Ciofi degli Atti, Marta Luisa; Massari, Marco; Bella, Antonino; Boccia, Delia; Filia, Antonietta; Salmaso, Stefania
Collecting information on patterns of drug prescriptions and on factors influencing prescribing decisions is fundamental for supporting the rational use of drugs. This study was aimed at investigating patterns of drug prescription in paediatric outpatients and at evaluating determinants of prescriptions for respiratory tract infections (RTIs). We conducted a national cross-sectional survey involving primary care paediatricians and parents. Diagnoses and prescriptions made at each consultation were described. Poisson regression models were used to analyse determinants of drug and antibiotic prescriptions for visits due to RTIs. A total of 4,302 physician and parent questionnaires were analysed. These corresponded to 2,151 visits, 792 of which were due to RTIs. Drugs were prescribed in 83.4% of RTI visits, while antibiotics were prescribed in 40.4%. According to paediatricians' perceptions, 84.2% of parents of children with a RTI expected to receive a drug prescription. Paediatricians' perception of parental expectations was the strongest determinant for prescription of drugs and specifically of antibiotics [adjusted relative risk (RR): 1.7 and 3.6, respectively; P decision to prescribe. This study underscores that relational factors, in particular perceived parental expectations, are one of the leading factors of drug prescriptions in paediatric ambulatory care settings, reinforcing the opinion that communication between physicians and parents can affect prescription patterns.
Substance use disorder - prescription drugs; Substance abuse - prescription drugs; Drug abuse - prescription drugs; Drug use - prescription drugs; Narcotics - substance use; Opioid - substance use; Sedative - substance ...
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
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.
... drug abuse. And it's illegal, just like taking street drugs. Why Do People Abuse Prescription Drugs? Some people abuse prescription drugs ... common risk of prescription drug abuse is addiction . People who abuse ... as if they were taking street drugs. That's one reason most doctors won't ...
... different competition is going on: the National Football League (NFL) vs. drug use. Read More » 92 Comments ... Future survey highlights drug use trends among the Nation’s youth for marijuana, alcohol, cigarettes, e-cigarettes (e- ...
U.S. Department of Health & Human Services — This release contains the Prescription Drug Profiles Public Use Files (PUFs) drawn from Medicare prescription drug claims for the year of the date on which the...
... what the doctor prescribed, it is called prescription drug abuse. It could be Taking a medicine that ... purpose, such as getting high Abusing some prescription drugs can lead to addiction. These include opioids, sedatives, ...
Head, Paediatric Cardiology Service of the Western Cape, Department of Paediatrics and Child Health, ... His interests also include the care of complex patients ... The pharmacy only has enalapril available – can you substitute this drug for the ...
Wilford, B B
An estimated 3% of the United States population deliberately misuse or abuse psychoactive medications, with severe consequences. According to the National Institute on Drug Abuse, more than half of patients who sought treatment or died of drug-related medical problems in 1989 were abusing prescription drugs. Physicians who contribute to this problem have been described by the American Medical Association as dishonest--willfully misprescribing for purposes of abuse, usually for profit; disabled by personal problems with drugs or alcohol; dated in their knowledge of current pharmacology or therapeutics; or deceived by various patient-initiated fraudulent approaches. Even physicians who do not meet any of these descriptions must guard against contributing to prescription drug abuse through injudicious prescribing, inadequate safeguarding of prescription forms or drug supplies, or acquiescing to the demands or ruses used to obtain drugs for other than medical purposes. PMID:2349801
Wilford, B B
An estimated 3% of the United States population deliberately misuse or abuse psychoactive medications, with severe consequences. According to the National Institute on Drug Abuse, more than half of patients who sought treatment or died of drug-related medical problems in 1989 were abusing prescription drugs. Physicians who contribute to this problem have been described by the American Medical Association as dishonest--willfully misprescribing for purposes of abuse, usually for profit; disable...
... were prescribed to someone else or if your child is already taking other prescription medications. Set rules. Let your teen know that it's not OK to share medications with others — or to take drugs prescribed for others. Emphasize the importance of taking the prescribed dose and talking with ...
Hughes, G; Spoudeas, H; Kovar, I Z; Millington, H T
A tape measure, based on 50th centile weight for height and designed to permit easy drug dosage calculation, endotracheal tube size and DC cardioversion current dosages in childrens' emergencies, was tested for reliability by medical and nursing staff with varying paediatric experience. We found that the tape measure gave a reproducible estimate of weight and suggest that its use would facilitate decision making by inexperienced medical and nursing staff in paediatric resuscitation when there...
Sadiqua Anjum, Nasir Mohiuddin M, Narayan Reddy U, Narsing Rao J, Sana Afreen, Mir S Adil, Javeedullah M
Full Text Available Introduction: Medical prescriptions are bound to be misinterpreted by patients and pharmacists if not properly conveyed. Pediatric prescriptions differ from adult prescriptions having wide variation in doses and formulations. There is a need to evaluate the lacunae in the parental understanding of pediatric prescriptions. Aims and objective: To evaluate the parental understanding of pediatric prescription and to evaluate the adequacy of communication with the physician and pharmacist regarding the same. Material and methods: 550 parents were enrolled and their literacy level was noted. They were subjected to modify MUSE questionnaire. Physician’s prescription was analyzed in terms of ease of understanding by parents. These parents were followed up till the pharmacies and the pharmacist understanding of prescription was analyzed and their communication with parents regarding drug usage was noted. Finally, ease of usage of drugs by parents was noted. Results: MUSE scale was modified to suit pediatric prescription understanding by parents and also additional questions were asked to include complete parental understanding of doctor’s prescription. Majority of parents failed to completely understand the written prescription. Though around 80% of pharmacist could understand the prescription, their communication with parents was poor resulting in difficulty for parents to even enquire about medicines from them. Parental overall understanding of prescription increased with their literacy levels. Conclusion: Not all prescriptions are completely understood by parents as well as a pharmacist. This can lead to misuse of drugs. Efforts to explain the drug usage are not adequate enough from the doctor or the pharmacist. While communicating literacy levels of parents is not being considered which may further worsen the understanding ability
Comet, D; Casajuana, J; Bordas, J M; Fuentes, M A; Arnáiz, J A; Núñez, B; Pou, R
Application of computerized program for detection of potential drug interactions (PDI) in chronic prescriptions in four primary care centers. To evaluate the clinical significance of PDI identified according to clinical criterions. An observational crossover study. Clutat Vella health district (City of Barcelona). Using information of Consejo General de Colegios Oficiales de Farmaceuticos databases and the chronic prescriptions database of the primary care centers, computerized drug-interaction system have been developed for detection of PDI in patients. A panel of primary care physicians and clinical pharmacists developed criteria that were used to evaluate the clinical significance of PDI. 9840 Cards of Authorized Prescription (CAP) were analyzed, 36108 medicaments and 42877 drugs. A total of 2140 patients were involved for a total of 3406 PDI, 21.75% of patients with CAP. Clinical signification for the panel was found in 40.07% of these 3406 PIF; 3.78% were suggest to avoid the association drugs. The incidence of PDI with clinical signification are lower than other studies of the literature; it suggest a appropriate knowledge of drug prescription. The application of computerized program make much more easy the detection of adverse drug interactions in chronic prescription.
Department of Justice, Washington, DC. National Drug Intelligence Center.
Prescription drugs, a category of psychotherapeutics that comprises prescription-type pain relievers, tranquilizers, stimulants, and sedatives, are among the substances most commonly abused by young people in the United States. Prescription drugs are readily available and can easily be obtained by teenagers who abuse these drugs to experience a…
This article provides an overview on prescription drug abuse and highlights a number of related legislative bills introduced during the 112th Congress in response to this growing epidemic. Prescription drug abuse has emerged as the nation's fastest growing drug problem. Although prescription drugs have been used effectively and appropriately for decades, deaths from prescription pain medicine in particular have reached epidemic proportions. Bills related to prescription drug abuse introduced during the 112th Congress focus on strengthening provider and consumer education, tracking and monitoring prescription drug abuse, improving data collection on drug overdose fatalities, combating fraud and abuse in Medicare and Medicaid programs, reclassifying drugs to make them more difficult to prescribe and obtain, and enforcing stricter penalties for individuals who operate scam pain clinics and sell pain pills illegitimately. This article underscores the importance of a multifaceted approach to combating prescription drug abuse and concludes with implications for nursing. Copyright © 2013. Published by Mosby, Inc.
... Branded Prescription Drug Fee AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Notice of proposed... issue of the Federal Register, the IRS is issuing temporary regulations relating to the branded... business of manufacturing or importing certain branded prescription drugs. The text of the temporary...
U.S. Department of Health & Human Services — The MMA legislation provides seniors and people with disabilities with the first comprehensive prescription drug benefit ever offered under the Medicare program, the...
McCabe, Sean Esteban; Boyd, Carol J.; Teter, Christian J.
This study used three characteristics (i.e., motive, route of administration, and co-ingestion with alcohol) of nonmedical prescription drug misuse across four separate classes (i.e., pain, sedative/anxiety, sleeping and stimulant medications) to examine subtypes and drug related problems. A Web survey was self-administered by a randomly selected sample of 3,639 undergraduate students attending a large Midwestern 4-year U.S. university. Self-treatment subtypes were characterized by motives consistent with the prescription drug's pharmaceutical main indication, oral only routes of administration, and no co-ingestion with alcohol. Recreational subtypes were characterized by recreational motives, oral or non-oral routes, and co-ingestion. Mixed subtypes consisted of other combinations of motives, routes, and co-ingestion. Among those who reported nonmedical prescription drug misuse, approximately 13% were classified into the recreational subtype, while 39% were in the self-treatment subtype, and 48% were in the mixed subtype. There were significant differences in the subtypes in terms of gender, race and prescription drug class. Approximately 50% of those in subtypes other than self-treatment screened positive for drug abuse. The odds of substance use and abuse were generally lower among self-treatment subtypes than other subtypes. The findings indicate subtypes should be considered when examining nonmedical prescription drug misuse, especially for pain medication. PMID:19278795
... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Prescription-drug advertisements. 202.1 Section 202.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL PRESCRIPTION DRUG ADVERTISING § 202.1 Prescription-drug advertisements. (e) * * * (6) * * * (ii) Represents or suggests that a...
Greenberg, R B
The Prescription Drug Marketing Act of 1987 is described, and its implications for hospitals and other health-care entities are discussed. The act, which became effective on July 21, 1988, is intended to reduce public health risks from adulterated, misbranded, and counterfeit drug products that enter the marketplace through drug diversion. The law provides that prescription drug products manufactured in the United States and exported can no longer be reimported, except by the product's manufacturer. It also establishes restrictions on sales of prescription drug products and samples. Samples of prescription drug products may be distributed only if a licensed prescriber requests them. Other distribution channels for samples specified in the law are permissible, provided records are maintained. Under the law, wholesale distributors must be licensed by the state and meet uniform standards. Penalties for violations of the law are also identified. According to FDA's advisory guidelines on the statute, the law will permit hospitals to return drug products, provided the return is made to the manufacturer or wholesaler and provided written notice is secured that the goods were received (for manufacturers) or the goods were destroyed or returned to the manufacturer (for wholesalers). The final chapter on drug diversion must await issuance of final FDA regulations.
Simonsen, Marianne; Skipper, Lars; Skipper, Niels
We investigate price sensitivity of demand for prescription drugs, using drug purchase records for the entire Danish population. We identify price responsiveness by exploiting variation in prices caused by kinked reimbursement schemes and implement a regression kink design. The results suggest some...... price responsiveness with corresponding price elasticities ranging from −0.2 to −0.7. Individuals with chronic disease and especially individuals above the age of 65 respond less to the price of drugs....
Skipper, Lars; Simonsen, Marianne; Skipper, Niels
This paper investigates price sensitivity of demand for prescription drugs using drug purchase records for at 20% random sample of the Danish population. We identify price responsiveness by exploiting exogenous variation in prices caused by kinked reimbursement schemes and implement a regression ...... education and income are, however, more responsive to the price. Also, essential drugs that prevent deterioration in health and prolong life have lower associated average price sensitivity....
Lindsey, Wesley T; Stewart, David; Childress, Darrell
The aim was to summarize the clinical literature on interactions between common illicit drugs and prescription therapies. Medline, Iowa Drug Information Service, International Pharmaceutical Abstracts, EBSCO Academic Search Premier, and Google Scholar were searched from date of origin of database to March 2011. Search terms were cocaine, marijuana, cannabis, methamphetamine, amphetamine, ecstasy, N-methyl-3,4-methylenedioxymethamphetamine, methylenedioxymethamphetamine, heroin, gamma-hydroxybutyrate, sodium oxybate, and combined with interactions, drug interactions, and drug-drug interactions. This review focuses on established clinical evidence. All applicable full-text English language articles and abstracts found were evaluated and included in the review as appropriate. The interactions of illicit drugs with prescription therapies have the ability to potentiate or attenuate the effects of both the illicit agent and/or the prescription therapeutic agent, which can lead to toxic effects or a reduction in the prescription agent's therapeutic activity. Most texts and databases focus on theoretical or probable interactions due to the kinetic properties of the drugs and do not fully explore the pharmacodynamic and clinical implications of these interactions. Clinical trials with coadministration of illicit drugs and prescription drugs are discussed along with case reports that demonstrate a potential interaction between agents. The illicit drugs discussed are cocaine, marijuana, amphetamines, methylenedioxymethamphetamine, heroin, and sodium oxybate. Although the use of illicit drugs is widespread, there are little experimental or clinical data regarding the effects of these agents on common prescription therapies. Potential drug interactions between illicit drugs and prescription drugs are described and evaluated on the Drug Interaction Probability Scale by Horn and Hansten.
Malm, Heli; Martikainen, Jaana; Klaukka, Timo; Neuvonen, Pertti J
Prescribing drugs to pregnant women requires the balancing of benefits and risks. Only a small proportion of drugs are known to be harmful to the fetus, but for the vast majority of drugs little evidence of fetal safety exists. To determine the prescription pattern of potentially and clearly harmful prescription drugs during pregnancy with reference to drug safety categorisation, and to define the drug groups primarily responsible for multiple drug use during pregnancy. A retrospective, register-based cohort study. Linkage of three nationwide registers in Finland. Data collection included prescription drugs purchased during the preconception period and each trimester in the pregnant cohort, and the corresponding time periods in the non-pregnant controls. The pregnancy safety categorisation was determined for each drug (Anatomic Therapeutic Chemical [ATC] code) by using the Swedish classification of approved medicinal products (Farmaceutiska Specialiteter i Sverige [FASS]) and if not available, the corresponding Australian (Australian Drug Evaluation Committee [ADEC]) or US categorisation (FDA). GROUPS STUDIED: Women applying for maternity support (maternal grants) during the year 1999 (n = 43 470) plus non-pregnant control women matched by age and hospital district (n = 43 470). In the pregnant cohort, 20.4% of women purchased at least one drug classified as potentially harmful during pregnancy, and 3.4% purchased at least one drug classified as clearly harmful. A significant decline occurred in the number of pregnant women purchasing potentially and clearly harmful drugs during the first trimester when compared with the preconception period, and the decline continued from the first to the second trimester. In the pregnant cohort, 107 (0.2%) women purchased at least ten different drugs during pregnancy. The drugs most commonly purchased in this group were topical corticosteroids and nasal preparations. The use of hazardous prescription drugs declines during
Wetterling, Tilman; Schneider, Barbara
Due to demographic changes there will be a fraction of elderly patients with substance use disorders. However, only a few data have been published about elderly abusers of prescription drugs. Since substance abuse is frequently comorbid with psychiatric disorders, treatment in a psychiatric hospital is often needed. In this explorative study elderly people with prescription drug abuse who required psychiatric inpatient treatment should be characterized. This study was part of the gerontopsychiatry study Berlin (Gepsy-B), an investigation of the data of all older inpatients (≥ 65 years) admitted to a psychiatric hospital within a period of 3 years. Among 1266 documented admissions in 110 cases (8.7 %) (mean age: 75.7 ± 7.1 years) prescription drug abuse, mostly of benzodiazepines was diagnosed. Females showed benzodiazepine abuse more often than males. In only a small proportion of the cases the reason for admission was withdrawal of prescribed drugs. 85.5 % suffered from psychiatric comorbidity, mostly depression. As risk factors for abuse depressive symptoms (OR: 3.32) as well as concurrent nicotine (OR: 2.69) or alcohol abuse (OR: 2.14) were calculated. Psychiatric inpatient treatment was primarily not necessary because of prescription drug abuse but because of other psychopathological symptoms. © Georg Thieme Verlag KG Stuttgart · New York.
... differences (p>0.05) in the prescription rates of the hospitals. The most commonly used antibiotics were beta-lactams (57.3%), aminoglycosides (28.3%) and co-trimoxazole (9.4%). Antibiotics were prescribed in all cases of bronchopneumonia, fever, sepsis and acute gastroenteritis. For malaria and undefined diagnoses, ...
Kolek, Ethan A.
The purpose of this study was to explore recreational prescription drug use among undergraduate students. Although anecdotal accounts on this subject abound, empirical research is extremely limited. Data from a survey of a random sample of 734 students at a large public research university in the Northeast were examined. Results indicate that a…
Full Text Available The aging process changes the way in which common drugs act in the elderly. Changes in both the pharmacokinetics and pharmacodynamics make prescribing drugs in geriatrics a process very different from that of the young adult. The aim of this article is to review the physiologic changes that occur with aging and that must be considered when indicating drugs in this age group. For this purpose we conducted a literature review of articles from various journals and textbooks devoted to geriatric medicine in order to extract recommendations for appropriate prescribing in the elderly, represented in easy to use listings of potentially inappropriate medications, according to the quality of evidence and rationale for their avoidance in advanced age.
... to know what your insurance company is paying…Health Insurance: Understanding What It CoversRead Article >>Insurance & BillsHealth Insurance: Understanding What It CoversYour insurance policy lists a package of medical benefits such as tests, drugs, and treatment services. These ...
Worley, Julie; Thomas, Sandra P
Doctor shopping is a term used to describe a form of diversion of prescription drugs when patients visit numerous prescribers to obtain controlled drugs for illicit use. Gender differences exist in regard to prescription drug abuse and methods of diversion. The purpose of this phenomenological study guided by the existential philosophy of Merleau-Ponty was to understand the lived experience of female doctor shoppers. Interviews were conducted with 14 women, which were recorded, transcribed, and analyzed. Included in the findings are figural aspects of the participants' experience of doctor shopping related to the existential grounds of world, time, body, and others. Four themes emerged from the data: (a) feeding the addiction, (b) networking with addicts, (c) playing the system, and (d) baiting the doctors. The findings suggest several measures that nurses can take to reduce the incidence of doctor shopping and to provide better care for female doctor shoppers.
U.S. Department of Health & Human Services — These public use files contain formulary, pharmacy network, and pricing data for Medicare Prescription Drug Plans and Medicare Advantage Prescription Drug Plans...
...] Prescription Drug User Fee Act; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of... Prescription Drug User Fee Act (PDUFA). The legislative authority for PDUFA expires in September 2012. At that time, new legislation will be required for FDA to continue collecting user fees for the prescription...
L G S Monteiro
Full Text Available Background. The need for healthcare in paediatric patients is often due to respiratory diseases, acute diarrhoea and viral fever, which suggests a limited need for the use of antibiotics. Objectives. To identify the determinants of antibiotic prescription in hospitalised paediatric patients in Mozambique. Methods. A cross-sectional study was conducted between January and June 2015. A total of 454 medical prescriptions and clinical records of children aged 0 - 14 years from Hospital Central de Maputo (HCM and Hospital Geral de Mavalane (HGM were analysed. Results. Antibiotics were used in 97.6% of the patients, with no significant differences (p>0.05 in the prescription rates of the hospitals. The most commonly used antibiotics were beta-lactams (57.3%, aminoglycosides (28.3% and co-trimoxazole (9.4%. Antibiotics were prescribed in all cases of bronchopneumonia, fever, sepsis and acute gastroenteritis. For malaria and undefined diagnoses, antibiotics were prescribed 97.8% and 99.3% of cases, respectively. It was clear that most severe clinical conditions (odds ratio (OR 9.06; 1.13 - 12.14 and age <5 years (OR 5.47;1.54 - 7.60 were treated with antibiotics. Conclusion. The prescription of antibiotics for paediatric patients at both HCM and HGM was largely influenced by patients’ clinical condition and age. It showed that physicians used an empirical approach, in the absence of laboratory tests, often leading to unnecessary antibiotic treatments with negative causative effects. Physicians should be encouraged to use an evidence-based approach for managing the cases correctly.
Christensen, Morten Bondo; Nørøxe, Karen Busk; Moth, Grete
of prescriptions per 100 contacts. RESULTS: Of 644,777 contacts, 154,668 (24.0%) involved medication prescriptions; 21.9% of telephone consultations, 32.9% of clinic consultations and 14.3% of home visits. Around 53% of all drug prescriptions were made in telephone consultations. Anti-infective medications...... for systemic use accounted for 45.5% of all prescriptions and were the most frequently prescribed drug group for all contact types, although accounting for less than 1/3 of telephone prescriptions. Other frequently prescribed drugs were ophthalmological anti-infectives (10.5%), NSAIDs (6.4%), opioids (3......) primary care services cover more than 75% of all hours during a normal week, insight into the extent and type of OOH drug prescription is important. General practitioners (GPs) are responsible for more than 80% of all drug prescriptions in Denmark. Of all contacts 24.0% involved medication prescriptions...
Siu, Emily; Sadasivam, Kalaimaran; Christiansen, Nanna
Prescription errors, including continuous infusion prescriptions are one major source of concern in the paediatric population. Evidence suggests that use of an electronic or web-based calculator could minimise these errors. In our paediatric critical care unit (PCCU) we have created an electronic continuous infusion prescription chart to target errors in this area and conducted an audit to assess its effect on error reduction. To create an electronic continuous infusion prescription chart and audit its effect on prescription errors. Similar electronic continuous infusion prescription charts were evaluated. A Choice of electronic formats were considered and excel was chosen for its simplicity and flexibility. The choice of medications to be included, dilution method, and dosage range was agreed between PCCU consultant, pharmacy and nursing staff. Formulas for calculating each medication infusion was created and validated for different age and weight ranges by at least 2 PCCU trained pharmacists, accounting for capping at certain age and weight bands as appropriate for the medication. These were programmed into the spreadsheet for automatic calculation using inputted age and weight for the selected medications. Continuous infusion prescriptions were audited 6 months before and after implementation in April 2015 of this electronic chart. Parameters audited include medication dose, infusion rate, concentration, route, legibility, and missing or incorrect patient details. A trial period of 4 weeks preceded implementation. The electronic continuous infusion prescription form was created and used on PCCU. Hand written prescriptions had higher error rate (30.7%) as compared to electronic charts (0.7%) with a p-value <0.002. No errors were found in electronic prescriptions in regards to dose, volume and rate calculation. The use of an electronic continuous infusion prescription chart has been successfully set up and used on PCCU. Its use has significantly reduced continuous
Full Text Available R Guzmán-Álvarezv,1 M Medeiros,2,3 LI Reyes Lagunes,4 AE Campos-Sepúlveda11Pharmacology Department, UNAM School of Medicine and Dentistry, Mexico City, 2Pharmacology Clinical Seminar, UNAM School of Medicine, Mexico City, 3Medical Sciences Department, Mexico Federico Gómez Children's Hospital, Mexico City, 4Measuring and Evaluation Unit, UNAM School of Psychology, Mexico City, MexicoBackground: Students in schools of dentistry attend to patients with illnesses, and often prescribe medication. Because students are still learning, they are influenced by a variety of factors: the different teaching approaches of the professors at the clinics and in the pharmacology course, fellow students, and even the information provided by the pharmaceutical industry.Objectives: The aim of this pilot study was to assess the prescription knowledge and common mistakes in fourth-year students at the School of Dentistry at the Universidad Nacional Autónoma de México.Methods: In March 2010, a survey was conducted among 66 fourth-year students at the School of Dentistry, applying a previously validated questionnaire consisting of six open-ended questions The following factors were assessed: the most frequent illness requiring dental prescription; the most prescribed nonsteroidal anti-inflammatory drugs and antibiotics; the most frequent errors; sources of information used for prescribing drugs; and whether the students knew and followed the World Health Organization Guide to Good Prescribing.Results: The most frequent response for each question was considered the most significant. The most common reason for prescribing medication was infection (n = 37, 56%, followed by pain (n = 24, 38%; the most used painkillers were ibuprofen and acetaminophen at equal levels (n = 25, 37.8%, followed by ketorolac (n = 7, 10.6%, naproxen (n = 6, 9.1%, diclofenac (n = 2, 3%, and aspirin (n = 1, 1.5%; the most widely prescribed antibiotics were amoxicillin (n = 52, 78
Huskamp, Haiden A; Keating, Nancy L; Dalton, Jesse B; Chernew, Michael E; Newhouse, Joseph P
Medicare Advantage prescription drug plans (MA-PDs) and standalone prescription drug plans (PDPs) face different incentives for plan design resulting from the scope of covered benefits (only outpatient drugs for PDPs versus all drug and nondrug services for Medicare Advantage [MA]/MA-PDs). The objective is to begin to explore how MA-PDs and PDPs may be responding to their different incentives related to benefit design. We compared 2012 PDP and MA-PD average formulary coverage, prior authorization (PA) or step therapy use, and copayment requirements for drugs in 6 classes used commonly among Medicare beneficiaries. We primarily used 2012 Prescription Drug Plan Formulary and Pharmacy Network Files and MA enrollment data. 2011 Truven Health MarketScan claims were used to estimate drug prices and to compute drug market share. Average coverage and PA/step rates, and average copayment requirements, were weighted by plan enrollment and drug market share. MA-PDs are generally more likely to cover and less likely to require PA/step for brand name drugs with generic alternatives than PDPs, and MA-PDs often have lower copayment requirements for these drugs. For brands without generics, we generally found no differences in average rates of coverage or PA/step, but MA-PDs were more likely to cover all brands without generics in a class. We found modest, confirmatory evidence suggesting that PDPs and MA-PDs respond to different incentives for plan design. Future research is needed to understand the factors that influence Medicare drug plan design decisions.
McHugh, R. Kathryn; Nielsen, Suzanne; Weiss, Roger D.
Prescription drug abuse has reached an epidemic level in the United States. The prevalence of prescription drug abuse escalated rapidly beginning in the late 1990s, requiring a significant increase in research to better understand the nature and treatment of this problem. Since this time, a research literature has begun to develop and has provided important information about how prescription drug abuse is similar to, and different from the abuse of other substances. This introduction to a spe...
Gabriele Camera; Bryan Engelhardt
The illicit nonmedical use of prescription drugs is studied in a model where individuals with imperfectly observable health conditions seek prescription drugs for either medical or nonmedical reasons. The equilibrium number of medical and nonmedical users is endogenous and depends on economic and non-economic barriers to drugs consumption, such as pricing, health care costs, refill policies, monitoring programs, and the medical community’s prescription standards. The results show policies cen...
Background: There is an increasing incidence of irrational drug use worldwide. The drug prescription pattern in Nigeria is characterised by inappropriate drug use which has led to increasing expenditure and loss of patient confidence in the health sector. This has led to calls to improve prescription patterns in Nigerian ...
Nielsen, Lars Hougaard; Løkkegaard, Ellen; Andreasen, Anne Helms
Pharmacoepidemiological studies often use prescription registries to assess patients' drug episodes. The databases usually provide information on the date of the redemption of the prescription as well as on the dispensed amount, and this allows us to define episodes of drug use. However, when...... that the retrospective exposure definition introduces an artificially protective effect of HT....
Karjalainen, Karoliina; Haukka, Jari; Lintonen, Tomi; Joukamaa, Matti; Lillsunde, Pirjo
The study seeks to increase understanding of the use of psychoactive prescription drugs among persons suspected of driving under the influence (DUI). We studied whether the use of prescribed psychoactive medication was associated with DUI, and examined the difference in the use of prescription drugs between DUI recidivists and those arrested only once. In this register-based study, persons suspected of DUI (n=29470) were drawn from the Register of DUI suspects, and an age- and gender-matched reference population (n=30043) was drawn from the Finnish general population. Data on prescription drug use was obtained by linkage to the National Prescription Register. The associations of DUI arrest and use of psychoactive prescription drugs in different DUI groups (findings for alcohol only, prescription drugs, prescription drugs and alcohol, illicit drugs) were estimated by using mixed-effect logistic regression. The use of psychoactive prescription drugs and DUI appeared to be strongly associated, with DUI suspects significantly more likely to use psychoactive prescription drugs compared to the reference population. Gender differences existed, with the use of benzodiazepines being more common among female DUI suspects. Moreover, DUI recidivists were more likely to use psychoactive prescription drugs compared to those arrested only once. In addition to alcohol and/or illicit drug use, a significant proportion of DUI suspects were using psychoactive prescription drugs. When prescribing psychoactive medication, especially benzodiazepines, physicians are challenged to screen for possible substance use problems and also to monitor for patients' alcohol or illicit drug use while being medicated. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.
