

  8. 15 CFR 806.8 - Real estate.

    Science.gov (United States)

    2010-01-01

    ... 15 Commerce and Foreign Trade 3 2010-01-01 2010-01-01 false Real estate. 806.8 Section 806.8 Commerce and Foreign Trade Regulations Relating to Commerce and Foreign Trade (Continued) BUREAU OF ECONOMIC ANALYSIS, DEPARTMENT OF COMMERCE DIRECT INVESTMENT SURVEYS § 806.8 Real estate. Residential real...

  9. 45 CFR 80.6 - Compliance information.

    Science.gov (United States)

    2010-10-01

    ... 45 Public Welfare 1 2010-10-01 2010-10-01 false Compliance information. 80.6 Section 80.6 Public... THE CIVIL RIGHTS ACT OF 1964 § 80.6 Compliance information. (a) Cooperation and assistance. The... reports at such times, and in such form and containing such information, as the responsible Department...

  10. 32 CFR 724.806 - Decisional issues.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 5 2010-07-01 2010-07-01 false Decisional issues. 724.806 Section 724.806... BOARD Procedures of Naval Discharge Review Board § 724.806 Decisional issues. (a) General. Under the guidance in this section, the decisional document shall discuss the issues that provide a basis for the...

  11. 15 CFR 806.4 - Response required.

    Science.gov (United States)

    2010-01-01

    ... ECONOMIC ANALYSIS, DEPARTMENT OF COMMERCE DIRECT INVESTMENT SURVEYS § 806.4 Response required. Reports, as... certifying in writing to the fact that the person has no direct investments within the purview of the Act or... 15 Commerce and Foreign Trade 3 2010-01-01 2010-01-01 false Response required. 806.4 Section 806.4...

  12. 26 CFR 1.806-2 - Taxable years affected.

    Science.gov (United States)

    2010-04-01

    ... 26 Internal Revenue 8 2010-04-01 2010-04-01 false Taxable years affected. 1.806-2 Section 1.806-2 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY (CONTINUED) INCOME TAX (CONTINUED) INCOME TAXES Investment Income § 1.806-2 Taxable years affected. Section 1.806-1 is applicable only to...

  13. 18 CFR 806.25 - Water conservation standards.

    Science.gov (United States)

    2010-04-01

    ... 18 Conservation of Power and Water Resources 2 2010-04-01 2010-04-01 false Water conservation standards. 806.25 Section 806.25 Conservation of Power and Water Resources SUSQUEHANNA RIVER BASIN COMMISSION REVIEW AND APPROVAL OF PROJECTS Standards for Review and Approval § 806.25 Water conservation...

  14. 12 CFR 608.806 - Demand for payment.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 6 2010-01-01 2010-01-01 false Demand for payment. 608.806 Section 608.806 Banks and Banking FARM CREDIT ADMINISTRATION ADMINISTRATIVE PROVISIONS COLLECTION OF CLAIMS OWED THE UNITED STATES Administrative Collection of Claims § 608.806 Demand for payment. (a) A total of three...

  15. 32 CFR 806b.49 - Disclosure accountings.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 6 2010-07-01 2010-07-01 false Disclosure accountings. 806b.49 Section 806b.49... PROGRAM Disclosing Records to Third Parties § 806b.49 Disclosure accountings. System managers must keep an... 771 10 , Accounting of Disclosures. Retain disclosure accountings for 5 years after the disclosure, or...

  16. 18 CFR 806.30 - Monitoring.

    Science.gov (United States)

    2010-04-01

    ... 18 Conservation of Power and Water Resources 2 2010-04-01 2010-04-01 false Monitoring. 806.30... APPROVAL OF PROJECTS Terms and Conditions of Approval § 806.30 Monitoring. The Commission, as part of the project review, shall evaluate the proposed methodology for monitoring consumptive uses, water withdrawals...

  17. 32 CFR 806b.2 - Basic guidelines.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 6 2010-07-01 2010-07-01 false Basic guidelines. 806b.2 Section 806b.2 National Defense Department of Defense (Continued) DEPARTMENT OF THE AIR FORCE ADMINISTRATION PRIVACY ACT PROGRAM Overview of the Privacy Act Program § 806b.2 Basic guidelines. This part implements the Privacy Act of 1974...

  18. 15 CFR 806.9 - Airlines and ship operators.

    Science.gov (United States)

    2010-01-01

    ... 15 Commerce and Foreign Trade 3 2010-01-01 2010-01-01 false Airlines and ship operators. 806.9 Section 806.9 Commerce and Foreign Trade Regulations Relating to Commerce and Foreign Trade (Continued) BUREAU OF ECONOMIC ANALYSIS, DEPARTMENT OF COMMERCE DIRECT INVESTMENT SURVEYS § 806.9 Airlines and ship...

  19. 49 CFR 236.806 - Signal, home.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 4 2010-10-01 2010-10-01 false Signal, home. 236.806 Section 236.806 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION... Signal, home. A roadway signal at the entrance to a route or block to govern trains in entering and using...

  20. 5 CFR 550.806 - Interest computations.

    Science.gov (United States)

    2010-01-01

    ... agency shall compound interest by dividing the applicable interest rate (expressed as a decimal) by 365... 5 Administrative Personnel 1 2010-01-01 2010-01-01 false Interest computations. 550.806 Section... ADMINISTRATION (GENERAL) Back Pay § 550.806 Interest computations. (a)(1) Interest begins to accrue on the date...

  1. 32 CFR 806b.8 - Obtaining law enforcement records.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 6 2010-07-01 2010-07-01 false Obtaining law enforcement records. 806b.8 Section 806b.8 National Defense Department of Defense (Continued) DEPARTMENT OF THE AIR FORCE ADMINISTRATION PRIVACY ACT PROGRAM Obtaining Law Enforcement Records and Confidentiality Promises § 806b.8 Obtaining law enforcement records. The Commander, Air...

  2. 32 CFR 806b.51 - Privacy and the Web.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 6 2010-07-01 2010-07-01 false Privacy and the Web. 806b.51 Section 806b.51... PROGRAM Disclosing Records to Third Parties § 806b.51 Privacy and the Web. Do not post personal information on publicly accessible DoD web sites unless clearly authorized by law and implementing regulation...

  3. 9 CFR 93.806 - Animals refused entry.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Animals refused entry. 93.806 Section 93.806 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EXPORTATION AND IMPORTATION OF ANIMALS (INCLUDING POULTRY) AND ANIMAL PRODUCTS IMPORTATION OF...

  4. 18 CFR 806.24 - Standards for diversions.

    Science.gov (United States)

    2010-04-01

    ... related to the following factors: (i) Any adverse effects and cumulative adverse effects the project may... 18 Conservation of Power and Water Resources 2 2010-04-01 2010-04-01 false Standards for diversions. 806.24 Section 806.24 Conservation of Power and Water Resources SUSQUEHANNA RIVER BASIN...

  5. 32 CFR 806b.35 - Balancing protection.

    Science.gov (United States)

    2010-07-01

    ... automated system with a log-on protocol. Others may require more sophisticated security protection based on..., Computer Security, 5 for procedures on safeguarding personal information in automated records. 5 http://www... 32 National Defense 6 2010-07-01 2010-07-01 false Balancing protection. 806b.35 Section 806b.35...

  6. 20 CFR 638.806 - Property management and procurement.

    Science.gov (United States)

    2010-04-01

    ... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false Property management and procurement. 638.806 Section 638.806 Employees' Benefits EMPLOYMENT AND TRAINING ADMINISTRATION, DEPARTMENT OF LABOR JOB CORPS... management and procurement. The Job Corps Director shall develop procedures to establish and maintain a...

  7. 32 CFR 806b.4 - Privacy Act complaints.

    Science.gov (United States)

    2010-07-01

    ... be identified, the local Privacy Act officer will assume these duties. Issues that cannot be resolved... 32 National Defense 6 2010-07-01 2010-07-01 false Privacy Act complaints. 806b.4 Section 806b.4 National Defense Department of Defense (Continued) DEPARTMENT OF THE AIR FORCE ADMINISTRATION PRIVACY ACT...

  8. 18 CFR 806.23 - Standards for water withdrawals.

    Science.gov (United States)

    2010-04-01

    ...) Investigate additional sources or storage options to meet the demand of the project. (ii) Submit a water... 18 Conservation of Power and Water Resources 2 2010-04-01 2010-04-01 false Standards for water withdrawals. 806.23 Section 806.23 Conservation of Power and Water Resources SUSQUEHANNA RIVER BASIN...

  9. 26 CFR 1.806-3 - Certain changes in reserves and assets.

    Science.gov (United States)

    2010-04-01

    ... 26 Internal Revenue 8 2010-04-01 2010-04-01 false Certain changes in reserves and assets. 1.806-3 Section 1.806-3 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY (CONTINUED) INCOME TAX (CONTINUED) INCOME TAXES Investment Income § 1.806-3 Certain changes in reserves and assets. (a...

  10. 45 CFR 73.735-806 - Documentation and publication of opinions.

    Science.gov (United States)

    2010-10-01

    ...-806 Section 73.735-806 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION... Department Ethics Counselor, deputy ethics counselors, and any other individuals required to be involved in... Department Ethics Counselor shall publish summaries of advisory opinions issued by his or her office...

  11. 17 CFR 8.06 - Investigations.

    Science.gov (United States)

    2010-04-01

    ....06 Commodity and Securities Exchanges COMMODITY FUTURES TRADING COMMISSION EXCHANGE PROCEDURES FOR DISCIPLINARY, SUMMARY, AND MEMBERSHIP DENIAL ACTIONS Disciplinary Procedure § 8.06 Investigations. (a) Each exchange shall establish and maintain a disciplinary procedure which requires the enforcement staff of the...

  12. R806 (part 1)

    CERN Multimedia

    CERN PhotoLab

    1976-01-01

    R806 was designed by the BNL-CERN-Syracuse-Yale Collaboration (Bill Willis spokesman) to study large transverse momentum phenomena, and installed in intersection 8 of the ISR. The main detectors were Lithium foil transition radiation detectors to identify electrons and liquid argon calorimeters to measure the energy of the electrons and photons (among the first such calorimeters to be used in an experiment). In part 1 there were two modules, top and bottom of the horizontal beam pipe; the black vertical pipe contains the cryogenics (LN2 and Lar) and is connected to the two modules with the horizontal piping.

  13. 15 CFR 806.10 - Determining place of residence and country of jurisdiction of individuals.

    Science.gov (United States)

    2010-01-01

    ... DIRECT INVESTMENT SURVEYS § 806.10 Determining place of residence and country of jurisdiction of... 15 Commerce and Foreign Trade 3 2010-01-01 2010-01-01 false Determining place of residence and country of jurisdiction of individuals. 806.10 Section 806.10 Commerce and Foreign Trade Regulations...

  14. 15 CFR 806.12 - Partnerships.

    Science.gov (United States)

    2010-01-01

    ... ECONOMIC ANALYSIS, DEPARTMENT OF COMMERCE DIRECT INVESTMENT SURVEYS § 806.12 Partnerships. Limited partners do not have voting rights in a partnership and therefore cannot have a direct investment in a... direct investment in a partnership shall be based on the country of residence of, and the percentage...

  15. 32 CFR 806b.29 - Sending personal information over electronic mail.

    Science.gov (United States)

    2010-07-01

    ... information over electronic mail. (a) Exercise caution before transmitting personal information over e-mail to... 32 National Defense 6 2010-07-01 2010-07-01 false Sending personal information over electronic mail. 806b.29 Section 806b.29 National Defense Department of Defense (Continued) DEPARTMENT OF THE AIR...

  16. 15 CFR 806.1 - Purpose.

    Science.gov (United States)

    2010-01-01

    ... ANALYSIS, DEPARTMENT OF COMMERCE DIRECT INVESTMENT SURVEYS § 806.1 Purpose. The purpose of this part is to... concerning direct investment as required by, or provided for in, the International Investment Survey Act of... investment, including direct investment, and to do so with a minimum of burden on respondents and with no...

  17. 26 CFR 1.806-4 - Change of basis in computing reserves.

    Science.gov (United States)

    2010-04-01

    .... For the taxable year 1959, S elects to revalue such reserves on a net level premium basis under... 26 Internal Revenue 8 2010-04-01 2010-04-01 false Change of basis in computing reserves. 1.806-4... TAX (CONTINUED) INCOME TAXES Investment Income § 1.806-4 Change of basis in computing reserves. (a) In...

  18. 15 CFR 806.7 - General definitions.

    Science.gov (United States)

    2010-01-01

    ... securities, or short- and long-term debt obligations of a foreign person; (j) Direct investment means the... OF ECONOMIC ANALYSIS, DEPARTMENT OF COMMERCE DIRECT INVESTMENT SURVEYS § 806.7 General definitions... enterprise; (k) Portfolio investment means any international investment which is not direct investment; (l...

  19. 15 CFR 806.3 - Reporting requirements.

    Science.gov (United States)

    2010-01-01

    ... be required from among others, U.S. persons which have direct investment abroad, U.S. persons in which foreign persons have direct investment, U.S. intermediaries, and U.S. persons which assist or... OF ECONOMIC ANALYSIS, DEPARTMENT OF COMMERCE DIRECT INVESTMENT SURVEYS § 806.3 Reporting requirements...

  20. 32 CFR 806b.19 - Information compiled in anticipation of civil action.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 6 2010-07-01 2010-07-01 false Information compiled in anticipation of civil action. 806b.19 Section 806b.19 National Defense Department of Defense (Continued) DEPARTMENT OF THE AIR... compiled in anticipation of civil action. Withhold records compiled in connection with a civil action or...

  1. 24 CFR 3280.806 - Receptacle outlets.

    Science.gov (United States)

    2010-04-01

    ... URBAN DEVELOPMENT MANUFACTURED HOME CONSTRUCTION AND SAFETY STANDARDS Electrical Systems § 3280.806... Article 406.3 of the National Electrical Code, NFPA No. 70-2005. (3) Except when supplying specific... compartments accessible from the outdoors, in bathrooms, and within 6 feet of a kitchen sink to serve counter...

  2. 26 CFR 601.806 - Solicitation of applications.

    Science.gov (United States)

    2010-04-01

    ... Internal Revenue Service Tax Counseling for the Elderly program should request an application from the: Program Manager, Tax Counseling for the Elderly, Taxpayer Service Division TX:T:I, Internal Revenue... 601.806 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY (CONTINUED) INTERNAL...

  3. 15 CFR 806.18 - OMB control numbers assigned to the Paperwork Reduction Act.

    Science.gov (United States)

    2010-01-01

    ... 15 Commerce and Foreign Trade 3 2010-01-01 2010-01-01 false OMB control numbers assigned to the Paperwork Reduction Act. 806.18 Section 806.18 Commerce and Foreign Trade Regulations Relating to Commerce and Foreign Trade (Continued) BUREAU OF ECONOMIC ANALYSIS, DEPARTMENT OF COMMERCE DIRECT INVESTMENT...

  4. 20 CFR 655.806 - Who may file a complaint and how is it processed?

    Science.gov (United States)

    2010-04-01

    ... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false Who may file a complaint and how is it processed? 655.806 Section 655.806 Employees' Benefits EMPLOYMENT AND TRAINING ADMINISTRATION, DEPARTMENT OF... local telephone directories, and on the Department's informational site on the Internet at http://www...

  5. 30 CFR 77.806 - Connection of single-phase loads.

    Science.gov (United States)

    2010-07-01

    ... COAL MINES Surface High-Voltage Distribution § 77.806 Connection of single-phase loads. Single-phase loads, such as transformer primaries, shall be connected phase to phase in resistance grounded systems. ...

  6. 15 CFR 806.16 - Rules and regulations for BE-10, Benchmark Survey of U.S. Direct Investment Abroad-2004.

    Science.gov (United States)

    2010-01-01

    ..., Benchmark Survey of U.S. Direct Investment Abroad-2004. 806.16 Section 806.16 Commerce and Foreign Trade... COMMERCE DIRECT INVESTMENT SURVEYS § 806.16 Rules and regulations for BE-10, Benchmark Survey of U.S. Direct Investment Abroad—2004. A BE-10, Benchmark Survey of U.S. Direct Investment Abroad will be...

  7. 32 CFR 806b.54 - Information collections, records, and forms or information management tools (IMT).

    Science.gov (United States)

    2010-07-01

    ... information management tools (IMT). 806b.54 Section 806b.54 National Defense Department of Defense (Continued..., records, and forms or information management tools (IMT). (a) Information Collections. No information.../pubfiles/af/37/afman37-139/afman37-139.pdf. (c) Forms or Information Management Tools (Adopted and...

  8. 15 CFR 806.11 - Estates, trusts, and intermediaries.

    Science.gov (United States)

    2010-01-01

    ... affiliate. (3) If a particular foreign direct investment in the United States is held, exercised... (Continued) BUREAU OF ECONOMIC ANALYSIS, DEPARTMENT OF COMMERCE DIRECT INVESTMENT SURVEYS § 806.11 Estates... direct investment, and the estate, not the beneficiary, is considered to be the owner. (b) A trust...

  9. 32 CFR 806.6 - Prompt action on requests.

    Science.gov (United States)

    2010-07-01

    ... source, records were part of the Air Force's decision-making process or are privileged. (d) Expedited... FREEDOM OF INFORMATION ACT PROGRAM § 806.6 Prompt action on requests. (a) Examples of letters to FOIA... processing. (1) Examples of letters to FOIA requesters (e.g., letters to individuals who have had their FOIA...

  10. Robust DEA under discrete uncertain data: a case study of Iranian electricity distribution companies

    Science.gov (United States)

    Hafezalkotob, Ashkan; Haji-Sami, Elham; Omrani, Hashem

    2015-06-01

    Crisp input and output data are fundamentally indispensable in traditional data envelopment analysis (DEA). However, the real-world problems often deal with imprecise or ambiguous data. In this paper, we propose a novel robust data envelopment model (RDEA) to investigate the efficiencies of decision-making units (DMU) when there are discrete uncertain input and output data. The method is based upon the discrete robust optimization approaches proposed by Mulvey et al. (1995) that utilizes probable scenarios to capture the effect of ambiguous data in the case study. Our primary concern in this research is evaluating electricity distribution companies under uncertainty about input/output data. To illustrate the ability of proposed model, a numerical example of 38 Iranian electricity distribution companies is investigated. There are a large amount ambiguous data about these companies. Some electricity distribution companies may not report clear and real statistics to the government. Thus, it is needed to utilize a prominent approach to deal with this uncertainty. The results reveal that the RDEA model is suitable and reliable for target setting based on decision makers (DM's) preferences when there are uncertain input/output data.

  11. 31 CFR 501.806 - Procedures for unblocking funds believed to have been blocked due to mistaken identity.

    Science.gov (United States)

    2010-07-01

    ... believed to have been blocked due to mistaken identity. 501.806 Section 501.806 Money and Finance: Treasury... funds believed to have been blocked due to mistaken identity. When a transaction results in the blocking... party to the transaction believes the funds have been blocked due to mistaken identity, that party may...

  12. 48 CFR 19.806 - Pricing the 8(a) contract.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Pricing the 8(a) contract...) Program) 19.806 Pricing the 8(a) contract. (a) The contracting officer shall price the 8(a) contract in accordance with subpart 15.4. If required by subpart 15.4, the SBA shall obtain certified cost or pricing...

  13. 26 CFR 1.806-1 - Adjustment for certain reserves.

    Science.gov (United States)

    2010-04-01

    ... unearned premiums, however, are less than 25 percent of the net premiums written during the taxable year on such other contracts, then the adjustment shall be 3 1/4 percent of 25 percent of the net premiums... 26 Internal Revenue 8 2010-04-01 2010-04-01 false Adjustment for certain reserves. 1.806-1 Section...

  14. 40 CFR 90.806 - Responsibility under other legal provisions preserved.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 20 2010-07-01 2010-07-01 false Responsibility under other legal... § 90.806 Responsibility under other legal provisions preserved. The filing of any report under the provisions of this subpart does not affect a manufacturer's responsibility to file reports or applications...

  15. 20 CFR 10.806 - How are the maximum fees defined?

    Science.gov (United States)

    2010-04-01

    ... AMENDED Information for Medical Providers Medical Fee Schedule § 10.806 How are the maximum fees defined? For professional medical services, the Director shall maintain a schedule of maximum allowable fees.../Current Procedural Terminology (HCPCS/CPT) code which represents the relative skill, effort, risk and time...

  16. 32 CFR 806b.12 - Requesting the Social Security Number.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 6 2010-07-01 2010-07-01 false Requesting the Social Security Number. 806b.12... Number. When asking an individual for his or her Social Security Number, always give a Privacy Act... Social Security Number; and whether providing the Social Security Number is voluntary or mandatory. Do...

  17. 29 CFR 780.806 - Exempt ginning limited to first processing.

    Science.gov (United States)

    2010-07-01

    ... cottonseed, is not exempt under section 13(b)(15). It is not first processing of the seed cotton; rather, it... 29 Labor 3 2010-07-01 2010-07-01 false Exempt ginning limited to first processing. 780.806 Section... AGRICULTURE, PROCESSING OF AGRICULTURAL COMMODITIES, AND RELATED SUBJECTS UNDER THE FAIR LABOR STANDARDS ACT...

  18. Synthesis and evaluation of [11C]Cimbi-806 as a potential PET ligand for 5-HT7 receptor imaging

    DEFF Research Database (Denmark)

    Herth, Matthias Manfred; Hansen, Hanne Demant; Ettrup, Anders Janusz

    2012-01-01

    )-N,N-dimethylethanamine ([(11)C]Cimbi-806) as a radioligand for imaging brain 5-HT(7) receptors with positron emission tomography (PET). Precursor and reference compound was synthesized and subsequent (11)C-labelling with [(11)C]methyltriflate produced [(11)C]Cimbi-806 in specific activities ranging from 50 to 300 GBq...... of appropriate in vivo blocking with a 5-HT(7) receptor selective compounds renders the conclusion that [(11)C]Cimbi-806 is not an appropriate PET radioligand for imaging the 5-HT(7) receptor in vivo....

  19. 15 CFR 806.15 - Foreign direct investment in the United States.

    Science.gov (United States)

    2010-01-01

    ... 15 Commerce and Foreign Trade 3 2010-01-01 2010-01-01 false Foreign direct investment in the... Foreign Trade (Continued) BUREAU OF ECONOMIC ANALYSIS, DEPARTMENT OF COMMERCE DIRECT INVESTMENT SURVEYS § 806.15 Foreign direct investment in the United States. (a) Specific definitions—(1) Foreign direct...

  20. 32 CFR 806.29 - Administrative processing of Air Force FOIA requests.

    Science.gov (United States)

    2010-07-01

    ... FORCE ADMINISTRATION AIR FORCE FREEDOM OF INFORMATION ACT PROGRAM § 806.29 Administrative processing of... information systems by processing a simple request/providing a response in the electronic format requested.../service/a nongovernment source (Exemption 4), records are part of the Air Force's decision-making process...

  1. 32 CFR 806.27 - Samples of Air Force FOIA processing documents.

    Science.gov (United States)

    2010-07-01

    ... ADMINISTRATION AIR FORCE FREEDOM OF INFORMATION ACT PROGRAM § 806.27 Samples of Air Force FOIA processing... determination within 20 workdays, we have instituted multitrack processing of requests. Based on the information... source; responsive records were part of the Air Force's decision-making process, and the prerelease...

  2. 15 CFR 806.17 - Rules and regulations for BE-12, 2007 Benchmark Survey of Foreign Direct Investment in the United...

    Science.gov (United States)

    2010-01-01

    ... Benchmark Survey of Foreign Direct Investment in the United States. 806.17 Section 806.17 Commerce and... Survey of Foreign Direct Investment in the United States. A BE-12, Benchmark Survey of Foreign Direct... of the BE-12, 2007 Benchmark Survey of Foreign Direct Investment in the United States, contained in...

  3. 42 CFR 417.806 - Financial records, statistical data, and cost finding.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 3 2010-10-01 2010-10-01 false Financial records, statistical data, and cost... MEDICAL PLANS, AND HEALTH CARE PREPAYMENT PLANS Health Care Prepayment Plans § 417.806 Financial records, statistical data, and cost finding. (a) The principles specified in § 417.568 apply to HCPPs, except those in...

  4. 32 CFR 806b.30 - Evaluating information systems for Privacy Act compliance.

    Science.gov (United States)

    2010-07-01

    ... privacy issues are unchanged. (d) The depth and content of the Privacy Impact Assessment should be... 32 National Defense 6 2010-07-01 2010-07-01 false Evaluating information systems for Privacy Act... FORCE ADMINISTRATION PRIVACY ACT PROGRAM Privacy Impact Assessments § 806b.30 Evaluating information...

  5. 30 CFR 250.806 - Safety and pollution prevention equipment quality assurance requirements.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 2 2010-07-01 2010-07-01 false Safety and pollution prevention equipment... Gas Production Safety Systems § 250.806 Safety and pollution prevention equipment quality assurance... install only certified safety and pollution prevention equipment (SPPE) in wells located on the OCS. SPPE...

  6. Antiretroviral Drug Use in a Cohort of HIV-Uninfected Women in the United States: HIV Prevention Trials Network 064.

    Directory of Open Access Journals (Sweden)

    Iris Chen

    Full Text Available Antiretroviral (ARV drug use was analyzed in HIV-uninfected women in an observational cohort study conducted in 10 urban and periurban communities in the United States with high rates of poverty and HIV infection. Plasma samples collected in 2009-2010 were tested for the presence of 16 ARV drugs. ARV drugs were detected in samples from 39 (2% of 1,806 participants: 27/181 (15% in Baltimore, MD and 12/179 (7% in Bronx, NY. The ARV drugs detected included different combinations of non-nucleoside reverse transcriptase inhibitors and protease inhibitors (1-4 drugs/sample. These data were analyzed in the context of self-reported data on ARV drug use. None of the 39 women who had ARV drugs detected reported ARV drug use at any study visit. Further research is needed to evaluate ARV drug use by HIV-uninfected individuals.

  7. 25 CFR 170.806 - What is an IRR Transportation Facilities Maintenance Management System?

    Science.gov (United States)

    2010-04-01

    ... AND WATER INDIAN RESERVATION ROADS PROGRAM BIA Road Maintenance § 170.806 What is an IRR Transportation Facilities Maintenance Management System? An IRR Transportation Facilities Maintenance Management... 25 Indians 1 2010-04-01 2010-04-01 false What is an IRR Transportation Facilities Maintenance...

  8. 32 CFR 806b.6 - Systems of records operated by a contractor.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 6 2010-07-01 2010-07-01 false Systems of records operated by a contractor... ADMINISTRATION PRIVACY ACT PROGRAM Overview of the Privacy Act Program § 806b.6 Systems of records operated by a contractor. Contractors who are required to operate or maintain a Privacy Act system of records by contract...

  9. Study Drugs

    Science.gov (United States)

    ... to quit, they may have withdrawal symptoms like depression, thoughts of suicide, intense drug cravings, sleep problems, and fatigue. The health risks aren't the only downside to study drugs. Students caught with illegal prescription drugs may get suspended ...

  10. Red laser-diode pumped 806 nm Tm3+: ZBLAN fibre laser

    Science.gov (United States)

    Juárez-Hernández, M.; Mejía, E. B.

    2017-06-01

    A Tm3+-doped fluorozirconate (ZBLAN) fibre laser operating CW at 806 nm when diode-pumped at 687 nm is described for the first time. This device is based on the 3F4  →  3H6 transition, and is suitable for first telecom window and sensing applications. A slope efficiency of 50.3% and low threshold pump-power of 11.6 mW were obtained. Maximum output power of 15 mW for 40 mW coupled pump was achieved.

  11. Technical Review on Fitness-for-Service for Buried Pipe by ASME Code Case N-806

    International Nuclear Information System (INIS)

    Park, Sang Kyu; Lee, Yo Seop; So, Il Su; Lim, Bu Taek

    2012-01-01

    Fitness-for-Service is a useful technology to determine replacement timing, next inspection timing or in-service when nuclear power plant's buried pipes are damaged. If is possible for buried pipes to be aged by material loss, cracks and occlusion as operating time goes by. Therefore Fitness-for-Service technology for buried pipe is useful for plant industry to perform replacement and repair. Fitness-for-Service for buried pipe is studied in terms of existing code and standard for Fitness-for-Service and a current developing code case. Fitness-for-Service for buried pipe was performed according to Code Case N-806 developed by ASME (American Society of Mechanical Engineers)

  12. Drug prescribing during pregnancy in a central region of Italy, 2008-2012.

    Science.gov (United States)

    Ventura, Martina; Maraschini, Alice; D'Aloja, Paola; Kirchmayer, Ursula; Lega, Ilaria; Davoli, Marina; Donati, Serena

    2018-05-15

    Drug consumption during pregnancy is a matter of concern, especially regarding drugs known or suspected to be teratogens. Little is known about drug use in pregnant women in Italy. The present study is aimed at examining the prevalence, and to detect potential inappropriateness of drug prescribing among pregnant women in Latium, a region of central Italy. This retrospective study was conducted on a cohort of women aged 18-45 years who delivered between 2008 and 2012 in public hospitals. Women were enrolled through the Regional Birth Register. After linking the regional Health Information Systems and the Regional Drug Claims Register, women's clinical data and prescribed medications were analyzed. Italian Medicine Agency (AIFA) and US Food and Drug Administration (FDA) evidence were used to investigate inappropriate prescribing and teratogenic risk. Excluding vitamins and minerals, 80.6% (n = 153,079) of the women were prescribed at least one drug during pregnancy, with an average of 4.6 medications per pregnancy. Drugs for blood and hematopoietic organs were the most commonly prescribed (53.0%,), followed by anti-infectives for systemic use (50.7%). Among the inappropriate prescriptions, progestogen supplementation was given in 20.1% of pregnancies; teratogen drugs were prescribed in 0.8%, mostly angiotensin co-enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) (0.3%). In Latium, drugs are widely used in pregnancy. Prescriptions of inappropriate drugs are observed in more than a fifth of pregnancies, and teratogens are still used, despite their known risk. Continuous updates of information provided to practitioners and an increased availability of information to women might reduce inappropriate prescribing.

  13. ACUTE NARCOTIC DRUG INTOXICATIONS: ETIOLOGY, SEX/AGE DISTRIBUTION AND CLINICAL OUTCOME

    Directory of Open Access Journals (Sweden)

    Petko Marinov

    2017-01-01

    Full Text Available Purpose: Poisoning with drugs is a serious medical and social problem worldwide. Retrospective analysis of acute poisoning with narcotic drugs had been performed in Varna region for 25 years (1991-2015. Material and Methods: The number of patients received hospital treatment after poisonings with narcotic substances was 677, which represented 3.9% of all acute exogenous intoxications. Results: Narcotic poisonings were more common in men – 546 (80.6%, than in women – 131 (19.4 %. The ratio male/ female was 4.17:1. The largest number of intoxications were in the age group up to 24 years – 1123 (66%, and only 2.65% of patients were over 45 years. Death was registered in 6 (0.9% patients.

  14. 47 CFR 90.615 - Individual channels available in the General Category in 806-824/851-869 MHz band.

    Science.gov (United States)

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Individual channels available in the General Category in 806-824/851-869 MHz band. 90.615 Section 90.615 Telecommunication FEDERAL COMMUNICATIONS... Critical Infrastructure Industry Categories from three to five years after the release of a public notice...

  15. Study Drugs

    OpenAIRE

    Lam, Stephanie Phuong; Roosta, Natalie; Nielsen, Mikkel Fuhr; Meyer, Maria Holmgaard; Friis, Katrine Birk

    2016-01-01

    In recent years, students around the world, started to use preparations as Ritalin and Modafinil,also known as study drugs, to improve their cognitive abilities1. It is a common use among thestudents in United States of America, but it is a new tendency in Denmark. Our main focus is tolocate whether study drugs needs to be legalized in Denmark or not. To investigate this ourstarting point is to understand central ethical arguments in the debate. We have chosen twoarguments from Nick Bostrom a...

  16. Utilization of Body Contouring Procedures Following Weight Loss Surgery: A Study of 37,806 Patients.

    Science.gov (United States)

    Altieri, Maria S; Yang, Jie; Park, Jihye; Novikov, David; Kang, Lijuan; Spaniolas, Konstantinos; Bates, Andrew; Talamini, Mark; Pryor, Aurora

    2017-11-01

    Bariatric surgery has substantial health benefits; however, some patients desire body contouring (BC) procedures following rapid weight loss. There is a paucity of data regarding the true rate of BC following bariatric procedures. The purpose of our study is to examine the utilization of two common procedures, abdominoplasty, and panniculectomy, following bariatric surgery in New York State. The SPARCS longitudinal administrative database was used to identify bariatric procedures by using ICD-9 and CPT codes between 2004 and 2010. Procedures included sleeve gastrectomy, Roux-en-Y gastric bypass, and laparoscopic adjustable gastric banding. Using a unique patient identifier, we tracked those patients who subsequently underwent either abdominoplasty or panniculectomy with at least a 4-year follow-up (until 2014). Multivariable Cox proportional hazard model was used to evaluate predictors of follow-up BC surgery. 37,806 patients underwent bariatric surgery between 2004 and 2010. Only 5.58% (n = 2112) of these patients subsequently had a BC procedure, with 143 of them (6.8%) having ≥1 plastic surgery. The average time to plastic surgery after band, bypass, or sleeve was 1134.83 ± 671.09, 984.70 ± 570.53, and 903.02 ± 497.31 days, respectively (P 80%ile in yearly income were more likely to have plastic surgery after adjusting for age, race/ethnicity, comorbidities and complications (P values plastic surgery is completed by only 6% of patients following bariatric procedures. As insurance and income are associated with pursuing surgery, improved access may increase the number of patients who are able to undergo these reconstructive procedures.

  17. Drug-Drug/Drug-Excipient Compatibility Studies on Curcumin using Non-Thermal Methods

    Directory of Open Access Journals (Sweden)

    Moorthi Chidambaram

    2014-05-01

    Full Text Available Purpose: Curcumin is a hydrophobic polyphenol isolated from dried rhizome of turmeric. Clinical usefulness of curcumin in the treatment of cancer is limited due to poor aqueous solubility, hydrolytic degradation, metabolism, and poor oral bioavailability. To overcome these limitations, we proposed to fabricate curcumin-piperine, curcumin-quercetin and curcumin-silibinin loaded polymeric nanoformulation. However, unfavourable combinations of drug-drug and drug-excipient may result in interaction and rises the safety concern. Hence, the present study was aimed to assess the interaction of curcumin with excipients used in nanoformulations. Methods: Isothermal stress testing method was used to assess the compatibility of drug-drug/drug-excipient. Results: The combination of curcumin-piperine, curcumin-quercetin, curcumin-silibinin and the combination of other excipients with curcumin, piperine, quercetin and silibinin have not shown any significant physical and chemical instability. Conclusion: The study concludes that the curcumin, piperine, quercetin and silibinin is compatible with each other and with other excipients.

  18. Risk factors for violent crime in Schizophrenia: a national cohort study of 13,806 patients.

    Science.gov (United States)

    Fazel, Seena; Grann, Martin; Carlström, Eva; Lichtenstein, Paul; Långström, Niklas

    2009-03-01

    To determine risk factors for and prevalence of violent crime in patients with schizophrenia, and in particular, to explore the contribution of familial risk factors. We designed a cohort study that followed up patients with 2 or more hospitalizations for schizophrenia (ICD-8, ICD-9, and ICD-10 criteria) and investigated the risk for a violent conviction using Cox proportional hazards models. All 13,806 patients with 2 hospital discharge diagnoses of schizophrenia from January 1, 1973, through December 31, 2004, in Sweden were followed until violent conviction, emigration, death, or end of follow-up (December 31, 2004), and associations with sociodemographic, individual (substance abuse comorbidity, and previous violence), and familial (parental violent crime and parental alcohol abuse) factors were examined. Over an average follow-up period of 12 years, 17.1% (N = 1519) of the men and 5.6% (N = 273) of the women with 2 or more hospitalizations for schizophrenia had a violent conviction after discharge from hospital. Familial risk factors had moderate effects, increasing the risk for violent convictions by 50% to 150%. After adjustment for sociodemographic and individual risk factors, the associations between parental violent crime and risk of violent convictions remained in men (adjusted hazard ratio [HR] = 1.65, 95% CI = 1.33 to 2.04) and in women (adjusted HR = 1.83, 95% CI = 1.11 to 3.01), whereas parental alcohol abuse was no longer significantly associated with violent crime. Parental violent crime had moderate associations with violent crime in male and female offspring with at least 2 hospitalizations for schizophrenia, which were mostly stronger than the better documented sociodemographic risk factors. This suggests that familial (genetic or early environmental) risk factors have an important role in the etiology of violent offending among individuals with schizophrenia and should be considered in violence risk assessment. ©Copyright 2009 Physicians

  19. 47 CFR 90.677 - Reconfiguration of the 806-824/851-869 MHz band in order to separate cellular systems from non...

    Science.gov (United States)

    2010-10-01

    ... in order to separate cellular systems from non-cellular systems. 90.677 Section 90.677... of the 806-824/851-869 MHz band in order to separate cellular systems from non-cellular systems. In...-density cellular systems from non-cellular systems, Nextel Communications, Inc. (Nextel) may relocate...

  20. A Partnership Training Program: Studying Targeted Drug Delivery Using Nanoparticles In Breast Cancer Diagnosis and Therapy

    Science.gov (United States)

    2015-12-01

    Imaging 28: 698–707. 15. Newman RJ, Bore PJ, Chan L, Gadian DG, Styles P, et al. (1982) Nuclear magnetic resonance studies of forearm muscle in Duchenne...against the parental U87 cells. In morphology, cell death was obvious after exposure to DT390-BiscFv806. We further analyzed the cytotoxicity of DT390...funded) 4. NIH Exploratory/Developmental Research Grant Program ( Parent R21) Sheddable Bivalent Fold-back Format Immunotoxin for Prostate Cancer Therapy

  1. Data mining of routine laboratory tests can predict liver disease progression in Egyptian diabetic patients with hepatitis C virus (G4) infection: a cohort study of 71 806 patients.

    Science.gov (United States)

    Saad, Yasmin; Awad, Abobakr; Alakel, Wafaa; Doss, Wahid; Awad, Tahany; Mabrouk, Mahasen

    2018-02-01

    Hepatitis C virus (HCV) and diabetes mellitus (DM) are prevalent diseases worldwide, associated with significant morbidity, mortality, and mutual association. The aims of this study were as follows: (i) find the prevalence of DM among 71 806 Egyptian patients with chronic HCV infection and its effect on liver disease progression and (ii) using data mining of routine tests to predict hepatic fibrosis in diabetic patients with HCV infection. A retrospective multicentered study included laboratory and histopathological data of 71 806 patients with HCV infection collected by Egyptian National Committee for control of viral hepatitis. Using data mining analysis, we constructed decision tree algorithm to assess predictors of fibrosis progression in diabetic patients with HCV. Overall, 12 018 (16.8%) patients were diagnosed as having diabetes [6428: fasting blood glucose ≥126 mg/dl (9%) and 5590: fasting blood glucose ≥110-126 mg/dl (7.8%)]. DM was significantly associated with advanced age, high BMI and α-fetoprotein (AFP), and low platelets and serum albumin (P≤0.001). Advanced liver fibrosis (F3-F4) was significantly correlated with DM (P≤0.001) irrespective of age. Of 16 attributes, decision tree model for fibrosis showed AFP was most decisive with cutoff of 5.25 ng/ml as starting point of fibrosis. AFP level greater than cutoff in patients was the first important splitting attribute; age and platelet count were second important splitting attributes. (i) Chronic HCV is significantly associated with DM (16.8%). (ii) Advanced age, high BMI and AFP, low platelets count and albumin show significant association with DM in HCV. (iii) AFP cutoff of 5.25 is a starting point of fibrosis development and integrated into mathematical model to predict development of liver fibrosis in diabetics with HCV (G4) infection.

  2. Pattern and Determinants of Antiretroviral Drug Adherence among Nigerian Pregnant Women

    Directory of Open Access Journals (Sweden)

    S. O. Ekama

    2012-01-01

    Full Text Available Background. The need for a high level of adherence to antiretroviral drugs has remained a major hurdle to achieving maximal benefit from its use in pregnancy. This study was designed to determine the level of adherence and identify factors that influence adherence during pregnancy. Method. This is a cross-sectional study utilizing a semistructured questionnaire. Bivariate and multiple logistic regression models were used to determine factors independently associated with good drug adherence during pregnancy. Result. 137 (80.6% of the interviewed 170 women achieved adherence level of ≥95% using 3 day recall. The desire to protect the unborn child was the greatest motivation (51.8% for good adherence. Fear of being identified as HIV positive (63.6% was the most common reason for nonadherence. Marital status, disclosure of HIV status, good knowledge of ART, and having a treatment supporter were found to be significantly associated with good adherence at bivariate analysis. However, after controlling for confounders, only HIV status disclosure and having a treatment partner retained their association with good adherence. Conclusion. Disclosure of HIV status and having treatment support are associated with good adherence. Maternal desire to protect the child was the greatest motivator for adherence.

  3. Comparative analysis of three drug-drug interaction screening systems against probable clinically relevant drug-drug interactions: a prospective cohort study.

    Science.gov (United States)

    Muhič, Neža; Mrhar, Ales; Brvar, Miran

    2017-07-01

    Drug-drug interaction (DDI) screening systems report potential DDIs. This study aimed to find the prevalence of probable DDI-related adverse drug reactions (ADRs) and compare the clinical usefulness of different DDI screening systems to prevent or warn against these ADRs. A prospective cohort study was conducted in patients urgently admitted to medical departments. Potential DDIs were checked using Complete Drug Interaction®, Lexicomp® Online™, and Drug Interaction Checker®. The study team identified the patients with probable clinically relevant DDI-related ADRs on admission, the causality of which was assessed using the Drug Interaction Probability Scale (DIPS). Sensitivity, specificity, and positive and negative predictive values of screening systems to prevent or warn against probable DDI-related ADRs were evaluated. Overall, 50 probable clinically relevant DDI-related ADRs were found in 37 out of 795 included patients taking at least two drugs, most common of them were bleeding, hyperkalemia, digitalis toxicity, and hypotension. Complete Drug Interaction showed the best sensitivity (0.76) for actual DDI-related ADRs, followed by Lexicomp Online (0.50), and Drug Interaction Checker (0.40). Complete Drug Interaction and Drug Interaction Checker had positive predictive values of 0.07; Lexicomp Online had 0.04. We found no difference in specificity and negative predictive values among these systems. DDI screening systems differ significantly in their ability to detect probable clinically relevant DDI-related ADRs in terms of sensitivity and positive predictive value.

  4. The importance of drug metabolites synthesis: the case-study of cardiotoxic anticancer drugs.

    Science.gov (United States)

    Hrynchak, Ivanna; Sousa, Emília; Pinto, Madalena; Costa, Vera Marisa

    2017-05-01

    Anticancer drugs are presently guarantying more survivors as a result of more powerful drugs or combinations of drugs used in therapy. Thus, it has become more crucial to study and overcome the side effects of these therapies. Cardiotoxicity is one of the most relevant side effects on the long-term cancer survivors, because of its high social and economic impact. Drug metabolism can result in active metabolites or toxic metabolites that can lead to important side effects. The metabolites of anticancer drugs are possible culprits of cardiotoxicity; however, the cardiotoxicity of many of the metabolites in several drug classes was not yet suitably studied so far. On the other hand, the use of prodrugs that are bioactivated through metabolism can be a good alternative to obtain more cardio safe drugs. In this review, the methods to obtain and study metabolites are summarized and their application to the study of a group of anticancer drugs with acknowledged cardiotoxicity is highlighted. In this group of drugs, doxorubicin (DOX, 1), mitoxantrone (MTX, 2), cyclophosphamide (CTX, 3) and 5-fluorouracil (5-FU, 4) are included, as well as the tyrosine kinase inhibitors, such as imatinib (5), sunitinib (6) and sorafenib (7). Only with the synthesis and purification of considerable amounts of the metabolites can reliable studies be performed, either in vitro or in vivo that allow accurate conclusions regarding the cardiotoxicity of anticancer drug metabolites and then pharmacological prevention or treatment of the cardiac side effects can be done.

  5. Observational study of drug-drug interactions in oncological inpatients

    Directory of Open Access Journals (Sweden)

    María Sacramento Díaz-Carrasco

    2018-01-01

    Full Text Available Objective: To determine the prevalence of potential clinically relevant drug- drug interactions in adult oncological inpatients, as well as to describe the most frequent interactions. A standard database was used. Method: An observational, transversal, and descriptive study including patients admitted to the Oncology Service of a reference hospital. All prescriptions were collected twice a week during a month. They were analysed using Lexicomp® database, recording all interactions classified with a level of risk: C, D or X. Results: A total of 1 850 drug-drug interactions were detected in 218 treatments. The prevalence of treatments with at least one clinically relevant interaction was 95%, being 94.5% for those at level C and 26.1% for levels D and X. The drugs most commonly involved in the interactions detected were opioid analgesics, antipsychotics (butyrophenones, benzodiazepines, pyrazolones, glucocorticoids and heparins, whereas interactions with antineoplastics were minimal, highlighting those related to paclitaxel and between metamizole and various antineoplastics. Conclusions: The prevalence of clinically relevant drug-drug interactions rate was very high, highlighting the high risk percentage of them related to level of risk X. Due to the frequency of onset and potential severity, highlighted the concomitant use of central nervous system depressants drugs with risk of respiratory depression, the risk of onset of anticholinergic symptoms when combining morphine or haloperidol with butylscopolamine, ipratropium bromide or dexchlorpheniramine and the multiple interactions involving metamizole.

  6. Knowledge of AIDS and HIV transmission among drug users in Rio de Janeiro, Brazil

    Directory of Open Access Journals (Sweden)

    Clair Scott

    2011-02-01

    Full Text Available Abstract Background Proper knowledge of HIV transmission is not enough for people to adopt protective behaviors, but deficits in this information may increase HIV/AIDS vulnerability. Objective To assess drug users' knowledge of HIV/AIDS and the possible association between knowledge and HIV testing. Methods A Cross-sectional study conducted in 2006/7 with a convenience sample of 295 illicit drug users in Rio de Janeiro, assessing knowledge on AIDS/HIV transmission and its relationship with HIV testing. Information from 108 randomly selected drug users who received an educational intervention using cards illustrating situations potentially associated with HIV transmission were assessed using Multidimensional Scaling (MDS. Results Almost 40% of drug users reported having never used condoms and more than 60% reported not using condoms under the influence of substances. Most drug users (80.6% correctly answered that condoms make sex safer, but incorrect beliefs are still common (e.g. nearly 44% believed HIV can be transmitted through saliva and 55% reported that HIV infection can be transmitted by sharing toothbrushes, with significant differences between drug users who had and who had not been tested for HIV. MDS showed queries on vaginal/anal sex and sharing syringes/needles were classified in the same set as effective modes of HIV transmission. The event that was further away from this core of properly perceived risks referred to blood donation, perceived as risky. Other items were found to be dispersed, suggesting inchoate beliefs on transmission modes. Conclusions Drug users have an increased HIV infection vulnerability compared to the general population, this specific population expressed relevant doubts about HIV transmission, as well as high levels of risky behavior. Moreover, the findings suggest that possessing inaccurate HIV/AIDS knowledge may be a barrier to timely HIV testing. Interventions should be tailored to such specific

  7. Use of anonymous Web communities and websites by medical consumers in Japan to research drug information.

    Science.gov (United States)

    Kishimoto, Keiko; Fukushima, Noriko

    2011-01-01

    In this study, we investigated the status of researching drug information online, and the type of Internet user who uses anonymous Web communities and websites. A Web-based cross-sectional survey of 10875 male and female Internet users aged 16 and over was conducted in March 2010. Of 10282 analyzed respondents, excluding medical professionals, about 47% reported that they had previously searched the Internet for drug information and had used online resources ranging from drug information search engines and pharmaceutical industry websites to social networking sites and Twitter. Respondents who had researched drug information online (n=4861) were analyzed by two multivariable logistic regressions. In Model 1, the use of anonymous websites associated with age (OR, 0.778; 95% CI, 0.742-0.816), referring to the reputation and the narrative of other Internet users on shopping (OR, 1.640; 95% CI, 1.450-1.855), taking a prescription drug (OR, 0.806; 95% CI, 0.705-0.922), and frequent consulting with non-professionals about medical care and health (OR, 1.613; 95% CI, 1.396-1.865). In Model 2, use of only anonymous websites was associated with age (OR, 0.753; 95% CI, 0.705-0.805), using the Internet daily (OR, 0.611; 95% CI, 0.462-0.808), taking a prescription drug (OR, 0.614; 95% CI, 0.505-0.747), and experience a side effect (OR, 0.526; 95% CI, 0.421-0.658). The analysis revealed the profiles of Internet users who researched drug information on social media sites where the information providers are anonymous and do not necessarily have adequate knowledge of medicine and online information literacy.

  8. Computational Studies of Drug Resistance

    DEFF Research Database (Denmark)

    da Silva Martins, João Miguel

    Drug resistance has been an increasing problem in patient treatment and drug development. Starting in the last century and becoming a major worry in the medical and scienti c communities in the early part of the current millennium, major research must be performed to address the issues of viral...... is of the utmost importance in developing better and less resistance-inducing drugs. A drug's in uence can be characterized in many diff erent ways, however, and the approaches I take in this work re ect those same different in uences. This is what I try to achieve in this work, through seemingly unrelated...... approaches that come together in the study of drug's and their in uence on proteins and vice-versa. In part I, I aim to understand through combined theoretical ensemble analysis and free energy calculations the e ects mutations have over the binding anity and function of the M2 proton channel. This research...

  9. Adverse drug reactions monitoring of psychotropic drugs: a tertiary care centre study

    Directory of Open Access Journals (Sweden)

    Hemendra Singh

    2017-06-01

    Full Text Available Background: Many new psychotropic drugs/ agents have been developed and found to be effective in the treatment of psychiatric disorders. However, these drugs also exhibit adverse drug reactions (ADRs which may affect compliance in psychiatric patients. Hence the present study was aimed at monitoring and assessing ADRs caused by psychotropic drugs. Methods: A hospital based prospective observational study was carried out in the psychiatry outpatient department of a tertiary care teaching hospital for the duration of six months. Two hundred and two patients were included in the study and ADRs were documented using a predesigned data collection form. The causality assessment was carried out as per the criteria of both the World Health Organization- Uppsala Monitoring Centre (WHO-UMC and Naranjo scale. Severity and predictability assessment of ADRs were also performed. Results: A total of 106 ADRs were observed during the study period with majority of them occurring in 25-35 years of age group (40.56%. Weight gain (18.86% followed by sedation (16.03% and insomnia (11.32% were found to be the commonest ADRs. Risperidone (19.8% and escitalopram (12.3% were the drugs responsible for majority of the ADRs. Causality assessment showed that most of ADRs were possible and probable. 94.33% of ADRs were found to be mild and 89% of them were predictable. Conclusion: A wide range of ADRs affecting central nervous and metabolic systems were reported with psychotropic drugs. The study findings necessitate the need for an active pharmacovigilance programme for the safe and effective use of psychotropics.

  10. Chimeric mice with humanized liver: Application in drug metabolism and pharmacokinetics studies for drug discovery.

    Science.gov (United States)

    Naritomi, Yoichi; Sanoh, Seigo; Ohta, Shigeru

    2018-02-01

    Predicting human drug metabolism and pharmacokinetics (PK) is key to drug discovery. In particular, it is important to predict human PK, metabolite profiles and drug-drug interactions (DDIs). Various methods have been used for such predictions, including in vitro metabolic studies using human biological samples, such as hepatic microsomes and hepatocytes, and in vivo studies using experimental animals. However, prediction studies using these methods are often inconclusive due to discrepancies between in vitro and in vivo results, and interspecies differences in drug metabolism. Further, the prediction methods have changed from qualitative to quantitative to solve these issues. Chimeric mice with humanized liver have been developed, in which mouse liver cells are mostly replaced with human hepatocytes. Since human drug metabolizing enzymes are expressed in the liver of these mice, they are regarded as suitable models for mimicking the drug metabolism and PK observed in humans; therefore, these mice are useful for predicting human drug metabolism and PK. In this review, we discuss the current state, issues, and future directions of predicting human drug metabolism and PK using chimeric mice with humanized liver in drug discovery. Copyright © 2017 The Japanese Society for the Study of Xenobiotics. Published by Elsevier Ltd. All rights reserved.

  11. Considerations for Pharmacoepidemiological Studies of Drug-Cancer Associations

    DEFF Research Database (Denmark)

    Pottegård, Anton; Friis, Søren; Stürmer, Til

    2018-01-01

    and future perspectives. Aspects of data sources include assessment of complete history of drug use and data on dose and duration of drug use, allowing estimates of cumulative exposure. Outcome data from formal cancer registries are preferable, but cancer data from other sources, for example, patient......In this MiniReview, we provide general considerations for the planning and conduct of pharmacoepidemiological studies of associations between drug use and cancer development. We address data sources, study design, assessment of drug exposure, ascertainment of cancer outcomes, confounder adjustment...... or pathology registries, medical records or claims are also suitable. The two principal designs for observational studies evaluating drug-cancer associations are the cohort and case-control designs. A key challenge in studies of drug-cancer associations is the exposure assessment due to the typically long...

  12. Caracterización de los estudios de utilización de medicamentos publicados en revistas médicas cubanas, 1990-2003 Characterization of the studies of drug use published in Cuban medical journals, 1990-2003

    Directory of Open Access Journals (Sweden)

    Juan Antonio Furones Mourelle

    2006-04-01

    Full Text Available Introducción : El análisis de los estudios de utilización de medicamentos (EUM en un determinado país puede ayudar al conocimiento de la investigación realizada en este campo y detectar deficiencias o aspectos de la investigación no abordados, que permitan planificarlos de manera eficiente. Métodos : Se realizó un estudio descriptivo, transversal y retrospectivo según la fuente de información, con el objetivo de cuantificar y caracterizar los EUM publicados en revistas médicas cubanas desde 1990 hasta el 2003. El universo de estudio lo constituyeron todos los EUM publicados en revistas médicas cubanas de la Editorial Ciencias Médicas. Se describieron las principales variables que caracterizan el comportamiento de los EUM como: especialidad del primer autor, provincia y nivel asistencial donde se realizó el estudio, tipo de EUM, grupo farmacológico y fuente de datos empleada. Se utilizaron como medidas de resumen los números y los porcentajes. Resultados : Se revisaron 785 números de revistas, en las cuales se localizaron solo 31 artículos, y se observó un incremento de su publicación a partir del año 2000. Los médicos (80,6 % fueron los principales investigadores y la atención primaria de salud (67,7 % el nivel asistencial más utilizado. Las encuestas (58,1 % constituyeron la fuente de información más empleada. La mayoría de los estudios fueron de prescripción-indicación (48,4 % y el grupo farmacológico antiinfeccioso (29 % el más estudiado. Conclusiones : Resulta insuficiente la publicación de EUM en revistas médicas cubanas, lo que pudiera reflejar una infraproducción de este tipo de investigacionesIntroduction: The analysis of the studies of drug use in a given country may help to know the research carried out in this field and detect deficiencies or untouched research aspects, and allow planning them more efficiently. Methods: a retrospective descriptive and cross-sectional study was conducted to quantify

  13. Microemulsion Drug Delivery Systems for Radiopharmacy Studies

    Directory of Open Access Journals (Sweden)

    Emre Ozgenc

    2016-11-01

    Full Text Available Microemulsions have been used increasingly for last year’s because of ideal properties like favorable drug delivery, ease of preparation and physical stability. They have been improved the solubility and efficacy of the drug and reduce the side effects. Use of radiolabeled microemulsions plays an alternative role in drug delivery systems by investigating the formation, stability and application of microemulsions in radiopharmacy. Gama scintigraphic method is well recognized for developing and detecting the biodistribution of newly developed drugs or formulation. This review will focus on how radionuclides are able to play role with characterization studies of microemulsion drug delivery systems.

  14. Ribonucleotide reductase as a drug target against drug resistance Mycobacterium leprae: A molecular docking study.

    Science.gov (United States)

    Mohanty, Partha Sarathi; Bansal, Avi Kumar; Naaz, Farah; Gupta, Umesh Datta; Dwivedi, Vivek Dhar; Yadava, Umesh

    2018-06-01

    Leprosy is a chronic infection of skin and nerve caused by Mycobacterium leprae. The treatment is based on standard multi drug therapy consisting of dapsone, rifampicin and clofazamine. The use of rifampicin alone or with dapsone led to the emergence of rifampicin-resistant Mycobacterium leprae strains. The emergence of drug-resistant leprosy put a hurdle in the leprosy eradication programme. The present study aimed to predict the molecular model of ribonucleotide reductase (RNR), the enzyme responsible for biosynthesis of nucleotides, to screen new drugs for treatment of drug-resistant leprosy. The study was conducted by retrieving RNR of M. leprae from GenBank. A molecular 3D model of M. leprae was predicted using homology modelling and validated. A total of 325 characters were included in the analysis. The predicted 3D model of RNR showed that the ϕ and φ angles of 251 (96.9%) residues were positioned in the most favoured regions. It was also conferred that 18 α-helices, 6 β turns, 2 γ turns and 48 helix-helix interactions contributed to the predicted 3D structure. Virtual screening of Food and Drug Administration approved drug molecules recovered 1829 drugs of which three molecules, viz., lincomycin, novobiocin and telithromycin, were taken for the docking study. It was observed that the selected drug molecules had a strong affinity towards the modelled protein RNR. This was evident from the binding energy of the drug molecules towards the modelled protein RNR (-6.10, -6.25 and -7.10). Three FDA-approved drugs, viz., lincomycin, novobiocin and telithromycin, could be taken for further clinical studies to find their efficacy against drug resistant leprosy. Copyright © 2018 Elsevier B.V. All rights reserved.

  15. Vaccine and Drug Ontology Studies (VDOS 2014).

    Science.gov (United States)

    Tao, Cui; He, Yongqun; Arabandi, Sivaram

    2016-01-01

    The "Vaccine and Drug Ontology Studies" (VDOS) international workshop series focuses on vaccine- and drug-related ontology modeling and applications. Drugs and vaccines have been critical to prevent and treat human and animal diseases. Work in both (drugs and vaccines) areas is closely related - from preclinical research and development to manufacturing, clinical trials, government approval and regulation, and post-licensure usage surveillance and monitoring. Over the last decade, tremendous efforts have been made in the biomedical ontology community to ontologically represent various areas associated with vaccines and drugs - extending existing clinical terminology systems such as SNOMED, RxNorm, NDF-RT, and MedDRA, developing new models such as the Vaccine Ontology (VO) and Ontology of Adverse Events (OAE), vernacular medical terminologies such as the Consumer Health Vocabulary (CHV). The VDOS workshop series provides a platform for discussing innovative solutions as well as the challenges in the development and applications of biomedical ontologies for representing and analyzing drugs and vaccines, their administration, host immune responses, adverse events, and other related topics. The five full-length papers included in this 2014 thematic issue focus on two main themes: (i) General vaccine/drug-related ontology development and exploration, and (ii) Interaction and network-related ontology studies.

  16. Evaluation of the Roche prototype 454 HIV-1 ultradeep sequencing drug resistance assay in a routine diagnostic laboratory.

    Science.gov (United States)

    Garcia-Diaz, A; Guerrero-Ramos, A; McCormick, A L; Macartney, M; Conibear, T; Johnson, M A; Haque, T; Webster, D P

    2013-10-01

    Studies have shown that low-frequency resistance mutations can influence treatment outcome. However, the lack of a standardized high-throughput assay has precluded their detection in clinical settings. To evaluate the performance of the Roche prototype 454 UDS HIV-1 drug resistance assay (UDS assay) in a routine diagnostic laboratory. 50 plasma samples, previously characterized by population sequencing and that had shown ≥1 resistance associated mutation (RAM), were retrospectively tested by the UDS assay, including 18 B and 32 non-B subtypes; viral loads between 114-1,806,407 cp/ml; drug-naive (n=27) and drug-experienced (n=23) individuals. The UDS assay was successful for 37/50 (74%) samples. It detected all RAMs found by population sequencing at frequencies above 20%. In addition, 39 low-frequency RAMs were exclusively detected by the UDS assay at frequencies below 20% in both drug-naïve (19/26, 73%) and drug-experienced (9/18, 50%) individuals. UDS results would lead to changes from susceptible to resistant to efavirenz (EFV) in one drug-naive individual with suboptimal response to an EFV-containing regimen and from susceptible to resistance to lamivudine (3TC) in one drug naïve subject who subsequently failed a 3TC-containing regimen and in a treatment experienced subject who had failed a 3TC-containing regimen. The UDS assay performed well across a wide range of subtypes and viral loads; it showed perfect agreement with population sequencing for all RAMs analyzed. In addition, the UDS assay detected additional mutations at frequencies below 20% which correlate with patients' treatment history and had in some cases important prognostic implications. Copyright © 2013 Elsevier B.V. All rights reserved.

  17. Drug-drug interactions in patients treated for cancer : a prospective study on clinical interventions

    NARCIS (Netherlands)

    van Leeuwen, R. W. F.; Jansman, F. G. A.; van den Bemt, P. M. L. A.; de Man, F.; Piran, F.; Vincenten, I.; Jager, A.; Rijneveld, A. W.; Brugma, J. D.; Mathijssen, R. H. J.; van Gelder, T.

    Background: Drug-drug interactions (DDIs) are of major concern in oncology, since cancer patients typically take many concomitant medications. Retrospective studies have been conducted to determine the prevalence of DDIs. However, prospective studies on DDIs needing interventions in cancer patients

  18. An Oral Contraceptive Drug Interaction Study

    Science.gov (United States)

    Bradstreet, Thomas E.; Panebianco, Deborah L.

    2004-01-01

    This article focuses on a two treatment, two period, two treatment sequence crossover drug interaction study of a new drug and a standard oral contraceptive therapy. Both normal theory and distribution-free statistical analyses are provided along with a notable amount of graphical insight into the dataset. For one of the variables, the decision on…

  19. Does the placebo effect modulate drug bioavailability? Randomized cross-over studies of three drugs.

    Science.gov (United States)

    Hammami, Muhammad M; Yusuf, Ahmed; Shire, Faduma S; Hussein, Rajaa; Al-Swayeh, Reem

    2017-05-23

    Medication effect is the sum of its drug, placebo, and drug*placebo interaction effects. It is conceivable that the interaction effect involves modulating drug bioavailability; it was previously observed that being aware of caffeine ingestion may prolong caffeine plasma half-life. This study was set to evaluate such concept using different drugs. Balanced single-dose, two-period, two-group, cross-over design was used to compare the pharmacokinetics of oral cephalexin, ibuprofen, and paracetamol, each described by its name (overt) or as placebo (covert). Volunteers and study coordinators were deceived as to study aim. Drug concentrations were determined blindly by in-house, high performance liquid chromatography assays. Terminal-elimination half-life (t ½ ) (primary outcome), maximum concentration (C max ), C max first time (T max ), terminal-elimination-rate constant (λ), area-under-the-concentration-time-curve, to last measured concentration (AUC T ), extrapolated to infinity (AUC I ), or to T max of overt drug (AUC Overttmax ), and C max /AUC I were calculated blindly using standard non-compartmental method. Covert-vs-overt effect on drug pharmacokinetics was evaluated by analysis-of-variance (ANOVA, primary analysis), 90% confidence interval (CI) using the 80.00-125.00% bioequivalence range, and percentage of individual pharmacokinetic covert/overt ratios that are outside the +25% range. Fifty, 30, and 50 healthy volunteers (18%, 10%, and 6% females, mean (SD) age 30.8 (6.2), 31.4 (6.6), and 31.2 (5.4) years) participated in 3 studies on cephalexin, ibuprofen, and paracetamol, respectively. Withdrawal rate was 4%, 0%, and 4%, respectively. Eighteen blood samples were obtained over 6, 10, and 14 h in each study period of the three drugs, respectively. ANOVA showed no significant difference in any pharmacokinetic parameter for any of the drugs. The 90% CIs for AUC T , AUC I , C max , AUC Overttmax , and C max /AUC I were within the bioequivalence range, except

  20. Clinically relevant potential drug-drug interactions among outpatients: A nationwide database study.

    Science.gov (United States)

    Jazbar, Janja; Locatelli, Igor; Horvat, Nejc; Kos, Mitja

    2018-06-01

    Adverse drug events due to drug-drug interactions (DDIs) represent a considerable public health burden, also in Slovenia. A better understanding of the most frequently occurring potential DDIs may enable safer pharmacotherapy and minimize drug-related problems. The aim of this study was to evaluate the prevalence and predictors of potential DDIs among outpatients in Slovenia. An analysis of potential DDIs was performed using health claims data on prescription drugs from a nationwide database. The Lexi-Interact Module was used as the reference source of interactions. The influence of patient-specific predictors on the risk of potential clinically relevant DDIs was evaluated using logistic regression model. The study population included 1,179,803 outpatients who received 15,811,979 prescriptions. The total number of potential DDI cases identified was 3,974,994, of which 15.6% were potentially clinically relevant. Altogether, 9.3% (N = 191,213) of the total population in Slovenia is exposed to clinically relevant potential DDIs, and the proportion is higher among women and the elderly. After adjustment for cofactors, higher number of medications and older age are associated with higher odds of clinically relevant potential DDIs. The burden of DDIs is highest with drug combinations that increase risk of bleeding, enhance CNS depression or anticholinergic effects or cause cardiovascular complications. The current study revealed that 1 in 10 individuals in the total Slovenian population is exposed to clinically relevant potential DDIs yearly. Taking into account the literature based conservative estimate that approximately 1% of potential DDIs result in negative health outcomes, roughly 1800 individuals in Slovenia experience an adverse health outcome each year as a result of clinically relevant potential interactions alone. Copyright © 2017 Elsevier Inc. All rights reserved.

  1. Mechanism-based drug exposure classification in pharmacoepidemiological studies

    NARCIS (Netherlands)

    Verdel, B.M.

    2010-01-01

    Mechanism-based classification of drug exposure in pharmacoepidemiological studies In pharmacoepidemiology and pharmacovigilance, the relation between drug exposure and clinical outcomes is crucial. Exposure classification in pharmacoepidemiological studies is traditionally based on

  2. Application of Model Animals in the Study of Drug Toxicology

    Science.gov (United States)

    Song, Yagang; Miao, Mingsan

    2018-01-01

    Drug safety is a key factor in drug research and development, Drug toxicology test is the main method to evaluate the safety of drugs, The body condition of an animal has important implications for the results of the study, Previous toxicological studies of drugs were carried out in normal animals in the past, There is a great deviation from the clinical practice.The purpose of this study is to investigate the necessity of model animals as a substitute for normal animals for toxicological studies, It is expected to provide exact guidance for future drug safety evaluation.

  3. Drug Release from ß-Cyclodextrin Complexes and Drug Transfer into Model Membranes Studied by Affinity Capillary Electrophoresis.

    Science.gov (United States)

    Darwish, Kinda A; Mrestani, Yahya; Rüttinger, Hans-Hermann; Neubert, Reinhard H H

    2016-05-01

    Is to characterize the drug release from the ß-cyclodextrin (ß-CD) cavity and the drug transfer into model membranes by affinity capillary electrophoresis. Phospholipid liposomes with and without cholesterol were used to mimic the natural biological membrane. The interaction of cationic and anionic drugs with ß-CD and the interaction of the drugs with liposomes were detected separately by measuring the drug mobility in ß-CD containing buffer and liposome containing buffer; respectively. Moreover, the kinetics of drug release from ß-CD and its transfer into liposomes with or without cholesterol was studied by investigation of changes in the migration behaviours of the drugs in samples, contained drug, ß-CD and liposome, at 1:1:1 molar ratio at different time intervals; zero time, 30 min, 1, 2, 4, 6, 8, 10 and 24 h. Lipophilic drugs such as propranolol and ibuprofen were chosen for this study, because they form complexes with ß-CD. The mobility of the both drug liposome mixtures changed with time to a final state. For samples of liposomal membranes with cholesterol the final state was faster reached than without cholesterol. The study confirmed that the drug release from the CD cavity and its transfer into the model membrane was more enhanced by the competitive displacement of the drug from the ß-CD cavity by cholesterol, the membrane component. The ACE method here developed can be used to optimize the drug release from CD complexes and the drug transfer into model membranes.

  4. Fabrication of drug eluting implants: study of drug release mechanism from titanium dioxide nanotubes

    International Nuclear Information System (INIS)

    Hamlekhan, Azhang; Shokuhfar, Tolou; Sinha-Ray, Suman; Yarin, Alexander L; Takoudis, Christos; Mathew, Mathew T; Sukotjo, Cortino

    2015-01-01

    Formation of titanium dioxide nanotubes (TNTs) on a titanium surface holds great potential for promoting desirable cellular response. However, prolongation of drug release from these nano-reservoirs remains to be a challenge. In our previous work TNTs were successfully loaded with a drug. In this study the effect of TNTs dimensions on prolongation of drug release is quantified aiming at the introduction of a simple novel technique which overcomes complications of previously introduced methods. Different groups of TNTs with different lengths and diameters are fabricated. Samples are loaded with a model drug and rate of drug release over time is monitored. The relation of the drug release rate to the TNT dimensions (diameter, length, aspect ratio and volume) is established. The results show that an increase in any of these parameters increases the duration of the release process. However, the strongest parameter affecting the drug release is the aspect ratio. In fact, TNTs with higher aspect ratios release drug slower. It is revealed that drug release from TNT is a diffusion-limited process. Assuming that diffusion of drug in (Phosphate-Buffered Saline) PBS follows one-dimensional Fick’s law, the theoretical predictions for drug release profile is compatible with our experimental data for release from a single TNT. (paper)

  5. 2013–2014 National Roadside Study of alcohol and drug use by drivers: drug results.

    Science.gov (United States)

    2017-05-01

    This was a nationally representative study to estimate the prevalence of alcohol and other drug use among drivers. : Drugs studied included 98 over-the-counter, prescription, and illegal substances. Drivers were randomly selected at : 60 sites (300 l...

  6. Drug-Drug/Drug-Excipient Compatibility Studies on Curcumin using Non-Thermal Methods

    OpenAIRE

    Moorthi Chidambaram; Kathiresan Krishnasamy

    2014-01-01

    Purpose: Curcumin is a hydrophobic polyphenol isolated from dried rhizome of turmeric. Clinical usefulness of curcumin in the treatment of cancer is limited due to poor aqueous solubility, hydrolytic degradation, metabolism, and poor oral bioavailability. To overcome these limitations, we proposed to fabricate curcumin-piperine, curcumin-quercetin and curcumin-silibinin loaded polymeric nanoformulation. However, unfavourable combinations of drug-drug and drug-excipient may result in interacti...

  7. Drug research methodology. Volume 5, Experimentation in drugs and highway safety : the study of drug effects on skills related to driving

    Science.gov (United States)

    1980-06-01

    This report presents the findings of a workshop on experimental research in the area of drugs and highway safety. Complementing studies of drug use in different driving populations, experimentation here refers to studies performed under controlled co...

  8. A pilot study of loss aversion for drug and non-drug commodities in cocaine users.

    Science.gov (United States)

    Strickland, Justin C; Beckmann, Joshua S; Rush, Craig R; Stoops, William W

    2017-11-01

    Numerous studies in behavioral economics have demonstrated that individuals are more sensitive to the prospect of a loss than a gain (i.e., loss aversion). Although loss aversion has been well described in "healthy" populations, little research exists in individuals with substance use disorders. This gap is notable considering the prominent role that choice and decision-making play in drug use. The purpose of this pilot study was to evaluate loss aversion in active cocaine users. Current cocaine users (N=38; 42% female) participated in this within-subjects laboratory pilot study. Subjects completed a battery of tasks designed to assess loss aversion for drug and non-drug commodities under varying risk conditions. Standardized loss aversion coefficients (λ) were compared to theoretically and empirically relevant normative values (i.e., λ=2). Compared to normative loss aversion coefficient values, a precise and consistent decrease in loss aversion was observed in cocaine users (sample λ≈1). These values were observed across drug and non-drug commodities as well as under certain and risky conditions. These data represent the first systematic study of loss aversion in cocaine-using populations and provide evidence for equal sensitivity to losses and gains or loss equivalence. Futures studies should evaluate the specificity of these effects to a history of cocaine use as well as the impact of manipulations of loss aversion on drug use to determine how this phenomenon may contribute to intervention development efforts. Copyright © 2017 Elsevier B.V. All rights reserved.

  9. Early discontinuation of attention-deficit/hyperactivity disorder drug treatment: a danish nationwide drug utilization study

    DEFF Research Database (Denmark)

    Pottegård, Anton; Bjerregaard, B. K.; Kortegaard, L. S.

    2015-01-01

    Knowledge of patterns of treatment discontinuation in attention-deficit/hyperactivity disorder (ADHD) drug treatment is of importance, for both the clinical practice and the study of long-term treatment outcomes. The purpose of this study was to describe early discontinuation of ADHD drug treatme...

  10. Predictive typing of drug-induced neurological sufferings from studies of the distribution of labelled drugs

    International Nuclear Information System (INIS)

    Takasu, T.

    1980-01-01

    A drug given to an animal becomes widely distributed throughout the body, acting on the living mechanisms or structures, and is gradually excreted. Some drugs can remain in some parts of the body for a long period. For example, 14 C-chloramphenical was found to remain preferentially in the salivary gland, liver and bone marrow of mice 24 hours after its oral administration. If such a drug is given repeatedly, it could possibly accumulate gradually in these organs. Thus, when its accumulation in a particular part of the body exceeds a certain level, the living mechanism or structure may possibly be injured. The harmful effects of a drug in repeated administration are called its chronic toxicity. The author discusses whether it is possible to predict the toxicity of a drug by studying its distribution in relation to time, and, if possible, the points in time. This problem is studied especially in relation to the nervous system. (Auth.)

  11. A drug utilisation study investigating prescribed daily doses of ...

    African Journals Online (AJOL)

    and drug groups. Design. Retrospective drug utilisation study using data .... drugs that were prescribed 20 or fewer times during the period under ... occurs in women and men at different ages and with different severity. group. On average, men ...

  12. Thermodynamic Studies for Drug Design and Screening

    Science.gov (United States)

    Garbett, Nichola C.; Chaires, Jonathan B.

    2012-01-01

    Introduction A key part of drug design and development is the optimization of molecular interactions between an engineered drug candidate and its binding target. Thermodynamic characterization provides information about the balance of energetic forces driving binding interactions and is essential for understanding and optimizing molecular interactions. Areas covered This review discusses the information that can be obtained from thermodynamic measurements and how this can be applied to the drug development process. Current approaches for the measurement and optimization of thermodynamic parameters are presented, specifically higher throughput and calorimetric methods. Relevant literature for this review was identified in part by bibliographic searches for the period 2004 – 2011 using the Science Citation Index and PUBMED and the keywords listed below. Expert opinion The most effective drug design and development platform comes from an integrated process utilizing all available information from structural, thermodynamic and biological studies. Continuing evolution in our understanding of the energetic basis of molecular interactions and advances in thermodynamic methods for widespread application are essential to realize the goal of thermodynamically-driven drug design. Comprehensive thermodynamic evaluation is vital early in the drug development process to speed drug development towards an optimal energetic interaction profile while retaining good pharmacological properties. Practical thermodynamic approaches, such as enthalpic optimization, thermodynamic optimization plots and the enthalpic efficiency index, have now matured to provide proven utility in design process. Improved throughput in calorimetric methods remains essential for even greater integration of thermodynamics into drug design. PMID:22458502

  13. Thermodynamic studies for drug design and screening.

    Science.gov (United States)

    Garbett, Nichola C; Chaires, Jonathan B

    2012-04-01

    A key part of drug design and development is the optimization of molecular interactions between an engineered drug candidate and its binding target. Thermodynamic characterization provides information about the balance of energetic forces driving binding interactions and is essential for understanding and optimizing molecular interactions. This review discusses the information that can be obtained from thermodynamic measurements and how this can be applied to the drug development process. Current approaches for the measurement and optimization of thermodynamic parameters are presented, specifically higher throughput and calorimetric methods. Relevant literature for this review was identified in part by bibliographic searches for the period 2004 - 2011 using the Science Citation Index and PUBMED and the keywords listed below. The most effective drug design and development platform comes from an integrated process utilizing all available information from structural, thermodynamic and biological studies. Continuing evolution in our understanding of the energetic basis of molecular interactions and advances in thermodynamic methods for widespread application are essential to realize the goal of thermodynamically driven drug design. Comprehensive thermodynamic evaluation is vital early in the drug development process to speed drug development toward an optimal energetic interaction profile while retaining good pharmacological properties. Practical thermodynamic approaches, such as enthalpic optimization, thermodynamic optimization plots and the enthalpic efficiency index, have now matured to provide proven utility in the design process. Improved throughput in calorimetric methods remains essential for even greater integration of thermodynamics into drug design. © 2012 Informa UK, Ltd.

  14. DRUG-UTILIZATION STUDY ON CURACAO

    NARCIS (Netherlands)

    VISSER, LE; OOSTERVELD, MH; DEJONGVANDENBERG, LTW

    1993-01-01

    The drug use on Curacao was evaluated with the help of the prescription forms of twelve community pharmacies at Curacao over a period of three months, The emphasis of the study was on three therapeutic groups: the systemic antibiotics, the psycholeptics and the anti-inflammatory and antirheumatic

  15. SODAS: Surveillance of Drugs of Abuse Study.

    Science.gov (United States)

    Lowe, David J; Torrance, Hazel J; Ireland, Alastair J; Bloeck, Felix; Stevenson, Richard

    2017-04-01

    Novel psychoactive substance (NPS) as a form of recreational drug use has become increasingly popular. There is a paucity of information with regard to the prevalence and clinical sequelae of these drugs. The aim of this study was to detect NPS in patients presenting to the emergency department with suspected toxicological ingestion. The prospective study was performed in a large emergency department in the UK. During a 3-month period 80 patients were identified by clinicians as having potentially ingested a toxicological agent. Urine samples were analysed using liquid chromatography high-resolution mass spectrometry, and basic clinical data was gathered. Eighty patients with a history of illicit or recreational drug consumption had urine screenings performed. Forty-nine per cent (39) of the patients undergoing a screen had more than one illicit substance detected. Twenty per cent (16) of the patients tested positive for at least one NPS. Almost half of the presented patients revealed ingestion of multiple substances, which correlated poorly with self-reporting of patients. Developing enhanced strategies to monitor evolving drug trends is crucial to the ability of clinicians to deliver care to this challenging group of patients.

  16. Chinese herbal therapy and Western drug use, belief and adherence for hypertension management in the rural areas of Heilongjiang province, China.

    Directory of Open Access Journals (Sweden)

    Xia Li

    Full Text Available Traditional Chinese medicine (TCM including Chinese herbal therapy has been widely practiced in China. However, little is known about Chinese herbal therapy use for hypertension management, which is one of the most prevalent chronic conditions in China. Thus we described Chinese herbal therapy and western drug users, beliefs, hypertension knowledge, and Chinese herbal and western drug adherence and determinants of Chinese herbal therapy use among patients with hypertension in rural areas of Heilongjiang Province, China.This face-to-face cross sectional survey included 665 hypertensive respondents aged 30 years or older in rural areas of Heilongjiang Province, China. Of 665 respondents, 39.7% were male, 27.4% were aged 65 years or older. At the survey, 14.0% reported using Chinese herbal therapy and 71.3% reported using western drug for hypertension management. A majority of patients had low level of treatment adherence (80.6% for the Chinese herbal therapy users and 81.2% for the western drug users. When respondents felt that their blood pressure was under control, 72.0% of the Chinese herbal therapy users and 69.2% of the western drug users sometimes stopped taking their medicine. Hypertensive patients with high education level or better quality of life are more likely use Chinese herbal therapy.Majority of patients diagnosed with hypertension use western drugs to control blood pressure. Chinese herbal therapy use was associated with education level and quality of life.

  17. Drug utilization in patients with OA: a population-based study.

    Science.gov (United States)

    Wilson, Nicholas; Sanchez-Riera, Lidia; Morros, Rosa; Diez-Perez, Adolfo; Javaid, M Kassim; Cooper, Cyrus; Arden, Nigel K; Prieto-Alhambra, Daniel

    2015-05-01

    Patients with OA use different drugs in their search for relief. We aimed to study the prevalence of use and combinations of different medications for OA in a population-based cohort of OA patients in Catalonia, Spain, while characterizing users of each of the drugs available, with a particular focus on cardiovascular risk factors. Data were obtained from the Sistema d'Informació per al Desenvolupament de l'Investigació en Atenció Primària (SIDIAP) database, which includes electronic medical records and pharmacy invoice data for >5 million people from Catalonia. Study participants were those with a clinical diagnosis of OA in 2006-10. Drugs studied included oral and topical NSAIDs, analgesics (paracetamol, metamizole), opioids (tramadol, fentanyl), cyclooxygenase 2 (COX-2) inhibitors and symptomatic slow-acting drugs in OA. Drug utilization was described using medication possession ratios (MPRs), equivalent to the proportion of days covered with the drug of interest. The annual incidence of new users in the first year after OA diagnosis from 2006 to 2010 was estimated for all studied drugs among newly diagnosed OA patients using Poisson regression. We identified 238 536 study participants. The most common regimen of treatment consisted of at least three drugs (53.9% of patients). The drugs most frequently used regularly (MPR ≥50%) were chondroitin (21.2%), glucosamine (15.8%) and oral NSAIDs (14.4%). The incidence of the use of opioids, COX-2 inhibitors and chondroitin increased over the 5 year period, whereas all others decreased. Drug combinations are common in the treatment of OA patients, who are thus exposed to potential drug interactions, with unknown impacts on their health. The increasing use of opioids and COX-2 inhibitors is noteworthy because of the potential impact on safety and costs. © The Author 2014. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email

  18. Remote controlled capsules in human drug absorption (HDA) studies.

    Science.gov (United States)

    Wilding, Ian R; Prior, David V

    2003-01-01

    The biopharmaceutical complexity of today's new drug candidates provides significant challenges for pharmaceutical scientists in terms of both candidate selection and optimizing subsequent development strategy. In addition, life cycle management of marketed drugs has become an important income stream for pharmaceutical companies, but the selection of least risk/highest benefit strategies is far from simple. The proactive adoption of human drug absorption (HDA) studies using remote controlled capsules offers the pharmaceutical scientist significant guidance for planning a route through the maze of product development. This review examines the position of HDA studies in drug development, using a variety of case histories and an insightful update on remote controlled capsules to achieve site-specific delivery.

  19. A Study on Drug Safety Monitoring Program in India

    Science.gov (United States)

    Ahmad, A.; Patel, Isha; Sanyal, Sudeepa; Balkrishnan, R.; Mohanta, G. P.

    2014-01-01

    Pharmacovigilance is useful in assuring the safety of medicines and protecting the consumers from their harmful effects. A number of single drugs as well as fixed dose combinations have been banned from manufacturing, marketing and distribution in India. An important issue about the availability of banned drugs over the counter in India is that sufficient adverse drug reactions data about these drugs have not been reported. The most common categories of drugs withdrawn in the last decade were nonsteroidal antiinflammatory drugs (28%), antidiabetics (14.28%), antiobesity (14.28%), antihistamines (14.28%), gastroprokinetic drugs (7.14%), breast cancer and infertility drugs (7.14%), irritable bowel syndrome and constipation drugs (7.14%) and antibiotics (7.14%). Drug withdrawals from market were made mainly due to safety issues involving cardiovascular events (57.14%) and liver damage (14.28%). Majority of drugs have been banned since 3-5 years in other countries but are still available for sale in India. The present study compares the drug safety monitoring systems in the developed countries such as the USA and UK and provides implications for developing a system that can ensure the safety and efficacy of drugs in India. Absence of a gold standard for a drug safety surveillance system, variations in culture and clinical practice across countries makes it difficult for India to completely adopt another country's practices. There should be a multidisciplinary approach towards drug safety that should be implemented throughout the entire duration spanning from drug discovery to usage by consumers. PMID:25425751

  20. Authoritarian parenting and youth depression: Results from a national study.

    Science.gov (United States)

    King, Keith A; Vidourek, Rebecca A; Merianos, Ashley L

    2016-01-01

    Depression is a prevalent illness affecting youth across the nation. The study purpose was to examine depression and authoritarian parenting among youth from 12 to 17 years of age. A secondary data analysis of the National Survey on Drug Use and Health was performed in the present study. All participants in the present study were youth (N = 17,399) nationwide. The results revealed that 80.6% of youth participants reported having five or more depressive symptoms. Parenting styles based on depression significantly differed among males, females, 12-13-year-olds, 14-15-year-olds, and 16-17-year-olds. Specifically, those who reported experiencing authoritarian parenting practices were more likely to report depressive symptoms compared to their counterparts who experienced authoritative parenting practices. Emphasizing the role of the parents and teaching positive parenting practices and authoritative parenting styles may increase success of prevention programs.

  1. Drug utilization study of gynecology OPD: In a tertiary care hospital.

    Directory of Open Access Journals (Sweden)

    Baig MS, Bagle TR,Gadappa SN, Deshpande Sonali, Doifode SM

    2013-04-01

    Full Text Available Background: The treatment of diseases by use of essential medicines, prescribed by generic names, has been emphasized by WHO and National Health Policy of India. Drugs used in gynaecology are one of the top selling drugs in India; however they are least studied with respect to drug utilization. Thus present study was undertaken to analyze drug utilization pattern of gynecology OPD in a tertiary care hospital. Materials and Methods: A retrospective, cross sectional, observational study of prescriptions in Gynecology OPD. Data was obtained from an electronic medical record database of patients that attended Gynecology OPD during the study period. Prescription records of patients were screened as per inclusion and exclusion criteria and 300 prescriptions were randomly selected by Openepi software. Patient related and drug related information was collected on a customized data collection sheet. Results: The mean age of patients was 30.19+9.83 years and common age of presentation was >18-30 years. In infective cases, vaginal discharge (10.33% was common, and in non-infective cases, menstrual disorders (24% were common. The average number of drugs per prescription was 3.47+1.53. In drug category, minerals (30.94% were most commonly prescribed, followed by antimicrobials (24.98%, and NSAIDs (13.37%. Polypharmacy was observed in 96.33% of the prescriptions. Conclusion: It is only by drug utilization studies that burden of diseases and corresponding utilization of drugs in gynecology can be measured. In our study majority of the drugs prescribed were generic which were from the essential medical list NLEM and WHO.

  2. Drug repurposing based on drug-drug interaction.

    Science.gov (United States)

    Zhou, Bin; Wang, Rong; Wu, Ping; Kong, De-Xin

    2015-02-01

    Given the high risk and lengthy procedure of traditional drug development, drug repurposing is gaining more and more attention. Although many types of drug information have been used to repurpose drugs, drug-drug interaction data, which imply possible physiological effects or targets of drugs, remain unexploited. In this work, similarity of drug interaction was employed to infer similarity of the physiological effects or targets for the drugs. We collected 10,835 drug-drug interactions concerning 1074 drugs, and for 700 of them, drug similarity scores based on drug interaction profiles were computed and rendered using a drug association network with 589 nodes (drugs) and 2375 edges (drug similarity scores). The 589 drugs were clustered into 98 groups with Markov Clustering Algorithm, most of which were significantly correlated with certain drug functions. This indicates that the network can be used to infer the physiological effects of drugs. Furthermore, we evaluated the ability of this drug association network to predict drug targets. The results show that the method is effective for 317 of 561 drugs that have known targets. Comparison of this method with the structure-based approach shows that they are complementary. In summary, this study demonstrates the feasibility of drug repurposing based on drug-drug interaction data. © 2014 John Wiley & Sons A/S.

  3. Young people's attitudes towards illicit drugs: A population-based study.

    Science.gov (United States)

    Friis, Karina; Østergaard, Jeanette; Reese, Sidsel; Lasgaard, Mathias

    2017-12-01

    Previous studies indicate that young people who have positive attitudes towards illicit drugs are more inclined to experiment with them. The first aim of our study was to identify the sociodemographic and risk behaviour characteristics of young people (16-24 years) with positive attitudes towards illicit drug use. The second aim was to identify the characteristics of young people with positive attitudes towards illicit drugs among those who had never tried drugs, those who had tried cannabis but no other illicit drugs, and those who regularly used cannabis and/or had tried other illicit drugs. The analysis was based on a population-based survey from 2013 ( N = 3812). Multiple logistic regression was used to analyse the association between sociodemographic and risk behaviour characteristics and positive attitudes towards illicit drugs. Young men had twice the odds of having positive attitudes towards illicit drug use compared with young women (AOR = 2.1). Also, young age, being single, being employed, smoking tobacco, practising unprotected sex, and experimental cannabis use were associated with positive attitudes towards illicit drug use. Finally, use of cannabis at least 10 times during the previous year and/or use of other illicit drugs had the strongest association with positive attitudes to illicit drug use (AOR = 6.0). Young people who have positive attitudes towards illicit drug use are characterized by a broad range of risky behaviours. These findings may help to identify young people at risk of initiating illicit drug use and thereby support the development and implementation of prevention programmes.

  4. Pharmacogenomic study using bio- and nanobioelectrochemistry: Drug-DNA interaction.

    Science.gov (United States)

    Hasanzadeh, Mohammad; Shadjou, Nasrin

    2016-04-01

    Small molecules that bind genomic DNA have proven that they can be effective anticancer, antibiotic and antiviral therapeutic agents that affect the well-being of millions of people worldwide. Drug-DNA interaction affects DNA replication and division; causes strand breaks, and mutations. Therefore, the investigation of drug-DNA interaction is needed to understand the mechanism of drug action as well as in designing DNA-targeted drugs. On the other hand, the interaction between DNA and drugs can cause chemical and conformational modifications and, thus, variation of the electrochemical properties of nucleobases. For this purpose, electrochemical methods/biosensors can be used toward detection of drug-DNA interactions. The present paper reviews the drug-DNA interactions, their types and applications of electrochemical techniques used to study interactions between DNA and drugs or small ligand molecules that are potentially of pharmaceutical interest. The results are used to determine drug binding sites and sequence preference, as well as conformational changes due to drug-DNA interactions. Also, the intention of this review is to give an overview of the present state of the drug-DNA interaction cognition. The applications of electrochemical techniques for investigation of drug-DNA interaction were reviewed and we have discussed the type of qualitative or quantitative information that can be obtained from the use of each technique. Copyright © 2015 Elsevier B.V. All rights reserved.

  5. Using Nonexperts for Annotating Pharmacokinetic Drug-Drug Interaction Mentions in Product Labeling: A Feasibility Study.

    Science.gov (United States)

    Hochheiser, Harry; Ning, Yifan; Hernandez, Andres; Horn, John R; Jacobson, Rebecca; Boyce, Richard D

    2016-04-11

    range of drug product labels. Preannotation of drug mentions may ease the annotation task. However, preannotation of PDDIs, as operationalized in this study, presented the participants with difficulties. Future work should test if these issues can be addressed by the use of better performing NLP and a different approach to presenting the PDDI preannotations to users during the annotation workflow.

  6. FTIR Drug-Polymer Interactions Studies of Perindopril Erbumine

    International Nuclear Information System (INIS)

    Modni, A.; Ahmad, S.; Din, I.; Hussain, Z.

    2014-01-01

    The present study was carried out to prepare different combinations of Perindopril Erbumine with different polymers like Hydroxy propyl methyl cellulose, Hydroxy propyl methyl cellulose K4M, Hydroxy propyl methyl cellulose K15M, Xanthan gum and Ethyl cellulose, thereby to determine any possible interactions between Perindopril erbumine and polymers. The analytical technique Fourier Transform Infrared (FTIR) spectroscopy was used to take spectra of individual drug, polymers and combination of drug with polymers. The results were analyzed to find out any interactions of Perindopril erbumine and polymers. From this study it was concluded that there were no any significant changes in characteristic peaks of drug after combinations with polymers which indicated no interaction between Perindopril erbumine and polymers. (author)

  7. Newsmaking on drugs: a qualitative study with journalism professionals.

    Science.gov (United States)

    Mastroianni, Fabio C; Noto, Ana Regina

    2008-09-01

    Drugs are a frequent subject in the news media. Despite the existence of an important dynamic interplay between the print media, public opinion, and public policies, studies on these relationships are still scarce regarding the drug issue. The objective of this study is to understand the newsmaking process regarding drugs from the vantage point of Brazilian journalism professionals. Using qualitative research, semistructured interviews were conducted among an intentional sample of 22 professionals who write news stories and articles about drugs in nationwide news media. Interviewees mentioned illegality and crime as the main factors leading to the production of stories and articles. They claimed that by instilling fear among readers, newspapers and magazines tend to increase their audiences and/or sales. Most interviewees considered the coverage of drugs in Brazil as weak. Main problems reported include lack of knowledge on the subject, and not enough time to prepare the stories. It was concluded that the newsmaking process regarding drugs undergoes a series of interferences that compromise the content of the stories, therefore social strategies are needed in order to improve the quality of the material published in Brazil.

  8. Simultaneous determination of antiretroviral drugs in human hair with liquid chromatography-electrospray ionization-tandem mass spectrometry.

    Science.gov (United States)

    Wu, Yan; Yang, Jin; Duan, Cailing; Chu, Liuxi; Chen, Shenghuo; Qiao, Shan; Li, Xiaoming; Deng, Huihua

    2018-04-15

    The determination of the concentrations of antiretroviral drugs in hair is believed to be an important means for the assessment of the long-term adherence to highly active antiretroviral therapy. At present, the combination of tenofovir, lamivudine and nevirapine is widely used in China. However, there was no research reporting simultaneous determination of the three drugs in hair. The present study aimed to develop a sensitive method for simultaneous determination of the three drugs in 2-mg and 10-mg natural hair (Method 1 and Method 2). Hair samples were incubated in methanol at 37 °C for 16 h after being rinsed with methanol twice. The analysis was performed on high performance liquid chromatography tandem mass spectrometry with electronic spray ionization in positive mode and multiple reactions monitoring. Method 1 and Method 2 showed the limits of detection at 160 and 30 pg/mg for tenofovir, at 5 and 6 pg/mg for lamivudine and at 15 and 3 pg/mg for nevirapine. The two methods showed good linearity with the square of correlation coefficient >0.99 at the ranges of 416-5000 and 77-5000 pg/mg for tenofovir, 12-5000 and 15-5000 pg/mg for lamivudine and 39-50,000 and 6-50,000 pg/mg for nevirapine. They gave intra-day and inter-day coefficient of variation <15% and the recoveries ranging from 80.6 to 122.3% and from 83.1 to 114.4%. Method 2 showed LOD and LOQ better than Method 1 for tenofovir and nevirapine and matched Method 1 for lamivudine, but there was high consistency between them in the determination of the three drugs in hair. The population analysis with Method 2 revealed that the concentrations in hair were decreased with the distance of hair segment away from the scalp for the three antiretroviral drugs. Copyright © 2018 Elsevier B.V. All rights reserved.

  9. Application of drug selective electrode in the drug release study of pH-responsive microgels.

    Science.gov (United States)

    Tan, Jeremy P K; Tam, Kam C

    2007-03-12

    The colloidal phenomenon of soft particles is becoming an important field of research due to the growing interest in using polymeric system in drug delivery. Previous studies have focused on techniques that require intermediate process step such as dialysis or centrifugation, which introduces additional errors in obtaining the diffusion kinetic data. In this study, a drug selective electrode was used to directly measure the concentration of procaine hydrochloride (PrHy) released from methacrylic acid-ethyl acrylate (MAA-EA) microgel, thereby eliminating the intermediate process step. PrHy selective membrane constructed using a modified poly (vinyl chloride) (PVC) membrane and poly (ethylene-co-vinyl acetate-co-carbon monoxide) as plasticizer exhibited excellent reproducibility and stability. The response was reproducible at pH of between 3 to 8.5 and the selectivity coefficients against various organic and inorganic cations were evaluated. Drug release was conducted using the drug electrode under different pHs and the release rate increased with pH. The release behavior of the system under different pH exhibited obvious gradient release characteristics.

  10. Study of the Dynamic Uptake of Free Drug and Nanostructures for Drug Delivery Based on Bioluminescence Measurements

    Directory of Open Access Journals (Sweden)

    Zhongjian Fang

    2017-01-01

    Full Text Available The past two decades have witnessed the great growth of the development of novel drug carriers. However, the releasing dynamics of drug from drug carriers in vivo and the interactions between cells and drug carriers remain unclear. In this paper, liposomes were prepared to encapsulate D-luciferin, which was the substrate of luciferase and served as a model drug. Based on the theoretical calculation of active loading, methods of preparation for liposomes were optimized. Only when D-luciferin was released from liposomes or taken in by the cells could bioluminescence be produced under the catalysis of luciferase. Models of multicellular tumor spheroid (MCTS were built with 4T1-luc cells that expressed luciferase stably. The kinetic processes of uptake and distribution of free drugs and liposomal drugs were determined with models of cell suspension, monolayer cells, MCTS, and tumor-bearing nude mice. The technology platform has been demonstrated to be effective for the study of the distribution and kinetic profiles of various liposomes as drug delivery systems.

  11. Personality, Drug Preference, Drug Use, and Drug Availability

    Science.gov (United States)

    Feldman, Marc; Boyer, Bret; Kumar, V. K.; Prout, Maurice

    2011-01-01

    This study examined the relationship between drug preference, drug use, drug availability, and personality among individuals (n = 100) in treatment for substance abuse in an effort to replicate the results of an earlier study (Feldman, Kumar, Angelini, Pekala, & Porter, 2007) designed to test prediction derived from Eysenck's (1957, 1967)…

  12. Pharmacokinetic equivalence study of nonsteroidal anti-inflammatory drug etoricoxib

    Directory of Open Access Journals (Sweden)

    Tjandrawinata RR

    2018-04-01

    Full Text Available Raymond R Tjandrawinata,1 Arini Setiawati,2 Dwi Nofiarny,1 Liana W Susanto,1 Effi Setiawati3 1Dexa Laboratories of Biomolecular Sciences Unit, Dexa Medica Group, Cikarang, West Java, Indonesia; 2Department of Pharmacology and Therapeutics, Medical Faculty, University of Indonesia, Jakarta, Indonesia; 3Bioavailability and Bioequivalence Laboratory Unit, PT Equilab International, Jakarta, Indonesia Purpose: The current study aimed to evaluate whether a generic product of etoricoxib 120 mg film-coated tablet (the test drug was bioequivalent to the reference product (Arcoxia® film-coated tablet 120 mg.Methods: This was a randomized, open-label, two-sequence, crossover study under fasting condition, with a 14-day washout period, involving 26 healthy adult male and female subjects. Blood samples were taken and analyzed for plasma concentrations of etoricoxib (Chemical Abstracts Service [CAS] 202409-33-4 using a high-pressure liquid chromatography–ultraviolet detector (HPLC-UV system capable of measuring etoricoxib concentrations ranging from 5.00 to 5002.90 ng/mL, with the lowest limit of quantitation of 5.00 ng/mL. A noncompartmental method was used to determine the pharmacokinetic parameters of a single-dose administration of the drug, including the area under plasma concentration–time curve from time zero to the time of last observed concentration (AUC0-t, the area under plasma concentration–time curve from time zero to infinity (AUC0-∞, the maximum plasma concentration (Cmax, the time to reach the maximum plasma concentration (tmax, and the terminal half-life (t½.Results: After a single-dose administration of etoricoxib 120 mg film-coated tablet, the mean (SD values for the AUC0-72h and Cmax of the test drug were 45913.42 (13142.19 ng·h/mL and 3155.93 (752.81 ng/mL, respectively; the values for the reference drug were 44577.20 (13541.85 ng⋅h/mL and 2915.13 (772.81 ng/mL, respectively. The geometric mean ratios (90% CIs of the test

  13. Drug Release Studies from Caesalpinia pulcherrima Seed Polysaccharide.

    Science.gov (United States)

    Jeevanandham, Somasundaram; Dhachinamoorthi, Duraiswamy; Bannoth Chandra Sekhar, Kothapalli

    2011-01-01

    This study examines the controlled release behavior of both water-soluble (acetaminophen, caffeine, theophylline and salicylic acid) and water insoluble (indomethacin) drugs derived from Caesalpinia pulcherrima seed Gum isolated from Caesalpinia pulcherrima kernel powder. It further investigates the effect of incorporating diluents such as microcrystalline cellulose and lactose on caffeine release. In addition the effect the gum's (polysaccharide) partial cross-linking had on release of acetaminophen was examined. Applying the exponential equation, the soluble drugs mechanism of release was found to be anomalous. The insoluble drugs showed a near case II or zero order release mechanism. The rate of release in descending order was caffeine, acetaminophen, theophylline, salicylic acid and indomethacin. An increase in the release kinetics of the drug was observed on blending with diluents. However, the rate of release varied with the type and amount of blend within the matrix. The mechanism of release due to effect of diluents was found to be anomalous. The rate of drug release decreased upon partial cross-linking and the mechanism of release was found to be of super case II.

  14. PET IMAGING STUDIES IN DRUG ABUSE RESEARCH.

    Energy Technology Data Exchange (ETDEWEB)

    Fowler, J.S.; Volkow, N.D.; Ding, Y.S.; Logan, J.; Wang, G.J.

    2001-01-29

    . This will be followed by highlights of PET studies of the acute effects of the psychostimulant drugs cocaine and methylphenidate (ritalin) and studies of the chronic effects of cocaine and of tobacco smoke on the human brain. This chapter concludes with the description of a study which uses brain imaging coupled with a specific pharmacological challenge to address the age-old question of why some people who experiment with drugs become addicted while others do not.

  15. Case Studies: Profiles of Women Recovering from Drug Addiction.

    Science.gov (United States)

    Miller, Suzanne M.

    1995-01-01

    Profiles two women over an eight-month study who abused alcohol and other drugs while pregnant and describes their recovery from the addiction. Examines, from an ecological framework, the women's experiences with drug addiction, treatment, and recovery, and recounts their situation through each. (JPS)

  16. Study of antimicrobial property of some hypoglycemic drugs

    Directory of Open Access Journals (Sweden)

    Arun Kumar Dash

    2011-01-01

    Full Text Available In the present work, a comparative antimicrobial study of different hypoglycemic drugs (Metformin, Phenformin, and Rosiglitazone was carried out. The main objective was to ascertain the antimicrobial activity by using "non-antibiotics" as the test substances. The antimicrobial activity was carried out against different bacteria and fungi namely Bacillus liceniformis, Escherichia coli, Proteus vulgaris, Pseudomonas aeruginosa, Shigella flexneri, Bacillus subtilis, Staphylococcus aureus subspp., and Staphylococcus epidermidis by using disc diffusion method and agar dilution method. Ciprofloxacin was taken as the standard antibiotic. The entire procedure was carried out in an aseptic area under the laminar flow by inoculating the bacterial strain to the agar media in which the drug solution was added. Different concentrations (300 and 400 μg/ml of the standard antibiotic and selected drugs were subjected for minimum inhibitory concentration, and zone of inhibition tests and the antimicrobial activity of the selected drugs were determined.

  17. MRI study of hydrophilic xanthan tablets with incorporated model drug

    OpenAIRE

    Mikac, Urša; Baumgartner, Saša; Sepe, Ana; Kristl, Julijana

    2015-01-01

    Magnetic resonance imaging was used to study swelling dynamics and hydrogel formation of xanthan tablets with or without Pentoxifylline drug in water and HCl pH 1.2 media at two different ionic strengths. Significant changes were observed only in the erosion front positions leading to different hydrogel thicknesses. The impact of the drug on the hydrogel thickness was found to be dependent on the medium conditions at high enough drug amount. The drug does not change the hydrogel thickness ...

  18. High Generic Drug Prices and Market Competition: A Retrospective Cohort Study.

    Science.gov (United States)

    Dave, Chintan V; Kesselheim, Aaron S; Fox, Erin R; Qiu, Peihua; Hartzema, Abraham

    2017-08-01

    Prices for some generic drugs have increased in recent years, adversely affecting patients who rely on them. To determine the association between market competition levels and the change in generic drug prices in the United States. Retrospective cohort study. Prescription claims from commercial health plans between 2008 and 2013. The 5.5 years of data were divided into 11 study periods of 6 months each. The Herfindahl-Hirschman Index (HHI)-calculated by summing the squares of individual manufacturers' market shares, with higher values indicating a less competitive market-and average drug prices were estimated for the generic drugs in each period. The HHI value estimated in the baseline period (first half of 2008) was modeled as a fixed covariate. Models estimated price changes over time by level of competition, adjusting for drug shortages, market size, and dosage forms. From 1.08 billion prescription claims, a cohort of 1120 generic drugs was identified. After adjustment, drugs with quadropoly (HHI value of 2500, indicating relatively high levels of competition), duopoly (HHI value of 5000), near-monopoly (HHI value of 8000), and monopoly (HHI value of 10 000) levels of baseline competition were associated with price changes of -31.7% (95% CI, -34.4% to -28.9%), -11.8% (CI, -18.6% to -4.4%), 20.1% (CI, 5.5% to 36.6%), and 47.4% (CI, 25.4% to 73.2%), respectively, over the study period. Study findings may not be generalizable to drugs that became generic after 2008. Market competition levels were associated with a change in generic drug prices. Such measurements may be helpful in identifying older prescription drugs at higher risk for price change in the future. None.

  19. Use of Fall-Risk Inducing Drugs in Patients Using Anti-Parkinson Drugs (APD: A Swedish Register-Based Study.

    Directory of Open Access Journals (Sweden)

    Ylva Haasum

    Full Text Available Many drugs increase the risk of falls in old age. Although persons with Parkinson's disease (PD are at increased risk of experiencing falls and fractures, the use of fall-risk inducing drugs (FRIDs in this population has not previously been investigated. The objective of this study was to investigate the burden of use of FRIDs in older persons treated with anti-Parkinson drugs (APD; used as a proxy for PD, compared to persons without APD.We analyzed individual data on age, sex, type of housing and drug use in 1 346 709 persons aged ≥ 65 years in the Swedish Prescribed Drug Register on the date of 30 September 2008. Main outcome measure was the use of FRIDs.FRIDs were used by 79% of persons with APD and 75% of persons without APD. Persons with APD were more likely to use ≥ 1 FRIDs compared to persons without APD (adjusted OR: 1.09; 95% CI: 1.06-1-12. The association was stronger for concomitant use of ≥ 5 FRIDS (adjusted OR: 1.49; 95% CI: 1.44-1.55.The high use of FRIDs among persons with APD indicates that these patients may be at increased risk of drug-induced falls. Further studies are needed to investigate how these drugs affect the risk of falling in persons with PD.

  20. 77 FR 9946 - Draft Guidance for Industry on Drug Interaction Studies-Study Design, Data Analysis, Implications...

    Science.gov (United States)

    2012-02-21

    ... industry entitled ``Drug Interaction Studies--Study Design, Data Analysis, Implications for Dosing, and... data analysis in the context of identifying potential drug interactions. The guidance also addresses... Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling.'' Comments were received...

  1. Examining factors that influence the effectiveness of cleaning antineoplastic drugs from drug preparation surfaces: a pilot study.

    Science.gov (United States)

    Hon, Chun-Yip; Chua, Prescillia Ps; Danyluk, Quinn; Astrakianakis, George

    2014-06-01

    Occupational exposure to antineoplastic drugs has been documented to result in various adverse health effects. Despite the implementation of control measures to minimize exposure, detectable levels of drug residual are still found on hospital work surfaces. Cleaning these surfaces is considered as one means to minimize the exposure potential. However, there are no consistent guiding principles related to cleaning of contaminated surfaces resulting in hospitals to adopt varying practices. As such, this pilot study sought to evaluate current cleaning protocols and identify those factors that were most effective in reducing contamination on drug preparation surfaces. Three cleaning variables were examined: (1) type of cleaning agent (CaviCide®, Phenokil II™, bleach and chlorhexidine), (2) application method of cleaning agent (directly onto surface or indirectly onto a wipe) and (3) use of isopropyl alcohol after cleaning agent application. Known concentrations of antineoplastic drugs (either methotrexate or cyclophosphamide) were placed on a stainless steel swatch and then, systematically, each of the three cleaning variables was tested. Surface wipes were collected and quantified using high-performance liquid chromatography-tandem mass spectrometry to determine the percent residual of drug remaining (with 100% being complete elimination of the drug). No one single cleaning agent proved to be effective in completely eliminating all drug contamination. The method of application had minimal effect on the amount of drug residual. In general, application of isopropyl alcohol after the use of cleaning agent further reduced the level of drug contamination although measureable levels of drug were still found in some cases.

  2. Toxicity studies of drugs and chemicals in animals: An overview

    Directory of Open Access Journals (Sweden)

    S. Saganuwan

    2017-12-01

    Full Text Available Toxicity study is the investigation of either short or long-term toxic effects of a drug or chemical on animals. The toxicity is dose-dependent as asserted by Paracelsus over 500 years ago. However, short-term toxic effect is determined using median lethal dose (LD50 first introduced by Trevan in 1927 and revised many times. Presently there is a growing preponderance of rejection of scientific papers on acute toxicity study, simply because of the belief that in the current hazard and safety as-sessment of drugs and chemicals, LD50 values are no longer used. In view of this, literature search was carried out with a view to investigating the relevance of LD50 in development and assessment of drugs and chemicals. The findings revealed that in the past, many animals had been used for LD50 determination. OECD has reduced the number of test animals to 5–15 and presently it is further re-duced to 2–6. Acute toxicity study is being carried out in medicinal plants research and in the study of patent medicine. Although the application of LD50 has been drastically reduced, it is still applied and accepted in some parts of the world. Moreover, animals on which LD50 tests are conducted, should be allowed to die to see the end effect of the test drug or chemical because euthanisia of test animals may mask some toxicity signs of the test agents. Therefore, toxicity study of drugs and chemicals is a sci-entific process necessary for discovery and development of drugs as well as identification of potential toxicants.

  3. An Approach for Zika Virus Inhibition Using Homology Structure of the Envelope Protein

    Czech Academy of Sciences Publication Activity Database

    Fernando, S.; Fernando, T.; Štefánik, M.; Eyer, Luděk; Růžek, Daniel

    2016-01-01

    Roč. 58, č. 12 (2016), s. 801-806 ISSN 1073-6085 Institutional support: RVO:60077344 Keywords : Zika virus * homology model * druggability * drug discovery Subject RIV: EE - Microbiology, Virology Impact factor: 1.634, year: 2016

  4. THE PROSPECTIVE OBSERVATIONAL STUDY ON CUTANEOUS ADVERSE DRUG REACTIONS TO CHEMOTHERAPY

    Directory of Open Access Journals (Sweden)

    Prakash Mani

    2016-07-01

    Full Text Available INTRODUCTION There are a wide spectrum of adverse cutaneous drug reactions (ACDRs varying from transient maculopapular rash to fatal toxic epidermal necrolysis (TEN. With the advent of newer and targeted therapy in the field of dermatology, the pattern of cutaneous adverse drug eruptions and the drugs responsible for them keep changing every year. Hence, this study was undertaken to ascertain the clinical spectrum of ACDRs and the causative drugs, in a tertiary care centre in South India. MATERIALS AND METHODS This study was a prospective, observational study conducted in Department of Medical Oncology, Government Rajaji Hospital, Madurai Medical College, Madurai during the period of March 2015 - August 2015 (6 months. Severity of the reaction was assessed using CTCAE (Common Terminology Criteria for Adverse Events scale version 4.1. Causality of the drug was assessed using Naranjo Causality Assessment Scale. The scale was calculated first for the regimen and then for individual drugs separately. The adverse events with score of 6 or more (probable and definite adverse events were taken for the study. RESULTS AND CONCLUSION The overall incidence of ACDRs found in this study was 85%. Alopecia was the commonest ACDR occurring in 51.6% of patients. Nail pigmentation and supravenous pigmentation were the next common ACDRs, recorded in 35% and 16% of patients respectively. Imatinib caused generalised hypopigmentation in 40% of patients. Bleomycin induced, flagellate erythema and pigmentation in 17% of patients and stomatitis was seen in 11% of patients. Acneiform eruptions were recorded with erlotinib and gefitinib therapy. Supravenous pigmentation was common with 5-fluorouracil and docetaxel, occurring in 53% & 48% respectively. Newer targeted therapies like EGFR (Epidermal growth factor receptor inhibitors recorded low incidence of ACDRs like alopecia as against conventional antineoplastic agents. The cancer chemotherapeutic drugs are associated

  5. SOME ASPECTS OF THE MARKETING STUDIES FOR THE PHARMACEUTICAL MARKET OF ANTIVIRAL DRUGS

    Directory of Open Access Journals (Sweden)

    A. G. Salnikova

    2015-01-01

    Full Text Available Antiviral drugs are widely used in medicinal practice. They suppress the originator and stimulate the protection of an organism. The drugs are used for the treatment of flu and ARVI, herpetic infections, virus hepatitis, HIV-infection. Contemporary pharmaceutical market is represented by a wide range of antiviral drugs. Marketing studies are conducted to develop strategies, used for the enhancement of pharmacy organization activity efficiency. Conduction of the marketing researches of pharmaceutical market is the purpose of this study. We have used State Registry of Drugs, State Record of Drugs, List of vital drugs, questionnaires of pharmaceutical workers during our work. Historical, sociological, mathematical methods, and a method of expert evaluation were used in the paper. As the result of the study we have made the following conclusions. We have studied and generalized the literature data about classification and application of antiviral drugs, marketing, competition. The assortment of antiviral drugs on the pharmaceutical market of the Russian Federation was also studied. We have conducted an analysis for the obtainment of the information about antiviral drugs by pharmaceutical workers. We have determined the competitiveness of antiviral drugs, and on the basis of the research conducted we have submitted an offer for pharmaceutical organizations to form the range of antiviral drugs.

  6. Take with Food: Study Tests Lowering Dose of Prostate Cancer Drug

    Science.gov (United States)

    ... Cancer Currents Blog Cancer Currents Blog Take with Food: Study Tests Lowering Dose of Prostate Cancer Drug Subscribe April ... to this page included, e.g., “Take with Food: Study Tests Lowering Dose of Prostate Cancer Drug was originally ...

  7. Study of deaths related to drug abuse in France and Europe.

    Science.gov (United States)

    Ingold, F R

    1986-01-01

    A study of deaths related to drug abuse, based on information available in France and Europe, shows that data on such deaths are divergent and difficult to compare between countries because the definition of "death related to drug abuse" may vary from country to country. For this reason, the author attaches little importance to the use of such data as an indirect indicator for assessing the incidence and prevalence of drug abuse. The author carried out an in-depth study of 99 deaths of this type recorded by the police in the Paris area in 1983, which showed that 80 per cent of the cases involved heroin that had been injected intravenously. An analysis of the biographical background of persons who had died as a result of drug abuse revealed that, in addition to severe drug intoxication, the length of drug abuse and psychopathological disorders, a number of so-called "risk situations" were important factors contributing to their deaths. The risk situations included use of heroin for a long period of time, recent discontinuation of heroin use, regular and intensive use of psychotropic substances and alcohol, and injection of drugs in public places where there was no way of testing the drugs beforehand.

  8. Physician adherence to hypertension treatment guidelines and drug acquisition costs of antihypertensive drugs at the cardiac clinic: a pilot study

    Directory of Open Access Journals (Sweden)

    Abdulameer SA

    2012-01-01

    Full Text Available Shaymaa Abdalwahed Abdulameer1, Mohanad Naji Sahib1, Noorizan Abd Aziz1,2, Yahaya Hassan1,2, Hadeer Akram Abdul AlRazzaq1, Omar Ismail31School of Pharmaceutical Sciences, Universiti Sains Malaysia, 11800 Minden, Penang, Malaysia; 2Faculty of Pharmacy, Universiti Teknologi MARA (UiTM, 42300 Puncak Alam, Selangor, Malaysia; 3Hospital Pulau Pinang, 10900, Penang, MalaysiaAbstract: Prescribing pattern surveys are one of the pharmacoepidemiological techniques that provide an unbiased picture of prescribing habits. Prescription surveys permit the identification of suboptimal prescribing patterns for further evaluation. The aims of this study were to determine the prescribing trend, adherence of the prescribers to the guideline, and the impact of drug expenditure on drug utilization at the cardiac clinic of Penang Hospital, Malaysia. This was a cross-sectional study. Demographic data of the patients, diagnoses and the drugs prescribed were recorded. The average drug acquisition costs (ADAC were calculated for each antihypertensive drug class on a daily and annual basis. Adherence to the guideline was calculated as a percentage of the total number of patients. A total of 313 individuals fulfilled the inclusion criteria. The average age of the study population was 59.30 ± 10.35 years. The mean number of drugs per prescription in the study was 2.09 ± 0.78. There were no significant differences in the demographic data. Antihypertensive drugs were used in monotherapy and polytherapy in 20.8% and 79.2% of the patients, respectively. Adherence to the guideline regarding prescription occurred in 85.30% of the patients. The lowest priced drug class was diuretics and the highest was angiotensin-receptor blockers. In conclusion, the total adherence to the guideline was good; the adherence percentage only slightly decreased with a co-existing comorbidity (such as diabetes mellitus. The use of thiazide diuretics was encouraged because they are well tolerated and

  9. Non-medical use of prescription drugs among illicit drug users: A case study on an online drug forum.

    Science.gov (United States)

    Rönkä, Sanna; Katainen, Anu

    2017-01-01

    The non-medical use of prescription drugs is a growing phenomenon associated with increasing health-related harms. However, little is known about the drivers of this process among illicit drug users. Our aim is to show how the qualities of pharmaceutical drugs, pharmaceutical related knowledge, online communities sharing this knowledge and medical professionals mediate and transform the consumption behaviour related to pharmaceutical drugs. The data consist of discussion threads from an online drug use forum. Using actor network theory (ANT), we analysed translations that mediate the online user community's relationship with pharmaceutical drugs. Differences in experienced drug effects are explained both as a process of 'learning' and as differences in brain chemistry at the receptor level. Both science- and experience-based information are shared on best practices to optimise use, avoid adverse health effects and maximise the experience of intoxication. The expanded context of doctors' practices places stress on the medical framework for drug use. Our analysis shows how the non-medical use of psychoactive pharmaceuticals relates to joint, medicalised ideas of bodies as sites of medical experimentation, as well as to the collective process of constructing 'pharmaceutical competences' in user networks. Understandings of intoxication have increasingly been permeated with the pharmacological and scientific logic of knowledge. The forum works as a platform for harm reduction inspired exchange of knowledge. However, the user community's knowledge sharing practices can generate a shared perception of a sufficient or even superior drug use experience and knowledge. This may lead to overdoses and other risky behaviour, and thereby contribute to increased harms related to non-medical use of prescription drugs. Copyright © 2016 Elsevier B.V. All rights reserved.

  10. An exploratory study of drug use in bar environments

    Science.gov (United States)

    Trocki, Karen; Michalak, Laurence; McDaniel, Patricia

    2010-01-01

    The purpose of this paper is to explore the characteristics of bars where drug use was observed compared to those where no drug use was observed. The study was done through a combination of qualitative and quantitative techniques gleaned through observations and interviews. Among the most important of indicators were the type of activity (particularly dancing) and the level of rowdiness evident in the bars. In addition drug use bars had higher levels of other types of rule-breaking. Patron characteristics (more men) and behavioral patterns (more sexual risk-taking) also distinguished these bars. PMID:25221431

  11. Unique characteristics of regulatory approval and pivotal studies of orphan anticancer drugs in Japan.

    Science.gov (United States)

    Nakayama, Hiroki; Tsukamoto, Katsura

    2018-04-17

    The approval of orphan anticancer drugs has increased, with the number exceeding that of non-orphan drugs in Japan in recent years. Although orphan anticancer drugs may have unique characteristics due to their rarity, these have not been fully characterized. We investigated anticancer drugs approved in Japan between April 2004 and November 2017 to reveal the characteristics of regulatory approval and pivotal studies on orphan anticancer drugs compared to non-orphan drugs. The median regulatory review time and number of patients in pivotal studies on orphan anticancer drugs (281.0 days [interquartile range, 263.3-336.0]; 222.5 patients [66.0-454.3]) were significantly lower than those on non-orphan drugs (353.0 days [277.0-535.5]; 521.0 patients [303.5-814.5], respectively) (P < 0.001). Phase II, non-randomized and non-controlled designs were more frequently used in pivotal studies on orphan anticancer drugs (45.9%, 41.9% and 43.2%) than non-orphan drugs (17.2%, 14.1% and 14.1%, respectively). Response rate was more commonly used as a primary endpoint in pivotal studies on orphan anticancer drugs (48.6%) than non-orphan drugs (17.2%). Indications limited by molecular features, second or later treatment line, and accelerated approval in the United States were associated with the use of response rate in orphan anticancer drug studies. In conclusion, we demonstrated that orphan anticancer drugs in Japan have unique characteristics compared to non-orphan drugs: shorter regulatory review and pivotal studies frequently using phase II, non-randomized, or non-controlled designs and response rate as a primary endpoint, with fewer patients.

  12. Adverse drug reaction reports for cardiometabolic drugs from sub-Saharan Africa: a study in VigiBase.

    Science.gov (United States)

    Berhe, Derbew Fikadu; Juhlin, Kristina; Star, Kristina; Beyene, Kidanemariam G M; Dheda, Mukesh; Haaijer-Ruskamp, Flora M; Taxis, Katja; Mol, Peter G M

    2015-06-01

    Identifying key features in individual case safety reports (ICSR) of suspected adverse drug reactions (ADRs) with cardiometabolic drugs from sub-Saharan Africa (SSA) compared with reports from the rest of the world (RoW). Reports on suspected ADRs of cardiometabolic drugs (ATC: A10[antidiabetic], B01[antithrombotics] and C[cardiovascular]) were extracted from WHO Global database, VigiBase(®) (1992-2013). We used vigiPoint, a logarithmic odds ratios (log2 OR)-based method to study disproportional reporting between SSA and RoW. Case-defining features were considered relevant if the lower limit of the 99% CI > 0.5. In SSA, 3773 (9%) of reported ADRs were for cardiometabolic drugs, in RoW for 18%. Of these, 79% originated from South Africa and 81% were received after 2007. Most reports were for drugs acting on the renin-angiotensin system (36% SSA & 14% RoW). Compared with RoW, reports were more often sent for patients 18-44 years old (log2 OR 0.95 [99 CI 0.80; 1.09]) or with non-fatal outcome (log2 OR 1.16 [99 CI 1.10; 1.22]). Eight ADRs (cough, angioedema, lip swelling, face oedema, swollen tongue, throat irritation, drug ineffective and blood glucose abnormal) and seven drugs (enalapril, rosuvastatin, perindopril, vildagliptin, insulin glulisine, nifedipine and insulin lispro) were disproportionally more reported in SSA than in the RoW. 'In recent years, the number of adverse drug reactions (ADRs) reported in Sub-Saharan Africa (SSA) has sharply increased. The data showed the well-known population-based differential ADR profile of ACE inhibitors in the SSA population.' © 2015 John Wiley & Sons Ltd.

  13. [Exploration and demonstration study on drug combination from clinical real world].

    Science.gov (United States)

    Xie, Yan-ming; Wang, Lian-xin; Wang, Yong-yan

    2014-09-01

    Drug combination is extensive in the clinical real world,which is an important part and the inherent requirements of the post-marketing evaluation of traditional Chinese medicine (TCM). The key issues and technology include multi-domain and multi-disciplinary such as the rationality, efficacy and safety evaluation of combination drug starting from clinical real world, study on component in vivo and mechanism of combination drug, the risk/benefit assessment and cost-benefit evaluation of combination drug and so on. The topic has been studied as clinical demonstration on combination therapy of variety of diseases such as coronary heart disease, stroke, insomnia, depression, hepatitis, herpes zoster, psoriasis and ectopic pregnancy. Meanwhile, multi-disciplinary dynamic innovation alliance of clinical drug combination has been presented, which can promote the academic development and improving service ability and level of TCM.

  14. Drug-related celebrity deaths: A cross-sectional study.

    Science.gov (United States)

    Just, Johannes M; Bleckwenn, Markus; Schnakenberg, Rieke; Skatulla, Philipp; Weckbecker, Klaus

    2016-12-09

    Celebrities are at risk for premature mortality as well as drug-related death. Despite being a vulnerable patient group, celebrities influence people's health behaviours through biological, psychological and social processes. Therefore, celebrity endorsement of the topic could be one way to challenge the current "opioid endemic". Our aim was to better understand the factors surrounding drug-related celebrity deaths by investigating the incidence as well as substances used between 1970 and 2015 using a cross-sectional study design. We searched public databases for drug-related celebrity deaths between 1970 and 2015. They were categorized for sex, profession, age at death, year of death and substances involved. The main outcome measures are descriptive values including number of drug deaths per year and substances involved. Secondary outcome measures are analytical questions to examine whether and which factors influence age at death and year of death (e.g. type of substance use disorder). We identified 220 celebrities who died a drug-related death with a clear indication of involved substances between 1970 and 2015. The average age at death was 38.6 years; 75% were male. Most celebrities died between the age of 25 and 40. The number of drug-related deaths increased in the 21st century, with a significant increase in the use of prescription opioids. Deaths involving prescription opioids and heroin were associated with a significantly lower mean age at death compared to deaths where these substances were not involved. Compared to the 20th century, the total number of celebrities who died from a drug-related death in the 21st century increased, possibly due to an increased involvement of prescription opioids. Negative effects on individual health decisions of celebrity's followers could be the result.

  15. EPIDEMIOLOGICAL STUDY OF DRUG INTOXICATION IN CHILDREN

    Directory of Open Access Journals (Sweden)

    F. Cheraghali M. Taymori

    2006-05-01

    Full Text Available Unintentional drug intoxication is still a major cause of morbidity and mortality in young children. In order to study the epidemiological pattern of childhood drug poisoning in Golestan province, all cases diagnosed with poisoning from 1997 to 2002 in the only pediatric hospital in province were recruited. During this period 563 cases of poisoned children were hospitalized in Taleqani hospital, of these 305 cases were due to drug poisoning. Opium was responsible for more than half of the poisoning cases, and 91% of deaths, among drug intoxicated children. Metoclopramide, benzodiazepines, tricyclic antidepressants and anticonvulsants were among the other frequent causes of poisoning. Neurological symptoms were the most prominent symptoms of poisoning and more than 80% of cases showed some neurological symptoms. Mortality rate among the cases was 3.6% and of total of 11 deaths, 10 were poisoned with opium. About 61% of cases were hospitalized between 24-48 hrs. Most of the poisoning cases in young children were unintentional and in many cases, their parents played a critical role in their intoxication. This role specially is crucial in infants and children under one year of age. Parents in Golestan province use opium widely for symptomatic treatment of routine illnesses in their young children and overdose of opium may cause severe intoxication and even death of the child.

  16. Potential drug-drug and drug-disease interactions in well-functioning community-dwelling older adults.

    Science.gov (United States)

    Hanlon, J T; Perera, S; Newman, A B; Thorpe, J M; Donohue, J M; Simonsick, E M; Shorr, R I; Bauer, D C; Marcum, Z A

    2017-04-01

    There are few studies examining both drug-drug and drug-disease interactions in older adults. Therefore, the objective of this study was to describe the prevalence of potential drug-drug and drug-disease interactions and associated factors in community-dwelling older adults. This cross-sectional study included 3055 adults aged 70-79 without mobility limitations at their baseline visit in the Health Aging and Body Composition Study conducted in the communities of Pittsburgh PA and Memphis TN, USA. The outcome factors were potential drug-drug and drug-disease interactions as per the application of explicit criteria drawn from a number of sources to self-reported prescription and non-prescription medication use. Over one-third of participants had at least one type of interaction. Approximately one quarter (25·1%) had evidence of had one or more drug-drug interactions. Nearly 10·7% of the participants had a drug-drug interaction that involved a non-prescription medication. % The most common drug-drug interaction was non-steroidal anti-inflammatory drugs (NSAIDs) affecting antihypertensives. Additionally, 16·0% had a potential drug-disease interaction with 3·7% participants having one involving non-prescription medications. The most common drug-disease interaction was aspirin/NSAID use in those with history of peptic ulcer disease without gastroprotection. Over one-third (34·0%) had at least one type of drug interaction. Each prescription medication increased the odds of having at least one type of drug interaction by 35-40% [drug-drug interaction adjusted odds ratio (AOR) = 1·35, 95% confidence interval (CI) = 1·27-1·42; drug-disease interaction AOR = 1·30; CI = 1·21-1·40; and both AOR = 1·45; CI = 1·34-1·57]. A prior hospitalization increased the odds of having at least one type of drug interaction by 49-84% compared with those not hospitalized (drug-drug interaction AOR = 1·49, 95% CI = 1·11-2·01; drug-disease interaction AOR = 1·69, CI = 1·15-2

  17. Drug Utilization Study in Ophthalmology Out‑patient Department of a ...

    African Journals Online (AJOL)

    PROMOTING ACCESS TO AFRICAN RESEARCH. AFRICAN ... Abstract. Background: Drug utilization studies provide a pharmacoeconomic basis for making evidence‑based health‑care decisions. ... Results: A total of 640 prescriptions were analyzed with the average number of drugs per prescription being 2.4 (0.9).

  18. Exploring drug-target interaction networks of illicit drugs.

    Science.gov (United States)

    Atreya, Ravi V; Sun, Jingchun; Zhao, Zhongming

    2013-01-01

    Drug addiction is a complex and chronic mental disease, which places a large burden on the American healthcare system due to its negative effects on patients and their families. Recently, network pharmacology is emerging as a promising approach to drug discovery by integrating network biology and polypharmacology, allowing for a deeper understanding of molecular mechanisms of drug actions at the systems level. This study seeks to apply this approach for investigation of illicit drugs and their targets in order to elucidate their interaction patterns and potential secondary drugs that can aid future research and clinical care. In this study, we extracted 188 illicit substances and their related information from the DrugBank database. The data process revealed 86 illicit drugs targeting a total of 73 unique human genes, which forms an illicit drug-target network. Compared to the full drug-target network from DrugBank, illicit drugs and their target genes tend to cluster together and form four subnetworks, corresponding to four major medication categories: depressants, stimulants, analgesics, and steroids. External analysis of Anatomical Therapeutic Chemical (ATC) second sublevel classifications confirmed that the illicit drugs have neurological functions or act via mechanisms of stimulants, opioids, and steroids. To further explore other drugs potentially having associations with illicit drugs, we constructed an illicit-extended drug-target network by adding the drugs that have the same target(s) as illicit drugs to the illicit drug-target network. After analyzing the degree and betweenness of the network, we identified hubs and bridge nodes, which might play important roles in the development and treatment of drug addiction. Among them, 49 non-illicit drugs might have potential to be used to treat addiction or have addictive effects, including some results that are supported by previous studies. This study presents the first systematic review of the network

  19. Using standardized methods for research on HIV and injecting drug use in developing/transitional countries: case study from the WHO Drug Injection Study Phase II

    Directory of Open Access Journals (Sweden)

    Stimson Gerry V

    2006-03-01

    Full Text Available Abstract Background Successful cross-national research requires methods that are both standardized across sites and adaptable to local conditions. We report on the development and implementation of the methodology underlying the survey component of the WHO Drug Injection Study Phase II – a multi-site study of risk behavior and HIV seroprevalence among Injecting Drug Users (IDUs. Methods Standardized operational guidelines were developed by the Survey Coordinating Center in collaboration with the WHO Project Officer and participating site Investigators. Throughout the duration of the study, survey implementation at the local level was monitored by the Coordinating Center. Surveys were conducted in 12 different cities. Prior rapid assessment conducted in 10 cities provided insight into local context and guided survey implementation. Where possible, subjects were recruited both from drug abuse treatment centers and via street outreach. While emphasis was on IDUs, non-injectors were also recruited in cities with substantial non-injecting use of injectable drugs. A structured interview and HIV counseling/testing were administered. Results Over 5,000 subjects were recruited. Subjects were recruited from both drug treatment and street outreach in 10 cities. Non-injectors were recruited in nine cities. Prior rapid assessment identified suitable recruitment areas, reduced drug users' distrust of survey staff, and revealed site-specific risk behaviors. Centralized survey coordination facilitated local questionnaire modification within a core structure, standardized data collection protocols, uniform database structure, and cross-site analyses. Major site-specific problems included: questionnaire translation difficulties; locating affordable HIV-testing facilities; recruitment from drug treatment due to limited/selective treatment infrastructure; access to specific sub-groups of drug users in the community, particularly females or higher income groups

  20. The FDA Unapproved Drugs Initiative: An Observational Study of the Consequences for Drug Prices and Shortages in the United States.

    Science.gov (United States)

    Gupta, Ravi; Dhruva, Sanket S; Fox, Erin R; Ross, Joseph S

    2017-10-01

    Hundreds of drug products are currently marketed in the United States without approval from the FDA. The 2006 Unapproved Drugs Initiative (UDI) requires manufacturers to remove these drug products from the market or obtain FDA approval by demonstrating evidence of safety and efficacy. Once the FDA acts against an unapproved drug, fewer manufacturers remain in the market, potentially enabling drug price increases and greater susceptibility to drug shortages. There is a need for systematic study of the UDI's effect on prices and shortages of all targeted drugs. To examine the clinical evidence for approval and association with prices and shortages of previously unapproved prescription drugs after being addressed by the UDI. Previously unapproved prescription drugs that faced UDI regulatory action or with at least 1 product that received FDA approval through manufacturers' voluntary compliance with the UDI between 2006 and 2015 were identified. The clinical evidence was categorized as either newly conducted clinical trials or use of previously published literature and/or bioequivalence studies to demonstrate safety and efficacy. We determined the change in average wholesale price, presence of shortage, and duration of shortage for each drug during the 2 years before and after UDI regulatory action or approval through voluntary compliance. Between 2006 and 2015, 34 previously unapproved prescription drugs were addressed by the UDI. Nearly 90% of those with a drug product that received FDA approval were supported by literature reviews or bioequivalence studies, not new clinical trial evidence. Among the 26 drugs with available pricing data, average wholesale price during the 2 years before and after voluntary approval or UDI action increased by a median of 37% (interquartile range [IQR] = 23%-204%; P Innovation; from the Blue Cross Blue Shield Association to better understand medical technology evidence generation; from the Centers for Medicare & Medicaid Services to

  1. Elderly users of fall-risk-increasing drug perceptions of fall risk and the relation to their drug use - a qualitative study.

    Science.gov (United States)

    Bell, Hege Therese; Steinsbekk, Aslak; Granas, Anne Gerd

    2017-09-01

    The aim of the study was to explore how home-dwelling elderly who use fall-risk-increasing drugs (FRIDs) perceive their fall risk and how they relate this to their drug use. A qualitative study with 14 home-dwelling elderly FRID users between 65 and 97 years in Central Norway participating in semi-structured individual interviews. The data were analyzed thematically by using systematic text condensation. The main finding was that the informants did not necessarily perceive the use of FRIDs to be a prominent risk factor for falls. Some informants said they did not reflect upon drug use whatsoever and said they fully trusted their physician's choices. When either experiencing dizziness, fall episodes or by reading the patient information leaflet the informants said to either adjust their drug use or to contact their physician. Some felt rejected due to not getting their point across or their wish to alter the drug was not granted by the physician. Elderly FRID users did not necessarily relate their drug use to fall risk or struggled to present their perceived drug-related problems. Physicians need to regularly inform, monitor and assess the drug treatment when treating elderly with FRIDs.

  2. DRUG UTILISATION STUDY IN THE TREATMENT OF HYPERTENSION IN A TERTIARY CARE HOSPITAL

    Directory of Open Access Journals (Sweden)

    Amol Chandrakant Deshmukh

    2017-11-01

    Full Text Available BACKGROUND Hypertension, a common clinical problem is considered as an ‘iceberg disease’ because its unknown morbidity far exceeds the known morbidity. In terms of attributable deaths, it is one of the leading behavioural and physiological risk factors amounting to 13% of global deaths. Drug selection is based on efficacy in lowering BP (blood pressure and in reducing Cardiovascular (CV endpoints like stroke, myocardial infarction and heart failure. This study was carried out to evaluate the pattern, extent, rationality and frequency of the use of antihypertensive drugs in the treatment of hypertension. The aim of the study is to analyse drug utilisation in the treatment of hypertension in a tertiary care hospital. MATERIALS AND METHODS This study was conducted during January 2014 to December 2015 in Medicine OPD (Outpatient Department in a tertiary care hospital. The sample size was selected as per the WHO recommendations on conducting Drug Utilisation Studies (DUS. Statistical Analysis- The collected data was numerically coded and entered in Microsoft Excel 2007 and analysed by SPSS version 16. Settings and Design- Prospective, cross-sectional, observational study. RESULTS Out of 612 patients, 262 (42.81% were in the age group of 60 and above. Considering gender distribution, 328 (53.59% were males and 284 (46.41% were females. Of these, 274 (44.78% were prescribed monotherapy, 256 (41.83% were prescribed two-drug therapy, 72 (11.76% were prescribed three-drug therapy and 10 (1.63% were prescribed four-drug therapy. Among 274 (44.78% patients prescribed with monotherapy, 112 (40.87% were prescribed with CCB (calcium channel blocker, 76 (27.73% were given BB (B-blocker, 45 (16.42% were prescribed ACEI (angiotensin converting enzyme inhibitor, 35 (12.77% were prescribed with ARB (angiotensin receptor blocker and 6 (2.18% were prescribed with Diuretics (D. Of the total antihypertensive drugs prescribed, 68.30% were prescribed by generic name

  3. A population-based prescription study of asthma drugs during pregnancy

    DEFF Research Database (Denmark)

    Olesen, Charlotte; Thrane, Nana; Nielsen, G.L.

    2001-01-01

    Background: Among the goals of gestational asthma, therapy is optimisation of pulmonary function. According to the US Food and Drug Administration, no asthma drugs can be considered ‘safe’ during pregnancy. Fear of adverse fetal effects may thus lead to restrictive use of asthma drugs during...... pregnancy, and no population-based studies concerning gestational asthma therapy exist. Objectives: To examine whether asthma drugs or changing intensity of asthma therapy during pregnancy was associated with deviations from expected values of gestational age, birth weight, length at birth, or malformations....... Methods: The Birth Registry was used to identify all 15,756 primiparous women who gave birth in the County of North Jutland between 1991 and 1996. According to the North Jutland Prescription Database, 303 of these women received prescriptions for asthma drugs during pregnancy. Women who did not purchase...

  4. Sex differences in drug addiction: a review of animal and human studies.

    Science.gov (United States)

    Fattore, Liana; Altea, Silvia; Fratta, Walter

    2008-01-01

    Addiction research has historically neglected research on women, and most studies have been conducted on men only, with the concluding results generalized to the female population. The role of sex differences in vulnerability to drug abuse, their repercussions on prevention and treatment strategies all require detailed studies, as does the progression from recreational drug use to dependence. This review synthesizes evidence of gender differences in drug addiction, with particular emphasis on women's health and implications. We first reviewed behavioral studies showing sex differences in the preference for and self-administration of licit (i.e., alcohol and nicotine) and illicit (i.e., cocaine, amphetamine, heroin and cannabis) substances as revealed by animal models of addiction. Clinical studies demonstrating differences between men and women in craving, drug use, abstinence and relapse will then be examined. For both animal and human studies, the effects of hormones and estrous/menstrual cycle will be reviewed. Finally, neurobiological factors underlying gender differences in vulnerability to drug addiction (i.e., brain morphology and neurotransmission) and need for gender-specific detoxification treatments will be discussed.