Haslund-Krog, Sissel; Mathiasen, René; Christensen, Hanne Rolighed; Holst, Helle
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.
Full Text Available Faika Zanjani,1,2 Aasha I Hoogland,1 Brian G Downer11Department of Gerontology, 2Building Interdisciplinary Research Careers in Women's Health University of Kentucky, Lexington, KY, USABackground: The objectives of this study were to investigate older adults' knowledge of prescription drug safety and interactions with alcohol, and to identify pharmacists' willingness to disseminate prescription drug safety information to older adults.Methods: The convenience sample consisted of 48 older adults aged 54–89 years who were recruited from a local pharmacy and who completed surveys addressing their alcohol consumption, understanding of alcohol and prescription drug interactions, and willingness to change habits regarding alcohol consumption and prescription drugs. To address pharmacist willingness, 90 pharmacists from local pharmacies volunteered and answered questions regarding their willingness to convey prescription drug safety information to older adults.Results: Older adults reported low knowledge of alcohol and prescription drug safety, with women tending to be slightly more knowledgeable. More importantly, those who drank in the previous few months were less willing to talk to family and friends about how alcohol can have harmful interactions with prescription drugs, or to be an advocate for safe alcohol and prescription drug use than those who had not had a drink recently. Pharmacists reported that they were willing to convey prescription drug safety information to older adults via a variety of formats, including displaying or distributing a flyer, and directly administering a brief intervention.Conclusion: In this study, older adults were found to have inadequate knowledge of prescription drug safety and interactions with alcohol, but pharmacists who regularly come in contact with older adults indicated that they were ready and willing to talk to older adults about prescription drug safety. Future research should focus on interventions
Nales, D.A.; Kozarewicz, Piotr; Aylward, Brian; de Vries, Rutger; Egberts, Toine C G; Rademaker, Carin M A; Schobben, Alfred F A M
The availability of licensed paediatric drugs is lagging behind those for adults, and there is a lack of safe formulations in suitable doses that children are able and willing to take. As a consequence, children are commonly treated with off-label or unlicensed drugs. As off-label and unlicensed
van Riet-Nales, Diana A.; Kozarewicz, Piotr; Aylward, Brian; de Vries, Rutger; Egberts, Toine C G; Rademaker, Carin M A; Schobben, Alfred F A M
The availability of licensed paediatric drugs is lagging behind those for adults, and there is a lack of safe formulations in suitable doses that children are able and willing to take. As a consequence, children are commonly treated with off-label or unlicensed drugs. As off-label and unlicensed
Office of National Drug Control Policy, 2007
This report synthesizes a number of national studies that show the intentional abuse of prescription drugs to get high is a growing concern, particularly among teens. The analysis shows that teens are turning away from street drugs and using prescription drugs to get high. New users of prescription drugs have caught up with new users of marijuana.…
Richard M. Reisman
Full Text Available Context The dramatic rise in the use of prescription opioids to treat non-cancer pain has been paralleled by increasing prescription opioid abuse. However, detailed analyses of these trends and programs to address them are lacking. Objective To study the association between state shipments of prescription opioids for medical use and prescription opioid abuse admissions and to assess the effects of state prescription drug monitoring programs (PDMPs on prescription opioid abuse admissions. Design and Setting A retrospective ecological cohort study comparing state prescription opioid shipments (source: Automation of Reports and Consolidated Orders Systems database and inpatient admissions for prescription opioid abuse (source: Treatment Episode Data Set in 14 states with PDMPs (intervention group and 36 states without PDMPs (control group for the period 1997–2003. Results From 1997 to 2003, oxycodone, morphine, and hydrocodone shipments increased by 479%, 100%, and 148% respectively. Increasing prescription oxycodone shipments were significantly associated with increasing prescription opioid admission rates (p < 0.001. PDMP states had significantly lower oxycodone shipments than the control group. PDMP states had less increase in prescription opioid admissions per year (p = 0.063. A patient admitted to an inpatient drug abuse rehabilitation program in a PDMP state was less likely to be admitted for prescription opioid drug abuse (Odds ratio = 0.775, 95% Confidence Interval 0.764–0.785. Conclusions PDMPs appear to decrease the quantity of oxycodone shipments and the prescription opioid admission rate for states with these programs. Overall, opioid shipments rose significantly in PDMP states during the study period indicating a negligible “chilling effect” on physician prescribing.
... 42 Public Health 3 2010-10-01 2010-10-01 false Electronic prescription drug program. 423.159 Section 423.159 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Cost Control and Quality...
Park, Nicholas K.; Melander, Lisa; Sanchez, Shanell
Prescription drug misuse has been an increasing problem in the United States, yet few studies have examined the protective factors that reduce risk of prescription drug abuse among rural adolescents. Using social control theory as a theoretical framework, we test whether parent, school, and community attachment reduce the likelihood of lifetime…
... Branded Prescription Drug Fee; Correction AGENCY: Internal Revenue Service (IRS), Treasury. ACTION... Register on Thursday, August 18, 2011. The proposed regulation provides guidance relating to the branded... as follows: 1. On Page 51311, column 2, under the part heading PART 51--BRANDED PRESCRIPTION DRUGS...
... DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 51 [REG-112805-10] RIN 1545-BJ39 Branded Prescription Drug Fee; Correction AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Notice..., August 6, 2012 (77 FR 46653) relating to the branded prescription drug fee imposed by the Affordable Care...
... DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 51 [TD 9544] RIN 1545-BK34 Branded... branded prescription drugs. This fee was enacted by section 9008 of the Patient Protection and Affordable...: This correction is effective on September 28, 2011 and applies to any fee on branded prescription drug...
Jones, Beth A.; Fullwood, Harry; Hawthorn, Melissa
With the growing awareness of adolescent prescription drug abuse, communities and schools are beginning to explore prevention and intervention strategies which are appropriate for their youth. This article provides a framework for developing a collaborative approach to prescription drug abuse prevention--called the Prevention Awareness Team--that…
Southwell, Brian G.; Rupert, Douglas J.
Despite increased availability of online promotional tools for prescription drug marketers, evidence on online prescription drug promotion is far from settled or conclusive. We highlight ways in which online prescription drug promotion is similar to conventional broadcast and print advertising and ways in which it differs. We also highlight five key areas for future research: branded drug website influence on consumer knowledge and behavior, interactive features on branded drug websites, mobile viewing of branded websites and mobile advertisements, online promotion and non-US audiences, and social media and medication decisions. PMID:26927597
Liang, Bryan A; Mackey, Tim K; Lovett, Kimberly M
Narrow therapeutic index (NTI) drugs, because of proximity of therapeutic amounts to toxic amounts, require close professional oversight, particularly when switching formulations. However, safe use may be compromised by unsupervised switching through access to online "no prescription" Web sites. We assessed no prescription online availability of NTI drugs, using an academically published list (core NTI drugs). Using the Google search term "buy DRUG no prescription," we reviewed the first 5 search result pages for marketing of no prescription NTI drugs. We further assessed if National Association of Boards of Pharmacy (NABP) Not Recommended vendors were marketing NTI drugs. Searches were conducted from November 3, 2012 to January 3, 2013. For core NTI drugs, we found 13 of 14 NTI drugs (92%) marketed as available without prescription, all from NABP Not Recommended vendors. On the basis of these initial findings, we expanded our core list to 12 additional NTI drugs; 11 of 12 of these drugs (92%) were available from no prescription Web sites. Overall, 24 of 26 NTI drugs (92%) were illegally marketed as available online without the need for a prescription. Suspect online NTI drug access from no prescription vendors represents a significant patient safety risk because of potential patient drug switching and risk of counterfeit versions. Further, state health care exchanges with coverage limitations may drive patients to seek formulations online. Food and Drug Administration harmonization with tighter international NTI drug standards should be considered, and aggressive action against suspect online marketers should be a regulatory and public health priority. Copyright © 2013 Elsevier HS Journals, Inc. All rights reserved.
This Issue Brief closely examines expenditures on prescription drugs, and discusses their potential to substitute for other types of health care services. In addition, it describes employer coverage of prescription drugs, direct-to-consumer advertising of prescription drugs, and potential legislation affecting the prescription drug market. Prescription drug expenditures grew at double-digit rates during almost every year since 1980, accelerating to 14.1 percent in 1997. In contrast, total national health expenditures, hospital service expenditures, and physician service expenditures growth rates decreased from approximately 13 percent in 1980 to less than 5 percent in 1997. Private insurance payments for prescription drugs increased 17.7 percent in 1997, after growing 22.1 percent in 1995 and 18.3 percent in 1996. This growth in prescription drug payments compares with 4 percent or less overall annual growth in private insurance payments for each of those three years. From 1993 to 1997, the overwhelming majority of the increases in expenditures on prescription drugs were attributable to increased volume, mix, and availability of pharmaceutical products. In 1997, these factors accounted for more than 80 percent of the growth in prescription drug expenditures. A leading explanation for the sharp growth in drug expenditures is that prescription drugs are a substitute for other forms of health care. While it is difficult to determine the extent to which this substitution occurs, various studies have associated cost savings with the use of pharmaceutical products in treating specific diseases. Evidence suggests that more appropriate utilization of prescription drugs has the potential to lower total expenditures and improve the quality of care. Also, some studies indicate the U.S. health care system needs to improve the way patients use and physicians prescribe current medications. Prescription drug plans offered by employers are likely to undergo changes to ensure that
Frosch, Dominick L; Grande, David
In 2007, the pharmaceutical industry spent more than $4.9 billion on direct-to-consumer advertising (DTCA) of prescription drugs in the U.S. Controversy over DTCA has grown since the Food and Drug Administration liberalized its regulations in 1997. Proponents claim that such advertising educates consumers, promotes patient participation in clinical decisions, and improves patient adherence to medication instructions. Opponents argue that such advertising is meant to persuade, not educate, and that it promotes inappropriate use of prescription drugs, or diverts consumers from better alternatives. This Issue Brief summarizes the evidence about the effects of DTCA, and proposes guidelines for improving the utility of prescription drug advertising.
Rozenbroek, Katelyn; Rothstein, William G
To examine medical and nonmedical users of prescription opioids, central nervous system depressants, and stimulants taken individually and in combination. Undergraduates at an urban mid-Atlantic university with 12,000 students. A questionnaire administered in classes provided 413 responses, with a usable response rate of 94%. Nonmedical users obtained prescription drugs from friends and took them with friends. More nonmedical users than medical users took combinations of drugs. Nonmedical users did not show strong preferences for particular drugs. Nonmedical users compared to medical users who took only 1 drug were more likely to take stimulants and less likely to take opioids. The nonmedical use of prescription drugs by college students is a social activity that involves sharing drugs and taking combinations of drugs with friends. Discouraging nonmedical use must focus on the dangers of combining drugs, sharing drugs, and using social gatherings to consume drugs.
Prescription drug abuse is a growing problem in the United States and many other countries. Estimates of prescription drug abuse rates during pregnancy range from 5% to 20%. The primary prescription drugs designated as controlled drugs with abuse potential in pregnancy are opiates prescribed for pain, benzodiazepines prescribed for anxiety, and stimulants prescribed for attention-deficit/hyperactivity disorder. Prescription drugs are obtained for abuse through diversion methods, such as purchasing them from others or by doctor shopping. The use of prescription drugs puts both the mother and the fetus at high risk during pregnancy. Identification of women who are abusing prescription drugs is important so that treatment can be ensured. It is crucial for healthcare professionals to use a multidisciplinary approach and be supportive and maintain a good rapport with pregnant women who abuse prescription drugs. Management includes inpatient hospitalization for detoxification and withdrawal symptoms, and in the case of opiate abuse, opiate maintenance is recommended for pregnant women for the duration of their pregnancy to reduce relapse rates and improve maternal and fetal outcomes. Other recommendations include referral for support groups and supportive housing.
McCall, Kenneth; Nichols, Stephanie D; Holt, Christina; Ochs, Leslie; Cattabriga, Gary; Tu, Chunhao
To evaluate controlled substance prescribing trends available in the Maine Prescription Monitoring Program (PMP) among individuals arrested for prescription drug "trafficking." The demographic characteristics of the individuals who had matching prescription records in the PMP within 90 days of the arrest were identified. A population-based, retrospective cohort study using data from the Maine Diversion Alert Program (DAP) and the Maine PMP. The study population consisted of persons arrested for trafficking prescription drugs in Maine during the 2014 calendar year from January 1 to December 31. There were 594 trafficking arrests reported by the Maine DAP in 2014. The study population consisted of the 235 persons (40%) with arrests involving controlled prescription medications. The mean age of these persons was 33 years (range 18-77 yrs), and 156 (66%) were male. Arrests involved 154 prescription opioids (65%), seven stimulants (3%), seven benzodiazepines (3%), and 77 unspecified controlled prescription drugs (33%). A minority of individuals (n=57, 24%) had a prescription record in the PMP that matched the substance involved in the arrest. Only one person with matching PMP and arrest records utilized ≥ 5 prescribers, while none used ≥ 5 pharmacies within 90 days before the arrest. Payment methods for matching prescriptions were commercial insurance (n=28, 49%), Medicaid (n=19, 33%), Medicare (n=5, 9%), and cash (n=5, 9%). The majority (76%) of persons arrested for prescription drug trafficking did not have PMP records and did not directly obtain the diverted medication from a licensed pharmacy. Traditional red flags, like cash payment and using multiple prescribers or pharmacies, were uncommon. Therefore, arrest records for diversion and PMPs are distinct and complementary tools for identifying individuals at risk for substance misuse. © 2016 Pharmacotherapy Publications, Inc.
... DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 51 [REG-112805-10] RIN 1545-BJ39 Branded Prescription Drug Fee; Hearing AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Notice of... document provides notice of public hearing on proposed regulations relating to the branded prescription...
There is little literature available on dispensing patterns and unsupervised sale of medicines from pharmacies in Tanzania. The present study assessed the patterns of drug acquisition from pharmacies by customers: whether by prescription, recommended by pharmacist, or requested by a customer without a prescription.
Paredes-Atenciano, J A; Roldán-Aviña, J P; González-García, Mercedes; Blanco-Sánchez, M C; Pinto-Melero, M A; Pérez-Ramírez, C; Calvo Rubio-Burgos, Miguel; Osuna-Navarro, F J; Jurado-Carmona, A M
To identify and analyze errors in drug prescriptions of patients treated in a "high resolution" hospital by applying a Failure mode and effects analysis (FMEA).Material and methods A multidisciplinary group of medical specialties and nursing analyzed medical records where drug prescriptions were held in free text format. An FMEA was developed in which the risk priority index (RPI) was obtained from a cross-sectional observational study using an audit of the medical records, carried out in 2 phases: 1) Pre-intervention testing, and (2) evaluation of improvement actions after the first analysis. An audit sample size of 679 medical records from a total of 2,096 patients was calculated using stratified sampling and random selection of clinical events. Prescription errors decreased by 22.2% in the second phase. FMEA showed a greater RPI in "unspecified route of administration" and "dosage unspecified", with no significant decreases observed in the second phase, although it did detect, "incorrect dosing time", "contraindication due to drug allergy", "wrong patient" or "duplicate prescription", which resulted in the improvement of prescriptions. Drug prescription errors have been identified and analyzed by FMEA methodology, improving the clinical safety of these prescriptions. This tool allows updates of electronic prescribing to be monitored. To avoid such errors would require the mandatory completion of all sections of a prescription. Copyright © 2014 SECA. Published by Elsevier Espana. All rights reserved.
... Alcohol Club Drugs Cocaine Fentanyl Hallucinogens Inhalants Heroin Marijuana MDMA (Ecstasy/Molly) Methamphetamine Opioids Over-the-Counter Medicines Prescription Medicines Steroids (Anabolic) Synthetic Cannabinoids (K2/Spice) Synthetic Cathinones (Bath Salts) Tobacco/ ...
... Alcohol Club Drugs Cocaine Fentanyl Hallucinogens Inhalants Heroin Marijuana MDMA (Ecstasy/Molly) Methamphetamine Opioids Over-the-Counter Medicines Prescription Medicines Steroids (Anabolic) Synthetic Cannabinoids (K2/Spice) Synthetic Cathinones (Bath Salts) Tobacco/ ...
U.S. Department of Health & Human Services — This is a Public Use File for Prescription Drug Events drawn from the 2008 Beneficiary Summary File of Medicare beneficiaries enrolled during the calendar year 2008,...
... data from the 2011 National Health Interview Survey (NHIS). Keywords: National Health Interview Survey, alternative therapies, medication ... to cost ( 9 ) that are not measured in NHIS. Definitions Strategies for reducing prescription drug costs : Based ...
Yuan, Peng; Qi, Lin; Wang, Long
China's government is considering legalization of online prescription drugs to increase the pharmaceutical market and enhance access to necessary medicines. However, challenges such as a shortage of licensed pharmacists and drug quality issues have raised concerns and delayed consensus on the proposal. China's government must address the most pressing issues so it can render a decision on online prescription sales. Copyright © 2016 Elsevier Ltd. All rights reserved.
Gøtzsche, Peter C
Our prescription drugs are the third leading cause of death after heart disease and cancer in the United States and Europe. Around half of those who die have taken their drugs correctly; the other half die because of errors, such as too high a dose or use of a drug despite contraindications. Our...
Yamamoto, Chikoto; Ishida, Takuya; Osawa, Takashi; Naito, Takafumi; Kawakami, Junichi
Recalls of non-prescription drugs can contribute to preventing harm to human health, however, they also interrupt the supply of medicines to the market. The aim of the present study was to investigate the trends in non-prescription drug recalls in Japan. Class I, II, and III recalls reported from April 2009 to March 2014 were obtained from the websites of the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency. Each drug recall was classified according to year, dosage form, therapeutic category, and reasons for the recall. The trends over the 5 year period were assessed for each class. A total of 220 recalls were reported in the 5-year study period. The numbers of drug recalls were 21, 16, 80, 58, and 45 in 2009, 2010, 2011, 2012, and 2013, respectively. The drugs recalled consisted of 177 internal medications, 35 topical agents, and 8 others. Drug recalls were observed in 12 therapeutic categories of drug effects. The largest number of recalls was for Chinese herbal medicines and crude drugs. Of all the drug recalls in 2011, Chinese herbal medicines and crude drugs produced by one manufacturer accounted for 84%. Slightly more than half (54%) of drug recalls were due to a violation of the regulations. One manufacturer recalled many drugs because of non-compliance with the standard regulations for manufacturing drugs after 2011. In conclusion, non-prescription drug recalls can occur for any drug regardless of the dosage form and therapeutic category.
This 60 second public service announcement is based on the July 2014 CDC Vital Signs report. Every day, 46 people in the U.S. die from an overdose of prescription opioid painkillers. Learn what can be done to make painkiller prescribing safer and help prevent overdoses.
This podcast is based on the July 2014 CDC Vital Signs report. Every day, 46 people in the U.S. die from an overdose of prescription opioid painkillers. Learn what can be done to make painkiller prescribing safer and help prevent overdoses.
... work well for them through the CR Best Buy Drugs program. Photo courtesy of Sara Jorde Photography A ... National Library of Medicine, the Consumer Reports Best Buy Drugs program helps consumers discuss drug choices with their ...
... Adolescent Brain Comorbidity College-Age & Young Adults Criminal Justice Drugged Driving Drug Testing Drugs and the Brain ... research findings for the educated lay public, legislators, educational groups, and practitioners. The series reports on research ...
... Adolescent Brain Comorbidity College-Age & Young Adults Criminal Justice Drugged Driving Drug Testing Drugs and the Brain ... research findings for the educated lay public, legislators, educational groups, and practitioners. The series reports on research ...
... at risk? Zika virus and pregnancy Folic acid Medicine safety and pregnancy Birth defects prevention Learn how ... the-counter drugs, supplements and herbal products Prescription drugs, over-the-counter drugs, supplements and herbal products ...
This 60 second public service announcement is based on the July 2014 CDC Vital Signs report. Every day, 46 people in the U.S. die from an overdose of prescription opioid painkillers. Learn what can be done to make painkiller prescribing safer and help prevent overdoses. Created: 7/1/2014 by National Center for Immunization and Respiratory Diseases (NCIRD). Date Released: 7/1/2014.
This podcast is based on the July 2014 CDC Vital Signs report. Every day, 46 people in the U.S. die from an overdose of prescription opioid painkillers. Learn what can be done to make painkiller prescribing safer and help prevent overdoses. Created: 7/1/2014 by National Center for Immunization and Respiratory Diseases (NCIRD). Date Released: 7/1/2014.
Fogel, Joshua; Shlivko, Alexander
Reality television watching and social media use are popular activities. Reality television can include mention of illegal drug use and prescription drug misuse. To determine if reality television and social media use of Twitter are associated with either illegal drug use or prescription drug misuse. Survey of 576 college students in 2011. Independent variables included watching reality television (social cognitive theory), parasocial interaction (parasocial interaction theory), television hours watched (cultivation theory), following a reality television character on Twitter, and demographics. Outcome variables were illegal drug use and prescription drug misuse. Watching reality television and also identifying with reality TV program characters were each associated with greater odds for illegal drug use. Also, following a reality TV character on Twitter had greater odds for illegal drug use and also in one analytical model for prescription drug misuse. No support was seen for cultivation theory. Those born in the United States had greater odds for illegal drug use and prescription drug misuse. Women and Asians had lower odds for illegal drug use. African Americans and Asians had lower odds for prescription drug misuse. Physicians, psychologists, and other healthcare practitioners may find it useful to include questions in their clinical interview about reality television watching and Twitter use. Physician and psychology groups, public health practitioners, and government health agencies should consider discussing with television broadcasting companies the potential negative impact of including content with illegal drugs and prescription drug misuse on reality television programs.
Eriksen, Sophie Isabel; Bjerrum, Lars
Prolonged consumption of benzodiazepine drugs (BZD) and benzodiazepine receptor agonists (zolpidem, zaleplon, zopiclone; altogether Z drugs) is related to potential physiological and psychological dependence along with other adverse effects. This study aimed to analyse the prescribing of long...... to the prescription. The observed reduction in BZD use was correlated to the introduction of new national guidelines on prescription of addictive drugs, but this study was not designed to detect a causal relationship. The prescribing of long-acting BZD decreased considerably more than the prescribing of short......-acting BZD (half-life >10 hr), compared to short-acting BZD in Denmark during a 10-year period. Descriptive analysis of total sales data from the Danish Register of Medicinal Product Statistics, to individuals in the primary healthcare sector, of all BZD and Z-drugs in the period of 2003-2013. Prescription...
Tiago Aparecido Maschio de Lima
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.
... public health problem will require a multifaceted approach. An important factor in many of the recent... pharmaceutical drugs pose a serious and growing threat to public health. While a very small number of drugs in... of these drugs endanger patient safety and burden doctors, hospitals, pharmacists, and patients. They...
Hoa, N B; Lauritsen, J M; Rieder, H L
SETTING: National Tuberculosis Program, Viet Nam, 2008. OBJECTIVES: To determine drug prescription adherence to national guidelines, to examine factors associated with an erroneous dosage of rifampin (RMP) and to evaluate the impact of an insufficient RMP dosage on treatment outcome. METHODS......: A representative sample of 30 treatment units was randomly selected. All patient treatment cards enrolled in these units were obtained, and data were double-entered and validated before calculating the adequacy of the individual drug prescriptions. RESULTS: Of 3412 tuberculosis treatment cards, 3225 (94.5%) had...
Kreeftmeijer-Vegter, Annemarie Rosan; de Boer, Anthonius; van der Vlugt-Meijer, Roselinda H; de Vries, Peter J
Drug development for rare diseases is challenging, especially when these orphan drugs (OD) are intended for children. In 2007 the EU Paediatric Drug Regulation was enacted to improve the development of high quality and ethically researched medicines for children through the establishment of Paediatric Investigation Plans (PIPs). The effect of the EU Paediatric Drug Regulation on the marketing authorisation (MA) of drugs for children with rare diseases was studied. Data on all designated orphan drugs, their indication, MA, PIPs and indication group (adult or child) were obtained from the European Medicines Agency (EMA). The outcome and duration of the process from orphan drug designation (ODD) to MA, was compared, per indication, by age group. The effect of the Paediatric Drug Regulation, implemented in 2007, on the application process was assessed with survival analysis. Eighty-one orphan drugs obtained MA since 2000 and half are authorised for (a subgroup of) children; another 34 are currently undergoing further investigations in children through agreed PIPs. The Paediatric Drug Regulation did not significantly increase the number of ODDs with potential paediatric indications (58% before vs 64% after 2007 of ODDs, p = 0.1) and did not lead to more MAs for ODs with paediatric indications (60% vs 43%, p = 0.22). ODs authorised after 2007 had a longer time to MA than those authorised before 2007 (Hazard ratio (95% CI) 2.80 (1.84-4.28), p < 0.001); potential paediatric use did not influence the time to MA (Hazard ratio (95% CI) 1.14 (0.77-1.70), p = 0.52). The EU Paediatric Drug Regulation had a minor impact on development and availability of ODs for children, was associated with a longer time to MA, but ensured the further paediatric development of drugs still off-label to children. The impact of the Paediatric Drug Regulation on research quantity and quality in children through PIPs is not yet clear.
Øymoen, Anita; Pottegård, Anton; Almarsdóttir, Anna Birna
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...
... Rev. Proc. 2011-24 (2011-20 IRB 787), which established a process for covered entities to submit... calculation, a dispute resolution process to allow covered entities to submit error reports relating to the... filer accordingly. C. Orphan Drug Sales Section 9008(e)(3) excludes orphan drug sales from the...
It's a drug prevention conversation--and program--that was largely missing as recently as a decade ago in most middle and high schools. In those days, the principal concern of health educators and disciplinarians alike was to keep students from misusing alcohol and illegal street drugs such as ecstasy, cocaine and even heroine. But driven by the…
Byard, Roger W; Kenneally, Michaela
A 39-year-old man died of multi-organ failure complicating mixed drug toxicity that included methadone, oxazepam, oxycodone and nitrazepam. His past medical history involved alcohol and poly-substance abuse with chronic self-harm and suicidal ideation. There had been multiple hospital admissions for drug overdoses. At autopsy the most unusual finding was of two packages of 10 tablets each, wrapped in thin plastic film within the rectum. The insertion of drugs into body orifices and cavities has been termed body pushing to distinguish it from body packing where illicit drugs are wrapped and swallowed for transport and smuggling, and body stuffing where small amounts of loosely wrapped or unwrapped drugs are swallowed to conceal evidence from police. This case demonstrates that body pushing may not always involve illicit drugs or attempted concealment from police or customs officials. It appears that the drugs had been hidden to ensure an additional supply during the time of residence in hospital. The extent to which body pushing is currently being used by patients to smuggle drugs into secure medical facilities is yet to be determined.
Niemann, Dorothee; Bertsche, Astrid; Meyrath, David; Koepf, Ellen D; Traiser, Carolin; Seebald, Katja; Schmitt, Claus P; Hoffmann, Georg F; Haefeli, Walter E; Bertsche, Thilo
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.
Monteith, Scott; Glenn, Tasha; Bauer, Rita; Conell, Jörn; Bauer, Michael
There is increasing use of online pharmacies to purchase prescription drugs. While some online pharmacies are legitimate and safe, there are many unsafe and illegal so-called "rogue" online pharmacies. This study investigated the availability of psychotropic drugs online to consumers in the US, using 5 commonly prescribed drugs for bipolar disorder. Using the search term "buy [drug name]" in the Google, Yahoo and Bing search engines, the characteristics of the online pharmacies found on the first two pages of search results were investigated. The availability of the requested dosage and formulations of two brand (Seroquel XR, Abilify) and three generic drugs (lamotrigine, lithium carbonate and bupropion SR) were determined. Of 30 online pharmacies found, 17 (57%) were rated as rogue by LegitScript. Of the 30 pharmacies, 15 (50%) require a prescription, 21 (70%) claim to be from Canada, with 20 of these having a Canadian International Pharmacy association (CIPA) seal on the website. Only 13 of the 20 sites with a CIPA seal were active CIPA members. There were about the same number of trust verification seals on the rogue and legitimate pharmacy sites. Some rogue pharmacies are professional in appearance, and may be difficult for consumers to recognize as rogue. All five brand and generic drugs were offered for sale online, with or without a prescription. However, many substitutions were presented such as different strengths and formulations including products not approved by the FDA. No evaluation of product quality, packaging or purchasing. Psychotropic medications are available online with or without a prescription. The majority of online pharmacy websites were rogue. Physicians should ask about the use of online pharmacies. For those who choose to use online pharmacies, two measures to detect rogue pharmacies are recommended: (1) only purchase drugs from pharmacies that require a prescription, and (2) check all pharmacy verification seals directly on the website
Canine parvovirus enteritis affects predominantly puppies with a high prevalence rate in Nigeria and is characterized by diarrhea, vomiting, anorexia and leucopenia. Treatment is non-specific; hence array of medications are usually prescribed to manage the condition symptomatically. Irrational drugs prescription has been ...