  5. Biomembrane models and drug-biomembrane interaction studies: Involvement in drug design and development

    Directory of Open Access Journals (Sweden)

    R Pignatello

    2011-01-01

    Full Text Available Contact with many different biological membranes goes along the destiny of a drug after its systemic administration. From the circulating macrophage cells to the vessel endothelium, to more complex absorption barriers, the interaction of a biomolecule with these membranes largely affects its rate and time of biodistribution in the body and at the target sites. Therefore, investigating the phenomena occurring on the cell membranes, as well as their different interaction with drugs in the physiological or pathological conditions, is important to exploit the molecular basis of many diseases and to identify new potential therapeutic strategies. Of course, the complexity of the structure and functions of biological and cell membranes, has pushed researchers toward the proposition and validation of simpler two- and three-dimensional membrane models, whose utility and drawbacks will be discussed. This review also describes the analytical methods used to look at the interactions among bioactive compounds with biological membrane models, with a particular accent on the calorimetric techniques. These studies can be considered as a powerful tool for medicinal chemistry and pharmaceutical technology, in the steps of designing new drugs and optimizing the activity and safety profile of compounds already used in the therapy.

  6. A study of drug use pattern among inmates of Jos prison, Nigeria ...

    African Journals Online (AJOL)

    A study of drug use pattern among inmates of Jos prison, Nigeria. ... A total of 3134 inmates who were admitted for drug use treatment in the ... children have been identified to abuse drugs should be co-opted into the rehabilitation process.

  7. Present studies on the radiosterilized drugs

    International Nuclear Information System (INIS)

    Marciniec, B.; Dettlaff, K.

    2007-01-01

    Lecture presents present status of radiosterilization of drugs and medical materials as compared to other sterilization methods. Literature review is shown on degradation of different kinds of drugs sterilized upon action of the sterilising doses of radiation

  8. [Six-month follow-up study of drug treatment for cannabis addiction: comparison study of four drugs].

    Science.gov (United States)

    Shoenfeld, Netta; Bodnik, Dana; Rosenberg, Oded; Kotler, Moshe; Dannon, Pinhas

    2011-12-01

    Marijuana addiction is one of the most common forms of addiction worldwide. A variety of reasons for use exist, however, there are only a few tested treatments with frequent relapses. In this study, we examined the efficacy of four pharmacotherapy agents for the treatment of marijuana addiction: naltrexone, bupropion, escitalopram and bromazepam. A total of 59 patients were randomly assigned into four groups. Each group received one of the pharmacological agents for 120 days. Four types of questionnaires were employed: The Hamilton Rating Scale for Depression--21 items, the Hamilton Rating Scale for Anxiety, the Global Assessment of Functioning and a Visual Analogue Scale for perceived need of the drug. In addition, random urine tests were performed to detect tetrahydrocannabinol [THC). Naltrexone proved to be the most efficacious of the four agents, with only four dropouts. Other agents proved less efficacious with six, seven and eights dropouts for bupropion, bromazepam and escitalopram, respectively. In addition, naltrexone was most efficacious in reducing anxiety and depression rates, and increasing functioning and perceived need for drug use. Out of four pharmacological agents, naltrexone proved to be most efficacious in treating marijuana addiction and related disorders. Further studies are needed to confirm our results.

  9. 76 FR 11790 - Drugs for Human Use; Drug Efficacy Study Implementation; Oral Prescription Drugs Offered for...

    Science.gov (United States)

    2011-03-03

    ... subject of an approved new drug application (NDA) or abbreviated new drug application (ANDA) (other than... 23, 1983, notice, the manufacturer had submitted supplemental applications proposing to reformulate... Laboratories, a subsidiary of Elan Corp., PLC, 800 Gateway Blvd., South San Francisco, CA 94080; Copley...

  10. A study of the web as DTC drug marketing agent.

    Science.gov (United States)

    Lorence, Daniel; Churchill, Rick

    2007-12-01

    The growth of direct-to-consumer (DTC) marketing of pharmaceuticals in the USA has spawned the generation of web sites for consumer information and discussion, related to specific medical conditions and the efficacy of specific drugs. In such an environment consumers often find and act upon health information of variable quality, with little input from health professionals. Some health policy analysts argue that the emergence of such consumer "drug networks" will lead to unnecessary expenditure of money on prescription drugs, as consumers see ads and then demand that their providers prescribe that drug. Others say that an intelligent consumer will be able to research the information and narrow down a drug that will likely work for them personally, rather than having the provider "experiment" with different medications. There exist few cross-disciplinary evaluative frameworks for assessing such health information, especially within commercial search engines. This study serves as an exploratory technology assessment that examines the prevalence of web-based DTC for a popular prescription drug and the impact on healthcare consumers.

  11. Bioprinting of Micro-Organ Tissue Analog for Drug Metabolism Study

    Science.gov (United States)

    Sun, Wei

    An evolving application of tissue engineering is to develop in vitro 3D cell/tissue models for drug screening and pharmacological study. In order to test in space, these in vitro models are mostly manufactured through micro-fabrication techniques and incorporate living cells with MEMS or microfluidic devices. These cell-integrated microfluidic devices, or referred as microorgans, are effective in furnishing reliable and inexpensive drug metabolism and toxicity studies [1-3]. This paper will present an on-going research collaborated between Drexel University and NASA JSC Radiation Physics Laboratory for applying a direct cell printing technique to freeform fabrication of 3D liver tissue analog in drug metabolism study. The paper will discuss modeling, design, and solid freeform fabrication of micro-fluidic flow patterns and bioprinting of 3D micro-liver chamber that biomimics liver physiological microenvironment for enhanced drug metabolization. Technical details to address bioprinting of 3D liver tissue analog, integration with a microfluidic device, and basic drug metabolism study for NASA's interests will presented. 1. Holtorf H. Leslie J. Chang R, Nam J, Culbertson C, Sun W, Gonda S, "Development of a Three-Dimensional Tissue-on-a-Chip Micro-Organ Device for Pharmacokinetic Analysis", the 47th Annual Meeting of the American Society for Cell Biology, Washington, DC, December 1-5, 2007. 2. Chang, R., Nam, J., Culbertson C., Holtorf, H., Jeevarajan, A., Gonda, S. and Sun, W., "Bio-printing and Modeling of Flow Patterns for Cell Encapsulated 3D Liver Chambers For Pharmacokinetic Study", TERMIS North America 2007 Conference and Exposition, Westin Harbour Castle, Toronto, Canada, June 13-16, 2007. 3.Starly, B., Chang, R., Sun, W., Culbertson, C., Holtorf, H. and Gonda, S., "Bioprinted Tissue-on-chip Application for Pharmacokinetic Studies", Proceedings of World Congress on Tissue Engineering and Regenerative Medicine, Pittsburgh, PA, USA, April 24-27, 2006.

  12. Drug treatment at the end of life: an epidemiologic study in nursing homes.

    Science.gov (United States)

    Jansen, Kristian; Schaufel, Margrethe Aase; Ruths, Sabine

    2014-12-01

    To examine drug treatment in nursing home patients at the end of life, and identify predictors of palliative drug therapy. A historical cohort study. Three urban nursing homes in Norway. All patients admitted from January 2008 and deceased before February 2013. Drug prescriptions, diagnoses, and demographic data were collected from electronic patient records. Palliative end-of-life drug treatment was defined on the basis of indication, drug, and formulation. 524 patients were included, median (range) age at death 86 (19-104) years, 59% women. On the day of death, 99.4% of the study population had active prescriptions; 74.2% had palliative drugs either alone (26.9%) or concomitantly with curative/preventive drugs (47.3%). Palliative drugs were associated with nursing home, length of stay > 16 months (AOR 2.10, 95% CI 1.12-3.94), age (1.03, 1.005-1.05), and a diagnosis of cancer (2.12, 1.19-3.76). Most initiations of palliative drugs and withdrawals of curative/preventive drugs took place on the day of death. Palliative drug therapy and drug therapy changes are common for nursing home patients on the last day of life. Improvements in end-of-life care in nursing homes imply addressing prognostication and earlier response to palliative needs.

  13. African Journal of Drug and Alcohol Studies

    African Journals Online (AJOL)

    The African Journal of Drug & Alcohol Studies is an international scientific journal published by the African Centre for Research and Information on Substance ... Anywhere, everywhere: alcohol industry promotion strategies in Nigeria and their influence on young people · EMAIL FREE FULL TEXT EMAIL FREE FULL TEXT

  14. Studies on dissolution enhancement and mathematical modeling of drug release of a poorly water-soluble drug using water-soluble carriers.

    Science.gov (United States)

    Ahuja, Naveen; Katare, Om Prakash; Singh, Bhupinder

    2007-01-01

    Role of various water-soluble carriers was studied for dissolution enhancement of a poorly soluble model drug, rofecoxib, using solid dispersion approach. Diverse carriers viz. polyethylene glycols (PEG 4000 and 6000), polyglycolized fatty acid ester (Gelucire 44/14), polyvinylpyrollidone K25 (PVP), poloxamers (Lutrol F127 and F68), polyols (mannitol, sorbitol), organic acid (citric acid) and hydrotropes (urea, nicotinamide) were investigated for the purpose. Phase-solubility studies revealed AL type of curves for each carrier, indicating linear increase in drug solubility with carrier concentration. The sign and magnitude of the thermodynamic parameter, Gibbs free energy of transfer, indicated spontaneity of solubilization process. All the solid dispersions showed dissolution improvement vis-à-vis pure drug to varying degrees, with citric acid, PVP and poloxamers as the most promising carriers. Mathematical modeling of in vitro dissolution data indicated the best fitting with Korsemeyer-Peppas model and the drug release kinetics primarily as Fickian diffusion. Solid state characterization of the drug-poloxamer binary system using XRD, FTIR, DSC and SEM techniques revealed distinct loss of drug crystallinity in the formulation, ostensibly accounting for enhancement in dissolution rate.

  15. In vitro drug interaction of levocetirizine and diclofenac: Theoretical and spectroscopic studies.

    Science.gov (United States)

    Abo Dena, Ahmed S; Abdel Gaber, Sara A

    2017-06-15

    Levocetirizine dihydrochloride is known to interact with some anti-inflammatory drugs. We report here a comprehensive integrated theoretical and experimental study for the in vitro drug interaction between levocetirizine dihydrochloride (LEV) and diclofenac sodium (DIC). The interaction of the two drugs was confirmed by the molecular ion peak obtained from the mass spectrum of the product. Moreover, FTIR and 1 HNMR spectra of the individual drugs and their interaction product were inspected to allocate the possible sites of interaction. In addition, quantum mechanical DFT calculations were performed to search for the interaction sites and to verify the types of interactions deduced from the spectroscopic studies such as charge-transfer and non-bonding π-π interactions. It was found that the studied drugs interact with each other in aqueous solution via four types of interactions, namely, ion-pair formation, three weak hydrogen bonds, non-bonding π-π interactions and charge-transfer from DIC to LEV. Copyright © 2017 Elsevier B.V. All rights reserved.

  16. In vitro drug interaction of levocetirizine and diclofenac: Theoretical and spectroscopic studies

    Science.gov (United States)

    Abo Dena, Ahmed S.; Abdel Gaber, Sara A.

    2017-06-01

    Levocetirizine dihydrochloride is known to interact with some anti-inflammatory drugs. We report here a comprehensive integrated theoretical and experimental study for the in vitro drug interaction between levocetirizine dihydrochloride (LEV) and diclofenac sodium (DIC). The interaction of the two drugs was confirmed by the molecular ion peak obtained from the mass spectrum of the product. Moreover, FTIR and 1HNMR spectra of the individual drugs and their interaction product were inspected to allocate the possible sites of interaction. In addition, quantum mechanical DFT calculations were performed to search for the interaction sites and to verify the types of interactions deduced from the spectroscopic studies such as charge-transfer and non-bonding π-π interactions. It was found that the studied drugs interact with each other in aqueous solution via four types of interactions, namely, ion-pair formation, three weak hydrogen bonds, non-bonding π-π interactions and charge-transfer from DIC to LEV.

  17. A Study of the Trend and Extent of Drug Abuse Among Drug ...

    African Journals Online (AJOL)

    The findings show that drug-abusers are predominantly males, single, unskilled workers, traders, unemployed and civil servants. Psychiatric hospitals and rehabilitation centres served as treatment centres for participants with previous admission records. Drug therapy, psychotherapy and occupational therapy were the ...

  18. Preparation, characterization, drug release and computational modelling studies of antibiotics loaded amorphous chitin nanoparticles.

    Science.gov (United States)

    Gayathri, N K; Aparna, V; Maya, S; Biswas, Raja; Jayakumar, R; Mohan, C Gopi

    2017-12-01

    We present a computational investigation of binding affinity of different types of drugs with chitin nanocarriers. Understanding the chitn polymer-drug interaction is important to design and optimize the chitin based drug delivery systems. The binding affinity of three different types of anti-bacterial drugs Ethionamide (ETA) Methacycline (MET) and Rifampicin (RIF) with amorphous chitin nanoparticles (AC-NPs) were studied by integrating computational and experimental techniques. The binding energies (BE) of hydrophobic ETA, hydrophilic MET and hydrophobic RIF were -7.3kcal/mol, -5.1kcal/mol and -8.1kcal/mol respectively, with respect to AC-NPs, using molecular docking studies. This theoretical result was in good correlation with the experimental studies of AC-drug loading and drug entrapment efficiencies of MET (3.5±0.1 and 25± 2%), ETA (5.6±0.02 and 45±4%) and RIF (8.9±0.20 and 53±5%) drugs respectively. Stability studies of the drug encapsulated nanoparticles showed stable values of size, zeta and polydispersity index at 6°C temperature. The correlation between computational BE and experimental drug entrapment efficiencies of RIF, ETA and MET drugs with four AC-NPs strands were 0.999 respectively, while that of the drug loading efficiencies were 0.854 respectively. Further, the molecular docking results predict the atomic level details derived from the electrostatic, hydrogen bonding and hydrophobic interactions of the drug and nanoparticle for its encapsulation and loading in the chitin-based host-guest nanosystems. The present results thus revealed the drug loading and drug delivery insights and has the potential of reducing the time and cost of processing new antibiotic drug delivery nanosystem optimization, development and discovery. Copyright © 2017 Elsevier Ltd. All rights reserved.

  19. Indolealkylamines: biotransformations and potential drug-drug interactions.

    Science.gov (United States)

    Yu, Ai-Ming

    2008-06-01

    Indolealkylamine (IAA) drugs are 5-hydroxytryptamine (5-HT or serotonin) analogs that mainly act on the serotonin system. Some IAAs are clinically utilized for antimigraine therapy, whereas other substances are notable as drugs of abuse. In the clinical evaluation of antimigraine triptan drugs, studies on their biotransformations and pharmacokinetics would facilitate the understanding and prevention of unwanted drug-drug interactions (DDIs). A stable, principal metabolite of an IAA drug of abuse could serve as a useful biomarker in assessing intoxication of the IAA substance. Studies on the metabolism of IAA drugs of abuse including lysergic acid amides, tryptamine derivatives and beta-carbolines are therefore emerging. An important role for polymorphic cytochrome P450 2D6 (CYP2D6) in the metabolism of IAA drugs of abuse has been revealed by recent studies, suggesting that variations in IAA metabolism, pharmaco- or toxicokinetics and dynamics can arise from distinct CYP2D6 status, and CYP2D6 polymorphism may represent an additional risk factor in the use of these IAA drugs. Furthermore, DDIs with IAA agents could occur additively at the pharmaco/toxicokinetic and dynamic levels, leading to severe or even fatal serotonin toxicity. In this review, the metabolism and potential DDIs of these therapeutic and abused IAA drugs are described.

  20. Severe idiosyncratic drug reactions with epidermal necrolysis: A 5-year study

    Directory of Open Access Journals (Sweden)

    I O Fadeyibi

    2011-01-01

    Full Text Available Introduction: Idiosyncratic drug reactions (IDRs are unexpected responses to a drug. The spectrums of severe cutaneous reactions include Stevens-Johnson Syndrome (SJS, SJS/Lyell Syndrome and Toxic Epidermal Necrolysis (TEN. The conditions are associated with high mortality. This study was designed to determine the causal agents, patterns of presentations, review the management and make recommendations to reduce the incidence and mortality of this class of drug reactions. Materials and Methods: A retrospective study was made of patients seen with IDR in the Lagos State University Teaching Hospital, LASUTH, between January, 2004 and December, 2008. They were cases admitted with bullous skin eruptions with associated systemic symptoms. Results: Sixty-seven patients were seen, with 45 (67.2% satisfying the inclusion criteria. Fifteen males and 30 females were involved, giving a male to female (M:F ratio of 1:2. Their ages ranged from 7 to 79 years (mean, 40.02 ± 17.89 years. Peak incidences occurred among the 20-24 and 30-34 year age groups. The causal agents were antibiotics (48.89%, sulphonamides (24.44%, herbal preparations (17.78% and artemisinin drugs (8.89%. Conclusions: The age groups with the peak incidence are the most likely to indulge more in drug abuse in environments with poor drug control. Diagnosis of SJS, SJS/TEN and TEN were missed in many patients at first contact due to the progressive nature of the conditions. Patients needed reviews at regular intervals when IDR was suspected. Health education to prevent drug abuse is important and herbal preparations should be scientifically studied to determine the efficacy and side-effects.

  1. Values and beliefs of psychedelic drug users: a cross-cultural study.

    Science.gov (United States)

    Lerner, Michael; Lyvers, Michael

    2006-06-01

    Psychedelic drugs such as LSD and psilocybin are often claimed to be capable of inducing life-changing experiences described as mystical or transcendental, especially if high doses are taken. The present study examined possible enduring effects of such experiences by comparing users of psychedelic drugs (n = 88), users of nonpsychedelic illegal drugs (e.g., marijuana, amphetamines) (n = 29) and non illicit drug-using social drinkers (n = 66) on questionnaire measures of values, beliefs and emotional empathy. Samples were obtained from Israel (n = 110) and Australia (n = 73) in a cross-cultural comparison to see if values associated with psychedelic drug use transcended culture of origin. Psychedelic users scored significantly higher on mystical beliefs (e.g., oneness with God and the universe) and life values of spirituality and concern for others than the other groups, and lower on the value of financial prosperity, irrespective of culture of origin. Users of nonpsychedelic illegal drugs scored significantly lower on a measure of coping ability than both psychedelic users and non illicit drug users. Both groups of illegal drug users scored significantly higher on empathy than non illicit drug users. Results are discussed in the context of earlier findings from Pahnke (1966) and Doblin (1991) of the transformative effect of psychedelic experiences, although the possibility remains that present findings reflect predrug characteristics of those who chose to take psychedelic drugs rather than effects of the drugs themselves.

  2. Drug Use among Street Children in Tehran, Iran: A Qualitative Study

    Directory of Open Access Journals (Sweden)

    Masoumeh eDejman

    2015-12-01

    Full Text Available Introduction and objective: Globally, children who work and live on the streets are at higher risk of undesired behavioral health outcomes, including increased drug use and abuse. Considering the rapid growth of this population in Iran and the lack of program planning that is partly due to a scarcity of research-based information, this study was conducted in 2013 to investigate drug use among street children in Tehran. Method: With a qualitative design, we conducted a Rapid Assessment and Response (RAS Survey of street children in Tehran, 2012-2013. Data were also obtained from ten focus group discussions with street children using semi-structured questionnaires and 27 in-depth interviews with key informants in governmental, non-governmental, and international organizations. Results: The variation in age at first use, type of drugs, and pattern of drug use were found based on ethnicity. Gypsy boys and girls reported consuming more alcohol than other groups. Drug use problems were commonly described among families of street children. Children whose parents had drug-use problems described using drugs earlier than other children. Informants reported that families with drug-related problems used children for procurement of drugs. Children themselves described using drugs to cope with stress, reduce physical and psychological stressors and problems such as fatigue, sadness, and pressure resulting from frequent failures in life. Conclusion: These results suggest that intervention and prevention programs dealing with drug use of street children in Iran should include family and peers when addressing drug use by street children.

  3. Drug induced xerostomia in elderly individuals: An institutional study

    Directory of Open Access Journals (Sweden)

    Shishir Ram Shetty

    2012-01-01

    Full Text Available Introduction : With better health care facilities and nutritional levels the average life expectancy of Indian population has been on the rise over the years. Most of the geriatric population is under long-term medication. Aim : The aim of this study was to evaluate the synergistic effect of multiple xerostomia drugs. Materials and Methods : Unstimulated saliva was measured in 60 geriatric patients, and xerostomia questionnaire and quality-of-life scale were also administered. Results : There was a very highly significant reduction in the salivary flow rates of patients under multiple xerostomia-inducing drugs. Conclusion : The synergistic effect of the xerostomia inducing medication could be the possible factor responsible for reduced salivary flow in elderly individuals using such drugs

  4. Biological basis of sex differences in drug abuse: preclinical and clinical studies.

    Science.gov (United States)

    Lynch, Wendy J; Roth, Megan E; Carroll, Marilyn E

    2002-11-01

    The recent focus on drug abuse in women has brought attention to numerous differences between women and men. In this review, we discuss both preclinical and clinical findings of sex differences in drug abuse as well as mechanisms that may underlie these differences. Recent evidence suggests that the progression to dependence and abuse may differ between women and men; thus, different prevention and treatment strategies may be required. Similar sex differences in drug sensitivity and self-administration have been reported in laboratory animal studies. Females appear to be more vulnerable than males to the reinforcing effects of psychostimulants, opiates, and nicotine during many phases of the addiction process (e.g. acquisition, maintenance, dysregulation-escalation, relapse). Male and female animals differ in their behavioral, neurological, and pharmacological responses to drugs. Although the role of sex in the mechanisms of drug action remains unclear, preclinical and clinical studies indicate that ovarian hormones, particularly estrogen, play a role in producing sex differences in drug abuse. Future research is necessary to provide information on how to design more effective drug abuse treatment programs and resources that are sex specific.

  5. Drug education in victorian schools (DEVS: the study protocol for a harm reduction focused school drug education trial

    Directory of Open Access Journals (Sweden)

    Midford Richard

    2012-02-01

    Full Text Available Abstract Background This study seeks to extend earlier Australian school drug education research by developing and measuring the effectiveness of a comprehensive, evidence-based, harm reduction focused school drug education program for junior secondary students aged 13 to 15 years. The intervention draws on the recent literature as to the common elements in effective school curriculum. It seeks to incorporate the social influence of parents through home activities. It also emphasises the use of appropriate pedagogy in the delivery of classroom lessons. Methods/Design A cluster randomised school drug education trial will be conducted with 1746 junior high school students in 21 Victorian secondary schools over a period of three years. Both the schools and students have actively consented to participate in the study. The education program comprises ten lessons in year eight (13-14 year olds and eight in year nine (14-15 year olds that address issues around the use of alcohol, tobacco, cannabis and other illicit drugs. Control students will receive the drug education normally provided in their schools. Students will be tested at baseline, at the end of each intervention year and also at the end of year ten. A self completion questionnaire will be used to collect information on knowledge, patterns and context of use, attitudes and harms experienced in relation to alcohol, tobacco, cannabis and other illicit drug use. Multi-level modelling will be the method of analysis because it can best accommodate hierarchically structured data. All analyses will be conducted on an Intent-to-Treat basis. In addition, focus groups will be conducted with teachers and students in five of the 14 intervention schools, subsequent to delivery of the year eight and nine programs. This will provide qualitative data about the effectiveness of the lessons and the relevance of the materials. Discussion The benefits of this drug education study derive both from the knowledge

  6. Drug induced acute kidney injury: an experimental animal study

    International Nuclear Information System (INIS)

    Khan, M.W.A.; Khan, B.T.; Qazi, R.A.; Ashraf, M.; Waqar, M.

    2017-01-01

    Objective: To assess the extent of drug induced nephrotoxicity in laboratory animals for determining the role and extent of iatrogenic kidney damage in patients exposed to nephrotoxic drugs in various clinical setups. Study Design: Randomized control trail. Place and Duration of study: Pharmacology department and animal house of Army Medical College from Jan 2011 to Aug 2011. Material and Methods: Thirty six mixed breed rabbits were used in this study. Animals were randomly divided into six groups consisting of six rabbits in each. Groups were named A, B, C, D, E and F. Group A was control group. Group B was given 0.9% normal saline. Group C rabbits were given acute nephrotoxic single dose of amphotericin B deoxycholate. Group D received 0.9% normal saline 10ml/kg followed by amphotericin B infusion. Group E was injected acute nephrotoxic regimen of cyclosporine and amphotericin B infusion. Group F received saline loading along with acute nephrotoxic regimen of cyclosporine and amphotericin B infusion. Results: Biochemical and histopathological analysis showed significant kidney injury in rabbits exposed to acute nephrotoxic doses of amphotericin B and cyclosporine. Toxicity was additive when the two drugs were administered simultaneously. Group of rabbits with saline loading had significantly lesser kidney damage. Conclusion: Iatrogenic acute kidney damage is a major cause of morbidity in experimental animals exposed to such nephrotoxic drugs like amphotericin B and cyclosporine, used either alone or in combination. Clinical studies are recommended to assess the extent of iatrogenic renal damage in patients and its economic burden. Efficient and cost effective protective measure may be adopted in clinical setups against such adverse effects. (author)

  7. Programma Conoscenza: Psycho-Educational, Integrated and Evolved Treatment for Cocaine Addiction

    Science.gov (United States)

    Leonardi, Andrea; Fioravanti, Paolo; Scavelli, Sonia; Velicogna, Francesco

    2009-01-01

    The 2005 EMCDDA (European Monitoring Centre for Drugs and Drug Addiction, Annual report 2005: the state of the drugs problem in Europe, from http://ar2005.emcdda.europa.eu/en/home-en.html?CFID=5556438&CFTOKEN=9393b63b806e64c7-FB015A79-E157-F9DE-99626FADD9F4C983&jsessionid=2e30185a01447c413a1e) annual report remarks the dearth of options…

  8. A review on the study of bioreductive drugs

    International Nuclear Information System (INIS)

    Chen Xiaojing; Jin Yizun

    2003-01-01

    Hypoxia is a feature that exists in most solid tumors. Bio-reductive drugs are pro-drugs that can selectively target the hypoxia cells in tumors. In reductive environment, they are reductively metabolized to generate toxic species. There are 3 main classes of bio-reductive drugs: the nitro-aromatics, N-oxides and quinones. Recently, bio-reductive drugs were combined with GDEPT for the treatment of cancer, in addition to radiation and the chemotherapeutic agents. Bio-reductive drugs will play a significant role in future cancer therapy

  9. Pilot Study of Essential Drug Quality in Two Major Cities in India

    Science.gov (United States)

    Bate, Roger; Tren, Richard; Mooney, Lorraine; Hess, Kimberly; Mitra, Barun; Debroy, Bibek; Attaran, Amir

    2009-01-01

    Background India is an increasingly influential player in the global pharmaceutical market. Key parts of the drug regulatory system are controlled by the states, each of which applies its own standards for enforcement, not always consistent with others. A pilot study was conducted in two major cities in India, Delhi and Chennai, to explore the question/hypothesis/extent of substandard and counterfeit drugs available in the market and to discuss how the Indian state and federal governments could improve drug regulation and more importantly regulatory enforcement to combat these drugs. Methodology/Principal Findings Random samples of antimalarial, antibiotic, and antimycobacterial drugs were collected from pharmacies in urban and peri-urban areas of Delhi and Chennai, India. Semi-quantitative thin-layer chromatography and disintegration testing were used to measure the concentration of active ingredients against internationally acceptable standards. 12% of all samples tested from Delhi failed either one or both tests, and were substandard. 5% of all samples tested from Chennai failed either one or both tests, and were substandard. Spatial heterogeneity between pharmacies was observed, with some having more or less substandard drugs (30% and 0% respectively), as was product heterogeneity, with some drugs being more or less frequently substandard (12% and 7% respectively). Conclusions/Significance In a study using basic field-deployable techniques of lesser sensitivity rather than the most advanced laboratory-based techniques, the prevalence of substandard drugs in Delhi and Chennai is confirmed to be roughly in accordance with the Indian government's current estimates. However, important spatial and product heterogeneity exists, which suggests that India's substandard drug problem is not ubiquitous, but driven by a subset of manufacturers and pharmacies which thrive in an inadequately regulated environment. It is likely that the drug regulatory system in India needs

  10. Pilot study of essential drug quality in two major cities in India.

    Directory of Open Access Journals (Sweden)

    Roger Bate

    Full Text Available BACKGROUND: India is an increasingly influential player in the global pharmaceutical market. Key parts of the drug regulatory system are controlled by the states, each of which applies its own standards for enforcement, not always consistent with others. A pilot study was conducted in two major cities in India, Delhi and Chennai, to explore the question/hypothesis/extent of substandard and counterfeit drugs available in the market and to discuss how the Indian state and federal governments could improve drug regulation and more importantly regulatory enforcement to combat these drugs. METHODOLOGY/PRINCIPAL FINDINGS: Random samples of antimalarial, antibiotic, and antimycobacterial drugs were collected from pharmacies in urban and peri-urban areas of Delhi and Chennai, India. Semi-quantitative thin-layer chromatography and disintegration testing were used to measure the concentration of active ingredients against internationally acceptable standards. 12% of all samples tested from Delhi failed either one or both tests, and were substandard. 5% of all samples tested from Chennai failed either one or both tests, and were substandard. Spatial heterogeneity between pharmacies was observed, with some having more or less substandard drugs (30% and 0% respectively, as was product heterogeneity, with some drugs being more or less frequently substandard (12% and 7% respectively. CONCLUSIONS/SIGNIFICANCE: In a study using basic field-deployable techniques of lesser sensitivity rather than the most advanced laboratory-based techniques, the prevalence of substandard drugs in Delhi and Chennai is confirmed to be roughly in accordance with the Indian government's current estimates. However, important spatial and product heterogeneity exists, which suggests that India's substandard drug problem is not ubiquitous, but driven by a subset of manufacturers and pharmacies which thrive in an inadequately regulated environment. It is likely that the drug regulatory

  11. [DESCRIPTIVE STUDY OF DRUGS OF ABUSE IN THE COMPLEJO HOSPITALARIO DE JAEN].

    Science.gov (United States)

    Alcántara Carrillo, José; Martínez Cañamero, Antonio; Martín Alcaide, Martín Ángel; Caño Garrido, Rosa; Nieto Martos, Manuela; Díaz Barranco, Ángeles

    2014-12-01

    Drugs is, according to the World Health Organization (WHO), any substance introduced into a living organism by any route is capable of acting on the central nervous system. For decades, drug abuse has increased in the population of our country but not all drugs are an illegal drug. The overall objective is the description of testing for drugs of abuse, and their distribution, as they were made in the Hospital Médico-Quirúrgico (HMQ) and Neurotraumatológico (HNT) of the Hospital of Jaén, in 2012. Secondary objectives analyzed the differences in the tests as variables: sex, months of the year and age of the subject (patient). We carry a description of differences by type of drug and associations of two, three, four or five drugs at once and finally, we study differences detected by drug or therapeutic use is illegal (of abuse). The results indicate a positive per 300 inhabitants, mostly men, adults and Hospital Neurotraumatológico. The most commonly detected drugs are benzodiazepines, alone or in association with cannabis.

  12. Factors influencing GPs’ choice between drugs in a therapeutic drug group. A qualitative study

    DEFF Research Database (Denmark)

    Buusman, Allan; Andersen, Morten; Merrild, Camilla Hoffmann

    2007-01-01

    (GPs) were selected with reference to variation in organizational structure, age, and gender. Main outcome measures. GPs' description of drug choice in relation to specific patient encounters involving a prescription. Results. All informants appeared to consider drug price important...... as it was a recurring theme during all interviews. External factors outside the GP's control such as governmental regulation on prescribing and the pharmaceutical industry influenced most GPs. Internal factors related to the actual consultation included characteristics of the GP and the patient, drug characteristics......, and repeat prescriptions. These factors interact in a non-linear and unpredictable way similar to complex adaptive systems. Conclusion. GPs balance both internal and external factors when choosing between analogues. Drug choice is a regulated process in the realm of complex prescribing behaviour with drug...

  13. 21 CFR 201.200 - Disclosure of drug efficacy study evaluations in labeling and advertising.

    Science.gov (United States)

    2010-04-01

    ... labeling and advertising. 201.200 Section 201.200 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... Efficacy Study § 201.200 Disclosure of drug efficacy study evaluations in labeling and advertising. (a)(1... bringing to the attention of the prescribers of prescription items the conclusions of the expert panels...

  14. Drug prescribing before and during pregnancy in south west France: a retrolective study.

    Science.gov (United States)

    Crespin, Sophie; Bourrel, Robert; Hurault-Delarue, Caroline; Lapeyre-Mestre, Maryse; Montastruc, Jean-Louis; Damase-Michel, Christine

    2011-07-01

    Several drugs that are known to exhibit teratogenic or fetotoxic risks when used during pregnancy should not be prescribed to pregnant women. However, most women of childbearing age use medications, and drug use cannot always be avoided during pregnancy, especially for women with chronic diseases for whom the benefit of treatment outweighs the potential risk of the drug for the fetus. Nevertheless, it is often possible to replace a drug with another one that has been better evaluated. The aim of the present study was to describe the prescribing of drugs to pregnant women before and during pregnancy in order to examine whether the occurrence of pregnancy modifies drug prescribing and dispensing to women. In particular, drugs that are contraindicated or must be avoided during pregnancy, such as retinoids, ACE inhibitors, angiotensin II receptor blockers, NSAIDs and valproic acid, will be analysed. This retrolective study used data already prospectively recorded in the database of the French Health Insurance Service. It analysed pharmacy records of women who gave birth between 1 January 2007 and 31 December 2007 in Midi-Pyrenees. Pharmacy data were analysed from 9 months before pregnancy until delivery. Drugs were classified according to the Anatomical Therapeutic Chemical code. The study included 23 898 women. Approximately 77% and 96% of the women received at least one prescription before and during pregnancy, respectively. The number of women who were prescribed contraindicated drugs significantly decreased with pregnancy (p drugs were stopped during the 3 months before pregnancy without alternative treatment, even for chronic diseases. However, for some women, potentially dangerous prescriptions were maintained during pregnancy, and for others these drugs were dispensed for the first time during critical periods of pregnancy. Despite recommendations, some teratogenic and/or fetotoxic drugs are still prescribed and dispensed to pregnant women in France. There is

  15. Drug and alcohol crash risk : a case-control study.

    Science.gov (United States)

    2016-12-01

    This study used a case-control design to estimate the risk of crashes involving drivers using drugs, alcohol or both. Data was collected in Virginia Beach, Virginia, for 20 months. The study obtained biological measures on more than 3,000 crash...

  16. Anti-addiction drug ibogaine inhibits voltage-gated ionic currents: A study to assess the drug's cardiac ion channel profile

    International Nuclear Information System (INIS)

    Koenig, Xaver; Kovar, Michael; Rubi, Lena; Mike, Agnes K.; Lukacs, Peter; Gawali, Vaibhavkumar S.; Todt, Hannes; Hilber, Karlheinz; Sandtner, Walter

    2013-01-01

    The plant alkaloid ibogaine has promising anti-addictive properties. Albeit not licenced as a therapeutic drug, and despite hints that ibogaine may perturb the heart rhythm, this alkaloid is used to treat drug addicts. We have recently reported that ibogaine inhibits human ERG (hERG) potassium channels at concentrations similar to the drugs affinity for several of its known brain targets. Thereby the drug may disturb the heart's electrophysiology. Here, to assess the drug's cardiac ion channel profile in more detail, we studied the effects of ibogaine and its congener 18-Methoxycoronaridine (18-MC) on various cardiac voltage-gated ion channels. We confirmed that heterologously expressed hERG currents are reduced by ibogaine in low micromolar concentrations. Moreover, at higher concentrations, the drug also reduced human Na v 1.5 sodium and Ca v 1.2 calcium currents. Ion currents were as well reduced by 18-MC, yet with diminished potency. Unexpectedly, although blocking hERG channels, ibogaine did not prolong the action potential (AP) in guinea pig cardiomyocytes at low micromolar concentrations. Higher concentrations (≥ 10 μM) even shortened the AP. These findings can be explained by the drug's calcium channel inhibition, which counteracts the AP-prolonging effect generated by hERG blockade. Implementation of ibogaine's inhibitory effects on human ion channels in a computer model of a ventricular cardiomyocyte, on the other hand, suggested that ibogaine does prolong the AP in the human heart. We conclude that therapeutic concentrations of ibogaine have the propensity to prolong the QT interval of the electrocardiogram in humans. In some cases this may lead to cardiac arrhythmias. - Highlights: • We study effects of anti-addiction drug ibogaine on ionic currents in cardiomyocytes. • We assess the cardiac ion channel profile of ibogaine. • Ibogaine inhibits hERG potassium, sodium and calcium channels. • Ibogaine’s effects on ion channels are a potential

  17. The impact of medicinal drugs on traffic safety: a systematic review of epidemiological studies.

    Science.gov (United States)

    Orriols, Ludivine; Salmi, Louis-Rachid; Philip, Pierre; Moore, Nicholas; Delorme, Bernard; Castot, Anne; Lagarde, Emmanuel

    2009-08-01

    To evaluate the quality of epidemiological research into effects of medicinal drugs on traffic safety and the current knowledge in this area. The bibliographic search was done in Medline electronic database using the keywords: ((accident* or crash*) and traffic and drug*) leading to 1141 references. Additional references were retrieved from the Safetylit website and the reference lists of selected studies. Original articles published in English or French, between 1 April 1979 and 31 July 2008, were considered for inclusion. We excluded descriptive studies, studies limited to alcohol or illicit drug involvement and investigations of injuries other than from traffic crashes. Studies based on laboratory tests, driving simulators or on-the-road driving tests were also excluded. Eligible studies had to evaluate the causal relationship between the use of medicinal drugs and the risk of traffic crashes. Study quality was assessed by two independent experts, according to a grid adapted from the strengthening the reporting of observational studies in epidemiology (STROBE) statement. Twenty two studies of variable methodological quality were included. Definition of drug exposure varied across studies and depended on the data sources. Potential confounding due to the interaction between the effects of the medicinal drug and disease-related symptoms was often not controlled. The risk of motor-vehicle crashes related to benzodiazepines has been amply studied and demonstrated. Results for other medicinal drugs remain controversial. There is a need for large studies, investigating the role of individual substances in the risk of road traffic crashes. Copyright 2009 John Wiley & Sons, Ltd.

  18. Enantiomeric profiling of chiral illicit drugs in a pan-European study

    NARCIS (Netherlands)

    Castrignanò, E.; Yang, Z.; Bade, R.; Baz-Lomba, J.A.; Castiglioni, S.; Causanilles, A.; Covaci, A.; Gracia-Lor, E.; Hernández, F.; Kinyua, J.; McCall, A.-K.; van Nuijs, A.L.N.; Ort, C.; Plósz, B.G.; Ramin, P.; Rousis, N.I.; Ryu, Y.; Thomas, K.V.; de Voogt, P.; Zuccato, E.; Kasprzyk-Hordern, B.

    2018-01-01

    The aim of this paper is to present the first study on spatial and temporal variation in the enantiomeric profile of chiral drugs in eight European cities. Wastewater-based epidemiology (WBE) and enantioselective analysis were combined to evaluate trends in illicit drug use in the context of their

  19. A baseline study of drug prescribing practices in a Nigerian military ...

    African Journals Online (AJOL)

    Military facilities provide health care services to an important segment of both themilitary and civil population. Methods: The aim of this study was to evaluate drug prescribing practices at a Nigerian military hospital (MilitaryHospital, Ikoyi, Lagos) and tomake recommendations for its improvement.UsingWHOrational drug use ...

  20. Bioanalysis and metabolite identification of anticancer drugs in mass balance studies

    NARCIS (Netherlands)

    Dubbelman, A.C.

    2012-01-01

    Anticancer drugs are valuable assets in the treatment of cancer. However, before a new drug is admitted to the market and available for patients, it has to survive a lengthy path of pre-clinical and clinical studies to demonstrate its efficacy and safety. Critical information required to understand

  1. A PROSPECTIVE, OBSERVATIONAL STUDY OF ADVERSE REACTIONS TO DRUG REGIME FOR MULTI-DRUG RESISTANT PULMONARY TUBERCULOSIS IN CENTRAL INDIA.

    Directory of Open Access Journals (Sweden)

    Dr. Rohan C. Hire

    2014-09-01

    Full Text Available Abstract Objective: 1 To assess the adverse drug reactions of second line anti-tubercular drugs used to treat Multi-drug resistant Tuberculosis (MDR TB in central India on the basis of causality, severity and avoidability scales. 2 To study the relationship of type of MDR TB (primary or secondary and presence of diabetes mellitus (DM with mean smear conversion time. Material and Methods: A prospective, observational study was carried out on diagnosed multidrug resistant tuberculosis patients enrolled for DOTS‑Plus regimen at TB and Chest Disease Department from January to December 2012. They were followed for 9 months thereafter and encountered adverse drug reactions (ADRs were noted along with the time of sputum conversion. The data were analysed by Chi-square or Fisher’s exact test and unpaired student’s‘t’ test. Results: Total 64 ADRs were reported in 55 patients out of total 110 patients (n = 110. As per the Naranjo causality assessment of ADRs, 7 patients had “definite” causal relation, 45 had “probable” causal relation and 3 had “possible” causal relation with drugs of DOTS Plus regime. As per the Hartwig’s severity assessment scale, there were total 7 ADRs in Level 1, 6 in Level 2, 33 in Level 3 and 9 in Level 4. Hallas avoidability assessment scale divided the ADRs as 3 being “Definitely avoidable”, 26 “Possibly avoidable”, 23 “Not avoidable” and 3 “unevaluable”. . Mean sputum smear conversion time is significantly higher in patients with secondary type than that of primary type of MDR TB (p = 0.0001 and in patients with DM than those without DM (p <0.0001. Conclusion: ADRs were common in patients of MDR TB on DOTs-Plus drug regime. It was due to lack of availability of safer and equally potent drugs in DOTs-Plus drug regime compared to DOTS regime in non-resistant TB. The frequency and severity of ADRs can be reduced by strict vigilance about known and unknown ADRs, monitoring their laboratory and

  2. Titration calorimetry of surfactant–drug interactions: Micelle formation and saturation studies

    International Nuclear Information System (INIS)

    Waters, Laura J.; Hussain, Talib; Parkes, Gareth M.B.

    2012-01-01

    Highlights: ► Isothermal titration calorimetry can be used to monitor the saturation of micelles with pharmaceutical compounds. ► The number of drug molecules per micelle varies depending on the drug used and the temperature of the calorimeter. ► The change in enthalpy for the saturation of micelles with drugs can be endothermic or exothermic. ► The critical micellar concentration of an anionic surfactant (SDS) does not appear to vary in the presence of drugs. - Abstract: Isothermal titration calorimetry (ITC) was employed to monitor the addition of five model drugs to anionic surfactant based micelles, composed of sodium dodecyl sulfate (SDS), through to the point at which they were saturated with drug. Analysis of the resultant data using this newly developed method has confirmed the suitability of the technique to acquire such data with saturation limits established in all cases. Values for the point at which saturation occurred ranged from 17 molecules of theophylline per micelle at T = 298 K up to 63 molecules of caffeine per micelle at 310 K. Micellar systems can be disrupted by the presence of additional chemicals, such as the drugs used in this study, therefore a separate investigation was undertaken to determine the critical micellar concentration (CMC) for SDS in the presence of each drug at T = 298 K and 310 K using ITC. In the majority of cases, there was no appreciable alteration to the CMC of SDS with drug present.

  3. Drug distribution in man: a positron emission tomography study after oral administration of the labelled neuroprotective drug vinpocetine

    International Nuclear Information System (INIS)

    Gulyas, Balazs; Halldin, Christer; Sandell, Johan; Farde, Lars; Sovago, Judit; Cselenyi, Zsolt; Vas, Adam; Kiss, Bela; Karpati, Egon

    2002-01-01

    Direct information on the distribution of a drug requires measurements in various tissues. Such data have until now been obtained in animals, or have indirectly been calculated from plasma measurements in humans using mathematical models. Here we suggest the use of positron emission tomography (PET) as a method to obtain direct measurements of drug distribution in the human body. The distribution in body and brain of vinpocetine, a neuroprotective drug widely used in the prevention and treatment of cerebrovascular diseases, was followed after oral administration. Vinpocetine was labelled with carbon-11 and radioactivity was measured by PET in stomach, liver, brain and kidney in six healthy volunteers. The radioactivity in blood and urine as well as the fractions of [ 11 C]vinpocetine and labelled metabolites in plasma were also determined. After oral administration, [ 11 C]vinpocetine appeared immediately in the stomach and within minutes in the liver and the blood. In the blood the level of radioactivity continuously increased until the end of the measurement period, whereas the fraction of the unchanged mother compound decreased. Radioactivity uptake and distribution in the brain were demonstrable from the tenth minute after the administration of the labelled drug. Brain distribution was heterogeneous, similar to the distribution previously reported after intravenous administration. These findings indicate that vinpocetine, administered orally in humans, readily enters the bloodstream from the stomach and gastrointestinal tract and, consequently, passes the blood-brain barrier and enters the brain. Radioactivity from [ 11 C]vinpocetine was also demonstrated in the kidneys and in urine, indicating that at least a part of the radioactive drug and labelled metabolites is eliminated from the body through the kidneys. This study is the first to demonstrate that PET might be a useful, direct and non-invasive tool to study the distribution and pharmacokinetics of orally

  4. Drug distribution in man: a positron emission tomography study after oral administration of the labelled neuroprotective drug vinpocetine.

    Science.gov (United States)

    Gulyás, Balázs; Halldin, Christer; Sóvágó, Judit; Sandell, Johan; Cselényi, Zsolt; Vas, Adám; Kiss, Béla; Kárpáti, Egon; Farde, Lars

    2002-08-01

    Direct information on the distribution of a drug requires measurements in various tissues. Such data have until now been obtained in animals, or have indirectly been calculated from plasma measurements in humans using mathematical models. Here we suggest the use of positron emission tomography (PET) as a method to obtain direct measurements of drug distribution in the human body. The distribution in body and brain of vinpocetine, a neuroprotective drug widely used in the prevention and treatment of cerebrovascular diseases, was followed after oral administration. Vinpocetine was labelled with carbon-11 and radioactivity was measured by PET in stomach, liver, brain and kidney in six healthy volunteers. The radioactivity in blood and urine as well as the fractions of [(11)C]vinpocetine and labelled metabolites in plasma were also determined. After oral administration, [(11)C]vinpocetine appeared immediately in the stomach and within minutes in the liver and the blood. In the blood the level of radioactivity continuously increased until the end of the measurement period, whereas the fraction of the unchanged mother compound decreased. Radioactivity uptake and distribution in the brain were demonstrable from the tenth minute after the administration of the labelled drug. Brain distribution was heterogeneous, similar to the distribution previously reported after intravenous administration. These findings indicate that vinpocetine, administered orally in humans, readily enters the bloodstream from the stomach and gastrointestinal tract and, consequently, passes the blood-brain barrier and enters the brain. Radioactivity from [(11)C]vinpocetine was also demonstrated in the kidneys and in urine, indicating that at least a part of the radioactive drug and labelled metabolites is eliminated from the body through the kidneys. This study is the first to demonstrate that PET might be a useful, direct and non-invasive tool to study the distribution and pharmacokinetics of orally

  5. Drug-drug interaction and doping, part 1: an in vitro study on the effect of non-prohibited drugs on the phase I metabolic profile of toremifene.

    Science.gov (United States)

    Mazzarino, Monica; de la Torre, Xavier; Fiacco, Ilaria; Palermo, Amelia; Botrè, Francesco

    2014-05-01

    The present study was designed to provide preliminary information on the potential impact of metabolic drug-drug interaction on the effectiveness of doping control strategies currently followed by the anti-doping laboratories to detect the intake of banned agents. In vitro assays based on the use of human liver microsomes and recombinant CYP isoforms were designed and performed to characterize the phase I metabolic profile of the prohibited agent toremifene, selected as a prototype drug of the class of selective oestrogen receptor modulators, both in the absence and in the presence of medicaments (fluconazole, ketoconazole, itraconazole, miconazole, cimetidine, ranitidine, fluoxetine, paroxetine, nefazodone) not included in the World Anti-Doping Agency list of prohibited substances and methods and frequently administered to athletes. The results show that the in vitro model developed in this study was adequate to simulate the in vivo metabolism of toremifene, confirming the results obtained in previous studies. Furthermore, our data also show that ketoconazole, itraconazole, miconazole and nefazodone cause a marked modification in the production of the metabolic products (i.e. hydroxylated and carboxylated metabolites) normally selected by the anti-doping laboratories as target analytes to detect toremifene intake; moderate variations were registered in the presence of fluconazole, paroxetine and fluoxetine; while no significant modifications were measured in the presence of ranitidine and cimetidine. This evidence imposes that the potential effect of drug-drug interactions is duly taken into account in anti-doping analysis, also for a broader significance of the analytical results. Copyright © 2014 John Wiley & Sons, Ltd.

  6. Photostability and Photostabilization of Drugs and Drug Products

    Directory of Open Access Journals (Sweden)

    Iqbal Ahmad

    2016-01-01

    Full Text Available Photostability studies of drugs and drug products are an integral part of the product development process in the pharmaceutical industry. These studies are carried out to ensure quality, efficacy, and safety of the formulated products during manufacture, storage, and use. This review deals with the concept of photostability and related aspects and the literature available in the field. It highlights the role of the photochemistry in the photostability studies, describes the functional groups important for the photoreactivity of drugs, explains photophysical processes, and deals with the kinetics of photochemical reactions. The various modes of photodegradation of drugs with examples of selected compounds are presented. The biological consequences of the effect of light on the drug degradation are described. The photostability testing of drugs and drug products and the requirements under ICH guideline are discussed. Some information on the packaging requirements for the formulated products is provided. The various methods used for the photostabilization of solid and liquid dosage forms are also discussed.

  7. Interaction of charged amphiphilic drugs with phosphatidylcholine vesicles studied by NMR

    International Nuclear Information System (INIS)

    Eriksson, L.E.G.

    1987-01-01

    Small unilamellar vesicles from egg phosphatidylcholine in NaCl solutions were exposed to some amphiphilic pharmaca. The aromatic drugs (chlorpromazine, dibucaine, tetracaine, imipramine and propranolol) were in their cationic form of the amines. By 1 H- and 31 P-NMR the membrane signals were observed. In particular, the N-methyl choline proton signals were followed upon drug addition. The intrinsic chemical shift difference (0.02 ppm) between the inner (upfield) and outer choline signals was influenced by the drug concentration. Packing properties of the lipid head groups and ring current shift probably contributed. At very high drug concentration, the vesicles are destroyed. A transformation into a micellar state with a high sample viscosity took place in a narrow concentration range of drug. The anion effects of Cl - were studied from the 35 Cl-NMR linewidth at 9.8 and 39.1 MHz. A continuous increase in the signal linewidth followed upon drug addition to the vesicles. Only chlorpromazine produced a broadening in the absence of vesicles (NaCl blank). The linewidth reflected a critical micelle concentration of this drug around 7 mM in 0.1 M NaCl. The 35 Cl-NMR experiments demonstrated the existence of an anionic counterion effect. This phenomenon should be accounted for when quantitatively analysing drug-membrane interactions in electrostatic terms. (Auth.)

  8. Beyond post-marketing research and MedWatch: Long-term studies of drug risks.

    Science.gov (United States)

    Resnik, David B

    2007-10-01

    Critics of the drug safety system have discussed many different potential reforms, ranging from mandatory registration of clinical trials to increasing the power of regulatory agencies, but few have discussed one of the most important ways of enhancing safety: increasing the number of long-term studies of medications. Long-term studies of the risks and benefits of drugs can provide useful information for regulators, healthcare professionals, and patients. Government funding agencies should lead the effort to conduct long-term studies of drugs, but private companies should also be required to lend financial support. Because cost-effectiveness is likely to be an important consideration in conducting this research, funding agencies should focus, at first, on drugs that are used to treat common, chronic conditions.

  9. Drug Target Identification and Elucidation of Natural Inhibitors for : An Study

    Directory of Open Access Journals (Sweden)

    Surya Narayan Rath

    2016-12-01

    Full Text Available Environmental microbes like Bordetella petrii has been established as a causative agent for various infectious diseases in human. Again, development of drug resistance in B. petrii challenged to combat against the infection. Identification of potential drug target and proposing a novel lead compound against the pathogen has a great aid and value. In this study, bioinformatics tools and technology have been applied to suggest a potential drug target by screening the proteome information of B. petrii DSM 12804 (accession No. PRJNA28135 from genome database of National Centre for Biotechnology information. In this regards, the inhibitory effect of nine natural compounds like ajoene (Allium sativum, allicin (A. sativum, cinnamaldehyde (Cinnamomum cassia, curcumin (Curcuma longa, gallotannin (active component of green tea and red wine, isoorientin (Anthopterus wardii, isovitexin (A. wardii, neral (Melissa officinalis, and vitexin (A. wardii have been acknowledged with anti-bacterial properties and hence tested against identified drug target of B. petrii by implicating computational approach. The in silico studies revealed the hypothesis that lpxD could be a potential drug target and with recommendation of a strong inhibitory effect of selected natural compounds against infection caused due to B. petrii, would be further validated through in vitro experiments.

  10. Pharmacogenetics of drug-induced arrhythmias : a feasibility study using spontaneous adverse drug reactions reporting data

    NARCIS (Netherlands)

    De Bruin, Marie L; van Puijenbroek, Eugene P; Bracke, Madelon; Hoes, Arno W; Leufkens, Hubert G M

    PURPOSE: The bottleneck in pharmacogenetic research on rare adverse drug reactions (ADR) is retrieval of patients. Spontaneous reports of ADRs may form a useful source of patients. We investigated the feasibility of a pharmacogenetic study, in which cases were selected from the database of a

  11. Asymmetrical flow field-flow fractionation with on-line detection for drug transfer studies: a feasibility study

    DEFF Research Database (Denmark)

    Hinna, A.; Steiniger, F.; Hupfeld, S.

    2014-01-01

    Knowledge about drug retention within colloidal carriers is of uppermost importance particularly if drug targeting is anticipated. The aim of the present study was to evaluate asymmetrical flow field-flow fractionation (AF4) with on-line UV/VIS drug quantification for its suitability to determine...... both release and transfer of drug from liposomal carriers to a model acceptor phase consisting of large liposomes. The hydrophobic porphyrin 5,10,15,20-tetrakis(4-hydroxyphenyl)21H,23H-porphine (p-THPP), a fluorescent dye with an absorbance maximum in the visible range and structural similarity...... channel geometries. Drug quantification by on-line absorbance measurements was established by comprehensive evaluation of the size-dependent turbidity contribution in on-line UV/VIS detection and by comparison with off-line results obtained for the respective dye-loaded donor formulations (dissolved...

  12. Antiepileptic drugs and risk of suicide: a nationwide study

    DEFF Research Database (Denmark)

    Olesen, J.B.; Hansen, Peter Riis; Erdal, Jesper

    2010-01-01

    Purpose Patients with epilepsy or psychiatric diseases have increased risk of suicide, but whether the risk is influenced by antiepileptic drug (AED) treatment is unclear. Studies have suggested that AEDs in general increase the risk of suicidal behaviour shortly after initiation. This study inve...

  13. Why Clinicians Don't Report Adverse Drug Events: Qualitative Study.

    Science.gov (United States)

    Hohl, Corinne M; Small, Serena S; Peddie, David; Badke, Katherin; Bailey, Chantelle; Balka, Ellen

    2018-02-27

    Adverse drug events are unintended and harmful events related to medications. Adverse drug events are important for patient care, quality improvement, drug safety research, and postmarketing surveillance, but they are vastly underreported. Our objectives were to identify barriers to adverse drug event documentation and factors contributing to underreporting. This qualitative study was conducted in 1 ambulatory center, and the emergency departments and inpatient wards of 3 acute care hospitals in British Columbia between March 2014 and December 2016. We completed workplace observations and focus groups with general practitioners, hospitalists, emergency physicians, and hospital and community pharmacists. We analyzed field notes by coding and iteratively analyzing our data to identify emerging concepts, generate thematic and event summaries, and create workflow diagrams. Clinicians validated emerging concepts by applying them to cases from their clinical practice. We completed 238 hours of observations during which clinicians investigated 65 suspect adverse drug events. The observed events were often complex and diagnosed over time, requiring the input of multiple providers. Providers documented adverse drug events in charts to support continuity of care but never reported them to external agencies. Providers faced time constraints, and reporting would have required duplication of documentation. Existing reporting systems are not suited to capture the complex nature of adverse drug events or adapted to workflow and are simply not used by frontline clinicians. Systems that are integrated into electronic medical records, make use of existing data to avoid duplication of documentation, and generate alerts to improve safety may address the shortcomings of existing systems and generate robust adverse drug event data as a by-product of safer care. ©Corinne M Hohl, Serena S Small, David Peddie, Katherin Badke, Chantelle Bailey, Ellen Balka. Originally published in JMIR

  14. Present studies on the radio-sterilized drugs

    International Nuclear Information System (INIS)

    Marciniec, B.; Dettlaff, K.

    2007-01-01

    Lecture presents present status of radiosterilization of drugs and medical materials as compared to other sterilization methods. Literature review is shown on degradation of different kinds of drugs sterilized upon action of the sterilising doses of radiation

  15. Transitions in drug use in a new generation of problem drug users in Amsterdam: a 6-year follow-up study

    NARCIS (Netherlands)

    Buster, Marcel C. A.; Witteveen, Ewald; Prins, Maria; van Ameijden, Erik J. C.; Schippers, Gerard; Krol, Anneke

    2009-01-01

    This study describes the transitions in drug use in Amsterdam among young drug users (YDUs) who are inhaling or injecting cocaine or using illicitly obtained opiates. From 2000 until 2003, 187 YDUs (

  16. Identification and quantification of drug-albumin adducts in serum samples from a drug exposure study in mice

    NARCIS (Netherlands)

    Switzar, L.; Kwast, L.M.; Lingeman, H.; Giera, M.; Pieters, R.H.H.; Niessen, W.M.A.

    2013-01-01

    The formation of drug-protein adducts following the bioactivation of drugs to reactive metabolites has been linked to adverse drug reactions (ADRs) and is a major complication in drug discovery and development. Identification and quantification of drug-protein adducts in vivo may lead to a better

  17. SC lipid model membranes designed for studying impact of ceramide species on drug diffusion and permeation--part II: diffusion and permeation of model drugs.

    Science.gov (United States)

    Ochalek, M; Podhaisky, H; Ruettinger, H-H; Wohlrab, J; Neubert, R H H

    2012-10-01

    The barrier function of two quaternary stratum corneum (SC) lipid model membranes, which were previously characterized with regard to the lipid organization, was investigated based on diffusion studies of model drugs with varying lipophilicities. Diffusion experiments of a hydrophilic drug, urea, and more lipophilic drugs than urea (i.e. caffeine, diclofenac sodium) were conducted using Franz-type diffusion cells. The amount of permeated drug was analyzed using either HPLC or CE technique. The subjects of interest in the present study were the investigation of the influence of physicochemical properties of model drugs on their diffusion and permeation through SC lipid model membranes, as well as the study of the impact of the constituents of these artificial systems (particularly ceramide species) on their barrier properties. The diffusion through both SC lipid model membranes and the human SC of the most hydrophilic model drug, urea, was faster than the permeation of the more lipophilic drugs. The slowest rate of permeation through SC lipid systems occurred in the case of caffeine. The composition of SC lipid model membranes has a significant impact on their barrier function. Model drugs diffused and permeated faster through Membrane II (presence of Cer [EOS]). In terms of the barrier properties, Membrane II is much more similar to the human SC than Membrane I. Copyright © 2012 Elsevier B.V. All rights reserved.

  18. ART drugs help reduce HIV transmission, Chinese study finds ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    International Development Research Centre Government of Canada ... ART drugs help reduce HIV transmission, Chinese study finds ... where only one person has HIV can reduce HIV transmission rates, at least in the short term, a Chinese study has found. ... Ecohealth Field-building Leadership Initiative in Southeast Asia.

  19. African Journal of Drug and Alcohol Studies: Editorial Policies

    African Journals Online (AJOL)

    Focus and Scope. The "African Journal of Drug & Alcohol Studies" is an international scientific journal published by the African Centre for Research and Information on Substance Abuse (CRISA). The Journal publishes original research, evaluation studies, case reports, review articles and book reviews of high scholarly ...

  20. A Clinico-Epidemiological Study on Poisonings due to Cardiovascular Drugs in Ahvaz, Iran

    Directory of Open Access Journals (Sweden)

    Marzie Zeinvand

    2017-03-01

    Full Text Available Background: Overdoses with cardiovascular drugs are related with significant morbidity and mortality. Beta-adrenergic blockers, calcium-channel blockers (CCBs, thiazide, digoxin and angiotensin converting enzyme (ACE inhibitors represent five of the most important classes of cardiovascular drugs. Overdoses with cardiovascular drugs are typically caused by exploratory ingestion by children or intentional ingestion by suicidal adults. As no study has been performed about poisoning with this kind of drug in Khuzestan, this study aimed to investigate the frequency of cardiovascular drug poisoning and its clinical features in patients presenting in Razi Hospital of Ahvaz from 2005 to 2009. Methods: A retrospective review of medical records of patients poisoned with cardiovascular who were treated at Clinical Toxicology Department was executed. A total of 70 poisoning cases referred to Razi Hospital were identified. These unselected cases included intentional, accidental, criminal and occupational circumstances. Beta-blocker poisoning, digital poisoning, calcium-channel blockers poisoning, ACE inhibitor poisoning, thiazide poisoning and poisoning with other cardiovascular drugs were evaluated on the basis of recorded data. Poisoning with one or several agents, time of admission, type of poisoned agents, sex, age, therapeutic intervention and mortality were investigated. Results: This study revealed that most of the people poisoned with cardiovascular drugs were females, single people and urban population. Most of the patients were 15-25 years old. Most poisoning was with beta blocker and calcium channel blockers. Their first symptom was headache and most of them needed ICU admission. Most of the patient ECGs were normal. There were 2 cases of death. Conclusion: This study revealed that continuous health care and the administration of the exact dose of drugs in the appropriate time and also developing of the toxicology centers seem necessary.

  1. Medical databases in studies of drug teratogenicity: methodological issues

    Directory of Open Access Journals (Sweden)

    Vera Ehrenstein

    2010-03-01

    Full Text Available Vera Ehrenstein1, Henrik T Sørensen1, Leiv S Bakketeig1,2, Lars Pedersen11Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark; 2Norwegian Institute of Public Health, Oslo, NorwayAbstract: More than half of all pregnant women take prescription medications, raising concerns about fetal safety. Medical databases routinely collecting data from large populations are potentially valuable resources for cohort studies addressing teratogenicity of drugs. These include electronic medical records, administrative databases, population health registries, and teratogenicity information services. Medical databases allow estimation of prevalences of birth defects with enhanced precision, but systematic error remains a potentially serious problem. In this review, we first provide a brief description of types of North American and European medical databases suitable for studying teratogenicity of drugs and then discuss manifestation of systematic errors in teratogenicity studies based on such databases. Selection bias stems primarily from the inability to ascertain all reproductive outcomes. Information bias (misclassification may be caused by paucity of recorded clinical details or incomplete documentation of medication use. Confounding, particularly confounding by indication, can rarely be ruled out. Bias that either masks teratogenicity or creates false appearance thereof, may have adverse consequences for the health of the child and the mother. Biases should be quantified and their potential impact on the study results should be assessed. Both theory and software are available for such estimation. Provided that methodological problems are understood and effectively handled, computerized medical databases are a valuable source of data for studies of teratogenicity of drugs.Keywords: databases, birth defects, epidemiologic methods, pharmacoepidemiology

  2. Recent updates on drug abuse analyzed by neuroproteomics studies: Cocaine, Methamphetamine and MDMA

    Directory of Open Access Journals (Sweden)

    Firas Kobeissy

    2014-06-01

    Full Text Available Currently, drug abuse and addiction represent a global public health concern with about 13.6 million people using illicit drugs in the USA alone. Substance abuse intervenes in normal brain functioning, causing alterations in memory, behavior and neuronal physiology. Although many studies have been conducted to elucidate the mode of action of different drugs, the heterogeneous modes of drug intake led to a complicated profile of drug-induced brain changes involving neurotoxicity and addiction. Given the complex interplay of genes and proteins in mediating these effects, neuroproteomics analysis has been considered among the methods of choice to complement what has already been discovered and to create targeted therapies. In this review, we will focus on three drugs, namely cocaine, methamphetamine (METH and 3,4-methylenedioxy-N-methylamphetamine (MDMA. In the context of neuroproteomics, these drugs have been extensively studied by utilizing different experimental models, including primate and non-primate animals along with postmortem human samples. Even though there are many variations in the results, these drugs were shown to employ common pathways in eliciting their effects. Neuroproteomics analysis of these drugs has led to the identification of differentially expressed proteins involved in metabolism, oxidative stress, cell signaling, cytoskeleton, cell death and synaptic plasticity. Finally, this work will discuss recent findings from our laboratory by looking at a model of chronic methamphetamine abuse and its effect on different brain regions.

  3. Pharmacological toxicological studies on certain drugs subjected to radiation or used radioprotective agents

    Energy Technology Data Exchange (ETDEWEB)

    Hassan, S H.M. [Durng Research Dept., National Center for Radiation Research and Technology, Atomic Energy Authority, Cairo, (Egypt)

    1995-10-01

    The present study represents two main subjects. The first encounters the effect of radiosterilization of certain pharmaceretical preparations such as antihistaminics (cimetidine), anticonvulsants (diazepam), beta and calcium channel blacker (propranolol and verapamil) on their pharmacological activity. Results of this study revealed that the previously mentioned drugs can be effectively and safely sterilized by gamma irradiation without deleterious effect on their pharmacological activity. The other subject presented in this study is essentially a pharmacological subject encountering toxicological problems. Data of this study demonstrated that chemical radiation protection has been successfully reported using single drug administration has been successfully reported using single drug administration such as imidazole, and Sh-bearing compounds. In the present work, the radioprotective effect of imidazole was demonstrated on the cardiovascular and respiratory systems. Furthermore, combined drug administration was found to exert more protective action with less toxicity and therefore minimize the side effects of the radioprotective drugs. Thus, combination of imidazole and serotonin showed potential protective effect on blood gases was also reported. In addition, combination of cysteine and vitamin E afforded a better protection on adrenocortical function in rats than either agent alone. 4 figs., 1 tab.

  4. Pharmacological toxicological studies on certain drugs subjected to radiation or used radioprotective agents

    International Nuclear Information System (INIS)

    Hassan, S.H.M.

    1995-01-01

    The present study represents two main subjects. The first encounters the effect of radiosterilization of certain pharmaceretical preparations such as antihistaminics (cimetidine), anticonvulsants (diazepam), beta and calcium channel blacker (propranolol and verapamil) on their pharmacological activity. Results of this study revealed that the previously mentioned drugs can be effectively and safely sterilized by gamma irradiation without deleterious effect on their pharmacological activity. The other subject presented in this study is essentially a pharmacological subject encountering toxicological problems. Data of this study demonstrated that chemical radiation protection has been successfully reported using single drug administration has been successfully reported using single drug administration such as imidazole, and Sh-bearing compounds. In the present work, the radioprotective effect of imidazole was demonstrated on the cardiovascular and respiratory systems. Furthermore, combined drug administration was found to exert more protective action with less toxicity and therefore minimize the side effects of the radioprotective drugs. Thus, combination of imidazole and serotonin showed potential protective effect on blood gases was also reported. In addition, combination of cysteine and vitamin E afforded a better protection on adrenocortical function in rats than either agent alone. 4 figs., 1 tab

  5. Study on drug costs associated with COPD prescription medicine in Denmark.

    Science.gov (United States)

    Jakobsen, Marie; Anker, Niels; Dollerup, Jens; Poulsen, Peter Bo; Lange, Peter

    2013-10-01

    Spirometric studies of the general population estimate that 430 000 Danes have chronic obstructive pulmonary disease (COPD). COPD is mainly caused by smoking, and smoking cessation is the most important intervention to prevent disease progression. Cost-of-illness studies conclude that the costs associated with COPD in Denmark are significant, but costs of prescription medicine for COPD were not analysed. To analyse the societal costs associated with prescription medicine for COPD in Denmark. The study was designed as a nationwide retrospective register study of the drug costs (ATC group R03) associated with COPD in the period 2001-2010. Data were retrieved from the Prescription Database, the National Patient Register and the Centralised Civil Register. The population comprised individuals (40+ years) who had at least one prescription of selected R03 drugs and who had been either hospitalised with a COPD diagnosis or had at least one prescription for drugs primarily used for COPD. The study population comprised 166 462 individuals of which 97 916 were alive on 31 December 2010. The average annual drug costs (R03) were DKK 7842 (EUR 1055) per patient in 2010 with total costs of DKK 685 million (EUR 92 million). The average lifetime costs associated with COPD prescription medicine were estimated to be DKK 70 000-75 000 (EUR 9416-10 089) per patient (2010 prices). The costs associated with prescription medicine for COPD in Denmark are significant. © 2012 John Wiley & Sons Ltd.

  6. A study of the distribution of schistosomicidal drug H-3-7505 in mice

    International Nuclear Information System (INIS)

    Hao, T.

    1985-01-01

    The authors have studied the distribution of H-3 labelled schistosomicidal drug in mice by autoradiography. The H-3-labelled substances were found in liver and kidney and in successfully decreasing amounts in brain, lung, heart, fat, testis, pancreas and spleen. In various cells the silver granules were present mainly in the cytoplasms but a few in the nucleus. After administration of this labelled schistosomicidal drug, the mice were killed and studied in groups successively at 4, 8, 24 hrs. No difference in the distribution of silver granules were observed. This fact indicated that, this drug was rapidly absorbed and highly concentrated with a long duration of reservation in liver. All of these favours the schistosomicidal effect of the drug. As this drug was highly concentrated in the cytoplasm of liver cells, that might provide a pathophysiologic basis for the explanation of jaundice in the clinical practice. Moreover, the appearance of toxic reaction in nervous system may be related to the relatively high concentration of the drug distributed in the brain

  7. Legal Drugs Are Good Drugs And Illegal Drugs Are Bad Drugs

    Directory of Open Access Journals (Sweden)

    Dina Indrati

    2011-07-01

    Full Text Available ABSTRACT : Labelling drugs are important issue nowadays in a modern society. Although it is generally believed that legal drugs are good drugs and illegal drugs are bad drugs, it is evident that some people do not aware about the side effects of drugs used. Therefore, a key contention of this philosophical essay is that explores harms minimisation policy, discuss whether legal drugs are good drugs and illegal drugs are bad drugs and explores relation of drugs misuse in a psychiatric nursing setting and dual diagnosis.Key words: Legal, good drugs, illegal, bad drugs.

  8. Psychomotor developmental effects of prenatal exposure to psychotropic drugs: a study in EFEMERIS database.

    Science.gov (United States)

    Hurault-Delarue, Caroline; Damase-Michel, Christine; Finotto, Laurent; Guitard, Claudine; Vayssière, Christophe; Montastruc, Jean-Louis; Montastruc, François; Lacroix, Isabelle

    2016-10-01

    Little is known about neurodevelopment of children exposed to psychotropic drugs during pregnancy. The purpose of this study was to evaluate the effects of prenatal exposure to psychotropic drugs on psychomotor development in children. This observational study used the EFEMERIS database. The database records the drugs prescribed and delivered during pregnancy and the resulting outcomes. Neurodevelopment at nine and 24 months of children born to women exposed to psychotropic drugs (anxiolytics, antidepressants, neuroleptics and anti-epileptics) during the second and/or third trimesters of pregnancy was compared to children who were not exposed to these drugs. Psychomotor development of 493 children (1.5%) exposed to psychotropic drugs during pregnancy was compared to 32 303 unexposed children. Exposure to psychotropic drugs during pregnancy was associated with an increased risk of abnormal motor development at 9 months (OR = 1.3 [1.1-2.2]) and abnormal motor and mental development at 24 months (OR = 4.8 [2.1-11.0] and OR = 2.3 [1.05-4.9]). Increased risk was observed in children born to women exposed to anti-epileptic drugs, neuroleptics or antidepressants during pregnancy. This study found a higher rate of deviation from the normal developmental milestones in children born to women exposed to psychotropic drugs during pregnancy and more particularly antidepressants, neuroleptics and anti-epileptics. © 2016 Société Française de Pharmacologie et de Thérapeutique.

  9. Bioresorbable polymer coated drug eluting stent: a model study.

    Science.gov (United States)

    Rossi, Filippo; Casalini, Tommaso; Raffa, Edoardo; Masi, Maurizio; Perale, Giuseppe

    2012-07-02

    In drug eluting stent technologies, an increased demand for better control, higher reliability, and enhanced performances of drug delivery systems emerged in the last years and thus offered the opportunity to introduce model-based approaches aimed to overcome the remarkable limits of trial-and-error methods. In this context a mathematical model was studied, based on detailed conservation equations and taking into account the main physical-chemical mechanisms involved in polymeric coating degradation, drug release, and restenosis inhibition. It allowed highlighting the interdependence between factors affecting each of these phenomena and, in particular, the influence of stent design parameters on drug antirestenotic efficacy. Therefore, the here-proposed model is aimed to simulate the diffusional release, for both in vitro and the in vivo conditions: results were verified against various literature data, confirming the reliability of the parameter estimation procedure. The hierarchical structure of this model also allows easily modifying the set of equations describing restenosis evolution to enhance model reliability and taking advantage of the deep understanding of physiological mechanisms governing the different stages of smooth muscle cell growth and proliferation. In addition, thanks to its simplicity and to the very low system requirements and central processing unit (CPU) time, our model allows obtaining immediate views of system behavior.

  10. [Discussion about traditional Chinese medicine pharmacokinetics study based on first botanical drug approved by FDA].

    Science.gov (United States)

    Huang, Fanghua

    2010-04-01

    Pharmacokinetics study is one of main components of pharmaceuticals development. Food and Drug Administration (FDA) approved Veregen as the first botanical drug in 2006. This article introduced FDA's requirement on pharmacokinetics study of botanical drug and pharmacokinetics studies of Veregen, summarized current requirement and status quo of pharmacokinetics study on traditional Chinese medicine (TCM) and natural medicine in China, and discussed about pharmacokinetics study strategy for TCM and natural medicine.

  11. Application of X-ray microanalysis to the study of drug uptake in cell culture

    International Nuclear Information System (INIS)

    Reasor, M.J.; Lee, P.; Kirk, R.G.

    1990-01-01

    X-ray microanalysis has been used previously to study the accumulation of iodine in alveolar macrophages of rats treated with the iodinated drug, amiodarone. Due to metabolism of the drug in vivo, primarily to desethylamiodarone, it was not possible to identify the source of the iodine signal. In the present study we have utilized primary cell cultures of alveolar macrophages to study the intracellular accumulation of each of these drug species in vitro. Neither drug is metabolized by these cells in culture, permitting characterization of the accumulation of each independent of the other. Cells were incubated with equimolar concentrations of either amiodarone or desethylamiodarone for 42 hr, and X-ray microanalysis of freeze-dried cryosections of cells was used to quantify accumulation by monitoring the iodine signal associated with each drug. For both drug exposures, the highest iodine content was present in amorphous bodies and dense granules, consistent with the pattern following in vivo exposure. Higher levels of desethylamiodarone, compared to amiodarone, were measured in all compartments of the cells. The results of the in vitro investigation further demonstrate the utility of X-ray microanalysis in the study of the cellular response to amiodarone and desethylamiodarone

  12. From Abstinence to Relapse: A Preliminary Qualitative Study of Drug Users in a Compulsory Drug Rehabilitation Center in Changsha, China.

    Directory of Open Access Journals (Sweden)

    Mei Yang

    Full Text Available Relapse among abstinent drug users is normal. Several factors are related to relapse, but it remains unclear what individuals' actual life circumstances are during periods of abstinence, and how these circumstances facilitate or prevent relapse.To illuminate drug users' experiences during abstinence periods and explore the real-life catalysts and inhibitors contributing to drug use relapse.Qualitative in-depth interviews were conducted with 20 drug users recruited from a compulsory isolated drug rehabilitation center in Changsha. The interviews were guided by open-ended questions on individuals' experiences in drug use initiation, getting addicted, treatment history, social environment, abstinence, and relapse. Participants were also encouraged to share their own stories. Interviews were digitally recorded and fully transcribed. The data of 18 participants who reported abstinence experiences before admission were included in the analyses. The data were analyzed using a thematic analysis with inductive hand coding to derive themes.Most drug users were able to successfully abstain from drugs. During abstinence, their lives were congested with challenges, such as adverse socioeconomic conditions, poor family/social support, interpersonal conflicts, and stigma and discrimination, all of which kept them excluded from mainstream society. Furthermore, the police's system of ID card registration, which identifies individuals as drug users, worsened already grave situations. Relapse triggers reported by the participants focused mainly on negative feelings, interpersonal conflicts, and stressful events. Craving was experienced but not perceived as a relapse trigger by most participants.This study of in-depth interview with drug users found evidence of situations and environments they live during abstinence appear rather disadvantaged, making it extremely difficult for them to remain abstinent. Comprehensive programs on relapse prevention that acknowledge

  13. Clinical Drug-Drug Pharmacokinetic Interaction Potential of Sucralfate with Other Drugs: Review and Perspectives.

    Science.gov (United States)

    Sulochana, Suresh P; Syed, Muzeeb; Chandrasekar, Devaraj V; Mullangi, Ramesh; Srinivas, Nuggehally R

    2016-10-01

    Sucralfate, a complex of aluminium hydroxide with sulfated sucrose, forms a strong gastrointestinal tract (GIT) mucosal barrier with excellent anti-ulcer property. Because sucralfate does not undergo any significant oral absorption, sucralfate resides in the GIT for a considerable length of time. The unabsorbed sucralfate may alter the pharmacokinetics of the oral drugs by impeding its absorption and reducing the oral bioavailability. Because of the increased use of sucralfate, it was important to provide a reappraisal of the published clinical drug-drug interaction studies of sucralfate with scores of drugs. This review covers several category of drugs such as non-steroidal anti-inflammatory drugs, fluoroquinolones, histamine H2-receptor blockers, macrolides, anti-fungals, anti-diabetics, salicylic acid derivatives, steroidal anti-inflammatory drugs and provides pharmacokinetic data summary along with study design, objectives and key remarks. While the loss of oral bioavailability was significant for the fluoroquinolone class, it generally varied for other classes of drugs, suggesting that impact of the co-administration of sucralfate is manageable in clinical situations. Given the technology advancement in formulation development, it may be in order feasible to develop appropriate formulation strategies to either avoid or minimize the absorption-related issues when co-administered with sucralfate. It is recommended that consideration of both in vitro and preclinical studies may be in order to gauge the level of interaction of a drug with sucralfate. Such data may aid in the development of appropriate strategies to navigate the co-administration of sucralfate with other drugs in this age of polypharmacy.

  14. Legal Drugs Are Good Drugs and Illegal Drugs Are Bad Drugs

    OpenAIRE

    Indrati, Dina; Prasetyo, Herry

    2011-01-01

    ABSTRACT : Labelling drugs are important issue nowadays in a modern society. Although it is generally believed that legal drugs are good drugs and illegal drugs are bad drugs, it is evident that some people do not aware about the side effects of drugs used. Therefore, a key contention of this philosophical essay is that explores harms minimisation policy, discuss whether legal drugs are good drugs and illegal drugs are bad drugs and explores relation of drugs misuse in a psychiatric nursing s...

  15. Drug distribution in man: a positron emission tomography study after oral administration of the labelled neuroprotective drug vinpocetine

    Energy Technology Data Exchange (ETDEWEB)

    Gulyas, Balazs [Department of Clinical Neuroscience, Psychiatry Section, Karolinska Hospital, 171 76 Stockholm (Sweden); Department of Neuroscience, Karolinska Institutet, 171 77 Stockholm (Sweden); Halldin, Christer; Sandell, Johan; Farde, Lars [Department of Clinical Neuroscience, Psychiatry Section, Karolinska Hospital, 171 76 Stockholm (Sweden); Sovago, Judit; Cselenyi, Zsolt [Department of Clinical Neuroscience, Psychiatry Section, Karolinska Hospital, 171 76 Stockholm (Sweden); Department of Neurology, Faculty of Medicine, University of Debrecen, Debrecen (Hungary); Vas, Adam; Kiss, Bela; Karpati, Egon [Chemical Works of Gedeon Richter Ltd., Budapest (Hungary)

    2002-08-01

    Direct information on the distribution of a drug requires measurements in various tissues. Such data have until now been obtained in animals, or have indirectly been calculated from plasma measurements in humans using mathematical models. Here we suggest the use of positron emission tomography (PET) as a method to obtain direct measurements of drug distribution in the human body. The distribution in body and brain of vinpocetine, a neuroprotective drug widely used in the prevention and treatment of cerebrovascular diseases, was followed after oral administration. Vinpocetine was labelled with carbon-11 and radioactivity was measured by PET in stomach, liver, brain and kidney in six healthy volunteers. The radioactivity in blood and urine as well as the fractions of [{sup 11}C]vinpocetine and labelled metabolites in plasma were also determined. After oral administration, [{sup 11}C]vinpocetine appeared immediately in the stomach and within minutes in the liver and the blood. In the blood the level of radioactivity continuously increased until the end of the measurement period, whereas the fraction of the unchanged mother compound decreased. Radioactivity uptake and distribution in the brain were demonstrable from the tenth minute after the administration of the labelled drug. Brain distribution was heterogeneous, similar to the distribution previously reported after intravenous administration. These findings indicate that vinpocetine, administered orally in humans, readily enters the bloodstream from the stomach and gastrointestinal tract and, consequently, passes the blood-brain barrier and enters the brain. Radioactivity from [{sup 11}C]vinpocetine was also demonstrated in the kidneys and in urine, indicating that at least a part of the radioactive drug and labelled metabolites is eliminated from the body through the kidneys. This study is the first to demonstrate that PET might be a useful, direct and non-invasive tool to study the distribution and

  16. Drugs and dilated cardiomyopathies: A case/noncase study in the French PharmacoVigilance Database.

    Science.gov (United States)

    Montastruc, Guillaume; Favreliere, Sylvie; Sommet, Agnès; Pathak, Atul; Lapeyre-Mestre, Maryse; Perault-Pochat, Marie-Christine; Montastruc, Jean-Louis

    2010-03-01

    To evaluate putative associations between drugs and dilated cardiomyopathy. We used the case/noncase method in the French PharmacoVigilance Database (FPVD). Cases were all the observations with dilated cardiomyopathy registered into the FPVD between 1 January 1990 and 30 June 2007. Noncases were all other reports other than those studied. Anthracyclines were used as positive controls. Data were expressed as reporting odds ratio (ROR) with their 95% confidence intervals. Out of the 258 729 adverse drug reaction (ADR) reports recorded in the FPVD between 1 January 1990 and 30 June 2007, 47 (22 men, mean age 49 years) were defined as dilated cardiomyopathy. In these 47 patients, 67 drugs were 'suspect'. A significant ROR was found with cytotoxic (epirubicin, mitoxantrone, cyclophosphamide, gemcitabine, fluorouracil) and antiretroviral (lamividune, zidovudine, abacavir) but also with isotretinoin, prednisone, appetite suppressant (clobenzorex) and psychotropic [antipsychotic (clozapine, olanzapine), lithium, antidepressant (clomipramine, amitriptyline, fluvoxamine)] drugs. The present study describes an association between some drugs and reports of dilated cardiomyopathies. This relationship involves not only some already suspected drugs (anthracyclines, antiretrovirals), but also other drugs (antipsychotics, lithium, antidepressants, retinoids) less known to induce such an ADR. Despite the mandatory limits of this kind of study (underreporting, confounding factors . . .), these data represent a pharmacovigilance signal and could contribute to establish further prospective studies in order to confirm such signals.

  17. Temporal differences in gamma-hydroxybutyrate overdoses involving injecting drug users versus recreational drug users in Helsinki: a retrospective study

    Directory of Open Access Journals (Sweden)

    Boyd James J

    2012-02-01

    Full Text Available Abstract Background Gamma-hydroxybutyrate (GHB and gamma-butyrolactone (GBL have been profiled as 'party drugs' used mainly at dance parties and in nightclubs on weekend nights. The purpose of this study was to examine the frequency of injecting drug use among GHB/GBL overdose patients and whether there are temporal differences in the occurrence of GHB/GBL overdoses of injecting drug and recreational drug users. Methods In this retrospective study, the ambulance and hospital records of suspected GHB- and GBL overdose patients treated by the Helsinki Emergency Medical Service from January 1st 2006 to December 31st 2007 were reviewed. According to the temporal occurrence of the overdose, patients were divided in two groups. In group A, the overdose occurred on a Friday-Saturday or Saturday-Sunday night between 11 pm-6 am. Group B consisted of overdoses occurring on outside this time frame. Results Group A consisted of 39 patient contacts and the remaining 61 patient contacts were in group B. There were statistically significant differences between the two groups in (group A vs. B, respectively: history of injecting drug abuse (33% vs. 59%, p = 0.012, reported polydrug and ethanol use (80% vs. 62%, p = 0.028, the location where the patients were encountered (private or public indoors or outdoors, 10%, 41%, 41% vs. 25%, 18%, 53%, p = 0.019 and how the knowledge of GHB/GBL use was obtained (reported by patient/bystanders or clinical suspicion, 72%, 28% vs. 85%, 10%, p = 0.023. Practically all (99% patients were transported to emergency department after prehospital care. Conclusion There appears to be at least two distinct groups of GHB/GBL users. Injecting drug users represent the majority of GHB/GBL overdose patients outside weekend nights.

  18. Comparative study of paediatric prescription drug utilization between the spanish and immigrant population

    Science.gov (United States)

    2009-01-01

    Background The immigrant population has increased greatly in Spain in recent years to the point where immigrants made up 12% of the infant population in 2008. There is little information available on the profile of this group with regard to prescription drug utilization in universal public health care systems such as that operating in Spain. This work studies the overall and specific differences in prescription drug utilization between the immigrant and Spanish population. Methods Use was made of the Aragonese Health Service databases for 2006. The studied population comprises 159,908 children aged 0-14 years, 13.6% of whom are foreign nationals. Different utilization variables were calculated for each group. Prescription-drug consumption is measured in Defined Daily Doses (DDD) and DDD/1000 persons/day/(DID). Results A total of 833,223 prescriptions were studied. Utilization is lower for immigrant children than in Spanish children for both DID (66.27 v. 113.67) and average annual expense (€21.55 v. €41.14). Immigrant children consume fewer prescription drugs than Spanish children in all of the therapy groups, with the most prescribed (in DID) being: respiratory system, anti-infectives for systemic use, nervous system, sensory organs. Significant differences were observed in relation to the type of drugs and the geographical background of immigrants. Conclusion Prescription drug utilization is much greater in Spanish children than in immigrant children, particularly with reference to bronchodilators (montelukast and terbutaline) and attention-disorder hyperactivity drugs such as methylphenidate. There are important differences regarding drug type and depending on immigrants' geographical backgrounds that suggest there are social, cultural and access factors underlying these disparities. PMID:19995453

  19. Comparative study of paediatric prescription drug utilization between the spanish and immigrant population

    Directory of Open Access Journals (Sweden)

    Macipe-Costa Rosa

    2009-12-01

    Full Text Available Abstract Background The immigrant population has increased greatly in Spain in recent years to the point where immigrants made up 12% of the infant population in 2008. There is little information available on the profile of this group with regard to prescription drug utilization in universal public health care systems such as that operating in Spain. This work studies the overall and specific differences in prescription drug utilization between the immigrant and Spanish population. Methods Use was made of the Aragonese Health Service databases for 2006. The studied population comprises 159,908 children aged 0-14 years, 13.6% of whom are foreign nationals. Different utilization variables were calculated for each group. Prescription-drug consumption is measured in Defined Daily Doses (DDD and DDD/1000 persons/day/(DID. Results A total of 833,223 prescriptions were studied. Utilization is lower for immigrant children than in Spanish children for both DID (66.27 v. 113.67 and average annual expense (€21.55 v. €41.14. Immigrant children consume fewer prescription drugs than Spanish children in all of the therapy groups, with the most prescribed (in DID being: respiratory system, anti-infectives for systemic use, nervous system, sensory organs. Significant differences were observed in relation to the type of drugs and the geographical background of immigrants. Conclusion Prescription drug utilization is much greater in Spanish children than in immigrant children, particularly with reference to bronchodilators (montelukast and terbutaline and attention-disorder hyperactivity drugs such as methylphenidate. There are important differences regarding drug type and depending on immigrants' geographical backgrounds that suggest there are social, cultural and access factors underlying these disparities.

  20. Strategies for the early detection of drug-induced hepatic steatosis in preclinical drug safety evaluation studies

    International Nuclear Information System (INIS)

    Amacher, David E.

    2011-01-01

    Hepatic steatosis is characterized by the accumulation of lipid droplets in the liver. Although relatively benign, simple steatosis can eventually lead to the development of steatohepatitis, a more serious condition characterized by fibrosis, cirrhosis, and eventual liver failure if the underlying cause is not eliminated. According to the 'two hit' theory of steatohepatitis, the initial hit involves fat accumulation in the liver, and a second hit leads to inflammation and subsequent tissue injury. Because some xenobiotics target liver fatty acid metabolism, especially mitochondrial β-oxidation, it is important to avoid potential drug candidates that can contribute to either the initiation of liver steatosis or progression to the more injurious steatohepatitis. The gold standard for the detection of these types of hepatic effects is histopathological examination of liver tissue. In animal studies, these examinations are slow, restricted to a single sampling time, and limited tissue sections. Recent literature suggests that rapid in vitro screening methods can be used early in the drug R and D process to identify compounds with steatotic potential. Further, progress in the identification of potential serum or plasma protein biomarkers for these liver changes may provide additional in vivo tools to the preclinical study toxicologist. This review summarizes recent developments for in vitro screening and in vivo biomarker detection for steatotic drug candidates.

  1. Effect of some radiosensitising drugs on human erythrocyte membrane - - spin label study

    Energy Technology Data Exchange (ETDEWEB)

    Mishra, K P [Bhabha Atomic Research Centre, Bombay (India). Biology and Agriculture Div.

    1982-02-01

    Electron spin resonance and spin label techniques have been employed to study the effects of local anaesthetic drugs, procaine and tetracaine, on human erythrocyte membrane. Both the drugs altered the protein and lipid arrangements in the membrane and these changes were reversible. Procaine had greater effect on the labels attached to proteins while tetracaine fluidized interior of lipid bilayer to a greater extent. The differential effects of these drugs on the protein and lipid labels have been interpreted in terms of their relative penetrability in the membrane. Present results have explained that radiation induced enhanced killing of cells in the presence of these drugs might be due to the alterations in membrane, particularly proteins both structural and enzymatic. In addition, these results indicate a possible relationship between drug-induced structural changes in membrane and their anaesthetic potency.

  2. Influence of drug colour on perceived drug effects and efficacy.

    Science.gov (United States)

    Tao, Da; Wang, Tieyan; Wang, Tieshan; Qu, Xingda

    2018-02-01

    A drug's physical characteristics, such as colour, could be factors influencing its therapeutic effects. It is not well understood whether people's expectations on drug effects and efficacy are affected by colour, especially among Chinese population. This study was conducted to examine people's expectations on drug effects and efficacy on the basis of drug colour, and to reveal possible gender differences in colour-related drug expectations. Participants (n = 224) were asked to classify seven single-coloured and six two-coloured capsules into one of four categories of drug effects, and to indicate the strength of drug efficacy. It is found that all the coloured capsules yielded non-chance distributions in classifications of drug effects, with six single-coloured and four two-coloured capsules associated with specific drug effects. Colour also conveyed differential strengths of drug efficacy in general and in relation to specific drug effects. There were gender differences in drug expectations for some colours and colour combinations. Practitioner Summary: Drug colour was found to have impacts on perceived drug effects and efficacy. The findings from the present study can be used by ergonomics practitioners to design appropriate drug colours in support of drug differentiation, therapeutic effects and medication adherence.

  3. Evaluation of rational drug use based on World Health Organization core drug use indicators in selected public hospitals of eastern Ethiopia: a cross sectional study.

    Science.gov (United States)

    Sisay, Mekonnen; Mengistu, Getnet; Molla, Bereket; Amare, Firehiwot; Gabriel, Tesfaye

    2017-02-23

    Despite the complexity of drug use, a number of indicators have been developed, standardized and evaluated by the World Health Organization (WHO). These indicators are grouped in to three categories namely: prescribing indicators, patient care indicators and facility indicators. The study was aimed to evaluate rational drug use based on WHO-core drug use indicators in Dilchora referral hospital, Dire Dawa; Hiwot Fana specialized university hospital, Harar and Karamara general hospital, Jigjiga, eastern Ethiopia. Hospital based quantitative cross sectional study design was employed to evaluate rational drug use based on WHO core drug use indicators in selected hospitals. Systematic random sampling for prescribing indicators and convenient sampling for patient care indicators was employed. Taking WHO recommendations in to account, a total of 1,500 prescription papers (500 from each hospitals) were investigated. In each hospital, 200 outpatient attendants and 30 key essential drugs were also selected using the WHO recommendation. Data were collected using retrospective and prospective structured observational check list. Data were entered to EPI Data Version 3.1, exported and analyzed using SPSS version 16.0. Besides, the data were evaluated as per the WHO guidelines. Statistical significance was determined by one way analysis of variance (ANOVA) for some variables. P-value of less than 0.05 was considered statistically significant. Finally, tabular presentation was used to present the data. Mean, 2.34 (±1.08) drugs were prescribed in the selected hospitals. Prescriptions containing antibiotics and that of injectables were 57.87 and 10.9% respectively. The average consultation and dispensing time were 276.5 s and 61.12 s respectively. Besides, 75.77% of the prescribed drugs were actually dispensed. Only 3.3% of prescriptions were adequately labeled and 75.7% patients know about the dosage of the prescription. Not more than, 20(66.7%) key drugs were available in

  4. Computational prediction of drug-drug interactions based on drugs functional similarities.

    Science.gov (United States)

    Ferdousi, Reza; Safdari, Reza; Omidi, Yadollah

    2017-06-01

    Therapeutic activities of drugs are often influenced by co-administration of drugs that may cause inevitable drug-drug interactions (DDIs) and inadvertent side effects. Prediction and identification of DDIs are extremely vital for the patient safety and success of treatment modalities. A number of computational methods have been employed for the prediction of DDIs based on drugs structures and/or functions. Here, we report on a computational method for DDIs prediction based on functional similarity of drugs. The model was set based on key biological elements including carriers, transporters, enzymes and targets (CTET). The model was applied for 2189 approved drugs. For each drug, all the associated CTETs were collected, and the corresponding binary vectors were constructed to determine the DDIs. Various similarity measures were conducted to detect DDIs. Of the examined similarity methods, the inner product-based similarity measures (IPSMs) were found to provide improved prediction values. Altogether, 2,394,766 potential drug pairs interactions were studied. The model was able to predict over 250,000 unknown potential DDIs. Upon our findings, we propose the current method as a robust, yet simple and fast, universal in silico approach for identification of DDIs. We envision that this proposed method can be used as a practical technique for the detection of possible DDIs based on the functional similarities of drugs. Copyright © 2017. Published by Elsevier Inc.

  5. Sedative Drug Use among King Saud University Medical Students: A Cross-Sectional Sampling Study

    Directory of Open Access Journals (Sweden)

    Ahmed A. Al-Sayed

    2014-01-01

    Full Text Available Introduction. Medical students experience significant psychological stress and are therefore at higher risk of using sedatives. There are currently no studies describing the prevalence of sedative drug use among medical students in Saudi Arabia. The aim of this study was to evaluate the prevalence and factors associated with sedative drug use among medical students in Saudi Arabia. Materials and Methods. A cross-sectional convenience sampling study gathered data by anonymous questionnaire from students enrolled at the King Saud University College of Medicine in 2011. The questionnaires collected data regarding social and demographic variables, sleep patterns, and the use of stimulant and sedative drugs since enrollment. Sedatives were defined as any pharmaceutical preparations that induce sleep. Results and Discussion. Of the 729 students who returned questionnaires, 17.0% reported sedative drug use at some time since enrollment. Higher academic year, lower grade point average, regular exercise, fewer hours of sleep per day, poorer quality of sleep, and the presence of sleeping disorders were found to be significantly associated with sedative drug use. Conclusions. Further study is required to increase our understanding of sedative drug use patterns in this relatively high-risk group, as such understanding will help in the development of early intervention programs.

  6. A Study of the Status of Use of Drug Plants and Its Related Factors

    Directory of Open Access Journals (Sweden)

    Reza Heidarifar

    2013-09-01

    Full Text Available Background and Objectives: Herbal medicine as a type of complementary medicine has long been used by different societies. The studies of the last two decades have indicated the growing use of drug plants in the world, sometimes without consulting a physician and with no knowledge about their side-effects. This study was done with the aim of determining the status of use of drug plants and its related factors in Qom city. Methods: This descriptive cross-sectional study was done on 372 people of Qom city in 2012, using convenience sampling. The data were collected through a questionnaire that its validity and reliability had been confirmed. The data were analyzed via frequency tables, chi 2, Mann-Whitney and Fisher’s tests. Significance level was considered p<0.05. Results: In this study, 35.48% and 11.55% of participants had used drug plants for treatment and prevention, respectively. The most cases of consumption belonged to abdominal pain (48.4%, cold (42.2% and sore throat (35.8%, and the most used plants were mint (72.3%, Sisymbrium irio (65.1% and cinnamon (62.9%. The most important reason of use of drug plants were fewer side-effects (51.1% and better results (39.9% compared to chemical medicine. Among studied variables, a statistically significant relationship was observed between gender and the amount of using drug plants (p=0.01. Conclusion: Concerning the results of this study, the most reason of using drug plants was their fewer side-effects compared to chemical drugs. So, it is necessary to give accurate information, at the society level, about their side-effects and possible interactions.

  7. A study of drug use in five urban centres in Kenya | Ndetei | African ...

    African Journals Online (AJOL)

    Few studies have addressed the reasons for substance use in Kenya, with most focusing on prevalence rates in school-based and general population samples. None have been carried out among people already using drugs. This study, based on five samples of drug users, aimed to identify patterns of factors contributing to ...

  8. Neutralizing antibody and anti-retroviral drug sensitivities of HIV-1 isolates resistant to small molecule CCR5 inhibitors

    International Nuclear Information System (INIS)

    Pugach, Pavel; Ketas, Thomas J.; Michael, Elizabeth; Moore, John P.

    2008-01-01

    The small molecule CCR5 inhibitors are a new class of drugs for treating infection by human immunodeficiency virus type 1 (HIV-1). They act by binding to the CCR5 co-receptor and preventing its use during HIV-1-cell fusion. Escape mutants can be raised against CCR5 inhibitors in vitro and will arise when these drugs are used clinically. Here, we have assessed the responses of CCR5 inhibitor-resistant viruses to other anti-retroviral drugs that act by different mechanisms, and their sensitivities to neutralizing antibodies (NAbs). The rationale for the latter study is that the resistance pathway for CCR5 inhibitors involves changes in the HIV-1 envelope glycoproteins (Env), which are also targets for NAbs. The escape mutants CC101.19 and D1/85.16 were selected for resistance to AD101 and vicriviroc (VVC), respectively, from the primary R5 HIV-1 isolate CC1/85. Each escape mutant was cross-resistant to other small molecule CCR5 inhibitors (aplaviroc, maraviroc, VVC, AD101 and CMPD 167), but sensitive to protein ligands of CCR5: the modified chemokine PSC-RANTES and the humanized MAb PRO-140. The resistant viruses also retained wild-type sensitivity to the nucleoside reverse transcriptase inhibitor (RTI) zidovudine, the non-nucleoside RTI nevirapine, the protease inhibitor atazanavir and other attachment and fusion inhibitors that act independently of CCR5 (BMS-806, PRO-542 and enfuvirtide). Of note is that the escape mutants were more sensitive than the parental CC1/85 isolate to a subset of neutralizing monoclonal antibodies and to some sera from HIV-1-infected people, implying that sequence changes in Env that confer resistance to CCR5 inhibitors can increase the accessibility of some NAb epitopes. The need to preserve NAb resistance may therefore be a constraint upon how escape from CCR5 inhibitors occurs in vivo

  9. e-Drug3D: 3D structure collections dedicated to drug repurposing and fragment-based drug design.

    Science.gov (United States)

    Pihan, Emilie; Colliandre, Lionel; Guichou, Jean-François; Douguet, Dominique

    2012-06-01

    In the drug discovery field, new uses for old drugs, selective optimization of side activities and fragment-based drug design (FBDD) have proved to be successful alternatives to high-throughput screening. e-Drug3D is a database of 3D chemical structures of drugs that provides several collections of ready-to-screen SD files of drugs and commercial drug fragments. They are natural inputs in studies dedicated to drug repurposing and FBDD. e-Drug3D collections are freely available at http://chemoinfo.ipmc.cnrs.fr/e-drug3d.html either for download or for direct in silico web-based screenings.

  10. Predicting drug?drug interactions through drug structural similarities and interaction networks incorporating pharmacokinetics and pharmacodynamics knowledge

    OpenAIRE

    Takeda, Takako; Hao, Ming; Cheng, Tiejun; Bryant, Stephen H.; Wang, Yanli

    2017-01-01

    Drug?drug interactions (DDIs) may lead to adverse effects and potentially result in drug withdrawal from the market. Predicting DDIs during drug development would help reduce development costs and time by rigorous evaluation of drug candidates. The primary mechanisms of DDIs are based on pharmacokinetics (PK) and pharmacodynamics (PD). This study examines the effects of 2D structural similarities of drugs on DDI prediction through interaction networks including both PD and PK knowledge. Our a...

  11. Profiles of risk: a qualitative study of injecting drug users in Tehran, Iran

    Directory of Open Access Journals (Sweden)

    Green Traci

    2006-03-01

    Full Text Available Abstract Background In Iran, there are an estimated 200,000 injecting drug users (IDUs. Injecting drug use is a relatively new phenomenon for this country, where opium smoking was the predominant form of drug use for hundreds of years. As in many countries experiencing a rise in injecting drug use, HIV/AIDS in Iran is associated with the injection of drugs, accounting for transmission of more than two-thirds of HIV infections. This study aimed to: describe the range of characteristics of IDUs in Tehran, Iran's capital city; 2 examine the injecting-related HIV risk behaviors of IDUs, and 3 suggest necessary interventions to prevent HIV transmission among IDUs and their families and sex partners. Methods Using rapid assessment and response methods with a qualitative focus, six districts of Tehran were selected for study. A total of 81 key informants from different sectors and 154 IDUs were selected by purposeful, opportunistic and snowball sampling, then interviewed. Ethnographic observations were done for mapping and studying injecting-related HIV risk settings and behaviors. Modified content analysis methods were used to analyze the data and extract typologies of injecting drug users in Tehran. Results Evidence of injecting drug use and drug-related harm was found in 5 of 6 study districts. Several profiles of IDUs were identified: depending on their socioeconomic status and degree of stability, IDUs employed different injecting behaviors and syringe hygiene practices. The prevalence of sharing injection instruments ranged from 30–100%. Varied magnitudes of risk were evident among the identified IDU typologies in terms of syringe disinfection methods, level of HIV awareness, and personal hygiene exhibited. At the time of research, there were no active HIV prevention programs in existence in Tehran. Conclusion The recent rise of heroin injection in Iran is strongly associated with HIV risk. Sharing injection instruments is a common and complex

  12. Photostability studies on the furosemide-triamterene drug association.

    Science.gov (United States)

    Fiori, J; Ballardini, R; Andrisano, V; Cavrini, V

    2003-09-01

    The photostability of the diuretic drugs triamterene and furosemide, individually and combined, was evaluated. Spectrophotometric, spectrofluorimetric and chromatographic (HPLC) methods were applied to monitor the drug photodegradation. Furosemide was confirmed to be highly photolable in both pH 7.4 solution and methanol. Differently triamterene proved to be highly fluorescent (emission quantum yield: 0.9 in methanol and 0.8 in pH 7.4 solution), but essentially photostable (photochemical reaction quantum yield: congruent with 5 x 10(-4)) under exposure at 365 and 313 nm radiations. When the combined drugs in pH 7.4 solutions were exposed to 365 nm radiations a significant photoprotective effect of triamterene on furosemide was observed. The photoreactivity of the drugs was exploited to develop an HPLC method involving a post-column on-line photochemical derivatization useful to confirm the analyte identity in a commercial dosage form (tablets). The commercial product, containing the combined drugs, proved to be photostable also after long (65 h) light exposure.

  13. Is Project Towards No Drug Abuse (Project TND) an evidence-based drug and violence prevention program? A review and reappraisal of the evaluation studies.

    Science.gov (United States)

    Gorman, Dennis M

    2014-08-01

    This paper critically reviews the published evidence pertaining to Project Towards No Drug Abuse (Project TND). Publications from seven evaluation studies of Project TND are reviewed, and the results from these are discussed as related to the following outcomes: main effects on the use of cigarettes, alcohol and marijuana; main effects on the use of "hard drugs," defined in the evaluations as cocaine, hallucinogens, stimulants, inhalants, ecstasy and other drugs (e.g., depressants, PCP, steroids and heroin); subgroup and interaction analyses of drug use; and violence-related behaviors. Very few main effects have been found for cigarette, alcohol and marijuana use in the Project TND evaluations. While studies do report main effects for hard drug use, these findings are subject to numerous threats to validity and may be attributable to the data analyses employed. Similarly, while isolated subgroup and interaction effects were found for alcohol use among baseline nonusers and some violence-related behaviors in the early Project TND evaluations, these findings have not been replicated in more recent studies and may result from multiple comparisons between study conditions. In conclusion, there is little evidence to support the assertion that Project TND is an effective drug or violence prevention program. The broader implications of these findings for prevention science are discussed and suggestions are made as to how the quality of research in the field might be improved.

  14. Benefit and risk information in prescription drug advertising: review of empirical studies and marketing implications.

    Science.gov (United States)

    Kopp, S W; Bang, H K

    2000-01-01

    As pharmaceutical companies began to advertise prescription drugs directly to consumers as well as to physicians, understanding the impact of benefit and risk information in drug advertising on physicians and consumers has become more critical. This paper reviews previous empirical studies that examined the content of benefit and risk information in drug advertising and its potential effects on physicians' subsequent prescribing behaviors. It also reviews studies that investigated how consumers process information on a drug's efficacy and side effects. Based on the findings of these studies, implications are discussed for effective marketing information development as well as for government regulation.

  15. Electrochemical studies of ropinirole, an anti-Parkinson's disease drug

    Indian Academy of Sciences (India)

    trochemical techniques have application to drug-protein. ∗. For correspondence ... drug bioavailability and toxicity tests. ... analysis ranging from the assay of drugs in bulk form, ... stability-indicating assays.13,14 Separation and quantifi-.

  16. Safety studies of homoeopathic drugs in acute, sub-acute and chronic toxicity in rats

    Directory of Open Access Journals (Sweden)

    Surender Singh

    2017-01-01

    Full Text Available Background: Homoeopathic drugs are frequently recommended in day to day life as therapeutic agents by homoeopathic practitioners. However, safety of homoeopathic drugs remains a challenge because of the high variability of chemical components involved. Aim: The objective of the present study was to investigate the acute, subacute, and chronic oral toxicity of different homoeopathic drugs (Ferrum phosphoricum 3X, Ferrum phosphoricum 6X, Calcarea phosphoricum 6X, and Magnesium phosphoricum 6X in experimental models. Materials and Methods: In acute oral toxicity study, homoeopathic drugs were administered orally at 2000mg/kg body weight, and animals were observed for toxic symptoms till 10 days as per the OECD guidelines. For subacute and chronic toxicity study, homoeopathic drugs were administered for 28 and 180 days, respectively, as per the OECD guidelines. At the end of 28 and 180 days, the animals were sacrificed and toxicity parameters were assessed. Histopathological evaluation of different organs was also performed to assess any toxicity. Results: In acute toxicity study, no mortality was found at a dose of 2000 mg/kg which indicates that oral LD50of homoeopathic drugs were more than 2000 mg/kg. The administration of drugs at a dose of 70 mg/kg body weight for 28 and 180 days did not produce any significant change in haematological and biochemical parameters of male and female rats as compared to normal control group. No pathological changes were observed in histology of various organs of treated rats as compared to normal control animals. Conclusion: These homoeopathic drugs are safe & produce no toxicity when administered for longer duration.

  17. Drugs related to motor vehicle crashes in northern European countries: A study of fatally injured drivers

    DEFF Research Database (Denmark)

    Mørland, Jørg; Steentoft, Anni; Simonsen, Kirsten Wiese

    2011-01-01

    The aim of this study was to find which drugs and drug combinations were most common in drivers who died, in particular, in single vehicle crashes where the responsibility for the crash would be referred to the driver killed. The study included all available blood samples from drivers, who died......% respectively of the drivers under 30 with drugs present). Similar findings were obtained for drivers 30–49 years of age (63% with alcohol and/or drugs). In drivers aged 50 years and above, killed in single vehicle crashes (48% with alcohol and/or drugs) illicit drugs were found in only one case...

  18. Title: Studies on drug switchability showed heterogeneity in methodological approaches: a scoping review.

    Science.gov (United States)

    Belleudi, Valeria; Trotta, Francesco; Vecchi, Simona; Amato, Laura; Addis, Antonio; Davoli, Marina

    2018-05-16

    Several drugs share the same therapeutic indication, including those undergoing patent expiration. Concerns on the interchangeability are frequent in clinical practice, challenging the evaluation of switchability through observational research. To conduct a scoping review of observational studies on drug switchability to identify methodological strategies adopted to deal with bias and confounding. We searched PubMed, EMBASE, and Web of Science (updated 1/31/2017) to identify studies evaluating switchability in terms of effectiveness/safety outcomes or compliance. Three reviewers independently screened studies extracting all characteristics. Strategies to address confounding, particularly, previous drug use and switching reasons were considered. All findings were summarized in descriptive analyses. Thirty-two studies, published in the last 10 years, met the inclusion criteria. Epilepsy, cardiovascular and rheumatology were the most frequently represented clinical areas. 75% of the studies reported data on effectiveness/safety outcomes. The most frequent study design was cohort (65.6%) followed by case-control (21.9%) and self-controlled (12.5%). Case-control and case-crossover studies showed homogeneous methodological strategies to deal with bias and confounding. Among cohort studies, the confounding associated with previous drug use was addressed introducing variables in multivariate model (47.3%) or selecting only adherent patients (14.3%). Around 30% of cohort studies did not report reasons for switching. In the remaining 70%, clinical parameters or previous occurrence of outcomes were measured to identify switching connected with lack of effectiveness or adverse events. This study represents a starting point for researchers and administrators who are approaching the investigation and assessment of issues related to interchangeability of drugs. Copyright © 2018. Published by Elsevier Inc.

  19. Polymeric nanoparticles containing diazepam: preparation, optimization, characterization, in-vitro drug release and release kinetic study

    Science.gov (United States)

    Bohrey, Sarvesh; Chourasiya, Vibha; Pandey, Archna

    2016-03-01

    Nanoparticles formulated from biodegradable polymers like poly(lactic-co-glycolic acid) (PLGA) are being extensively investigated as drug delivery systems due to their two important properties such as biocompatibility and controlled drug release characteristics. The aim of this work to formulated diazepam loaded PLGA nanoparticles by using emulsion solvent evaporation technique. Polyvinyl alcohol (PVA) is used as stabilizing agent. Diazepam is a benzodiazepine derivative drug, and widely used as an anticonvulsant in the treatment of various types of epilepsy, insomnia and anxiety. This work investigates the effects of some preparation variables on the size and shape of nanoparticles prepared by emulsion solvent evaporation method. These nanoparticles were characterized by photon correlation spectroscopy (PCS), transmission electron microscopy (TEM). Zeta potential study was also performed to understand the surface charge of nanoparticles. The drug release from drug loaded nanoparticles was studied by dialysis bag method and the in vitro drug release data was also studied by various kinetic models. The results show that sonication time, polymer content, surfactant concentration, ratio of organic to aqueous phase volume, and the amount of drug have an important effect on the size of nanoparticles. Hopefully we produced spherical shape Diazepam loaded PLGA nanoparticles with a size range under 250 nm with zeta potential -23.3 mV. The in vitro drug release analysis shows sustained release of drug from nanoparticles and follow Korsmeyer-Peppas model.

  20. Role of drug transporters and drug accumulation in the temporal acquisition of drug resistance

    International Nuclear Information System (INIS)

    Hembruff, Stacey L; Laberge, Monique L; Villeneuve, David J; Guo, Baoqing; Veitch, Zachary; Cecchetto, Melanie; Parissenti, Amadeo M

    2008-01-01

    Anthracyclines and taxanes are commonly used in the treatment of breast cancer. However, tumor resistance to these drugs often develops, possibly due to overexpression of drug transporters. It remains unclear whether drug resistance in vitro occurs at clinically relevant doses of chemotherapy drugs and whether both the onset and magnitude of drug resistance can be temporally and causally correlated with the enhanced expression and activity of specific drug transporters. To address these issues, MCF-7 cells were selected for survival in increasing concentrations of doxorubicin (MCF-7 DOX-2 ), epirubicin (MCF-7 EPI ), paclitaxel (MCF-7 TAX-2 ), or docetaxel (MCF-7 TXT ). During selection cells were assessed for drug sensitivity, drug uptake, and the expression of various drug transporters. In all cases, resistance was only achieved when selection reached a specific threshold dose, which was well within the clinical range. A reduction in drug uptake was temporally correlated with the acquisition of drug resistance for all cell lines, but further increases in drug resistance at doses above threshold were unrelated to changes in cellular drug uptake. Elevated expression of one or more drug transporters was seen at or above the threshold dose, but the identity, number, and temporal pattern of drug transporter induction varied with the drug used as selection agent. The pan drug transporter inhibitor cyclosporin A was able to partially or completely restore drug accumulation in the drug-resistant cell lines, but had only partial to no effect on drug sensitivity. The inability of cyclosporin A to restore drug sensitivity suggests the presence of additional mechanisms of drug resistance. This study indicates that drug resistance is achieved in breast tumour cells only upon exposure to concentrations of drug at or above a specific selection dose. While changes in drug accumulation and the expression of drug transporters does occur at the threshold dose, the magnitude of

  1. Pharmacognostic study of Chamaecyparis lawsoniana (Murr. Parl.: A drug used in Homoeopathy

    Directory of Open Access Journals (Sweden)

    Anshu Rathi

    2015-01-01

    Full Text Available The pharmacognostic profile of crude drug has a key role in standardization for quality, purity and drug identification. The present study deals with pharmacognostic evaluation of aerial part of Chamaecyparis lawsoniana (Murr. Parl. a drug used in homoeopathic system of medicine for diverse clinical uses such as terrible pain in stomach, tumors, keloid, warts and lipoma of thigh. The study includes collection, identification, macroscopy, microscopy and organoleptic characteristics of aerial part of Chamaecyparis lawsoniana. Anatomically the leaf is distinguishable into a layer of the epidermis followed by parenchymatous mesophyll and resin duct in the parenchymatous cortex. Powder microscopy shows the presence of epidermal cells, parenchymatous cells and tracheids. These observations may be used as pharmacopoeial standards for identification of Cha maecyparis lawsoniana.

  2. Anti-addiction drug ibogaine inhibits voltage-gated ionic currents: A study to assess the drug's cardiac ion channel profile

    Energy Technology Data Exchange (ETDEWEB)

    Koenig, Xaver; Kovar, Michael; Rubi, Lena; Mike, Agnes K.; Lukacs, Peter; Gawali, Vaibhavkumar S.; Todt, Hannes [Center for Physiology and Pharmacology, Department of Neurophysiology and -pharmacology, Medical University of Vienna, 1090 Vienna (Austria); Hilber, Karlheinz, E-mail: karlheinz.hilber@meduniwien.ac.at [Center for Physiology and Pharmacology, Department of Neurophysiology and -pharmacology, Medical University of Vienna, 1090 Vienna (Austria); Sandtner, Walter [Center for Physiology and Pharmacology, Institute of Pharmacology, Medical University of Vienna, 1090 Vienna (Austria)

    2013-12-01

    The plant alkaloid ibogaine has promising anti-addictive properties. Albeit not licenced as a therapeutic drug, and despite hints that ibogaine may perturb the heart rhythm, this alkaloid is used to treat drug addicts. We have recently reported that ibogaine inhibits human ERG (hERG) potassium channels at concentrations similar to the drugs affinity for several of its known brain targets. Thereby the drug may disturb the heart's electrophysiology. Here, to assess the drug's cardiac ion channel profile in more detail, we studied the effects of ibogaine and its congener 18-Methoxycoronaridine (18-MC) on various cardiac voltage-gated ion channels. We confirmed that heterologously expressed hERG currents are reduced by ibogaine in low micromolar concentrations. Moreover, at higher concentrations, the drug also reduced human Na{sub v}1.5 sodium and Ca{sub v}1.2 calcium currents. Ion currents were as well reduced by 18-MC, yet with diminished potency. Unexpectedly, although blocking hERG channels, ibogaine did not prolong the action potential (AP) in guinea pig cardiomyocytes at low micromolar concentrations. Higher concentrations (≥ 10 μM) even shortened the AP. These findings can be explained by the drug's calcium channel inhibition, which counteracts the AP-prolonging effect generated by hERG blockade. Implementation of ibogaine's inhibitory effects on human ion channels in a computer model of a ventricular cardiomyocyte, on the other hand, suggested that ibogaine does prolong the AP in the human heart. We conclude that therapeutic concentrations of ibogaine have the propensity to prolong the QT interval of the electrocardiogram in humans. In some cases this may lead to cardiac arrhythmias. - Highlights: • We study effects of anti-addiction drug ibogaine on ionic currents in cardiomyocytes. • We assess the cardiac ion channel profile of ibogaine. • Ibogaine inhibits hERG potassium, sodium and calcium channels. • Ibogaine’s effects on

  3. rTMS in the treatment of drug addiction: an update about human studies.

    Science.gov (United States)

    Bellamoli, Elisa; Manganotti, Paolo; Schwartz, Robert P; Rimondo, Claudia; Gomma, Maurizio; Serpelloni, Giovanni

    2014-01-01

    Drug addiction can be a devastating and chronic relapsing disorder with social, psychological, and physical consequences, and more effective treatment options are needed. Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive brain stimulation technique that has been assessed in a growing number of studies for its therapeutic potential in treating addiction. This review paper offers an overview on the current state of clinical research in treating drug addiction with rTMS. Because of the limited research in this area, all studies (including case reports) that evaluated the therapeutic use of rTMS in nicotine, alcohol, or illicit drug addiction were included in this review. Papers published prior to December 2012 were found through an NCBI PubMed search. A total of eleven studies were identified that met review criteria. There is nascent evidence that rTMS could be effective in reducing cocaine craving and nicotine and alcohol craving and consumption and might represent a potential therapeutic tool for treating addiction. Further studies are needed to identify the optimal parameters of stimulation for the most effective treatment of drug addiction, to improve our comprehension of the treatment neurophysiological effects, and to conduct rigorous, controlled efficacy studies with adequate power.

  4. Multiple comparisons in drug efficacy studies: scientific or marketing principles?

    Science.gov (United States)

    Leo, Jonathan

    2004-01-01

    When researchers design an experiment to compare a given medication to another medication, a behavioral therapy, or a placebo, the experiment often involves numerous comparisons. For instance, there may be several different evaluation methods, raters, and time points. Although scientifically justified, such comparisons can be abused in the interests of drug marketing. This article provides two recent examples of such questionable practices. The first involves the case of the arthritis drug celecoxib (Celebrex), where the study lasted 12 months but the authors only presented 6 months of data. The second case involves the NIMH Multimodal Treatment Study (MTA) study evaluating the efficacy of stimulant medication for attention-deficit hyperactivity disorder where ratings made by several groups are reported in contradictory fashion. The MTA authors have not clarified the confusion, at least in print, suggesting that the actual findings of the study may have played little role in the authors' reported conclusions.

  5. Semantic Web Ontology and Data Integration: a Case Study in Aiding Psychiatric Drug Repurposing.

    Science.gov (United States)

    Liang, Chen; Sun, Jingchun; Tao, Cui

    2015-01-01

    There remain significant difficulties selecting probable candidate drugs from existing databases. We describe an ontology-oriented approach to represent the nexus between genes, drugs, phenotypes, symptoms, and diseases from multiple information sources. We also report a case study in which we attempted to explore candidate drugs effective for bipolar disorder and epilepsy. We constructed an ontology incorporating knowledge between the two diseases and performed semantic reasoning tasks with the ontology. The results suggested 48 candidate drugs that hold promise for further breakthrough. The evaluation demonstrated the validity our approach. Our approach prioritizes the candidate drugs that have potential associations among genes, phenotypes and symptoms, and thus facilitates the data integration and drug repurposing in psychiatric disorders.

  6. ETHICAL PRACTICES IN DRUG PRESCRIBING. A COMPARATIVE STUDY BETWEEN DOCTORS’ AND PHARMACISTS’ OPINION ABOUT DRUG PRESCRIBING IN ROMANIA

    Directory of Open Access Journals (Sweden)

    LASZLO-ZOLTAN SZTANKOVSZKY

    2015-11-01

    Full Text Available The prescription of drugs is influenced by a number of factors with a great impact upon the health of the main beneficiaries of health services. The purpose of the study is to identify the perception of doctors and pharmacists on drug prescription practices adopted by doctors. Material and Methods: a number of 349 subjects (149 pharmacists and 200 doctors answered a survey about the perception of drug dispensing in Romania. Variables like age, work environment (urban, rural, length of employment were taken into account. Results: When prescribing a treatment, 93% of doctors follow the standard treatment protocol for the given diagnosis and 93,5% of them are declaring that personal resources are the main source for training while the percent appreciated by pharmacists is evaluated to 65,78%. A total of 50% of doctors are considering other criteria than the treatment when prescribing a drug (financial contribution for the patient or National Health Insurance House. A total of 59% of doctors are recommending overthe-counter products while pharmacists consider that is happening in more than 70% of the cases. Conclusions: There are differences of opinion between doctors and pharmacists regarding doctor’s practices of prescribing drugs to their patients, like: kinds of sponsorship for the continuing education, the relationship with the pharmaceutical representative or the frequency of prescribing over-the-counter products or supplements when they are recommending a certain treatment.

  7. Drug Use and Sex Work Among At-risk Women: A Qualitative Study of Initial Factors.

    Science.gov (United States)

    Roshanfekr, Payam; Noori, Roya; Dejman, Masoumeh; Fathi Geshnigani, Zahra; Rafiey, Hassan

    2015-06-01

    In recent years, there has been an increasing interest in performing research on drug use and sex work among at-risk women. Although there is a well-documented literature of the initial reasons associated with drug use and sex work among women, there is, however, a paucity of information in this area in Iran. This study aimed to explore the initial reasons associated with drug use and sex work in a group of female treatment seekers, who presented health-related risk behaviors, in Tehran, Iran. This qualitative study enrolled a total of 65 at-risk women, from five women-specific drug clinics, who participated in the study in 2011. Individual in-depth interviews were conducted. Focus group interviews were conducted with 10 key informants. All interviews were audio-taped and thematically written. The recorded data were analyzed using ATLASti qualitative research software version 10. The median age of the sample was 34 years. In addition, 44.6% of subjects were opiate users, and 55.4% were users of opiates and methamphetamine. Sex work was the main source of income for almost half of the sample. The most frequently reported reasons, associated with initial drug use, were extrinsic motivations, including the drug-using family, friends or social networks. Intrinsic motivations, including curiosity and individual willingness to use drugs, were other initial reasons. The most frequently reported reasons, associated with initial sex work, included the need to purchase drugs and financial problems. The study findings demonstrated a number of reasons associated with initial drug use and sex work. The role of sex work in providing drugs necessitates education and prevention. Special treatment programs should be implemented to prevent sex work among at-risk women in Iran.

  8. Drug utilization study in a burn care unit of a tertiary care hospital

    Directory of Open Access Journals (Sweden)

    Santoshkumar R Jeevangi

    2011-03-01

    Full Text Available Objective: To evaluate drug utilization and associated costs for the treatment of patients admitted in burn care unit of a tertiary care hospital. Methods: A prospective cross sectional study was conducted for a period of 15 months at Basaweshwara Teaching and General Hospital (BTGH, Gulbarga and the data collected was analyzed for various drug use indicators. Results: A total of 100 prescriptions were collected with 44% belonging to males and 56% to females. The average number of drugs per prescription ranged from 4.5 to 9.5. 9.5% of generics and 92% of essential drugs were prescribed. The opioid analgesics and sedatives were prescribed to all the patients who were admitted in burn care unit. The (Defined daily dose DDD/1 000/day for amikacin (359 was the highest followed by diclofenac sodium (156, pantoprazole (144, diazepam (130, ceftazidime (124, tramadol (115, ceftriaxone (84 and for paracetamol (4 which was the lowest. Conclusions: Significant amount of the money was spent on procurement of drugs. Most of the money was spent on prescribed antibiotics. The prescription of generic drugs should be promoted, for cost effective treatment. Hence the results of the present study indicate that there is a considerable scope for improvement in the prescription pattern.

  9. Interaction of anthraquinone anti-cancer drugs with DNA:Experimental and computational quantum chemical study

    Science.gov (United States)

    Al-Otaibi, Jamelah S.; Teesdale Spittle, Paul; El Gogary, Tarek M.

    2017-01-01

    Anthraquinones form the basis of several anticancer drugs. Anthraquinones anticancer drugs carry out their cytotoxic activities through their interaction with DNA, and inhibition of topoisomerase II activity. Anthraquinones (AQ4 and AQ4H) were synthesized and studied along with 1,4-DAAQ by computational and experimental tools. The purpose of this study is to shade more light on mechanism of interaction between anthraquinone DNA affinic agents and different types of DNA. This study will lead to gain of information useful for drug design and development. Molecular structures were optimized using DFT B3LYP/6-31 + G(d). Depending on intramolecular hydrogen bonding interactions two conformers of AQ4 were detected and computed as 25.667 kcal/mol apart. Molecular reactivity of the anthraquinone compounds was explored using global and condensed descriptors (electrophilicity and Fukui functions). Molecular docking studies for the inhibition of CDK2 and DNA binding were carried out to explore the anti cancer potency of these drugs. NMR and UV-VIS electronic absorption spectra of anthraquinones/DNA were investigated at the physiological pH. The interaction of the three anthraquinones (AQ4, AQ4H and 1,4-DAAQ) were studied with three DNA (calf thymus DNA, (Poly[dA].Poly[dT]) and (Poly[dG].Poly[dC]). NMR study shows a qualitative pattern of drug/DNA interaction in terms of band shift and broadening. UV-VIS electronic absorption spectra were employed to measure the affinity constants of drug/DNA binding using Scatchard analysis.

  10. Mechanisms Underlying the Risk to Develop Drug Addiction, Insights From Studies in Drosophila melanogaster.

    Science.gov (United States)

    Ryvkin, Julia; Bentzur, Assa; Zer-Krispil, Shir; Shohat-Ophir, Galit

    2018-01-01

    The ability to adapt to environmental changes is an essential feature of biological systems, achieved in animals by a coordinated crosstalk between neuronal and hormonal programs that allow rapid and integrated organismal responses. Reward systems play a key role in mediating this adaptation by reinforcing behaviors that enhance immediate survival, such as eating or drinking, or those that ensure long-term survival, such as sexual behavior or caring for offspring. Drugs of abuse co-opt neuronal and molecular pathways that mediate natural rewards, which under certain circumstances can lead to addiction. Many factors can contribute to the transition from drug use to drug addiction, highlighting the need to discover mechanisms underlying the progression from initial drug use to drug addiction. Since similar responses to natural and drug rewards are present in very different animals, it is likely that the central systems that process reward stimuli originated early in evolution, and that common ancient biological principles and genes are involved in these processes. Thus, the neurobiology of natural and drug rewards can be studied using simpler model organisms that have their systems stripped of some of the immense complexity that exists in mammalian brains. In this paper we review studies in Drosophila melanogaster that model different aspects of natural and drug rewards, with an emphasis on how motivational states shape the value of the rewarding experience, as an entry point to understanding the mechanisms that contribute to the vulnerability of drug addiction.

  11. Mechanisms Underlying the Risk to Develop Drug Addiction, Insights From Studies in Drosophila melanogaster

    Directory of Open Access Journals (Sweden)

    Julia Ryvkin

    2018-04-01

    Full Text Available The ability to adapt to environmental changes is an essential feature of biological systems, achieved in animals by a coordinated crosstalk between neuronal and hormonal programs that allow rapid and integrated organismal responses. Reward systems play a key role in mediating this adaptation by reinforcing behaviors that enhance immediate survival, such as eating or drinking, or those that ensure long-term survival, such as sexual behavior or caring for offspring. Drugs of abuse co-opt neuronal and molecular pathways that mediate natural rewards, which under certain circumstances can lead to addiction. Many factors can contribute to the transition from drug use to drug addiction, highlighting the need to discover mechanisms underlying the progression from initial drug use to drug addiction. Since similar responses to natural and drug rewards are present in very different animals, it is likely that the central systems that process reward stimuli originated early in evolution, and that common ancient biological principles and genes are involved in these processes. Thus, the neurobiology of natural and drug rewards can be studied using simpler model organisms that have their systems stripped of some of the immense complexity that exists in mammalian brains. In this paper we review studies in Drosophila melanogaster that model different aspects of natural and drug rewards, with an emphasis on how motivational states shape the value of the rewarding experience, as an entry point to understanding the mechanisms that contribute to the vulnerability of drug addiction.

  12. Motility in blastogregarines (Apicomplexa): Native and drug-induced organisation of Siedleckia nematoides cytoskeletal elements

    Czech Academy of Sciences Publication Activity Database

    Valigurová, A.; Vaškovicová, Naděžda; Diakin, A.; Paskerová, G.G.; Simdyanov, T.G.; Kováčiková, M.

    2017-01-01

    Roč. 12, č. 6 (2017), č. článku e0179709. E-ISSN 1932-6203 R&D Projects: GA MŠk(CZ) LM2015062 Institutional support: RVO:68081731 Keywords : toxoplasma-gondii * fine-structure * cell invasion Subject RIV: JA - Electronics ; Optoelectronics, Electrical Engineering OBOR OECD: Electrical and electronic engineering Impact factor: 2.806, year: 2016

  13. Confusing the drug facts on one nonprescription drug label with those on another: The Drug Facts Label as a text schema

    Directory of Open Access Journals (Sweden)

    Michael P Ryan

    2016-04-01

    Full Text Available The Drug Facts Label is designed to guide consumers in comparing nonprescription drugs. Undergraduates studied and recalled drug facts for three analgesic or non-analgesic labels using Drug Facts Label headings as retrieval cues. They then studied and recalled drug facts from an aspirin label. Aspirin recall was greater when the prior labels were analgesics, but prior-label intrusion errors were also greater. These two effects were associated with the number of prior drug labels on which facilitating and interfering drug facts appeared. Using the Drug Facts Label schema to read drug labels can both enhance and degrade the recall of nonprescription drug facts.

  14. A new scleroglucan/borax hydrogel: swelling and drug release studies.

    Science.gov (United States)

    Coviello, Tommasina; Grassi, Mario; Palleschi, Antonio; Bocchinfuso, Gianfranco; Coluzzi, Gina; Banishoeib, Fateme; Alhaique, Franco

    2005-01-31

    The aim of the work was the characterization of a new polysaccharidic physical hydrogel, obtained from Scleroglucan (Sclg) and borax, following water uptake and dimension variations during the swelling process. Furthermore, the release of molecules of different size (Theophylline (TPH), Vitamin B12 (Vit. B12) and Myoglobin (MGB)) from the gel and from the dried system used as a matrix for tablets was studied. The increase of weight of the tablets with and without the loaded drugs was followed together with the relative variation of the dimensions. The dry matrix, in the form of tablets was capable, during the swelling process, to incorporate a relevant amount of solvent (ca. 20 g water/g dried matrix), without dissolving in the medium, leading to a surprisingly noticeable anisotropic swelling that can be correlated with a peculiar supramolecular structure of the system induced by compression. Obtained results indicate that the new hydrogel can be suitable for sustained drug release formulations. The delivery from the matrix is deeply dependent on the size of the tested model drugs. The experimental release data obtained from the gel were satisfactorily fitted by an appropriate theoretical approach and the relative drug diffusion coefficients in the hydrogel were estimated. The release profiles of TPH, Vit. B12 and MGB from the tablets have been analyzed in terms of a new mathematical approach that allows calculating of permeability values of the loaded drugs.

  15. Pharmacodynamics and common drug-drug interactions of the third-generation antiepileptic drugs.

    Science.gov (United States)

    Stefanović, Srđan; Janković, Slobodan M; Novaković, Milan; Milosavljević, Marko; Folić, Marko

    2018-02-01

    Anticonvulsants that belong to the third generation are considered as 'newer' antiepileptic drugs, including: eslicarbazepine acetate, lacosamide, perampanel, brivaracetam, rufinamide and stiripentol. Areas covered: This article reviews pharmacodynamics (i.e. mechanisms of action) and clinically relevant drug-drug interactions of the third-generation antiepileptic drugs. Expert opinion: Newer antiepileptic drugs have mechanisms of action which are not shared with the first and the second generation anticonvulsants, like inhibition of neurotransmitters release, blocking receptors for excitatory amino acids and new ways of sodium channel inactivation. New mechanisms of action increase chances of controlling forms of epilepsy resistant to older anticonvulsants. Important advantage of the third-generation anticonvulsants could be their little propensity for interactions with both antiepileptic and other drugs observed until now, making prescribing much easier and safer. However, this may change with new studies specifically designed to discover drug-drug interactions. Although the third-generation antiepileptic drugs enlarged therapeutic palette against epilepsy, 20-30% of patients with epilepsy is still treatment-resistant and need new pharmacological approach. There is great need to explore all molecular targets that may directly or indirectly be involved in generation of seizures, so a number of candidate compounds for even newer anticonvulsants could be generated.

  16. A case-control study estimating accident risk for alcohol, medicines and illegal drugs.

    Directory of Open Access Journals (Sweden)

    Kim Paula Colette Kuypers

    Full Text Available The aim of the present study was to assess the risk of having a traffic accident after using alcohol, single drugs, or a combination, and to determine the concentrations at which this risk is significantly increased.A population-based case-control study was carried out, collecting whole blood samples of both cases and controls, in which a number of drugs were detected. The risk of having an accident when under the influence of drugs was estimated using logistic regression adjusting for gender, age and time period of accident (cases/sampling (controls. The main outcome measures were odds ratio (OR for accident risk associated with single and multiple drug use. In total, 337 cases (negative: 176; positive: 161 and 2726 controls (negative: 2425; positive: 301 were included in the study.Main findings were that 1 alcohol in general (all the concentrations together caused an elevated crash risk; 2 cannabis in general also caused an increase in accident risk; at a cut-off of 2 ng/mL THC the risk of having an accident was four times the risk associated with the lowest THC concentrations; 3 when ranking the adjusted OR from lowest to highest risk, alcohol alone or in combination with other drugs was related to a very elevated crash risk, with the highest risk for stimulants combined with sedatives.The study demonstrated a concentration-dependent crash risk for THC positive drivers. Alcohol and alcohol-drug combinations are by far the most prevalent substances in drivers and subsequently pose the largest risk in traffic, both in terms of risk and scope.

  17. An exploratory wastewater analysis study of drug use in Auckland, New Zealand.

    Science.gov (United States)

    Lai, Foon Yin; Wilkins, Chris; Thai, Phong; Mueller, Jochen F

    2017-09-01

    New Zealand is considered to have unusual drug use patterns by international standards. However, this understanding has largely been obtained from social surveys where respondents self-report use. The aim of this paper is to conduct the first wastewater study of drug use in Auckland. Wastewater sampling was completed from 2 May to 18 July 2014 at 2 Auckland wastewater treatment plants which service 1.3 million people. Samples were analysed for 17 drug residues by using liquid chromatography-tandem mass spectrometry. Consumption of methamphetamine, 3,4-methylenedioxymethamphetamine (MDMA), cocaine, codeine and methadone (mg/day/1000 people) was estimated by using a back-calculation formula. Methamphetamine, codeine, morphine and methadone were detected with high frequency (80-100%), followed by amphetamine (~60%), MDMA (~7%, i.e. 8 occasions) and methylone (3 occasions). An overall mean of 360 mg of methamphetamine and 60 mg of MDMA was estimated to have been consumed per day per 1000 people. Methamphetamine consumption was found at similar levels in both catchments (377 and 351 mg/day/1000 people). Cocaine was only detected in 1 catchment and on only 8 occasions. JWH-018 was detected in 1 catchment and only on 1 occasion. Methamphetamine, codeine and other opioids were detected at a consistent level throughout the week. 3,4-Methylenedioxymethamphetamine and methylone were detected only during the weekends. Wastewater analysis confirms that methamphetamine was one of the most commonly detected illegal drugs in Auckland and was detected consistently throughout the week. In contrast, cocaine and MDMA were rarely detected, with detection limited to weekends. [Lai FY, Wilkins C, Thai P, Mueller JF. An exploratory wastewater analysis study of drug use in Auckland, New Zealand. Drug Alcohol Rev 2017;00:000-000]. © 2017 Australasian Professional Society on Alcohol and other Drugs.