The aim of the study is to investigate the prescribing pattern and drug use in the management of essential hypertension in a specialist hospital and its conformity to the JNC VII and WHO/ISH management guidelines. A total of 1572 prescriptions from 490 case files of hypertensive patients (> 18 years) attending the ...
Lanssiers, R; Everaert, E; De Win, M; Van De Velde, R; De Clercq, H
Using the hospital's drug prescription and distribution system as a guide, benefits and drawbacks of a medical activity management system that is tightly integrated with the supply chain management of a hospital will be discussed from the point of view of various participating healthcare actors.
Demers, Virginie; Melo, Magda; Jackevicius, Cynthia; Cox, Jafna; Kalavrouziotis, Dimitri; Rinfret, Stéphane; Humphries, Karin H; Johansen, Helen; Tu, Jack V; Pilote, Louise
Reimbursement for outpatient prescription drugs is not mandated by the Canada Health Act or any other federal legislation. Provincial governments independently establish reimbursement plans. We sought to describe variations in publicly funded provincial drug plans across Canada and to examine the impact of this variation on patients' annual expenditures. We collected information, accurate to December 2006, about publicly funded prescription drug plans from all 10 Canadian provinces. Using clinical scenarios, we calculated the impact of provincial cost-sharing strategies on individual annual drug expenditures for 3 categories of patients with different levels of income and 2 levels of annual prescription burden ($260 and $1000). We found that eligibility criteria and cost-sharing details of the publicly funded prescription drug plans differed markedly across Canada, as did the personal financial burden due to prescription drug costs. Seniors pay 35% or less of their prescription costs in 2 provinces, but elsewhere they may pay as much as 100%. With few exceptions, nonseniors pay more than 35% of their prescription costs in every province. Most social assistance recipients pay 35% or less of their prescription costs in 5 provinces and pay no costs in the other 5. In an example of a patient with congestive heart failure, his out-of-pocket costs for a prescription burden of $1283 varied between $74 and $1332 across the provinces. Considerable interprovincial variation in publicly funded prescription drug plans results in substantial variation in annual expenditures by Canadians with identical prescription burdens. A revised pharmaceutical strategy might reduce these major inequities.
Islam, M Mofizul; McRae, Ian S
Background In an effort to control non-medical use and/or medical abuse of prescription drugs, particularly prescription opioids, electronic prescription drug monitoring programs (PDMP) have been introduced in North-American countries, Australia and some parts of Europe. Paradoxically, there are simultaneous pressures to increase opioid prescribing for the benefit of individual patients and to reduce it for the sake of public health, and this pressure warrants a delicate balance of appropriat...
A.C. Van Der Vossen (Anna C.); I. Van Der Velde (Iris); O. Smeets (Oscar); Postma, D.J.; Eckhardt, M.; A. Vermes (Andras); B.C.P. Koch (Birgit C. P.); A.G. Vulto (Arnold); L.M. Hanff (Lidwien)
textabstractIntroduction Many drugs are unavailable in suitable oral paediatric dosage forms, and pharmacists often have to compound drugs to provide paediatric patients with an acceptable formulation in the right dose. Liquid formulations offer the advantage of dosing flexibility and ease of
Frakt, Austin B; Pizer, Steven D
The Medicare stand-alone prescription drug plan (PDP) came into existence in 2006 as part of the Medicare prescription drug benefit. It is the most popular plan type among Medicare drug plans and large numbers of plans are available to all beneficiaries. In this article we present the first analysis of beneficiary price sensitivity in the PDP market. Our estimate of elasticity of enrollment with respect to premium, -1.45, is larger in magnitude than has been found in the Medicare HMO market. This high degree of beneficiary price sensitivity for PDPs is consistent with relatively low product differentiation, low fixed costs of entry in the PDP market, and the fact that, in contrast to changing HMOs, beneficiaries can select a PDP without disrupting doctor-patient relationships.
Cronin-Fenton, Deirdre; Lash, Timothy L; Ahern, Thomas P
Breast Cancer Group (DBCG) clinical database provides high-quality prospectively collected data on breast cancer diagnosis, treatment, and routine follow-up for breast cancer recurrence. Individual-level linkage of DBCG data to other population-based and medical registries in Denmark, including......BACKGROUND: Myriad reports suggest that frequently used prescription drugs alter the viability of breast cancer cells in pre-clinical studies. Routine use of these drugs, therefore, may impact breast cancer prognosis, and could have important implications for public health. METHODS: The Danish...... the Danish National Prescription Registry, has facilitated large population-based pharmacoepidemiology studies. A unique advantage of using DBCG data for such studies is the ability to investigate the association of drugs with breast cancer recurrence rather than breast cancer mortality - which may...
Bundorf, M Kate; Mata, Rui; Schoenbaum, Michael; Bhattacharya, Jay
To determine the extent to which people make choices inconsistent with expected utility theory when choosing among prescription drug insurance plans and whether tabular or graphical presentation format influences the consistency of their choices. Members of an Internet-enabled panel chose between two Medicare prescription drug plans. The "low variance" plan required higher out-of-pocket payments for the drugs respondents usually took but lower out-of-pocket payments for the drugs they might need if they developed a new health condition than the "high variance" plan. The probability of a change in health varied within subjects and the presentation format (text vs. graphical) and the affective salience of the clinical condition (abstract vs. risk related to specific clinical condition) varied between subjects. Respondents were classified based on whether they consistently chose either the low or high variance plan. Logistic regression models were estimated to examine the relationship between decision outcomes and task characteristics. The majority of respondents consistently chose either the low or high variance plan, consistent with expected utility theory. Half of respondents consistently chose the low variance plan. Respondents were less likely to make discrepant choices when information was presented in graphical format. Many people, although not all, make choices consistent with expected utility theory when they have information on differences among plans in the variance of out-of-pocket spending. Medicare beneficiaries would benefit from information on the extent to which prescription drug plans provide risk protection. PsycINFO Database Record (c) 2013 APA, all rights reserved.
Farooqui, Riffat; Hoor, Talea; Karim, Nasim; Muneer, Mehtab
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.
Huh, Jisu; DeLorme, Denise E; Reid, Leonard N; An, Soontae
Direct-to-consumer advertising has changed the way prescription drugs are marketed in the United States. This article traces the history of direct-to-consumer advertising of prescription and over-the-counter medications and describes how drug advertising is regulated and by whom. It also discusses the controversies that surround direct-to-consumer marketing of prescription drugs.
... on Prescription Drug Container Labels AGENCY: Architectural and Transportation Barriers Compliance... information on prescription drug container labels accessible to people who are blind or visually impaired. The... stakeholder working group to develop best practices for making information on prescription drug container...
Bell, Robert A; Kravitz, Richard L; Wilkes, Michael S
OBJECTIVE Drug manufacturers are intensely promoting their products directly to consumers, but the impact has not been widely studied. Consumers' awareness and understanding of, attitudes toward, and susceptibility to direct-to-consumer (DTC) drug advertising were examined. DESIGN Random-digit dialing telephone survey with a random household member selection procedure (completion and response rates, 58% and 69%, respectively). SETTING Respondents were interviewed while they were at their residences. PARTICIPANTS Complete data were obtained from 329 adults in Sacramento County, California. MEASUREMENTS AND MAIN RESULTS Outcome measures included awareness of advertisements for 10 selected drugs, misconceptions about DTC advertising, attitudes toward DTC ads, and behavioral responses to such promotions. The influence of demographic characteristics, health status, attitudes, beliefs, and media exposure on awareness and behaviors was examined. On average, respondents were aware of advertisements for 3.7 of the 10 drugs; awareness varied from 8% for Buspar (buspirone) to 72% for Claritin (loratadine). Awareness was associated with prescription drug use, media exposure, positive attitudes toward DTC advertising, poorer health, and insurance status. Substantial misconceptions were revealed; e.g., 43% thought that only “completely safe” drugs could be advertised. Direct-to-consumer advertisements had led one third of respondents to ask their physicians for drug information and one fifth to request a prescription. CONCLUSIONS Direct-to-consumer advertisements are reaching the public, but selectively so, and affecting their behaviors. Implications for public policy are examined. PMID:10571712
Bell, R A; Kravitz, R L; Wilkes, M S
Drug manufacturers are intensely promoting their products directly to consumers, but the impact has not been widely studied. Consumers' awareness and understanding of, attitudes toward, and susceptibility to direct-to-consumer (DTC) drug advertising were examined. Random-digit dialing telephone survey with a random household member selection procedure (completion and response rates, 58% and 69%, respectively). Respondents were interviewed while they were at their residences. Complete data were obtained from 329 adults in Sacramento County, California. Outcome measures included awareness of advertisements for 10 selected drugs, misconceptions about DTC advertising, attitudes toward DTC ads, and behavioral responses to such promotions. The influence of demographic characteristics, health status, attitudes, beliefs, and media exposure on awareness and behaviors was examined. On average, respondents were aware of advertisements for 3.7 of the 10 drugs; awareness varied from 8% for Buspar (buspirone) to 72% for Claritin (loratadine). Awareness was associated with prescription drug use, media exposure, positive attitudes toward DTC advertising, poorer health, and insurance status. Substantial misconceptions were revealed; e.g., 43% thought that only "completely safe" drugs could be advertised. Direct-to-consumer advertisements had led one third of respondents to ask their physicians for drug information and one fifth to request a prescription. Direct-to-consumer advertisements are reaching the public, but selectively so, and affecting their behaviors. Implications for public policy are examined.
Full Text Available The Center for Disease Control and Prevention (CDC has published significant data and trendsrelated to opioid prescription pain relievers (OPR. In 2008, 20,044 deaths were attributedto prescription drug overdose of which 14,800 (73.8% were due to OPR, an amount greaterthan the number of overdose deaths from heroin and cocaine combined. The majority of thesedeaths were unintentional. Between 1999-2008, overdose deaths from OPR increased almostfour-fold. Correspondingly, sales of OPR were four times greater in 2010 than in 1999. Mostsignificant to emergency physicians is the estimate that 39% of all opioids prescribed, administeredor continued come from the emergency department (ED. We present findings from theCDC’s Morbidity and Mortality Weekly Report (MMWR with commentary on current recommendationsand policies for curtailing the OPR epidemic.1
Fajreldines, A; Insua, J; Schnitzler, E
One of the causes of preventable adverse drug events (ADES) in older patients constitutes inappropriate prescription of drugs (PIM). The PIM is where risks exceed the clinical benefit. Several instruments can be use to measure this problem, the most used are: a) Beers criteria; b) Screening tool to Older People Potentially inappropriate Prescription (STOPP); c) Screening tool to Alert Doctors to Right Appropriate indicated Treatments (START); d) The Medication Appropriateness Index (MAI). This study aims to assess the prevalence of PIM, in a population of older adults in three clinical scopes of university hospital. cross sectional study of 300 cases from a random sample of fields: hospitalization (n=100), ambulatory (n=100) and emergency (n=100), all patients over 65 years old or more who where treated at our hospital. 1355 prescription drugs were analized, finding patients hospitalized (PIM) of 57.7%, 55%, 26%, and 80% according to Beers, in ambulatory 36%, 36.5%, 5% and 52% with the same tools and in emergency 35%, 35%, 6% y 52% with the same tools. Was found significant association the PIM with polipharmacy with Beers, STOPP and MAI. results can be compare to world literature (26-80% vs 11-73.1%). The STOPP-START used in an integrated manner would be best estimating the problem of PIM. Copyright © 2016 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.
Czechowski, Jessica L; Tjia, Jennifer; Triller, Darren M
To describe the history of generic prescription pricing programs at major pharmacy chains and their potential implications on prescribing, quality of care, and patient safety. Publicly available generic prescription discount program drug lists as of May 1, 2009. Fierce competition among major pharmacy chains such as Walgreens, CVS, and Walmart has led to a generic prescription pricing war with unclear public health implications. Introduced in 2006, currently 7 of the 10 largest pharmacy chains advertise a version of a deeply discounted medication (DDM) program, accounting for more than 25,000 locations nationally. By early 2008, almost 70 million Americans had used these programs. Although DDM programs lower drug costs for many patients, DDM formularies include potentially ineffective or harmful medications, have the potential to influence physician prescribing behavior, and may impair pharmacists' ability to review complete drug-dispensing records. DDMs are widespread but have the potential for unintended consequences on patients, providers, and the health care system. A systematic review of DDMs needs to evaluate the clinical, economic, and system-level implications of such programs.
Aagaard, Lise; Hansen, Ebba H
of these products in childhood. Little evidence has been reported about the adverse drug reactions (ADRs) of these medicines in practice. As spontaneous reports are the main source for information about previously unknown ADRs, we analysed data submitted to a national ADR database. The objective was to characterise...... ADRs reported for psychotropic medicines in the Danish paediatric population over a decade. FINDINGS: All spontaneous ADR reports from 1998 to 2007 for children from birth to 17 years of age were included. The unit of analysis was one ADR. We analysed the distribution of ADRs per year, seriousness, age...... and gender of the child, suspected medicine and type of reported ADR. A total of 429 ADRs were reported for psychotropic medicines and 56% of these were classified as serious. Almost 20% of psychotropic ADRs were reported for children from birth up to 2 years of age and one half of ADRs were reported...
where approximately 75% of the global 300,000 births of affected children ... occlusive crisis is the most common symptom of SCD and ... High rate of antibiotic prescription, low use of opioid analgesics and non- prescription of prophylactic penicillin/ pneumococcal ... records of ten patients to identify potential problems. Two.
Vuittenez, F; Guignard, E; Comte, S
Assess changes in the number of prescriptions for peripheral and cerebral vasoactive drugs for the treatment of lower limb arteritis and cerebrovascular disease since the promulgation in 1995 of prescription standards for the treatment of lower limb arteritis. Assess compliance to prescription standards with a detailed analysis of patient features, prescriptions written for lower limb arteritis, cerebrovascular disease and concomitant diseases and evaluate changes in treatment costs for lower limb arteritis and cerebrovascular disease as well as cost of the full prescription, including treatments for associated diseases. This study was based on data recorded during the Permanent Study of Medical Prescriptions conducted from March 1994 to February 1995 and from March 1995 to February 1996 by the IMS. Prescription costs were established from the National Description Files of the IMS. Treatment costs were expressed as public price (FF) tax included. Prescriptions meeting the following criteria were selected for each period: prescriptions written by general practitioners for drugs with peripheral and cerebral vasoactivity (excepting calcium antagonists with a cerebral target) belonging to the Anatomic Therapeutic Classes C4A1 of the European Pharmaceutical Marketing Research Association, Bromly 1996; prescriptions for diagnoses 447.6 (arteritis) and 437.9 (cerebrovascular disease) according to the 9th WHO classification. A random sample of 500 prescriptions was selected to calculate costs. Since the advent of the prescription standards in 1995, prescriptions have dropped off by 6.3% for lower limb arteritis and by 14.8% for cerebrovascular disease. There was a 3.7 point decline in the percentage of multiple prescriptions of vasoactive drugs for lower limb arteritis (21.7% prior to March 1995 versus 18% after promulgation of the prescription standards, p > 0.1) and a 1.8 increase in the percentage of multiple prescriptions for cerebrovascular disease (14% prior to March
... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Amphetamine and methamphetamine inhalers regarded... DRUGS New Drug or Prescription Status of Specific Drugs § 250.101 Amphetamine and methamphetamine inhalers regarded as prescription drugs. (a) Recurring reports of abuse and misuse of methamphetamine (also...
Hoa, N B; Lauritsen, J M; Rieder, H L
National Tuberculosis Program, Viet Nam, 2008. To determine drug prescription adherence to national guidelines, to examine factors associated with an erroneous dosage of rifampin (RMP) and to evaluate the impact of an insufficient RMP dosage on treatment outcome. A representative sample of 30 treatment units was randomly selected. All patient treatment cards enrolled in these units were obtained, and data were double-entered and validated before calculating the adequacy of the individual drug prescriptions. Of 3412 tuberculosis treatment cards, 3225 (94.5%) had information on treatment regimen and the patient's weight. Treatment was successful in 89.4%. Prescriptions of tablets/vials conforming to recommendations were found for respectively 91.2%, 89.9%, 92.3% and 94.6% of the patients for RMP/isoniazid, pyrazinamide, ethambutol and streptomycin. Patients in the 25-39 kg weight bracket received insufficient dosages. This was almost entirely attributable to patients at the end of the weight bracket. Nevertheless, no significant association was found between treatment failure and death, body weight and insufficient RMP dosage. Adherence to national recommendations was high. RMP was given in insufficient dosage for patients at the end of a weight range bracket, but the under-dosage was small and did not measurably affect treatment outcome.
Full Text Available Walter Ling,1 Li-Tzy Wu21Department of Psychiatry and Biobehavioral Science, Integrated Substance Abuse Programs, University of California, Los Angeles, CA, USA; 2Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USAPrescription drug overdoses, mainly involving prescription opioids, have reached epidemic proportions in the United States over the past 20 years.1,2 Since 2003, prescription opioids have been involved in more drug-related overdose deaths than heroin and cocaine combined. Among patients who were prescribed opioids, an estimated 20% were prescribed high doses of opioids by either single or multiple physicians, and these patients appeared to account for the majority of prescription opioid-related overdoses.1,3,4 The increase in prescription overdose deaths has coincided with a major increase in prescription opioid sales.2 The prescribing practices of some physicians are often believed to have contributed in part to the increase in these overdose deaths. In a recently published perspective, Anna Lembke speculated on why doctors prescribe opioids to known prescription opioid abusers.5 Her article raises a timely and troubling issue for all of us interested in this area of medicine. Lembke identifies the root of the problem to lie in the changing societal attitude towards pain and suffering, the ever-growing availability of opioid medications, the regulatory requirements promulgated, and the perceived shift in the role of the medical professional in this context. Central to her argument is that physicians must now practice according to a set of externally imposed expectations of patients, payers, and regulators, putting the prescriber in the position of being "damned if you do and damned if you don’t". If Lembke is right, the physician now prescribes not according to what he or she wants to do, but according to what he or she must do. The result, at one extreme, is the patient acting as their
... and advertising, and regulatory control of the human prescription drugs falling within the... continued approval for marketing; or (3) A particular drug is properly classified as a new drug, an old drug...
Full Text Available Objective: Prescription drug diversion, the transfer of prescription drugs from lawful to unlawful channels for distribution or use, is a problem in the United States. Despite the pervasiveness of diversion, there are gaps in the literature regarding characteristics of individuals who participate in the illicit trade of prescription drugs. This study examines a range of predictors (e.g., demographics, prescription insurance coverage, perceived risk associated with prescription drug diversion of membership in three distinct diverter groups: individuals who illicitly acquire prescription drugs, those who redistribute them, and those who engage in both behaviors. Methods: Data were drawn from a cross-sectional Internet study (N = 846 of prescription drug use and diversion patterns in New York City, South Florida, and Washington, D.C.. Participants were classified into diversion categories based on their self-reported involvement in the trade of prescription drugs. Group differences in background characteristics of diverter groups were assessed by Chi-Square tests and followed up with multivariate logistic regressions. Results: While individuals in all diversion groups were more likely to be younger and have a licit prescription for any of the assessed drugs in the past year than those who did not divert, individuals who both acquire and redistribute are more likely to live in New York City, not have prescription insurance coverage, and perceive fewer legal risks of prescription drug diversion. Conclusion: Findings suggest that predictive characteristics vary according to diverter group.
Harris, Shana; Nikulina, Valentina; Gelpí-Acosta, Camila; Morton, Cory; Newsome, Valerie; Gunn, Alana; Hoefinger, Heidi; Aikins, Ross; Smith, Vivian; Barry, Victoria; Downing, Martin J
Prescription drug diversion, the transfer of prescription drugs from lawful to unlawful channels for distribution or use, is a problem in the United States. Despite the pervasiveness of diversion, there are gaps in the literature regarding characteristics of individuals who participate in the illicit trade of prescription drugs. This study examines a range of predictors (e.g., demographics, prescription insurance coverage, perceived risk associated with prescription drug diversion) of membership in three distinct diverter groups: individuals who illicitly acquire prescription drugs, those who redistribute them, and those who engage in both behaviors. Data were drawn from a cross-sectional Internet study ( N = 846) of prescription drug use and diversion patterns in New York City, South Florida, and Washington, D.C.. Participants were classified into diversion categories based on their self-reported involvement in the trade of prescription drugs. Group differences in background characteristics of diverter groups were assessed by Chi-Square tests and followed up with multivariate logistic regressions. While individuals in all diversion groups were more likely to be younger and have a licit prescription for any of the assessed drugs in the past year than those who did not divert, individuals who both acquire and redistribute are more likely to live in New York City, not have prescription insurance coverage, and perceive fewer legal risks of prescription drug diversion. Findings suggest that predictive characteristics vary according to diverter group.
This paper estimates the price elasticity of demand for prescription drugs using an exogenous shift in consumer co-payment caused by a reform in the Danish subsidy scheme for the general public. Using purchasing records for the entire Danish population, I show that the average price response for the most commonly used drug yields demand elasticities in the range of -0.36 to -0.5. The reform is shown to affect women, the elderly, and immigrants the most. Furthermore, this paper shows significant heterogeneity in the price response over different types of antibiotics, suggesting that the price elasticity of demand varies considerably even across relatively similar drugs. Copyright © 2012 John Wiley & Sons, Ltd.
Melisa I. Barliana
Full Text Available The potential of Drug-Drug Interactions (DDI in prescription have high incidence around the world, including Indonesia. However, scientific evidence regarding DDI in Indonesia is not available. Therefore, in this study we have conducted survey in 2 pharmacies in Bandung against pediatric prescription given by pediatrician. These prescriptions then analyzed the potential for DDI contained in the prescription and clinical manifestation. The analysis showed that in pharmacy A, there are 33 prescriptions (from a total of 155 prescriptions that have potential DDI, or approximately 21.19% (2 prescriptions have the potential DDI major categories, 23 prescriptions categorized as moderate, and 8 prescriptions as minor. In Pharmacy B, there are 6 prescriptions (from a total of 40 prescriptions or 15% of potential DDI (4 prescriptions categorized as moderate and 2 prescriptions as minor. This result showed that potential DDI happened less than 50% in pediatric prescription from both pharmacies. However, this should get attention because DDI should not happen in a prescription considering its clinical manifestations caused by DDI. Moreover, current pharmaceutical care refers to patient oriented than product oriented. In addition, further study for the pediatric prescription on DDI incidence in large scale need to be investigated.
.... FDA-2011-N-0446] Removal of Certain Requirements Related to the Prescription Drug Marketing Act... Food and Drug Administration (FDA) is proposing to remove a section of the Prescription Drug Marketing... prior sale, purchase, or trade of such drug,'' starting with the manufacturer, and that the identifying...
Friese, Bettina; Moore, Roland S.; Grube, Joel W.; Jennings, Vanessa K.
Qualitative interviews were conducted with parents of teens to explore how parents store and monitor prescription drugs in the home. Most parents had prescription drugs in the house, but took few precautions against teens accessing these drugs. Strategies for monitoring included moving the drugs to different locations, remembering how many pills…
Steiger, Rena M; Stoddard, Sarah A; Pierce, Jennifer
How adolescents think about their future (i.e., future orientation) impacts their risk-taking behavior. The purpose of the present analysis was to explore whether future orientation (future planning, perceived risk to future goals, and positive future expectations) was associated with nonmedical use of stimulants and analgesics in a sample of high school students. Information on future orientation and nonmedical use of prescription drugs (NMUPD) were collected using a paper-and-pencil survey from a sample of 9th-12th grade students in a Midwestern school. Higher perceived risk to future goals and positive future expectations were associated with a lower likelihood of self-reported nonmedical use of stimulants (n=250; OR=0.46, 95% CI: 0.26, 0.83; OR=0.15, 95% CI: 0.05, 0.47, respectively). Only higher perceived risk to future goals was associated with a lower likelihood of self-reported nonmedical use of analgesics (n=250; OR=0.40, 95% CI: 0.24, 0.68). In a follow-up analysis limited to students who endorsed alcohol or marijuana use, perceived risk to future goals remained associated with a lower likelihood of nonmedical use of stimulants and analgesics. Results suggest that risk perception might be a salient protective factor against both nonmedical use of stimulants and analgesics. Overall, the differential impact of conceptualizations of future orientation might depend on the class of prescription drug used, demonstrating a need to consider prescription drugs individually in the development of future studies and interventions. Copyright Â© 2016 Elsevier Ltd. All rights reserved.
Orsolini, Laura; Francesconi, Giulia; Papanti, Duccio; Giorgetti, Arianna; Schifano, Fabrizio
Internet and social networking sites play a significant role in the marketing and distribution of recreational/prescription drugs without restrictions. We aimed here at reviewing data relating to the profile of the online drug customer and at describing drug vending websites. The PubMed, Google Scholar, and Scopus databases were searched here in order to elicit data on the socio-demographic characteristics of the recreational marketplaces/online pharmacies' customers and the determinants relating to online drug purchasing activities. Typical online recreational drugs' customers seem to be Caucasian, men, in their 20s, highly educated, and using the web to impact as minimally as possible on their existing work/professional status. Conversely, people without any health insurance seemed to look at the web as a source of more affordable prescription medicines. Drug vending websites are typically presented here with a "no prescription required" approach, together with aggressive marketing strategies. The online availability of recreational/prescriptions drugs remains a public health concern. A more precise understanding of online vending sites' customers may well facilitate the drafting and implementation of proper prevention campaigns aimed at counteracting the increasing levels of online drug acquisition and hence intake activities. Copyright © 2015 John Wiley & Sons, Ltd.
... utility of the prescription drug labeling as a communication tool and to discuss strategies for making it... the Web site after this document publishes in the Federal Register.) All holders of marketing... before June 30, 2001, and for generic drugs. The initiative is anticipated to take place over several...
Full Text Available Abstract Background Although the survival benefits of antiretroviral therapy (ART for the treatment of HIV infection are well established, the clinical management of HIV disease continues to present major challenges. There are particular concerns regarding access to appropriate HIV treatment among HIV-infected injection drug users (IDU. Methods In a prospective cohort study of HIV-infected IDU in Vancouver, Canada, we examined initial ART regimens vis-à-vis the provincial government's therapeutic guidelines at the time ART was initiated. Briefly, there have been four sets of guidelines: Era 1 (1992 to November 1995; double-drug (dual NRTIs ART for patients with a CD4 cell count of 350 or less; Era 2 (December 1995 to May 1996; double-drug therapy for patients with a CD4+ cell count of 500 or less; Era 3 (June 1996 to June 1997; triple-drug therapy (dual NRTIs with a PI or NNRTI for patients who had a plasma viral load of > 100,000 HIV-1 RNA copies/mL; dual therapy with two NRTIs for those with a plasma viral load of 5,000 to 100,000 HIV-1 RNA copies/mL; Era 4 (since July 1997; universal use of triple drug therapy as first-line treatment. Results Between May 1996 and May 2003, 431 HIV-infected individuals were enrolled into the cohort. By May 31, 2003, 291 (67.5% individuals had initiated ART. We noted instances of inappropriate antiretroviral prescription in each guideline era, with 9 (53% in Era 1, 3 (12% in Era 2, 22 (28% in Era 3, and 23 (15% in Era 4. Of the 57 subjects who received an inappropriate ART regimen initially, 14 never received the appropriate therapy; among the remaining 43, the median time to the initiation of a guideline-appropriate ART regimen was 12 months (inter-quartile range 5 – 20. Conclusion The present study identified measurable rates of guideline-inappropriate ART prescription for patients who were injection drug users. Rates were highest in the era of dual therapy, although high rates persisted into the triple
Sasha A. Fleary
Full Text Available This study explored the extent to which nonprescription and prescription drugs misuse among adolescents/young adults are related to their perception that it is safer than illicit drugs, ease of access, and lower societal stigma. Adolescents/young adults (; , completed an online survey about their nonprescription and prescription drug misuse, other substance use, and correlates of use. Perceived risk, societal stigma, and access to nonprescription and prescription drugs were predictive of misuse. Results support program planners working towards targeting perceived risk and societal stigma in reducing misuse and the need to restrict and monitor access to nonprescription and prescription drugs for adolescents/young adults.