  18. Rapid assessment response (RAR study: drug use and health risk - Pretoria, South Africa

    Directory of Open Access Journals (Sweden)

    Trautmann Franz

    2011-06-01

    Full Text Available Abstract Background Within a ten year period South Africa has developed a substantial illicit drug market. Data on HIV risk among drug using populations clearly indicate high levels of HIV risk behaviour due to the sharing of injecting equipment and/or drug-related unprotected sex. While there is international evidence on and experience with adequate responses, limited responses addressing drug use and drug-use-related HIV and other health risks are witnessed in South Africa. This study aimed to explore the emerging problem of drug-related HIV transmission and to stimulate the development of adequate health services for the drug users, by linking international expertise and local research. Methods A Rapid Assessment and Response (RAR methodology was adopted for the study. For individual and focus group interviews a semi-structured questionnaire was utilised that addressed key issues. Interviews were conducted with a total of 84 key informant (KI participants, 63 drug user KI participants (49 males, 14 females and 21 KI service providers (8 male, 13 female. Results and Discussion Adverse living conditions and poor education levels were cited as making access to treatment harder, especially for those living in disadvantaged areas. Heroin was found to be the substance most available and used in a problematic way within the Pretoria area. Participants were not fully aware of the concrete health risks involved in drug use, and the vague ideas held appear not to allow for concrete measures to protect themselves. Knowledge with regards to substance related HIV/AIDS transmission is not yet widespread, with some information sources disseminating incorrect or unspecific information. Conclusions The implementation of pragmatic harm-reduction and other evidence-based public health care policies that are designed to reduce the harmful consequences associated with substance use and HIV/AIDS should be considered. HIV testing and treatment services also need to

  19. Cardiovascular drugs and the risk of suicide: a nested case-control study

    DEFF Research Database (Denmark)

    Callréus, Torbjörn; Agerskov Andersen, Ulla; Hallas, Jesper

    2007-01-01

    OBJECTIVE: During the past 30 years, various cardiovascular drugs have been implicated as causes of depression or suicide. Although the evidence for causal relationships has generally been conflicting, both beta-blockers and angiotensin-converting-enzyme inhibitors (ACE-inhibitors) have been...... related to depression. Lipid-lowering therapies and calcium-channel blockers have also been linked to an increased risk of suicide. In this study, we investigated the possible association between the use of cardiovascular drugs and suicide using population-based register data. METHODS: We performed...... a nested case-control study in the county of Funen, Denmark, that consisted of 743 cases of completed suicide identified in a Death Registry for the period 1991-1998 and 14,860 age- and sex-matched controls. Information on previous drug use was retrieved from prescription data and the association between...

  20. The effect of newer anti-rheumatic drugs on osteogenic cell proliferation: an in-vitro study

    Directory of Open Access Journals (Sweden)

    Laing Patrick

    2009-05-01

    Full Text Available Abstract Background Disease modifying anti-rheumatic drugs (DMARDs may interfere with bone healing. Previous studies give conflicting advice regarding discontinuation of these drugs in the peri-operative setting. No consensus exists in current practice especially with the newer DMARDs such as Leflunomide, Etanercept, and Infliximab. The aim of this study was to assess the in-vitro effect of these drugs alone and in relevant clinical combinations on Osteoblast activity. Methods Osteoblasts were cultured from femoral heads obtained from five young otherwise healthy patients undergoing total hip replacement. The cells were cultured using techniques that have been previously described. A full factorial design was used to set up the experiment on samples obtained from the five donors. Normal therapeutic concentrations of the various DMARDs were added alone and in combination to the media. The cell proliferation was estimated after two weeks using spectrophotometric technique using Roche Cell proliferation Kit. Multilevel regression analysis was used to estimate which drugs or combination of drugs significantly affected cell proliferation. Results Infliximab and Leflunomide had an overall significant inhibitory effect (p Conclusion Our study indicates that in-vitro osteoblast proliferation can be inhibited by the presence of certain DMARDs. Combinations of drugs had an influence and could negate the action of a drug on osteoblast proliferation. The response to drugs may be donor-dependent.

  1. California drug courts: outcomes, costs and promising practices: an overview of Phase II in a statewide study.

    Science.gov (United States)

    Carey, Shannon M; Finigan, Michael; Crumpton, Dave; Waller, Mark

    2006-11-01

    The rapid expansion of drug courts in California and the state's uncertain fiscal climate highlighted the need for definitive cost information on drug court programs. This study focused on creating a research design that can be utilized for statewide and national cost-assessment of drug courts by conducting in-depth case studies of the costs and benefits in nine adult drug courts in California. A Transactional Institutional Costs Analysis (TICA) approach was used, allowing researchers to calculate costs based on every individual's transactions within the drug court or the traditional criminal justice system. This methodology also allows the calculation of costs and benefits by agency (e.g., Public Defender's office, court, District Attorney). Results in the nine sites showed that the majority of agencies save money in processing an offender though drug court. Overall, for these nine study sites, participation in drug court saved the state over 9 million dollars in criminal justice and treatment costs due to lower recidivism in drug court participants. Based on the lessons learned in Phases I and II, Phase III of this study focuses on the creation of a web-based drug court cost self-evaluation tool (DC-CSET) that drug courts can use to determine their own costs and benefits.

  2. Effect of drug law enforcement on drug market violence: a systematic review.

    Science.gov (United States)

    Werb, Dan; Rowell, Greg; Guyatt, Gordon; Kerr, Thomas; Montaner, Julio; Wood, Evan

    2011-03-01

    Violence is amongst the primary concerns of communities around the world and research has demonstrated links between violence and the illicit drug trade, particularly in urban settings. Given the growing emphasis on evidence-based policy-making, and the ongoing severe drug market violence in Mexico and other settings, we conducted a systematic review to examine the impacts of drug law enforcement on drug market violence. We conducted a systematic review using Preferred Reporting Items for Systematic Reviews and Meta Analyses (PRISMA) guidelines. Specifically, we undertook a search of English language electronic databases (Academic Search Complete, PubMed, PsycINFO, EMBASE, Web of Science, Sociological Abstracts, Social Service Abstracts, PAIS International and Lexis-Nexis), the Internet (Google, Google Scholar), and article reference lists, from database inception to January 24, 2011. Overall, 15 studies were identified that evaluated the impact of drug law enforcement on drug market violence, including 11 (73%) longitudinal analyses using linear regression, 2 (13%) mathematical drug market models, and 2 (13%) qualitative studies. Fourteen (93%) studies reported an adverse impact of drug law enforcement on levels of violence. Ten of the 11 (91%) studies employing longitudinal qualitative analyses found a significant association between drug law enforcement and drug market violence. Our findings suggest that increasing drug law enforcement is unlikely to reduce drug market violence. Instead, the existing evidence base suggests that gun violence and high homicide rates may be an inevitable consequence of drug prohibition and that disrupting drug markets can paradoxically increase violence. In this context, and since drug prohibition has not meaningfully reduced drug supply, alternative regulatory models will be required if drug supply and drug market violence are to be meaningfully reduced. Copyright © 2011 Elsevier B.V. All rights reserved.

  3. Prescription drug use during pregnancy in France: a study from the national health insurance permanent sample.

    Science.gov (United States)

    Demailly, Romain; Escolano, Sylvie; Quantin, Catherine; Tubert-Bitter, Pascale; Ahmed, Ismaïl

    2017-09-01

    To provide an up-to-date account of drug prescription during pregnancy in France from 2011 to 2014 using the permanent sample of the French national computerized healthcare database and with a focus on recommended supplementations, fetotoxic drugs and teratogenic drugs. All pregnancies identified by the International Classification of Diseases, 10th Revision codes list in the hospitalization database, lasting more than 9 weeks of amenorrhea and whose delivery occurred between 01/01/2011 and 12/31/2014, were included. Drugs delivered between the trimester before and until the end of the pregnancy were included. Drug exposure prevalence was calculated for each year and according to pregnancy trimesters. The study included 28,491 pregnancies with a median number of 9 [5-13] (median [IQ range]) drugs delivered. The most prescribed drug class was antianemia (in 72.5% of exposed). The prescription rate of recommended vitamins (B9 and D) increased over the study period (+10%). Influenza vaccination also increased but remained at a low rate (1%). Exposure to fetotoxic drugs decreased as pregnancy advanced. Exposure to the main teratogenic antiepileptics was stable over the study period. Low-income pregnant women had a higher average drug consumption except for recommended vitamins. Pregnant French women are among the largest consumers of prescription medications worldwide. Overall, the dispensation trends observed in this study are in line with the recommendations of the French National College of Gynecologists and Obstetricians. Nevertheless, while being low, exposure to fetotoxic drugs, teratogenic drugs or those under safety alerts still occurred. Supplementations and vaccines in low-income pregnant women should also be increased. Copyright © 2017 John Wiley & Sons, Ltd.

  4. A study on nanodiamond-based drug delivery system

    International Nuclear Information System (INIS)

    Li Jing; Zhang Xiaoyong; Zhu Ying; Li Wenxin; Huang Qing

    2010-01-01

    A multifunctional drug delivery system based on nanodiamonds (NDs) has been developed. FITC, HCPT and TF were absorbed on NDs successively to form the multifunctional complex. The NDs and ND complex samples were characterized by TEM, FR-IR and UV-V. The results indicated that this drug delivery system is a high loading system. Efficacy of the drug delivery system on Hela cell was evaluated with MTT assays and fluorescence microscopy. The results show that multifunction of the NDs complex include fluorescence, targeting and high efficacy. (authors)

  5. 'Silk Road', the virtual drug marketplace: a single case study of user experiences.

    Science.gov (United States)

    Van Hout, Marie Claire; Bingham, Tim

    2013-09-01

    The online promotion of 'drug shopping' and user information networks is of increasing public health and law enforcement concern. An online drug marketplace called 'Silk Road' has been operating on the 'Deep Web' since February 2011 and was designed to revolutionise contemporary drug consumerism. A single case study approach explored a 'Silk Road' user's motives for online drug purchasing, experiences of accessing and using the website, drug information sourcing, decision making and purchasing, outcomes and settings for use, and perspectives around security. The participant was recruited following a lengthy relationship building phase on the 'Silk Road' chat forum. The male participant described his motives, experiences of purchasing processes and drugs used from 'Silk Road'. Consumer experiences on 'Silk Road' were described as 'euphoric' due to the wide choice of drugs available, relatively easy once navigating the Tor Browser (encryption software) and using 'Bitcoins' for transactions, and perceived as safer than negotiating illicit drug markets. Online researching of drug outcomes, particularly for new psychoactive substances was reported. Relationships between vendors and consumers were described as based on cyber levels of trust and professionalism, and supported by 'stealth modes', user feedback and resolution modes. The reality of his drug use was described as covert and solitary with psychonautic characteristics, which contrasted with his membership, participation and feelings of safety within the 'Silk Road' community. 'Silk Road' as online drug marketplace presents an interesting displacement away from 'traditional' online and street sources of drug supply. Member support and harm reduction ethos within this virtual community maximises consumer decision-making and positive drug experiences, and minimises potential harms and consumer perceived risks. Future research is necessary to explore experiences and backgrounds of other users. Copyright © 2013

  6. Drug Taking Beliefs of Australian Adolescents: A Pilot Study

    Science.gov (United States)

    Skrzypiec, Grace; Owens, Laurence

    2013-01-01

    In this study adolescents offered their insights and perspectives of factors associated with adolescent illicit drug taking intentions. The factors explored were identified using a cross-disciplinary approach involving the Theory of Planned Behavior (TPB) and criminological theories, and these formed the framework for data analysis. Interviews…

  7. Suicidal ideation among young French adults: association with occupation, family, sexual activity, personal background and drug use.

    Science.gov (United States)

    Legleye, S; Beck, F; Peretti-Watel, P; Chau, N; Firdion, J M

    2010-06-01

    To assess associations among young adults between suicidal ideation in the previous year and adverse childhood events, occupation, education, tobacco use, alcohol abuse, cannabis use in the previous month, illicit drug use, sexual orientation and activity, depression, physical violence in the previous year, and lifetime forced sexual intercourse. A subsample of 4075 French adults aged 18-30 years was drawn from a random national telephone survey in 2005. Major depressive episode and alcohol abuse were assessed using CIDI-SF and AUDIT-C (score above 4). Data were analysed with logistic regressions. Suicidal ideation affected 5.7% of men and 4.9% of women. Among men depression had the highest adjusted odds ratio (ORa=8.06, 5.07-12.79), followed by homosexual intercourse (3.37, 1.62-7.04), absence of sexual activity (2.83, 1.80-4.44); ORa between 1.6 and 2.0 were observed for living alone, daily tobacco smoking, being unemployed, serious health event concerning the father, age 26-30 and bad relationships between parents. Among women, depression had the highest ORa (7.60, 4.70-12.29), followed by lifetime experience of forced sexual intercourse (5.37, 2.89-9.96), having consumed illicit drugs other than cannabis (4.01, 1.48-10.89); ORa between 1.7 and 2.5 were observed for living alone, being unemployed, bad relationship between parents and age 26-30. Cross-sectional survey, sexual orientation inferred from sexual activity. Suicide prevention should integrate the fact that besides depression, unemployment, family history, age, and sexual activity and orientation are specific risk factors among men, whereas illicit drug use, violence and forced sexual intercourse are more important among women. Copyright 2009 Elsevier B.V. All rights reserved.

  8. Multi-target drugs: the trend of drug research and development.

    Science.gov (United States)

    Lu, Jin-Jian; Pan, Wei; Hu, Yuan-Jia; Wang, Yi-Tao

    2012-01-01

    Summarizing the status of drugs in the market and examining the trend of drug research and development is important in drug discovery. In this study, we compared the drug targets and the market sales of the new molecular entities approved by the U.S. Food and Drug Administration from January 2000 to December 2009. Two networks, namely, the target-target and drug-drug networks, have been set up using the network analysis tools. The multi-target drugs have much more potential, as shown by the network visualization and the market trends. We discussed the possible reasons and proposed the rational strategies for drug research and development in the future.

  9. Plasmonic nanocarrier grid-enhanced Raman sensor for studies of anticancer drug delivery.

    Science.gov (United States)

    Kurzątkowska, Katarzyna; Santiago, Ty; Hepel, Maria

    2017-05-15

    Targeted drug delivery systems using nanoparticle nanocarriers offer remarkable promise for cancer therapy by discriminating against devastating cytotoxicity of chemotherapeutic drugs to healthy cells. To aid in the development of new drug nanocarriers, we propose a novel plasmonic nanocarrier grid-enhanced Raman sensor which can be applied for studies and testing of drug loading onto the nanocarriers, attachment of targeting ligands, dynamics of drug release, assessment of nanocarrier stability in biological environment, and general capabilities of the nanocarrier. The plasmonic nanogrid sensor offers strong Raman enhancement due to the overlapping plasmonic fields emanating from the nearest-neighbor gold nanoparticle nanocarriers and creating the enhancement "hot spots". The sensor has been tested for immobilization of an anticancer drug gemcitabine (2',2'-difluoro-2'-deoxycytidine, GEM) which is used in treatment of pancreatic tumors. The drawbacks of currently applied treatment include high systemic toxicity, rapid drug decay, and low efficacy (ca. 20%). Therefore, the development of a targeted GEM delivery system is highly desired. We have demonstrated that the proposed nanocarrier SERS sensor can be utilized to investigate attachment of targeting ligands to nanocarriers (attachment of folic acid ligand recognized by folate receptors of cancer cells is described). Further testing of the nanocarrier SERS sensor involved drug release induced by lowering pH and increasing GSH levels, both occurring in cancer cells. The proposed sensor can be utilized for a variety of drugs and targeting ligands, including those which are Raman inactive, since the linkers can act as the Raman markers, as illustrated with mercaptobenzoic acid and para-aminothiophenol. Copyright © 2017 Elsevier B.V. All rights reserved.

  10. Psychotropic Drug Prescription in Adolescents: A Retrospective Study in a Swiss Psychiatric University Hospital.

    Science.gov (United States)

    Ansermot, Nicolas; Jordanov, Véronique; Smogur, Michal; Holzer, Laurent; Eap, Chin B

    2018-04-01

    This retrospective study aims to evaluate off-label prescriptions and administrations of psychotropic medications in adolescents in a university psychiatric hospital in Switzerland. Data were collected during the entire stays from the electronic database for 76 inpatients in 2008 and 76 inpatients in 2014. Data collected included gender, age, psychiatric diagnosis, duration of hospitalization, and psychotropic drug prescriptions and administrations. A total of 224 psychotropic drugs (mean 2.9 drugs/patient) were prescribed in 2008 and 268 (mean 3.5 drugs/patient) in 2014. Due to the prescriptions of some drugs as required, only 76% of the prescriptions were actually administered in 2008 (mean 2.3 drugs/patient) and 55% in 2014 (mean 1.9 drugs/patient). Antipsychotics were the most frequently prescribed drugs in 2008 (74% of patients) and 2014 (86% of patients). Anxiolytics were also highly prescribed in 2008 (54% of patients) and 2014 (66% of patients), as well as antidepressants in 2008 (30% of patients), but less in 2014 (13% of patients). Overall, 69% of prescriptions were found to be off label in 2008 and 68% in 2014, according to age, diagnosis, dose, or formulation as approved by Swissmedic. The medication classes with the highest rate of off-label prescriptions were antidepressants (100% for both years), antipsychotics (94% in 2008 and 92% in 2014), and hypnotics (67% in 2008 and 100% in 2014). For both study periods, at least one off-label psychotropic drug prescription and administration was recorded in 96% and 79% of the patients, respectively. The high rate of off-label psychotropic drug use strengthens the need for clinical trials to better evaluate the efficacy and safety of these treatments in adolescents.

  11. Antineoplastic Drugs

    Science.gov (United States)

    Sadée, Wolfgang; El Sayed, Yousry Mahmoud

    The limited scope of therapeutic drug-level monitoring in cancer chemotherapy results from the often complex biochemical mechanisms that contribute to antineoplastic activity and obscure the relationships among drug serum levels and therapeutic benefits. Moreover, new agents for cancer chemotherapy are being introduced at a more rapid rate than for the treatment of other diseases, although the successful application of therapeutic drug-level monitoring may require several years of intensive study of the significance of serum drug levels. However, drug level monitoring can be of considerable value during phase I clinical trials of new antineoplastic agents in order to assess drug metabolism, bioavailability, and intersubject variability; these are important parameters in the interpretation of clinical studies, but have no immediate benefit to the patient. High performance liquid chromatography (HPLC) probably represents the most versatile and easily adaptable analytical technique for drug metabolite screening (1). HPLC may therefore now be the method of choice during phase I clinical trials of antineoplastic drugs. For example, within a single week we developed an HPLC assay—using a C18 reverse-phase column, UV detection, and direct serum injection after protein precipitation—for the new radiosensitizer, misonidazole (2).

  12. Market Exclusivity Time for Top Selling Originator Drugs in Canada: A Cohort Study.

    Science.gov (United States)

    Lexchin, Joel

    2017-09-01

    This study looks at market exclusivity time for the top selling originator drugs in Canada. Total sales for drugs without competition were also calculated. A list of the top selling originator drugs by dollar sales from 2009 to 2015 inclusive, except for 2010, was compiled along with their annual sales. Health Canada databases were used to extract the following information: generic name, date of Notice of Compliance (NOC, date of marketing authorization), whether the product was a small molecule drug or a biologic, and date of NOC for a generic or biosimilar. Market exclusivity time was calculated in days for drugs. A total of 121 drugs were identified. There were 96 small molecule drugs (63 with a generic competitor and 33 with no generic competitor) and 25 biologics (none with a biosimilar competitor). The 63 drugs with a competitor had a mean market exclusivity time of 4478 days (12.3 years) (95% CI 4159-4798). The 58 drugs without competition had total annual sales of Can$8.59 billion and were on the market for a median of 5357 days (14.7 years) (interquartile range 3291-6679) as of January 31, 2017. Top selling originator drugs in Canada have a considerably longer period of market exclusivity than the 8 to 10 years that the research-based pharmaceutical industry claims. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  13. Influence of depression and early adverse experiences on illicit drug dependence: a case-control study.

    Science.gov (United States)

    Ferigolo, Maristela; Stein, Airton T; Fuchs, Flavio D; Barros, Helena M T

    2009-06-01

    The purpose of this study was to investigate the association between depression and illicit drug dependence among a Latin-American population. illicit drug dependent patients (n = 137) and controls (n = 274) were interviewed using the Diagnostic Interview for Genetic Studies, in order to detect lifetime and current depressive disorder and illicit (cocaine, cannabis or inhalants) substance dependence. A regression analysis was used to estimate the odds ratio for drug dependence according to the diagnosis of depression. The lifetime diagnosis of depression (p = 0.001; OR = 4.9; 95% CI, 1.9-12.7) predicts illegal drugs dependence. Sociodemographic variables such as male gender (p drug dependence. Additional influent factors detected were having parents (p = 0.006; OR = 18.9; 95% CI, 2.3-158) or friends (p illicit drugs dependents. although a causal relationship between dependence on illicit drugs and depression cannot be determined, comparison of the sequence of events point to the occurrence of depression later in life than dependence. It remains to be determined whether depression is a comorbidity of dependence, sharing etiological factors, or a consequence of drug abuse and/or abstinence.

  14. In vivo 7Li and 19F NMR studies of drugs in the brain

    International Nuclear Information System (INIS)

    Komoroski, Richard A.

    1999-01-01

    For various reasons, it is advantageous to measure the concentration of a psychoactive drug in the brain in vivo. Many drugs contain the element fluorine. Using 19 F NMR spectroscopy, we have studied the psychoactive drugs trifluoperazine and fluoxetine in the brain in vivo. Using 7 Li NMR, it is possible to detect lithium ion, used to treat manic depressive illness. We have measured the concentration and distribution of lithium in both human and rat brain in vivo. Measurement of drug levels in the human brain may provide a measure of therapeutic or toxic effects, as well as insight into drug metabolism and mechanism of action. (author)

  15. NIR spectrometry for counterfeit drug detection - A feasibility study

    DEFF Research Database (Denmark)

    Rodionova, O.Y.; Houmøller, Lars P.; Pomerantsev, A.L.

    2005-01-01

    for mathematical data processing for false drugs detection is demonstrated. Also, multivariate hyperspectral image analysis is applied providing additional diagnostic information. Hyperspectral imaging is becoming a useful diagnostic tool for identifying non-homogeneous spatial regions of drug formulation. Two...... types of drugs are used to demonstrate the applicability of these approaches....

  16. Functionalized silica nanoparticles as a carrier for Betamethasone Sodium Phosphate: Drug release study and statistical optimization of drug loading by response surface method.

    Science.gov (United States)

    Ghasemnejad, M; Ahmadi, E; Mohamadnia, Z; Doustgani, A; Hashemikia, S

    2015-11-01

    Mesoporous silica nanoparticles with a hexagonal structure (SBA-15) were synthesized and modified with (3-aminopropyl) triethoxysilane (APTES), and their performance as a carrier for drug delivery system was studied. Chemical structure and morphology of the synthesized and modified SBA-15 were characterized by SEM, BET, TEM, FT-IR and CHN technique. Betamethasone Sodium Phosphate (BSP) as a water soluble drug was loaded on the mesoporous silica particle for the first time. The response surface method was employed to obtain the optimum conditions for the drug/silica nanoparticle preparation, by using Design-Expert software. The effect of time, pH of preparative media, and drug/silica ratio on the drug loading efficiency was investigated by the software. The maximum loading (33.69%) was achieved under optimized condition (pH: 1.8, time: 3.54 (h) and drug/silica ratio: 1.7). The in vitro release behavior of drug loaded particles under various pH values was evaluated. Finally, the release kinetic of the drug was investigated using the Higuchi and Korsmeyer-Peppas models. Cell culture and cytotoxicity assays revealed the synthesized product doesn't have any cytotoxicity against human bladder cell line 5637. Accordingly, the produced drug-loaded nanostructures can be applied via different routes, such as implantation and topical or oral administration. Copyright © 2015 Elsevier B.V. All rights reserved.

  17. Studies in youth, drug and alcohol consumption at the Centre for Alcohol and Drug Research

    DEFF Research Database (Denmark)

    Kolind, Torsten; Demant, Jakob Johan; Hunt, Geoffrey

    2013-01-01

    or providing genuine contribution to the sociological analysis and understanding of youth cultures. From the mid-00 s and forward however, a range of analytical tools were developed at Centre for Alcohol and Drug Research (CRF) in order to understand the relationship between youth, drug and alcohol use......Background: During the 90 s and especially in the beginning of the 00 s research in youth, drug and alcohol consumption increased markedly in Denmark. Much of this research was applied and placed in a dilemma between reproducing existing social problem characterizations of youthful behaviors...... and to move beyond the applied perspective into a more social science analytical approach. Aim: The article investigates the relationship developments between drug and alcohol research and youth research in Denmark in general, with a special focus on research conducted at CRF. Specifically, we will focus...

  18. Microfluidics Enables Small-Scale Tissue-Based Drug Metabolism Studies With Scarce Human Tissue

    NARCIS (Netherlands)

    van Midwoud, Paul M.; Verpoorte, Elisabeth; Groothuis, Geny M. M.; Merema, M.T.

    2011-01-01

    Early information on the metabolism and toxicity properties of new drug candidates is crucial for selecting the right candidates for further development. Preclinical trials rely on cell-based in vitro tests and animal studies to characterize the in vivo behavior of drug candidates, although neither

  19. Drug-eluting stents studies in mice: Do we need atherosclerosis to study restenosis?

    NARCIS (Netherlands)

    Pires, N.M.M.; Jukema, J.W.; Daemen, M.J.A.P.; Quax, P.H.A.

    2006-01-01

    In 2001, the first human study with drug-eluting stents (DES) was published showing a nearly complete abolition of restenosis by using a sirolimus-eluting stent. This success was very encouraging to test new compounds in combination with the DES platform. Nevertheless, several other anti-restenotic

  20. Drug Release Studies from Caesalpinia pulcherrima Seed Polysaccharide

    OpenAIRE

    Jeevanandham, Somasundaram; Dhachinamoorthi, Duraiswamy; Bannoth Chandra Sekhar, Kothapalli

    2011-01-01

    This study examines the controlled release behavior of both water-soluble (acetaminophen, caffeine, theophylline and salicylic acid) and water insoluble (indomethacin) drugs derived from Caesalpinia pulcherrima seed Gum isolated from Caesalpinia pulcherrima kernel powder. It further investigates the effect of incorporating diluents such as microcrystalline cellulose and lactose on caffeine release. In addition the effect the gum?s (polysaccharide) partial cross-linking had on release of aceta...

  1. Drug-drug interactions between anti-retroviral therapies and drugs of abuse in HIV systems.

    Science.gov (United States)

    Kumar, Santosh; Rao, P S S; Earla, Ravindra; Kumar, Anil

    2015-03-01

    Substance abuse is a common problem among HIV-infected individuals. Importantly, addictions as well as moderate use of alcohol, smoking, or other illicit drugs have been identified as major reasons for non-adherence to antiretroviral therapy (ART) among HIV patients. The literature also suggests a decrease in the response to ART among HIV patients who use these substances, leading to failure to achieve optimal virological response and increased disease progression. This review discusses the challenges with adherence to ART as well as observed drug interactions and known toxicities with major drugs of abuse, such as alcohol, smoking, methamphetamine, cocaine, marijuana, and opioids. The lack of adherence and drug interactions potentially lead to decreased efficacy of ART drugs and increased ART, and drugs of abuse-mediated toxicity. As CYP is the common pathway in metabolizing both ART and drugs of abuse, we discuss the possible involvement of CYP pathways in such drug interactions. We acknowledge that further studies focusing on common metabolic pathways involving CYP and advance research in this area would help to potentially develop novel/alternate interventions and drug dose/regimen adjustments to improve medication outcomes in HIV patients who consume drugs of abuse.

  2. Data-driven prediction of adverse drug reactions induced by drug-drug interactions.

    Science.gov (United States)

    Liu, Ruifeng; AbdulHameed, Mohamed Diwan M; Kumar, Kamal; Yu, Xueping; Wallqvist, Anders; Reifman, Jaques

    2017-06-08

    The expanded use of multiple drugs has increased the occurrence of adverse drug reactions (ADRs) induced by drug-drug interactions (DDIs). However, such reactions are typically not observed in clinical drug-development studies because most of them focus on single-drug therapies. ADR reporting systems collect information on adverse health effects caused by both single drugs and DDIs. A major challenge is to unambiguously identify the effects caused by DDIs and to attribute them to specific drug interactions. A computational method that provides prospective predictions of potential DDI-induced ADRs will help to identify and mitigate these adverse health effects. We hypothesize that drug-protein interactions can be used as independent variables in predicting ADRs. We constructed drug pair-protein interaction profiles for ~800 drugs using drug-protein interaction information in the public domain. We then constructed statistical models to score drug pairs for their potential to induce ADRs based on drug pair-protein interaction profiles. We used extensive clinical database information to construct categorical prediction models for drug pairs that are likely to induce ADRs via synergistic DDIs and showed that model performance deteriorated only slightly, with a moderate amount of false positives and false negatives in the training samples, as evaluated by our cross-validation analysis. The cross validation calculations showed an average prediction accuracy of 89% across 1,096 ADR models that captured the deleterious effects of synergistic DDIs. Because the models rely on drug-protein interactions, we made predictions for pairwise combinations of 764 drugs that are currently on the market and for which drug-protein interaction information is available. These predictions are publicly accessible at http://avoid-db.bhsai.org . We used the predictive models to analyze broader aspects of DDI-induced ADRs, showing that ~10% of all combinations have the potential to induce ADRs

  3. Influence of lipophilicity on drug-cyclodextrin interactions: A calorimetric study

    International Nuclear Information System (INIS)

    Waters, Laura J.; Bedford, Susan; Parkes, Gareth M.B.; Mitchell, J.C.

    2010-01-01

    This study presents a systematic investigation of the interaction of three functionally related drugs, ibuprofen, ketoprofen and flurbiprofen, with two distinct forms of cyclodextrin at three specific temperatures, 298, 303 and 310 K using isothermal titration calorimetry (ITC). Although all three pharmaceutical compounds have similar pKa values, they exhibit widely differing lipophilicities. While previous authors have presented data regarding the binding of flurbiprofen and ibuprofen with β-cyclodextrin, this is the first report of the interaction of all three drug substances with β-cyclodextrin and 2-(hydroxypropyl)-β-cyclodextrin at controlled pH and temperature. For all scenarios, the associated changes in Gibbs free energy, enthalpy and entropy are presented alongside the stoichiometry and binding constants concerned. In all cases the binding was found to occur at a 1:1 ratio with an associated negative enthalpy and Gibbs free energy with the formation of the complex enthalpically, rather than entropically driven. The data further demonstrates a clear relationship between the thermodynamic behaviour and log P of the drug molecules. This work confirms the suitability of ITC to determine thermodynamic data for drug-cyclodextrin complex formations and provides an insight into the selection of appropriate cyclodextrins for bespoke pharmaceutical formulations.

  4. Influence of lipophilicity on drug-cyclodextrin interactions: A calorimetric study

    Energy Technology Data Exchange (ETDEWEB)

    Waters, Laura J., E-mail: l.waters@hud.ac.uk [School of Applied Sciences, University of Huddersfield, Queensgate, Huddersfield, HD1 3DH (United Kingdom); Bedford, Susan; Parkes, Gareth M.B. [School of Applied Sciences, University of Huddersfield, Queensgate, Huddersfield, HD1 3DH (United Kingdom); Mitchell, J.C. [Medway Sciences, School of Science, University of Greenwich at Medway, Chatham Maritime, Kent ME4 4TB (United Kingdom)

    2010-11-20

    This study presents a systematic investigation of the interaction of three functionally related drugs, ibuprofen, ketoprofen and flurbiprofen, with two distinct forms of cyclodextrin at three specific temperatures, 298, 303 and 310 K using isothermal titration calorimetry (ITC). Although all three pharmaceutical compounds have similar pKa values, they exhibit widely differing lipophilicities. While previous authors have presented data regarding the binding of flurbiprofen and ibuprofen with {beta}-cyclodextrin, this is the first report of the interaction of all three drug substances with {beta}-cyclodextrin and 2-(hydroxypropyl)-{beta}-cyclodextrin at controlled pH and temperature. For all scenarios, the associated changes in Gibbs free energy, enthalpy and entropy are presented alongside the stoichiometry and binding constants concerned. In all cases the binding was found to occur at a 1:1 ratio with an associated negative enthalpy and Gibbs free energy with the formation of the complex enthalpically, rather than entropically driven. The data further demonstrates a clear relationship between the thermodynamic behaviour and log P of the drug molecules. This work confirms the suitability of ITC to determine thermodynamic data for drug-cyclodextrin complex formations and provides an insight into the selection of appropriate cyclodextrins for bespoke pharmaceutical formulations.

  5. Drugs as instruments: Describing and testing a behavioral approach to the study of neuroenhancement

    Directory of Open Access Journals (Sweden)

    Ralf Brand

    2016-08-01

    Full Text Available Neuroenhancement (NE is the non-medical use of psychoactive substances to produce a subjective enhancement in psychological functioning and experience. So far empirical investigations of individuals’ motivation for NE however have been hampered by the lack of theoretical foundation. This study aimed to apply drug instrumentalization theory to user motivation for NE. We argue that NE should be defined and analyzed from a behavioral perspective rather than in terms of the characteristics of substances used for NE. In the empirical study we explored user behavior by analyzing relationships between drug options (use over-the-counter products, prescription drugs, illicit drugs and postulated drug instrumentalization goals (e.g. improved cognitive performance, counteracting fatigue, improved social interaction. Questionnaire data from 1,438 university students were subjected to exploratory and confirmatory factor analysis to address the question of whether analysis of drug instrumentalization should be based on the assumption that users are aiming to achieve a certain goal and choose their drug accordingly or whether NE behavior is more strongly rooted in a decision to try or use a certain drug option. We used factor mixture modeling to explore whether users could be separated into qualitatively different groups defined by a shared ‘goal × drug option’ configuration. Our results indicate, first, that individuals’ decisions about NE are eventually based on personal attitude to drug options (e.g. willingness to use an over-the-counter product but not to abuse prescription drugs rather than motivated by desire to achieve a specific goal (e.g. fighting tiredness for which different drug options might be tried. Second, data analyses suggested two qualitatively different classes of users. Both predominantly used over-the-counter products, but ‘neuroenhancers’ might be characterized by a higher propensity to instrumentalize over

  6. Brand-name drug, generic drug, orphan drug. Pharmacological therapy with biosimilar drugs - provision of due diligence in the treatment process.

    Science.gov (United States)

    Zajdel, Justyna; Zajdel, Radosław

    2013-01-01

    Due diligence in the process of provision of healthcare services refers, among other elements, to the application of pharmacological therapy at a time which offers the greatest chance for a successful outcome of treatment, i.e. for achieving the optimum expected effect understood as an improvement in the patient's health, reduction of health risks or elimination of the disease. However, due diligence may also refer to actions aimed at ensuring that neither the patient nor the healthcare payer is required to incur unreasonable costs in the process of treatment. The validity of that statement stems not only from normative acts but also from ethical standards laid down in the Medical Code of Ethics (Article 57 section 2). It often happens that the provision of optimal treatment calls for deviations from the formal provisions included in Summary Product Characteristics (SPCs), and the application of drugs that are bioequivalent to reference drugs, which translates into a significant reduction of costs. The present study addresses the problem of acceptability of a specific form of drug substitution consisting in the replacement of a reference drug with a generic drug. Also explored are legal aspects associated with the possibility of therapy based on "off-label use". The study reviews normative acts existing in the Polish and EU legislation. It also provides a clear definition of orphan drug, which has made it possible to make a distinction and investigate mutual relations between the concepts of brand-name (reference) drug, orphan drug and generic drug.

  7. Open Access Could Transform Drug Discovery: A Case Study of JQ1.

    Science.gov (United States)

    Arshad, Zeeshaan; Smith, James; Roberts, Mackenna; Lee, Wen Hwa; Davies, Ben; Bure, Kim; Hollander, Georg A; Dopson, Sue; Bountra, Chas; Brindley, David

    2016-01-01

    The cost to develop a new drug from target discovery to market is a staggering $1.8 billion, largely due to the very high attrition rate of drug candidates and the lengthy transition times during development. Open access is an emerging model of open innovation that places no restriction on the use of information and has the potential to accelerate the development of new drugs. To date, no quantitative assessment has yet taken place to determine the effects and viability of open access on the process of drug translation. This need is addressed within this study. The literature and intellectual property landscapes of the drug candidate JQ1, which was made available on an open access basis when discovered, and conventionally developed equivalents that were not are compared using the Web of Science and Thomson Innovation software, respectively. Results demonstrate that openly sharing the JQ1 molecule led to a greater uptake by a wider and more multi-disciplinary research community. A comparative analysis of the patent landscapes for each candidate also found that the broader scientific diaspora of the publically released JQ1 data enhanced innovation, evidenced by a greater number of downstream patents filed in relation to JQ1. The authors' findings counter the notion that open access drug discovery would leak commercial intellectual property. On the contrary, JQ1 serves as a test case to evidence that open access drug discovery can be an economic model that potentially improves efficiency and cost of drug discovery and its subsequent commercialization.

  8. Standardization Study of Antifertility Drug - Pippalyadiyoga

    Directory of Open Access Journals (Sweden)

    D. Shaila

    2005-01-01

    Full Text Available The present paper deals with the standardization study of pippalyadiyoga powder. It is used as a long acting contraceptive. The standardization of compound drug has been achieved by physico-chemical analysis and high performance liquid chromatography (HPLC fingerprint studies. Quantitative evaluation of borax in pippalyadiyoga showed 19.08% as sodium borate. RP-HPLC was performed using methanol and water as mobile phase. The detection and quantification was performed at a wavelength of 345 nm. Linearity of detector response for piperine was between the concentrations 0.005% to 0.1%. The correlation coefficient obtained for the linearity was 0.998. The recovery value of standard piperine was 99.4%. Low value of standard deviation and coefficient of variation are indicative of high precision of the method. Quantitative evaluation of piperine in pippalyadiyoga was found to be 0.339%.

  9. Drug utilization of biological drugs in the treatment of chronic Immune-Mediated Inflammatory Diseases (IMIDs: an observational study on Italian patients

    Directory of Open Access Journals (Sweden)

    Paolo Faccendini

    2017-09-01

    Full Text Available Drug utilization of biological drugs in the treatment of chronic Immune-Mediated Inflammatory Diseases (IMIDs: an observational study on Italian patientsObjectives:The aim of this analysis was to provide an estimate of drug utilization indicators (dose escalation and dose tapering related to biologic drugs in the chronic treatment of adult patients with Immune-Mediated Inflammatory Diseases (IMIDs.Methods:We conducted an observational retrospective cohort analysis using the Policlinico di Tor Vergata (PTV database. We considered all biologic drugs dispensed by the PTV hospital pharmacy between January 2010 and December 2015:abatacept, adalimumab, certolizumab, etanercept, golimumab, infliximab (originator and biosimilar, tocilizumab, and ustekinumab were included. Drug dose escalation and dose tapering were calculated and compared with their Defined Daily Dose (DDD.Results:A total of 1803 patients with IMID and biologic drug prescription were analyzed (male: 51.2%. The majority of patients were in the class 36-50 years (n = 612. The median follow-up was 33.8 months (IQR 14.43-56.20. Dermatology was the ward with the largest number of patients (n = 882; 48.9%, followed by rheumatology (n = 619; 34.3% and gastroenterology (n = 302; 16.8%. Dose escalation was observed in 406 patients (22.5%. Infliximab biosimilar (n = 51 was the biological drug with the highest dose escalation rate (86.3%, followed by infliximab originator (n = 28; 60.3% and ustekinumab (37.8%. Etanercept was the biological drug with the lowest dose escalation rate (7.4%, followed by golimumab (12.2% and adalimumab (13.8%. In 677 patients (37.5% a dose tapering was observed. Etanercept showed the highest rate of patients with dose tapering (41.6%, followed by adalimumab (33.6%.Conclusions:The results of this analysis show that dose modification is quite common in PTV clinical practice. Considering the strong focus on the pharmaceutical expenditure and the need of cost containment

  10. Cannabis as a substitute for prescription drugs – a cross-sectional study

    Directory of Open Access Journals (Sweden)

    Corroon Jr JM

    2017-05-01

    Full Text Available James M Corroon Jr,1 Laurie K Mischley,2 Michelle Sexton3 1Center for Medical Cannabis Education, Del Mar, CA, 2Bastyr University Research Institute, Kenmore, WA, 3Department of Medical Research, Center for the Study of Cannabis and Social Policy, Seattle, WA, USA Background: The use of medical cannabis is increasing, most commonly for pain, anxiety and depression. Emerging data suggest that use and abuse of prescription drugs may be decreasing in states where medical cannabis is legal. The aim of this study was to survey cannabis users to determine whether they had intentionally substituted cannabis for prescription drugs.Methods: A total of 2,774 individuals were a self-selected convenience sample who reported having used cannabis at least once in the previous 90 days. Subjects were surveyed via an online anonymous questionnaire on cannabis substitution effects. Participants were recruited through social media and cannabis dispensaries in Washington State.Results: A total of 1,248 (46% respondents reported using cannabis as a substitute for prescription drugs. The most common classes of drugs substituted were narcotics/opioids (35.8%, anxiolytics/benzodiazepines (13.6% and antidepressants (12.7%. A total of 2,473 substitutions were reported or approximately two drug substitutions per affirmative respondent. The odds of reporting substituting were 4.59 (95% confidence interval [CI], 3.87–5.43 greater among medical cannabis users compared with non-medical users and 1.66 (95% CI, 1.27–2.16 greater among those reporting use for managing the comorbidities of pain, anxiety and depression. A slightly higher percentage of those who reported substituting resided in states where medical cannabis was legal at the time of the survey (47% vs. 45%, p=0.58, but this difference was not statistically significant.Discussion: These patient-reported outcomes support prior research that individuals are using cannabis as a substitute for prescription drugs

  11. Epidemiological methods for research with drug misusers: review of methods for studying prevalence and morbidity

    Directory of Open Access Journals (Sweden)

    Dunn John

    1999-01-01

    Full Text Available Epidemiological studies of drug misusers have until recently relied on two main forms of sampling: probability and convenience. The former has been used when the aim was simply to estimate the prevalence of the condition and the latter when in depth studies of the characteristics, profiles and behaviour of drug users were required, but each method has its limitations. Probability samples become impracticable when the prevalence of the condition is very low, less than 0.5% for example, or when the condition being studied is a clandestine activity such as illicit drug use. When stratified random samples are used, it may be difficult to obtain a truly representative sample, depending on the quality of the information used to develop the stratification strategy. The main limitation of studies using convenience samples is that the results cannot be generalised to the whole population of drug users due to selection bias and a lack of information concerning the sampling frame. New methods have been developed which aim to overcome some of these difficulties, for example, social network analysis, snowball sampling, capture-recapture techniques, privileged access interviewer method and contact tracing. All these methods have been applied to the study of drug misuse. The various methods are described and examples of their use given, drawn from both the Brazilian and international drug misuse literature.

  12. Self nano-emulsifying drug delivery system for Embelin: Design, characterization and in-vitro studies

    Directory of Open Access Journals (Sweden)

    Komal Parmar

    2015-10-01

    Full Text Available CThe objective of the present study was to prepare solid self-nanoemulsifying drug delivery system (S-SNEDDS containing Capryol-90 as oil phase for the delivery of Embelin, a poorly water soluble herbal active ingredient. Box-Behnken experimental design was employed to optimise the formulation variables, X1 (amount of oil; Capryol 90, X2 (amount of surfactant; Acrysol EL 135 and X3 (amount of co-surfactant; PEG 400. Systems were appraised for visual characteristics for self emulsifying time, globule size and drug release. Optimised liquid formulations were formulated into free flowing granules (S-SNEDDS by adsorption on the porous materials like Aerosil 200 and Neusilin and thereby compressed into tablet. In vitro dissolution studies of SNEDDS revealed increased in the dissolution rate of the drug. FT-IR data revealed no physicochemical interaction between drug and excipients. Solid state characterization of S-SNEDDS by DSC and Powder XRD confirmed reduction in drug crystallinity which further supports the results of dissolution studies. TEM analysis exhibited spherical globules. Further, the accelerated stability studies for 6 months revealed that S-SNEDDS of Embelin are found to be stable without any significant change in physicochemical properties. Thus, the present studies demonstrated dissolution enhancement potential of porous carrier based S-SNEDDS for poorly water soluble herbal active ingredient, Embelin.

  13. Human Drug Discrimination: Elucidating the Neuropharmacology of Commonly Abused Illicit Drugs.

    Science.gov (United States)

    Bolin, B Levi; Alcorn, Joseph L; Reynolds, Anna R; Lile, Joshua A; Stoops, William W; Rush, Craig R

    2016-06-07

    Drug-discrimination procedures empirically evaluate the control that internal drug states have over behavior. They provide a highly selective method to investigate the neuropharmacological underpinnings of the interoceptive effects of drugs in vivo. As a result, drug discrimination has been one of the most widely used assays in the field of behavioral pharmacology. Drug-discrimination procedures have been adapted for use with humans and are conceptually similar to preclinical drug-discrimination techniques in that a behavior is differentially reinforced contingent on the presence or absence of a specific interoceptive drug stimulus. This chapter provides a basic overview of human drug-discrimination procedures and reviews the extant literature concerning the use of these procedures to elucidate the underlying neuropharmacological mechanisms of commonly abused illicit drugs (i.e., stimulants, opioids, and cannabis) in humans. This chapter is not intended to review every available study that used drug-discrimination procedures in humans. Instead, when possible, exemplary studies that used a stimulant, opioid, or Δ 9 -tetrahydrocannabinol (the primary psychoactive constituent of cannabis) to assess the discriminative-stimulus effects of drugs in humans are reviewed for illustrative purposes. We conclude by commenting on the current state and future of human drug-discrimination research.

  14. Prescriptions for category D and X drugs during pregnancy in Taiwan: a population-based study.

    Science.gov (United States)

    Kao, Li-Ting; Chen, Yi-Hua; Lin, Herng-Ching; Chung, Shiu-Dong

    2014-10-01

    This study aimed to investigate the most prescribed medications and principle diagnoses for category D and X drugs during pregnancy using a population-based dataset in Taiwan. The data for the present study were sourced from the Taiwan Longitudinal Health Insurance Database 2000. We selected 14 125 women who had live singleton births between 1 January 2009 and 31 December 2011. In total, 217 226 prescriptions prescribed to these pregnant women were identified. Of the total 217 226 prescriptions, 1.1% were category D or X drugs; in the first, second, and third trimesters of pregnancy, 1.8%, 0.7%, and 0.5% of prescriptions were category D or X drugs, respectively. Progestins (15.3%) and propylthiouracil (10.7%) were the two most frequently prescribed category D or X drugs during pregnancy. In particular, progestins (20.4%) and estrogens (15.6%) were the most frequently prescribed category D or X drug in the first trimester of pregnancy. Propylthiouracil was the most prescribed category D or X drug in the second (20.3%) and third trimesters (23.1%) of pregnancy, respectively. The most common principal diagnosis during pregnancy was "disorders of menstruation and other abnormal bleeding from the female genital tract" (22% of all principal diagnoses for prescribing category D and X drugs). Our study found that the physicians obviously reduced the use of category D and X drugs for women after becoming aware that they were pregnant. Copyright © 2014 John Wiley & Sons, Ltd.

  15. Preparation of grafted microspheres CPVA-g-PSSS and studies on their drug-carrying and colon-specific drug delivery properties

    International Nuclear Information System (INIS)

    Gao, Baojiao; Fang, Li; Men, Jiying; Zhang, Yanyan

    2013-01-01

    Sodium 4-styrene sulfonate (SSS) was graft-polymerized on the surfaces of crosslinked polyvinyl alcohol (CPVA) microspheres in a manner of surface-initiated graft-polymerization by using cerium salt-hydroxyl group redox initiation system, obtaining the grafted microspheres CPVA-g-PSSS. The chemical structure and physicochemical characters of CPVA-g-PSSS microspheres were fully characterized with infrared spectroscopy (FTIR), scanning electron microscopy (SEM) and zeta potential determination. The aim of this work is to constitute a novel colon-specific drug delivery system via molecular design by using CPVA-g-PSSS microspheres as the drug-carrying material and by taking metronidazole (MTZ) as the model drug. The drug-carrying ability and mechanism of the grafted microspheres CPVA-g-PSSS for MTZ were investigated. Finally, in-vitro release tests for the drug-carrying microspheres were conducted. The experimental results show that in an acidic medium, the grafted microspheres CPVA-g-PSSS exhibit strong adsorption ability for MTZ by driving of electrostatic interaction, and have an adsorption capacity of 112 mg/g, displaying the high efficiency of drug-carrying. The in-vitro release behavior of the drug-carried microspheres is highly pH-sensitive. In the medium of pH = 1, the drug-carrying microspheres do not release the drug, whereas in the medium of pH = 7.4, a sudden delivery phenomenon of the drug will occur, displaying an excellent colon-specific drug delivery behavior. Highlights: ► A metronidazole colon-specific drug delivery was constituted using grafted polymeric microspheres. ► Grafted polymeric microspheres CPVA-g-PSSS were prepared via surface-initiated graft-polymerization. ► The release of the drug-carrying microspheres is highly pH-sensitive. ► The drug-carrying microspheres display an excellent colon-specific drug delivery behavior

  16. Preparation of grafted microspheres CPVA-g-PSSS and studies on their drug-carrying and colon-specific drug delivery properties

    Energy Technology Data Exchange (ETDEWEB)

    Gao, Baojiao, E-mail: gaobaojiao@126.com [Department of Chemical Engineering, North University of China, Taiyuan 030051, People' s Republic of China (China); Fang, Li [School of Chemistry and Chemical engineering, Shanxi University, Taiyuan 030006 (China); Men, Jiying; Zhang, Yanyan [Department of Chemical Engineering, North University of China, Taiyuan 030051, People' s Republic of China (China)

    2013-04-01

    Sodium 4-styrene sulfonate (SSS) was graft-polymerized on the surfaces of crosslinked polyvinyl alcohol (CPVA) microspheres in a manner of surface-initiated graft-polymerization by using cerium salt-hydroxyl group redox initiation system, obtaining the grafted microspheres CPVA-g-PSSS. The chemical structure and physicochemical characters of CPVA-g-PSSS microspheres were fully characterized with infrared spectroscopy (FTIR), scanning electron microscopy (SEM) and zeta potential determination. The aim of this work is to constitute a novel colon-specific drug delivery system via molecular design by using CPVA-g-PSSS microspheres as the drug-carrying material and by taking metronidazole (MTZ) as the model drug. The drug-carrying ability and mechanism of the grafted microspheres CPVA-g-PSSS for MTZ were investigated. Finally, in-vitro release tests for the drug-carrying microspheres were conducted. The experimental results show that in an acidic medium, the grafted microspheres CPVA-g-PSSS exhibit strong adsorption ability for MTZ by driving of electrostatic interaction, and have an adsorption capacity of 112 mg/g, displaying the high efficiency of drug-carrying. The in-vitro release behavior of the drug-carried microspheres is highly pH-sensitive. In the medium of pH = 1, the drug-carrying microspheres do not release the drug, whereas in the medium of pH = 7.4, a sudden delivery phenomenon of the drug will occur, displaying an excellent colon-specific drug delivery behavior. Highlights: ► A metronidazole colon-specific drug delivery was constituted using grafted polymeric microspheres. ► Grafted polymeric microspheres CPVA-g-PSSS were prepared via surface-initiated graft-polymerization. ► The release of the drug-carrying microspheres is highly pH-sensitive. ► The drug-carrying microspheres display an excellent colon-specific drug delivery behavior.

  17. Does innovation in obesity drugs affect stock markets? An event study analysis.

    Science.gov (United States)

    Pérez-Rodríguez, Jorge V; González López-Valcárcel, Beatriz

    2012-01-01

    This study empirically analyzes the effects of public information about the pharmaceutical R&D process on the market valuation of the sponsoring firm. We examined the market's response to scientific news and regulatory decisions about an antiobesity drug, rimonabant, and the effects on the sponsoring company (Sanofi-Aventis) and its incumbent competitors (Abbott and Roche). Event study methodology was used to test the null hypothesis of no market response. We covered the full life cycle of rimonabant (1994-2008), using a data set of daily closing price and volume. The results suggest that scientific news in the initial stages of the drug R&D process (i.e., drug discovery, preclinical and clinical trials) had no significant effects. However, news related to regulatory decisions, such as recall or safety warning, had significant negative effects on the company's market value. No spillover/contagion effects on competitor firms were detected. Market reactions occur at the time when the regulator takes decisions about drugs. Scientific news, even those of high-impact, may pass unnoticed. Copyright © 2011 SESPAS. Published by Elsevier España, S.L. All rights reserved.

  18. Microstructural effects in drug release by solid and cellular polymeric dosage forms: A comparative study.

    Science.gov (United States)

    Blaesi, Aron H; Saka, Nannaji

    2017-11-01

    In recent studies, we have introduced melt-processed polymeric cellular dosage forms to achieve both immediate drug release and predictable manufacture. Dosage forms ranging from minimally-porous solids to highly porous, open-cell and thin-walled structures were prepared, and the drug release characteristics investigated as the volume fraction of cells and the excipient molecular weight were varied. In the present study, both minimally-porous solid and cellular dosage forms consisting of various weight fractions of Acetaminophen drug and polyethylene glycol (PEG) excipient are prepared and analyzed. Microstructures of the solid forms and the cell walls range from single-phase solid solutions of the excipient and a small amount of drug molecules to two-phase composites of the excipient and tightly packed drug particles. Results of dissolution experiments show that the minimally-porous solid forms disintegrate and release drug by slow surface erosion. The erosion rate decreases as the drug weight fraction is increased. By contrast, the open-cell structures disintegrate rapidly by viscous exfoliation, and the disintegration time is independent of drug weight fraction. Drug release models suggest that the solid forms erode by convective mass transfer of the faster-eroding excipient if the drug volume fraction is small. At larger drug volume fractions, however, the slower-eroding drug particles hinder access of the free-flowing fluid to the excipient, thus slowing down erosion of the composite. Conversely, the disintegration rate of the cellular forms is limited by diffusion of the dissolution fluid into the excipient phase of the thin cell walls. Because the wall thickness is of the order of the drug particle size, and the particles are enveloped by the excipient during melt-processing, the drug particles cannot hinder diffusion through the excipient across the walls. Thus the disintegration time of the cellular forms is mostly unaffected by the volume fraction of drug

  19. A study on programmed drug release from tablets

    NARCIS (Netherlands)

    Veen, Jacoba van der

    1993-01-01

    This thesis shows the extension of the applicability of the megaloporous system for drugs with different physico-chemical properties, like solubility and pK.. Procaine HC1, a highly soluble drug, can successfully be formulated in the programmed release megaloporous system, by using Carnauba wax,

  20. Drug-resistant tuberculosis: Study of clinical practices of chest physicians, Maharashtra, India

    Directory of Open Access Journals (Sweden)

    Yatin Dholakia

    2012-01-01

    Full Text Available Background: Patients suffering from drug-resistant tuberculosis (DR TB avail of private care since Programmatic Management of DR TB (PMDT is not universally available in India. Management of DR TB is challenging and involves great expertise. Chest physicians (CPs play a major role in this area. The study was undertaken with the objective to see whether the practices of CPs comply with current guidelines and to identify areas where they could be involved to improve access to PMDT. Materials and Methods : For this cross-sectional study, CPs from Mumbai and Nagpur, Maharashtra, India, were given pretested questionnaires to be filled in and returned. Observations : Of 70 enlisted CPs, 29 (41% responded. Twenty-six (89% respondents used the drug susceptibility test (DST for diagnosis: private labs and hospitals were preferred; 9 (31% used standard treatment, 15 (51% switched to individual treatment after starting standard therapy and 12 (41% started empirical treatment later switched to individual treatment as per the WHO guidelines. Seven consultants (10% used in addition drugs from alternative systems of medicine for immune modulation and adverse drug effects. Eighty-six per cent CPs monitored treatment by smear examination, 51% by culture and 93% used X-rays. Reported case holding in the form of regular follow-up consultation visits was around 70%, treatment success estimated to be between 30% and 70%, and deaths around 30%. Adverse drug reactions were reported in around 30% cases. Conclusion : This study shows that most private CPs generally comply with current guidelines for management of DR TB. Accreditation of private labs for DST, involving CPs in diagnosis, treatment and monitoring of patients through public private partnerships can improve access to PMDT.

  1. Current Situation, Determinants, and Solutions to Drug Shortages in Shaanxi Province, China: A Qualitative Study.

    Science.gov (United States)

    Yang, Caijun; Wu, Lina; Cai, Wenfang; Zhu, Wenwen; Shen, Qian; Li, Zongjie; Fang, Yu

    2016-01-01

    Drug shortages were a complex global problem. The aim of this study was to analyze, characterize, and assess the drug shortages, and identify possible solutions in Shaanxi Province, western China. A qualitative methodological approach was conducted during May-June 2015 and December 2015-January 2016. Semi-structured interviews were performed to gather information from representatives of hospital pharmacists, wholesalers, pharmaceutical producers, and local health authorities. Thirty participants took part in the study. Eight traditional Chinese medicines and 87 types of biologicals and chemicals were reported to be in short supply. Most were essential medicines. Five main determinants of drug shortages were detected: too low prices, too low market demands, Good Manufacturing Practice (GMP) issues, materials issues, and approval issues for imported drugs. Five different solutions were proposed by the participants: 1) let the market decide the drug price; 2) establish an information platform; 3) establish a reserve system; 4) enhance the communication among the three parties in the supply chain; and 5) improve hospital inventory management. Western China was currently experiencing a serious drug shortage. Numerous reasons for the shortage were identified. Most drug shortages in China were currently because of "too low prices." To solve this problem, all of the stakeholders, especially the government, needed to participate in managing the drug shortages.

  2. Study on drug resistance of mycobacterium tuberculosis in patients with pulmonary tuberculosis by drug resistance gene detecting

    International Nuclear Information System (INIS)

    Wang Wei; Li Hongmin; Wu Xueqiong; Wang Ansheng; Ye Yixiu; Wang Zhongyuan; Liu Jinwei; Chen Hongbing; Lin Minggui; Wang Jinhe; Li Sumei; Jiang Ping; Feng Bai; Chen Dongjing

    2004-01-01

    To investigate drug resistance of mycobacterium tuberculosis in different age group, compare detecting effect of two methods and evaluate their the clinical application value, all of the strains of mycobacterium tuberculosis were tested for resistance to RFP, INH SM PZA and EMB by the absolute concentration method on Lowenstein-Jensen medium and the mutation of the rpoB, katG, rpsL, pncA and embB resistance genes in M. tuberculosis was tested by PCR-SSCP. In youth, middle and old age group, the rate of acquired drug resistance was 89.2%, 85.3% and 67.6% respectively, the gene mutation rate was 76.2%, 81.3% and 63.2% respectively. The rate of acquired drug resistance and multiple drug resistance in youth group was much higher than those in other groups. The gene mutation was correlated with drug resistance level of mycobacterium tuberculosis. The gene mutation rate was higher in strains isolated from high concentration resistance than those in strains isolated from low concentration resistance. The more irregular treatment was longer, the rate of drug resistance was higher. Acquired drug resistance varies in different age group. It suggested that surveillance of drug resistence in different age group should be taken seriously, especially in youth group. PCR - SSCP is a sensitive and specific method for rapid detecting rpoB, katG, rpsL, pncA and embB genes mutations of MTB. (authors)

  3. Ursodeoxycholic Acid Can Improve Liver Transaminase Quantities in Children with Anticonvulsant Drugs Hepatotoxicity: a Pilot Study.

    Directory of Open Access Journals (Sweden)

    Masoumeh Asgarshirazi

    2015-06-01

    Full Text Available The present study has been directed to investigate Ursodeoxycholic Acid (UDCA effect in children, to reduce the high Liver transaminases induced by Anticonvulsant drugs (drug induced hepatitis. This idea has been driven from Cytoprotective and antioxidant properties of UDCA to be used in drug induced inflammation in Liver. Twenty two epileptic patients aged between 4 mo - 3 yr whom were under anticonvulsant therapy with drugs such as valperoic acid, primidone, levetiracetam, Phenobarbital or any combination of them and had shown Liver transaminases rise , after rule out of Viral-Autoimmune, Metabolic and Anatomic causes, have been prescribed UDCA in dose of 10-15 mg/kg/day, at least for 6 months. Any patient who have shown confusing factors such as genetic disorders with liver involvement or spontaneous decline in enzymes or had not treatment compliance has been excluded from the study. Transaminases range changes as well as Probable side effects of the drug have been monitored. The results indicated that UDCA is effective and well tolerable in the children with drug induced hyper transaminasemia. No side effect has been seen and recorded in this study. Based on this study and its results, we recommend UDCA as a safe and effective choice in drug induced hepatotoxicities.

  4. Fertility drug use and the risk of ovarian tumors in infertile women: a case-control study.

    Science.gov (United States)

    Asante, Albert; Leonard, Phoebe H; Weaver, Amy L; Goode, Ellen L; Jensen, Jani R; Stewart, Elizabeth A; Coddington, Charles C

    2013-06-01

    To assess the influence of infertility and fertility drugs on risk of ovarian tumors. Case-control study (Mayo Clinic Ovarian Cancer Study). Ongoing academic study of ovarian cancer. A total of 1,900 women (1,028 with ovarian tumors and 872 controls, frequency matched on age and region of residence) who had provided complete information in a self-report questionnaire about history of infertility and fertility drug use. None. Effect of infertility history, use of fertility drugs and oral contraception, and gravidity on the risk of ovarian tumor development, after controlling for potential confounders. Among women who had a history of infertility, use of fertility drugs was reported by 44 (24%) of 182 controls and 38 (17%) of 226 cases. Infertile women who used fertility drugs were not at increased risk of developing ovarian tumors compared with infertile women who did not use fertility drugs; the adjusted odds ratio was 0.64 (95% CI, 0.37, 1.11). The findings were similar when stratified by gravidity and when analyzed separately for borderline versus invasive tumors. We found no statistically significant association between fertility drug use and risk of ovarian tumors. Further larger, prospective studies are needed to confirm this observation. Published by Elsevier Inc.

  5. Liquid crystalline systems for transdermal delivery of celecoxib: in vitro drug release and skin permeation studies.

    Science.gov (United States)

    Estracanholli, Eder André; Praça, Fabíola Silva Garcia; Cintra, Ana Beatriz; Pierre, Maria Bernadete Riemma; Lara, Marilisa Guimarães

    2014-12-01

    Liquid crystalline systems of monoolein/water could be a promising approach for the delivery of celecoxib (CXB) to the skin because these systems can sustain drug release, improve drug penetration into the skin layers and minimize side effects. This study evaluated the potential of these systems for the delivery of CXB into the skin based on in vitro drug release and skin permeation studies. The amount of CXB that permeated into and/or was retained in the skin was assayed using an HPLC method. Polarizing light microscopy studies showed that liquid crystalline systems of monoolein/water were formed in the presence of CXB, without any changes in the mesophases. The liquid crystalline systems decreased drug release when compared to control solution. Drug release was independent of the initial water content of the systems and CXB was released from cubic phase systems, irrespective of the initial water content. The systems released the CXB following zero-order release kinetics. In vitro drug permeation studies showed that cubic phase systems allowed drug permeation and retention in the skin layers. Cubic phase systems of monoolein/water may be promising vehicles for the delivery of CXB in/through the skin because it improved CXB skin permeation compared with the control solution.

  6. Injection Drug Use Quality of Life scale (IDUQOL: A validation study

    Directory of Open Access Journals (Sweden)

    Palepu Anita

    2005-07-01

    Full Text Available Abstract Background Existing measures of injection drug users' quality of life have focused primarily on health and health-related factors. Clearly, however, quality of life among injection drug users is impacted by a range of unique cultural, socioeconomic, medical, and geographic factors that must also be considered in any measure. The Injection Drug User Quality of Life (IDUQOL scale was designed to capture the unique and individual circumstances that determine quality of life among injection drug users. The overall purpose of the present study was to examine the validity of inferences made from the IDUQOL by examining the (a dimensionality, (b reliability of scores, (c criterion-related validity evidence, and (d both convergent and discriminant validity evidence. Methods An exploratory factor analysis using principal axis factoring in SPSS 12.0 was conducted to determine whether the use of a total score on the IDUQOL was advisable. Reliability of scores from the IDUQOL was obtained using internal consistency and one-week test-retest reliability estimates. Criterion-related validity evidence was gathered using variables such as stability of housing, sex trade involvement, high-risk injection behaviours, involvement in treatment programs, emergency treatment or overdose over the previous six months, hospitalization and emergency treatment over the subsequent six month period post data collection. Convergent and discriminant validity evidence was gathered using measures of life satisfaction, self-esteem, and social desirability. Results The sample consisted of 241 injection drug users ranging in age from 19 to 61 years. Factor analysis supports the use of a total score. Both internal consistency (alpha = .88 and one-week test-retest reliability (r = .78 for IDUQOL total scores were good. Criterion-related, convergent, and discriminant validity evidence supports the interpretation of IDUQOL total scores as measuring a construct consistent with

  7. Methods in pharmacoepidemiology: a review of statistical analyses and data reporting in pediatric drug utilization studies.

    Science.gov (United States)

    Sequi, Marco; Campi, Rita; Clavenna, Antonio; Bonati, Maurizio

    2013-03-01

    To evaluate the quality of data reporting and statistical methods performed in drug utilization studies in the pediatric population. Drug utilization studies evaluating all drug prescriptions to children and adolescents published between January 1994 and December 2011 were retrieved and analyzed. For each study, information on measures of exposure/consumption, the covariates considered, descriptive and inferential analyses, statistical tests, and methods of data reporting was extracted. An overall quality score was created for each study using a 12-item checklist that took into account the presence of outcome measures, covariates of measures, descriptive measures, statistical tests, and graphical representation. A total of 22 studies were reviewed and analyzed. Of these, 20 studies reported at least one descriptive measure. The mean was the most commonly used measure (18 studies), but only five of these also reported the standard deviation. Statistical analyses were performed in 12 studies, with the chi-square test being the most commonly performed test. Graphs were presented in 14 papers. Sixteen papers reported the number of drug prescriptions and/or packages, and ten reported the prevalence of the drug prescription. The mean quality score was 8 (median 9). Only seven of the 22 studies received a score of ≥10, while four studies received a score of statistical methods and reported data in a satisfactory manner. We therefore conclude that the methodology of drug utilization studies needs to be improved.

  8. Altered drug metabolism during pregnancy: hormonal regulation of drug-metabolizing enzymes.

    Science.gov (United States)

    Jeong, Hyunyoung

    2010-06-01

    Medication use during pregnancy is prevalent, but pharmacokinetic information of most drugs used during pregnancy is lacking in spite of known effects of pregnancy on drug disposition. Accurate pharmacokinetic information is essential for optimal drug therapy in mother and fetus. Thus, understanding how pregnancy influences drug disposition is important for better prediction of pharmacokinetic changes of drugs in pregnant women. Pregnancy is known to affect hepatic drug metabolism, but the underlying mechanisms remain unknown. Physiological changes accompanying pregnancy are probably responsible for the reported alteration in drug metabolism during pregnancy. These include elevated concentrations of various hormones such as estrogen, progesterone, placental growth hormones and prolactin. This review covers how these hormones influence expression of drug-metabolizing enzymes (DMEs), thus potentially responsible for altered drug metabolism during pregnancy. The reader will gain a greater understanding of the altered drug metabolism in pregnant women and the regulatory effects of pregnancy hormones on expression of DMEs. In-depth studies in hormonal regulatory mechanisms as well as confirmatory studies in pregnant women are warranted for systematic understanding and prediction of the changes in hepatic drug metabolism during pregnancy.

  9. Effect of pretreatment HIV-1 drug resistance on immunological, virological, and drug-resistance outcomes of first-line antiretroviral treatment in sub-Saharan Africa: a multicentre cohort study

    NARCIS (Netherlands)

    Hamers, Raph L.; Schuurman, Rob; Sigaloff, Kim C. E.; Wallis, Carole L.; Kityo, Cissy; Siwale, Margaret; Mandaliya, Kishor; Ive, Prudence; Botes, Mariette E.; Wellington, Maureen; Osibogun, Akin; Wit, Ferdinand W.; van Vugt, Michèle; Stevens, Wendy S.; de Wit, Tobias F. Rinke

    2012-01-01

    Background The effect of pretreatment HIV-1 drug resistance on the response to first-line combination antiretroviral therapy (ART) in sub-Saharan Africa has not been assessed. We studied pretreatment drug resistance and virological, immunological, and drug-resistance treatment outcomes in a large

  10. African Journal of Drug & Alcohol Studies, 16(1), 2017 Copyright ...

    African Journals Online (AJOL)

    African Journal of Drug & Alcohol Studies, 16(1), 2017. Copyright © 2017 ... Linear regression showed that males are more likely to abuse alcohol than females. (β= -.17; t = -3.47; ..... gerians through depression, suicide, road traffic accidents ...

  11. Brand-name drug, generic drug, orphan drug. Pharmacological therapy with biosimilar drugs – provision of due diligence in the treatment process

    Science.gov (United States)

    Zajdel, Justyna

    2013-01-01

    Due diligence in the process of provision of healthcare services refers, among other elements, to the application of pharmacological therapy at a time which offers the greatest chance for a successful outcome of treatment, i.e. for achieving the optimum expected effect understood as an improvement in the patient's health, reduction of health risks or elimination of the disease. However, due diligence may also refer to actions aimed at ensuring that neither the patient nor the healthcare payer is required to incur unreasonable costs in the process of treatment. The validity of that statement stems not only from normative acts but also from ethical standards laid down in the Medical Code of Ethics (Article 57 section 2). It often happens that the provision of optimal treatment calls for deviations from the formal provisions included in Summary Product Characteristics (SPCs), and the application of drugs that are bioequivalent to reference drugs, which translates into a significant reduction of costs. The present study addresses the problem of acceptability of a specific form of drug substitution consisting in the replacement of a reference drug with a generic drug. Also explored are legal aspects associated with the possibility of therapy based on “off-label use”. The study reviews normative acts existing in the Polish and EU legislation. It also provides a clear definition of orphan drug, which has made it possible to make a distinction and investigate mutual relations between the concepts of brand-name (reference) drug, orphan drug and generic drug. PMID:24592133

  12. Evaluation of drug-drug interactions among patients with chronic ...

    African Journals Online (AJOL)

    Introduction: The risk of drug-drug interactions (DDIs) is high in patients with chronic kidney disease (CKD) necessitating dose adjustments or the avoidance of drug combinations. This study aimed to evaluate DDIs among patients with CKD in the University of Nigeria Teaching Hospital (UNTH), Enugu, South-East Nigeria.

  13. Study of interaction between antiobesity and hypolipidemic drugs ...

    African Journals Online (AJOL)

    PURPOSE: To explore the interaction between antiobesity drug, topiramate, and hypolipidemic drug, atorvastatin, in rats. METHODS: Obesity was induced in Wistar albino rats by administering cafeteria diet (CD) for 40 days and divided into 5 groups. While one group served as control, each other group received either ...

  14. Brain tumor chemo-radiotherapy: a study of direct intratumoral perfusion with antineoplastic drugs

    International Nuclear Information System (INIS)

    Rousseau, J.

    2007-10-01

    High grade gliomas are aggressive tumors for which current treatments remain palliative. Radiotherapy efficacy is restricted by the surrounding brain tissue tolerance. One method based on the concomitant use of chemotherapeutic drugs and external photon irradiation has been proposed to improve the treatment outcome. The systemic administration of drugs is not effective in achieving the therapeutic level of drug needed for brain tumor treatment. This is due to the blood brain barrier (BBB) that prevents molecules passing through the vascular endothelium. Recent methods have been developed to circumvent the BBB. Among them, convection-enhanced delivery (CED) relies on the continuous infusion of a fluid containing a therapeutic agent, under a pressure gradient. It permits a homogeneous and controlled drug distribution. The aims of this study were to characterise the CED method, and then to utilize it for glioma treatment in preclinical studies. Several drugs were tested: cisplatin, carbo-platin, oxaliplatin, and iodo-deoxyuridine. Two radiation modalities were evaluated: synchrotron stereotactic radiotherapy (monochromatic beam < 100 keV) and high energy irradiation (6 MV) obtained with a conventional medical linear accelerator. The results obtained reveal that the effectiveness of the combined treatment (platinated drug plus photon irradiation) is highly related to that of the chemotherapy. The data, obtained with the platinated chemotherapy, also show that high-energy X-ray irradiation (6 MV) is as effective as synchrotron X-ray irradiation. The results broaden the applicability of this chemotherapeutic approach to clinical trials. (author)

  15. Online availability and safety of drugs in shortage: a descriptive study of internet vendor characteristics.

    Science.gov (United States)

    Liang, Bryan A; Mackey, Tim K

    2012-02-09

    Unprecedented drug shortages announced by the US Food and Drug Administration (FDA) have severely affected therapeutic access, patient safety, and public health. With continued shortages, patients may seek drugs online. To assess the prevalence of online marketing for current FDA shortage drugs and potential patient safety risks. We performed a descriptive study of the prevalence of online marketing for shortage drugs-that is, offers for sale of each drug, including characteristics of online drug sellers and intermediary sites marketing these drugs. Of the 72 FDA shortage-listed drugs, 68 (94%) were offered for sale online. We found 291 offers for these drugs, the vast majority (n = 207, 71.1%) by online drug sellers selling direct to consumers. Intermediary sites included data aggregators (n = 22, 8%), forum links (n = 23, 8%), and personal page data links (n = 34, 12%), as well as Flickr social media links (n = 5, 2%), all advertising drugs without a prescription. Of the 91 online drug sellers identified, 31 (34%) had more than 1 shortage drug offered for sale, representing most (n = 148, 71%) of all online drug seller sales offers. The majority of these online drug sellers (n = 21, 68%) were on the National Association of Boards of Pharmacy (NABP) Not Recommended Sites list. Finally, for shortage drugs with an online drug seller (n = 58, 85%), 53 (91%) had at least one site on the Not Recommended list and 21 (36%) had only sites on the Not Recommended list. FDA shortage drugs are widely marketed over the Internet. Suspect online drug sellers and intermediaries dominate these sales offers. As a critical risk management issue, patients, providers, and policymakers should be extremely cautious in procuring shortage drugs through Internet sourcing.

  16. Factors associated with psychotropic drug use among community-dwelling older persons: A review of empirical studies

    Directory of Open Access Journals (Sweden)

    Lauzon Sylvie

    2004-08-01

    Full Text Available Abstract Background In the many descriptive studies on prescribed psychotropic drug use by community-dwelling older persons, several sociodemographic and other factors associated with drug use receive inconsistent support. Method Empirical reports with data on at least benzodiazepine or antidepressant drug use in samples of older persons published between 1990 and 2001 (n = 32 were identified from major databases and analyzed to determine which factors are most frequently associated with psychotropic drug use in multivariate analyses. Methodological aspects were also examined. Results Most reports used probability samples of users and non-users and employed cross-sectional designs. Among variables considered in 5 or more reports, race, proximity to health centers, medical consultations, sleep complaints, and health perception were virtually always associated to drug use. Gender, mental health, and physical health status were associated in about two-thirds of reports. Associations with age, marital status, medication coverage, socioeconomic status, and social support were usually not observed. Conclusions The large variety of methods to operationalize drug use, mental health status, and social support probably affected the magnitude of observed relationships. Employing longitudinal designs and distinguishing short-term from long-term use, focusing on samples of drug users exclusively, defining drug use and drug classes more uniformly, and utilizing measures of psychological well-being rather than only of distress, might clarify the nature of observed associations and the direction of causality. Few studies tested specific hypotheses. Most studies focused on individual characteristics of respondents, neglecting the potential contribution of health care professionals to the phenomenon of psychotropic drug use among seniors.

  17. Spectroscopic, structural and drug docking studies of carbocysteine

    Science.gov (United States)

    Manivannan, M.; Rajeshwaran, K.; Govindhan, R.; Karthikeyan, B.

    2017-09-01

    Carbocysteine or carbocisteine having the empirical formula C5H9NO4S,is one of the most therapeutically prescribed expectorant, sold under the brand name viz., Mucodyne (UK and India), Rhinathiol and Mucolite. In pediatric respiratory pathology, it can relieve the symptoms of obstructive pulmonary disease (COPD) and bronchiectasis. On the consideration of its extensive pharmaceutical usage and medicinal value, we have investigated its chemical structure and composition by employing various spectral techniques like 1H, 13C NMR, FT-IR,Raman, UV-Visible spectroscopy and powder X-ray diffraction method. Density Functional Theoretical (DFT) studies on its electronic structure is also carried out. Drug docking studies were carried out to ascertain the nature of molecular interaction with the biological protein system. Furthermore theoretical Raman spectrum of this molecule has been computed and compared with the experimental Raman spectrum. The forbidden energy gap between its frontier molecular orbitals, viz., HOMO-LUMO is calculated and correlated with its observed λmax value. Atomic orbitals which are mainly contributes to the frontier molecular orbitals were identified. Molecular electrostatic potential diagram has been mapped to explain its chemical activity. Based on the results, a suitable mechanism of its protein binding mode and drug action has been discussed.

  18. A study on demographic characteristics of drug resistant Mycobacterium tuberculosis isolates in Belarus

    Directory of Open Access Journals (Sweden)

    L Surkova

    2012-01-01

    Conclusion: As Belarus is a high-burden MDR-TB country and treatment of drug-resistant TB is long and complicated, the findings of this study provided useful information to deliver effective community-based disease control measures and a proposed plane for the effective management of drug-resistant TB at the national level.

  19. Drug use patterns among Thai illicit drug injectors amidst increased police presence

    Directory of Open Access Journals (Sweden)

    Suwannawong Paisan

    2009-07-01

    Full Text Available Abstract Thailand has traditionally pursued an aggressive enforcement-based anti-illicit drug policy in an effort to make the country "drug-free." In light of this ongoing approach, we sought to assess impacts of enforcement on drug use behaviors among a cohort of injection drug users (IDU in Thailand. We examined drug use patterns among IDU participating in a cross-sectional study conducted in Bangkok (n = 252. Participants were asked to provide data regarding patterns of drug use in the previous six months, including types of drugs consumed, method of consumption, frequency of use, and weekly income spent on drugs. We also conducted bivariate analyses to identify a possible effect of a reported increase in police presence on measures of drug use and related risk behaviors among study participants. One hundred fifty-five (61.5% individuals reported injection heroin use and 132 (52.4% individuals reported injection midazolam use at least daily in the past six months. Additionally, 86 (34.1% individuals reported at least daily injection Yaba and Ice (i.e., methamphetamine use. Participants in our study reported high levels of illicit drug use, including the injection of both illicit and licit drugs. In bivariate analyses, no association between increased police presence and drug use behaviors was observed. These findings demonstrate high ongoing rates of drug injecting in Thailand despite reports of increased levels of strict enforcement and enforcement-related violence, and raise questions regarding the merits of this approach.

  20. New types of drug use and risks of drug use among men who have sex with men: a cross-sectional study in Hangzhou, China.

    Science.gov (United States)

    He, Lin; Pan, Xiaohong; Wang, Ning; Yang, Jiezhe; Jiang, Jun; Luo, Yan; Zhang, Xingliang; Li, Xiting

    2018-04-17

    The use of new types of drugs has become more common among men who have sex with men (MSM). The aim of this study was to describe the patterns of the use of new types of drugs, such as methamphetamine, ketamine, ecstasy, and rush poppers, and to examine the factors associated with drug use and HIV infection among MSM in Hangzhou, China. This cross-sectional study was conducted between August 2015 and April 2016. We used snowball sampling to recruit MSM; participants were recruited from voluntary counseling and testing centers, baths, bars, Blued (an app for the gay community), QQ groups, clubs, and other types of venues. MSM were included if their previous HIV test results were negative or unknown, or they had not been tested for HIV. MSM were excluded if they were known to be HIV positive before the survey. Face-to-face questionnaires were conducted and a venous blood specimen was drawn from each participant following the interview. In total, 555 MSM were included; 18.2% (101/555) of the participants had used new types of drugs in the past 3 months. Among the users, 65.3% used single-use rush poppers, while the remainder used ketamine, methamphetamine, ecstasy, or other mixed combinations of drugs. The HIV positivity rate was 14.8% (82/555). Factors associated with increased odds of using new types of drugs in the past 3 months were higher education levels (adjusted odds ratio [AOR] 4.45, 95% confidence interval [CI] 2.12-9.37), having multiple sexual partners (AOR 1.76, 95 CI 1.02-3.05), alcohol use before sexual intercourse (AOR 33.44, 95% CI 10.80-103.50), and seeing friends using new types of drugs. We revealed the widespread use of new types of drugs, as well as a high diagnosis rate of new HIV infection, among MSM in Hangzhou. The use of new types of drugs was associated with an increased number of sexual partners among MSM; the high-risk sexual behaviors increased the risk of HIV infection. Attention should be given to the use of new types of drugs in MSM

  1. Enantiomeric profiling of chiral illicit drugs in a pan-European study

    DEFF Research Database (Denmark)

    Castrignanò, Erika; Yang, Zhugen; Bade, Richard

    2018-01-01

    The aim of this paper is to present the first study on spatial and temporal variation in the enantiomeric profile of chiral drugs in eight European cities. Wastewater-based epidemiology (WBE) and enantioselective analysis were combined to evaluate trends in illicit drug use in the context....... High loads of racemic methamphetamine were detected in Oslo (EF = 0.49 ± 0.02). This is in contrast to other European cities where S-(+)-methamphetamine was the predominant enantiomer. This indicates different methods of methamphetamine synthesis and/or trafficking routes in Oslo, compared...... with the other cities tested. An enrichment of MDMA with the R-(−)-enantiomer was observed in European wastewaters indicating MDMA consumption rather than disposal of unused drug. MDA's chiral signature indicated its enrichment with the S-(+)-enantiomer, which confirms its origin from MDMA metabolism in humans...

  2. In silico studies in drug research against neurodegenerative diseases.

    Science.gov (United States)

    Makhouri, Farahnaz Rezaei; Ghasemi, Jahan B

    2017-08-22

    Neurodegenerative diseases such as Alzheimer's disease (AD), progressive neurodegenerative forms of Huntington's disease, Parkinson's disease (PD), amyotrophic lateral sclerosis, spinal cerebellar ataxias, and spinal and bulbar muscular atrophy are described by slow and selective dysfunction and degeneration of neurons and axons in the central nervous system (CNS). Computer-aided or in silico design methods have matured into powerful tools for reducing the number of ligands that should be screened in experimental assays. In the present review, the authors provide a basic background about neurodegenerative diseases and in silico techniques in the drug research. Furthermore, they review the various in silico studies reported against various targets in neurodegenerative diseases, including homology modeling, molecular docking, virtual high-throughput screening, quantitative structure activity relationship (QSAR), hologram quantitative structure activity relationship (HQSAR), 3D pharmacophore mapping, proteochemometrics modeling (PCM), fingerprints, fragment-based drug discovery, Monte Carlo simulation, molecular dynamic (MD) simulation, quantum-mechanical methods for drug design, support vector machines, and machine learning approaches. Neurodegenerative diseases have a multifactorial pathoetiological origin, so scientists have become persuaded that a multi-target therapeutic strategy aimed at the simultaneous targeting of multiple proteins (and therefore etiologies) involved in the development of a disease is recommended in future. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  3. Drug-drug interactions in prescriptions for hospitalized elderly with Acute Coronary Syndrome

    Directory of Open Access Journals (Sweden)

    Tiago Aparecido Maschio de Lima

    2017-11-01

    Full Text Available The objective was to determine the rate of potential drug-drug interactions in prescriptions for elderly diagnosed with Acute Coronary Syndrome in a teaching hospital. This is an exploratory, descriptive study that analyzed 607 prescriptions through databases to identify and classify the interactions based on intensity (major, moderate or minor, the mechanism (pharmacokinetic or pharmacodynamics and documentation relevance. We detected 10,162 drug-drug interactions, distributed in 554 types of different combinations within the prescribed drugs, and 99% of prescriptions presented at least one and a maximum of 53 interactions; highlighting the prevalence of major and moderates ones. There was a correlation between the number of drug-drug interactions and the number of prescribed drugs and the hospitalization time. This study contributes for the delimitation of a prevalence pattern in drug-drug interactions in prescriptions for Acute Coronary Syndrome, besides subsidizing the importance of the effective implementation of the Clinical Pharmacy in teaching hospitals.

  4. Online Availability and Safety of Drugs in Shortage: A Descriptive Study of Internet Vendor Characteristics

    Science.gov (United States)

    Mackey, Tim K

    2012-01-01

    Background Unprecedented drug shortages announced by the US Food and Drug Administration (FDA) have severely affected therapeutic access, patient safety, and public health. With continued shortages, patients may seek drugs online. Objective To assess the prevalence of online marketing for current FDA shortage drugs and potential patient safety risks. Methods We performed a descriptive study of the prevalence of online marketing for shortage drugs—that is, offers for sale of each drug, including characteristics of online drug sellers and intermediary sites marketing these drugs. Results Of the 72 FDA shortage-listed drugs, 68 (94%) were offered for sale online. We found 291 offers for these drugs, the vast majority (n = 207, 71.1%) by online drug sellers selling direct to consumers. Intermediary sites included data aggregators (n = 22, 8%), forum links (n = 23, 8%), and personal page data links (n = 34, 12%), as well as Flickr social media links (n = 5, 2%), all advertising drugs without a prescription. Of the 91 online drug sellers identified, 31 (34%) had more than 1 shortage drug offered for sale, representing most (n = 148, 71%) of all online drug seller sales offers. The majority of these online drug sellers (n = 21, 68%) were on the National Association of Boards of Pharmacy (NABP) Not Recommended Sites list. Finally, for shortage drugs with an online drug seller (n = 58, 85%), 53 (91%) had at least one site on the Not Recommended list and 21 (36%) had only sites on the Not Recommended list. Conclusions FDA shortage drugs are widely marketed over the Internet. Suspect online drug sellers and intermediaries dominate these sales offers. As a critical risk management issue, patients, providers, and policymakers should be extremely cautious in procuring shortage drugs through Internet sourcing. PMID:22321731

  5. Drug decriminalization and the price of illicit drugs.

    Science.gov (United States)

    Félix, Sónia; Portugal, Pedro

    2017-01-01

    This study is an empirical assessment of the impact of the drug decriminalization policy followed by Portugal in July 2001, on the price of illicit drugs. The analysis is performed using a difference-in-differences approach and the Synthetic Control Method in order to construct a synthetic control unit from a convex combination of countries. The results suggest that the prices of opiates and cocaine in the post-treatment period did not decrease in the sequence of the policy change. We conclude that the drug decriminalization policy seems to have caused no harm through lower illicit drugs prices, which would lead to higher drug usage and dependence. Copyright © 2016 Elsevier B.V. All rights reserved.

  6. Local Delivery System of Immune Modulating Drug for Unresectable Adenocarcinoma: In Vitro Experimental Study and In Vivo Animal Study

    International Nuclear Information System (INIS)

    Lee, Don Haeng; Kang, Sung-Gwon; Jeong, Seok; Yoon, Chang Jin; Choi, Jung-Ah; Byun, Ju Nam; Park, Jae Hyung; Lee, Kyu Back

    2006-01-01

    The purpose of the study was to evaluate the efficacy and safety of a developed drug delivery system containing OK-432 through in vitro and animal study. An OK-432-impregnated polycarbonate/polyurethane stent membrane was used to develop a drug delivery system (DDS) enabling the locoregional release of OK-432. Polyethyleneglycol was used as a detergent and porosity generator. The stability of OK-432 in solvent, releasing kinetics of drug, and cytotoxicity of the DDS were evaluated. OK-432-impregnated DDS was implanted in mice in which a human adenocarcinoma cell line was injected and grown in their back. Flow cytometry and enzyme-linked immunosorbent assay were used for quantifying the amount of drug. OK-432 exposed to phosphate-buffered saline and OK-432 exposed to N,N-dimethylacetamide showed similar results on dot graphs and histograms. However, OK-432 exposed to tetrahydrofurane showed different dot graphs and histograms, which means that the antigenicity of the drug was changed. The release rate of OK-432 was maintained at a constant level for 6 weeks. The local delivery of OK-432 was found to have an antitumor effect on a human adenocarcinoma cell line in an animal study, but no effect on this cell line in in vitro cell culture. Histologic examination showed minimal inflammatory reaction in surrounding tissue. Our study shows that local treatment using this OK-432 release system is safe and effective in reducing adenocarcinoma in a mouse model

  7. The Study of early maladaptive Schemas in Men Dependent on Drugs and those Not Dependent

    Directory of Open Access Journals (Sweden)

    MR Firoozi

    2015-11-01

    Full Text Available Introduction and Objectives of the Study Dependence on drugs is a prevalent problem throughout the world, in general and in Iran, in particular. Such a phenomenon is associated with numerous negative consequences. Given the changes in the consumption patterns in different countries, especially in Iran, and the abuse of drugs, identifying the factors which may pave the way for drug abuse is absolutely essential, which can be taken into account in setting the objectives of therapy programs. Cognizant of this, the present study has sought to study early maladaptive schemas in men dependent on drugs and those that are not. Materials and Method: The research design adopted in the present study was causal-comparative. The populaiton of interest was all the men dependent on drugs in the city of Yasouj, who had presented to recovery centers affiliated to welfare organization and Yasouj University of Medical Sciences in the year 2014 and were undergoing treatment. Using multi-stage cluster sampling, initially out of 23 centers for recovery programs, four centers were randomly chosen. Following that, out of each center, 20 and in total, 80 clients were chosen as the sample through convenience sampling. In addition, 80 men not dependent on drugs were chosen through matching with the sample dependent on drugs in terms of age, gender and locality. For the purpsoe of measuing early maladaptive schemas, we made use of the short version of Young’s early maladaptive Schemas Questionnaire. In order to determine the prevalent schemas in men dependent on drugs and those not dependent and the difference between the two groups, use was made of independent-sample t-test and effect size (d. Findings: The findings suggest that mean values of those dependent on drugs in all the schemas in quesiton were significantly higher than those of men not dependent. Although the difference in effect size of all schemas fell in the domain of the large effect, the largest

  8. Do advertisements for antihypertensive drugs in Australia promote quality prescribing? A cross-sectional study

    Directory of Open Access Journals (Sweden)

    Spurling Geoffrey K

    2008-05-01

    Full Text Available Abstract Background Antihypertensive medications are widely prescribed by doctors and heavily promoted by the pharmaceutical industry. Despite strong evidence of the effectiveness and cost-effectiveness of thiazide diuretics, trends in both promotion and prescription of antihypertensive drugs favour newer, less cost-effective agents. Observational evidence shows correlations between exposure to pharmaceutical promotion and less ideal prescribing. Our study therefore aimed to determine whether print advertisements for antihypertensive medications promote quality prescribing in hypertension. Methods We performed a cross-sectional study of 113 advertisements for antihypertensive drugs from 4 general practice-oriented Australian medical publications in 2004. Advertisements were evaluated using a quality checklist based on a review of hypertension management guidelines. Main outcome measures included: frequency with which antihypertensive classes were advertised, promotion of thiazide class drugs as first line agents, use of statistical claims in advertisements, mention of harms and prices in the advertisements, promotion of assessment and treatment of cardiovascular risk, promotion of lifestyle modification, and targeting of particular patient subgroups. Results Thiazides were the most frequently advertised drug class (48.7% of advertisements, but were largely promoted in combination preparations. The only thiazide advertised as a single agent was the most expensive, indapamide. No advertisement specifically promoted any thiazide as a better first-line drug. Statistics in the advertisements tended to be expressed in relative rather than absolute terms. Drug costs were often reported, but without cost comparisons between drugs. Adverse effects were usually reported but largely confined to the advertisements' small print. Other than mentioning drug interactions with alcohol and salt, no advertisements promoted lifestyle modification. Few

  9. Do advertisements for antihypertensive drugs in Australia promote quality prescribing? A cross-sectional study.

    Science.gov (United States)

    Montgomery, Brett D; Mansfield, Peter R; Spurling, Geoffrey K; Ward, Alison M

    2008-05-20

    Antihypertensive medications are widely prescribed by doctors and heavily promoted by the pharmaceutical industry. Despite strong evidence of the effectiveness and cost-effectiveness of thiazide diuretics, trends in both promotion and prescription of antihypertensive drugs favour newer, less cost-effective agents. Observational evidence shows correlations between exposure to pharmaceutical promotion and less ideal prescribing. Our study therefore aimed to determine whether print advertisements for antihypertensive medications promote quality prescribing in hypertension. We performed a cross-sectional study of 113 advertisements for antihypertensive drugs from 4 general practice-oriented Australian medical publications in 2004. Advertisements were evaluated using a quality checklist based on a review of hypertension management guidelines. Main outcome measures included: frequency with which antihypertensive classes were advertised, promotion of thiazide class drugs as first line agents, use of statistical claims in advertisements, mention of harms and prices in the advertisements, promotion of assessment and treatment of cardiovascular risk, promotion of lifestyle modification, and targeting of particular patient subgroups. Thiazides were the most frequently advertised drug class (48.7% of advertisements), but were largely promoted in combination preparations. The only thiazide advertised as a single agent was the most expensive, indapamide. No advertisement specifically promoted any thiazide as a better first-line drug. Statistics in the advertisements tended to be expressed in relative rather than absolute terms. Drug costs were often reported, but without cost comparisons between drugs. Adverse effects were usually reported but largely confined to the advertisements' small print. Other than mentioning drug interactions with alcohol and salt, no advertisements promoted lifestyle modification. Few advertisements (2.7%) promoted the assessment of cardiovascular risk

  10. Drug Use before and during Pregnancy in Japan: The Japan Environment and Children’s Study

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    Hidekazu Nishigori

    2017-04-01

    Full Text Available Purpose: To elucidate drug use before and during pregnancy in Japan. Methods: The Japan Environment and Children’s Study (JECS is an ongoing nationwide birth cohort study. We analyzed data from JECS involving cases where drugs were used for 12 months before pregnancy was diagnosed, between the time of diagnosis of pregnancy until week 12 of pregnancy, and after week 12 of pregnancy. Results: We analyzed data from 97,464 pregnant women. The percentages of pregnant women who had taken one or more drugs and supplements before diagnosis of pregnancy, between the time of diagnosis of pregnancy until week 12 of pregnancy, and after week 12 of pregnancy, were 78.4%, 57.1%, and 68.8% respectively. Excluding iron supplements, folic acid, and other vitamins and minerals, the percentages of women taking supplements were 75.3%, 36.0%, and 51.7% at each respective time point. The following drugs and supplements were frequently used for 12 months before pregnancy diagnosis: Commercially available antipyretics, analgesics, and/or medicine for treating common cold (34.7%, antipyretics, analgesics, and/or medicine for treating common colds, which were prescribed in hospitals (29.8%, antimicrobial drugs (14.0%, and anti-allergy drugs (12.5%. The following drugs and supplements were frequently used from the time of pregnancy diagnosis until week 12 of pregnancy, and after week 12 of pregnancy: folic acid (28.9% and 26.2%, antipyretics, analgesics and/or medicines for treating common cold, that were prescribed in hospitals (7.8% and 13.3%, Chinese herbal medicines (6.0% and 9.4%, and uterine relaxants (5.1% and 15.2%. Conclusions: The analysis of a nationwide cohort study showed that a high percentage of Japanese pregnant women were taking medicinal drugs. Further research is required to elucidate the relationship between drug use during pregnancy and birth defects in Japan.

  11. DRUG MANAGEMENT REVIEWS IN DISTRICT DRUG MANAGEMENT UNIT AND GENERAL HOSPITAL

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    Max Joseph Herman

    2009-12-01

    Full Text Available Drug is one of the essential elements in healthcare that should be effectively and efficiently managed. Following thedecentralization in 2001 in Indonesia, drug management has changed in district drug management units and also in District General Hospitals. Certainly this condition influences the sustainability of drug access in primary health care such as in Community Health Center and District General Hospital, especially in drug financing policy. A cross sectional descriptive study to obtain information on drug management in public healthcare in district had been carried out between July and December 2006 in 10 District Public Drug Management Units from 10 district health offices and 9 district general hospitals as samples. Data were collected by interviewing heads of Drug Section in District Health Offices and heads of Hospital Pharmacies using structured questionnaires and observing drug storage in District Drug Management Units, Community Health Centers, and Hospital Pharmacies. Results of the study show that drug planning in District Health Offices and General Hospitals did not meet the basic real need in some districts nor District Hospitals. The minimum health service standards had no been achieved yet. Furthermore, drug procurement, storage and recording as well as reporting was not good enough either, such as shown by the existence of expired drugs. Lead time for drug delivery to community health centers in some districts was longer than the average of lead time in the past 3 years.

  12. Study on the effects of radiation on microbial; contamination of crude drugs

    International Nuclear Information System (INIS)

    Satake, Motoyoshi; Sekita, Setsuko; Kamakura, Hiroyuki

    1999-01-01

    The effects of radiation on five kinds of crude drugs (fennel, cinnamon bark, rhubarb, senna leaf and peony root) from various countries were studied by 6, 12, 24, 30 and 60 KGy 60 Co-gamma-ray. Number of fungus and bacteria in these crude drugs were changed by radiation and decreased to 10 1 by 12 KGy. But a part of them needed 30 KGy. Contents of components such as PGG and paeonifrolin in peony root and aloe-emodin, rhein, aloe-emodin 8-Glc, rhein 8-Glc, sennoside A and sennoside B in senna leaf were not changed by radiation. Accordingly, the components of crude drugs were not affected by 60 KGy-gamma-ray. (S.Y.)

  13. Drug-Drug Multicomponent Solid Forms: Cocrystal, Coamorphous and Eutectic of Three Poorly Soluble Antihypertensive Drugs Using Mechanochemical Approach.

    Science.gov (United States)

    Haneef, Jamshed; Chadha, Renu

    2017-08-01

    The present study deals with the application of mechanochemical approach for the preparation of drug-drug multicomponent solid forms of three poorly soluble antihypertensive drugs (telmisartan, irbesartan and hydrochlorothiazide) using atenolol as a coformer. The resultant solid forms comprise of cocrystal (telmisartan-atenolol), coamorphous (irbesartan-atenolol) and eutectic (hydrochlorothiazide-atenolol). The study emphasizes that solid-state transformation of drug molecules into new forms is a result of the change in structural patterns, diminishing of dimers and creating new facile hydrogen bonding network based on structural resemblance. The propensity for heteromeric or homomeric interaction between two different drugs resulted into diverse solid forms (cocrystal/coamorphous/eutectics) and become one of the interesting aspects of this research work. Evaluation of these solid forms revealed an increase in solubility and dissolution leading to better antihypertensive activity in deoxycorticosterone acetate (DOCA) salt-induced animal model. Thus, development of these drug-drug multicomponent solid forms is a promising and viable approach to addressing the issue of poor solubility and could be of considerable interest in dual drug therapy for the treatment of hypertension.

  14. Design, Characterization, and Optimization of Controlled Drug Delivery System Containing Antibiotic Drug/s

    Directory of Open Access Journals (Sweden)

    Apurv Patel

    2016-01-01

    Full Text Available The objective of this work was design, characterization, and optimization of controlled drug delivery system containing antibiotic drug/s. Osmotic drug delivery system was chosen as controlled drug delivery system. The porous osmotic pump tablets were designed using Plackett-Burman and Box-Behnken factorial design to find out the best formulation. For screening of three categories of polymers, six independent variables were chosen for Plackett-Burman design. Osmotic agent sodium chloride and microcrystalline cellulose, pore forming agent sodium lauryl sulphate and sucrose, and coating agent ethyl cellulose and cellulose acetate were chosen as independent variables. Optimization of osmotic tablets was done by Box-Behnken design by selecting three independent variables. Osmotic agent sodium chloride, pore forming agent sodium lauryl sulphate, and coating agent cellulose acetate were chosen as independent variables. The result of Plackett-Burman and Box-Behnken design and ANOVA studies revealed that osmotic agent and pore former had significant effect on the drug release up to 12 hr. The observed independent variables were found to be very close to predicted values of most satisfactory formulation which demonstrates the feasibility of the optimization procedure in successful development of porous osmotic pump tablets containing antibiotic drug/s by using sodium chloride, sodium lauryl sulphate, and cellulose acetate as key excipients.

  15. Study of adverse drug reactions in out-patient departments of a teaching hospital

    Directory of Open Access Journals (Sweden)

    Zinnat Ara Begum

    2012-06-01

    Full Text Available The study conducted in the Medicine and Skin outpatient departments of Dhaka Medical College, Dhaka revealed 19 cases (7 males, 12 females of adverse drug reactions (ADR out of 160 patients. 31.58% ADRs were of mild type, 42.1% were of moderate and 26.32% were of severe in nature. Gastrointestinal complications were the most frequent adverse effect (56%. Antimicrobial drugs were the most common cause of ADR (42.86% followed by NSAIDs (33.33%. This study is a preliminary study for getting information on the pattern of ADRs in Bangladesh needing further studies.

  16. A Bibliographic Study of Drug Abuse Research during last 30 years in Iran

    Directory of Open Access Journals (Sweden)

    Afarin Rahimi Movaghar

    2009-05-01

    Full Text Available In the last decades, the produced science has been significantly increased in the field of drug abuse, globally. The objective of this study was to assess the bibliographic aspects of the science produced in Iran on drug abuse in the last 30 years. All scientific papers published from Iran in a 30-year period (1973-2002 in national as well as international scientific journals were assessed for this study. These papers are indexed in the database for Iranian Mental Health Researches, called IranPsych. The total number of 218 papers on drug and drug abuse were found and assessed by six psychiatrists and psychologists with good inter-rater reliability. About half of these papers were published in the last two years. About half of the papers have been published in the Persian medical journals. One-third have been published in international journals. Overall, 449 authors contributed to the 218 published papers from whom 80 percent had only one paper. Half of the papers were written by only 15 authors (3.3 percent. Most of the authors were Medical Doctors and from Medical Universities. None of the researches was received financial support from pharmacologic industries. This study shows that in recent years, the increase in the publication of the researches conducted on drug abuse has been significant. Nevertheless, according to the high prevalence of drug abuse problem in Iran and improvements in the scientific, as well as executive structures, the whole scientific output is insignificant. The findings guide us to a more systematic approach toward training of researchers and promotion of resaerch in this area. Moreover, more active involvement of social scientists and publication of their research findings are recommended.

  17. Non-clinical studies in the process of new drug development - Part II: Good laboratory practice, metabolism, pharmacokinetics, safety and dose translation to clinical studies.

    Science.gov (United States)

    Andrade, E L; Bento, A F; Cavalli, J; Oliveira, S K; Schwanke, R C; Siqueira, J M; Freitas, C S; Marcon, R; Calixto, J B

    2016-12-12

    The process of drug development involves non-clinical and clinical studies. Non-clinical studies are conducted using different protocols including animal studies, which mostly follow the Good Laboratory Practice (GLP) regulations. During the early pre-clinical development process, also known as Go/No-Go decision, a drug candidate needs to pass through several steps, such as determination of drug availability (studies on pharmacokinetics), absorption, distribution, metabolism and elimination (ADME) and preliminary studies that aim to investigate the candidate safety including genotoxicity, mutagenicity, safety pharmacology and general toxicology. These preliminary studies generally do not need to comply with GLP regulations. These studies aim at investigating the drug safety to obtain the first information about its tolerability in different systems that are relevant for further decisions. There are, however, other studies that should be performed according to GLP standards and are mandatory for the safe exposure to humans, such as repeated dose toxicity, genotoxicity and safety pharmacology. These studies must be conducted before the Investigational New Drug (IND) application. The package of non-clinical studies should cover all information needed for the safe transposition of drugs from animals to humans, generally based on the non-observed adverse effect level (NOAEL) obtained from general toxicity studies. After IND approval, other GLP experiments for the evaluation of chronic toxicity, reproductive and developmental toxicity, carcinogenicity and genotoxicity, are carried out during the clinical phase of development. However, the necessity of performing such studies depends on the new drug clinical application purpose.

  18. Radiometric studies on the oxidation of (I-14C) fatty acids by drug-susceptible and drug-resistant mycobacteria

    International Nuclear Information System (INIS)

    Camargo, E.E.; Kopajtic, T.M.; Hopkins, G.K.; Cannon, N.P.; Wagner Junior, H.N.

    1987-01-01

    A radiometric assay system has been used to study oxidation patterns of (l - 14 C) fatty acids by drug-susceptible and drug-resistant organisms of the genus Mycobacterium (M. tuberculosis - H 37 Rv and Erdman, M. bovis, M. avium, M. intracellulare, M.Kansasii and M. chelonei). The organisms were inoculated in sterile reaction vials containing liquid 7H9 medium, 10% ADC enrichment and 1.0 uli of one of the (l- 14 C) fatty acids (butyric, hexanoic, octanoic, decanoic, lauric, myristic, palmitic, stearic, oleic, linoleic, linolenic). Vials were incubated at 37 0 C and the 14 CO 2 envolved was measured daily for 3 days with a Bactec R-301 instrument. (M.A.C.) [pt

  19. Caenorhabditis elegans as a Model System for Studying Drug Induced Mitochondrial Toxicity.

    Directory of Open Access Journals (Sweden)

    Richard de Boer

    Full Text Available Today HIV-1 infection is recognized as a chronic disease with obligatory lifelong treatment to keep viral titers below detectable levels. The continuous intake of antiretroviral drugs however, leads to severe and even life-threatening side effects, supposedly by the deleterious impact of nucleoside-analogue type compounds on the functioning of the mitochondrial DNA polymerase. For detailed investigation of the yet partially understood underlying mechanisms, the availability of a versatile model system is crucial. We therefore set out to develop the use of Caenorhabditis elegans to study drug induced mitochondrial toxicity. Using a combination of molecular-biological and functional assays, combined with a quantitative analysis of mitochondrial network morphology, we conclude that anti-retroviral drugs with similar working mechanisms can be classified into distinct groups based on their effects on mitochondrial morphology and biochemistry. Additionally we show that mitochondrial toxicity of antiretroviral drugs cannot be exclusively attributed to interference with the mitochondrial DNA polymerase.

  20. Detecting drug-drug interactions using a database for spontaneous adverse drug reactions: an example with diuretics and non-steroidal anti-inflammatory drugs.

    Science.gov (United States)

    van Puijenbroek, E P; Egberts, A C; Heerdink, E R; Leufkens, H G

    2000-12-01

    Drug-drug interactions are relatively rarely reported to spontaneous reporting systems (SRSs) for adverse drug reactions. For this reason, the traditional approach for analysing SRS has major limitations for the detection of drug-drug interactions. We developed a method that may enable signalling of these possible interactions, which are often not explicitly reported, utilising reports of adverse drug reactions in data sets of SRS. As an example, the influence of concomitant use of diuretics and non-steroidal anti-inflammatory drugs (NSAIDs) on symptoms indicating a decreased efficacy of diuretics was examined using reports received by the Netherlands Pharmacovigilance Foundation Lareb. Reports received between 1 January 1990 and 1 January 1999 of patients older than 50 years were included in the study. Cases were defined as reports with symptoms indicating a decreased efficacy of diuretics, non-cases as all other reports. Exposure categories were the use of NSAIDs or diuretics versus the use of neither of these drugs. The influence of the combined use of both drugs was examined using logistic regression analysis. The odds ratio of the statistical interaction term of the combined use of both drugs was increased [adjusted odds ratio 2.0, 95% confidence interval (CI) 1.1-3.7], which may indicate an enhanced effect of concomitant drug use. The findings illustrate that spontaneous reporting systems have a potential for signal detection and the analysis of possible drug-drug interactions. The method described may enable a more active approach in the detection of drug-drug interactions after marketing.

  1. African Journal of Drug & Alcohol Studies, 16(1), 2017 Copyright ...

    African Journals Online (AJOL)

    The early age at initiation begs for more comprehensive drug prevention programmes especially in ... in terms of prevention, treatment and care of drug ... drug treatment unit in a Federal Neuropsy- .... sonal income or from family and friends,.

  2. Drug information, misinformation, and disinformation on social media: a content analysis study.

    Science.gov (United States)

    Al Khaja, Khalid A J; AlKhaja, Alwaleed K; Sequeira, Reginald P

    2018-05-24

    Dissemination of misleading drug information through social media can be detrimental to the health of the public. This study, carried out in Bahrain, evaluated the truthfulness of 22 social media claims about drugs (72.7%), dietary supplements (22.7%), and toxic bisphenol-A (4.5%). They circulated on WhatsApp platform, as case studies. We categorized claims as objectively true, false, or potentially misleading. The content analysis revealed that "potentially misleading" claims were the most frequent messages (59.1%). They tend to exaggerate the efficacy or safety without sufficient evidence to substantiate claims. False claims (27.3%) were likely due to unfair competition or deception. Overall, 13.6% of the messages were objectively true claims that could withstand regulatory scrutiny. Majority of the drug-related messages on social media were potentially misleading or false claims that lacked credible evidence to support them. In the public interest, regulatory authorities should monitor such information disseminated via social media platforms.

  3. At R806

    CERN Multimedia

    CERN PhotoLab

    1976-01-01

    The Brookhaven CERN-Saclay-Syracuse-Yale Collaboration studied large transverse momentum phenomena with transition radiation detectors and liquid argon calorimeters. Here Italo Mannelli and Christine Kourkoumelis. Italo Mannelli and Christine Kourkoumelis

  4. Way for reducing drug supply chain cost for a hospital district: a case study

    OpenAIRE

    Postacchini, Leonardo; Ciarapica, Filippo Emanuele; Bevilacqua, Maurizio; Mazzuto, Giovanni; Paciarotti, Claudia

    2016-01-01

    Purpose: This work aims at providing insights to optimise healthcare logistic of the drug management, in order to deal with the healthcare expenditure cut. In this paper the effects of different drug supply chain configurations, on the resulting average stock, service level and Bullwhip effect, of the studied supply chain, is quantitatively assessed. Design/methodology/approach: A case study of an Italian district has been studied, taking into account three echelons: suppliers,...

  5. Drug metabolism in birds

    Science.gov (United States)

    Pan, Huo Ping; Fouts, James R.

    1979-01-01

    Papers published over 100 years since the beginning of the scientific study of drug metabolism in birds were reviewed. Birds were found to be able to accomplish more than 20 general biotransformation reactions in both functionalization and conjugation. Chickens were the primary subject of study but over 30 species of birds were used. Large species differences in drug metabolism exist between birds and mammals as well as between various birds, these differences were mostly quantitative. Qualitative differences were rare. On the whole, drug metabolism studies in birds have been neglected as compared with similar studies on insects and mammals. The uniqueness of birds and the advantages of using birds in drug metabolism studies are discussed. Possible future studies of drug metabolism in birds are recommended.

  6. Analysis of Intra- and Intersubject Variability in Oral Drug Absorption in Human Bioequivalence Studies of 113 Generic Products.

    Science.gov (United States)

    Sugihara, Masahisa; Takeuchi, Susumu; Sugita, Masaru; Higaki, Kazutaka; Kataoka, Makoto; Yamashita, Shinji

    2015-12-07

    In this study, the data of 113 human bioequivalence (BE) studies of immediate release (IR) formulations of 74 active pharmaceutical ingredients (APIs) conducted at Sawai Pharmaceutical Co., Ltd., was analyzed to understand the factors affecting intra- and intersubject variabilities in oral drug absorption. The ANOVA CV (%) calculated from area under the time-concentration curve (AUC) in each BE study was used as an index of intrasubject variability (Vintra), and the relative standard deviation (%) in AUC was used as that of intersubject variability (Vinter). Although no significant correlation was observed between Vintra and Vinter of all drugs, Vintra of class 3 drugs was found to increase in association with a decrease in drug permeability (P(eff)). Since the absorption of class 3 drugs was rate-limited by the permeability, it was suggested that, for such drugs, the low P(eff) might be a risk factor to cause a large intrasubject variability. To consider the impact of poor water solubility on the variability in BE study, a parameter of P(eff)/Do (Do; dose number) was defined to discriminate the solubility-limited and dissolution-rate-limited absorption of class 2 drugs. It was found that the class 2 drugs with a solubility-limited absorption (P(eff)/Do high intrasubject variability. Furthermore, as a reason for high intra- or intersubject variability in AUC for class 1 drugs, effects of drug metabolizing enzymes were investigated. It was demonstrated that intrasubject variability was high for drugs metabolized by CYP3A4 while intersubject variability was high for drugs metabolized by CYP2D6. For CYP3A4 substrate drugs, the Km value showed the significant relation with Vintra, indicating that the affinity to the enzyme can be a parameter to predict the risk of high intrasubject variability. In conclusion, by analyzing the in house data of human BE study, low permeability, solubility-limited absorption, and high affinity to CYP3A4 are identified as risk factors for

  7. Comparison of a drug versus money and drug versus drug self-administration choice procedure with oxycodone and morphine in opioid addicts.

    Science.gov (United States)

    Comer, Sandra D; Metz, Verena E; Cooper, Ziva D; Kowalczyk, William J; Jones, Jermaine D; Sullivan, Maria A; Manubay, Jeanne M; Vosburg, Suzanne K; Smith, Mary E; Peyser, Deena; Saccone, Phillip A

    2013-09-01

    This double-blind, placebo-controlled study investigated the effects of oral morphine (0, 45, 135 mg/70 kg) and oral oxycodone (0, 15, 45 mg/70 kg) on buprenorphine-maintained opioid addicts. As a 3: 1 morphine : oxycodone oral dose ratio yielded equivalent subjective and physiological effects in nondependent individuals, this ratio was used in the present study. Two self-administration laboratory procedures - that is, a drug versus money and a drug versus drug procedure - were assessed. Study participants (N=12) lived in the hospital and were maintained on 4 mg/day sublingual buprenorphine. When participants chose between drug and money, money was preferred over all drug doses; only high-dose oxycodone was self-administered more than placebo. When participants chose between drug and drug, both drugs were chosen more than placebo, high doses of each drug were chosen over low doses, and high-dose oxycodone was preferred over high-dose morphine. The subjective, performance-impairing, and miotic effects of high-dose oxycodone were generally greater than those of high-dose morphine. The study demonstrated that a 3: 1 oral dose ratio of morphine : oxycodone was not equipotent in buprenorphine-dependent individuals. Both self-administration procedures were effective for assessing the relative reinforcing effects of drugs; preference for one procedure should be driven by the specific research question of interest.

  8. Boron nitride nanotubes for delivery of 5-fluorouracil as anticancer drug: a theoretical study

    Science.gov (United States)

    Shayan, Kolsoom; Nowroozi, Alireza

    2018-01-01

    The electronic structure and properties of the armchair boron nitride nanotubes (BNNTs) interacted with the 5-FU drug, as an anticancer drug, are studied at the B3LYP/6-31G(d,p) level of theory. D3-Corrections were carried out for the treatment of intermolecular interactions in the hybrid complexes and encapsulated nanotubes, exactly. Results have shown that the encapsulation and adsorption of 5-FU molecule on the studied BNNTs surface are favorable processes, with a few exceptions. Also, it is found that the encapsulated nanotubes are stable than the hybrid complexes. Furthermore, we estimated the strengths of the intermolecular bonds of the benchmark systems by energetic, geometric, topological and molecular orbital descriptors. Some analyses have been made to explore any changes in the binding characteristics of the drug molecule after its attachment to the nanotubes. According to the NBO results, the charge transfer phenomenon is observed from the bonding or nonbonding orbitals of drug to the antibonding orbitals of BNNTs. Moreover, HOMO-LUMO analysis indicated that, after the adsorption process, the HOMO value slightly increased, while the LUMO value in these systems significantly reduced in the both of Drug@BNNTs groups. So, the energy gaps between HOMO and LUMO (Eg) are reduced, which emphasis on the greater intermolecular bond strength. Finally, the stability and reactivity of the Drug@BNNTs complexes have been examined from the magnitudes of the chemical reactivity descriptors such as chemical potential, global hardness, and electrophilicity index. As a consequence, BNNTs can be considered as a drug delivery vehicle for the transportation of 5-FU as anticancer drug within the biological systems.

  9. Sale of anti-tuberculosis drugs through private pharmacies: a cross sectional study in Kerala, India.

    Directory of Open Access Journals (Sweden)

    Binoo Divakaran

    2011-03-01

    Full Text Available

    Background: Private health care providers are largely the first point of contact for Tuberculosis (TB patients, who either undergo treatment from private practitioners or buy medicines on their own from private pharmacies. Aims: This study assessed the availability, sale and magnitude of anti-tuberculosis drugs dispensing through private pharmacies.

    Methodology: The present cross sectional study was conducted among private pharmacies located along the national highway from Thalassery to Payyannur in the Kannur district of Kerala, India. A total of 38 private pharmacies located along the national highway were included.

    Results: The duration that anti–TB drugs had been on sale showed that 74.3% of pharmacies had started to sell these drugs only less than ten years ago. The majority (82.9% of the private pharmacies received up to 5 prescriptions for anti-TB drugs weekly. Out of the total of 35 pharmacies selling these drugs, 22 (62.9% reported an increase in their sales. Nearly 82% of those pharmacies that reported an increase in the sale of anti-TB drugs were selling these drugs for less than the past ten years.

    Conclusions: The current study shows that a large number of tuberculosis patients are still approaching private pharmacies for anti-tuberculosis drugs. This tendency has to be completely stopped and needs properly planned strategies to encourage private pharmacies to participate actively in the DOTS (Direct Observation Treatment Short course program of the Government, by providing them attractive alternative incentives

  10. Transmission of Multidrug-Resistant and Drug-Susceptible Tuberculosis within Households: A Prospective Cohort Study

    Science.gov (United States)

    Grandjean, Louis; Gilman, Robert H.; Martin, Laura; Soto, Esther; Castro, Beatriz; Lopez, Sonia; Coronel, Jorge; Castillo, Edith; Alarcon, Valentina; Lopez, Virginia; San Miguel, Angela; Quispe, Neyda; Asencios, Luis; Dye, Christopher; Moore, David A. J.

    2015-01-01

    Background The “fitness” of an infectious pathogen is defined as the ability of the pathogen to survive, reproduce, be transmitted, and cause disease. The fitness of multidrug-resistant tuberculosis (MDRTB) relative to drug-susceptible tuberculosis is cited as one of the most important determinants of MDRTB spread and epidemic size. To estimate the relative fitness of drug-resistant tuberculosis cases, we compared the incidence of tuberculosis disease among the household contacts of MDRTB index patients to that among the contacts of drug-susceptible index patients. Methods and Findings This 3-y (2010–2013) prospective cohort household follow-up study in South Lima and Callao, Peru, measured the incidence of tuberculosis disease among 1,055 household contacts of 213 MDRTB index cases and 2,362 household contacts of 487 drug-susceptible index cases. A total of 35/1,055 (3.3%) household contacts of 213 MDRTB index cases developed tuberculosis disease, while 114/2,362 (4.8%) household contacts of 487 drug-susceptible index patients developed tuberculosis disease. The total follow-up time for drug-susceptible tuberculosis contacts was 2,620 person-years, while the total follow-up time for MDRTB contacts was 1,425 person-years. Using multivariate Cox regression to adjust for confounding variables including contact HIV status, contact age, socio-economic status, and index case sputum smear grade, the hazard ratio for tuberculosis disease among MDRTB household contacts was found to be half that for drug-susceptible contacts (hazard ratio 0.56, 95% CI 0.34–0.90, p = 0.017). The inference of transmission in this study was limited by the lack of genotyping data for household contacts. Capturing incident disease only among household contacts may also limit the extrapolation of these findings to the community setting. Conclusions The low relative fitness of MDRTB estimated by this study improves the chances of controlling drug-resistant tuberculosis. However, fitter

  11. Relation between body mass index, physical inactivity and use of prescription drugs: the Doetinchem Cohort Study.

    Science.gov (United States)

    Milder, I E J; Klungel, O H; Mantel-Teeuwisse, A K; Verschuren, W M M; Bemelmans, W J E

    2010-06-01

    Obesity and physical inactivity are associated with several diseases such as diabetes, cardiovascular diseases, musculoskeletal complaints, osteoporosis, certain types of cancer and depression. However, few data are available on the specific types of medication associated with obesity and physical inactivity. The aim of this study was to determine the independent association of body mass index (BMI) and physical inactivity with use of specific classes of prescription drugs, and the interaction between BMI and physical inactivity. The Doetinchem Cohort Study is a population-based longitudinal study. We analyzed cross-sectional data of 1703 men and 1841 women, examined between 1998 and 2002, for whom drug-dispending data were available from the PHARMO database. Drugs were coded according to the WHO Anatomical Therapeutic Chemical (ATC) classification system. Body weight was measured during the physical examination. Physical activity was assessed using an extensive questionnaire. Persons were defined as a user of a certain drug class if they filed at least one prescription in the year around (+/-6 months) the examination. Compared with normal weight persons (BMI 18.5-25 kg m(-2)), obese persons (BMI>30 kg m(-2)) had a higher use of prescription drugs of several drug classes, especially cardiovascular drugs (OR (95% CI): 3.83 (2.61-5.64) in men and 2.80 (2.03-3.86) in women) and diabetes drugs (OR (95% CI): 5.72 (2.32-14.14) in men and 3.92 (1.80-8.54) in women). In women, physical inactivity was also associated with higher use of certain drug classes, such as drugs for blood and blood-forming organs (OR (95% CI): 2.11 (1.22-3.65)) and musculoskeletal drugs (OR (95% CI): 2.07 (1.45-2.97)), whereas in men this was not the case. We found no interaction between BMI and physical inactivity with respect to use of prescription drugs. In both men and women, obesity was associated with a higher use of several types of prescription drugs, whereas physical inactivity was only

  12. Violent and Non-Violent Criminal Behavior among Young Chinese Drug Users: A Mixed Methods Study.

    Science.gov (United States)

    Liu, Liu; Chui, Wing Hong; Chen, Ye

    2018-03-02

    Young drug users are found to be increasingly involved in criminal justice issues. This exploratory and descriptive study aims to analyze the criminal behaviors among young Chinese drug users through a mixed methods research design. Quantitative analysis indicates that young drug users with and without a history of criminality show significant differences in terms of several features. Male drug users, particularly, those who are older, with religious beliefs, and initiated into drug use at younger age were most likely to commit crimes. Among drug users with criminal experiences, those who committed crimes prior to drug initiation have a greater likelihood of committing violent crimes. Furthermore, young drug users with severe depression are more likely to commit crimes, especially violent ones. Qualitative analysis further illustrates that young male drug users often get involved in criminal conduct of the youth gang nature with propensity for engaging in violent crimes as compared to their female counterparts who are more likely to turn into drug dealers and traffickers, in addition to engaging in larceny. The research findings are consistent with developmental theories and "victim to offender cycle". Integrated mental health and substance use services are suggested for crime prevention among young Chinese drug users.

  13. Laboratory monitoring of patients treated with antihypertensive drugs and newly exposed to non steroidal anti-inflammatory drugs: a cohort study.

    Directory of Open Access Journals (Sweden)

    Jean-Pascal Fournier

    Full Text Available BACKGROUND: Drug-Drug Interactions between Non Steroidal Anti-Inflammatory Drugs (NSAIDs and Angiotensin Converting Enzyme Inhibitors (ACEIs, Angiotensin Receptor Blocker (ARBs or diuretics can lead to renal failure and hyperkalemia. Thus, monitoring of serum creatinine and potassium is recommended when a first dispensing of NSAID occur in patients treated with these drugs. METHODS: We conducted a pharmacoepidemiological retrospective cohort study using data from the French Health Insurance Reimbursement Database to evaluate the proportion of serum creatinine and potassium laboratory monitoring in patients treated with ACEI, ARB or diuretic and receiving a first dispensing of NSAID. We described the first dispensing of NSAID among 3,500 patients of a 4-year cohort (6,633 patients treated with antihypertensive drugs and analyzed serum creatinine and potassium laboratory monitoring within the 3 weeks after the first NSAID dispensing. RESULTS: General Practitioners were the most frequent prescribers of NSAIDs (85.5%, 95% CI: 84.3-86.6. The more commonly prescribed NSAIDs were ibuprofen (20%, ketoprofen (15%, diclofenac (15% and piroxicam (12%. Serum creatinine and potassium monitoring was 10.7% (95% CI: 9.5-11.8 in patients treated by ACEIs, ARBs or diuretics. Overall, monitoring was more frequently performed to women aged over 60, treated with digoxin or glucose lowering drugs, but not to patients treated with ACEIs, ARBs or diuretics. Monitoring was more frequent when NSAIDs' prescribers were cardiologists or anesthesiologists. CONCLUSION: Monitoring of serum creatinine and potassium of patients treated with ACEIs, ARBs or diuretics and receiving a first NSAID dispensing is insufficiently performed and needs to be reinforced through specific interventions.

  14. Meta-analysis of recent studies on patients admitted to hospital due to adverse drug effects

    NARCIS (Netherlands)

    Atiqi, R.; Cleophas, T. J.; van Bommel, E.; Zwinderman, A. H.

    2009-01-01

    The use of drugs has expanded during the previous decade. However, earlier studies oil patients admitted for adverse drugs effects (ADEs) have been heterogeneous. The objectives of this Study were to assess the number of recent admissions to hospital Clue to ADEs and to assess the degree of

  15. 75 FR 36425 - Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Studies...

    Science.gov (United States)

    2010-06-25

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0076] (formerly Docket No. 2007D-0387) Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Studies--Frequently Asked Questions; Availability AGENCY: Food and Drug Administration, HHS...

  16. Nonsteroidal antiinflammatory drugs and dyspepsia in general practice – a prospective, controlled study

    Directory of Open Access Journals (Sweden)

    Marija Skok

    2005-01-01

    Full Text Available Background: Treatment of dyspeptic patients is a diagnostic and therapeutic problem frequently encountered by general and family practitioners, by internists and gastroenterologists.Aims: In our study we attempted to assess the prevalence of dyspeptic symptoms in patients over 60 who are regular users of nonsteroidal antiinflammatory drugs.Patients and methods: This is a prospective cohort study based on an interview during examination in the OPC, the results obtained by the diagnostic procedures and follow-up. It was carried out between 1999 and 2003 at a family practitioner’s and a gastroenterologic OPC. In patients who were regular users of nonsteroidal antiinflammatory drugs, we established the prevalence of dyspeptic symptoms, the most often used drugs and the type of diagnostic procedure applied to define the cause of dyspepsia. The control group was composed of patients over 60 who were also exhibiting dyspeptic symptoms but not using any NSAID.Results: The study comprised 50 patients, 27 women and 23 men, the mean age was 67.3 years, the range 60–80 years. The control group comprised 50 patients, 28 women and 22 men, the mean age was 66.6 years, the range 61–80 years. All patients of the study group had used NSAR or preparations of acetylsalicylic acid during the past 3 months. There were no statistically significant differences between the patients of both groups as regards the number and use of other drugs, p = 0.65. The average score of dyspeptic complaints in our study group was 3.02, SD ± 0.6, and 70% of patients wished to use H2 antagonists or proton pump inhibitors for these complaints. In patients of the control group, the average score of complaints was 2.72, SD ± 0.7, and they also took drugs for the alleviation of their complaints more rarely.Conclusions: Nonsteroidal antiinflammatory drugs belong among the important causes of dyspepsia in the elderly. When making decisions about the various diagnostic procedures for

  17. Glutamatergic transmission in drug reward: implications for drug addiction.

    Science.gov (United States)

    D'Souza, Manoranjan S

    2015-01-01

    Individuals addicted to drugs of abuse such as alcohol, nicotine, cocaine, and heroin are a significant burden on healthcare systems all over the world. The positive reinforcing (rewarding) effects of the above mentioned drugs play a major role in the initiation and maintenance of the drug-taking habit. Thus, understanding the neurochemical mechanisms underlying the reinforcing effects of drugs of abuse is critical to reducing the burden of drug addiction in society. Over the last two decades, there has been an increasing focus on the role of the excitatory neurotransmitter glutamate in drug addiction. In this review, pharmacological and genetic evidence supporting the role of glutamate in mediating the rewarding effects of the above described drugs of abuse will be discussed. Further, the review will discuss the role of glutamate transmission in two complex heterogeneous brain regions, namely the nucleus accumbens (NAcc) and the ventral tegmental area (VTA), which mediate the rewarding effects of drugs of abuse. In addition, several medications approved by the Food and Drug Administration that act by blocking glutamate transmission will be discussed in the context of drug reward. Finally, this review will discuss future studies needed to address currently unanswered gaps in knowledge, which will further elucidate the role of glutamate in the rewarding effects of drugs of abuse.

  18. Cutaneous adverse drug reactions in a tertiary care teaching hospital in India: An intensive monitoring study

    Directory of Open Access Journals (Sweden)

    Sejal Thakkar

    2017-01-01

    Full Text Available Background: The epidemiological data based on intensive monitoring studies are limited for the cutaneous adverse drug reactions (CADRs in terms of incidence. Most of earlier Indian studies focused only on types and causative drugs of CADRs. Aim: The aim of this study is to analyze the CADRs with reference to the incidence, its subgroup analysis, causative drugs, and other clinical characteristics in Indian population. Methodology: Intensive monitoring study was carried out over a period of 3 years in the dermatology outpatient and inpatient department. CADRs due to only systematically administered drugs were considered. The WHO definition for CADR, the WHO causality definitions, modified Schumock and Thornton's criteria for preventability, and International Conference on Harmonisation E2A guidelines for seriousness were considered. Incidence was expressed in percentage and its 95% confidence interval. The incidence was analyzed on basis of characteristics of study population and CADRs. Results: A total of 171 CADRs were observed from 37,623 patients. The CADR incidence was 0.45% (95% CI: 0.39–0.53. The incidence did not significantly differ in different age groups and gender. Commonly observed CADRs were maculopapular rash (23.98%, urticaria (21.64%, and fixed drug eruptions (FDEs (18.13%. Antimicrobials (35.18% and nonsteroidal anti-inflammatory drugs (NSAIDs were suspected in all common CADRs. Anti-infective and NSAIDs were most commonly suspected drugs in overall CADRs, maculopapular rash, urticaria, FDEs, and erythema multiforme. The exact nature of drugs remained inaccessible in one-fourth cases due to use of the over-the-counter self-medications. The incidence of preventable and serious and fatal CADRs was 0.08% (95% CI: 0.05–0.11, 0.04% (95% CI: 0.02–0.06, and 0.003% (95% CI: 0.000–0.001, respectively. Conclusion: Ethnic characteristics should be considered while interpreting incidence from the international studies. The

  19. Drug utilization and cost in a Medicaid population: A simulation study of community vs. mail order pharmacy

    Directory of Open Access Journals (Sweden)

    Seoane-Vazquez Enrique

    2007-07-01

    Full Text Available Abstract Background Outpatient drugs are dispensed through both community and mail order pharmacies. There is no empirical evidence that substitution of community pharmacy with mail order reduces overall drug expenditures. The need for evaluating the potential effects on utilization and costs of the possible extension of mail order services in Medicaid provides the rationale for conducting this study. This study compares drug utilization and drug product cost in community vs. mail order pharmacy dispensing services in a Medicaid population. Methods This study is a retrospective cohort study comparing utilization and cost patterns in community vs. mail order pharmacy. A simulation model was employed to assess drug utilization and cost in mail order pharmacy using community pharmacy claim data. The model assumed that courses of drug therapy (CDT in mail order pharmacy would have utilization patterns similar to those found in community pharmacy. A 95% confidence interval surrounding changes in average utilization and average cost were estimated using bootstrap analysis. A sensitivity analysis was performed by varying drug selection criteria and supply, fill point, and medication possession ratio (MPR. Sub-analyses were performed to address differences between mail order and community pharmacy related to therapeutic class and dual-eligible patients. Data for the study derived from pharmacy claims database of Ohio Medicaid State program for the period January 2000-September 2004. Drug claims were aggregated to obtain a set of CDTs representing unique patient IDs and unique drug products. Drug product cost estimates excluded dispensing fees and were used to estimate the cost reduction required in mail order to become cost neutral in comparison with community pharmacy. Results The baseline model revealed that the use of mail order vs. community pharmacy would result in a 5.5% increase in drug utilization and a 5.4% cost reduction required in mail order

  20. Exploring drug-target interaction networks of illicit drugs

    OpenAIRE

    Atreya, Ravi V; Sun, Jingchun; Zhao, Zhongming

    2013-01-01

    Background Drug addiction is a complex and chronic mental disease, which places a large burden on the American healthcare system due to its negative effects on patients and their families. Recently, network pharmacology is emerging as a promising approach to drug discovery by integrating network biology and polypharmacology, allowing for a deeper understanding of molecular mechanisms of drug actions at the systems level. This study seeks to apply this approach for investigation of illicit dru...

  1. A prospective three-step intervention study to prevent medication errors in drug handling in paediatric care.

    Science.gov (United States)

    Niemann, Dorothee; Bertsche, Astrid; Meyrath, David; Koepf, Ellen D; Traiser, Carolin; Seebald, Katja; Schmitt, Claus P; Hoffmann, Georg F; Haefeli, Walter E; Bertsche, Thilo

    2015-01-01

    To prevent medication errors in drug handling in a paediatric ward. One in five preventable adverse drug events in hospitalised children is caused by medication errors. Errors in drug prescription have been studied frequently, but data regarding drug handling, including drug preparation and administration, are scarce. A three-step intervention study including monitoring procedure was used to detect and prevent medication errors in drug handling. After approval by the ethics committee, pharmacists monitored drug handling by nurses on an 18-bed paediatric ward in a university hospital prior to and following each intervention step. They also conducted a questionnaire survey aimed at identifying knowledge deficits. Each intervention step targeted different causes of errors. The handout mainly addressed knowledge deficits, the training course addressed errors caused by rule violations and slips, and the reference book addressed knowledge-, memory- and rule-based errors. The number of patients who were subjected to at least one medication error in drug handling decreased from 38/43 (88%) to 25/51 (49%) following the third intervention, and the overall frequency of errors decreased from 527 errors in 581 processes (91%) to 116/441 (26%). The issue of the handout reduced medication errors caused by knowledge deficits regarding, for instance, the correct 'volume of solvent for IV drugs' from 49-25%. Paediatric drug handling is prone to errors. A three-step intervention effectively decreased the high frequency of medication errors by addressing the diversity of their causes. Worldwide, nurses are in charge of drug handling, which constitutes an error-prone but often-neglected step in drug therapy. Detection and prevention of errors in daily routine is necessary for a safe and effective drug therapy. Our three-step intervention reduced errors and is suitable to be tested in other wards and settings. © 2014 John Wiley & Sons Ltd.

  2. Experiences with policing among people who inject drugs in Bangkok, Thailand: a qualitative study.

    Directory of Open Access Journals (Sweden)

    Kanna Hayashi

    2013-12-01

    Full Text Available Despite Thailand's commitment to treating people who use drugs as "patients" not "criminals," Thai authorities continue to emphasize criminal law enforcement for drug control. In 2003, Thailand's drug war received international criticism due to extensive human rights violations. However, few studies have since investigated the impact of policing on drug-using populations. Therefore, we sought to examine experiences with policing among people who inject drugs (PWID in Bangkok, Thailand, between 2008 and 2012.Between July 2011 and June 2012, semi-structured, in-depth interviews were conducted with 42 community-recruited PWID participating in the Mitsampan Community Research Project in Bangkok. Interviews explored PWID's encounters with police during the past three years. Audio-recorded interviews were transcribed verbatim, and a thematic analysis was conducted to document the character of PWID's experiences with police. Respondents indicated that policing activities had noticeably intensified since rapid urine toxicology screening became available to police. Respondents reported various forms of police misconduct, including false accusations, coercion of confessions, excessive use of force, and extortion of money. However, respondents were reluctant to report misconduct to the authorities in the face of social and structural barriers to seeking justice. Respondents' strategies to avoid police impeded access to health care and facilitated transitions towards the misuse of prescribed pharmaceuticals. The study's limitations relate to the transferability of the findings, including the potential biases associated with the small convenience sample.This study suggests that policing in Bangkok has involved injustices, human rights abuses, and corruption, and policing practices in this setting appeared to have increased PWID's vulnerability to poor health through various pathways. Novel to this study are findings pertaining to the use of urine drug

  3. Factors influencing recording of drug misuse in primary care: a qualitative study of GPs in England.

    Science.gov (United States)

    Davies-Kershaw, Hilary; Petersen, Irene; Nazareth, Irwin; Stevenson, Fiona

    2018-04-01

    Drug misuse is a serious public health problem. Evidence from previous epidemiological studies show that GPs are recording drug misuse in electronic patient records (EPR). However, although the recording trends are similar to national surveys, recording rates are much lower. To explore the factors that influence GPs to record drug misuse in the EPR, and to gain a clearer understanding of the gap between the amount of drug misuse recorded in primary care and that in national surveys and other studies. A semi-structured qualitative interview study of GPs working in general practices across England. Purposive sampling was employed to recruit 12 GPs, both with and without a special interest in drug misuse, from across England. Semi-structured face-to-face interviews were conducted to consider whether and why GPs record drug misuse, which methods GPs use for recording, GPs' actions if a patient asks for the information not to be recorded, and GPs' actions if they think a patient misuses drugs but does not disclose the information. Resulting data were analysed using a combination of inductive and deductive thematic analysis. The complexity of asking about drug misuse preceded GPs' decision to record. They described how the context of the general practice protocols, interaction between GP and patient, and the questioning process affected whether, how, and in which circumstances they asked about drug use. This led to GPs making a clinical decision on whether, who, and how to record in the EPR. When making decisions about whether or not to record drug misuse, GPs face complex choices. Aside from their own views, they reported feelings of pressure from the general practice environment in which they worked and their clinical commissioning group, as well as government policies. © British Journal of General Practice 2018.

  4. Different frequencies of drug resistance mutations among HIV-1 subtypes circulating in China: a comprehensive study.

    Directory of Open Access Journals (Sweden)

    Hongshuai Sui

    Full Text Available The rapid spreading of HIV drug resistance is threatening the overall success of free HAART in China. Much work has been done on drug-resistant mutations, however, most of which were based on subtype B. Due to different genetic background, subtypes difference would have an effect on the development of drug-resistant mutations, which has already been proved by more and more studies. In China, the main epidemic subtypes are CRF07_BC, CRF08_BC, Thai B and CRF01_AE. The depiction of drug resistance mutations in those subtypes will be helpful for the selection of regimens for Chinese. In this study, the distributions difference of amino acids at sites related to HIV drug resistance were compared among subtype B, CRF01_AE, CRF07_BC and CRF08_BC strains prevalent in China. The amino acid composition of sequences belonging to different subtypes, which were obtained from untreated and treated individuals separately, were also compared. The amino acids proportions of 19 sites in RT among subtype B, CRF01_AE and CRF08_BC have significant difference in drug resistance groups (chi-square test, p<0.05. Genetic barriers analysis revealed that sites 69, 138, 181, 215 and 238 were significantly different among subtypes (Kruskal Wallis test, p<0.05. All subtypes shared three highest prevalent drug resistance sites 103, 181 and 184 in common. Many drug resistant sites in protease show surprising high proportions in almost all subtypes in drug-naïve patients. This is the first comprehensive study in China on different development of drug resistance among different subtypes. The detailed data will lay a foundation for HIV treatment regimens design and improve HIV therapy in China.

  5. Incidence and epidemiology of spinal cord injury within a closed American population: the United States military (2000-2009).

    Science.gov (United States)

    Schoenfeld, A J; McCriskin, B; Hsiao, M; Burks, R

    2011-08-01

    Cohort study. The objective of this study was to characterize the incidence of spinal cord injury (SCI) within the population of the United States military from 2000-2009. This investigation also sought to define potential risk factors for the development of SCI. The population of the United States military from 2000-2009. The Defense Medical Epidemiology Database was queried for the years 2000-2009 using the International Classification of Diseases, Ninth Revision, Clinical Modification codes for SCI (806.0, 806.1, 806.2, 806.3, 806.4, 806.5, 806.8, 806.9, 952.0, 952.1, 952.2, 952.8, 952.9). The raw incidence of SCI was calculated and unadjusted incidence rates were generated for the risk factors of age, sex, race, military rank and branch of service. Adjusted incidence rate ratios were subsequently determined via multivariate Poisson regression analysis that controlled for other factors in the model and identified significant independent risk factors for SCI. Between 2000 and 2009, there were 5928 cases of SCI among a population at-risk of 13,813,333. The raw incidence of SCI within the population was 429 per million person-years. Male sex, white race, enlisted personnel and service in the Army, Navy or Marine Corps were found to be significant independent risk factors for SCI. The age groups 20-24, 25-29 and >40 were also found to be at significantly greater risk of developing the condition. This study is one of the few investigations to characterize the incidence, epidemiology and risk factors for SCI within the United States. Results presented here may represent the best-available evidence for risk factors of SCI in a large and diverse American cohort.