Ali, Mir M; Dean, David; Lipari, Rachel; Dowd, William N; Aldridge, Arnie P; Novak, Scott P
Nonmedical prescription drug use is estimated to be the second most abused category of drugs after marijuana among adolescents. Prescription drugs can be highly addictive and prolonged use can produce neurological changes and physiological dependence and could result in adverse mental health outcomes. This topic is largely unexplored, as current knowledge of possible mechanisms of the linkage between adverse mental health consequences and prescription drug misuse is limited. This study explores the relationship between nonmedical use of prescription drugs and depression outcomes among adolescents. Given their complex and confounded relationship, our purpose is to better understand the extent to which nonmedical use of prescription drugs is an antecedent of depressive episodes. Using data from the 2008-2012 National Survey on Drug Use and Health, the study employs a propensity score matching methodology to ascertain whether nonmedical use of prescription drugs is linked to major depressive episodes among adolescents. The results document a positive relationship between nonmedical prescription drug use and major depressive episodes among adolescents. Specifically, the results indicate that adolescents who used prescription drugs non-medically are 33% to 35% more likely to experience major depressive episodes compared to their non-abusing counterparts. This provides additional evidence about the potential public health consequences of misuse of prescription drugs on adverse mental health outcomes. Given the significant increased risk of major depressive episode among adolescents who use prescription drugs nonmedically, it seems that the prevention of nonmedical prescription drug use warrants the utilization of both educational and public health resources. An important area for future research is to understand how any policy initiatives in this area must strike a balance between the need to minimize the misuse of prescription drugs and the need to ensure access for
This commentary discusses pertinent issues from Hyosun Kim's paper on online prescription drug promotion. The study is well-designed and the findings highlight some of the consequences of the Food and Drug Administration's (FDA's) decision to deregulate online advertising of prescription drugs. While Kim's findings confirm some of the early concerns, they also provide a perspective of implementation challenges in the ever-changing technological environment. © 2016 by Kerman University of Medical Sciences.
Kreeftmeijer-Vegter, Annemarie Rosan; de Boer, Anthonius; van der Vlugt-Meijer, Roselinda H.; de Vries, Peter J.
Background: Drug development for rare diseases is challenging, especially when these orphan drugs (OD) are intended for children. In 2007 the EU Paediatric Drug Regulation was enacted to improve the development of high quality and ethically researched medicines for children through the establishment
Kreeftmeijer-Vegter, Annemarie Rosan; de Boer, Anthonius; van der Vlugt-Meijer, Roselinda H; de Vries, Peter J
BACKGROUND: Drug development for rare diseases is challenging, especially when these orphan drugs (OD) are intended for children. In 2007 the EU Paediatric Drug Regulation was enacted to improve the development of high quality and ethically researched medicines for children through the establishment
Lee, Annisa Lai
This study tracks the changes of the effects of 4 information sources for direct-to-consumer drug advertising on patients' requests for prescription drugs from physicians since the inception of the "Guidance for Industry about Consumer-directed Broadcast Advertisements." The Guidance advises pharmaceuticals to use four information sources for consumers to seek further information to supplement broadcast drug advertisements: small-print information, the Internet, a toll-free number, and health-care providers (nurses, doctors, and pharmacists). Logistic models were created by using survey data collected by the Food and Drug Administration in 1999 and 2002. Results show that throughout the years, health-care providers remain the most used and strongest means associated with patients' direct requests for nonspecific and specific prescription drugs from doctors. The small-print information source gains power and changes from an indirect means associated with patients' discussing drugs with health-care providers to a direct means associated with patients' asking about nonspecific and specific drugs from their doctors. The Internet is not directly related to drug requests, but the effect of its association with patients seeking information from health-care providers grew 11-fold over the course of the study. The toll-free number lost its power altogether for both direct request for a prescription drug and further discussion with health-care providers. Patient demographics will be considered for specific policy implications.
Social Security Administration — This file contains information about Social Security determinations of eligibility for Extra Help with Medicare Prescription Drug Plan Costs. Specific data elements...
Social Security Administration — This file contains information about Social Security determinations of eligibility for Extra Help with Medicare Prescription Drug Plan Costs. Specific data elements...
Full Text Available This paper applies insights from linguistics and discourse analysis to prescription drug brand Web sites, with special reference to the 100 top-selling drugs. Such sites give the outward appearance of being a place to go for straightforward information about a specific brand. In reality, they present a confused mix of brand information, health information and hype, muddled organization, and poor indication of authority, creating an imbalance between benefit and risk content. In so doing, they breach the letter and spirit of the regulations governing direct-to-consumer advertising, which the FDA has by default applied to such Web sites but which were not designed for this special type of discourse. The many communicative difficulties proven to be caused by Web sites in general, in particular for the elderly and less literate, also pose ethical problems. A rethinking of the verbal and visual design of these drug sites is needed -- and new regulatory guidance, for which this paper offers recommendations. At stake is not just the quality of health information at brand drug sites but also their credibility. Type: Original Research
Lewis Glinert, Ph.D
Full Text Available This paper applies insights from linguistics and discourse analysis to prescription drug brand Web sites, with special reference to the 100 top-selling drugs. Such sites give the outward appearance of being a place to go for straightforward information about a specific brand. In reality, they present a confused mix of brand information, health information and hype, muddled organization, and poor indication of authority, creating an imbalance between benefit and risk content. In so doing, they breach the letter and spirit of the regulations governing direct-to-consumer advertising, which the FDA has by default applied to such Web sites but which were not designed for this special type of discourse. The many communicative difficulties proven to be caused by Web sites in general, in particular for the elderly and less literate, also pose ethical problems. A rethinking of the verbal and visual design of these drug sites is needed -- and new regulatory guidance, for which this paper offers recommendations. At stake is not just the quality of health information at brand drug sites but also their credibility.
Drazdowski, Tess K; Jäggi, Lena; Borre, Alicia; Kliewer, Wendy L
Non-medical use of prescription drugs (NMUPD) by adolescents is a significant public health concern. The present study investigated the profile of NMUPD in 1349 adolescent offenders from the Pathways to Desistance project, and whether NMUPD predicted future delinquency using longitudinal data. Results indicated that increased frequency and recency of NMUPD in adolescent offenders are related to some demographic factors, as well as increased risk for violence exposure, mental health diagnoses, other drug use, and previous delinquency, suggesting that severity of NMUPD is important to consider. However, ANCOVA analyses found that NMUPD was not a significant predictor of drug-related, non-aggressive, or aggressive delinquency 12 months later beyond other known correlates of delinquency. Age, sex, exposure to violence, lower socioeconomic status, more alcohol use, and having delinquency histories were more important than NMUPD in predicting future delinquency. These findings suggest that although NMUPD is an important risk factor relating to many correlates of delinquency, it does not predict future delinquency beyond other known risk factors. Copyright © 2014 Elsevier Inc. All rights reserved.
Blanca E. Martínez de Morentin-Aldabe
Full Text Available Obesity has become a major public health burden, not only by the rising prevalence but also because of the associated complications. Furthermore there is a number of diseases whose risk and onset is increased in subjects with overweight such as type 2 diabetes, dislipemias, tumors (endometrial, colon, breast, cancer, etc, skeletal disorders, digestive disturbances, cardiovascular diseases, respiratory disorders, psychological problems, obstetric and gynecological disorders.The prescription of psychotropic drugs is important and, in most countries, consumption has been increased in recent years. Indeed, several drugs used in the treatment of anxiety, depression, bipolar disorder, schizophrenia or epilepsy, can increase body weight and fat deposition or eventually decrease it. These side effects could make a previous situation of obesity to worsen, and it can even cause excessive weight gain in patients with a normal weight at the beginning of the treatment. This increase in adiposity may also contribute to the lack of adherence to the medication and thus a possible relapse of the patients.In this review we report the links between psychotropic drugs administration and weight gain as well as the potential mechanisms that are involved.DOI: http://dx.doi.org/10.14306/renhyd.17.1.4
Ham, Lindsay S; Wiersma-Mosley, Jacquelyn D; Feldner, Matthew T; Melkonian, Alexander J; Milner, Lauren A; Lewis, Sarah F
Nonmedical prescription drug use, defined as using the drug without a prescription or in ways for which it is not prescribed, and traumatic event exposure are highly prevalent among college students. Despite evidence that posttraumatic stress symptoms could place college students at risk for nonmedical prescription drug problems, no studies have examined this relationship. This study was a preliminary examination of posttraumatic stress symptoms, lifetime nonmedical prescription drug use, hazardous use, and dependence symptoms among college students with trauma exposure. Participants were students attending a rural college in Virginia, recruited through psychology classes, flyers, LISTSERVs, and announcements at student events. All students who reported experiencing at least one traumatic event were included (N = 119); participants' mean age was 19.7 years (SD = 1.90), about half were women (n = 63, 53%), and most were Caucasian (n = 103, 87%). Nearly 60% of participants (n = 71) reported using nonmedical prescription drugs at least once during their lifetime and were more likely than those with no use to report hazardous alcohol use (p drugs. Regression analyses showed that posttraumatic stress symptom frequency was positively associated with hazardous nonmedical prescription drug use, after controlling for gender, depressive symptoms, and hazardous alcohol use (p stress symptom frequency was higher for those with any nonmedical prescription drug dependence symptoms (p drug use. Findings suggest that consideration of the types of behaviors and problems a college student is experiencing related to nonmedical prescription drug use may be more relevant to posttraumatic stress symptom frequency than dichotomous measures of nonmedical prescription drug use alone. Further, the association between the frequency of posttraumatic stress symptoms and both hazardous nonmedical prescription drug use and dependence symptoms among college students with a trauma history
...), prescription drug benefit program (Part D) and section 1876 cost plans including conforming changes to the MA... accounts (MSA) plans, cost-sharing for dual-eligible enrollees in the MA program and prescription drug pricing, coverage, and payment processes in the Part D program, and requirements governing the marketing...
Lamonica, Aukje K.; Boeri, Miriam
This study examines patterns of use of prescription drugs and methamphetamine. We drew our sample from a study about 130 active and inactive methamphetamine users and focused on 16 participants with a recent history of methamphetamine and prescription drug use. We collected in-depth interviews to explore relationships in use trajectory patterns.…
Leth-Petersen, Søren; Skipper, Niels
In this paper, we estimate how demand for prescription drugs varies with income for a sample of near retirement individuals. The analysis is based on a novel panel data set with information about the purchase of prescription drugs for a large number of Danish individuals over the period 1995...
Duryea, Daniel G.; Calleja, Nancy G.; MacDonald, Douglas A.
Results from the 2009 "National College Health Assessment" were analyzed by gender and sexual orientation for college students' nonmedical use of prescription drugs. Male and female students identified as having a minority sexual orientation (gay or bisexual) were significantly more likely to use nonmedical prescription drugs than…
Ginn, Clifford M.
The article examines the effects of prescription drug advertising on patients and physicians, and explains how a requirement of pre-approval by the FDA for prescription drug advertisements could eliminate many of the problems such advertisements create, without limiting the benefits of advertising or violating the First Amendment of the U.S. Constitution.
Klisch, Yvonne; Bowling, Kristi G.; Miller, Leslie M.; Ramos, Miguel A.
Two online science education games, in which players learn about the risks of prescription drug abuse in the context of investigating crimes, were evaluated to determine shifts of prescription drug abuse attitudes attributable to game exposure. High school students from grades 11 and 12 (n = 179) were assigned to one of the games and participated…
Ford, Jason A.
Objective: Given the substantial increase in nonmedical prescription drug use in recent years and a lack of research on the topic, the author analyzed data on nonmedical prescription drug use among college students. Participants and Methods: Using data from the 2001 College Alcohol Study (N = 10,904), the author examined variation in nonmedical…
Guan, N.C.; Boks, M.P.; Smeets, H.M.; Zainal, N.Z.; Wit, N.J. de
Background: Psychotropic drugs are commonly prescribed for various psychological complaints in cancer patients. We aim to examine the prescription pattern in cancer patients of three common psychotropic drugs: benzodiazepine, antidepressant and antipsychotic. Methods: This is a retrospective
Miao-Sheng, Chen; Yu-Ti, Shih
This research presents an analysis of Taiwan's health care market with the focus on the pricing of prescription drugs and its impact on physicians' choice behavior. Since the advent of Taiwan's national health insurance, with the competent authority being Bureau of National Health Insurance (BNHI), hospitals are allowed to sell prescription drugs to patients at prices above the purchasing prices, so each prescription drug has two prices: one at which drugs are sold to hospitals; the other which BNHI reimbursement to hospitals. The margin between the different prices is the sales discount that pharmaceutical companies offer to the hospitals. We find that sales discount has a great impact on physicians' choice behavior: i.e., physicians are price-sensitive to prescription drugs. In addition, it is found that too high a sales discount of a prescription drug would result in a too low weighted average price of that drug sold; thus BNHI would be more likely to adjust downward the rate it reimbursement to the hospital. This presents a sales strategy problem to pharmaceutical companies. To solve this, we use the distribution of physicians' evaluations of prescription drugs to establish a profit maximization model in hopes of helping companies to price drugs and find the optimal promotion expending. Ten popular prescription drugs are used in this research as examples.
Morgan, Maria A; Cragan, Janet D; Goldenberg, Robert L; Rasmussen, Sonja A; Schulkin, Jay
To assess screening and treatment patterns of obstetrician-gynecologists regarding medication use during pregnancy. A questionnaire was mailed to 770 members of the American College of Obstetricians and Gynecologists who participate in the Collaborative Ambulatory Research Network. The response rate was 58%. Most respondents reported always asking pregnant patients about use of over-the-counter (OTC) (86%) and prescription (98%) drugs; 24% reported not always asking about alternative medications. Far fewer reported always asking nonpregnant patients about use of alcohol (67%), illegal drugs (51%) and OTC medications (52%) than pregnant patients. Two-fifths (41%) reported prescribing a medication during pregnancy for which they had insufficient information about potential effects on the fetus; nearly half (47%) reported that there are medical conditions for which they would like to prescribe medications but do not due to insufficient safety information. Physician responses indicate that they are less likely to refer pregnant than nonpregnant patients to a specialist for treatment of certain conditions. These results indicate that obstetrician-gynecologists sometimes prescribe medications for pregnant patients under less than optimal conditions and emphasize the importance of generating up-to-date information on effects of medications during pregnancy and having it readily available to health care providers.
Congressional Budget Office
Concerns about direct-to-consumer advertising of prescription drugs have spurred recent proposals for a moratorium on advertising brand-name prescription drugs to consumers during the first two years following a drug's approval by the Food and Drug Administration. This Congressional Budget Office brief examines some of the effects of such a moratorium, drawing on data documenting direct-to-consumer advertising and other promotional activities used by pharmaceutical producers as well as academ...
Simonaitis, Linas; McDonald, Clement J
The utility of National Drug Codes (NDCs) and drug knowledge bases (DKBs) in the organization of prescription records from multiple sources was studied. The master files of most pharmacy systems include NDCs and local codes to identify the products they dispense. We obtained a large sample of prescription records from seven different sources. These records carried a national product code or a local code that could be translated into a national product code via their formulary master. We obtained mapping tables from five DKBs. We measured the degree to which the DKB mapping tables covered the national product codes carried in or associated with the sample of prescription records. Considering the total prescription volume, DKBs covered 93.0-99.8% of the product codes from three outpatient sources and 77.4-97.0% of the product codes from four inpatient sources. Among the in-patient sources, invented codes explained 36-94% of the noncoverage. Outpatient pharmacy sources rarely invented codes, which comprised only 0.11-0.21% of their total prescription volume, compared with inpatient pharmacy sources for which invented codes comprised 1.7-7.4% of their prescription volume. The distribution of prescribed products was highly skewed, with 1.4-4.4% of codes accounting for 50% of the message volume and 10.7-34.5% accounting for 90% of the message volume. DKBs cover the product codes used by outpatient sources sufficiently well to permit automatic mapping. Changes in policies and standards could increase coverage of product codes used by inpatient sources.
Otto, Monica; Armeni, Patrizio; Jommi, Claudio
This paper analyses the determinants of cross-regional variations in expenditure and consumption for non-prescription drugs using the Italian Health Care Service as a case study. This research question has never been posed in other literature contributions. Per capita income, the incidence of elderly people, the presence of distribution points alternative to community pharmacies (para-pharmacies and drug corners in supermarkets), and the disease prevalence were included as possible explanatory variables. A trade-off between consumption of non-prescription and prescription-only drugs was also investigated. Correlation was tested through linear regression models with regional fixed-effects. Demand-driven variables, including the prevalence of the target diseases and income, were found to be more influential than supply-side variables, such as the presence of alternative distribution points. Hence, the consumption of non-prescription drugs appears to respond to needs and is not induced by the supply. The expected trade-off between consumption for prescription-only and non-prescription drugs was not empirically found: increasing the use of non-prescription drugs did not automatically imply savings on prescription-only drugs covered by third payers. Despite some caveats (the short period of time covered by the longitudinal data and some missing monthly data), the regression model revealed a high explanatory power of the variability and a strong predictive ability of future values. Copyright © 2018 Elsevier B.V. All rights reserved.
Frauger, Elisabeth; Nordmann, Sandra; Orleans, Veronica; Pradel, Vincent; Pauly, Vanessa; Thirion, Xavier; Micallef, Joëlle
The objective of the study was to determine which psychoactive prescription drugs are illegally obtained and through which ways of acquisition. OPPIDUM is an annual national study. It is based on specialized care centers that included subjects presenting a drug dependency or under opiate maintenance treatment. All their psychoactive substances consumed are reported. This work focuses on the different ways of acquisition specially the illegal ways of acquisition (bought on the street, forged prescription, stolen, given, internet). For each medication illegally obtained, a ratio has been calculated (number of illegal acquisitions divided by the number of described acquisitions). In 2008, 5542 subjects have been included and have described the consumption of 11 027 substances including 63.8% of prescription drugs. Among them, 11% were illegally obtained. The different illegal acquisition ways were 'street market' (77.6%), 'gift' (16.6%), 'theft' (2.3%), 'forged prescription' (2.3%), and 'internet' (0.7%). The third first drugs illegally obtained were high dosage buprenorphine, methadone, and clonazepam. Some prescription drugs, less consumed, have an important ratio of illegal acquisition like ketamine, flunitrazepam, morphine, trihexyphenidyl, or methylphenidate. This study confirms that theft, forged prescription and internet are few used and permits to highlight diversion of prescription drugs. It is important to inform healthcare professionals on the different prescription drugs that are illegally obtained. © 2011 The Authors Fundamental and Clinical Pharmacology © 2011 Société Française de Pharmacologie et de Thérapeutique.
Islam, M Mofizul; McRae, Ian S
In an effort to control non-medical use and/or medical abuse of prescription drugs, particularly prescription opioids, electronic prescription drug monitoring programs (PDMP) have been introduced in North-American countries, Australia and some parts of Europe. Paradoxically, there are simultaneous pressures to increase opioid prescribing for the benefit of individual patients and to reduce it for the sake of public health, and this pressure warrants a delicate balance of appropriate therapeutic uses of these drugs with the risk of developing dependence. This article discusses pros and cons of PDMP in reducing diversion of prescription opioids, without hampering access to those medications for those with genuine needs, and highlights tensions around PDMP implementation. PDMPs may help alleviate diversion, over-prescription and fraudulent prescribing/dispensing; prompt drug treatment referrals; avoid awkward drug urine test; and inform spatial changes in prescribing practices and help designing tailored interventions. Fear of legal retribution, privacy and data security, potential confusion about addiction and pseudo-addiction, and potential undue pressure of detecting misuse/diversion - are the major problems. There are tensions about unintended consequence of excessive regulatory enforcements, corresponding collateral damages particularly about inadequate prescribing for patients with genuine needs, and mandatory consultation requirements of PDMP. In this era of information technology PDMP is likely to flourish and remain with us for a long time. A clear standard of practice against which physicians' care will be judged may expedite the utilisation of PDMP. In addition, adequate training on addiction and pain management along with public awareness, point-of-supply data entry from pharmacy, point-of-care real-time access to data, increasing access to addiction treatment and appropriate regulatory enforcement preferably through healthcare administration, together
Alperstein, Neil M
This study examines awareness and knowledge of and attitudes toward direct-to-consumer (DTC) prescription drug advertising among young adults between 18 and 24 years of age. The study finds that young adults are not as aware of prescription drug advertising as older consumers, however, they are aware of specific heavily advertised drugs, especially those for allergy medications, birth control, and sleep aids. Young adults hold mixed to negative views about advertising in general, and they do not view DTC prescription drug advertising as a beneficial source of information, nor do they believe such advertising serves to educate consumers.
de Kuijper, G.; Hoekstra, P.; Visser, F.; Scholte, F. A.; Penning, C.; Evenhuis, H.
Background We investigated antipsychotic drug prescription practice of Dutch ID physicians, studying prevalence of antipsychotic drug use, reasons for prescription and the relationship between these reasons and patient characteristics. Methods A cross-sectional study of medical and pharmaceutical
Leth-Petersen, Søren; Skipper, Niels
Understanding how demand for prescription drugs responds to changes in income is important for assessing the welfare consequences of reforms affecting income. This becomes more imminent as age progresses, because the use of prescription drugs and the associated budgetary burden increases dramatic......Understanding how demand for prescription drugs responds to changes in income is important for assessing the welfare consequences of reforms affecting income. This becomes more imminent as age progresses, because the use of prescription drugs and the associated budgetary burden increases...... dramatically from about age 55. In this paper we estimate how demand for prescription drugs varies with income for a sample of near retirement individuals. Estimating the prescription drug demand response to income changes is complicated because an important explanatory variable, the health capital......, is unobserved, and because demand is potentially dynamic, for example because some drugs are habitual. The analysis is based on a novel panel data set with information about purchase of prescription drug demand for a very large number of Danish individuals over the period 1995-2003. Our preferred model...
Miyakis S, Pefanis A, Tsakris A. The challenges of antimicrobial drug resistance in Greece. Clin Infect Dis 2011; 53(2): 177-84. 35.Dik JW, Vemer P, Friedrich AW, et al. Financial evaluations of antibiotic stewardship programs-a systematic review.
Stebbing, Claire; Wong, Ian C K; Kaushal, Rainu; Jaffe, Adam
Medication errors cause substantial harm to patients, and considerable cost to healthcare systems. Evidence suggests that communication plays a crucial role in the generation, management and prevention of such incidents. This review identifies how paediatric medication errors can be managed, and in particular focuses on the pathway of steps that can operationalise the current research findings. Furthermore, the current data suggesting how communication can help to prevent errors occurring in ...
Jakobsen, M; Anker, N; Dollerup, J
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...
Jakobsen, Iris Marie; Anker, Niels; Dolleru, Jens
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...
Wittkampf, Laura Christina; Smeets, Hugo M; Knol, Mirjam J; Geerlings, Mirjam I; Braam, Arjan W; De Wit, Niek J
Psychotropic drug use in Europe and the USA has increased in the past 20 years. The rise in mental health-care use instigated a debate about possible differences in prevalence rates between different ethnic groups in the Netherlands, although the exact differences were unknown. The aim of this study was to determine whether these minority groups were more or less likely than the native population to receive psychotropic drugs. A descriptive population study was conducted using the Agis Health Database, containing demographic and health-care consumption data of approximately 1.5 million inhabitants of the Netherlands. Rates of prescriptions of psychotropic drugs from 2001 to 2006 and adjusted odds ratios for psychotropic drug prescriptions among native Dutch, Turkish and Moroccan ethnic groups were calculated. These data were analysed using logistic regression, after being adjusted for age, gender and socioeconomic status. The mean year prevalence of psychotropic drug prescriptions from 2001 to 2006 was 14.0%. Except for a decrease in anxiolytic drugs, the prescriptions of psychotropic drugs increased from 2001 to 2006. These trends were the same for all of the ethnic groups considered. Among both the Moroccan and Turkish populations, there was a higher risk of antidepressant and antipsychotic drug prescriptions, and a pronounced lower risk of ADHD medication and lithium prescriptions compared to the native population. Among the Turkish population, the risk of anxiolytic drug prescriptions was greater than in the native population. Compared to the native population in the Netherlands, first- and second-generation Turkish and Moroccan immigrants had an increased risk of antidepressant and antipsychotic drug prescriptions and a decreased risk of ADHD medication and Lithium prescriptions. Further research is needed to clarify whether patients of different ethnic backgrounds with the same symptoms receive similar diagnosis and adequate treatment.
Caputi, Theodore L; Humphreys, Keith
Previous studies have found a negative population-level correlation between medical marijuana availability in US states, and trends in medical and nonmedical prescription drug use. These studies have been interpreted as evidence that use of medical marijuana reduces medical and nonmedical prescription drug use. This study evaluates whether medical marijuana use is a risk or protective factor for medical and nonmedical prescription drug use. Simulations based upon logistic regression analyses of data from the 2015 National Survey on Drug Use and Health were used to compute associations between medical marijuana use, and medical and nonmedical prescription drug use. Adjusted risk ratios (RRs) were computed with controls added for age, sex, race, health status, family income, and living in a state with legalized medical marijuana. Medical marijuana users were significantly more likely (RR 1.62, 95% confidence interval [CI] 1.50-1.74) to report medical use of prescription drugs in the past 12 months. Individuals who used medical marijuana were also significantly more likely to report nonmedical use in the past 12 months of any prescription drug (RR 2.12, 95% CI 1.67-2.62), with elevated risks for pain relievers (RR 1.95, 95% CI 1.41-2.62), stimulants (RR 1.86, 95% CI 1.09-3.02), and tranquilizers (RR 2.18, 95% CI 1.45-3.16). Our findings disconfirm the hypothesis that a population-level negative correlation between medical marijuana use and prescription drug harms occurs because medical marijuana users are less likely to use prescription drugs, either medically or nonmedically. Medical marijuana users should be a target population in efforts to combat nonmedical prescription drug use.
Lucas, Gale; Neeper, Michael; Linde, Brittany; Bennett, Joel
It is becoming more commonplace for employees to use prescription medication outside of intended use. Opioid and other prescription misuse has implications for the health and productivity of workers. Easy-to-access webinars that help employees learn about alternatives to prescription use may decrease risk. The aim of this study was to examine the efficacy of an interactive but brief health consciousness and prescription drug intervention for a diverse sample of employees and show effectiveness via both Internet-delivered webinar and classroom delivery. Employees from a variety of workplaces filled out pre- and post-questionnaires upon completion of a one-hour long intervention. A total of 114 participants completed the pre- and post-questionnaires. Results showed that, compared with before the training, participants reported significantly more knowledge about prescription drug misuse and alternatives to prescription drug use after the training (t 113 =7.91, P<.001). Moreover, the medium of presentation (ie, face-to-face vs webinar) did not significantly impact effectiveness of the training (F 1,98 =1.15, P=.29). In both webinar and classroom formats, participants gained knowledge about alternatives to prescription drug use. This intervention appears to be beneficial to employees and assists in the awareness of prescription drug use in general and in the workplace. ©Gale Lucas, Michael Neeper, Brittany Linde, Joel Bennett. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 06.07.2017.
... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Prescription drugs; reminder advertisements and reminder labeling to provide price information to consumers. 200.200 Section 200.200 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL GENERAL Prescription Drug Consumer Price Listing §...
Nelson, Richard E; McAdam-Marx, Carrie; Evans, Megan L; Ward, Robert; Campbell, Benjamin; Brixner, Diana; Lafleur, Joanne
The Food and Drug Administration Modernization Act (FDAMA) of 1997, Best Pharmaceuticals for Children Act (BPCA) of 2002 and Pediatric Research Equity Act of 2007 provide an extended period of 6 months of marketing exclusivity (i.e. patent extension) to prescription drug manufacturers that conduct paediatric studies. Branded drugs in the statin, ACE inhibitor and selective serotonin reuptake inhibitor (SSRI) classes were three of many classes with drugs granted patent extensions. We estimated the cost impact of the 6-month exclusivity extension policy on the Utah Medicaid drug programme by comparing actual costs to projected costs had the 6-month exclusivity extension not been granted for these drugs and thus less expensive generic alternatives been available sooner. Using these results, we then projected the cost impact of this policy on Medicaid programmes in the US during the 18 months following patent expiration. The Utah Medicaid prescription claims obtained for statins, ACE inhibitors and SSRIs included reimbursement amount, number of units dispensed, days supplied, date of service and drug strength. Actual expenditures for each drug were calculated for the 6 months before and 12 months after generic availability. The percentage difference between the brand name prescription reimbursement amount to Medicaid in the last 2 months of the 6-month extension and the generic prescription reimbursement amount to Medicaid in the first 2 months following exclusivity expiration was then calculated for each drug. This was done using data from the 5 months surrounding the exclusivity expiration by regressing the log-transformed Utah Medicaid reimbursement amount on an indicator for patent expiration, controlling for number of units, volume of sales, month filled and strength. This was used to estimate what the initial generic prescription price would have been without the 6-month patent extension and what costs would have been in the 18 months following the original
Inciardi, James A; Surratt, Hilary L; Cicero, Theodore J; Rosenblum, Andrew; Ahwah, Candice; Bailey, J Elise; Dart, Richard C; Burke, John J
Although prescription drugs are readily available on the Internet, little is known about the prevalence of Internet use for the purchase of medications without a legitimate prescription, and the characteristics of those that obtain non-prescribed drugs through online sources. The scientific literature on this topic is limited to anecdotal reports or studies plagued by small sample sizes. Within this context, the focus of this paper is an examination of five national data sets from the U.S. with the purpose of estimating: (1) how common obtaining prescription medications from the Internet actually is, (2) who are the typical populations of "end users" of these non-prescribed medications, and (3) which drugs are being purchased without a prescription. Three of the data sets are drawn from the RADARS (Researched Abuse Diversion and Addiction-Related Surveillance) System, a comprehensive series of studies designed to collect timely and geographically specific data on the abuse and diversion of a number of prescription stimulants and opioid analgesics. The remaining data sets include the National Survey on Drug Use and Health (NSDUH) and the Monitoring the Future (MTF) survey. Our analysis yielded uniformly low rates of prescription drug acquisition from online sources across all five data systems we examined. The consistency of this finding across very diverse populations suggests that the Internet is a relatively minor source for illicit purchases of prescription medications by the individual end-users of these drugs. Copyright 2010 Elsevier Ireland Ltd. All rights reserved.