  6. Polypharmacy and the risk of drug-drug interactions among Danish elderly

    DEFF Research Database (Denmark)

    Rosholm, J U; Bjerrum, L; Hallas, J

    1998-01-01

    OBJECTIVE: To analyze the use of all subsidized prescription drugs with special attention to the elderly (> or = 70 years of age), including their use of drug combination generally accepted as carrying a risk of severe interactions. DESIGN: Descriptive prevalence study. SETTING: Odense...... accepted as carrying a risk of severe interactions. RESULTS: Among persons less than 70 years, 67.9% used none, 16.5% used one drug and 15.6% used two or more prescription drugs. The corresponding prevalences for the elderly were 35.7%, 15.9% and 48.4%. The 26,337 elderly patients with at least two drugs...... used 21,293 different combinations. Of the elderly patients who had purchased > or = two drugs, 4.4% had combinations of drugs carrying a risk of severe interactions. CONCLUSIONS: Most elderly use drugs and usually several drugs concomitantly. The elderly form a heterogeneous group of drug users. Drug...

  7. Novel 3D Culture Systems for Studies of Human Liver Function and Assessments of the Hepatotoxicity of Drugs and Drug Candidates.

    Science.gov (United States)

    Lauschke, Volker M; Hendriks, Delilah F G; Bell, Catherine C; Andersson, Tommy B; Ingelman-Sundberg, Magnus

    2016-12-19

    The liver is an organ with critical importance for drug treatment as the disposition and response to a given drug is often determined by its hepatic metabolism. Patient-specific factors can entail increased susceptibility to drug-induced liver injury, which constitutes a major risk for drug development programs causing attrition of promising drug candidates or costly withdrawals in postmarketing stages. Hitherto, mainly animal studies and 2D hepatocyte systems have been used for the examination of human drug metabolism and toxicity. Yet, these models are far from satisfactory due to extensive species differences and because hepatocytes in 2D cultures rapidly dedifferentiate resulting in the loss of their hepatic phenotype and functionality. With the increasing comprehension that 3D cell culture systems more accurately reflect in vivo physiology, in the recent decade more and more research has focused on the development and optimization of various 3D culture strategies in an attempt to preserve liver properties in vitro. In this contribution, we critically review these developments, which have resulted in an arsenal of different static and perfused 3D models. These systems include sandwich-cultured hepatocytes, spheroid culture platforms, and various microfluidic liver or multiorgan biochips. Importantly, in many of these models hepatocytes maintain their phenotype for prolonged times, which allows probing the potential of newly developed chemical entities to cause chronic hepatotoxicity. Moreover, some platforms permit the investigation of drug action in specific genetic backgrounds or diseased hepatocytes, thereby significantly expanding the repertoire of tools to detect drug-induced liver injuries. It is concluded that the development of 3D liver models has hitherto been fruitful and that systems are now at hand whose sensitivity and specificity in detecting hepatotoxicity are superior to those of classical 2D culture systems. For the future, we highlight the

  8. Risk of falls after withdrawal of fall-risk-increasing drugs: a prospective cohort study

    NARCIS (Netherlands)

    van der Velde, Nathalie; Stricker, Bruno H. Ch; Pols, Huib A. P.; van der Cammen, Tischa J. M.

    2007-01-01

    AIMS: Falling in older persons is a frequent and serious clinical problem. Several drugs have been associated with increased fall risk. The objective of this study was to identify differences in the incidence of falls after withdrawal (discontinuation or dose reduction) of fall-risk-increasing drugs

  9. Adverse drug reaction reports for cardiometabolic drugs from sub Sahara Africa: A study in VigiBase

    NARCIS (Netherlands)

    Berhe, Derbew F.; Juhlin, Kristina; Star, Kristina; Haaijer-Ruskamp, Flora M.; Michael, Kidane; Taxis, Katja; Mol, Peter G. M.

    2014-01-01

    Background: Many pharmacovigilance centers have been established in Sub Sahara Africa (SSA) in recent years. Their focus has been on ADRs to drugs for communicable diseases. Little is known about ADRs caused by drugs for cardiometabolic diseases, although its burden is increasing rapidly in SSA.

  10. Thermal safety of ultrasound-enhanced ocular drug delivery: A modeling study

    Energy Technology Data Exchange (ETDEWEB)

    Nabili, Marjan, E-mail: mnabili@gwmail.gwu.edu [Department of Electrical and Computer Engineering, The George Washington University, 800 22nd Street NW, Room 5000, Washington, DC 20052 (United States); Geist, Craig, E-mail: cgeist@mfa.gwu.edu, E-mail: zderic@gwu.edu [Department of Ophthalmology, The George Washington University, 2150 Pennsylvania Avenue NW, Floor 2A, Washington, DC 20037 (United States); Zderic, Vesna, E-mail: cgeist@mfa.gwu.edu, E-mail: zderic@gwu.edu [Department of Biomedical Engineering, The George Washington University, 800 22nd Street NW, Room 6670, Washington, DC 20052 (United States)

    2015-10-15

    Purpose: Delivery of sufficient amounts of therapeutic drugs into the eye for treatment of various ocular diseases is often a challenging task. Ultrasound was shown to be effective in enhancing ocular drug delivery in the authors’ previous in vitro and in vivo studies. Methods: The study reported here was designed to investigate the safety of ultrasound application and its potential thermal effects in the eye using PZFlex modeling software. The safety limit in this study was set as a temperature increase of no more than 1.5 °C based on regulatory recommendations and previous experimental safety studies. Acoustic and thermal specifications of different human eye tissues were obtained from the published literature. The tissues of particular interest in this modeling safety study were cornea, lens, and the location of optic nerve in the posterior eye. Ultrasound application was modeled at frequencies of 400 kHz–1 MHz, intensities of 0.3–1 W/cm{sup 2}, and exposure duration of 5 min, which were the parameters used in the authors’ previous drug delivery experiments. The baseline eye temperature was 37 °C. Results: The authors’ results showed that the maximal tissue temperatures after 5 min of ultrasound application were 38, 39, 39.5, and 40 °C in the cornea, 39.5, 40, 42, and 43 °C in the center of the lens, and 37.5, 38.5, and 39 °C in the back of the eye (at the optic nerve location) at frequencies of 400, 600, 800 kHz, and 1 MHz, respectively. Conclusions: The ocular temperatures reached at higher frequencies were considered unsafe based on current recommendations. At a frequency of 400 kHz and intensity of 0.8 W/cm{sup 2} (parameters shown in the authors’ previous in vivo studies to be optimal for ocular drug delivery), the temperature increase was small enough to be considered safe inside different ocular tissues. However, the impact of orbital bone and tissue perfusion should be included in future modeling efforts to determine the safety

  11. Thermal safety of ultrasound-enhanced ocular drug delivery: A modeling study

    International Nuclear Information System (INIS)

    Nabili, Marjan; Geist, Craig; Zderic, Vesna

    2015-01-01

    Purpose: Delivery of sufficient amounts of therapeutic drugs into the eye for treatment of various ocular diseases is often a challenging task. Ultrasound was shown to be effective in enhancing ocular drug delivery in the authors’ previous in vitro and in vivo studies. Methods: The study reported here was designed to investigate the safety of ultrasound application and its potential thermal effects in the eye using PZFlex modeling software. The safety limit in this study was set as a temperature increase of no more than 1.5 °C based on regulatory recommendations and previous experimental safety studies. Acoustic and thermal specifications of different human eye tissues were obtained from the published literature. The tissues of particular interest in this modeling safety study were cornea, lens, and the location of optic nerve in the posterior eye. Ultrasound application was modeled at frequencies of 400 kHz–1 MHz, intensities of 0.3–1 W/cm 2 , and exposure duration of 5 min, which were the parameters used in the authors’ previous drug delivery experiments. The baseline eye temperature was 37 °C. Results: The authors’ results showed that the maximal tissue temperatures after 5 min of ultrasound application were 38, 39, 39.5, and 40 °C in the cornea, 39.5, 40, 42, and 43 °C in the center of the lens, and 37.5, 38.5, and 39 °C in the back of the eye (at the optic nerve location) at frequencies of 400, 600, 800 kHz, and 1 MHz, respectively. Conclusions: The ocular temperatures reached at higher frequencies were considered unsafe based on current recommendations. At a frequency of 400 kHz and intensity of 0.8 W/cm 2 (parameters shown in the authors’ previous in vivo studies to be optimal for ocular drug delivery), the temperature increase was small enough to be considered safe inside different ocular tissues. However, the impact of orbital bone and tissue perfusion should be included in future modeling efforts to determine the safety of this

  12. Photostability and Photostabilization of Drugs and Drug Products

    OpenAIRE

    Ahmad, Iqbal; Ahmed, Sofia; Anwar, Zubair; Sheraz, Muhammad Ali; Sikorski, Marek

    2016-01-01

    Photostability studies of drugs and drug products are an integral part of the product development process in the pharmaceutical industry. These studies are carried out to ensure quality, efficacy, and safety of the formulated products during manufacture, storage, and use. This review deals with the concept of photostability and related aspects and the literature available in the field. It highlights the role of the photochemistry in the photostability studies, describes the functional groups ...

  13. Characterization of p38 MAPK isoforms for drug resistance study using systems biology approach.

    Science.gov (United States)

    Peng, Huiming; Peng, Tao; Wen, Jianguo; Engler, David A; Matsunami, Risë K; Su, Jing; Zhang, Le; Chang, Chung-Che Jeff; Zhou, Xiaobo

    2014-07-01

    p38 mitogen-activated protein kinase activation plays an important role in resistance to chemotherapeutic cytotoxic drugs in treating multiple myeloma (MM). However, how the p38 mitogen-activated protein kinase signaling pathway is involved in drug resistance, in particular the roles that the various p38 isoforms play, remains largely unknown. To explore the underlying mechanisms, we developed a novel systems biology approach by integrating liquid chromatography-mass spectrometry and reverse phase protein array data from human MM cell lines with computational pathway models in which the unknown parameters were inferred using a proposed novel algorithm called modularized factor graph. New mechanisms predicted by our models suggest that combined activation of various p38 isoforms may result in drug resistance in MM via regulating the related pathways including extracellular signal-regulated kinase (ERK) pathway and NFкB pathway. ERK pathway regulating cell growth is synergistically regulated by p38δ isoform, whereas nuclear factor kappa B (NFкB) pathway regulating cell apoptosis is synergistically regulated by p38α isoform. This finding that p38δ isoform promotes the phosphorylation of ERK1/2 in MM cells treated with bortezomib was validated by western blotting. Based on the predicted mechanisms, we further screened drug combinations in silico and found that a promising drug combination targeting ERK1/2 and NFκB might reduce the effects of drug resistance in MM cells. This study provides a framework of a systems biology approach to studying drug resistance and drug combination selection. RPPA experimental Data and Matlab source codes of modularized factor graph for parameter estimation are freely available online at http://ctsb.is.wfubmc.edu/publications/modularized-factor-graph.php. © The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  14. Repurposing salicylanilide anthelmintic drugs to combat drug resistant Staphylococcus aureus.

    Science.gov (United States)

    Rajamuthiah, Rajmohan; Fuchs, Beth Burgwyn; Conery, Annie L; Kim, Wooseong; Jayamani, Elamparithi; Kwon, Bumsup; Ausubel, Frederick M; Mylonakis, Eleftherios

    2015-01-01

    Staphylococcus aureus is a Gram-positive bacterium that has become the leading cause of hospital acquired infections in the US. Repurposing Food and Drug Administration (FDA) approved drugs for antimicrobial therapy involves lower risks and costs compared to de novo development of novel antimicrobial agents. In this study, we examined the antimicrobial properties of two commercially available anthelmintic drugs. The FDA approved drug niclosamide and the veterinary drug oxyclozanide displayed strong in vivo and in vitro activity against methicillin resistant S. aureus (minimum inhibitory concentration (MIC): 0.125 and 0.5 μg/ml respectively; minimum effective concentration: ≤ 0.78 μg/ml for both drugs). The two drugs were also effective against another Gram-positive bacteria Enterococcus faecium (MIC 0.25 and 2 μg/ml respectively), but not against the Gram-negative species Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa and Enterobacter aerogenes. The in vitro antimicrobial activity of niclosamide and oxyclozanide were determined against methicillin, vancomycin, linezolid or daptomycin resistant S. aureus clinical isolates, with MICs at 0.0625-0.5 and 0.125-2 μg/ml for niclosamide and oxyclozanide respectively. A time-kill study demonstrated that niclosamide is bacteriostatic, whereas oxyclozanide is bactericidal. Interestingly, oxyclozanide permeabilized the bacterial membrane but neither of the anthelmintic drugs exhibited demonstrable toxicity to sheep erythrocytes. Oxyclozanide was non-toxic to HepG2 human liver carcinoma cells within the range of its in vitro MICs but niclosamide displayed toxicity even at low concentrations. These data show that the salicylanilide anthelmintic drugs niclosamide and oxyclozanide are suitable candidates for mechanism of action studies and further clinical evaluation for treatment of staphylococcal infections.

  15. Drug-drug interactions and adverse drug reactions in polypharmacy among older adults: an integrative review 1

    Science.gov (United States)

    Rodrigues, Maria Cristina Soares; de Oliveira, Cesar

    2016-01-01

    ABSTRACT Objective: to identify and summarize studies examining both drug-drug interactions (DDI) and adverse drug reactions (ADR) in older adults polymedicated. Methods: an integrative review of studies published from January 2008 to December 2013, according to inclusion and exclusion criteria, in MEDLINE and EMBASE electronic databases were performed. Results: forty-seven full-text studies including 14,624,492 older adults (≥ 60 years) were analyzed: 24 (51.1%) concerning ADR, 14 (29.8%) DDI, and 9 studies (19.1%) investigating both DDI and ADR. We found a variety of methodological designs. The reviewed studies reinforced that polypharmacy is a multifactorial process, and predictors and inappropriate prescribing are associated with negative health outcomes, as increasing the frequency and types of ADRs and DDIs involving different drug classes, moreover, some studies show the most successful interventions to optimize prescribing. Conclusions: DDI and ADR among older adults continue to be a significant issue in the worldwide. The findings from the studies included in this integrative review, added to the previous reviews, can contribute to the improvement of advanced practices in geriatric nursing, to promote the safety of older patients in polypharmacy. However, more research is needed to elucidate gaps. PMID:27598380

  16. Buying drugs on a Darknet market: A better deal? Studying the online illicit drug market through the analysis of digital, physical and chemical data.

    Science.gov (United States)

    Rhumorbarbe, Damien; Staehli, Ludovic; Broséus, Julian; Rossy, Quentin; Esseiva, Pierre

    2016-10-01

    Darknet markets, also known as cryptomarkets, are websites located on the Darknet and designed to allow the trafficking of illicit products, mainly drugs. This study aims at presenting the added value of combining digital, chemical and physical information to reconstruct sellers' activities. In particular, this research focuses on Evolution, one of the most popular cryptomarkets active from January 2014 to March 2015. Evolution source code files were analysed using Python scripts based on regular expressions to extract information about listings (i.e., sales proposals) and sellers. The results revealed more than 48,000 listings and around 2700 vendors claiming to send illicit drug products from 70 countries. The most frequent categories of illicit drugs offered by vendors were cannabis-related products (around 25%) followed by ecstasy (MDA, MDMA) and stimulants (cocaine, speed). The cryptomarket was then especially studied from a Swiss point of view. Illicit drugs were purchased from three sellers located in Switzerland. The purchases were carried out to confront digital information (e.g., the type of drug, the purity, the shipping country and the concealment methods mentioned on listings) with the physical analysis of the shipment packaging and the chemical analysis of the received product (purity, cutting agents, chemical profile based on minor and major alkaloids, chemical class). The results show that digital information, such as concealment methods and shipping country, seems accurate. But the illicit drugs purity is found to be different from the information indicated on their respective listings. Moreover, chemical profiling highlighted links between cocaine sold online and specimens seized in Western Switzerland. This study highlights that (1) the forensic analysis of the received products allows the evaluation of the accuracy of digital data collected on the website, and (2) the information from digital and physical/chemical traces are complementary to

  17. Collaborative Behavioral Management for Drug-Involved Parolees: Rationale and Design of the Step'n Out Study

    Science.gov (United States)

    Friedmann, Peter D.; Katz, Elizabeth C.; Rhodes, Anne G.; Taxman, Faye S.; O'Connell, Daniel J.; Frisman, Linda K.; Burdon, William M.; Fletcher, Bennett W.; Litt, Mark D.; Clarke, Jennifer; Martin, Steven S.

    2008-01-01

    This article describes the rationale, study design, and implementation for the Step'n Out study of the Criminal Justice Drug Abuse Treatment Studies. Step'n Out tests the relative effectiveness of collaborative behavioral management of drug-involved parolees. Collaborative behavioral management integrates the roles of parole officers and treatment…

  18. Drug Education Based on a Knowledge, Attitude, and Experience Study

    Science.gov (United States)

    Grant, John A.

    1971-01-01

    Results of a questionnaire concerning factual knowledge of attitudes toward, and experience with a variety of drugs are reported. It was concluded that marihuana and other drugs are readily available to secondary school students, and widespread experimentation exists; however, a strict dichotomy exists between marihuana and other drugs. (Author/BY)

  19. METHODOLOGY OF DOMESTIC STUDIES OF MEDICINAL DRUGS NEED AND THEIR CONSUMPTION

    Directory of Open Access Journals (Sweden)

    N. B. Dryomova

    2015-01-01

    Full Text Available At the current development stage of Russian healthcare rational use of limited financial resources for the fullest satisfaction of population's need in medicinal drugs acquires a special importance. Therefore, the issue about knowledge of experts in determination of need in drugs and evaluation of the consumption, as well as methods applied for these scientific and practical tasks resolution has a critical character. The purpose of our work is to characterize the development of research methodology of medicinal drugs need and their consumption in Russia. We have revealed the dynamics and tendencies of analyzed scientific direction development, leading scientists, principal methods, and study objects using scientometric methods of content-analysis and scientific works calculation (dissertations autoab-stracts. We have established the fact of significant change of methodology beginning with 2000 comparing with a period 1970-1980s. According to authors' opinion this was conditioned by objective need in problem solving connected with pharmaceutical support in the frameworks of state guarantees.

  20. The impact of legislation on drug substances used off-label in paediatric wards--a nationwide study.

    Science.gov (United States)

    Haslund-Krog, Sissel; Mathiasen, René; Christensen, Hanne Rolighed; Holst, Helle

    2014-04-01

    This nationwide study is aimed at describing to what extent the European Paediatric Regulation has met therapeutic needs in children. Data for each drug substance in defined daily doses (DDD) were extracted from the national Danish data base. We evaluated if drug substances were used off-label and whether they had a paediatric investigation plan (PIP). This study did not include drug prescriptions for individual paediatric patients; thus, it was not possible to make use of all off-label categories previously used. Additionally, paediatric standard assortments (SA) were compared to the European survey on paediatric medicinal products. Thirteen percent of the 100 most used drug substances were determined as being used off-label, four of which had a PIP and one had a full waiver. Only one of the three drug substances used off-label most often, accounting for 85 % of such use, had a PIP. Neonates were included in one-third of PIPs and adolescents in 15. Nineteen out of 21 PIPs had a waiver and 14 PIPs were deferred. In line with the European survey, carbapenems, corticosteroids and proton pump inhibitors were frequent found in SAs. PIPs only cover a small proportion of the drugs found to be used off-label in this study. Despite waivers granted, drug substances were used nonetheless. Unmet regulatory needs are still considerable in some therapeutic areas in neonates as well as in children.

  1. [A prospective study of drug-facilitated sexual assault in Barcelona].

    Science.gov (United States)

    Xifró-Collsamata, Alexandre; Pujol-Robinat, Amadeo; Barbería-Marcalain, Eneko; Arroyo-Fernández, Amparo; Bertomeu-Ruiz, Antonia; Montero-Núñez, Francisco; Medallo-Muñiz, Jordi

    2015-05-08

    To determine the frequency and characteristics of suspected drug-facilitated sexual assault (DFSA) among the victims of sexual assault in Barcelona. Prospective study of every adult consulting an emergency service because of alleged sexual assault and receiving forensic assessment in the city of Barcelona in 2011. A total of 35 of 114 cases (30.7%) met suspected DFSA criteria. Compared with the other victims, suspected DFSA cases were more likely to experience amnesia, to have been assaulted by night, after a social situation and by a recently acquainted man, to have used alcohol before the assault and to be foreigners. In this group ethanol was detected in blood or urine in 48.4% of analyzed cases; their mean back calculated blood alcohol concentration was 2.29g/l (SD 0.685). Also, at least one central nervous system drug other than ethanol was detected in 60,6%, mainly stimulant drugs of abuse. Suspected DFSA is frequent among victims of alleged sexual assault in Barcelona nowadays. The depressor substance most commonly encountered is alcohol, which contributes to victims' vulnerability. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

  2. Cannabis as a substitute for prescription drugs – a cross-sectional study

    Science.gov (United States)

    Corroon, James M; Mischley, Laurie K; Sexton, Michelle

    2017-01-01

    Background The use of medical cannabis is increasing, most commonly for pain, anxiety and depression. Emerging data suggest that use and abuse of prescription drugs may be decreasing in states where medical cannabis is legal. The aim of this study was to survey cannabis users to determine whether they had intentionally substituted cannabis for prescription drugs. Methods A total of 2,774 individuals were a self-selected convenience sample who reported having used cannabis at least once in the previous 90 days. Subjects were surveyed via an online anonymous questionnaire on cannabis substitution effects. Participants were recruited through social media and cannabis dispensaries in Washington State. Results A total of 1,248 (46%) respondents reported using cannabis as a substitute for prescription drugs. The most common classes of drugs substituted were narcotics/opioids (35.8%), anxiolytics/benzodiazepines (13.6%) and antidepressants (12.7%). A total of 2,473 substitutions were reported or approximately two drug substitutions per affirmative respondent. The odds of reporting substituting were 4.59 (95% confidence interval [CI], 3.87–5.43) greater among medical cannabis users compared with non-medical users and 1.66 (95% CI, 1.27–2.16) greater among those reporting use for managing the comorbidities of pain, anxiety and depression. A slightly higher percentage of those who reported substituting resided in states where medical cannabis was legal at the time of the survey (47% vs. 45%, p=0.58), but this difference was not statistically significant. Discussion These patient-reported outcomes support prior research that individuals are using cannabis as a substitute for prescription drugs, particularly, narcotics/opioids, and independent of whether they identify themselves as medical or non-medical users. This is especially true if they suffer from pain, anxiety and depression. Additionally, this study suggests that state laws allowing access to, and use of, medical

  3. Understanding drugs in breast cancer through drug sensitivity screening.

    Science.gov (United States)

    Uhr, Katharina; Prager-van der Smissen, Wendy J C; Heine, Anouk A J; Ozturk, Bahar; Smid, Marcel; Göhlmann, Hinrich W H; Jager, Agnes; Foekens, John A; Martens, John W M

    2015-01-01

    With substantial numbers of breast tumors showing or acquiring treatment resistance, it is of utmost importance to develop new agents for the treatment of the disease, to know their effectiveness against breast cancer and to understand their relationships with other drugs to best assign the right drug to the right patient. To achieve this goal drug screenings on breast cancer cell lines are a promising approach. In this study a large-scale drug screening of 37 compounds was performed on a panel of 42 breast cancer cell lines representing the main breast cancer subtypes. Clustering, correlation and pathway analyses were used for data analysis. We found that compounds with a related mechanism of action had correlated IC50 values and thus grouped together when the cell lines were hierarchically clustered based on IC50 values. In total we found six clusters of drugs of which five consisted of drugs with related mode of action and one cluster with two drugs not previously connected. In total, 25 correlated and four anti-correlated drug sensitivities were revealed of which only one drug, Sirolimus, showed significantly lower IC50 values in the luminal/ERBB2 breast cancer subtype. We found expected interactions but also discovered new relationships between drugs which might have implications for cancer treatment regimens.

  4. Biological studies of matrix metalloproteinase sensitive drug delivery systems

    DEFF Research Database (Denmark)

    Johansen, Pia Thermann

    due to severe side effects as a result of drug distribution to healthy tissues. To enhance ecacy of treatment and improve life quality of patients, tumor specific drug delivery strategies, such as liposome encapsulated drugs, which accumulate in tumor tissue, has gained increased attention. Several....... The system exploits the increased MMP-2 activity present in tumor tissue as a site-specific trigger of liposomal activation and controlled drug release after accumulation due to the enhanced permeability and retention effect. Enzymatic activity of MMP-2 results in shedding of a novel PEG coating, consisting...... of a negatively charged lipopeptide-PEG conjugates containing a MMP-2 cleavable peptide, which leads to cationic liposomes with enhanced ability to interact with negatively charged cell membranes. Activation of the liposomal formulation developed here resulted in enhanced association of liposomes with cancer...

  5. Suspected Lonely Mouse Syndrome as a Cage Effect in a Drug Safety Study.

    Science.gov (United States)

    Ye, Xiaobu; Itzoe, MariaLisa; Sarabia-Estrada, Rachel; DeTolla, Louis; Tyler, Betty M; Guarnieri, Michael

    2018-01-01

    Studies have demonstrated that buprenorphine, a front line drug for veterinary analgesia, may alleviate symptoms of chronic pain. A cage side observation protocol was used to record behavioral signs in a mouse clinical trial of extended release buprenorphine. A retrospective review of the observations for signs of pain and stress revealed that mice given a fivefold overdose of buprenorphine (16.25 mg/kg) showed lethargy and facial signs associated with stress. However, similar signs were observed in the drug-free control mice as early as Day 3 of single-cage housing. This appears to be the first report of cage effects in a clinical trial for a veterinary drug.

  6. Glutamatergic transmission in drug reward: Implications for drug addiction

    Directory of Open Access Journals (Sweden)

    Manoranjan S Dsouza

    2015-11-01

    Full Text Available Individuals addicted to drugs of abuse such as alcohol, nicotine, cocaine, and heroin are a significant burden on healthcare systems all over the world. The positive reinforcing (rewarding effects of the above mentioned drugs play a major role in the initiation and maintenance of the drug-taking habit. Thus, understanding the neurochemical mechanisms underlying the reinforcing effects of drugs of abuse is critical to reducing the burden of drug addiction in society. Over the last two decades, there has been an increasing focus on the role of the excitatory neurotransmitter glutamate in drug addiction. In this review, pharmacological and genetic evidence supporting the role of glutamate in mediating the rewarding effects of the above described drugs of abuse will be discussed. Further, the review will discuss the role of glutamate transmission in two complex heterogeneous brain regions, namely the nucleus accumbens (NAcc and the ventral tegmental area (VTA, which mediate the rewarding effects of drugs of abuse. In addition, several medications approved by the Food and Drug Administration that act by blocking glutamate transmission will be discussed in the context of drug reward. Finally, this review will discuss future studies needed to address currently unanswered gaps in knowledge, which will further elucidate the role of glutamate in the rewarding effects of drugs of abuse.

  7. Labor Migration, Drug Trafficking Organizations, and Drug Use: Major Challenges for Transnational Communities in Mexico

    Science.gov (United States)

    González, Laura

    2009-01-01

    In our article, we present the recent findings of our ethnographic field study on drug use and the emergence of a drug use culture in transnational communities in Mexico. Transnational communities are part of a larger migratory labor circuit that transcends political borders and are not restricted to a single locality. Transnational migrants and returning immigrants link the multiple localities through their social networks. In southern Guanajuato, Mexico, using a transnational migration paradigm, we examined the manner in which transnational migration and drug trafficking organizations are contributing to a growing drug problem in these communities. We found that transnational migrants and returning immigrants, including deported workers, introduce drugs and drug use practices, and contribute to the creation of a drug use culture within the communities. The social conditions in the community that foster and proliferate drug use are many: the erosion of the traditional family, truncated kinship bases, and new social formations. These conditions are all consequences of migration and emigration. Recent drug cartel activities are also contributing to this growing drug problem. The cartels have aggressively targeted these communities because of availability of money, existing drug use, a drug use culture, and the breakdown of traditional deterrents to substance abuse. Although a number of communities in three municipalities were part of our study, we focus on two: Lindavista, a rancho, Progreso, a municipal seat. Our field study in Mexico, one of four sequential ethnographic field studies conducted in Guanajuato and Pennsylvania, was completed over a six month period, from September, 2008, through February, 2009, using traditional ethnography. The four field studies are part of a larger, ongoing, three-year bi-national study on drug use among transnational migrants working in southeastern Pennsylvania. This larger study, near its third and final year, is funded by the

  8. Variational finite element method to study the absorption rate of drug ...

    African Journals Online (AJOL)

    M.A. Khanday

    2014-11-25

    Nov 25, 2014 ... ematical transport models describing the release of drug from various delivery systems and ... numerical simulations to describe the pharmacokinetics of ... studied the diffusion of heat and mass in biological tissues particularly ...

  9. A Qualitative and Quantitative Assay to Study DNA/Drug Interaction ...

    African Journals Online (AJOL)

    Research Article. A Qualitative and Quantitative Assay to Study. DNA/Drug Interaction Based on Sequence Selective. Inhibition of Restriction Endonucleases. Syed A Hassan1*, Lata Chauhan2, Ritu Barthwal2 and Aparna Dixit3. 1 Faculty of Computing and Information Technology, King Abdul Aziz University, Rabigh-21911 ...

  10. Patterns of drug use among a sample of drug users and injecting drug users attending a General Practice in Iran

    Directory of Open Access Journals (Sweden)

    Shakeshaft Anthony

    2006-01-01

    Full Text Available Abstract Aim This study aimed to examine drug use, drug treatment history and risk behaviour among a sample of Iranian drug users seeking treatment through a general practice clinic in Iran. Methods Review of medical records and an intake questionnaire at a large general practice in Marvdasht, Iran, with a special interest in drug dependence treatment. Records from a random sample of injecting drug users (IDU, non-injecting drug users (DU and non-drug using patients were examined. Results 292 records were reviewed (34% IDU, 31% DU and 35% non-drug users. Eighty-three percent were males; all females were non-drug users. The mean age of the sample was 30 years. Of the IDU sample, 67% reported sharing a needle or syringe, 19% of these had done so in prison. Of those who had ever used drugs, being 'tired' of drug use was the most common reason for seeking help (34%. Mean age of first drug use was 20 years. The first drugs most commonly used were opium (72%, heroin (13% and hashish/ other cannabinoids (13%. Three quarters reported having previously attempted to cease their drug use. IDU were more likely than DU to report having ever been imprisoned (41% vs 7% and 41% to have used drugs in prison. Conclusion This study has shown that there is a need for general practice clinics in Iran to treat drug users including those who inject and that a substantial proportion of those who inject have shared needles and syringes, placing them at risk of BBVI such as HIV and hepatitis C. The expansion of services for drug users in Iran such as needle and syringe programs and pharmacotherapies are likely to be effective in reducing the harms associated with opium use and heroin injection.

  11. Adverse drug reactions induced by cardiovascular drugs in outpatients

    Directory of Open Access Journals (Sweden)

    Gholami K

    2008-03-01

    Full Text Available Considering increased use of cardiovascular drugs and limitations in pre-marketing trials for drug safety evaluation, post marketing evaluation of adverse drug reactions (ADRs induced by this class of medicinal products seems necessary.Objectives: To determine the rate and seriousness of adverse reactions induced by cardiovascular drugs in outpatients. To compare sex and different age groups in developing ADRs with cardiovascular agents. To assess the relationship between frequencies of ADRs and the number of drugs used. Methods: This cross-sectional study was done in cardiovascular clinic at a teaching hospital. All patients during an eight months period were evaluated for cardiovascular drugs induced ADRs. Patient and reaction factors were analyzed in detected ADRs. Patients with or without ADRs were compared in sex and age by using chi-square test. Assessing the relationship between frequencies of ADRs and the number of drugs used was done by using Pearson analysis. Results: The total number of 518 patients was visited at the clinic. ADRs were detected in 105 (20.3% patients. The most frequent ADRs were occurred in the age group of 51-60. The highest rate of ADRs was recorded to be induced by Diltiazem (23.5% and the lowest rate with Atenolol (3%. Headache was the most frequent detected ADR (23%. Assessing the severity and preventability of ADRs revealed that 1.1% of ADRs were detected as severe and 1.9% as preventable reactions. Women significantly developed more ADRs in this study (chi square = 3.978, P<0.05. ADRs more frequently occurred with increasing age in this study (chi square = 15.871, P<0.05. With increasing the number of drugs used, the frequency of ADRs increased (Pearson=0.259, P<0.05. Conclusion: Monitoring ADRs in patients using cardiovascular drugs is a matter of importance since this class of medicines is usually used by elderly patients with critical conditions and underlying diseases.

  12. Drug use in business bathrooms: An exploratory study of manager encounters in New York City

    Science.gov (United States)

    Wolfson-Stofko, Brett; Bennett, Alex S.; Elliott, Luther; Curtis, Ric

    2017-01-01

    Background Though public bathroom drug injection has been documented from the perspective of people who inject drugs, no research has explored the experiences of the business managers who oversee their business bathrooms and respond to drug use. These managers, by default, are first-responders in the event of a drug overdose and thus of intrinsic interest during the current epidemic of opioid-related overdoses in the United States. This exploratory study assists in elucidating the experiences that New York City business managers have with people who inject drugs, their paraphernalia, and their overdoses. Methods A survey instrument was designed to collect data on manager encounters with drug use occurring in their business bathrooms. Recruitment was guided by convenience and purposive approaches. Results More than half of managers interviewed (58%, n = 50/86) encountered drug use in their business bathrooms, more than a third (34%) of these managers also found syringes, and the vast majority (90%) of managers had received no overdose recognition or naloxone training. Seven managers encountered unresponsive individuals who required emergency assistance. Conclusion The results from this study underscore the need for additional research on the experiences that community stakeholders have with public injection as well as educational outreach efforts among business managers. This research also suggests that there is need for a national dialogue about potential interventions, including expanded overdose recognition and naloxone training and supervised injection facilities (SIF)/drug consumption rooms (DCR), that could reduce public injection and its associated health risks. PMID:27768996

  13. Hybrid nanostructured drug carrier with tunable and controlled drug release

    International Nuclear Information System (INIS)

    Depan, D.; Misra, R.D.K.

    2012-01-01

    We describe here a transformative approach to synthesize a hybrid nanostructured drug carrier that exhibits the characteristics of controlled drug release. The synthesis of the nanohybrid architecture involved two steps. The first step involved direct crystallization of biocompatible copolymer along the long axis of the carbon nanotubes (CNTs), followed by the second step of attachment of drug molecule to the polymer via hydrogen bonding. The extraordinary inorganic–organic hybrid architecture exhibited high drug loading ability and is physically stable even under extreme conditions of acidic media and ultrasonic irradiation. The temperature and pH sensitive characteristics of the hybrid drug carrier and high drug loading ability merit its consideration as a promising carrier and utilization of the fundamental aspects used for synthesis of other promising drug carriers. The higher drug release response during the application of ultrasonic frequency is ascribed to a cavitation-type process in which the acoustic bubbles nucleate and collapse releasing the drug. Furthermore, the study underscores the potential of uniquely combining CNTs and biopolymers for drug delivery. - Graphical abstract: Block-copolymer crystallized on carbon nanotubes (CNTs). Nanohybrid drug carrier synthesized by attaching doxorubicin (DOX) to polymer crystallized CNTs. Crystallized polymer on CNTs provide mechanical stability. Triggered release of DOX. Highlights: ► The novel synthesis of a hybrid nanostructured drug carrier is described. ► The drug carrier exhibits high drug loading ability and is physically stable. ► The high drug release is ascribed to a cavitation-type process.

  14. The role of drug profiles as similarity metrics: applications to repurposing, adverse effects detection and drug-drug interactions.

    Science.gov (United States)

    Vilar, Santiago; Hripcsak, George

    2017-07-01

    Explosion of the availability of big data sources along with the development in computational methods provides a useful framework to study drugs' actions, such as interactions with pharmacological targets and off-targets. Databases related to protein interactions, adverse effects and genomic profiles are available to be used for the construction of computational models. In this article, we focus on the description of biological profiles for drugs that can be used as a system to compare similarity and create methods to predict and analyze drugs' actions. We highlight profiles constructed with different biological data, such as target-protein interactions, gene expression measurements, adverse effects and disease profiles. We focus on the discovery of new targets or pathways for drugs already in the pharmaceutical market, also called drug repurposing, in the interaction with off-targets responsible for adverse reactions and in drug-drug interaction analysis. The current and future applications, strengths and challenges facing all these methods are also discussed. Biological profiles or signatures are an important source of data generation to deeply analyze biological actions with important implications in drug-related studies. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  15. Application of chimeric mice with humanized liver for study of human-specific drug metabolism.

    Science.gov (United States)

    Bateman, Thomas J; Reddy, Vijay G B; Kakuni, Masakazu; Morikawa, Yoshio; Kumar, Sanjeev

    2014-06-01

    Human-specific or disproportionately abundant human metabolites of drug candidates that are not adequately formed and qualified in preclinical safety assessment species pose an important drug development challenge. Furthermore, the overall metabolic profile of drug candidates in humans is an important determinant of their drug-drug interaction susceptibility. These risks can be effectively assessed and/or mitigated if human metabolic profile of the drug candidate could reliably be determined in early development. However, currently available in vitro human models (e.g., liver microsomes, hepatocytes) are often inadequate in this regard. Furthermore, the conduct of definitive radiolabeled human ADME studies is an expensive and time-consuming endeavor that is more suited for later in development when the risk of failure has been reduced. We evaluated a recently developed chimeric mouse model with humanized liver on uPA/SCID background for its ability to predict human disposition of four model drugs (lamotrigine, diclofenac, MRK-A, and propafenone) that are known to exhibit human-specific metabolism. The results from these studies demonstrate that chimeric mice were able to reproduce the human-specific metabolite profile for lamotrigine, diclofenac, and MRK-A. In the case of propafenone, however, the human-specific metabolism was not detected as a predominant pathway, and the metabolite profiles in native and humanized mice were similar; this was attributed to the presence of residual highly active propafenone-metabolizing mouse enzymes in chimeric mice. Overall, the data indicate that the chimeric mice with humanized liver have the potential to be a useful tool for the prediction of human-specific metabolism of xenobiotics and warrant further investigation.

  16. Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies

    Science.gov (United States)

    Prugger, Christof; Doshi, Peter; Ostrowski, Kerstin; Witte, Thomas; Hüsgen, Dieter; Keil, Ulrich

    2017-01-01

    Objectives To investigate the practice of post-marketing studies in Germany during a three year period and to evaluate whether these trials meet the aims specified in the German Medicinal Products Act. Design Survey of notifications submitted to German regulatory agencies before post-marketing studies were carried out, 2008-10. Setting Notifications obtained through freedom of information requests to the three authorities responsible for registering post-marketing studies in Germany. Main outcome measures Descriptive statistics of post-marketing studies, including the products under study, intended number of patients, intended number of participating physicians, proposed remunerations, study plan and protocol, and availability of associated scientific publications and reports on adverse drug reactions. Results Information was obtained from 558 studies, with a median of 600 (mean 2331, range 2-75 000) patients and 63 (270, 0-7000) participating physicians per study. The median remuneration to physicians per patient was €200 (€441, €0-€7280) (£170, £0-£6200; $215, $0-$7820), with a total remuneration cost of more than €217m for 558 studies registered over the three year period. The median remuneration per participating physician per study was €2000 (mean €19 424), ranging from €0 to €2 080 000. There was a broad range of drugs and non-drug products, of which only a third represented recently approved drugs. In many notifications, data, information, and results were, by contract, strictly confidential and the sole property of the respective sponsor. No single adverse drug reaction report could be identified from any of the 558 post-marketing studies. Less than 1% of studies could be verified as published in scientific journals. Conclusions Post-marketing studies are not improving drug safety surveillance. Sample sizes are generally too small to allow the detection of rare adverse drug reactions, and many participating physicians are

  17. Impact of online counseling on drug use: a pilot study.

    Science.gov (United States)

    Alemi, Farrokh; Haack, Mary; Nemes, Susie; Harge, Angela; Baghi, Heibatollah

    2010-01-01

    To examine the effect of online counseling abuse counseling on drug use among underserved patients. Subjects were recruited from an Indian Reservation in Eagle Butte, South Dakota; a family court in Newark, New Jersey; a probation office in Alexandria, Virginia; and a co-occurring disorders treatment clinic in Washington, District of Columbia. Subjects were predominantly poor, undereducated, unemployed, court involved, or diagnosed with co-occurring psychiatric disorders. A total of 79 subjects volunteered to participate in the project. Subjects were randomly assigned to either a control group or an experimental group. The control and experimental groups were both issued an Internet-ready computer and 1 year of Internet service. Only the experimental group had access to online counseling intervention. Drug use was measured using a combination of self-usage reporting and supervised urine tests. Urine tests were available for 37% of subjects. Exit surveys containing self-reported usage were obtained from 54% of the subjects. Self-usage reports or urine test results were available from 70% of subjects. The difference of the rates of drug use in the control and experimental groups (as calculated from urine tests or through self-report) was not significantly different from zero, suggesting that online counseling had not led to a reduction in substance use. It is possible that the study lacked sufficient power to detect small differences in the rate of drug use in the experimental and control groups. Additional research is needed to establish the efficacy of online counseling in hard-to-reach populations.

  18. Drug abuse identification and pain management in dental patients: a case study and literature review.

    Science.gov (United States)

    Hussain, Fahmida; Frare, Robert W; Py Berrios, Karen L

    2012-01-01

    Properly identifying patients with a history of drug abuse is the first step in providing effective dental care. Dental professionals need to be fully aware of the challenges associated with treating this population. In the current study, the authors analyzed the physical and oral manifestations of illicit drug abuse to aid in the identification of patients who abuse drugs and the pain management strategies needed to treat them. The authors also present a clinical case of a patient with unique skin lesions and discuss the typical clinical findings of drug abuse based on a literature review.

  19. Predictors of injection drug use cessation and relapse in a prospective cohort of young injection drug users in San Francisco, CA (UFO Study).

    Science.gov (United States)

    Evans, Jennifer L; Hahn, Judith A; Lum, Paula J; Stein, Ellen S; Page, Kimberly

    2009-05-01

    Studies of injection drug use cessation have largely sampled adults in drug treatment settings. Little is known about injection cessation and relapse among young injection drug users (IDU) in the community. A total of 365 HCV-negative IDU under age 30 years were recruited by street outreach and interviewed quarterly for a prospective cohort between January 2000 and February 2008. Participants were followed for a total of 638 person-years and 1996 visits. We used survival analysis techniques to identify correlates of injection cessation (> or =3 months) and relapse to injection. 67% of subjects were male, median age was 22 years (interquartile range (IQR) 20-26) and median years injecting was 3.6 (IQR 1.3-6.5). 28.8% ceased injecting during the follow-up period. Among those that ceased injecting, nearly one-half resumed drug injection on subsequent visits, one-quarter maintained injecting cessation, and one-quarter were lost to follow-up. Participating in a drug treatment program in the last 3 months and injecting less than 30 times per month were associated with injection cessation. Injecting heroin or heroin mixed with other drugs, injecting the residue from previously used drug preparation equipment, drinking alcohol, and using benzodiazepines were negatively associated with cessation. Younger age was associated with relapse to injection. These results suggest that factors associated with stopping injecting involve multiple areas of intervention, including access to drug treatment and behavioral approaches to reduce injection and sustain cessation. The higher incidence of relapse in the younger subjects in this cohort underscores the need for earlier detection and treatment programs targeted to adolescents and transition-age youth.

  20. The Relationship of Students' Awareness on Drug Policy, Procedures, and Intervention Programs to the Drug and Alcohol Use on College Campuses: A Correlational Study

    Science.gov (United States)

    Love-Quick, Sharon J.

    2016-01-01

    One of the most pressing concerns that universities and colleges face today is the drug and alcohol abuse of students. In order to address this, there is a need to strengthen university policies in order to mitigate the increasing rate and cases of drug and alcohol abuse among students. The purpose of this quantitative study was to examine the…

  1. A Qualitative and Quantitative Assay to Study DNA/Drug Interaction ...

    African Journals Online (AJOL)

    Purpose: To explore the use of restriction inhibition assay (RIA) to study the binding specificity of some anticancer drugs. Methods: A 448 bp DNA fragment derived from pBCKS+ plasmid (harboring the polylinker region with multiple restriction endonuclease sites) was used as a template for sequence selective inhibition of ...

  2. Variational finite element method to study the absorption rate of drug ...

    African Journals Online (AJOL)

    M.A. Khanday

    2014-11-25

    Nov 25, 2014 ... Abstract Background: The delivery of drugs through dermal layers known as transdermal ... number of factors which includes the physio-co-chemical prop- ..... 9. Kumari B, Adlakha N. One dimensional model to study the effect.

  3. Injecting Drug Users and Their Health Seeking Behavior: A Cross-Sectional Study in Dhaka, Bangladesh

    Directory of Open Access Journals (Sweden)

    Sheikh Mohammed Shariful Islam

    2015-01-01

    Full Text Available Introduction and Aim. Injecting drug users (IDUs are amongst the most vulnerable people to acquisition of HIV/AIDS. This study aims to collect information on IDUs and their health seeking behavior in Bangladesh. Design and Methods. A cross-sectional study was conducted among 120 IDUs attending a drug rehabilitation center in Dhaka, Bangladesh. Data were collected on sociodemographics, drug use, health seeking behavior, knowledge of injecting drugs, and sexual behavior. Results. The mean ± SD and median (IQR age of the participants were 32.5±21.3 and 33 (27–38 years, respectively, with only 9.2% females. Injection buprenorphine was the drug of choice for 40% of participants, and 58% of the participants first started drug use with smoking cannabis. 73.3% of participants shared needles sometimes and 57.5% were willing to use the needle exchange programs. 60% of the participants had no knowledge about the diseases spread by injection. Condom use during the last intercourse with regular partners was 11.7% and with any partners 15.8%. Conclusion. IDUs in Bangladesh are a high-risk group for HIV/AIDS due to lack of knowledge and risky behaviors. Education and interventions specifically aimed at IDUs are needed, because traditional education may not reach IDUs or influence their behavior.

  4. Maturing Out: An empirical study of personal histories and processes in hard-drug addiction

    NARCIS (Netherlands)

    E.H. Prins

    1995-01-01

    textabstractEver since the fiftieth, the sixtieth and the seventieth, the time I worked and studied in the United States, I developed an interest in the fate of the many drug addicts I met there. What struck me particularly was the fact that these drug addicts were almost always quite young. In

  5. Lung and heart pathology in fatal drug addiction. A consecutive autopsy study.

    Science.gov (United States)

    Kringsholm, B; Christoffersen, P

    1987-01-01

    Lung and heart sections from 33 drug addicts submitted for medico-legal autopsy at the Institute of Forensic Medicine in Copenhagen were studied together with tissue sections from 20 'normal' persons. In the drug addict cases focal bleedings in lung tissue were found in 94%, signs of earlier bleedings, haemosiderin containing histiocytes, were seen in 91%, and focal fibrosis in 46%. The bleeding episodes may be due to hypoxia in connection with heroin intake. In 94% of the drug addicts birefringent material in lung tissue was demonstrated, in 58% in granulomas and giant cells, in 27% in giant cells only and in 9% in isolated histiocytes. The material was localized in the wall of pulmonar arteries and/or in the interstitial tissue, undoubtedly depending on the duration of the abuse. In 18% angiothrombosis was seen, in all cases granulomas/giant cells were observed in the wall of the vessel concerned. The results indicate periodical intravenous injection of dissolved tablets in addition to heroin. Histological signs of pulmonary hypertension were not seen, possibly due to the fact that abuse of central stimulants is very rare in Denmark. Regarding heart alterations no significant differences were demonstrated between drug addicts and controls. The only note-worthy finding was focal infiltration of lymphocytes in the atrio-ventricular bundle in two drug addicts, the meaning of which is uncertain.

  6. Forensic drug intelligence and the rise of cryptomarkets. Part I: Studying the Australian virtual market.

    Science.gov (United States)

    Broséus, Julian; Morelato, Marie; Tahtouh, Mark; Roux, Claude

    2017-10-01

    Analysing and understanding cryptomarkets is essential to become proactive in the fight against the illicit drug trade. Such a research seeks to combine a diversity of indicators related to the virtual (darknet markets) and physical (the traditional "offline" market) aspects of the illicit drug trade to provide information on the distribution and consumption as well as to assess similarities/differences between the virtual and physical markets. This study analysed data that had previously been collected on cryptomarkets from December 2013 to March 2015. In this article, the data was extracted from two marketplaces, Evolution and Silk Road 2, and analysed to evaluate the illicit drug trade of the Australian virtual market (e.g. information about the supply and demand, trafficking flows, prices of illicit drugs and market share) and highlight its specificities. The results revealed the domestic nature of the virtual Australian illicit drug trade (i.e. Australian sellers essentially ship their products to local customers). This may explain the coherence between supply and demand. Particularly, the virtual Australian illicit drug trade is dominated by amphetamine-type substances (ATS), mainly methamphetamine and 3,4-methylenedioxymethamphetamine (MDMA), and cannabis. Australia, as a shipping country, accounts for half of the methamphetamine offered and purchased on Silk Road 2. Moreover, it was observed that the online price fixed by Australian sellers for the considered illicit drugs is higher than for any other shipping countries, which is in line with previous studies. Understanding the virtual and physical drug market necessitates the integration and fusion of different perspectives to capture the dynamic nature of drug trafficking, monitor its evolution and finally improve our understanding of the phenomenon so policy makers can make informed decisions. Copyright © 2017 Elsevier B.V. All rights reserved.

  7. Scientific perspectives on extending the provision for waivers of in vivo bioavailability and bioequivalence studies for drug products containing high solubility-low permeability drugs (BCS-Class 3).

    Science.gov (United States)

    Stavchansky, Salomon

    2008-06-01

    Recently, there has been increased interest in extending the provision for waivers of in vivo bioavailability and bioequivalence (BA-BE) studies that appeared in the guidance published by the Food and Drug Administration (FDA) (1) to pharmaceutical products containing Class 3 drugs (High solubility-Low Permeability). The extension of the Biopharmaceutics Classification System (BCS) to Class 3 drugs is meritorious because of its impact on public health policy considerations. The rate limiting step in the absorption of Class 3 drugs is the permeability through the intestinal membrane. This commentary will focus its attention on the scientific considerations which need to be examined to assess the risk and the benefit prior to granting a waiver of in vivo bioavailability and/or bioequivalence studies for Class 3 drugs. It will examine the forces affecting the interconnectivity of the neuronal, immunological and hormonal systems in the gastrointestinal tract that may affect its permeability and functionality. It will also challenge the assumption that in vitro dissolution and in vitro permeability studies in tissue cultures in the presence and absence of excipients are good predictors for in vivo dissolution and in vivo permeability which are at the heart of the BCS.

  8. Adverse Drug Reactions Related to Drug Administration in Hospitalized Patients.

    Science.gov (United States)

    Gallelli, Luca; Siniscalchi, Antonio; Palleria, Caterina; Mumoli, Laura; Staltari, Orietta; Squillace, Aida; Maida, Francesca; Russo, Emilio; Gratteri, Santo; De Sarro, Giovambattista

    2017-01-01

    Drug treatment may be related to the development of adverse drug reactions (ADRs). In this paper, we evaluated the ADRs in patients admitted to Catanzaro Hospital. After we obtained the approval by local Ethical Committee, we performed a retrospective study on clinical records from March 01, 2013 to April 30, 2015. The association between drug and ADR or between drug and drug-drug-interactions (DDIs) was evaluated using the Naranjo's probability scale and Drug Interaction Probability Scale (DIPS), respectively. During the study period, we analyzed 2870 clinical records containing a total of 11,138 prescriptions, and we documented the development of 770 ADRs. The time of hospitalization was significantly higher (P<0.05) in women with ADRs (12.6 ± 1.2 days) with respect to men (11.8± 0.83 days). Using the Naranjo score, we documented a probable association in 78% of these reactions, while DIPS revealed that about 22% of ADRs were related to DDIs. Patients with ADRs received 3052 prescriptions on 11,138 (27.4%) having a mean of 6.1±0.29 drugs that was significantly higher (P<0.01) with respect to patients not experiencing ADRs (mean of 3.4±0.13 drugs). About 19% of ADRs were not diagnosed and were treated as new diseases. Our results indicate that drug administration induces the development of ADRs also during the hospitalization, particularly in elderly women. Moreover, we also documented that ADRs in some patients are under-diagnosed, therefore, it is important to motivate healthcare to report the ADRs in order to optimize the patients' safety. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  9. Design and mechanistic study of a novel gold nanocluster-based drug delivery system.

    Science.gov (United States)

    Li, Qinzhen; Pan, Yiting; Chen, Tiankai; Du, Yuanxin; Ge, Honghua; Zhang, Buchang; Xie, Jianping; Yu, Haizhu; Zhu, Manzhou

    2018-05-22

    Chemically-triggered drug delivery systems (DDSs) have been extensively studied as they do not require specialized equipment to deliver the drug and can deeply penetrate human tissue. However, their syntheses are complicated and they tend to be cytotoxic, which restricts their clinical utility. In this work, the self-regulated drug loading and release capabilities of peptide-protected gold nanoclusters (Pep-Au NCs) are investigated using vancomycin (Van) as the model drug. Gold nanoclusters (Au NCs) coated with a custom-designed pentapeptide are synthesized as drug delivery nanocarriers and loaded with Van - a spontaneous process reliant on the specific binding between Van and the custom-designed peptide. The Van-loaded Au NCs show comparable antimicrobial activity with Van on its own, and the number of Van released by the Pep-Au NCs is found to be proportional to the amount of bacteria present. The controlled nature of the Van release is very encouraging, and predominantly due to the stronger binding affinity of Van with bacteria than that with Au NCs. In addition, these fluorescent Au NCs could also be used to construct temperature sensors, which enable the in vitro and in vivo bioimaging.

  10. Suspected Lonely Mouse Syndrome as a Cage Effect in a Drug Safety Study

    Directory of Open Access Journals (Sweden)

    Xiaobu Ye

    2018-01-01

    Full Text Available Studies have demonstrated that buprenorphine, a front line drug for veterinary analgesia, may alleviate symptoms of chronic pain. A cage side observation protocol was used to record behavioral signs in a mouse clinical trial of extended release buprenorphine. A retrospective review of the observations for signs of pain and stress revealed that mice given a fivefold overdose of buprenorphine (16.25 mg/kg showed lethargy and facial signs associated with stress. However, similar signs were observed in the drug-free control mice as early as Day 3 of single-cage housing. This appears to be the first report of cage effects in a clinical trial for a veterinary drug.

  11. Risk of myocardial infarction in patients with HIV infection exposed to specific individual antiretroviral drugs from the 3 major drug classes: the data collection on adverse events of anti-HIV drugs (D:A:D) study

    DEFF Research Database (Denmark)

    Worm, Signe Westring; Sabin, Caroline; Weber, Rainer

    2010-01-01

    BACKGROUND. The risk of myocardial infarction (MI) in patients with human immunodeficiency virus (HIV) infection has been assessed in 13 anti-HIV drugs in the Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) study. METHODS. Poisson regression models were adjusted for cardiovascular risk...... factors, cohort, calendar year, and use of other antiretroviral drugs and assessed the association between MI risk and cumulative (per year) or recent (current or in the past 6 months) use of antiretroviral drugs, with >30,000 person-years of exposure. RESULTS. Over 178,835 person-years, 580 patients......% CI, 1.01-1.17], respectively) after adjustment for lipids but were not altered further after adjustment for other metabolic parameters. CONCLUSIONS. Of the drugs considered, only indinavir, lopinavir-ritonavir, didanosine, and abacavir were associated with a significantly increased risk of MI...

  12. A way for reducing drug supply chain cost for a hospital district: A case study

    OpenAIRE

    Leonardo Postacchini; Filippo Emanuele Ciarapica; Maurizio Bevilacqua; Giovanni Mazzuto; Claudia Paciarotti

    2016-01-01

    Purpose: This work aims at providing insights to optimise healthcare logistic of the drug management, in order to deal with the healthcare expenditure cut. In this paper the effects of different drug supply chain configurations, on the resulting average stock, service level and Bullwhip effect, of the studied supply chain, is quantitatively assessed. Design/methodology/approach: A case study of an Italian district has been studied, taking into account three echelons: suppliers, centra...

  13. Systemic barriers accessing HIV treatment among people who inject drugs in Russia: a qualitative study.

    Science.gov (United States)

    Sarang, Anya; Rhodes, Tim; Sheon, Nicolas

    2013-10-01

    Achieving 'universal access' to antiretroviral HIV treatment (ART) in lower income and transitional settings is a global target. Yet, access to ART is shaped by local social condition and is by no means universal. Qualitative studies are ideally suited to describing how access to ART is socially situated. We explored systemic barriers to accessing ART among people who inject drugs (PWID) in a Russian city (Ekaterinburg) with a large burden of HIV treatment demand. We undertook 42 in-depth qualitative interviews with people living with HIV with current or recent experience of injecting drug use. Accounts were analysed thematically, and supplemented here with an illustrative case study. Three core themes were identified: 'labyrinthine bureaucracy' governing access to ART; a 'system Catch 22' created by an expectation that access to ART was conditional upon treated drug use in a setting of limited drug treatment opportunity; and 'system verticalization', where a lack of integration across HIV, tuberculosis (TB) and drug treatment compromised access to ART. Taken together, we find that systemic factors play a key role in shaping access to ART with the potential adverse effects of reproducing treatment initiation delay and disengagement from treatment. We argue that meso-level systemic factors affecting access to ART for PWID interact with wider macro-level structural forces, including those related to drug treatment policy and the social marginalization of PWID. We note the urgent need for systemic and structural changes to improve access to ART for PWID in this setting, including to simplify bureaucratic procedures, foster integrated HIV, TB and drug treatment services, and advocate for drug treatment policy reform.

  14. Alcohol as a Gateway Drug: A Study of US 12th Graders

    Science.gov (United States)

    Kirby, Tristan; Barry, Adam E.

    2012-01-01

    Background: The Gateway Drug Theory suggests that licit drugs, such as tobacco and alcohol, serve as a "gateway" toward the use of other, illicit drugs. However, there remains some discrepancy regarding which drug--alcohol, tobacco, or even marijuana--serves as the initial "gateway" drug subsequently leading to the use of…

  15. Cumulative Vulnerability: A Case Study on intrafamilial violence, Drug Addiction and Adolescent Pregnancy.

    Science.gov (United States)

    Miura, Paula Orchiucci; Passarini, Gislaine Martins Ricardo; Ferreira, Loraine Seixas; Paixão, Rui Alexandre Paquete; Tardivo, Leila Salomão de La Plata Cury; Barrientos, Dora Mariela Salcedo

    2014-12-01

    A pregnant adolescent's vulnerability increases when she is a victim of intrafamilial violence and drug addiction, which cause physical and biopsychosocial damage to the mother and her baby. Objective Present and analyze the case of an adolescent who is addicted to drugs, pregnant and the victim of lifelong intrafamilial violence. Method A case study based on a semi-structured interview conducted in the Obstetrics Emergency Unit at the Teaching Hospital of the University of São Paulo. The data were interpreted and analyzed using Content Analysis. Results intrafamilial violence experienced at the beginning of the adolescent's early relationships seriously affected her emotional maturity, triggering the development of psychopathologies and leaving her more susceptible to the use and abuse of alcohol and other drugs. The adolescent is repeating her history with her daughter, reproducing the cycle of violence. Conclusion Adolescent pregnancy combined with intrafamilial violence and drug addiction and multiplies the adolescent's psychosocial vulnerability increased the adolescent's vulnerability.

  16. Cumulative Vulnerability: A Case Study on intrafamilial violence, Drug Addiction and Adolescent Pregnancy

    Directory of Open Access Journals (Sweden)

    Paula Orchiucci Miura

    2014-12-01

    Full Text Available A pregnant adolescent’s vulnerability increases when she is a victim of intrafamilial violence and drug addiction, which cause physical and biopsychosocial damage to the mother and her baby. Objective Present and analyze the case of an adolescent who is addicted to drugs, pregnant and the victim of lifelong intrafamilial violence. Method A case study based on a semi-structured interview conducted in the Obstetrics Emergency Unit at the Teaching Hospital of the University of São Paulo. The data were interpreted and analyzed using Content Analysis. Results intrafamilial violence experienced at the beginning of the adolescent’s early relationships seriously affected her emotional maturity, triggering the development of psychopathologies and leaving her more susceptible to the use and abuse of alcohol and other drugs. The adolescent is repeating her history with her daughter, reproducing the cycle of violence. Conclusion Adolescent pregnancy combined with intrafamilial violence and drug addiction and multiplies the adolescent’s psychosocial vulnerability increased the adolescent’s vulnerability.

  17. Drug-induced acute interstitial nephritis: A clinicopathological study and comparative trial of steroid regimens

    Directory of Open Access Journals (Sweden)

    R Ramachandran

    2015-01-01

    Full Text Available Steroids are used in the management of drug-induced acute interstitial nephritis (AIN. The present study was undertaken to compare the efficacy of pulse methyl prednisolone with oral prednisolone in the treatment of drug-induced AIN. Patients with biopsy-proven AIN with a history of drug intake were randomized to oral prednisolone (Group 1 1 mg/kg for 3 weeks or a pulse methyl prednisolone (Group II 30 mg/kg for 3 days followed by oral prednisolone 1 mg/kg for 2 weeks, tapered over 3 weeks. Kidney biopsy scoring was done for interstitial edema, infiltration and tubular damage. The response was reported as complete remission (CR (improvement in estimated glomerular filtration rate [eGFR] to ≥60 ml/min/1.73 m 2 , partial remission (PR (improvement but eGFR <60 ml/min/1.73 m 2 or resistance (no CR/PR. A total of 29 patients, Group I: 16 and Group II: 13 were studied. Offending drugs included nonsteroidal anti-inflammatory drugs, herbal drugs, antibiotics, diuretic, rifampicin and omeprazole. There was no difference in the baseline parameters between the two groups. The biopsy score in Groups I and II was 5.9 ΁ 1.1 and 5.1 ΁ 1.2, respectively. At 3 months in Group I, eight patients each (50% achieved CR and PR. In Group II, 8 (61% achieved CR and 5 (39% PR. This was not significantly different. Percentage fall in serum creatinine at 1 week (56% was higher in CR as compared to (42% those with PR. ( P = 0.14. Patients with neutrophil infiltration had higher CR compared to patients with no neutrophil infiltration ( P = 0.01. Early steroid therapy, both oral and pulse steroid, is equally effective in achieving remission in drug-induced AIN.

  18. Electrochemical studies of ropinirole, an anti-Parkinson's disease drug

    Indian Academy of Sciences (India)

    The oxidation behaviour of a potent anti-Parkinson's disease drug ropinirole hydrochloride was investigated over a wide pH range in aqueous solution at glassy carbon electrode using cyclic and square-wave voltammetry. The oxidation of drug is a pH dependent irreversible process and occurs in two steps.

  19. Pharmacotherapies for decreasing maladaptive choice in drug addiction: Targeting the behavior and the drug.

    Science.gov (United States)

    Perkins, Frank N; Freeman, Kevin B

    2018-01-01

    Drug addiction can be conceptualized as a disorder of maladaptive decision making in which drugs are chosen at the expense of pro-social, nondrug alternatives. The study of decision making in drug addiction has focused largely on the role of impulsivity as a facilitator of addiction, in particular the tendency for drug abusers to choose small, immediate gains over larger but delayed outcomes (i.e., delay discounting). A parallel line of work, also focused on decision making in drug addiction, has focused on identifying the determinants underlying the choice to take drugs over nondrug alternatives (i.e., drug vs. nondrug choice). Both tracks of research have been valuable tools in the development of pharmacotherapies for treating maladaptive decision making in drug addiction, and a number of common drugs have been studied in both designs. However, we have observed that there is little uniformity in the administration regimens of potential treatments between the designs, which hinders congruence in the development of single treatment strategies to reduce both impulsive behavior and drug choice. The current review provides an overview of the drugs that have been tested in both delay-discounting and drug-choice designs, and focuses on drugs that reduced the maladaptive choice in both designs. Suggestions to enhance congruence between the findings in future studies are provided. Finally, we propose the use of a hybridized, experimental approach that may enable researchers to test the effectiveness of therapeutics at decreasing impulsive and drug choice in a single design. Published by Elsevier Inc.

  20. Drugs@FDA: FDA Approved Drug Products

    Science.gov (United States)

    ... Cosmetics Tobacco Products Home Drug Databases Drugs@FDA Drugs@FDA: FDA Approved Drug Products Share Tweet Linkedin Pin it More sharing ... Download Drugs@FDA Express for free Search by Drug Name, Active Ingredient, or Application Number Enter at ...

  1. The study of direct-to-consumer advertising for prescription drugs.

    Science.gov (United States)

    Schommer, Jon C; Hansen, Richard A

    2005-06-01

    The objectives of this article are to (1) identify key methodological issues related to investigating the effects of direct-to-consumer advertising (DTCA) for prescription drugs, (2) highlight opportunities and challenges that these issues pose, and (3) provide suggestions to address these challenges and opportunities from a social and administrative pharmacy perspective. Through a review of existing literature and consultation with research colleagues, we identified 3 broad issues regarding the study of DTCA for prescription drugs: (1) the importance of problem formulation, (2) the role of health behavior and decision-making perspectives, and (3) data collection and data analysis challenges and opportunities. Based upon our findings, we developed recommendations for future research in this area. Clear problem formulation will be instructive for prioritizing research needs and for determining the role that health behavior and decision-making perspectives can serve in DTCA research. In addition, it appears that cluster bias, nonlinear relationships, mediating/moderating effects, time effects, acquiescent response, and case mix are particularly salient challenges for the DTCA research domain. We suggest that problem formulation, selection of sound theories upon which to base research, and data collection and data analysis challenges are key methodological issues related to investigating the effects of DTCA for prescription drugs.

  2. Drug-drug interactions among recently hospitalised patients--frequent but mostly clinically insignificant

    DEFF Research Database (Denmark)

    Glintborg, Bente; Andersen, Stig Ejdrup; Dalhoff, Kim

    2005-01-01

    OBJECTIVE: Patients use and store considerable amounts of drugs. The aim of the present study was to identify potential drug-drug interactions between drugs used by patients recently discharged from the hospital and, subsequently, to estimate the clinical implications of these interactions. METHODS......: Patients were visited within 1 week following their discharge from hospital and interviewed about their drug use. Stored products were inspected. We used a bibliography (Hansten and Horn; Wolters Kluwer Health, St. Louis, Mo., 2004) to identify and classify potential drug-drug interactions. RESULTS......: eight per patient; range: 1-24). With respect to those drugs used daily or on demand, 476 potential interactions were identified (126 patients); none were class 1 (always avoid drug combination) and 25 were class 2 (usually avoid combination; 24 patients). Eleven of the potential class 2 interactions...

  3. Evaluation of the physicochemical properties of liposomes as potential carriers of anticancer drugs: spectroscopic study

    International Nuclear Information System (INIS)

    Pentak, Danuta

    2016-01-01

    Vesicle size and composition are a critical parameter for determining the circulation half-life of liposomes. Size influences the degree of drug encapsulation in liposomes. The geometry, size, and properties of liposomes in an aqueous environment have to be described to enable potential applications of liposome systems as drug carriers. The characteristics of multiple thermotropic phase transitions are also an important consideration in liposomes used for analytical and bioanalytical purposes. The aim of this study was to evaluate the physicochemical properties of liposomes which accommodate hydrophilic and amphiphilic drugs used in cancer therapy. The studied liposomes were prepared with the involvement of the modified reverse-phase evaporation method (mREV). The prepared liposomes had a diameter of 70–150 nm. The analyzed compounds were 1-β-d-arabinofuranosylcytosine, cyclophosphamide, and ifosfamide. In literature, there is no information about simultaneous incorporation of cytarabine, ifosfamide, and cyclophosphamide, in spite of the fact that these drugs have been used for more than 30 years. A combination of the examined drugs is used in CODOX-M/IVAC therapy. CODOX-M/IVAC (cyclophosphamide, doxorubicin, high-dose methotrexate/ifosfamide, etoposide, and high-dose cytarabine) is one of the currently preferred intensive-dose chemotherapy regimens for Burkitt lymphoma (BL). The present research demonstrates the pioneering studies of incorporation of ifosfamide into liposome vesicles, location of and competition between the analyzed drugs and liposome vesicles. The applied methods were nuclear magnetic resonance (NMR), atomic force microscopy (AFM), differential scanning calorimetry (DSC).Graphical Abstract.

  4. Evaluation of the physicochemical properties of liposomes as potential carriers of anticancer drugs: spectroscopic study

    Energy Technology Data Exchange (ETDEWEB)

    Pentak, Danuta, E-mail: danuta.pentak@us.edu.pl [University of Silesia, Department of Materials Chemistry and Chemical Technology, Institute of Chemistry (Poland)

    2016-05-15

    Vesicle size and composition are a critical parameter for determining the circulation half-life of liposomes. Size influences the degree of drug encapsulation in liposomes. The geometry, size, and properties of liposomes in an aqueous environment have to be described to enable potential applications of liposome systems as drug carriers. The characteristics of multiple thermotropic phase transitions are also an important consideration in liposomes used for analytical and bioanalytical purposes. The aim of this study was to evaluate the physicochemical properties of liposomes which accommodate hydrophilic and amphiphilic drugs used in cancer therapy. The studied liposomes were prepared with the involvement of the modified reverse-phase evaporation method (mREV). The prepared liposomes had a diameter of 70–150 nm. The analyzed compounds were 1-β-d-arabinofuranosylcytosine, cyclophosphamide, and ifosfamide. In literature, there is no information about simultaneous incorporation of cytarabine, ifosfamide, and cyclophosphamide, in spite of the fact that these drugs have been used for more than 30 years. A combination of the examined drugs is used in CODOX-M/IVAC therapy. CODOX-M/IVAC (cyclophosphamide, doxorubicin, high-dose methotrexate/ifosfamide, etoposide, and high-dose cytarabine) is one of the currently preferred intensive-dose chemotherapy regimens for Burkitt lymphoma (BL). The present research demonstrates the pioneering studies of incorporation of ifosfamide into liposome vesicles, location of and competition between the analyzed drugs and liposome vesicles. The applied methods were nuclear magnetic resonance (NMR), atomic force microscopy (AFM), differential scanning calorimetry (DSC).Graphical Abstract.

  5. Safeguards for healthy volunteers in drug studies.

    Science.gov (United States)

    Smith, R N

    1975-09-06

    Safeguards for healthy volunteers in drug studies have not been as strict as those involving patients. The shortcomings include the lack of surveillance over the scientific validity of the protocol and its ethical review, and over the financial inducements to volunteers. Recruitment is open to abuse because the volunteers may have some allegiance to the investigators. There is an urgent need to institute checks on these aspects. Most important, however, is the lack of legal safeguards for volunteers taking part in research done outside the pharmaceutical industry. The suggested procedure for obtaining consent, for health checks, and for providing compensation can be equitable to all concerned, and yet not restrict initiative, nor curtail research aims.

  6. Working conditions and psychotropic drug use: cross-sectional and prospective results from the French national SIP study.

    Science.gov (United States)

    Lassalle, Marion; Chastang, Jean-François; Niedhammer, Isabelle

    2015-04-01

    Prospective studies exploring the associations between a large range of occupational factors and psychotropic drug use among national samples of workers are seldom. This study investigates the cross-sectional and prospective associations between occupational factors, including a large set of psychosocial work factors, and psychotropic drug use in the national French working population. The study sample comprised 7542 workers for the cross-sectional analysis and 4213 workers followed up for a 4-year period for the prospective analysis. Psychotropic drug use was measured within the last 12 months and defined by the use of antidepressants, anxiolytics or hypnotics. Three groups of occupational factors were explored: classical and emergent psychosocial work factors, working time/hours and physical work exposures. Weighted Poisson regression analyses were performed to adjust for covariates. In the cross-sectional analysis, psychological demands, low social support and hiding emotions were associated with psychotropic drug use. Job insecurity for men and night work for women were associated with psychotropic drug use. In the prospective analysis, hiding emotions and physical exposure were predictive of psychotropic drug use. Dose-response associations were observed for the frequency/intensity of exposure and repeated exposure to occupational factors. This study underlines the role of psychosocial work factors, including emergent factors, in psychotropic drug use. Prevention policies oriented toward psychosocial work factors comprehensively may be useful to reduce this use. Copyright © 2015 Elsevier Ltd. All rights reserved.

  7. QT interval and dispersion in drug-free anorexia nervosa adolescents: a case control study.

    Science.gov (United States)

    Bomba, Monica; Tremolizzo, Lucio; Corbetta, Fabiola; Nicosia, Franco; Lanfranconi, Francesca; Poggioli, Gianni; Goulene, Karine; Stramba-Badiale, Marco; Conti, Elisa; Neri, Francesca; Nacinovich, Renata

    2017-11-16

    Long QT values have been reported in patients with anorexia nervosa of the restricting type (ANr) potentially increasing the risk of fatal arrhythmia, especially if psychotropic drug treatment is required. Nevertheless, the previous studies on this topic are biased by drug exposure, long disease durations, and small sample sizes. This study is aimed at assessing QTc and QTcd values in ANr adolescents with recent onset and drug free, as compared to subjects affected by psychiatric disorders other than ANr. We evaluated QTc and its dispersion (QTcd) in a population of 77 drug-free ANr female adolescents and compared to an equal number of healthy controls (H-CTRL) and pathological controls (P-CTRL, mixed psychiatric disorders). The QT determination was performed on a standard simultaneous 12-lead ECG in blind by a single experienced investigator. QTc was calculated by the Bazett's formula and QTcd was determined as the difference between the maximum and minimum QTc intervals in different leads. Only for ANr patients, clinico-demographic data, hormones, and electrolytes were obtained. QTc was slightly reduced in ANr patients (27.7 ms, studies are needed to understand if the previously reported increase might be related to other associated chronic disorders, such as hormonal or electrolyte imbalance.

  8. Adverse drug reactions induced by cardiovascular drugs in outpatients.

    Science.gov (United States)

    Gholami, Kheirollah; Ziaie, Shadi; Shalviri, Gloria

    2008-01-01

    Considering increased use of cardiovascular drugs and limitations in pre-marketing trials for drug safety evaluation, post marketing evaluation of adverse drug reactions (ADRs) induced by this class of medicinal products seems necessary. To determine the rate and seriousness of adverse reactions induced by cardiovascular drugs in outpatients. To compare sex and different age groups in developing ADRs with cardiovascular agents. To assess the relationship between frequencies of ADRs and the number of drugs used. This cross-sectional study was done in cardiovascular clinic at a teaching hospital. All patients during an eight months period were evaluated for cardiovascular drugs induced ADRs. Patient and reaction factors were analyzed in detected ADRs. Patients with or without ADRs were compared in sex and age by using chi-square test. Assessing the relationship between frequencies of ADRs and the number of drugs used was done by using Pearson analysis. The total number of 518 patients was visited at the clinic. ADRs were detected in 105 (20.3%) patients. The most frequent ADRs were occurred in the age group of 51-60. The highest rate of ADRs was recorded to be induced by Diltiazem (23.5%) and the lowest rate with Atenolol (3%). Headache was the most frequent detected ADR (23%). Assessing the severity and preventability of ADRs revealed that 1.1% of ADRs were detected as severe and 1.9% as preventable reactions. Women significantly developed more ADRs in this study (chi square = 3.978, PPearson=0.259, P<0.05). Monitoring ADRs in patients using cardiovascular drugs is a matter of importance since this class of medicines is usually used by elderly patients with critical conditions and underlying diseases.

  9. COMPARATIVE STUDY OF NEW DRUG OF LONG ACTING METOPROLOL TARTRATE - EGILOK RETARD AND ORIGINAL DRUG OF METOPROLOL SUCCINATE – BETALOC ZOK IN PATIENTS WITH MILD TO MODERATE ARTERIAL HYPERTENSION

    Directory of Open Access Journals (Sweden)

    J. V. Lukina

    2015-12-01

    Full Text Available Aim. To study efficiency and safety of new drug of long acting metoprolol tartrate, “Egilok retard” (ER in patients with mild to moderate arterial hypertension (AH in comparison with the original drug of metoprolol succinat, “Betaloc ZOK” (BZ, possibility of reaching target blood pressure (BP level with treatment with each drug.Material and methods. 30 patients (11 men and 19 women with mild to moderate AH took part in randomized, open, cross over study. Previous antihypertensive treatment had been canceled for all the patients 10-14 days before the study started. Each patient by turns was treated during 6 weeks with ER and BZ 50-100 mg daily. After cancellation of the previous antihypertensive therapy, BZ and ER were prescribed (according to the randomization table in dose 50 mg daily. Drugs were taken once per day. 29 patients completed therapy with the first drug of randomization, 25 patients – with the second. After 2 weeks efficiency of treatment was assessed by target BP level achievement (< 140/90 mmHg. If efficiency of beta-adrenoblocker (BB was not sufficient, the dose of the drug was doubled to 100 mg daily, if target level was reached – the dose remained unchanged. Treatment with the settled dose was held within next 4 weeks. After 6-week treatment with the first randomized drug antihypertensive therapy was canceled for 10-14 days depending on the BB dose. At each visit office BP and heart rate were assessed, EKG was registered. Side-effects were registered according to the self-control diary, questionnaire results, examination and EKG data.Results. After 6-week treatment with ER and BZ average level of systolic BP reduced by 15,7 and 15,2 mmHg, of diastolic BP – by 8,0 and 4,5 mmHg, heart rate – by 4,1 and 4,3 beat/min respectively. Differences between antihypertensive and heart rate lowering effect of the studied drugs were not significant. Target BP level with treatment with both drugs was reached in approximately

  10. COMPARATIVE STUDY OF NEW DRUG OF LONG ACTING METOPROLOL TARTRATE - EGILOK RETARD AND ORIGINAL DRUG OF METOPROLOL SUCCINATE – BETALOC ZOK IN PATIENTS WITH MILD TO MODERATE ARTERIAL HYPERTENSION

    Directory of Open Access Journals (Sweden)

    J. V. Lukina

    2005-01-01

    Full Text Available Aim. To study efficiency and safety of new drug of long acting metoprolol tartrate, “Egilok retard” (ER in patients with mild to moderate arterial hypertension (AH in comparison with the original drug of metoprolol succinat, “Betaloc ZOK” (BZ, possibility of reaching target blood pressure (BP level with treatment with each drug.Material and methods. 30 patients (11 men and 19 women with mild to moderate AH took part in randomized, open, cross over study. Previous antihypertensive treatment had been canceled for all the patients 10-14 days before the study started. Each patient by turns was treated during 6 weeks with ER and BZ 50-100 mg daily. After cancellation of the previous antihypertensive therapy, BZ and ER were prescribed (according to the randomization table in dose 50 mg daily. Drugs were taken once per day. 29 patients completed therapy with the first drug of randomization, 25 patients – with the second. After 2 weeks efficiency of treatment was assessed by target BP level achievement (< 140/90 mmHg. If efficiency of beta-adrenoblocker (BB was not sufficient, the dose of the drug was doubled to 100 mg daily, if target level was reached – the dose remained unchanged. Treatment with the settled dose was held within next 4 weeks. After 6-week treatment with the first randomized drug antihypertensive therapy was canceled for 10-14 days depending on the BB dose. At each visit office BP and heart rate were assessed, EKG was registered. Side-effects were registered according to the self-control diary, questionnaire results, examination and EKG data.Results. After 6-week treatment with ER and BZ average level of systolic BP reduced by 15,7 and 15,2 mmHg, of diastolic BP – by 8,0 and 4,5 mmHg, heart rate – by 4,1 and 4,3 beat/min respectively. Differences between antihypertensive and heart rate lowering effect of the studied drugs were not significant. Target BP level with treatment with both drugs was reached in approximately

  11. Effect of Drug Loading Method and Drug Physicochemical Properties on the Material and Drug Release Properties of Poly (Ethylene Oxide Hydrogels for Transdermal Delivery

    Directory of Open Access Journals (Sweden)

    Rachel Shet Hui Wong

    2017-07-01

    Full Text Available Novel poly (ethylene oxide (PEO hydrogel films were synthesized via UV cross-linking with pentaerythritol tetra-acrylate (PETRA as cross-linking agent. The purpose of this work was to develop a novel hydrogel film suitable for passive transdermal drug delivery via skin application. Hydrogels were loaded with model drugs (lidocaine hydrochloride (LID, diclofenac sodium (DIC and ibuprofen (IBU via post-loading and in situ loading methods. The effect of loading method and drug physicochemical properties on the material and drug release properties of medicated film samples were characterized using scanning electron microscopy (SEM, swelling studies, differential scanning calorimetry (DSC, fourier transform infrared spectroscopy (FT-IR, tensile testing, rheometry, and drug release studies. In situ loaded films showed better drug entrapment within the hydrogel network and also better polymer crystallinity. High drug release was observed from all studied formulations. In situ loaded LID had a plasticizing effect on PEO hydrogel, and films showed excellent mechanical properties and prolonged drug release. The drug release mechanism for the majority of medicated PEO hydrogel formulations was determined as both drug diffusion and polymer chain relaxation, which is highly desirable for controlled release formulations.

  12. Distribution of red blood cell antigens in drug-resistant and drug ...

    African Journals Online (AJOL)

    sofo

    Frequency distribution of ABO, Rh-Hr, MN, Kell blood group system antigens were studied in 277 TB patients (151-drug-sensitive and 126 drug-resistant) of pulmonary tuberculosis to know whether there was any association between them, and also between drug resistance and sensitiveness. They were compared with 485 ...

  13. 78 FR 73199 - Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs...

    Science.gov (United States)

    2013-12-05

    ... exposure measures is suitable for documenting BE (e.g., transdermal delivery systems and certain rectal and... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-1464] Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted...

  14. MRI in ocular drug delivery

    OpenAIRE

    Li, S. Kevin; Lizak, Martin J.; Jeong, Eun-Kee

    2008-01-01

    Conventional pharmacokinetic methods for studying ocular drug delivery are invasive and cannot be conveniently applied to humans. The advancement of MRI technology has provided new opportunities in ocular drug-delivery research. MRI provides a means to non-invasively and continuously monitor ocular drug-delivery systems with a contrast agent or compound labeled with a contrast agent. It is a useful technique in pharmacokinetic studies, evaluation of drug-delivery methods, and drug-delivery de...

  15. EXPLORING THE PATTERN OF POLYPHARMACY AND PROPORTION OF DRUG TO DRUG INTERACTIONS AND ADVERSE DRUG REACTIONS IN THE ELDERLY

    Directory of Open Access Journals (Sweden)

    Vijayashree Thyagaraj

    2017-07-01

    Full Text Available BACKGROUND The geriatric population is increasing as a result of advanced medical facilities. This population also faces a number of medical health challenges. They tend to receive multiple medications often leading to Drug-Drug Interactions (DDIs Adverse Drug Reactions (ADRs and other clinical consequences, which compromises their quality of life if not endangering it as well. There are few Indian studies focusing on this problem. Hence, this study was undertaken with the aim to assess the polypharmacy pattern, proportion of DDIs and adverse drug reactions in the geriatric population in a tertiary care hospital. MATERIALS AND METHODS This was a cross-sectional study wherein data from 201 geriatric inpatient’s prescriptions were collected. The prescriptions were assessed for demographic details such as age, gender, comorbidities and drugs prescribed. All prescriptions were evaluated for polypharmacy, DDIs and ADRs. DDIs were assessed using Micromedex software. Patients were stratified into groups and DDIs were compared between the groups, gender and also with number of drugs used. RESULTS There were 201 patients with a mean age of approximately 70 years. Polypharmacy occurred in 73.63% of them with mean number of drugs being 6.23. The number of drugs used increased significantly with age (p=0.0001. Hypertension was the most common comorbidity. Polypharmacy was strongly associated with hypertension and dyslipidaemia. A total of 129 (64.17% patients accounted for 425 potential DDIs. The most common drug involved in DDIs was aspirin. A subset analysis of ADRs showed an occurrence of 50.68% with 10.81% being definitely avoidable. CONCLUSION Elderly individuals are at increased risk of being on polypharmacy. This comes with the risk of several potential DDIs, which in turn may lead to adverse drug reactions, which results in morbidity. Doctors involved in the care of the elderly should be aware of these facts and exercise caution while adding any

  16. Drug specificity in drug versus food choice in male rats.

    Science.gov (United States)

    Tunstall, Brendan J; Riley, Anthony L; Kearns, David N

    2014-08-01

    Although different classes of drug differ in their mechanisms of reinforcement and effects on behavior, little research has focused on differences in self-administration behaviors maintained by users of these drugs. Persistent drug choice despite available reinforcement alternatives has been proposed to model behavior relevant to addiction. The present study used a within-subjects procedure, where male rats (Long-Evans, N = 16) were given a choice between cocaine (1.0 mg/kg/infusion) and food (a single 45-mg grain pellet) or between heroin (0.02 mg/kg/infusion) and food in separate phases (drug order counterbalanced). All rats were initially trained to self-administer each drug, and the doses used were based on previous studies showing that small subsets of rats tend to prefer drug over food reinforcement. The goal of the present study was to determine whether rats that prefer cocaine would also prefer heroin. Choice sessions consisted of 2 forced-choice trials with each reinforcer, followed by 14 free-choice trials (all trials separated by 10-min intertrial interval). Replicating previous results, small subsets of rats preferred either cocaine (5 of the 16 rats) or heroin (2 of the 16 rats) to the food alternative. Although 1 of the 16 rats demonstrated a preference for both cocaine and heroin to the food alternative, there was no relationship between degree of cocaine and heroin preference in individual rats. The substance-specific pattern of drug preference observed suggests that at least in this animal model, the tendencies to prefer cocaine or heroin in preference to a nondrug alternative are distinct behavioral phenomena.

  17. Clinical risk management in Dutch community pharmacies: the case of drug-drug interactions.

    NARCIS (Netherlands)

    Buurma, H.; Smet, P.A.G.M. de; Egberts, A.C.G.

    2006-01-01

    BACKGROUND: The prevention of drug-drug interactions requires a systematic approach for which the concept of clinical risk management can be used. The objective of our study was to measure the frequency, nature and management of drug-drug interaction alerts as these occur in daily practice of Dutch

  18. Studies on Dissolution Enhancement of Prednisolone, a Poorly Water-Soluble Drug by Solid Dispersion Technique

    Directory of Open Access Journals (Sweden)

    Parvin Zakeri-Milani

    2011-06-01

    Full Text Available Introduction: Prednisolone is a class II substance according to the Biopharmaceutics Classification System. It is a poorly water soluble agent. The aim of the present study was to improve dissolution rate of a poorly water-soluble drug, prednisolone, by a solid dispersion technique. Methods: Solid dispersion of prednisolone was prepared with PEG 6000 or different carbohydrates such as lactose and dextrin with various ratios of the drug to carrier i.e., 1:10, 1:20 and 1:40. Solid dispersions were prepared by coevaporation method. The evaluation of the properties of the dispersions was performed using dissolution studies, Fourier-transform infrared spectroscopy and x-ray powder diffractometery. Results: The results indicated that lactose is suitable carriers to enhance the in vitro dissolution rate of prednisolone. The data from the x-ray diffraction showed that the drug was still detectable in its solid state in all solid dispersions except solid dispersions prepared by dextrin as carrier. The results from infrared spectroscopy showed no well-defined drug–carrier interactions for coevaporates. Conclusion: Solid dispersion of a poorly water-soluble drug, prednisolone may alleviate the problems of delayed and inconsistent rate of dissolution of the drug.

  19. Binding of several anti-tumor drugs to bovine serum albumin: Fluorescence study

    Energy Technology Data Exchange (ETDEWEB)

    Bi Shuyun [College of Chemistry, Changchun Normal University, Changchun 130032 (China)], E-mail: sy_bi@sina.com; Sun Yantao [College of Chemistry, Jilin University, Changchun 130023 (China); College of Chemistry, Jilin Normal University, Siping 136000 (China); Qiao Chunyu; Zhang Hanqi [College of Chemistry, Jilin University, Changchun 130023 (China); Liu Chunming [College of Chemistry, Changchun Normal University, Changchun 130032 (China)

    2009-05-15

    The interactions of mitomycin C (MMC), fluorouracil (FU), mercaptopurine (MP) and doxorubicin hydrochloride (DXR) with bovine serum albumin (BSA) were studied by spectroscopic method. Quenching of fluorescence of serum albumin by these drugs was found to be a static quenching process. The binding constants (K{sub A}) were 9.66x10{sup 3}, 2.08x10{sup 3}, 8.20x10{sup 2} and 7.50x10{sup 3} L mol{sup -1} for MMC-, FU-, MP- and DXR-BSA, respectively, at pH 7.4 Britton-Robinson buffer at 28 deg. C. The thermodynamic functions such as enthalpy change ({delta}H), entropy change ({delta}S) and Gibbs free-energy change ({delta}G) for the reactions were also calculated according to the thermodynamic equations. The main forces in the interactions of these drugs with BSA were evaluated. It was found that the interactions of MMC and FU with BSA were exothermic processes and those of MP and DXR with BSA were endothermic. In addition, the binding sites on BSA for the four drugs were probed by the changes of binding properties of these drugs with BSA in the presence of two important site markers such as ibuprofen and indomethacin. Based on the Foester theory of non-radiation energy transfer, the binding distances between the drugs and tryptophane were calculated and they were 3.00, 1.14, 2.85, and 2.79 nm for MMC, FU, MP and DXR, respectively.

  20. Study on drug costs associated with COPD prescription medicine in Denmark

    DEFF Research Database (Denmark)

    Jakobsen, M; Anker, N; Dollerup, J

    2013-01-01

    that the costs associated with COPD in Denmark are significant, but costs of prescription medicine for COPD were not analysed. OBJECTIVES: To analyse the societal costs associated with prescription medicine for COPD in Denmark. METHODS: The study was designed as a nationwide retrospective register study...... in 2010 with total costs of DKK 685 million (EUR 92 million). The average lifetime costs associated with COPD prescription medicine were estimated to be DKK 70,000-75,000 (EUR 9,416-10,089) per patient (2010 prices). CONCLUSION: The costs associated with prescription medicine for COPD in Denmark...... of the drug costs (ATC group R03) associated with COPD in the period 2001-2010. Data were retrieved from the Prescription Database, the National Patient Register and the Centralised Civil Register. The population comprised individuals (40+ years) who had at least one prescription of selected R03 drugs and who...

  1. STUDY ON DRUG COSTS ASSOCIATED WITH COPD PRESCRIPTION MEDICINE IN DENMARK

    DEFF Research Database (Denmark)

    Jakobsen, Iris Marie; Anker, Niels; Dolleru, Jens

    2012-01-01

    that the costs associated with COPD in Denmark are significant, but costs of prescription medicine for COPD were not analysed. OBJECTIVES: To analyse the societal costs associated with prescription medicine for COPD in Denmark. METHODS: The study was designed as a nationwide retrospective register study...... in 2010 with total costs of DKK 685 million (EUR 92 million). The average lifetime costs associated with COPD prescription medicine were estimated to be DKK 70,000-75,000 (EUR 9,416-10,089) per patient (2010 prices). CONCLUSION: The costs associated with prescription medicine for COPD in Denmark...... of the drug costs (ATC group R03) associated with COPD in the period 2001-2010. Data were retrieved from the Prescription Database, the National Patient Register and the Centralised Civil Register. The population comprised individuals (40+ years) who had at least one prescription of selected R03 drugs and who...

  2. Recent trends for drug lag in clinical development of oncology drugs in Japan: does the oncology drug lag still exist in Japan?

    Science.gov (United States)

    Maeda, Hideki; Kurokawa, Tatsuo

    2015-12-01

    This study exhaustively and historically investigated the status of drug lag for oncology drugs approved in Japan. We comprehensively investigated oncology drugs approved in Japan between April 2001 and July 2014, using publicly available information. We also examined changes in the status of drug lag between Japan and the United States, as well as factors influencing drug lag. This study included 120 applications for approval of oncology drugs in Japan. The median difference over a 13-year period in the approval date between the United States and Japan was 875 days (29.2 months). This figure peaked in 2002, and showed a tendency to decline gradually each year thereafter. In 2014, the median approval lag was 281 days (9.4 months). Multiple regression analysis identified the following potential factors that reduce drug lag: "Japan's participation in global clinical trials"; "bridging strategies"; "designation of priority review in Japan"; and "molecularly targeted drugs". From 2001 to 2014, molecularly targeted drugs emerged as the predominant oncology drug, and the method of development has changed from full development in Japan or bridging strategy to global simultaneous development by Japan's taking part in global clinical trials. In line with these changes, the drug lag between the United States and Japan has significantly reduced to less than 1 year.

  3. Characteristics of pregnant illicit drug users and associations between cannabis use and perinatal outcome in a population-based study.

    NARCIS (Netherlands)

    Gelder, M.M.H.J. van; Reefhuis, J.; Caton, A.R.; Werler, M.M.; Druschel, C.M.; Roeleveld, N.

    2010-01-01

    BACKGROUND: According to the 2004 National Survey on Drug Use and Health, 4.6% of American women reported use of an illicit drug during pregnancy. Previous studies on illicit drug use during pregnancy and perinatal outcomes showed inconsistent results. METHODS: This population-based study included

  4. Drug residues in used syringes in Switzerland: A comparative study.

    Science.gov (United States)

    Lefrançois, Elodie; Augsburger, Marc; Esseiva, Pierre

    2018-05-01

    Harm reduction services, including needle-exchange programmes, have been implemented in Switzerland for over 20 years. Their main aim is to lessen the negative social and/or physical consequences associated with illicit drug consumption and, therefore, improve prevention messages. To this end, knowledge of illicit drug consumption practices is necessary. Periodic self-report surveys are the primary source of data for monitoring drug users' behaviour. Analysis of residual content of used syringes can bring further and objective knowledge about consumed products through analytically confirmed data. Used syringes were sampled in 2 syringe-exchange facilities in Lausanne. These structures are a bus where the users bring back their syringes (ABS) and an automatic injecting kit dispenser (AIKD). Once syringes were collected, a validated gas chromatography-mass spectrometry (GC-MS) method was implemented in order to detect drugs (licit or illicit) contained in the residual content of used syringes. Cocaine was the most common drug detected alone (39% in ABS and 31% in AIKD), followed by the simultaneous detection of heroin and cocaine (12% and 17%) and heroin and midazolam (12% and 17%). The differences between the illicit drugs distribution of used syringes collected in AIKD and ABS were not statistically significant. Analysis of residual content of used syringes as a monitoring tool is an original approach that has already led to a better understanding of the habits of drug-injection users. Over the long term, this approach is a powerful tool to track and detect new consumption practices in a quasi-real-time. Copyright © 2017 John Wiley & Sons, Ltd.

  5. Intensive monitoring of new drugs based on first prescription signals from pharmacists : a pilot study

    NARCIS (Netherlands)

    Van Grootheest, AC; Groote, JK; de Jong-van den Berg, LTW

    Background Intensive monitoring can be a valuable tool in the early detection of adverse drug reactions, especially of new drugs. Aim of this pilot study was to investigate the practical possibilities of a system of intensive monitoring, using the pharmacy computer system to detect the first

  6. Drug research methodology. Volume 4, Epidemiology in drugs and highway safety : the study of drug use among drivers and its role in traffic crashes

    Science.gov (United States)

    1980-06-01

    This report presents the findings of a workshop on epidemiology in drugs and highway safety. A cross-disciplinary panel of experts (1) identified methodological issues and constraints present in research to define the nature and magnitude of the drug...

  7. Drug-associated cutaneous vasculitis: study of 239 patients from a single referral center.

    Science.gov (United States)

    Ortiz-Sanjuán, Francisco; Blanco, Ricardo; Hernández, José L; Pina, Trinitario; González-Vela, María C; Fernández-Llaca, Héctor; Calvo-Río, Vanesa; Loricera, Javier; Armesto, Susana; González-López, Marcos A; Rueda-Gotor, Javier; González-Gay, Miguel A

    2014-11-01

    The 2012 International Chapel Hill Consensus Conference on the Nomenclature of Vasculitides defined drug-associated immune complex vasculitis as a distinct entity included within the category of vasculitis associated with probable etiology. In the present study we assessed the clinical spectrum of patients with drug-associated cutaneous vasculitis (DACV). Case records were reviewed of patients with DACV treated at a tertiary referral hospital over a 36-year period. A diagnosis of DACV was considered if the drug was taken within a week before the onset of the disease. From a series of 773 unselected cutaneous vasculitis cases, 239 patients (30.9%; 133 men and 106 women; mean age 36 yrs) were diagnosed with DACV. Antibiotics (n=149; 62.3%), mainly β-lactams and nonsteroidal antiinflammatory drugs (NSAID; n=24; 10%) were the most common drugs. Besides skin lesions (100%), the most common clinical features were joint (51%) and gastrointestinal (38.1%) manifestations, nephropathy (34.7%), and fever (23.8%). The most remarkable laboratory data were increased erythrocyte sedimentation rate (40.2%), presence of serum cryoglobulins (26%), leukocytosis (24.7%), positive antinuclear antibodies (21.1%), anemia (18.8%), and positive rheumatoid factor (17.5%). Despite drug discontinuation and bed rest, 108 patients (45.2%) required medical treatment, mainly corticosteroids (n=71) or immunosuppressive drugs (n=7). After a median followup of 5 months, relapses occurred in 18.4% of patients, and persistent microhematuria or renal insufficiency in 3.3% and 5%, respectively. DACV is generally associated with antibiotics and NSAID. In most cases it has a favorable prognosis, although a small percentage of patients may develop residual renal damage.

  8. Rational drug use in Cambodia: study of three pilot health centers in Kampong Thom Province.

    Science.gov (United States)

    Chareonkul, Chanin; Khun, Va Luong; Boonshuyar, Chaweewon

    2002-06-01

    This study obtained baseline information for the design of a strategy to address irrational prescribing practices in three health centers in Kampong Thom Province, Cambodia. Indicators of rational drug use have been measured and compared with Standard Guidelines. Data were collected from patients' registers and by interviewing patients immediately after patient-prescriber and patient-dispenser encounters. Checklists and pre-designed forms were used to collect data regarding the World Health Organization drug use indicators and some additional indices. Of the 330 prescriptions analyzed, the results showed that the average number of drugs per prescription was 2.35 and that a large proportion of the prescriptions contained two or more drugs that could result in adverse drug interactions. Prescribing by generic names (99.8%) was encouraging. The exposure of patients to antibiotics (66% to 100%) was high, and injection use (2.4%) was often unnecessary. Prescribing from the Essential Drugs List (99.7%) was satisfactory. The average consultation and dispensing times were short and not sufficient for patients to get health information. All the prescribed drugs were supplied, but all were inadequately labeled. Some 55% of patients knew the correct dosage of their drugs. The availability of key essential drugs (86.6%) was below the Standard. The percentages of appropriate prescriptions for treating malaria, diarrhea and acute respiratory infection treatment were 68.3%, 3.3%, and 45%, respectively. Inappropriate prescriptions were mostly due to unsuitable dosages, incorrect drugs, and the improper duration of treatment. The results suggest a need for intervention to curb the irrational use of drugs in prescribing at the three pilot health centers. Continuing education of prescribers and healthcare providers, monitoring, supervision, public education would be beneficial.

  9. Scientific Perspectives on Extending the Provision for Waivers of In vivo Bioavailability and Bioequivalence Studies for Drug Products Containing High Solubility-Low Permeability Drugs (BCS-Class 3)

    OpenAIRE

    Stavchansky, Salomon

    2008-01-01

    Recently, there has been increased interest in extending the provision for waivers of in vivo bioavailability and bioequivalence (BA–BE) studies that appeared in the guidance published by the Food and Drug Administration (FDA) (1) to pharmaceutical products containing Class 3 drugs (High solubility–Low Permeability). The extension of the Biopharmaceutics Classification System (BCS) to Class 3 drugs is meritorious because of its impact on public health policy considerations. The rate limiting ...

  10. Investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans. Final rule.

    Science.gov (United States)

    2010-09-29

    The Food and Drug Administration (FDA) is amending its regulations governing safety reporting requirements for human drug and biological products subject to an investigational new drug application (IND). The final rule codifies the agency's expectations for timely review, evaluation, and submission of relevant and useful safety information and implements internationally harmonized definitions and reporting standards. The revisions will improve the utility of IND safety reports, reduce the number of reports that do not contribute in a meaningful way to the developing safety profile of the drug, expedite FDA's review of critical safety information, better protect human subjects enrolled in clinical trials, subject bioavailability and bioequivalence studies to safety reporting requirements, promote a consistent approach to safety reporting internationally, and enable the agency to better protect and promote public health.

  11. Sport participation and alcohol and illicit drug use in adolescents and young adults: a systematic review of longitudinal studies.

    Science.gov (United States)

    Kwan, Matthew; Bobko, Sarah; Faulkner, Guy; Donnelly, Peter; Cairney, John

    2014-03-01

    Sport participation can play an important and positive role in the health and development of children and youth. One area that has recently been receiving greater attention is the role that sport participation might play in preventing drug and alcohol use among youth. The current study is a systematic review of 17 longitudinal studies examining the relationship between sport participation and alcohol and drug use among adolescents. Results indicated that sport participation is associated with alcohol use, with 82% of the included studies (14/17) showing a significant positive relationship. Sport participation, however, appears to be related to reduced illicit drug use, especially use of non-cannabis related drugs. Eighty percent of the studies found sport participation associated with decreased illicit drug use, while 50% of the studies found negative association between sport participation and marijuana use. Further investigation revealed that participation in sports reduced the risk of overall illicit drug use, but particularly during high school; suggesting that this may be a critical period to reduce or prevent the use of drugs through sport. Future research must better understand what conditions are necessary for sport participation to have beneficial outcomes in terms of preventing alcohol and/or illicit drug use. This has been absent in the extent literature and will be central to intervention efforts in this area. Copyright © 2013 Elsevier Ltd. All rights reserved.

  12. Drug abuse among the students

    Directory of Open Access Journals (Sweden)

    Muhammad Zaman

    2015-01-01

    Full Text Available ABSTRACT:Drug abuse is the willful misuse of either licit or illicit drugs for the purpose of recreation, perceived necessity or convenience. Drug abuse is a more intense and often willful misuse of drugs often to the point of addiction. In the eastern world the incidence shows a decline or a static pattern but the number of drug addicts is still enormous.. The major drug of abuse are heroin and marijuana but designer drugs are shown to be on the increase. The aim of the study is to determine the ratio of the drug abuse in student. For this purpose we selected different institutions including “the university of Lahore”, “Forman Christian college”(private sector and Punjab university(Govt sector and conducted survey in 500 student. High proportion of students was found abusing drugs. From this study, we came across multiple factors which are the main cause of drug abuse in medical student including depression, anxiety, schizophrenia, as well as personality disorder like antisocial personality disorder. The most commonly abused drugs include stimulants, opioids, and benzodiazepines, antihistamines. Although survey have indicated high rate of illicit and prescription drugs misuse among college students, few have assessed the negative consequences, personel concerns, or interest in intervention for drugs use. Drug abuse although regarded as a personality disorder, may also be seen as worldwide epidemic with evolutionary genetic, physiology and environmental influences Controlling and affecting human behavior. Globally, the use has reached all time high. The study showed males are more drug abusers as compared to females. The drug abuse ratio in students of private sector is more as compared to Govt sector.

  13. Factors Associated with the Transition from Drug Abuse to Initiation of Injection Drug Use

    Directory of Open Access Journals (Sweden)

    Mosayeb Yarmohamadi Vasel

    2015-06-01

    Full Text Available Objectives: Drug injection carries with it many risks and therefore it is important to understand the initiating factors of injection and its origins. Thus,  the purpose of this study was to identify factors associated with the initiation of injection drug use among substance abusers. Methods:  Study method was a cross-sectional study. The research statistics universe constitutes all people suffering from a substance dependence disorder with a pattern of injection use in Tehran and Hamedan. This study was conducted among 216 individuals with substance dependence disorders who were selected from harm reduction centers in Tehran and Hamedan. The sampling selection method was simply random. The instruments used for data collection included: demographic information, patterns of drug use and initiation of injection scales.  Results: In this study, the average age of initiation to injections was 22.5 years. Factors associated with initiation of drug injection included: acquired more pleasure, easier use, faster effect of injection, ineffective previous use method, curiosity, peer pressure, lack of availability of the drug, poverty, and low quality drugs. Discussion: Results of this study indicate that initiation factors to drug injection are multifaceted (Psychological, Social, Economic and Environmental, therefore, injection interventionists should consider all these factors for prevention, treatment and harm reduction.

  14. The Impact of College Drug Policy on Students' Drug Usage

    Science.gov (United States)

    Sawyer, Holly N.

    2012-01-01

    Illicit drug usage at Historically Black Colleges and Universities (HBCU) is a topic of limited research. The research questions that guided this study were (a) What is the relationship between college policy on illicit drugs and students' frequency of drug usage after controlling for college location (urban or rural) and students' age,…

  15. Immediate or deferred adjustment of drug regimens in multidose drug dispensing systems.

    Science.gov (United States)

    Mertens, Bram J; Kwint, Henk-Frans; van Marum, Rob J; Bouvy, Marcel L

    2018-05-18

    Multidose drug dispensing (MDD) is used to help patients take their medicines appropriately. Little is known about drug regimen changes within these MDD systems and how they are effectuated by the community pharmacist. Manual immediate adjustments of the MDD system could introduce dispensing errors. MDD guidelines therefore recommend to effectuate drug regimen changes at the start of a new MDD system. The aim of this study was to investigate the frequency, type, procedure followed, immediate necessity, and time taken to make MDD adjustments. This was a cross-sectional study in eight community pharmacies in the Netherlands. All adjustments to MDD systems were systematically documented for 3 weeks by the community pharmacist. Overall, 261 MDD adjustments involving 364 drug changes were documented for 250 patients: 127 (35%) drug changes involved the addition of a new drug, 124 (34%) a change in dosage, and 95 (26%) drug discontinuation. Of the MDD adjustments, 135 (52%) were effectuated immediately: 81 (31%) by adjusting the MDD system manually, 49 (19%) by temporarily dispensing the drug separately from the MDD system, and 5 (2%) by ordering a new MDD system. Pharmacists considered that 36 (27%) of the immediate MDD adjustments could have been deferred until the next MDD system was produced. Immediate adjustment took significantly longer than deferred adjustment (p < 0.001). This study shows that in patients using MDD systems, over half of the drug regimen changes are adjusted immediately. The necessity of these immediate changes should be critically evaluated. Copyright © 2018. Published by Elsevier Inc.

  16. Characteristics and drug utilization patterns for heavy users of prescription drugs among the elderly

    DEFF Research Database (Denmark)

    Øymoen, Anita; Pottegård, Anton; Almarsdóttir, Anna Birna

    2015-01-01

    drug users accounted for 75.4% of their use in 2012, and five of these were cardiovascular drugs. The development over time for the ten most used drug classes followed the same pattern among heavy drug users and in the general population. CONCLUSION: There is a skewed utilization of prescription drugs...... frequently used drugs among heavy drug users and development in use over time. METHOD: This is a descriptive study. Heavy drug users were defined as the accumulated top 1 percentile who accounted for the largest share of prescription drug use measured in number of dispensed defined daily doses (DDDs...

  17. Medication competency of nurses according to theoretical and drug calculation online exams: A descriptive correlational study.

    Science.gov (United States)

    Sneck, Sami; Saarnio, Reetta; Isola, Arja; Boigu, Risto

    2016-01-01

    Medication administration is an important task of registered nurses. According to previous studies, nurses lack theoretical knowledge and drug calculation skills and knowledge-based mistakes do occur in clinical practice. Finnish health care organizations started to develop a systematic verification processes for medication competence at the end of the last decade. No studies have yet been made of nurses' theoretical knowledge and drug calculation skills according to these online exams. The aim of this study was to describe the medication competence of Finnish nurses according to theoretical and drug calculation exams. A descriptive correlation design was adopted. Participants and settings All nurses who participated in the online exam in three Finnish hospitals between 1.1.2009 and 31.05.2014 were selected to the study (n=2479). Quantitative methods like Pearson's chi-squared tests, analysis of variance (ANOVA) with post hoc Tukey tests and Pearson's correlation coefficient were used to test the existence of relationships between dependent and independent variables. The majority of nurses mastered the theoretical knowledge needed in medication administration, but 5% of the nurses struggled with passing the drug calculation exam. Theoretical knowledge and drug calculation skills were better in acute care units than in the other units and younger nurses achieved better results in both exams than their older colleagues. The differences found in this study were statistically significant, but not high. Nevertheless, even the tiniest deficiency in theoretical knowledge and drug calculation skills should be focused on. It is important to identify the nurses who struggle in the exams and to plan targeted educational interventions for supporting them. The next step is to study if verification of medication competence has an effect on patient safety. Copyright © 2015 Elsevier Ltd. All rights reserved.

  18. MARKETING PREDICTIONS IN ANTI-DRUG SOCIAL PROGRAMS: USE OF CAUSAL METHODS IN THE STUDY AND PREVENTION OF DRUG ABUSE

    Directory of Open Access Journals (Sweden)

    Serban Corina

    2010-12-01

    Full Text Available Drug use is one of the major challenges that todays society faces; its effects are felt at the level of various social, professional and age categories. Over 50 non-profit organizations are involved in the development of anti-drug social programs in Romania. Their role is to improve the degree of awareness of the target population concerning the risks associated with drug use, but also to steer consumers towards healthy areas, beneficial to their future. This paper aims to detail the issue of drug use in Romania, by making predictions based on the evolution of this phenomenon during the next five years. The obtained results have revealed the necessity to increase the number of programs preventing drug use, aswell as the need to continue social programs that have proved effective in previous years.

  19. Effects of transnational migration on drug use: an ethnographic study of Nepali female heroin users in Hong Kong.

    Science.gov (United States)

    Tang, Wai-Man

    2015-01-01

    Past studies of female drug users in South Asia tend to focus on their plights, for instance, how they have been driven to drug use and encounter more problems than their male counterparts, such as HIV/AIDS and sexual abuse. Few studies focus on their active role--how they actively make use of resources in the external environment to construct their desired femininity through drug consumption. Furthermore, little is known about the situation of female South Asian drug users who are living overseas. This paper is a study of transnational migration, drug use and gender--how transnational migration influences the drug use of female transnational migrants. An 18-month ethnography has been carried out in a Nepali community in Hong Kong and 13 informants were interviewed. Data were coded and analyzed by using the grounded-theory approach. Themes related to the drug use of the female Nepali heroin users were identified. The findings show that there are three important themes that significantly affect the drug use of female Nepali heroin users, which include (1) their relationships with intimate partners, (2) their means of support, and (3) their legal status in migration. The findings are consistent with the concept of post-structuralism in gender and transnationalism theories. Female Nepali heroin users in Hong Kong are neither active agents nor passive victims; their active/passive role is largely dependent on their reconfigured opportunities and constraints in transnational migration. Thus, transnationalism should be taken as an important perspective to study the situation of female drug users in a globalized context. Copyright © 2014 Elsevier B.V. All rights reserved.

  20. Drug accumulation by means of noninvasive magnetic drug delivery system

    International Nuclear Information System (INIS)

    Chuzawa, M.; Mishima, F.; Akiyama, Y.; Nishijima, S.

    2011-01-01

    The medication is one of the most general treatment methods, but drugs diffuse in the normal tissues other than the target part by the blood circulation. Therefore, side effect in the medication, particularly for a drug with strong effect such as anti-cancer drug, are a serious issue. Drug Delivery System (DDS) which accumulates the drug locally in the human body is one of the techniques to solve the side-effects. Magnetic Drug Delivery System (MDDS) is one of the active DDSs, which uses the magnetic force. The objective of this study is to accumulate the ferromagnetic drugs noninvasively in the deep part of the body by using MDDS. It is necessary to generate high magnetic field and magnetic gradient at the target part to reduce the side-effects to the tissues with no diseases. The biomimetic model was composed, which consists of multiple model organs connected with diverged blood vessel model. The arrangement of magnetic field was examined to accumulate ferromagnetic drug particles in the target model organ by using a superconducting bulk magnet which can generate high magnetic fields. The arrangement of magnet was designed to generate high and stable magnetic field at the target model organ. The accumulation experiment of ferromagnetic particles has been conducted. In this study, rotating HTS bulk magnet around the axis of blood vessels by centering on the target part was suggested, and the model experiment for magnet rotation was conducted. As a result, the accumulation of the ferromagnetic particles to the target model organ in the deep part was confirmed.

  1. Examining the relationship between ethnicity and the use of drug-related services: an ethnographic study of Nepali drug users in Hong Kong

    Directory of Open Access Journals (Sweden)

    Tang WM

    2014-06-01

    Full Text Available Wai-Man Tang Anthropology Department, The Chinese University of Hong Kong, Hong Kong Abstract: A recent survey has shown that Nepali drug users in Hong Kong tend to have a low rate of usage of day-care and residential rehabilitation services, but a high rate of usage of methadone services. Little is known about the reasons behind such a pattern. Therefore, in this study, a 12-month ethnographic examination has been implemented in three sites, including a day-care center, residential rehabilitation center, and methadone clinic, to explore the experiences of 20 Nepali drug users in their use of drug-related services in Hong Kong and to examine the relationship between ethnicity and the use of drug-related services. The result shows that the reason for this pattern of service use is related to the approach of the services and the cultural perception of the service providers about the service users. The day-care and residential rehabilitation services emphasize an integrated approach, but the staff tend to overlook the heterogeneity of their clients, for example, the differences in caste and sex, and fail to provide suitable services to them, whereas the methadone service follows a biomedical model, which seldom addresses the social characteristics of the service users, which in turn minimizes the opportunity for misunderstandings between the staff and the clients. This research shows that ethnicity is a significant factor in drug treatment and that culture-specific treatment that takes into consideration the treatment approach and the heterogeneity of the clients is strongly needed. Keywords: methadone, residential rehabilitation services, drug treatment, ethnicity, Nepalis

  2. Synergistic Cytotoxicity from Drugs and Cytokines In Vitro as an Approach to Classify Drugs According to Their Potential to Cause Idiosyncratic Hepatotoxicity: A Proof-of-Concept Study.

    Science.gov (United States)

    Maiuri, Ashley R; Wassink, Bronlyn; Turkus, Jonathan D; Breier, Anna B; Lansdell, Theresa; Kaur, Gurpreet; Hession, Sarah L; Ganey, Patricia E; Roth, Robert A

    2017-09-01

    Idiosyncratic drug-induced liver injury (IDILI) typically occurs in a small fraction of patients and has resulted in removal of otherwise efficacious drugs from the market. Current preclinical testing methods are ineffective in predicting which drug candidates have IDILI liability. Recent results suggest that immune mediators such as tumor necrosis factor- α (TNF) and interferon- γ (IFN) interact with drugs that cause IDILI to kill hepatocytes. This proof-of-concept study was designed to test the hypothesis that drugs can be classified according to their ability to cause IDILI in humans using classification modeling with covariates derived from concentration-response relationships that describe cytotoxic interaction with cytokines. Human hepatoma (HepG2) cells were treated with drugs associated with IDILI or with drugs lacking IDILI liability and cotreated with TNF and/or IFN. Detailed concentration-response relationships were determined for calculation of parameters such as the maximal cytotoxic effect, slope, and EC 50 for use as covariates for classification modeling using logistic regression. These parameters were incorporated into multiple classification models to identify combinations of covariates that most accurately classified the drugs according to their association with human IDILI. Of 14 drugs associated with IDILI, almost all synergized with TNF to kill HepG2 cells and were successfully classified by statistical modeling. IFN enhanced the toxicity mediated by some IDILI-associated drugs in the presence of TNF. In contrast, of 10 drugs with little or no IDILI liability, none synergized with inflammatory cytokines to kill HepG2 cells and were classified accordingly. The resulting optimal model classified the drugs with extraordinary selectivity and specificity. Copyright © 2017 by The American Society for Pharmacology and Experimental Therapeutics.

  3. P-glycoprotein interaction with risperidone and 9-OH-risperidone studied in vitro, in knock-out mice and in drug-drug interaction experiments

    DEFF Research Database (Denmark)

    Ejsing, Thomas B.; Pedersen, Anne D.; Linnet, Kristian

    2005-01-01

    P-glycoprotein, risperidone, nortriptyline, cyclosporine A, drug-drug interaction, blood-brain barrier, knock-out mice......P-glycoprotein, risperidone, nortriptyline, cyclosporine A, drug-drug interaction, blood-brain barrier, knock-out mice...

  4. Characterization of Schizophrenia Adverse Drug Interactions through a Network Approach and Drug Classification

    Directory of Open Access Journals (Sweden)

    Jingchun Sun

    2013-01-01

    Full Text Available Antipsychotic drugs are medications commonly for schizophrenia (SCZ treatment, which include two groups: typical and atypical. SCZ patients have multiple comorbidities, and the coadministration of drugs is quite common. This may result in adverse drug-drug interactions, which are events that occur when the effect of a drug is altered by the coadministration of another drug. Therefore, it is important to provide a comprehensive view of these interactions for further coadministration improvement. Here, we extracted SCZ drugs and their adverse drug interactions from the DrugBank and compiled a SCZ-specific adverse drug interaction network. This network included 28 SCZ drugs, 241 non-SCZs, and 991 interactions. By integrating the Anatomical Therapeutic Chemical (ATC classification with the network analysis, we characterized those interactions. Our results indicated that SCZ drugs tended to have more adverse drug interactions than other drugs. Furthermore, SCZ typical drugs had significant interactions with drugs of the “alimentary tract and metabolism” category while SCZ atypical drugs had significant interactions with drugs of the categories “nervous system” and “antiinfectives for systemic uses.” This study is the first to characterize the adverse drug interactions in the course of SCZ treatment and might provide useful information for the future SCZ treatment.

  5. Methodological Study to Develop Standard Operational Protocol on Oral Drug Administration for Children.

    Science.gov (United States)

    Bijarania, Sunil Kumar; Saini, Sushma Kumari; Verma, Sanjay; Kaur, Sukhwinder

    2017-05-01

    To develop standard operational protocol (SOP) on oral drug administration and checklist to assess the implementation of the developed SOP. In this prospective methodological study, SOPs were developed in five phases. In the first phase, the preliminary draft of SOPs and checklists were prepared based on literature review, assessment of current practices and focus group discussion (FGD) with bedside working nurses. In the second phase, content validity was checked with the help of Delphi technique (12 experts). Total four drafts were prepared in stages and necessary modifications were made as per suggestions after each Delphi round. Fourth Delphi round was performed after conducting a pilot study. In the fourth phase, all bedside nurses were trained as per SOPs and asked to practice accordingly and observation of thirty oral drug administrations in children was done to check reliability of checklists for implementation of SOPs. In Phase-V, 7 FGDs were conducted with bedside nurses to assess the effectiveness of SOPs. The Content Validity Index (CVI) of SOP and checklists was 99.77%. Overall standardized Cronbach's alpha was calculated as 0.94. All the nurses felt that the SOP is useful. Valid and feasible SOP for drug administration to children through oral route along with valid and reliable checklist were developed. It is recommended to use this document for drug administration to children.

  6. Polymeric micelles for ocular drug delivery: From structural frameworks to recent preclinical studies.

    Science.gov (United States)

    Mandal, Abhirup; Bisht, Rohit; Rupenthal, Ilva D; Mitra, Ashim K

    2017-02-28

    Effective intraocular drug delivery poses a major challenge due to the presence of various elimination mechanisms and physiological barriers that result in low ocular bioavailability after topical application. Over the past decades, polymeric micelles have emerged as one of the most promising drug delivery platforms for the management of ocular diseases affecting the anterior (dry eye syndrome) and posterior (age-related macular degeneration, diabetic retinopathy and glaucoma) segments of the eye. Promising preclinical efficacy results from both in-vitro and in-vivo animal studies have led to their steady progression through clinical trials. The mucoadhesive nature of these polymeric micelles results in enhanced contact with the ocular surface while their small size allows better tissue penetration. Most importantly, being highly water soluble, these polymeric micelles generate clear aqueous solutions which allows easy application in the form of eye drops without any vision interference. Enhanced stability, larger cargo capacity, non-toxicity, ease of surface modification and controlled drug release are additional advantages with polymeric micelles. Finally, simple and cost effective fabrication techniques render their industrial acceptance relatively high. This review summarizes structural frameworks, methods of preparation, physicochemical properties, patented inventions and recent advances of these micelles as effective carriers for ocular drug delivery highlighting their performance in preclinical studies. Copyright © 2017 Elsevier B.V. All rights reserved.

  7. Metabonomics and drug development.

    Science.gov (United States)

    Ramana, Pranov; Adams, Erwin; Augustijns, Patrick; Van Schepdael, Ann

    2015-01-01

    Metabolites as an end product of metabolism possess a wealth of information about altered metabolic control and homeostasis that is dependent on numerous variables including age, sex, and environment. Studying significant changes in the metabolite patterns has been recognized as a tool to understand crucial aspects in drug development like drug efficacy and toxicity. The inclusion of metabonomics into the OMICS study platform brings us closer to define the phenotype and allows us to look at alternatives to improve the diagnosis of diseases. Advancements in the analytical strategies and statistical tools used to study metabonomics allow us to prevent drug failures at early stages of drug development and reduce financial losses during expensive phase II and III clinical trials. This chapter introduces metabonomics along with the instruments used in the study; in addition relevant examples of the usage of metabonomics in the drug development process are discussed along with an emphasis on future directions and the challenges it faces.

  8. Population and Drugs

    OpenAIRE

    Feberová, Beata

    2008-01-01

    PEOPLE AND DRUGS II. Author: Križanová L. Tutor: Práznovcová L. Dept. of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Kralove, Charles University in Prague, Czech Republic Background: It is necessary to rationalize the system of funding of health service. One of the ways how to achieve this aim is monitoring of drug prescription and patient's financial participation on the therapy. Aim of study: Observation and analysis of drug prescription aimed at the prescription of the drug...

  9. Determination of mu-, delta- and kappa-opioid receptors in forebrain cortex of rats exposed to morphine for 10 days: Comparison with animals after 20 days of morphine withdrawal

    Czech Academy of Sciences Publication Activity Database

    Ujčíková, Hana; Hloušková, Martina; Cechová, Kristina; Stolařová, Kateřina; Roubalová, Lenka; Svoboda, Petr

    2017-01-01

    Roč. 12, č. 10 (2017), č. článku e0186797. E-ISSN 1932-6203 R&D Projects: GA ČR(CZ) GA17-05903S; GA ČR(CZ) GA17-07070S Institutional support: RVO:67985823 Keywords : morphine * rat brain cortex * opioid receptors * drug withdrawal * cholesterol Subject RIV: CE - Biochemistry OBOR OECD: Biochemistry and molecular biology Impact factor: 2.806, year: 2016

  10. Kinetic Degradation and Controlled Drug Delivery System Studies for Sensitive Hydrogels Prepared by Gamma Irradiation

    International Nuclear Information System (INIS)

    Eid, M.; El-Arnaouty, M.B.

    2008-01-01

    Ternary mixtures of N-vinyle-2-pyrrolidone(NVP ), itaconic acid (IA) and gelatin (G) were gamma irradiated to prepared poly(NVP/IA/G) hydrogels. The equilibrium kinetic swelling, drug release behavior, Scan Electron Microscope (SEM) and the swelling-degradation kinetics were studied. Both the diffusion exponent and the diffusion coefficient increase with increasing content of (IA). Also, the swelling behavior of copolymer hydrogels in response to ph value of the external media was studied, it is noted that the highest swelling values at ph 4. The in vitro drug release behavior of these hydrogels was examined by quantification analysis with a UV/VIS spectrophotometers. Chlorpromazine hydrochloride was loaded into dried hydrogels to investigate the stimuli-sensitive property at the specific ph. The release studies show that the highest value of release was at ph 4 which can be used for drug delivery system

  11. Development of PET and SPECT radiopharmaceuticals to study multi-drug resistance (MDR)

    International Nuclear Information System (INIS)

    Katsififs, A.; Dikic, B.; Greguric, I.; Knott, R.; Mattner, F.

    2002-01-01

    Full text: Cellular resistance or Multidrug Resistance (MDR) to cytotoxic agents is the major cause of treatment failure in many human cancers. P-glycoprotein (Pgp), a Mr 17,0000 transmembrane protein and Multi Resistance Protein (MRP) are two proteins that are over expressed and confer resistance to a large number of chemotherapeutic agents by enhancing their extracellular transport. P-glycoprotein is expressed at a relative high level in treated and untreated human malignant tumours, including renal, colonic, adrenal, hepatocellular carcinoma and a considerable percentage of breast carcinomas. 99m Tc-Sestamibi, a lipophilic cationic complex is a transport substrate for Pgp. In clinical studies of human neoplasms it was found that tumour uptake and clearance of this tracer correlate with Pgp expression and may be used for the phenotypic assessment of MDR. However, new tracers with better substrate specificity for Pgp and other drug transporters would greatly assist in optimising chemotherapeutic treatment and improving patient management by predicting tumour response to therapy and to assist in the development of antagonists, which may reverse or halt MDR. The aim of this project is therefore to develop PET and SPECT radiopharmaceuticals with improved affinity and selectivity for Pgp and MRP for the clinical evaluation of MDR in cancer patients. To optimise cellular transport characteristics, a number of chemical families that have been found to be substrates of Pgp and other drug efflux pumps, will be investigated. In the first instance, a series of drugs based on the flavonol natural product, Quercetin will be developed, screened for MDR and radiolabelled with PET and SPECT isotopes. Quercetin and related flavonol derivatives have been selected for this project because of their moderate to good affinity for Pgp. With the assistance of molecular modeling and in vitro studies, structural modification will be undertaken to improve the specificity and affinity for

  12. Concurrent Use of Conventional Drugs with Chinese Herbal Products in Taiwan: A Population-based Study

    Directory of Open Access Journals (Sweden)

    Ming-Chen Chen

    2013-10-01

    Full Text Available The increased use of Chinese herbal products (CHPs worldwide has raised the concern of herb–drug interactions. The aim of this study was to determine the prevalence and utilization patterns of concurrent use of conventional drugs and CHPs in Taiwan. The usage and frequency of services in the co-prescription of a CHP and a conventional drug were evaluated. Subjects were recruited from a simple random sample of 1,000,000 subjects from over 22 million beneficiaries of the National Health Insurance in 2007. The logistic regression method was employed to estimate the odds ratios (ORs for the co-prescription of a CHP and a conventional drug (CH+D and a conventional drug alone (D-alone. The prevalence of the CH+D was 14.1%. Females, regular salary earners, and elderly (65 years and above were more likely to consume a CHP and a conventional drug concurrently. Painkillers, especially acetaminophen, and anti-cough medicines were the top two conventional drugs that were most frequently co-prescribed with a CHP. Anti-cough medication is the most common conventional drug co-prescribed with CHP, after painkillers. We recommend that safety issues be investigated in future research and integrating both healthcare technologies may be beneficial for the overall health and quality of life of patients.

  13. Species differences in drug glucuronidation: Humanized UDP-glucuronosyltransferase 1 mice and their application for predicting drug glucuronidation and drug-induced toxicity in humans.

    Science.gov (United States)

    Fujiwara, Ryoichi; Yoda, Emiko; Tukey, Robert H

    2018-02-01

    More than 20% of clinically used drugs are glucuronidated by a microsomal enzyme UDP-glucuronosyltransferase (UGT). Inhibition or induction of UGT can result in an increase or decrease in blood drug concentration. To avoid drug-drug interactions and adverse drug reactions in individuals, therefore, it is important to understand whether UGTs are involved in metabolism of drugs and drug candidates. While most of glucuronides are inactive metabolites, acyl-glucuronides that are formed from compounds with a carboxylic acid group can be highly toxic. Animals such as mice and rats are widely used to predict drug metabolism and drug-induced toxicity in humans. However, there are marked species differences in the expression and function of drug-metabolizing enzymes including UGTs. To overcome the species differences, mice in which certain drug-metabolizing enzymes are humanized have been recently developed. Humanized UGT1 (hUGT1) mice were created in 2010 by crossing Ugt1-null mice with human UGT1 transgenic mice in a C57BL/6 background. hUGT1 mice can be promising tools to predict human drug glucuronidation and acyl-glucuronide-associated toxicity. In this review article, studies of drug metabolism and toxicity in the hUGT1 mice are summarized. We further discuss research and strategic directions to advance the understanding of drug glucuronidation in humans. Copyright © 2017 The Japanese Society for the Study of Xenobiotics. Published by Elsevier Ltd. All rights reserved.

  14. Hydrophobic Drug-Loaded PEGylated Magnetic Liposomes for Drug-Controlled Release

    Science.gov (United States)

    Hardiansyah, Andri; Yang, Ming-Chien; Liu, Ting-Yu; Kuo, Chih-Yu; Huang, Li-Ying; Chan, Tzu-Yi

    2017-05-01

    Less targeted and limited solubility of hydrophobic-based drug are one of the serious obstacles in drug delivery system. Thus, new strategies to enhance the solubility of hydrophobic drug and controlled release behaviors would be developed. Herein, curcumin, a model of hydrophobic drug, has been loaded into PEGylated magnetic liposomes as a drug carrier platform for drug controlled release system. Inductive magnetic heating (hyperthermia)-stimulated drug release, in vitro cellular cytotoxicity assay of curcumin-loaded PEGylated magnetic liposomes and cellular internalization-induced by magnetic guidance would be investigated. The resultant of drug carriers could disperse homogeneously in aqueous solution, showing a superparamagnetic characteristic and could inductive magnetic heating with external high-frequency magnetic field (HFMF). In vitro curcumin release studies confirmed that the drug carriers exhibited no significant release at 37 °C, whereas exhibited rapid releasing at 45 °C. However, it would display enormous (three times higher) curcumin releasing under the HFMF exposure, compared with that without HFMF exposure at 45 °C. In vitro cytotoxicity test shows that curcumin-loaded PEGylated magnetic liposomes could efficiently kill MCF-7 cells in parallel with increasing curcumin concentration. Fluorescence microscopy observed that these drug carriers could internalize efficiently into the cellular compartment of MCF-7 cells. Thus, it would be anticipated that the novel hydrophobic drug-loaded PEGylated magnetic liposomes in combination with inductive magnetic heating are promising to apply in the combination of chemotherapy and thermotherapy for cancer therapy.

  15. Physician assessments of drug seeking behavior: A mixed methods study.

    Directory of Open Access Journals (Sweden)

    Michael A Fischer

    Full Text Available Pain complaints are common, but clinicians are increasingly concerned about overuse of opioid pain medications. This may lead patients with actual pain to be stigmatized as "drug-seeking," or attempting to obtain medications they do not require medically. We assessed whether patient requests for specific opioid pain medication would lead physicians to classify them as drug-seeking and change management decisions.Mixed-methods analysis of interviews with 192 office-based primary care physicians after viewing video vignettes depicting patients presenting with back pain. For each presentation physicians were randomly assigned to see either an active request for a specific medication or a more general request for help with pain. The main outcome was assignment by the physician of "drug-seeking" as a potential diagnosis among patients presenting with back pain. Additional outcomes included other actions the physician would take and whether the physician would prescribe the medication requested. A potential diagnosis of drug-seeking behavior was included by 21% of physicians seeing a specific request for oxycodone vs. 3% for a general request for help with back pain(p<0.001. In multivariable models an active request was most strongly associated with a physician-assigned diagnosis of drug-seeking behavior(OR 8.10; 95% CI 2.11-31.15;p = 0.002; other major patient and physician characteristics, including gender and race, did not have strong associations with drug-seeking diagnosis. Physicians described short courses of opioid medications as a strategy for managing patients with pain while avoiding opioid overuse.When patients make a specific request for opioid pain medication, physicians are far more likely to suspect that they are drug-seeking. Physician suspicion of drug-seeking behavior did not vary by patient characteristics, including gender and race. The strategies used to assess patients further varied widely. These findings indicate a need for

  16. Financial incentives for generic drugs: case study on a reimbursement program

    Directory of Open Access Journals (Sweden)

    Marcos Inocencio

    2010-06-01

    Full Text Available Objective: To discuss the use of financial incentives in choice of medication and to assess the economic results concerning the use of financial incentives to promote the use of genetic medication in lieu of reference drugs in a company with a reimbursement program. Methods: A case study was carried out in a large supermarket. The data was obtained in the company responsible for managing medication. The study reached 83,625 users between August 2005 and July 2007. The data was submitted to regressions in order to analyze trends and hypothesis tests to assess differences in medication consumption. The results were compared with general data regarding medication consumption of five other organizations and also with data about the national consumption of generic medication in Brazil. Results: The use of financial incentives to replace brand medications for generics, in the company studied, increased the consumption of generic drugs without reducing the company expenses with the reimbursement programs. Conclusions: This study show the occurrence of unplanned results (increase in the consumption of medications and the positive consequences of the reimbursement program concerning access to medication.

  17. Study of drug release and tablet characteristics of silicone adhesive matrix tablets.

    Science.gov (United States)

    Tolia, Gaurav; Li, S Kevin

    2012-11-01

    Matrix tablets of a model drug acetaminophen (APAP) were prepared using a highly compressible low glass transition temperature (T(g)) polymer silicone pressure sensitive adhesive (PSA) at various binary mixtures of silicone PSA/APAP ratios. Matrix tablets of a rigid high T(g) matrix forming polymer ethyl cellulose (EC) were the reference for comparison. Drug release study was carried out using USP Apparatus 1 (basket), and the relationship between the release kinetic parameters of APAP and polymer/APAP ratio was determined to estimate the excipient percolation threshold. The critical points attributed to both silicone PSA and EC tablet percolation thresholds were found to be between 2.5% and 5% w/w. For silicone PSA tablets, satisfactory mechanical properties were obtained above the polymer percolation threshold; no cracking or chipping of the tablet was observed above this threshold. Rigid EC APAP tablets showed low tensile strength and high friability. These results suggest that silicone PSA could eliminate issues related to drug compressibility in the formulation of directly compressed oral controlled release tablets of poorly compressible drug powder such as APAP. No routinely used excipients such as binders, granulating agents, glidants, or lubricants were required for making an acceptable tablet matrix of APAP using silicone PSA. Copyright © 2012 Elsevier B.V. All rights reserved.

  18. Study on optimization design of superconducting magnet for magnetic force assisted drug delivery system

    International Nuclear Information System (INIS)

    Fukui, S.; Abe, R.; Ogawa, J.; Oka, T.; Yamaguchi, M.; Sato, T.; Imaizumi, H.

    2007-01-01

    Analytical study on the design of the superconducting magnet for the magnetic force assisted drug delivery system is presented in this paper. The necessary magnetic field condition to reside the magnetic drug particle in the blood vessels is determined by analyzing the particle motion in the blood vessel. The design procedure of the superconducting magnet for the M-DDS is presented and some case studies are conducted. The analytical results show that the superconducting magnet to satisfy the magnetic field conduction for the M-DDS is practically feasible

  19. Potential Drug-Drug Interactions among Patients prescriptions collected from Medicine Out-patient Setting.

    Science.gov (United States)

    Farooqui, Riffat; Hoor, Talea; Karim, Nasim; Muneer, Mehtab

    2018-01-01

    To identify and evaluate the frequency, severity, mechanism and common pairs of drug-drug interactions (DDIs) in prescriptions by consultants in medicine outpatient department. This cross sectional descriptive study was done by Pharmacology department of Bahria University Medical & Dental College (BUMDC) in medicine outpatient department (OPD) of a private hospital in Karachi from December 2015 to January 2016. A total of 220 prescriptions written by consultants were collected. Medications given with patient's diagnosis were recorded. Drugs were analyzed for interactions by utilizing Medscape drug interaction checker, drugs.com checker and stockley`s drug interactions index. Two hundred eleven prescriptions were selected while remaining were excluded from the study because of unavailability of the prescribed drugs in the drug interaction checkers. In 211 prescriptions, two common diagnoses were diabetes mellitus (28.43%) and hypertension (27.96%). A total of 978 medications were given. Mean number of medications per prescription was 4.6. A total of 369 drug-drug interactions were identified in 211 prescriptions (175%). They were serious 4.33%, significant 66.12% and minor 29.53%. Pharmacokinetic and pharmacodynamic interactions were 37.94% and 51.21% respectively while 10.84% had unknown mechanism. Number wise common pairs of DDIs were Omeprazole-Losartan (S), Gabapentine- Acetaminophen (M), Losartan-Diclofenac (S). The frequency of DDIs is found to be too high in prescriptions of consultants from medicine OPD of a private hospital in Karachi. Significant drug-drug interactions were more and mostly caused by Pharmacodynamic mechanism. Number wise evaluation showed three common pairs of drugs involved in interactions.

  20. Intimate partner violence and prescription of potentially addictive drugs: prospective cohort study of women in the Oslo Health Study

    Science.gov (United States)

    Dyb, Grete; Tverdal, Aage; Jacobsen, Geir Wenberg; Schei, Berit

    2012-01-01

    Objectives To investigate the prescription of potentially addictive drugs, including analgesics and central nervous system depressants, to women who had experienced intimate partner violence (IPV). Design Prospective population-based cohort study. Setting Information about IPV from the Oslo Health Study 2000/2001 was linked with prescription data from the Norwegian Prescription Database from 1 January 2004 through 31 December 2009. Participants The study included 6081 women aged 30–60 years. Main outcome measures Prescription rate ratios (RRs) for potentially addictive drugs derived from negative binomial models, adjusted for age, education, paid employment, marital status, chronic musculoskeletal pain, mental distress and sleep problems. Results Altogether 819 (13.5%) of 6081 women reported ever experiencing IPV: 454 (7.5%) comprised physical and/or sexual IPV and 365 (6.0%) psychological IPV alone. Prescription rates for potentially addictive drugs were clearly higher among women who had experienced IPV: crude RRs were 3.57 (95% CI 2.89 to 4.40) for physical/sexual IPV and 2.13 (95% CI 1.69 to 2.69) for psychological IPV alone. After full adjustment RRs were 1.83 (1.50 to 2.22) for physical/sexual IPV, and 1.97 (1.59 to 2.45) for psychological IPV alone. Prescription rates were increased both for potentially addictive analgesics and central nervous system depressants. Furthermore, women who reported IPV were more likely to receive potentially addictive drugs from multiple physicians. Conclusions Women who had experienced IPV, including psychological violence alone, more often received prescriptions for potentially addictive drugs. Researchers and clinicians should address the possible adverse health and psychosocial impact of such prescription and focus on developing evidence-based healthcare for women who have experienced IPV. PMID:22492384