Pickover, Alison M; Messina, Bryan G; Correia, Christopher J; Garza, Kimberly B; Murphy, James G
The nonmedical use of prescription drugs is a widely recognized public health issue, and young adults are particularly vulnerable to their use. Behavioral economic drug purchase tasks capture an individual's strength of desire and motivation for a particular drug. We examined young adult prescription drug purchase and consumption patterns using hypothetical behavioral economic purchase tasks for prescription sedatives/tranquilizers, stimulants, and opiate pain relievers. We also examined relations between demand, use frequency, and Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM-5) substance use disorder (SUD) symptoms, and sex differences in these relations. Undergraduate students who endorsed past-year prescription drug use (N = 393) completed an online questionnaire for course credit. Measures assessed substance use frequency and DSM-5 SUD symptoms. Hypothetical purchase tasks for sedatives, stimulants, and pain relievers assessed participants' consumption and expenditure patterns for these substances across 25 prices. Past-year prescription sedative, stimulant, and pain reliever use was endorsed by 138, 258, and 189 participants, respectively. Among these users, consumption for their respective substance decreased as a function of ascending price, as expected. Demand indices for a prescription drug were associated with each other and with use frequency and SUD symptoms, with variability across substances but largely not by sex. In addition, demand for prescription pain relievers differentially predicted symptoms independent of use, with differences for females and males. In conclusion, hypothetical consumption and expenditure patterns for prescription drugs were generally well described by behavioral economic demand curves, and the observed associations with use and SUD symptoms provide support for the utility of prescription drug purchase tasks. PsycINFO Database Record (c) 2016 APA, all rights reserved.
...] Indexing Structured Product Labeling for Human Prescription Drug and Biological Products; Request for... Biologics Evaluation and Research (CBER) are indexing certain categories of information in product labeling for use as terms to search repositories of approved prescription medical product structured product...
... say it all comes down to intention and motivation (FDA, 2010). Someone is misusing a prescription medication ... advisors, coaches and health care providers ask the right questions and intervene early. • Ease nervousness in social ...
Dube Shanta R
Full Text Available Abstract Background Prescription drugs account for approximately 11% of national health expenditures. Prior research on adverse childhood experiences (ACEs, which include common forms of child maltreatment and related traumatic stressors, has linked them to numerous health problems. However, data about the relationship of these experiences to prescription drug use are scarce. Method We used the ACE Score (an integer count of 8 different categories of ACEs as a measure of cumulative exposure to traumatic stress during childhood. We prospectively assessed the relationship of the Score to prescription drug use in a cohort of 15,033 adult HMO patients (mean follow-up: 6.1 years and assessed mediation of this relationship by documented ACE-related health and social problems. Results Nearly 1.2 million prescriptions were recorded; prescriptions rates increased in a graded fashion as the ACE Score increased (p for trend Conclusion ACEs substantially increase the number of prescriptions and classes of drugs used for as long as 7 or 8 decades after their occurrence. The increases in prescription drug use were largely mediated by documented ACE-related health and social problems.
Nianogo, Thierry; Okunade, Albert; Fofana, Demba; Chen, Weiwei
Prescription drugs are the third largest component of U.S. healthcare expenditures. The 2006 Medicare Part D and the 2010 Affordable Care Act are catalysts for further growths in utilization becuase of insurance expansion effects. This research investigating the determinants of prescription drug utilization is timely, methodologically novel, and policy relevant. Differences in population health status, access to care, socioeconomics, demographics, and variations in per capita number of scripts filled at retail pharmacies across the U.S.A. justify fitting separate econometric models to county data of the states partitioned into low, medium, and high prescription drug users. Given the skewed distribution of per capita number of filled prescriptions (response variable), we fit the variance stabilizing Box-Cox power transformation regression models to 2011 county level data for investigating the correlates of prescription drug utilization separately for low, medium, and high utilization states. Maximum likelihood regression parameter estimates, including the optimal Box-Cox λ power transformations, differ across high (λ = 0.214), medium (λ = 0.942), and low (λ = 0.302) prescription drug utilization models. The estimated income elasticities of -0.634, 0.031, and -0.532 in high, medium, and low utilization models suggest that the economic behavior of prescriptions is not invariant across different utilization levels. Copyright © 2015 John Wiley & Sons, Ltd.
Full Text Available Background: Medication communication from physicians to patients often is poor, by this among others enhancing the risk of non-adherence. In this context, a neglect regarding the prescription talk has been complained.Aim of the project: In a newly developed elective medical students work on physician-patient conversations dealing with drug prescription. Essential aspects related to an effective and safe drug treatment are combined with steps of shared decision-making. Together with a tutor, students develop a (model conversation guide that might be tailored according to individual needs and views.Description/Methods: In a one-week course 3rd-5th year medical students treat a paper case according to problem-based learning. This is accompanied by a one-hour lecture and literature provided on an online learning platform (ILIAS. During a workshop, aspects of drug treatment and patient participation are integrated into a guide for a prescription talk. At the end of the week the students are invited to apply the (if need be individualized guide in a simulated physician-patient communication with an actor. The conversation is evaluated using a checklist based upon the (model conversation guide.Results: Informal and formalized feedback indicate high acceptance and satisfaction of participants with this elective. The checklist turned out to be of acceptable to good reliability with mostly selective items. Portfolio entries and written evaluation suggest that participants’ positions and attitudes are influenced.
co.uk, Tel.: +234-8054693770. Abstract. Objective: This study examined the pattern of physicians' prescription of antihypertensive drugs and its possible effects on blood pressure control as well as physicians' compliance with recommended.
Jos Journal of Medicine, Volume 9 No. 1. PATTERN OF ANTI ... diabetic drug prescription at a private health facility in North Central Nigeria. Methodology: this was a ... Figure gender distribution of subjects ( 0 = males 1. = females ). Regimen.
Groves, K E M; Sketris, I; Tett, S E
Prescription drug samples, as used by the pharmaceutical industry to market their products, are of current interest because of their influence on prescribing, and their potential impact on consumer safety. Very little research has been conducted into the use and misuse of prescription drug samples, and the influence of samples on health policies designed to improve the rational use of medicines. This is a topical issue in the prescription drug debate, with increasing costs and increasing concerns about optimizing use of medicines. This manuscript critically evaluates the research that has been conducted to date about prescription drug samples, discusses the issues raised in the context of traditional marketing theory, and suggests possible alternatives for the future.
Faerber, Adrienne E; Kreling, David H
False and misleading advertising for drugs can harm consumers and the healthcare system, and previous research has demonstrated that physician-targeted drug advertisements may be misleading. However, there is a dearth of research comparing consumer-targeted drug advertising to evidence to evaluate whether misleading or false information is being presented in these ads. To compare claims in consumer-targeted television drug advertising to evidence, in order to evaluate the frequency of false or misleading television drug advertising targeted to consumers. A content analysis of a cross-section of television advertisements for prescription and nonprescription drugs aired from 2008 through 2010. We analyzed commercial segments containing prescription and nonprescription drug advertisements randomly selected from the Vanderbilt Television News Archive, a census of national news broadcasts. For each advertisement, the most-emphasized claim in each ad was identified based on claim iteration, mode of communication, duration and placement. This claim was then compared to evidence by trained coders, and categorized as being objectively true, potentially misleading, or false. Potentially misleading claims omitted important information, exaggerated information, made lifestyle associations, or expressed opinions. False claims were factually false or unsubstantiated. Of the most emphasized claims in prescription (n = 84) and nonprescription (n = 84) drug advertisements, 33 % were objectively true, 57 % were potentially misleading and 10 % were false. In prescription drug ads, there were more objectively true claims (43 %) and fewer false claims (2 %) than in nonprescription drug ads (23 % objectively true, 7 % false). There were similar numbers of potentially misleading claims in prescription (55 %) and nonprescription (61 %) drug ads. Potentially misleading claims are prevalent throughout consumer-targeted prescription and nonprescription drug advertising on
Zeinali, Majid; Tabeshpour, Jamshid; Maziar, Seyed Vahid; Taherzadeh, Zhila; Zirak, Mohammad Reza; Sent, Danielle; Azarkhiavi, Kamal Razavi; Eslami, Saeid
Inappropriate nonsteroidal anti-inflammatory drugs (NSAIDs) therapy is a common cause of actual and potential adverse effects, such as bleeding and gastrointestinal ulceration, which exacerbates the patient's medical condition and might even be life threatening. We aimed to evaluate and analyze the prescription pattern of NSAIDs in Northeastern Iranian population and also provide suggestions for a more rational prescription behavior for such drugs. In this cross-sectional retrospective study, pattern of 1-year prescriptions was inspected based on 9.3 million prescriptions from two insurance companies. Type of NSAIDs, all dispensed doses and the number of NSAIDs ordered per prescription, and the route of administration for each patient were extracted from the databases. The prescription pattern of NSAIDs was analyzed seasonally. Out of 9,303,585 prescriptions, 19.3% contained at least one NSAID. Diclofenac was the most commonly prescribed NSAID (49.21%). At least two NSAIDs were simultaneously prescribed in 7% of prescriptions. General practitioners prescribed NSAIDs more frequently (67%) than specialists. Orthopedic surgeons and internists more frequently prescribed NSAIDs in comparison with other physicians (6% and 4%, respectively). Gastroprotective agents (GPAs) were coprescribed to only 7.62% of prescriptions. The frequency of NSAIDs prescription was relatively high in Northeast of Iran. A significant number of prescriptions were associated with irrational prescribing in both coadministration of NSAIDs and GPAs and NSAIDs combination. A strategy must be developed and implemented for prescribing and rational use of medications, e.g., continuing medical education regarding the potential risks of NSAIDs, importance of their appropriate and rational use, and necessity of appropriate prescription writing regarding both content and indication.
Ansermot, Nicolas; Jordanov, Véronique; Smogur, Michal; Holzer, Laurent; Eap, Chin B
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.
Jakobsen, Marie; Anker, Niels; Dollerup, Jens; Poulsen, Peter Bo; Lange, Peter
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.
.../Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FoodandDrugAdministration... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0128] Prescription Drug User Fee Act; Meetings on Reauthorization; Request for Notification of Stakeholder Intention...
Market research companies analyse drug prescriptions and sales in community and hospital pharmacies, thus enabling drug companies to refine their marketing strategies. Some information of interest to drug companies is provided directly by healthcare professionals, sometimes unwittingly, and sometimes in return for small "favours".
Datti, Balaji; Carter, Mary W
Although older adults are frequent consumers of prescription drugs and increasingly the intended audience of direct-to-consumer advertising (DTCA) marketing efforts, little is known about the effect of DTCA on older adults' prescription drug-seeking behaviour. In response, the objective of this study is to examine factors associated with requesting a prescription drug from a physician following exposure to DTCA among older adults, and whether the drug or other medical treatment was prescribed during the encounter. A secondary data analysis of the "Public Health Impact of Direct-to-Consumer Advertising of Prescription Drugs", a data set publicly available through the Inter-university Consortium for Political and Social Research (ICPSR 3687), was conducted. For the purposes of this study, only those respondents who indicated that they had been exposed to DTCA (n = 2601) were included in the study sample. Using a two-step weighted logistic regression approach, separate models were estimated to examine first, whether a request for the advertised drug was made following exposure to DTCA and secondly, the outcomes of any patient-physician encounters that occurred following exposure to DTCA. Descriptive analysis of the outcome variables revealed that, among respondents exposed to DTCA, 31% (n = 801) requested a prescription drug from their physician. Approximately 5% of those who made a request were > or =75 years of age. Among respondents requesting a prescription drug, 69% (n = 556) received a prescription in response to their request, of whom, approximately 5% were > or =75 years of age. Multivariate findings suggest that although adults > or =75 years of age are less likely to request a prescription drug following exposure to DTCA (odds ratio [OR] = 0.58; p = 0.032), when they do approach their physicians, they are more likely to receive recommendations for further treatment, with ORs indicating a 250% (OR = 3.507; p = 0.002) increase in the odds of further referral
Mendelson, Dan; Ramchand, Rajeev; Abramson, Richard; Tumlinson, Anne
This brief provides a description of prescription drug use in nursing homes and a summary of current policy issues in this area. The brief first profiles the nursing home pharmaceutical market, outlining the major trends in demographics and drug utilization, the supply chain by which drugs go from manufacturers to pharmacies to nursing home residents, and the alternative arrangements by which prescription drugs in nursing homes are financed. The brief then provides a synopsis of current policy issues, focusing in turn on cost containment and quality improvement initiatives.
Rozenbroek, Katelyn; Rothstein, William G.
Objectives: To examine medical and nonmedical users of prescription opioids, central nervous system depressants, and stimulants taken individually and in combination. Participants: Undergraduates at an urban mid-Atlantic university with 12,000 students. Methods: A questionnaire administered in classes provided 413 responses, with a usable response…
Wright, R Eric; Reed, Nia; Carnes, Neal; Kooreman, Harold E
Prescription drug misuse and abuse has reached epidemic levels in the U.S., and stands as a leading cause of death. As the primary gatekeepers to the medications contributing to this epidemic, it is critical to understand the views of licensed health care professionals. In this study, we examine health care professionals' concern regarding prescription drug abuse in their communities and the impact their concern has had on their prescribing and dispensing practices. An online survey of licensed health care providers. Conducted in Indiana. This study was a state-wide evaluation of Indiana's prescription drug monitoring program. The questionnaire asked respondents how concerned they were about prescription drug abuse in their community. Variation in the level of concern was examined using ordinary least squares regression and information about the respondents' demographic background and clinical experience. In addition, we used logistic regression to examine whether concern was associated with changing prescribing and/or dispensing behavior. The majority of providers indicated they were "moderately" or "extremely concerned" about prescription drug abuse in their communities. The level of concern, however, varied significantly by profession, with pharmacists, physicians, nurse practitioners/physician assistants being more concerned than dentists. Additional analyses indicate that providers with higher levels of concern were those who also reported recently changing their prescribing and/or dispensing behavior. The voluntary nature and geographical focus of the study limits the generalizability of the findings. Concern about prescription drug abuse is generally high across the major health care professions; however, a significant minority of providers, particularly among dentists, expressed little or no concern about the epidemic. Increasing health care providers' general level of concern about prescription drug abuse may be an effective public health tool for
Ibaraki, Ai; Goto, Wataru; Iura, Rie; Tominaga, Mitsuhiro; Tsuchihashi, Takuya
The guidelines for the management of hypertension recommend the inclusion of diuretics, especially when three or more antihypertensive drugs are used. The present study investigated the current prescription status of antihypertensive drugs with a particular focus on the use of diuretics in a local district in Japan. Prescriptions, including antihypertensive drugs, were collected from a dispensing pharmacy of the Yahata Pharmacist Association, located in Kitakyushu City, in October 2014. Of the 10 585 prescriptions, calcium channel blockers (CCBs) were prescribed in 73.5%, followed by angiotensin II receptor blockers (ARB, 62.7%), diuretics (16.5%) and β-blockers (13.6%). The average number of drugs used was 1.80. The rates of prescription of diuretics for patients with one, two, three and four drugs were 0.6%, 13.1%, 55.2% and 82.6%, respectively. Diuretics were more frequently prescribed in elderly patients, and the prescription rate of doctors in hospitals was significantly higher than that of general practitioners (19.1% vs. 15.7%, Pdiuretics were prescribed combination tablets of hydrochlorothiazide with ARB, whereas trichlormethiazide (34.9%) and indapamide (19.8%) were used in other patients. Based on these findings, the use of diuretics remains limited, even among patients taking multiple antihypertensive drugs.
Patel, Harshali K; Bapat, Shweta S; Bhansali, Archita H; Sansgiry, Sujit S
The objective of this study was to develop a one-page (1-page) prescription drug information leaflet (PILs) and assess their impact on the information processing variables, across 2 levels of patient involvement. One-page PILs were developed using cognitive principles to lower mental effort and improve comprehension. An experimental, 3 × 2 repeated measures study was conducted to determine the impact of cognitive effort, manipulated using leaflet type on comprehension across 2 levels (high/low) of patient involvement. Adults (≥18 years) in a university setting in Houston were recruited for the study. Each participant was exposed to 3 different types of prescription drug information leaflet (the current practice, preexisting 1-page text-only, and 1-page PILs) for the 3 drugs (Celebrex, Ventolin HFA, Prezista) for a given involvement scenario. A prevalidated survey instrument was used to measure product knowledge, attitude toward leaflet, and intention to read. Multivariate analysis of variance indicated significant positive effect of cognitive effort, involvement, and their interaction effect across all measured variables. Mean scores for product knowledge, attitude toward leaflet, and intention to read were highest for PILs ( P information processing for consumers by reducing their cognitive effort.
Rönkä, Sanna; Katainen, Anu
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.
Weiner, Scott G; Griggs, Christopher A; Mitchell, Patricia M; Langlois, Breanne K; Friedman, Franklin D; Moore, Rebecca L; Lin, Shuo Cheng; Nelson, Kerrie P; Feldman, James A
We compare emergency provider impression of drug-seeking behavior with objective criteria from a state prescription drug monitoring program, assess change in opioid pain reliever prescribing after prescription drug monitoring program review, and examine clinical factors associated with suspected drug-seeking behavior. This was a prospective observational study of emergency providers assessing a convenience sample of patients aged 18 to 64 years who presented to either of 2 academic medical centers with chief complaint of back pain, dental pain, or headache. Drug-seeking behavior was objectively defined as present when a patient had greater than or equal to 4 opioid prescriptions by greater than or equal to 4 providers in the 12 months before emergency department evaluation. Emergency providers completed data forms recording their impression of the likelihood of drug-seeking behavior, patient characteristics, and plan for prescribing pre- and post-prescription drug monitoring program review. Descriptive statistics were generated. We calculated agreement between emergency provider impression of drug-seeking behavior and prescription drug monitoring program definition, and sensitivity, specificity, and positive predictive value of emergency provider impression, using prescription drug monitoring program criteria as the criterion standard. A multivariate logistic regression analysis was conducted to determine clinical factors associated with drug-seeking behavior. Thirty-eight emergency providers with prescription drug monitoring program access participated. There were 544 patient visits entered into the study from June 2011 to January 2013. There was fair agreement between emergency provider impression of drug-seeking behavior and prescription drug monitoring program (κ=0.30). Emergency providers had sensitivity 63.2% (95% confidence interval [CI] 54.8% to 71.7%), specificity 72.7% (95% CI 68.4% to 77.0%), and positive predictive value 41.2% (95% CI 34.4% to 48
Patients over age 50 typically present with one chronic disease per decade. Each chronic disease typically requires long-term drug therapy, meaning most older patients require several drugs to maintain health. Simultaneously, use of complementary and alternative medicine (CAM) has increased in the United States in the last 20 years, reaching 36% in 2002; herbal medicine use accounts for approximately 22% of all CAM use. Older adults often add herbal medicines to prescription medications, yet do not always inform their physicians. The drug metabolizing enzyme systems process all compounds foreign to the body, including prescription and herbal medications. Therefore use of both medicinals simultaneously has a potential for adverse interactions. This review, which discusses saw palmetto, is the last in a series covering the documented interactions among the top 5 efficacious herbal medicines and prescription drugs.
Kowalski-McGraw, Michele; Green-McKenzie, Judith; Pandalai, Sudha P; Schulte, Paul A
Prescription opioid and benzodiazepine drug use, which has risen significantly, can affect worker health. Exploration of the scientific literature assessed (1) interrelationships of such drug use, occupational risk factors, and illness and injury, and (2) occupational and personal risk factor combinations that can affect their use. The scientific literature from 2000 to 2015 was searched to determine any interrelationships. Evidence for eight conceptual models emerged based on the search yield of 133 articles. These models summarize interrelationships among prescription opioid and benzodiazepine use with occupational injury and illness. Factors associated with the use of these drugs included fatigue, impaired cognition, falls, motor vehicle crashes, and the use of multiple providers. Prescription opioid and benzodiazepine drugs may be both a personal risk factor for work-related injury and a consequence of workplace exposures.
Miller, Ted; Novak, Scott P; Galvin, Deborah M; Spicer, Rebecca S; Cluff, Laurie; Kasat, Sandeep
We assessed the prevalence and characteristics of prescription drug misuse among youth ages 15-25 to examine differences by student and employment status, and associations with workplace antidrug policies and programs. Multivariate logistic regressions analyzed associations in weighted data on the 20,457 young adults in the combined 2004-2008 National Surveys on Drug Use and Health. Demographic controls included sex, race, community size, and age group. After we accounted for demographic controls, at ages 15-25, students were less likely than nonstudents to misuse prescription drugs. Segmenting student from nonstudent groups, working consistently was associated with a further reduction in misuse for those ages 18-25. When we controlled for demographics and substance use history, both Employee Assistance Program (EAP) services and awareness that one's employer had a drug-free workplace policy were associated with significantly lower misuse of prescription drugs (OR = 0.85 for each program, 95% CI [0.73, 1.00] and [0.72, 1.00]). Associations of workplace antidrug policies and programs with marijuana use and with Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition, criteria for alcohol abuse and dependence contrasted sharply with these patterns. All four aspects were significantly associated with lower marijuana use. None was associated with problem drinking. Protective effects of drug-free workplace policy and EAPs persist after other substance use was controlled for. Comparing the effects of workplace programs on illicit drug use and problem drinking versus prescription misuse suggests that those protective associations do not result from selection bias. Thus, drug-free workplace policies and EAPs appear to help protect younger workers against prescription misuse. If workplace substance use disorder programs focused prevention messages and interventions on prescription drug misuse, their impact on misuse might increase.
...--Implementing the Physician Labeling Rule Content and Format Requirements; Availability AGENCY: Food and Drug...--Implementing the PLR Content and Format Requirements.'' This guidance is intended to assist applicants in complying with the content and format requirements of labeling for human prescription drug and biological...
...] Prescription Drug User Fee Act IV Information Technology Plan AGENCY: Food and Drug Administration, HHS. ACTION... information technology (IT) plan entitled ``PDUFA IV Information Technology Plan'' (updated plan) to achieve... Information Technology Plan.'' This plan will meet one of the performance goals agreed to under the 2007...
... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Potassium permanganate preparations as... or Prescription Status of Specific Drugs § 250.108 Potassium permanganate preparations as... women resulting from the misuse of potassium permanganate in an effort to induce abortion. Reports from...
Conclusions: Our investigation suggested that, compared to ENTs, GPs and IMs have a lower tendency to concomitantly prescribe drugs for localized treatment such as nasal corticosteroids and eye drops with oral medication. There may be differences in prescription patterns of drugs for pollinosis between ENTs and non-specialist physicians.
Helen W Sullivan
Full Text Available The volume of prescription drug promotion over time is often measured by assessing changes in ad spending. However, this method obscures the fact that some types of advertising are more expensive than others. Another way to measure the changes in prescription drug promotion over time is to assess the number of promotional pieces submitted to the U.S. Food and Drug Administration (FDA. Form FDA 2253 collects information such as the date submitted and the type of material submitted. We analyzed data from Forms FDA 2253 received from 2001-2014. We examined the frequency of submissions by audience (consumer and healthcare professional and type of promotional material. There was a noted increase in prescription drug promotion submissions across all media in the early 2000s. Although non-Internet promotion submissions have since plateaued, Internet promotion continued to increase. These results can help public health advocates and regulators focus attention and resources.
Bakker, Marian; Boersma - Jentink, Janneke; Vroom, Fokaline; van den Berg, Paulus; de Walle, Hermien; de Jong-van den Berg, L.T.W.
Objective To compare the prescription of drugs in women over a period from 2 years before until 3 months after pregnancy, regarding the type of drugs used and the fetal risk. Design A cohort study based on pharmacy records of women giving birth to a child between 1994 and 2003. Setting The study was
O'Donoghue, Amie C; Sullivan, Helen W; Aikin, Kathryn J; Chowdhury, Dhuly; Moultrie, Rebecca R; Rupert, Douglas J
We evaluated whether presenting prescription drug efficacy information in direct-to-consumer (DTC) advertising helps individuals accurately report a drug's benefits and, if so, which numerical format is most helpful. We conducted a randomized, controlled study of individuals diagnosed with high cholesterol (n=2807) who viewed fictitious prescription drug print or television ads containing either no drug efficacy information or efficacy information in one of five numerical formats. We measured drug efficacy recall, drug perceptions and attitudes, behavioral intentions, and drug risk recall. Individuals who viewed absolute frequency and/or percentage information more accurately reported drug efficacy than participants who viewed no efficacy information. Participants who viewed relative frequency information generally reported drug efficacy less accurately than participants who viewed other numerical formats. Adding efficacy information to DTC ads-both in print and on television-may potentially increase an individual's knowledge of a drug's efficacy, which may improve patient-provider communication and promote more informed decisions. Providing quantitative efficacy information in a combination of formats (e.g., absolute frequency and percent) may help patients remember information and make decisions about prescription drugs. Published by Elsevier Ireland Ltd.
Huertas, Melby Karina Zuniga; Campomar, Marcos Cortez
The Direct-to-Consumer (DTC) advertising of medicines encourages people to ask doctors for certain medicines and treatments that require medical prescription. In order to enhance their persuasive power, advertising models recommend matching the appeals (rational and/or emotional) to the consumer's attitude (cognitive and/ or affective) towards the product. This recommendation leads to controversies in the context of DTC advertising. Emotional appeals, although frequently used, would always be inadequate in that kind of advertising. In absence of empiric evidence of the consumer's perspective, a descriptive research was undertaken with the objective of evaluating: i) the components of the attitude toward medicines; ii) attitude and behavioral intentions in response to DTC ads (one appealing to reason and the other appealing to emotion). A prescription weight loss drug was chosen for this purpose. The results revealed a predominantly cognitive attitude toward the product and an attitude and behavioral intention more favorable to the rational ad. Negative cognition about the product played an outstanding role canceling the persuasive power of emotional appeals.
north-western Tanzania. GIVENESS ... Background: Drug therapy can improve a patient's quality of life and health outcomes if only used properly. .... Irrational use of drugs occurs in all countries and causes harm to people (El Mahalli 2012).
Ganther-Urmie, Julie M; Nair, Kavita V; Valuck, Robert; McCollum, Marianne; Lewis, Sonya J; Turpin, Robin S
To examine patient attitudes related to formulary medications and medication-related decision making in multitier copayment prescription drug plans. A cross-sectional retrospective analysis. Data were collected via mail survey from a random sample of 25,008 members of a managed care organization. The selected members were enrolled in a variety of 2- and 3-tier copayment plans and were taking prescription medication to treat 1 or more of 5 chronic disease states. Most respondents did not believe that formulary drugs were safer or more effective than nonformulary drugs, but 39.7% thought that formulary drugs were relatively less expensive. Most respondents appeared willing to consider switching from a nonformulary drug to a formulary drug with a lower copayment. The percent of respondents who reported they would be very unlikely or unlikely to switch was only 15.3% for a new prescription and 24.2% for a refill prescription. Medication efficacy and physician opinion were important factors in plan members' switching decisions. Cost was an important factor for some members, but older plan members were less likely to report that cost was important. Multitier plan members generally believed that drugs are placed on the formulary for reasons of cost rather than safety or efficacy. Most plan members were receptive to switching from a nonformulary to a formulary medication, but financial incentives alone may not convince some plan members to make the switch.
... self- harm (suicide attempts). Approach: ONDCP highlighted prescription drug abuse in its 2010 National... a Possible Surgeon General Action on Prescription Drug Abuse in Youth AGENCY: National Institute on Drug Abuse, National Institutes of Health, Department of Health and Human Services (HHS). ACTION...
Han, Euna; Liu, Gordon G
Racial minorities are a rapidly growing portion of the US population. Research suggests that racial minorities are more vulnerable to mental illness due to risk factors, such as higher rates of poverty. Given that the burden of mental illnesses is significant, equal likelihood of mental health services utilization is important to reduce such burden. Racial minorities have been known to use mental health services less than Whites. However, it is unclear whether racial disparity in prescription drug use for mental illnesses exists in a nationally representative sample. For a valid estimation of prescription drug use patterns, the characteristic in the distribution of prescription drug use should be accounted for in the estimation model. This study is intended to document whether there was a disparity in psychiatric drug use in both extensive and intensive margins between Whites and three racial minorities: Blacks, Hispanics, and Asian-Indians. The study looked at several specified mental illnesses, controlling for underlying health status and other confounding factors. Secondary data analysis was conducted using the multiyear Medical Expenditure Panel Survey (MEPS), a nationally representative panel sample from 1996 through 2000. This analysis provides estimates of the actual expenditure on prescription drug use for people with specified mental illnesses for this study, based on comparison of Whites and other racial minorities. We derived the estimates from the two-part model, a framework that adjusts the likelihood of using prescription drugs for the specified mental illnesses while estimating the total actual expenditures on prescription drugs among the users. This study found that Blacks, Hispanics, and Asian-Indians were less likely than Whites to use prescription drugs by 8.3, 6.1 and 23.6 percentage points, respectively, holding other factors constant in the sample, with at least one of the specified mental illnesses. The expenditure on prescription drugs for
Simonsen, Marianne; Skipper, Lars; Skipper, Niels
This paper provides evidence of forward-looking behavior in the demand for prescription drugs, while relying on registry-based, individual-level information about the universe of Danish prescription drug purchases from 1995–2014. We exploit a universal shift in policy in early 2000 from a flat......-rate to a non-linear insurance plan for prescription drugs that incentivizes stockpiling at the end of the coverage year. We extend the original framework of Keeler et al. (1977) and discuss how the institutional features of most health insurance contracts, at least theoretically, incentivize intertemporal...... immediately prior to the end-of-year reset in the non-linear plan using a difference-in-difference strategy. We provide evidence that consumers react to this reset by stockpiling toward the end of the coverage year: consumers buy what amounts to an additional 20%. We detect heterogeneity in the size...
This document contains final regulations that provide guidance on the annual fee imposed on covered entities engaged in the business of manufacturing or importing branded prescription drugs. This fee was enacted by section 9008 of the Patient Protection and Affordable Care Act, as amended by section 1404 of the Health Care and Education Reconciliation Act of 2010. This document also withdraws the Branded Prescription Drug Fee temporary regulations and contains new temporary regulations regarding the definition of controlled group that apply beginning on January 1, 2015. The final regulations and the new temporary regulations affect persons engaged in the business of manufacturing or importing certain branded prescription drugs. The text of the temporary regulations in this document also serves as the text of proposed regulations set forth in a notice of proposed rulemaking (REG-123286-14) on this subject in the Proposed Rules section in this issue of the Federal Register.
Broman, Clifford L; Miller, Paula K; Jackson, Emmanuel
The research here investigates race-ethnicity and self-esteem in the misuse of prescription drugs. While there has been much research into the demographic factors that predict prescription drug misuse (PDM), we lack a full accounting of psychosocial factors of possible importance in influencing patterns of race-ethnicity and PDM. One possible influence is self-esteem. We use data from the National Longitudinal Survey on Adolescent Health to investigate race-ethnicity, PDM and self-esteem. Findings indicate first that race-ethnicity is significant is PDM. Secondly, results indicate that self-esteem is important in understanding patterns of prescription drug misuse among young adults, but only among whites.
LeClair, Amy; Kelly, Brian C; Pawson, Mark; Wells, Brooke E; Parsons, Jeffrey T
As part of a larger study on prescription drug misuse among young adults active in urban nightlife scenes, we examined participants' motivations for misuse. Prescription painkillers, stimulants and sedatives were the primary substances of interest. Participants were recruited from nightlife venues in New York using time-space sampling. Subjects completed a mixed-methods assessment at project research offices. The data presented here are from a subsample of 70 qualitative interviews conducted during the baseline assessment. We identified experimentation and a "work hard, play hard" ethos as key motivations for misusing prescription drugs and argue that these motivations are specific, though not necessarily unique, to the participants' social location as young adults. These findings highlight the role of life stage and social context in the misuse of prescription drugs. Future studies of prescription drug misuse should pay attention to the larger social contexts in which users are embedded and, therefore, make decisions about how and why to misuse. Moving beyond the very broad concepts of "recreation" and "self-medication" presently established in the research, policies targeting young adults may want to tailor intervention efforts based on motivations.
Full Text Available Spontaneous reporting on adverse drug reactions (ADR has been established in Malaysia since 1987, and although these reports are monitored by the Malaysia drug monitoring authority, the National Pharmaceutical Control Bureau, information about ADRs in the paediatric patient population still remains unexplored. The aims of this study, therefore, were to characterize the ADRs reported in respect to the Malaysian paediatric population and to relate the data to specific paediatric age groups.Data on all ADRs reported to the National Pharmaceutical Control Bureau between 2000 and 2013 for individuals aged from birth to 17 years old were analysed with respect to age and gender, type of reporter, suspected medicines (using the Anatomical Therapeutic Chemical classification, category of ADR (according to system organ class as well as the severity of the ADR.In total, 11,523 ADR reports corresponding to 22,237 ADRs were analysed, with half of these reporting one ADR per report. Vaccines comprised 55.7% of the 11,523 ADR reports with the remaining being drug related ADRs. Overall, 63.9% of ADRs were reported for paediatric patients between 12 and 17 years of age, with the majority of ADRs reported in females (70.7%. The most common ADRs reported were from the following system organ classes: application site disorders (32.2%, skin and appendages disorders (20.6%, body as a whole general disorders (12.8% and central and peripheral nervous system disorders (11.2%. Meanwhile, ADRs in respect to anti-infectives for systemic use (2194/5106; 43.0% were the most frequently reported across all age groups, followed by drugs from the nervous system (1095/5106; 21.4%. Only 0.28% of the ADR cases were reported as fatal. A large proportion of the reports were received from healthcare providers in government health facilities.ADR reports concerning vaccines and anti-infectives were the most commonly reported in children, and are mainly seen in adolescents, with most of
Song, Inmyung; Choi, So-Hyun; Shin, Ju-Young
This study aims to evaluate changes in use of contraindicated drugs during pregnancy in Korea using the nationwide Health Insurance and Assessment Service (HIRA) database. Study drugs were 314 drugs that were announced as pregnancy-contraindicated on December 11, 2008. The study population consisted of the pregnant women who gave birth and were prescribed any of the drugs in 2007-2011 before giving birth. Pregnancy-contraindicated drug use was defined as the proportion of prescriptions among pregnant women that were for study drugs. The relative and absolute reductions in contraindicated drug use after the 2008 action were estimated with 95% confidence interval (CI) by medical institution type, region, and drug class. The predicted monthly contraindicated drug use was estimated by performing ordinary least-squares regression analysis of data before the action and compared with observed data after the action. Between 2007 and 2011, a total of 1,468,588 pregnant women received 1,796,208 prescriptions. Contraindicated drug use accounted for 15.96% of total prescriptions (N = 355,783) before the action but decreased to 11.52% (N = 453,832) afterward. Overall, the relative reduction was 27.77% (95% CI: 27.64%-27.90%) and greatest for hormones at 46.56% (95% CI: 46.21%-46.93%). The relative reduction was 55.43% (95% CI: 54.60%-55.43%) for all category X drugs, 17.09% (95% CI: 16.46%-17.75%) for category X drugs excluding hormones, and 0.14% (95% CI: 0.14%-0.15%) for category D drugs including hormones. A regulatory action toward pregnancy-contraindicated drugs led to moderate decrease in contraindicated drug use during pregnancy. Despite the decreases, contraindicated drugs were still widely prescribed to pregnant women, highlighting the need to develop strategies to assess and improve drug safety during pregnancy. Copyright © 2015 Elsevier Inc. All rights reserved.
Mbonye, Anthony K; Buregyeya, Esther; Rutebemberwa, Elizeus
OBJECTIVES: The main objective of this study was to assess practices of antibiotic prescription at registered drug shops with a focus on upper respiratory tract infections among children in order to provide data for policy discussions aimed at improving quality of care and patient safety......-line drug for treatment of pneumonia in children according to the guidelines. CONCLUSIONS: There is urgent need to regulate drug shop practices of prescribing and selling antibiotics, for the safety of patients seeking care at these outlets....
This American College of Physicians position paper, initiated and written by its Health and Public Policy Committee and approved by the Board of Regents on 16 February 2016, reports policy recommendations from the American College of Physicians to address the escalating costs of prescription drugs in the United States. Prescription drugs play an important part in treating and preventing disease. However, the United States often pays more for some prescription drugs than other developed countries, and the high price and increasing costs associated with prescription medication is a major concern for patients, physicians, and payers. Pharmaceutical companies have considerable flexibility in how they price drugs, and the costs that payers and patients see are dependent on how payers are able to negotiate discounts or rebates. Beyond setting list prices are issues of regulatory approval, patents and intellectual property, assessment of value and cost-effectiveness, and health plan drug benefits. These issues are linked, and comprehensive efforts will be needed to affect how drugs are priced in the United States.
Maier, Larissa J; Liechti, Matthias E; Herzig, Fiona; Schaub, Michael P
Neuroenhancement is the use of substances by healthy subjects to enhance mood or cognitive function. The prevalence of neuroenhancement among Swiss university students is unknown. Investigating the prevalence of neuroenhancement among students is important to monitor problematic use and evaluate the necessity of prevention programs. To describe the prevalence of the use of prescription medications and drugs of abuse for neuroenhancement among Swiss university students. In this cross-sectional study, students at the University of Zurich, University of Basel, and Swiss Federal Institute of Technology Zurich were invited via e-mail to participate in an online survey. A total of 28,118 students were contacted, and 6,275 students completed the survey. Across all of the institutions, 13.8% of the respondents indicated that they had used prescription drugs (7.6%) or drugs of abuse including alcohol (7.8%) at least once specifically for neuroenhancement. The most frequently used prescription drugs for neuroenhancement were methylphenidate (4.1%), sedatives (2.7%), and beta-blockers (1.2%). Alcohol was used for this purpose by 5.6% of the participants, followed by cannabis (2.5%), amphetamines (0.4%), and cocaine (0.2%). Arguments for neuroenhancement included increased learning (66.2%), relaxation or sleep improvement (51.2%), reduced nervousness (39.1%), coping with performance pressure (34.9%), increased performance (32.2%), and experimentation (20%). Neuroenhancement was significantly more prevalent among more senior students, students who reported higher levels of stress, and students who had previously used illicit drugs. Although "soft enhancers", including coffee, energy drinks, vitamins, and tonics, were used daily in the month prior to an exam, prescription drugs or drugs of abuse were used much less frequently. A significant proportion of Swiss university students across most academic disciplines reported neuroenhancement with prescription drugs and drugs of
William Encinosa; Didem Bernard; Avi Dor
We estimate the impact of diabetic drug adherence on hospitalizations, ER visits, and hospital costs, using insurance claims from MarketScan® employer data. However, it is often difficult to measure the impact of drug adherence on hospitalizations since both adherence and hospitalizations may be correlated with unobservable patient severity. We control for such unobservables using propensity score methods and instrumental variables for adherence such as drug coinsurance levels and direct-to- ...
Aikin, Kathryn J; Sullivan, Helen W; O'Donoghue, Amie C; Betts, Kevin R
Information on the effects of promotional offers in direct-to-consumer prescription drug ads is limited. In two studies, we examined the effect of promotional offers (e.g., money-back guarantee) and ad type (creating prescription and over-the-counter drug ads by varying the presence of benefit and risk information). We found little effect of promotional offers. Adding benefit (risk) information to the ad increased consumers' knowledge of the benefit (risk) information and their efficacy (risk) perceptions. In most cases, adding risk information to an ad with benefit information increased risk knowledge and perceptions without decreasing benefit knowledge or perceptions.
Scott, Kevin R; Nelson, Lewis; Meisel, Zachary; Perrone, Jeanmarie
The rising toll of opioid overdoses in the past decade has been declared a prescription drug epidemic by the Centers for Disease Control. In that same period, Internet platforms, such as Facebook and Twitter, have grown exponentially, being used primarily by a population similar to new initiates of substance abuse. Researchers have utilized social media to gain insights into use patterns and prevailing attitudes about various substances. Social media has potential to enhance screening, prevention, and treatment of addiction. With future funding, they should be leveraged to advance understanding of prescription drug use and improve treatment and prevention of abuse.
Full Text Available Drug prescription errors are a common cause of adverse incidents and may lead to adverse outcomes, sometimes in subtle ways, being compounded by circumstances or further errors. Therefore, it is important that veterinarians issue the correct drug at the correct dose. Using two or more prescribed drugs may lead to drug interactions. Some drug interactions are very harmful and may have potential threats to the patient's health that is called antagonism. In a survey study, medication errors of 750 prescriptions, including dosage errors and drug interactions were studied. The results indicated that 20.8% of prescriptions had at least one drug interaction. The most interactions were related to antibiotics (69.1%, Sulfonamides (46.7%, Methenamine (46.7% and Florfenicol (20.2%. Analysis of dosage errors indicated that total drugs consumed by broilers in the summer are more than winter seasons. Based on these results, avoiding medication errors are important in the balanced prescribing of drugs and regular education of veterinary practitioners in a certain interval is needed.
Pottegård, Anton; Hallas, Jesper
PURPOSE: Cancers often have considerable induction periods. This confers a risk of reverse causation bias in studies of cancer risk associated with drug use, as early symptoms of a yet undiagnosed cancer might lead to drug treatment in the period leading up to the diagnosis. This bias can be alle...
... which it is possible to determine the complete manufacturing history of the package of the drug. (7) A... which the manufacturer's original package is designed and intended to be dispensed to patients without..., or graphic matter containing no representation or suggestion relating to the drug product. If the...
Yolles, Stanley F.
This article emphasizes the need to prepare youth to make decisions about drug use. To do this it is essential to eliminate hypocrisy about the use of marihuana, to "infuse" the curriculum with drug information and to provide students with realistic learning experiences. (Author)
Andersen, Morten; Søndergaard, Jens
20 th International Conference on Pharmacoepiemiology and Risk Management. Bordeaux, France. Pharmacoepidemiology and Drug Safety, 2004;13:Sl 1:159......20 th International Conference on Pharmacoepiemiology and Risk Management. Bordeaux, France. Pharmacoepidemiology and Drug Safety, 2004;13:Sl 1:159...
Amanda L. Divin
Full Text Available Adolescence represents a vulnerable time for the development of both drug use/abuse and mental illness. Although previous research has substantiated a relationship between drug use and suicidal behavior, little research has examined this relationship with non-medical prescription drug use. Given the growing prevalence of non-medical prescription drug use (NMPDU among adolescents, this study explored the association between NMPDU and suicidal behavior. Nationally representative data were derived from 16, 410 adolescents who completed the 2009 National Youth Risk Behavior Survey. Approximately 19.8% of participants reported lifetime NMPDU. NMPDU was associated with significantly increased odds of suicidal behavior (P < 0.01, with seriously considering attempting suicide and making a plan about attempting suicide representing the strongest correlates for males and females. Results suggest the importance of 1 continued reinforcement of drug education programs in high school begun at earlier ages and 2 mental health care and screenings among adolescents.
Bachhuber, Marcus A; Arnsten, Julia H; Cunningham, Chinazo O; Sohler, Nancy
: In observational and retrospective studies, people who use cannabis are more likely than people who do not use cannabis to also use other drugs. People who take medical cannabis are also more likely to report medical and non-medical use of opioid analgesics, stimulants, and tranquilizers. Given that people who take medical cannabis and those who do not are likely to have different underlying morbidity, it is possible that medical cannabis use reduces prescription drug use yet prescription drug use remains relatively high. Studies comparing people who take medical cannabis with people who do not take it cannot draw conclusions about the effect of medical cannabis on drug use. To fully understand the effect of medical cannabis on the use of other drugs, prospective longitudinal studies randomizing individuals to cannabis versus other treatments are urgently needed.
Olesen, Charlotte; Thrane, Nana; Nielsen, G.L.
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...
Kajungu Dan K
Full Text Available Abstract Background Drug prescription practices depend on several factors related to the patient, health worker and health facilities. A better understanding of the factors influencing prescription patterns is essential to develop strategies to mitigate the negative consequences associated with poor practices in both the public and private sectors. Methods A cross-sectional study was conducted in rural Tanzania among patients attending health facilities, and health workers. Patients, health workers and health facilities-related factors with the potential to influence drug prescription patterns were used to build a model of key predictors. Standard data mining methodology of classification tree analysis was used to define the importance of the different factors on prescription patterns. Results This analysis included 1,470 patients and 71 health workers practicing in 30 health facilities. Patients were mostly treated in dispensaries. Twenty two variables were used to construct two classification tree models: one for polypharmacy (prescription of ≥3 drugs on a single clinic visit and one for co-prescription of artemether-lumefantrine (AL with antibiotics. The most important predictor of polypharmacy was the diagnosis of several illnesses. Polypharmacy was also associated with little or no supervision of the health workers, administration of AL and private facilities. Co-prescription of AL with antibiotics was more frequent in children under five years of age and the other important predictors were transmission season, mode of diagnosis and the location of the health facility. Conclusion Standard data mining methodology is an easy-to-implement analytical approach that can be useful for decision-making. Polypharmacy is mainly due to the diagnosis of multiple illnesses.
Findlay, S D
Spending on outpatient prescription drugs in the US is accelerating rapidly. Although numerous factors are driving this trend, attention has recently focused on the role played by the marketing, promotion and advertising of pharmaceuticals, in particular direct-to-consumer (DTC) advertising. In 1997, the US Food and Drug Administration (FDA) issued a 'guidance' on such mass media promotion. The guidance altered existing FDA rules and effectively permitted pharmaceutical companies to promote prescription drugs on television and radio without giving detailed or even summary information on indications, efficacy or potential adverse effects. Since then, television commercials, in particular, and print advertisements in consumer magazines and newspapers have proliferated rapidly. Pharmaceutical companies spent $US1.8 billion on DTC advertising in 1999, a 40% increase over 1998. This spending in 1999 was heavily concentrated on about 50 drugs. Evidence is growing that DTC promotion of prescription drugs is: (i) alerting consumers to the existence of new drugs and the conditions they treat; (ii) increasing consumer demand for many drugs; (iii) contributing increasingly to the recent sharp increase in the number of prescriptions being dispensed; (iv) raising sales revenues; and, thus, (v) contributing to the higher pharmaceutical costs of health insurers, government and consumers. The public policy issues surrounding DTC advertisements centre on the following questions: (i) are the advertisements leading to the inappropriate clinical use of some drugs? (ii) are the advertisements inducing both consumers and physicians to choose more costly new brand-name drugs over less expensive, but equally effective, older brand or generic drugs? (iii) do television advertisements for prescription drugs contain a balanced amount of information on benefits versus potential adverse effects? and (iv) will the revenue benefits generated by DTC advertising cause pharmaceutical companies to
Haukka, Jari; Kriikku, Pirkko; Mariottini, Claudia; Partonen, Timo; Ojanperä, Ilkka
The aims of this study were to estimate the prevalence and predictors of non-medical substance use, and to assess the association between non-medical substance use and fatal poisoning or history of drug abuse in Finland. Retrospective cohort study of all medico-legally investigated death cases in Finland. The postmortem toxicology database was linked together with the register on reimbursed prescription medicines. All postmortem cases between 2011 and 2013 positive for one or more of the following drugs: oxycodone, fentanyl, tramadol, clonazepam, gabapentin, pregabalin, tizanidine, olanzapine, quetiapine, risperidone, alprazolam, zolpidem, mirtazapine and bupropion, n = 2974. Non-medical use of substance was the outcome variable. Predictors were the following: gender, residence at the time of death, place of death, blood alcohol concentration, age, drug abuse, number of prescriptions of any psychoactive drugs in last year and proportion of prescriptions issued by psychiatrist in last year. In 50.4% of the studied cases, at least one drug was detected without a prescription. Clonazepam, alprazolam and tramadol were the most prevalent non-medical findings in these cases (6.6, 6.1 and 5.6%, respectively). The risk of non-medical use of prescription drugs was especially high in cases with history of drug abuse (88.5%) and in fatal poisonings (71.0%). The proportion of non-medical use of the studied substances varied between 5.9% [95% confidence interval (CI) = 3.1-10.1%)] for risperidone and 55.7% for fentanyl (95% CI = 44.1-66.9%). Valid prescription for one or more of any psychoactive drug was associated with lower odds for non-medical use of the studied substances. Additionally, the higher the proportion of psychoactive drugs prescribed by a psychiatrist, the lower the probability of non-medical use. Non-prescribed psychoactive drugs are found commonly at postmortem in drug poisoning deaths in Finland, with history of drug abuse being a major contributing
Recent rapid spending growth for retail drugs has largely arisen from increased use of new drugs, rather than from increasing prices of existing drugs. A sizable shift in the payment from consumers to third parties has also contributed to faster growth. Strategies such as negotiating for rebates and using tiered copayments have sought to slow spending growth but simultaneously have complicated the estimation of spending in the National Health Accounts (NHA). NHA estimates show that retail pharmaceuticals' share of health spending is not much different than it was in 1960, although its share of gross domestic product (GDP) has tripled.
Future Challenges and Opportunities in Online Prescription Drug Promotion Research; Comment on “Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters”
Brian G. Southwell
Full Text Available Despite increased availability of online promotional tools for prescription drug marketers, evidence on online prescription drug promotion is far from settled or conclusive. We highlight ways in which online prescription drug promotion is similar to conventional broadcast and print advertising and ways in which it differs. We also highlight five key areas for future research: branded drug website influence on consumer knowledge and behavior, interactive features on branded drug websites, mobile viewing of branded websites and mobile advertisements, online promotion and non-US audiences, and social media and medication decisions.
Future Challenges and Opportunities in Online Prescription Drug Promotion Research Comment on "Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters".
Southwell, Brian G; Rupert, Douglas J
Despite increased availability of online promotional tools for prescription drug marketers, evidence on online prescription drug promotion is far from settled or conclusive. We highlight ways in which online prescription drug promotion is similar to conventional broadcast and print advertising and ways in which it differs. We also highlight five key areas for future research: branded drug website influence on consumer knowledge and behavior, interactive features on branded drug websites, mobile viewing of branded websites and mobile advertisements, online promotion and non-US audiences, and social media and medication decisions. © 2016 by Kerman University of Medical Sciences.
... 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...
... RS, et al. Drug treatments for obesity: Orlistat, sibutramine and remonabant. The Lancet. 2007;369:71. Rucker ... Updated meta-analysis. BMJ. 2007;335:1194. Meridia (sibutramine): Market withdrawal due to risk of serious cardiovascular ...
Juurlink, David; Yao, Zhan; Camacho, Ximena; Paterson, J. Michael; Singh, Samantha; Dhalla, Irfan; Sproule, Beth; Mamdani, Muhammad
Background The increased use of opioid analgesics, sedative hypnotics and stimulants, coupled with the associated risks of overdose have raised concerns around the inappropriate prescribing of these monitored drugs. We assessed the impact of new legislation, the Narcotics Safety and Awareness Act, and a centralized Narcotics Monitoring System (implemented November 2011 and May 2012, respectively), on the dispensing of prescriptions suggestive of misuse. Methods We conducted a time series analysis of publicly funded prescriptions for opioids, benzodiazepines and stimulants dispensed monthly in Ontario from January 2007 to May 2013, based on information in the Ontario Public Drug Benefit Database. In the primary analysis, a prescription was deemed potentially inappropriate if it was dispensed within 7 days of an earlier prescription and was for at least 30 tablets of a drug in the same class as the earlier prescription, but originated from a different physician and a different pharmacy. Results After enactment of the new legislation, the prevalence of potentially inappropriate opioid prescriptions decreased by 12.5% in 6 months (from 1.6% in October 2011 to 1.4% in April 2012; p = 0.01). No further significant change was observed after the introduction of the narcotic monitoring system (p = 0.8). By May 2013, the prevalence had dropped to 1.0%. Inappropriate benzodiazepine prescribing was significantly influenced by both the legislation (p significantly influenced by the introduction of the monitoring system in May 2012, falling from 0.7% in April 2012 to 0.3% in May 2013 (p = 0.02). Interpretation For a select group of drugs prone to misuse and diversion, legislation and a prescription monitoring program reduced the prevalence of prescriptions suggestive of misuse. This suggests that regulatory interventions can promote appropriate prescribing which could potentially be applied to other jurisdictions and drugs of concern. PMID:25485251
Martins, Silvia S; Kim, June H; Chen, Lian-Yu; Levin, Deysia; Keyes, Katherine M; Cerdá, Magdalena; Storr, Carla L
Little is known about nonmedical use of prescription drugs among non-college-attending young adults in the United States. Data were drawn from 36,781 young adults (ages 18-22 years) from the 2008-2010 National Survey on Drug Use and Health public use files. The adjusted main effects for current educational attainment, along with its interaction with gender and race/ethnicity, were considered. Compared to those attending college, non-college-attending young adults with at least and less than a HS degree had a higher prevalence of past-year nonmedical use of prescription opioids [NMUPO 13.1 and 13.2 %, respectively, vs. 11.3 %, adjusted odds ratios (aORs) 1.21 (1.11-1.33) and 1.25 (1.12-1.40)], yet lower prevalence of prescription stimulant use. Among users, regardless of drug type, non-college-attending youth were more likely to have past-year disorder secondary to use [e.g., NMUPO 17.4 and 19.1 %, respectively, vs. 11.7 %, aORs 1.55 (1.22-1.98) and 1.75 (1.35-2.28)]. Educational attainment interacted with gender and race: (1) among nonmedical users of prescription opioids, females who completed high school but were not enrolled in college had a significantly greater risk of opioid disorder (compared to female college students) than the same comparison for men; and (2) the risk for nonmedical use of prescription opioids was negligible across educational attainment groups for Hispanics, which was significantly different than the increased risk shown for non-Hispanic whites. There is a need for young adult prevention and intervention programs to target nonmedical prescription drug use beyond college campuses.
Milder, I E J; Klungel, O H; Mantel-Teeuwisse, A K; Verschuren, W M M; Bemelmans, W J E
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
Hawk, Kathryn; D'Onofrio, Gail; Fiellin, David A; Chawarski, Marek C; O'Connor, Patrick G; Owens, Patricia H; Pantalon, Michael V; Bernstein, Steven L
Despite increasing reliance on prescription drug monitoring programs (PDMPs) as a response to the opioid epidemic, the relationship between aberrant drug-related behaviors captured by the PDMP and opioid use disorder is incompletely understood. How PDMP data should guide emergency department (ED) assessment has not been studied. The objective was to evaluate a relationship between PDMP opioid prescription records and self-reported nonmedical opioid use of prescription opioids in a cohort of opioid-dependent ED patients enrolled in a treatment trial. PDMP opioid prescription records during 1 year prior to study enrollment on 329 adults meeting Diagnostic and Statistical Manual IV criteria for opioid dependence entering a randomized clinical trial in a large, urban ED were cross-tabulated with data on 30-day nonmedical prescription opioid use self-report. The association among these two types of data was assessed by the Goodman and Kruskal's gamma; a logistic regression was used to explore characteristics of participants who had PDMP record of opioid prescriptions. During 1 year prior to study enrollment, 118 of 329 (36%) patients had at least one opioid prescription (range = 1-51) in our states' PDMP. Patients who reported ≥15 of 30 days of nonmedical prescription opioid use were more likely to have at least four PDMP opioid prescriptions (20/38; 53%) than patients reporting 1 to 14 days (14/38, 37%) or zero days of nonmedical prescription opioid use (4/38, 11%; p = 0.002). Female sex and having health insurance were significantly more represented in the PDMP (p Medicine.
Menezes, Vishma Hydie; Nair, Shoba N; Soumya, M S; Tarey, S D
Drugs used in the palliative care unit for managing symptoms are major contributors toward the expenditure occurring in palliative care. This study was conducted to understand the prescription pattern of analgesic drugs in the patients who are receiving palliative care in a teaching hospital in India by a retrospective study of case records. Case record based, retrospective, descriptive study was conducted at the Pain and Palliative Care Department of St. John's Medical College Hospital, Bengaluru. Case record files of all patients referred to Pain and Palliative Care Department for the treatment of pain in the year of 2012 were studied. Patients' age, gender, diagnoses, numerical pain rating scale (0-10), drugs prescribed, dosage, frequency, route of administration were recorded. The difference in drug utilization between the genders was done using Chi-square test. Data were collected from 502 patients of which 280 (56%) were males and 222 (44%) were females. Twelve percent of patients had mild pain (1-3), 34% had moderate pain (4-6), and 54% had severe pain (7-10). The most commonly used analgesic drugs were opioids (47%), followed by nonsteroidal anti-inflammatory drugs (36%). The opioids used were tramadol (56%), and morphine (38%). Ninety percent of patients with numerical pain scale more than 6 received morphine. There was no difference in analgesic drug utilization with regards to gender. Prescription pattern differed depending on the severity of pain. Opioids were the most commonly used drugs for pain management. The study shows that prescription pattern in palliative care unit of this hospital was in accordance with WHO pain management guidelines. The study showed the current trend in prescription of analgesic drugs in the teaching hospital where the study was conducted.
Havens Jennifer R
Full Text Available Abstract Background Nonmedical prescription opioid use has emerged as a major public health concern in recent years, particularly in rural Appalachia. Little is known about the routes of administration (ROA involved in nonmedical prescription opioid use among rural and urban drug users. The purpose of this study was to describe rural-urban differences in ROA for nonmedical prescription opioid use. Methods A purposive sample of 212 prescription drug users was recruited from a rural Appalachian county (n = 101 and a major metropolitan area (n = 111 in Kentucky. Consenting participants were given an interviewer-administered questionnaire examining sociodemographics, psychiatric disorders, and self-reported nonmedical use and ROA (swallowing, snorting, injecting for the following prescription drugs: buprenorphine, fentanyl, hydrocodone, hydromorphone, methadone, morphine, OxyContin® and other oxycodone. Results Among urban participants, swallowing was the most common ROA, contrasting sharply with substance-specific variation in ROA among rural participants. Among rural participants, snorting was the most frequent ROA for hydrocodone, methadone, OxyContin®, and oxycodone, while injection was most common for hydromorphone and morphine. In age-, gender-, and race-adjusted analyses, rural participants had significantly higher odds of snorting hydrocodone, OxyContin®, and oxycodone than urban participants. Urban participants had significantly higher odds of swallowing hydrocodone and oxycodone than did rural participants. Notably, among rural participants, 67% of hydromorphone users and 63% of morphine users had injected the drugs. Conclusions Alternative ROA are common among rural drug users. This finding has implications for rural substance abuse treatment and harm reduction, in which interventions should incorporate methods to prevent and reduce route-specific health complications of drug use.
González Hernando, Santiago; González Mieres, Celina; Díaz Martín, Ana M
Ascertaining how consumers perceive the risk related to the use of generic prescription drugs and those factors which have the greatest impact on the intention to request a generic drug from the prescribing physician and/or the pharmacist for the purpose of determining any possible barriers or hindrances to the acceptance of generics and to gather information to aid healthcare managers in their decision-making processes. Study on prescription drug use revolving around the degree to which patients are willing to request an EFG. In this quantitative transversal study, a total of 542 individuals were individually surveyed upon exiting a healthcare center or pharmacy in Asturias. A scale for measuring the perceived risk involved in the purchase of a prescription drug including 15 attributes grouped into five aspects was included in the questionnaire. Information was also gathered regarding the intention of using generic prescription drugs and on the demographic and socioeconomic characteristics of those surveyed. For the analysis of the results, a factorial confirmational analysis, multiple regression and univariate analysis were used. The data was processed using the EQS and SPSS statistics programs. Mean perception of the risk (scales 1-7): functional: 2.75; physical: 2.68: financial: 2.19; psychological: 1.99; social: 1.42. Factors having a bearing on the intention of requesting generic prescription drugs from their physician: psychological risk (p = 0.000). On requesting the same from their pharmacist: psychological risk (p = 0.000) and social risk (p = 0.020). The agents interested in the development on the EFG market should target their communication efforts on putting the functional and financial aspects of the manufacturer's specialties and generic specialties on the same level, but should not leave out psychological and social aspects of the consumers' purchasing behavior.
Full Text Available Background: Rationalize of drug use in societies is one of the main responsibilities of health policy makers. In our country irrational use of dugs has increased in the recent years, for example one study in 1998 has shown that average number of medicines per prescription was 3.6, percentage of prescriptions containing antibiotics was 43% and percentage of prescriptions containing Injections was 39%. One of the best tools for evaluation of drug use is the WHO guideline for calculating prescribing indicators. In this study, we had an assessment about prescribing patterns in South of Tehran, Islamshahr and Rey Health Centers.Methods: In order to evaluating prescribing indicators in Tehran University of Medical Sciences region 35 facilities which had pharmacy were selected according to WHO gridline and 4190 prescription from these facilities were studied. Indicators were calculated according to formulas has explained in article. Results: The average number of drug per prescription was 2.58, percentage of drug prescribed by generic name: 99.8%, percentage of encounters prescribed Antibiotics: 62.39% percentage of encounters prescribed Injection: 28.96% & the percentage of drugs prescribed from PHC formulary 99.46%. These findings were almost similar in the three Health Centers.Conclusions: Health facilities are one of the most important bases to improve rational use of Drugs and general practitioners are the major chain in RUD cycle. Results show that we need to design intervention especially educational interventions to improve two WHO prescribing indicators, percentage of encounters prescribed Antibiotics & Injections in this region. For reaching this goals we need to design educational programs for physicians, pharmacists and people too. These educations can be as workshops, seminars, conferences or printed materials such as books, leaflets and etc.
Salvatore, Stefania; Røislien, Jo; Baz-Lomba, Jose A; Bramness, Jørgen G
Wastewater-based epidemiology is an alternative method for estimating the collective drug use in a community. We applied functional data analysis, a statistical framework developed for analysing curve data, to investigate weekly temporal patterns in wastewater measurements of three prescription drugs with known abuse potential: methadone, oxazepam and methylphenidate, comparing them to positive and negative control drugs. Sewage samples were collected in February 2014 from a wastewater treatment plant in Oslo, Norway. The weekly pattern of each drug was extracted by fitting of generalized additive models, using trigonometric functions to model the cyclic behaviour. From the weekly component, the main temporal features were then extracted using functional principal component analysis. Results are presented through the functional principal components (FPCs) and corresponding FPC scores. Clinically, the most important weekly feature of the wastewater-based epidemiology data was the second FPC, representing the difference between average midweek level and a peak during the weekend, representing possible recreational use of a drug in the weekend. Estimated scores on this FPC indicated recreational use of methylphenidate, with a high weekend peak, but not for methadone and oxazepam. The functional principal component analysis uncovered clinically important temporal features of the weekly patterns of the use of prescription drugs detected from wastewater analysis. This may be used as a post-marketing surveillance method to monitor prescription drugs with abuse potential. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.
Tsiropoulos, Ioannis; Andersen, Morten; Hallas, Jesper
Database (OPED) for the period of 1 August 1990-31 December 2006, and diagnoses from the County Hospital register for the period of 1994-2006 to perform sequence symmetry analysis. The method assesses the distribution of disease entities and prescription of other drugs (ODs), before and after initiation...
Tobi, H.; Meijer, W.M.; Tuinstra, J.; de Jong-van den Berg, L.T.
OBJECTIVE: To detect whether there were socio-economic differences in the overall use of prescription and OCT drugs among adolescents. METHODS: This study was a secondary analysis of questionnaire data collected to investigate socio-economic differences in health risk behaviour and decision-making.
Shadick, Richard; Dagirmanjian, Faedra Backus; Trub, Leora; Dawson, Heather
Objective: To examine differences between heterosexual and lesbian, gay, bisexual, and questioning students' nonmedical use of prescription drugs (NMUPD). Participants: First-year university students between October 2009 and October 2013 who self-identified as heterosexual, lesbian, gay, bisexual, or questioning. Methods: Students completed…
S. Stremersch (Stefan); V. Schwartz-Landsman (Vardit); S. Venkataraman (Sriram)
textabstractPatients increasingly request their physicians to prescribe specific brands of pharmaceutical drugs. A popular belief is that requests are triggered by direct-to-consumer advertising (DTCA). We examine the relationship between DTCA, patient requests, and prescriptions for statins. We
F.M. Bakker (Frank); R.C.J.A. van Vliet (René)
textabstractWe consider a situation of full insurance coverage for prescription drugs where, at a certain point in time, people are given the opportunity to take a deductible in exchange for a lower premium. Four determinants of this premium reduction can be considered: expected out-of-pocket
Wade-Mdivanian, R.; Anderson-Butcher, D.; Hale, K.; Kwiek, N.; Smock, J.; Radigan, D.; Lineberger, J.
"Generation Rx" is a prescription drug abuse prevention strategy which includes a "toolkit" designed to be used with youth. Developed by Cardinal Health Foundation and the Ohio State University, it provides health care providers (especially pharmacists), parents, teachers, youth workers, and other community leaders with…
Braüner, Julie Vestergaard; Johansen, Lily Manzello; Roesbjerg, Troels M I
This study aimed to describe the frequency of off-label prescriptions of psychopharmacological drugs in a child and adolescent psychiatric setting. A cross-sectional study was conducted on November 1, 2014, including all inpatients and outpatients at the Mental Health Centre for Child...
Davis, Joel J.
Explores the communicative effectiveness of imprecise frequency descriptors within the context of consumer prescription drug advertising. Conducts two separate studies using a total sample of 147 adults. Finds that consumers are unable to accurately estimate the relative likelihood of side effect occurrence when a list of side effects are preceded…
Bijl, D; van Sonderen, E; Haaijer-Ruskamp, FM
Objective: To explore the relevance of prescription changes and related drug costs when patients are referred from primary to secondary care. Patients and methods: Secondary analysis of data derived from a study on the quality of referrals, which was performed in 1989-1990. New and non-acute
Smeets, Claudia H. W.; Smalbrugge, Martin; Zuidema, Sytse U.; Derksen, Els; de Vries, Erica; van der Spek, Klaas; Koopmans, Raymond T. C. M.; Gerritsen, Debby L.
Objectives: The objective of this study is to explore factors that elucidate reasons for psychotropic drug (PD) prescription for neuropsychiatric symptoms (NPS) in nursing home (NH) residents with dementia. Design: A qualitative study using a grounded theory approach. Setting: Twelve NHs in The
de Kuijper, G.; Hoekstra, P.; Visser, F.; Scholte, F. A.; Penning, C.; Evenhuis, H.
Background: We investigated antipsychotic drug prescription practice of Dutch ID physicians, studying prevalence of antipsychotic drug use, reasons for prescription and the relationship between these reasons and patient characteristics. Methods: A cross-sectional study of medical and pharmaceutical records in a population living in residential…
McCauley, Jenna L; Amstadter, Ananda B; Macdonald, Alexandra; Danielson, Carla Kmett; Ruggiero, Kenneth J; Resnick, Heidi S; Kilpatrick, Dean G
Non-medical use of prescription drugs (NMUPD) is one of the fastest growing forms of illicit drug use, with research indicating that college students represent a particularly high risk population. The current study examined demographic characteristics, health/mental health, substance misuse, and rape experiences as potential risk correlates of NMUPD among a national sample of college women (N=2000). Interviews were conducted via telephone using Computer-Assisted Telephone Interviewing technology. NMUPD was assessed by asking if, participants had used a prescription drug non-medically in the past year. NMUPD was endorsed by 7.8% of the sample (n=155). Although incapacitated and drug-alcohol facilitated rape were associated with NMUPD in the initial model, the final multivariable model showed that only lifetime major depression and other forms of substance use/abuse were significantly uniquely associated with an increased likelihood of NMUPD. Implications for primary and secondary prevention and subsequent research are addressed. Published by Elsevier Ltd.
quality health care with the meagre resources allocated to the health care sector in these countries. The introduction of the manual “How to investigate drug use in ... in the North-Western region of Nigeria. This .... and life threatening infections.
Army Dental Centre, Military Hospital, Awolowo Road, Ikoyi, 1Department of ... Correspondence to: Dr. E. Taiwo Adebayo, General Post Office Box 3338, Kaduna – 800 001, Nigeria. .... meet their individual requirements for an adequate ..... reference materials such as essential drugs list, ... and sterilization equipment.
Wang, H.; Bos, J.H.; de Jong-van den Berg, L.T.
Background: Enzyme-inducing antiepileptic drugs (AEDs) reduce the efficacy of oral contraceptives. Little is known of contraceptive practice among reproductive-age women who receive AEDs. Study Design: We explored the use of contraceptive methods among Dutch women aged 15 to 49 years with
Blankart, Carl Rudolf; Stargardt, Tom
In recent years, the expiration of patents for large drug classes has increased the importance of post-patent drug markets. However, previous research has focused solely on patent drug markets. In this study, the authors evaluate the influence of preferred supplier contracts, the German approach to tendering, in post-patent drug markets using a hierarchical market share attraction model. The authors find that preferred supplier contracts are a powerful strategic instrument for generic manufacturers in a highly competitive environment. They quantify the effects of signing a preferred supplier contract and show that brand-name manufacturers are vulnerable to tendering. Therefore, brand-name manufacturers should readjust their strategies and consider including preferred supplier contracts in their marketing mix. In addition, the authors employ a simulation to demonstrate that a first-mover advantage might be gained from signing a preferred supplier contract. Furthermore, their results can be used as a blueprint for decision makers in the pharmaceutical industry to assess the market share effects of different contracting strategies regarding preferred supplier contracts.
... safety and effectiveness of new drug applications (NDAs) and biologics license applications (BLAs) to be... public health, often targeted at severe illnesses where few or no therapeutic options exist. PDUFA funds... uncertainty for patients and health professionals. To do this, FDA must work quickly to conduct its own meta...
Kopp, S W; Bang, H K
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.
Kiernicki, Kristen; Helme, Donald W
Although direct-to-consumer (DTC) prescription drug advertising is regulated by the U.S. Food and Drug Administration, content analyses suggest advertisers may not disclose drug risks in the same way they describe drug benefits. This study tests the relationship between image congruency in televised DTC advertisements, recall of risks/benefits, and perceived persuasiveness. Advertisements for Nasonex, Advair, and Lunesta were shown to college students in either their original (image incongruent) or modified (image neutral) form. Risks were easier to recall with image-neutral advertisements. Gender also had a significant interaction effect, suggesting that males and females process DTC advertisement differently.
Stephen E. Lankenau
Full Text Available Background. Prescription drug misuse among young adults is increasingly viewed as a public health concern, yet most research has focused on student populations and excluded high-risk groups. Furthermore, research on populations who report recent prescription drug misuse is limited. This study examined patterns of prescription drug misuse among high-risk young adults in Los Angeles (LA and New York (NY, which represent different local markets for illicit and prescription drugs. Design and Methods. Between 2009 and 2011, 596 young adults (16 to 25 years old who had misused prescription drugs within the past 90 days were interviewed in Los Angeles and New York. Sampling was stratified to enroll three groups of high-risk young adults: injection drug users (IDUs; homeless persons; and polydrug users. Results. In both sites, lifetime history of receiving a prescription for an opioid, tranquilizer, or stimulant was high and commonly preceded misuse. Moreover, initiation of opioids occurred before heroin and initiation of prescription stimulants happened prior to illicit stimulants. NY participants more frequently misused oxycodone, heroin, and cocaine, and LA participants more frequently misused codeine, marijuana, and methamphetamine. Combining prescription and illicit drugs during drug using events was commonly reported in both sites. Opioids and tranquilizers were used as substitutes for other drugs, e.g., heroin, when these drugs were not available. Conclusion. Patterns of drug use among high-risk young adults in Los Angeles and New York appear to be linked to differences in local markets in each city for illicit drugs and diverted prescription drugs.
Demailly, Romain; Escolano, Sylvie; Quantin, Catherine; Tubert-Bitter, Pascale; Ahmed, Ismaïl
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.
Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; policies, requirements, and administrative procedures; delay of effective date; reopening of administrative record. Food and Drug Administration, HHS. Final rule; delay of effective date; reopening of administrative record.
The Food and Drug Administration (FDA) is delaying until October 1, 2001, the effective date and reopening the administrative record to receive additional comments regarding certain requirements of a final rule published in the Federal Register of December 3, 1999 (64 FR 67720). The other provisions of the final rule become effective on December 4, 2000. The final rule implements the Prescription Drug Marketing Act of 1987 (PDMA), as modified by the Prescription Drug Amendments of 1992 (PDA) and the FDA Modernization Act of 1997 (the Modernization Act). FDA is delaying the effective date for certain requirements relating to wholesale distribution of prescription drugs by distributors that are not authorized distributors of record. FDA is also delaying the effective date of another requirement that would prohibit blood centers functioning as "health care entities" to act as wholesale distributors of blood derivatives. The agency is taking this action to address numerous concerns about the provisions raised by affected parties.
Dagirmanjian, Faedra R; McDaniel, Anne E; Shadick, Richard
Nonmedical use of prescription pain medications, sedatives, and stimulants is a well-documented problem among college students. Research has indicated that students who identify as lesbian, gay, or bisexual are at elevated risk. However, little is known about students' reasons for use. (1) To replicate findings that sexual minority students report higher nonmedical use than heterosexual students, moving from a campus-specific to a multicampus sample and (2) to test for an association between sexual orientation and reasons for use. The 2015 College Prescription Drug Study surveyed 3389 students from nine 4-year public and private colleges and universities across the United States using an anonymous online survey. Measures assessed demographic information, prevalence of nonmedical use, frequency of use, where the drugs were obtained, reasons for use, and consequences of use. Stepwise logistic regression models were used to determine if sexual orientation predicted use. Chi-square tests of independence were also used to analyze prevalence of use by demographics as well as to assess differences in reasons for use by sexual orientation. Sexual minority students were significantly more likely than heterosexual students to nonmedically use any prescription drug, pain medications, and sedatives. Sexual minority students were also more likely to select that they used pain medications to relieve anxiety, enhance social interactions, and to feel better. Conclusions/Importance: Although sexual minority students are more likely to report nonmedical use, students overall use prescription medications for similar reasons, with the exception of painkillers. Implications and areas for future research are discussed.
Solange Aparecida Nappo
Full Text Available A study was conducted on 22,158 special B prescriptions (notificações B containing amphetamine-type anorectic drugs or benzodiazepines, obtained from compounding pharmacies or drugstores located in the city of Natal, RN, Brazil. The data obtained were compared with those from other Brazilian cities. Results showed that compounding pharmacies dispensed 85.4% of the prescriptions, indicating that these pharmacies filled out nearly 10 times more of these prescriptions than did the drugstores. The majority (83.5% of B prescriptions issued for the compounding pharmacies were for women, where the female/male patient ratio ranged from 7.1/1.0 for mazindol to 10.3/1.0 for amfepramone. Similar results were obtained for the benzodiazepines with ratios of 1.9/1.0 for clonazepam to 15.6/1.0 for oxazepam. Omissions and mistakes were present in the B prescriptions, including missing information about the patient (in 49.6% of the documents or about the pharmacies or drugstores (50.4%. There were cases where the name and/or CRM of the physician was lacking. It was noted that one medical doctor made out 1855 B prescriptions within one year. The same patient's name appeared on 138 prescriptions, and the same RG (identification card number was present in 125 others. Comparison of Natal's data with those of several other Brazilian cities disclosed a striking similarity throughout Brazil, from Pelotas - Rio Grande do Sul State to Belem-Para State, revealing a practically identical medical/pharmaceutical behavior. This pattern of prescription/dispensation of amphetamine-type substances mostly to women for weight loss is therefore for cosmetic reasons. Consequently, there is an urgent need for an ethical review of this behavior.Foram examinadas 22.158 notificações B contendo substâncias anoréticas tipo-anfetamina ou de benzodiazepínicos, obtidas de drogarias e de farmácias de manipulação. Os dados foram comparados com os de outras cidades do Brasil, obtendo
The Food and Drug Administration (FDA) is further delaying, until December 1, 2006, the effective date of certain requirements of a final rule published in the Federal Register of December 3, 1999 (64 FR 67720). In the Federal Register of May 3, 2000 (65 FR 25639), the agency delayed until October 1, 2001, the effective date of certain requirements in the final rule relating to wholesale distribution of prescription drugs by distributors that are not authorized distributors of record, and distribution of blood derivatives by entities that meet the definition of a "health care entity" in the final rule. The agency further delayed the effective date of these requirements in three subsequent Federal Register notices. Most recently, in the Federal Register of January 31, 2003 (68 FR 4912), FDA delayed the effective date until April 1, 2004. This action further delays the effective date of these requirements until December 1, 2006. The final rule implements the Prescription Drug Marketing Act of 1987 (PDMA), as modified by the Prescription Drug Amendments of 1992 (PDA), and the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The agency is taking this action to address concerns about the requirements in the final rule raised by affected parties. As explained in the SUPPLEMENTARY INFORMATION section, FDA is working with stakeholders through its counterfeit drug initiative to facilitate widespread, voluntary adoption of track and trace technologies that will generate a de facto electronic pedigree, including prior transaction history back to the original manufacturer, as a routine course of business. If this technology is widely adopted, it is expected to help fulfill the pedigree requirements of the PDMA and obviate or resolve many of the concerns that have been raised with respect to the final rule by ensuring that an electronic pedigree travels with a drug product at all times. Therefore, it is necessary to delay the effective date of Sec
Rose, Klaus; Senn, Stephen
The European Medicines Agency (EMA) website lists all diseases that officially exist in adults only. The class waiver for juvenile melanoma was revoked in 2008 referring to US SEER statistics. This statistical justification is misleading. Melanoma in adolescents is much rarer than claimed by EMA/Paediatric Committee; < 1 ∕ 4 of adolescents with melanoma need systemic treatment; separate efficacy studies are neither medically justified nor feasible. The scarce adolescent patients should be allowed to participate in adult trials. To force companies to investigate them separately turns them into paediatric hostages, to adapt the term therapeutic orphans coined in 1968 by Shirkey. There are now five melanoma Paediatric Investigation Plans (PIPs). Probably none of the PIP-triggered clinical studies will ever be completed; we propose to call them ghost studies. An oncology research network considering a reasonable trial in melanoma, including adolescents, will compete for recruitment with the PIP-triggered trials designed by regulatory tunnel vision and sponsored by companies under EMA-imposed pressure. EMA/Paediatric Committee's territorial enthusiasm ("our patients") damages oncology research. Copyright © 2014 John Wiley & Sons, Ltd.
Genici Weyh Bleich
Full Text Available CONTEXT AND OBJECTIVE: Drug interactions form part of current clinical practice and they affect between 3 and 5% of polypharmacy patients. The aim of this study was to identify the frequency of potential drug-drug interactions in prescriptions for adult and elderly patients. TYPE OF STUDY AND SETTING: Cross-sectional pharmacoepidemiological survey in the Parque Verde housing project, municipality of Cascavel, Paraná, Brazil, between December 2006 and February 2007. METHODS: Stratified cluster sampling, proportional to the total number of homes in the housing project, was used. The sample consisted of 95 homes and 96 male or female patients aged 19 or over, with medical prescriptions for at least two pharmaceutical drugs. Interactions were identified using DrugDigest, Medscape and Micromedex softwares. RESULTS: Most of the patients were female (69.8%, married (59.4% and in the age group of 60 years or over (56.3%, with an income less than or equal to three minimum monthly salaries (81.3% and less than eight years of schooling (69.8%; 90.6% of the patients were living with another person. The total number of pharmaceutical drugs was 406 (average of 4.2 medications per patient. The drugs most prescribed were antihypertensives (47.5%. The frequency of drug interactions was 66.6%. Among the 154 potential drug interactions, 4.6% were classified as major, 65.6% as moderate and 20.1% as minor. CONCLUSION: The high frequency of drug prescriptions with a potential for differentiated interactions indicates a situation that has so far been little explored, albeit a reality in household surveys.
The data presented by Joel Weissman and colleagues and by Robert Dubois do not justify the conclusions that the effects of pharmaceutical promotion are beneficial. Among consumers of direct-to-consumer advertising (Weissman and colleagues), those heavily influenced by such promotion were no more likely than others were to have new conditions diagnosed or confirmed and were much less likely to have laboratory studies ordered or lifestyle changes recommended. A second study (Dubois) arguing that drug advertising improves the appropriateness of prescribing relies on unconvincing ecological arguments. A greater presence of noncommercial, public health-oriented communication would make a more useful and cost-effective impact on the nation's health.
Plank, Linda S
The evolution of drug regulation and awarding of prescriptive authority is a complex and sometimes convoluted process that can be confusing for health care providers. A review of the history of how drugs have been manufactured and dispensed helps explain why this process has been so laborious and complicated. Because the federal and state governments have the responsibility for protecting the public, most regulations have been passed with the intentions of ensuring consumer safety. The current system of laws and regulations is the result of many years of using the legal system to correct drug marketing that had adverse health consequences. Government oversight will continue as prescribing medications transitions to an electronic form and as health care professionals in addition to physicians seek to gain prescriptive authority. © 2011 by the American College of Nurse-Midwives.
Khanfar, Nile; Loudon, David; Sircar-Ramsewak, Feroza
The effect of direct-to-consumer (DTC) television advertising of prescription medications is a growing concern of the United States (U.S.) Congress, state legislatures, and the Food and Drug Administration (FDA). This research study was conducted in order to examine consumers' perceived preferences of DTC television advertisement in relation to "reminder" "help-seeking," and "product-claim" FDA-approved advertisement categories. An additional objective was to examine the influence of DTC television advertising of prescription drugs on consumers' tendency to seek more information about the medication and/or the medical condition. The research indicates that DTC television drug ads appear to be insufficient for consumers to make informed decisions. Their mixed perception and acceptance of the advertisements seem to influence them to seek more information from a variety of medical sources.
Bianchi, Lorenzo; Paganelli, Federica; Pettenati, Maria Chiara; Turchi, Stefano; Ciofi, Lucia; Iadanza, Ernesto; Giuli, Dino
Drug prescription and administration processes strongly impact on the occurrence of risks in medical settings for they can be sources of adverse drug events (ADEs). A properly engineered use of information and communication technologies has proven to be a promising approach to reduce these risks. In this study, we propose PHARMA, a web information system which supports healthcare staff in the secure cooperative execution of drug prescription, transcription and registration tasks. PHARMA allows the easy sharing and management of documents containing drug-related information (i.e., drug prescriptions, medical reports, screening), which is often inconsistent and scattered across different information systems and heterogeneous organization domains (e.g., departments, other hospital facilities). PHARMA enables users to access such information in a consistent and secure way, through the adoption of REST and web-oriented design paradigms and protocols. We describe the implementation of the PHARMA prototype, and we discuss the results of the usability evaluation that we carried out with the staff of a hospital in Florence, Italy.
Full Text Available Carcinoma is one of the most common cause of morbidity and mortality all over the world . Chemotherapy is main stay of treatment with other modalities in the management. Present study had been conducted to evaluate prescribing pattern of anticancer drugs. An observational, retrospective study was conducted in the oncology department of ESI hos pital over a period of one year. Data of patients greater than 19 years and diagnosed as carcinoma were included in the study. Out of 197 enrolled patients, majority were female (134, 68% and in the age group of 41 - 60 years (147, 74.61% patients. Carcino ma of breast (58, 29.44% was most commonly reported followed by carcinoma head and neck (46, 23.35%, and carcinoma cervix (34, 17.25%. Chemotherapy was commonly used as combination regimens (160, 81.21%. 5 - Fluoro Uracil (5 - FU and platinum based combin ation were most frequently prescribed (60, 30.45% especially in head and neck carcinoma (46, 23.35%. Platinum based combinations were also used in management of lung carcinoma. Dexamethasone, Ranitidine, Ondansetron, were used as palliative therapy eithe r to prevent or manage adverse reactions of anticancer drugs
Weinstein, B D
Some pharmacists opposed to abortion on moral ground are concerned by having to fill prescriptions for abortifacient drugs like mifepristone (RU-486). The issue of the right of pharmacists to refuse to fill such prescriptions depends on the model of the physician-pharmacist-patient relationship. The libertarian model of pharmacy practice holds that physicians, pharmacists, and patients are bound only by the contract that they freely negotiate with one another, thus the pharmacist has no moral obligation to fill a prescription for mifepristone unless he or she has expressly contracted to do so. The American Pharmaceutical Association's 1981 Code of Ethics does not specify what a pharmacist ought to do in particular circumstances. The right to refuse is strongly supported by the principles of nonmaleficence and respect for autonomy. These are principles of the libertarian model of the pharmacist-patient relationship but are also present in the guild or societal models stressing the duty to avoid harming others. Justification for pharmacists right of refusal appeals to their autonomy rights as members of the moral community rather than the profession of pharmacy. Since the professional right to autonomy is not absolute, moral consideration circumscribe it: it is difficult to argue that a pharmacist who believes that homosexuality is immoral has the right to refuse to fill a prescription for AZT. Even if a person who presents such a prescription is homosexual there is no causal relationship between filling a prescription for AZT and participating in a homosexual act. At the opposite end the libertarians reject the notion of even a basic right to health care. A woman in the above situation would not have a right to the abortifacient drug, so a pharmacist has no duty to dispense it. According to the technician model of professionalism, the pharmacist's personal values do not matter, so a pharmacist has a duty to provide the service.
Humaraut, C; Caron, J; Bayonne, L; Moalic, Y
The elderly are particularly vulnerable to the iatrogenic effects of drugs that are a major public health problem. In a geriatric care unit of a psychiatric hospital, the pharmacist, in close cooperation with the various health professionals, takes part in the optimization of drug therapy of these patients during cross-professional consultation meetings. From 2009 to 2011, an evaluation of professional practices was run through a targeted clinical audit on the theme of "prescription drugs at the age of 75 and over". The main objective of this study is to measure the differences between the practices and the guidelines for prescription drugs concerning the elderly, and then to analyze and amend these differences. The secondary objective is to gather data on the prescription drugs for the elderly in the particular context of a psychiatric unit. The evaluation was performed using two standards: the evaluation chart of prescriptions of the Professional College of French Geriatrics (CPGF) and the French National Authority for Health and the list of Laroche et al. In the first round, after analyzing the prescriptions of 105 patients, the gap between practice and accepted standards led to the definition of three areas of improvement on the associations of neuroleptics, on the use of anticholinergic drugs and on the prescription of benzodiazepines, the latter being subject of another communication. After reassessment, the prescriptions of 101 patients were thereafter analyzed in relation to the identified areas of improvement. Patient samples of both phases were statistically homogeneous. Between the two evaluations, the percentage of prescriptions with at least two neuroleptics remained stable, the decline was not significant (18.1% to 13.9%, P≥0.05). However, it was observed that the second suggested a "conditional" decline with dosages less than or equal to those recommended for the elderly dosages. The proportion of patients who did not take anticholinergic drugs
Merla, Anna; Schulz, Peter J; Gelatti, Umberto
Background Online pharmacies are companies that sell pharmaceutical preparations, including prescription-only drugs, on the Internet. Very little is known about this phenomenon because many online pharmacies operate from remote countries, where legal bases and business practices are largely inaccessible to international research. Objective The aim of the study was to perform an up-to-date and comprehensive review of the scientific literature focusing on the broader picture of online pharmacies by scanning several scientific and institutional databases, with no publication time limits. Methods We searched 4 electronic databases up to January 2011 and the gray literature on the Internet using the Google search engine and its tool Google Scholar. We also investigated the official websites of institutional agencies (World Health Organization, and US and European centers for disease control and drug regulation authorities). We focused specifically on online pharmacies offering prescription-only drugs. We decided to analyze and report only articles with original data, in order to review all the available data regarding online pharmacies and their usage. Results We selected 193 relevant articles: 76 articles with original data, and 117 articles without original data (editorials, regulation articles, or the like) including 5 reviews. The articles with original data cover samples of online pharmacies in 47 cases, online drug purchases in 13, consumer characteristics in 15, and case reports on adverse effects of online drugs in 12. The studies show that random samples with no specific limits to prescription requirements found that at least some websites sold drugs without a prescription and that an online questionnaire was a frequent tool to replace prescription. Data about geographical characteristics show that this information can be concealed in many websites. The analysis of drug offer showed that online a consumer can get virtually everything. Regarding quality of drugs
Orizio, Grazia; Merla, Anna; Schulz, Peter J; Gelatti, Umberto
Online pharmacies are companies that sell pharmaceutical preparations, including prescription-only drugs, on the Internet. Very little is known about this phenomenon because many online pharmacies operate from remote countries, where legal bases and business practices are largely inaccessible to international research. The aim of the study was to perform an up-to-date and comprehensive review of the scientific literature focusing on the broader picture of online pharmacies by scanning several scientific and institutional databases, with no publication time limits. We searched 4 electronic databases up to January 2011 and the gray literature on the Internet using the Google search engine and its tool Google Scholar. We also investigated the official websites of institutional agencies (World Health Organization, and US and European centers for disease control and drug regulation authorities). We focused specifically on online pharmacies offering prescription-only drugs. We decided to analyze and report only articles with original data, in order to review all the available data regarding online pharmacies and their usage. We selected 193 relevant articles: 76 articles with original data, and 117 articles without original data (editorials, regulation articles, or the like) including 5 reviews. The articles with original data cover samples of online pharmacies in 47 cases, online drug purchases in 13, consumer characteristics in 15, and case reports on adverse effects of online drugs in 12. The studies show that random samples with no specific limits to prescription requirements found that at least some websites sold drugs without a prescription and that an online questionnaire was a frequent tool to replace prescription. Data about geographical characteristics show that this information can be concealed in many websites. The analysis of drug offer showed that online a consumer can get virtually everything. Regarding quality of drugs, researchers very often found
Sumida, Wesley K; Taniguchi, Ronald; Juarez, Deborah Taira
Prescription drugs have reduced morbidity and mortality and improved the quality of life of millions of Americans. Yet, concerns over drug price increases loom. Drug spending has risen relatively slowly over the past decade because many of the most popular brand-name medicines lost patent protection. In the near future, there will be fewer low-cost generics coming into the market to offset the rising prices of brand-name drugs. Drug expenditures are influenced by both volume and price. This article focuses on how drug prices are set in the United States and current trends. Drug prices are determined through an extremely complicated set of interactions between pharmaceutical manufacturers, wholesalers, retailers, insurers, pharmacy benefit managers (PBMs), managed care organizations, hospitals, chain stores, and consumers. The process differs depending on the type of drug and place of delivery. Rising drug prices have come under increased scrutiny due to increased cost inflation and because many price increases come as a result of mergers and acquisitions of generic drug companies or changes in ownership of brand name drug manufacturers. Other countries have reigned in drug prices by negotiating with or regulating pharmaceutical manufacturers. The best long-term solution to rising drug prices is yet to be determined but the United States will continue to debate this issue and the discussions will get more heated if drug expenditures continue to rise at a rapid rate (ie, increasing 13% in 2014 from the previous year).
Dushyant Pal Singh
Full Text Available Introduction: Dentists prescribe antibiotics routinely to manage oral and dental infections. Unscrupulous antibiotic prescriptions can be associated with unfavorable side effects and the development of resistance. Thus, the aim of this study was to assess the level of knowledge regarding antibiotic prescription use among dentists in Jaipur City, Rajasthan. Materials and Methods: A questionnaire survey was conducted among 300 dentists in Jaipur city. A validated, self-designed, 21-item, closed-ended questionnaire was used to collect data on knowledge regarding antibiotic prescription. Descriptive statistics were calculated. Results: A total of 300 dental practitioners were included in the study. The majority of the respondents seem to prescribe antibiotics that are broad spectrum or the ones that are commonly used. A considerable percentage of the respondents were not aware of the pregnancy drug risk categories by Food and Drug Administration. The most of the respondents said that they prescribe antibiotics on the basis of the diagnosis, whereas more than two-thirds of the respondents said that they never advise culture sensitivity test before prescribing the antibiotics. Conclusion: Our findings suggest the knowledge of dentists regarding antibiotic prescription is inadequate and more focus should be given to the ongoing training regarding the pharmacological aspects, pertinent medical conditions, and prophylactic use of antibiotics in dentistry.
Larissa J Maier
Full Text Available BACKGROUND: Neuroenhancement is the use of substances by healthy subjects to enhance mood or cognitive function. The prevalence of neuroenhancement among Swiss university students is unknown. Investigating the prevalence of neuroenhancement among students is important to monitor problematic use and evaluate the necessity of prevention programs. STUDY AIM: To describe the prevalence of the use of prescription medications and drugs of abuse for neuroenhancement among Swiss university students. METHOD: In this cross-sectional study, students at the University of Zurich, University of Basel, and Swiss Federal Institute of Technology Zurich were invited via e-mail to participate in an online survey. RESULTS: A total of 28,118 students were contacted, and 6,275 students completed the survey. Across all of the institutions, 13.8% of the respondents indicated that they had used prescription drugs (7.6% or drugs of abuse including alcohol (7.8% at least once specifically for neuroenhancement. The most frequently used prescription drugs for neuroenhancement were methylphenidate (4.1%, sedatives (2.7%, and beta-blockers (1.2%. Alcohol was used for this purpose by 5.6% of the participants, followed by cannabis (2.5%, amphetamines (0.4%, and cocaine (0.2%. Arguments for neuroenhancement included increased learning (66.2%, relaxation or sleep improvement (51.2%, reduced nervousness (39.1%, coping with performance pressure (34.9%, increased performance (32.2%, and experimentation (20%. Neuroenhancement was significantly more prevalent among more senior students, students who reported higher levels of stress, and students who had previously used illicit drugs. Although "soft enhancers", including coffee, energy drinks, vitamins, and tonics, were used daily in the month prior to an exam, prescription drugs or drugs of abuse were used much less frequently. CONCLUSIONS: A significant proportion of Swiss university students across most academic disciplines reported
Newland, Shelby E
In terms of health care access, bioethics has an important role to inform and shape policy issues and develop interdisciplinary ideas and interventions. The rising price of prescription drugs presents one of the most looming barriers to health care access in the world today. Including both theoretical and practical features of the pharmaceutical industry's behavior is necessary to find ethical solutions towards increasing access. Bioethics can evaluate global justice by weighing human rights theory and future innovation at the macro level, and by addressing market forces and responsibilities at the micro level. Inherent structural features of pharmaceuticals, such as its reliance on research and development, cause the industry to employ pricing strategies that seem counter-intuitive to conventional wisdom, but that result in producing a just allocation as defined by market forces. Parallel trade and drug exportation/reimportation threaten the saliency of the industry's differential pricing scheme; a case-study of a single "Euro-price" within the European Union illustrates how this will actually create harm to the most needy member states. This complex situation requires solutions weighing arguments from human rights theory with those from economic theory to arrive at the most globally just allocation of prescription drugs in the global marketplace, as well as to ensure future innovation and scientific progress. Bioethicists as well as economists need to partake urgently in this discourse for the betterment of the global injustices in the international prescription drug market.
Arora, Sanjay; Sood, Neeraj; Terp, Sophie; Joyce, Geoffrey
To measure variations in drug prices across and within zip codes that may reveal simple strategies to improve patients' access to prescribed medications. We compared drug prices at different types of pharmacies across and within local markets. In-store prices were compared with a Web-based service providing discount coupons for prescription medications. Prices were collected for 2 generic antibiotics because most patients have limited experience with them and are less likely to know the price ranges for them. Drug prices were obtained via telephone from 528 pharmacies in Los Angeles (LA) County, California, from July to August 2014. Online prices were collected from GoodRx, a popular Web-based service that aggregates available discounts and directly negotiates with retail outlets. Drug prices found at independent pharmacies and by using discount coupons available online were lower on average than at grocery, big-box, or chain drug stores for 2 widely prescribed antibiotics. The lowest-price prescription was offered at a grocery, big-box, or chain drug store in 6% of zip codes within the LA County area. Drug prices varied dramatically within a zip code, however, and were less expensive in lower-income areas. The average price difference within a zip code was $52 for levofloxacin and $17 for azithromycin. Price shopping for medications within a small geographic area can yield considerable cost savings for the uninsured and consumers in high-deductible health plans with high negotiated prices. Clinicians and patient advocates have an incentive to convey this information to patients to improve adherence to prescribed medicines and lower the financial burden of purchasing prescription drugs.
Kao, Li-Ting; Chen, Yi-Hua; Lin, Herng-Ching; Chung, Shiu-Dong
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.
Williams, Pamela A; O'Donoghue, Amie C; Sullivan, Helen W; Willoughby, Jessica Fitts; Squire, Claudia; Parvanta, Sarah; Betts, Kevin R
Drug efficacy can be measured by composite scores, which consist of two or more symptoms or other clinical components of a disease. We evaluated how individuals interpret composite scores in direct-to-consumer (DTC) prescription drug advertising. We conducted an experimental study of seasonal allergy sufferers (n=1967) who viewed a fictitious print DTC ad that varied by the type of information featured (general indication, list of symptoms, or definition of composite scores) and the presence or absence of an educational intervention about composite scores. We measured composite score recognition and comprehension, and perceived drug efficacy and risk. Ads that featured either (1) the composite score definition alone or (2) the list of symptoms or general indication information along with the educational intervention improved composite score comprehension. Ads that included the composite score definition or the educational intervention led to lower confidence in the drug's benefits. The composite score definition improved composite score recognition and lowered drug risk perceptions. Adding composite score information to DTC print ads may improve individuals' comprehension of composite scores and affect their perceptions of the drug. Providing composite score information may lead to more informed patient-provider prescription drug decisions. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.
Donohue, Julie M; Fischer, Michael A; Huskamp, Haiden A; Weissman, Joel S
To estimate potential savings associated with the Consumer Reports Best Buy Drugs program, a national educational program that provides consumers with price and effectiveness information on prescription drugs. National data on 2006 prescription sales and retail prices paid for angiotensin-converting enzyme inhibitors (ACEIs), β-blockers, calcium channel blockers, and 3-hydroxy-3-methylglutaryl coenzyme A (HMG-coA) reductase inhibitors (statins). We converted national data on aggregate unit sales of drugs in the four classes to defined daily doses (DDD) and estimated a range of potential savings from generic and therapeutic substitution. We estimated that $2.76 billion, or 7.83 percent of sales, could be saved if use of the drugs recommended by the educational program was increased. The recommended drugs' prices were 15-65 percent lower per DDD than their therapeutic alternatives. The majority (57.4 percent) of potential savings would be achieved through therapeutic substitution. Substantial savings can be achieved through greater use of comparatively effective and lower cost drugs recommended by a national consumer education program. However, barriers to dissemination of consumer-oriented drug information must be addressed before savings can be realized. © Health Research and Educational Trust.
Danzon, Patricia M; Wilensky, Gail R; Means, Kathleen E
Reimbursement options for pharmaceuticals reimbursed under Medicare Part B (physician-dispensed drugs) are changing and the new comprehensive Part D Medicare outpatient drug benefit brings further changes. The Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA) replaces traditional policy, of reimbursing Part B drugs at 95% of average wholesale price (AWP, a list price), with a percentage markup over the manufacturer's average selling price; in 2005 an indirect competitive procurement option will be introduced. In our view, although AWP-based reimbursement has been fraught with problems in the past, these could be fixed by constraining growth in AWP and periodically adjusting the discount off AWP. With these revisions, an AWP-based rule would preserve incentives for competitive discounting and deliver savings to Medicare. By contrast, basing Medicare reimbursement on a manufacturer's average selling price undermines incentives for discounting and, like any cost-based reimbursement rule, may result in higher prices to both public and private purchasers. Indirect competitive procurement for drugs alone, using specialty pharmacies, pharmacy benefit managers, or prescription drug plans, is unlikely to constrain costs to acceptable levels unless contractors retain flexibility to use standard benefit management tools. Folding Part B and Part D into comprehensive contracting with health plans for full health services is likely to offer the most efficient approach to managing the drug benefit.
Full Text Available The use of prescription or recreational drugs for cognitive enhancement (CE is prevalent among students. However, the prevalence of CE among Swiss school students is unknown. We therefore performed a cross-sectional online survey including ≥ 16-year-old students from bridge-year schools (10th grade, vocational schools, and upper secondary schools (10th-12th grade in the Canton of Zurich to investigate the prevalence of and motives for the use of prescription drugs, recreational drugs, and/or freely available soft enhancers for CE. A total of 1,139 students were included. Of these, 54.5% reported the use of prescription drugs (9.2%, recreational drugs including alcohol (6.2%, or soft enhancers (51.3% explicitly for CE at least once in their lives. The last-year and last-month prevalence for CE considering all substances was 45.5% and 39.5%, respectively. Soft enhancers were the substances that were most commonly used (ever, last-year, and last-month, respectively, including energy drinks (33.3%, 28.4%, and 24.6%, coffee (29.8%, 25.1%, and 21.9%, and tobacco (12.6%, 9.3%, and 8.3%. CE with methylphenidate was less prevalent (4.0%, 2.8%, and 2.0%. However, the use of prescription drugs, alcohol, or illegal drugs for CE was reported by 13.3% of the participants. The most common motives for use were to stay awake and improve concentration. CE was more prevalent among students who reported higher levels of stress or performance pressure and students with psychiatric disorders. In conclusion, half of the school students had used a substance at least once in their lives to improve school performance. Soft enhancers were most commonly used. Prevalence rates were similar to those reported by Swiss university students, indicating that the use of prescription or recreational drugs for CE already occurs before starting higher education. Performance pressure, stress, and psychiatric disorders may be associated with CE.
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Warnings required on drugs exempted from prescription-dispensing requirements of section 503(b)(1)(C). 369.3 Section 369.3 Food and Drugs FOOD AND DRUG... subject to the labeling requirements prescribed in § 310.201(a) of this chapter. Although, for convenience...
Corroon Jr JM
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
Katsuki, Takeo; Mackey, Tim Ken; Cuomo, Raphael
Youth and adolescent non-medical use of prescription medications (NUPM) has become a national epidemic. However, little is known about the association between promotion of NUPM behavior and access via the popular social media microblogging site, Twitter, which is currently used by a third of all teens. In order to better assess NUPM behavior online, this study conducts surveillance and analysis of Twitter data to characterize the frequency of NUPM-related tweets and also identifies illegal access to drugs of abuse via online pharmacies. Tweets were collected over a 2-week period from April 1-14, 2015, by applying NUPM keyword filters for both generic/chemical and street names associated with drugs of abuse using the Twitter public streaming application programming interface. Tweets were then analyzed for relevance to NUPM and whether they promoted illegal online access to prescription drugs using a protocol of content coding and supervised machine learning. A total of 2,417,662 tweets were collected and analyzed for this study. Tweets filtered for generic drugs names comprised 232,108 tweets, including 22,174 unique associated uniform resource locators (URLs), and 2,185,554 tweets (376,304 unique URLs) filtered for street names. Applying an iterative process of manual content coding and supervised machine learning, 81.72% of the generic and 12.28% of the street NUPM datasets were predicted as having content relevant to NUPM respectively. By examining hyperlinks associated with NUPM relevant content for the generic Twitter dataset, we discovered that 75.72% of the tweets with URLs included a hyperlink to an online marketing affiliate that directly linked to an illicit online pharmacy advertising the sale of Valium without a prescription. This study examined the association between Twitter content, NUPM behavior promotion, and online access to drugs using a broad set of prescription drug keywords. Initial results are concerning, as our study found over 45,000 tweets
This study content analyzed online direct-to-consumer advertisements (DTCA) for prescription drug treatments to explore whether ads for prescription treatments for psychiatric conditions, which are commonly untreated, differ from other drug advertisements. Coded variables included the presence of interactive technological components, use of promotional incentives, and the social contexts portrayed in images shown on each site. Statistical analysis revealed ads for psychiatric medications contained fewer interactive website features, financial incentives, and calls to action than other types of prescription drug advertisements. Implications for health communication researchers are discussed.
Levaggi, Rosella; Marcantoni, Claudio; Filippucci, Laura; Gelatti, Umberto
In this note we study the value for money of purchases of fluoxetine made through on-line pharmacies without prescription. We show that this channel is not good value from an economic point of view and that it can be dangerous in medical terms because of the poor quality of the drugs received and the lack of prescribing instructions. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.
Hagemeier, Nicholas E; Tudiver, Fred; Brewster, Scott; Hagy, Elizabeth J; Hagaman, Angela; Pack, Robert P
Interpersonal communication is inherent in a majority of strategies seeking to engage prescriber and pharmacist health care professionals (HCPs) in the reduction and prevention of prescription drug abuse (PDA). However, research on HCP PDA communication behavioral engagement and factors that influence it is limited. This study quantitatively examined communication behaviors and trait-level communication metrics, and qualitatively described prescription drug abuse-related communication perceptions and behaviors among primary care prescribers and community pharmacists. Five focus groups (N = 35) were conducted within the Appalachian Research Network (AppNET), a rural primary care practice-based research network (PBRN) in South Central Appalachia between February and October, 2014. Focus groups were structured around the administration of three previously validated trait-level communication survey instruments, and one instrument developed by the investigators to gauge HCP prescription drug abuse communication engagement and perceived communication importance. Using a grounded theory approach, focus group themes were inductively derived and coded independently by study investigators. Member-checking interviews were conducted to validate derived themes. Respondents' trait-level communication self-perceptions indicated low communication apprehension, high self-perceived communication competence, and average willingness to communicate as compared to instrument specific criteria and norms. Significant variation in HCP communication behavior engagement was noted specific to PDA. Two overarching themes were noted for HCP-patient communication: 1) influencers of HCP communication and prescribing/dispensing behaviors, and 2) communication behaviors. Multiple sub-themes were identified within each theme. Similarities were noted in perceptions and behaviors across both prescribers and pharmacists. Despite the perceived importance of engaging in PDA communication, HCPs reported
... defined in an official compendium, to help ensure that its identity, strength, quality, and purity are not adversely affected. (2) Appropriate manual, electromechanical, or electronic temperature and humidity... examined for identity and to prevent the acceptance of contaminated prescription drugs or prescription...
Pharmacists have a crucial role to ensure regulated public access to prescription drugs. The study aimed to investigate the views of community pharmacists practising in Saudi Arabia on their role in the unauthorised supply of prescription drugs, consider the possible contributory factors and report pharmacists' suggested strategies to regulate supply. One hundred community pharmacists were invited to participate in an interview-based survey, including questions on demographic characteristics, and the unauthorised supply of prescription drugs. Descriptive statistics were conducted, and associations between categorical responses tested; a P value of ≤0.05 was considered significant. Responses to open questions were analysed thematically. In Saudi Arabia, there is widespread unregulated supply of prescription drugs; pharmacists are under pressure from patients to provide prescription drugs for a wide range of clinical conditions. There are safety and appropriateness concerns when drugs are provided based on patient demand rather than clinical need. Pharmacists do not maintain patient records with information on drugs supplied and associated actions. While most pharmacists supply prescription drugs without the necessary prescriber authorisation, they also this may jeopardise patients safety. While we have many concerns about this practice its present form, we believe pharmacists should have certain prescribing privileges within their areas of competence. A legal framework is needed to guarantee proper pharmacists' training, support, mentorship and access to the tools required to provide safe pharmacy practice. © 2015 Royal Pharmaceutical Society.
Schommer, Jon C; Hansen, Richard A
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.
This paper analyzes how prices in the retail pharmaceutical market affect health care utilization. Specifically, I study the impact of Walmart's $4 Prescription Drug Program on utilization of antihypertensive drugs and on hospitalizations for conditions amenable to drug therapy. Identification relies on the change in the availability of cheap drugs introduced by Walmart's program, exploiting variation in the distance to the nearest Walmart across ZIP codes in a difference-in-differences framework. I find that living close to a source of cheap drugs increases utilization of antihypertensive medications by 7 percent and decreases the probability of an avoidable hospitalization by 6.2 percent. Copyright © 2015 Elsevier B.V. All rights reserved.
Nagar, Vittal R; Springer, Joe E; Salles, Sara
To investigate the incidence of spinal abscess and substance abuse in a tertiary care hospital after state legislation titled "House Bill 1" (HB1) mandated stricter regulation of prescription drugs of abuse in Kentucky in 2012. A retrospective case series study design was used to review the incidence of spinal abscess and drug abuse diagnoses admissions from 2010 to 2014. Variances in the incidence of spinal abscess and substance abuse were plotted across this time frame. The incidence of intraspinal abscess increased 1.56-fold in 2011 (n = 26) and 2012 (n = 25) relative to 2010 (n = 16). However, in 2013, the year following implementation of HB1 legislation, the incidence of intraspinal abscess increased 2.38-fold (n = 38) and then 4.19-fold (n = 67) in 2014. The incidence of intraspinal abscess in subjects with drug abuse diagnosis remained constant between 2010 (n = 3) and 2012 (n = 3). However, it increased twofold (n = 7) in 2013 and then ninefold (n = 27) in 2014. A correlation coefficient (rSAD ) of 0.775 revealed a strong association between the increase incidence of intraspinal abscess and diagnosis of drug abuse. The results of this retrospective study demonstrate an increased incidence of intraspinal abscess associated with drug abuse after passage of HB1 legislation regulating prescriptions of controlled medications in Kentucky. This increased incidence may be related to individuals relying on nonprescription drugs of abuse due to more highly regulated access to controlled prescription medications. However, additional factors unrelated to HB1 legislation must be taken into account. Wiley Periodicals, Inc.
Steven G Morgan
Full Text Available Increasing attention is being paid to variations in the use of prescription drugs because their role in health care has grown to the point where their use can be considered a proxy for health system performance. Studies have shown that prescription drug use varies across regions in the US, UK, and Canada by more than would be predicted based on age and health status alone. In this paper, we explore the determinants of variations in the use of prescription drugs, drawing on health services theories of access to care.We conducted a cross-sectional analysis using population-based administrative health care data for British Columbia (BC, Canada. We used logistic and hierarchical regressions to analyze the effects of individual- and area-level determinants of use of prescriptions overall and rates of purchase of prescriptions from five therapeutic categories representing a range of indications: antihypertensives, statins, acid reducing drugs, opioid drugs, and antidepressants. To indicate the relative scale of regional variations and the importance of individual- and area-level variables in explaining them, we computed standardized rates of utilization for 49 local health areas in BC.We found that characteristics of individuals and the areas in which they live affect likelihood of prescription drug purchase. Individual-level factors influenced prescription drug purchases in ways generally consistent with behavioral models of health services use. Contextual variables exerted influences that differed by type of drug studied. Population health, education levels, and ethnic composition of local areas were associated with significant differences in the likelihood of purchasing medications. Relatively modest regional variations remained after both individual-level and area-level determinants were taken into account.The results of this study suggest that individual- and area-level factors should be considered when studying variations in the use of
Morgan, Steven G; Cunningham, Colleen M; Hanley, Gillian E
Increasing attention is being paid to variations in the use of prescription drugs because their role in health care has grown to the point where their use can be considered a proxy for health system performance. Studies have shown that prescription drug use varies across regions in the US, UK, and Canada by more than would be predicted based on age and health status alone. In this paper, we explore the determinants of variations in the use of prescription drugs, drawing on health services theories of access to care. We conducted a cross-sectional analysis using population-based administrative health care data for British Columbia (BC), Canada. We used logistic and hierarchical regressions to analyze the effects of individual- and area-level determinants of use of prescriptions overall and rates of purchase of prescriptions from five therapeutic categories representing a range of indications: antihypertensives, statins, acid reducing drugs, opioid drugs, and antidepressants. To indicate the relative scale of regional variations and the importance of individual- and area-level variables in explaining them, we computed standardized rates of utilization for 49 local health areas in BC. We found that characteristics of individuals and the areas in which they live affect likelihood of prescription drug purchase. Individual-level factors influenced prescription drug purchases in ways generally consistent with behavioral models of health services use. Contextual variables exerted influences that differed by type of drug studied. Population health, education levels, and ethnic composition of local areas were associated with significant differences in the likelihood of purchasing medications. Relatively modest regional variations remained after both individual-level and area-level determinants were taken into account. The results of this study suggest that individual- and area-level factors should be considered when studying variations in the use of prescription drugs. Some
Bhutada, Nilesh S; Menon, Ajit M; Deshpande, Aparna D; Perri, Matthew
Online surveys were conducted to determine the impact of endorser credibility, endorser effectiveness, and consumers' involvement in direct-to-consumer advertising. In a randomized posttest only study, using the elaboration likelihood model, survey participants (U.S. adults) were either exposed to a fictitious prescription drug ad with a celebrity or a noncelebrity endorser. There was no significant difference in credibility and effectiveness between the celebrity and the noncelebrity endorser. High involvement consumers viewed the ad more favorably and exhibited significantly stronger drug inquiry intentions during their next doctor visit. Further, consumers' involvement did not moderate the effect of celebrity endorser.
Holtgräfe, Catherine; Zentes, Joachim
The growing importance of the Internet as an information and purchasing channel is drawing widespread attention from marketing decision makers. Nevertheless, the relevance of the Internet to the so-called self-medication market in Germany has been paid barely enough attention. Our study aims to contribute insights concerning the penetration of the Internet in this market, as well as to give an overview of the critical determinants of Internet use for non-prescription drug information seeking, such as the accessibility of professional information, trust in health professionals' opinion and the ability to search online, as well as the perceived usefulness and credibility of online non-prescription drug information. Furthermore, we demonstrate that the preferred use of the Internet as a non-prescription drug information source positively influences the choice of unconventional purchase channels for non-prescription drugs and negatively affects the use of stationary pharmacies.
In late September 2010, Members of the European Parliament (MEPs) issued their verdict on European Commission proposals aimed at lifting the ban on pharmaceutical companies communicating directly with the general public about prescription drugs. The MEPs were able to limit the scope of some of the more harmful aspects of these proposals, in particular by proposing that drug regulatory agencies should pre-screen the "information" produced by drug companies before it is made available to the public. In December 2010, faced with ongoing opposition from European Member States, the Commission appeared to back down, announcing that it was drawing up "amended proposals". They were publicly released in February 2012 but still leave the door open to direct-to-consumer advertising of prescription drugs, particularly "reminder advertising". As of 4 July 2012, the amended proposals had not yet been examined by Member States, thus obstructing the legislative process. Public health and management of the costs of social services for Member States are at stake. The Medicines in Europe Forum (MiEF) and the International Society of Drug Bulletins (ISDB) urge Member States to continue to refuse to examine the Commission's proposals, and have drawn up concrete counterproposals that would enable the general public to obtain relevant health information.
Bismuth, Serge; Chalvignac, Caroline; Bagheri, Haleh; Oustric, Stéphane
In French patients over 65 years, drug intake is characterized by polytherapy, causing iatrogenic events. The general practitioner is the main actor in the follow-up and reassessment of drug prescriptions. To assess the proportion of ASMR V (Amélioration du service medical rendu - additional therapeutic benefit versus current standards) drugs [drugs producing no medical improvement] prescribed to patients over 65 years in the management of a chronic disease. In May 2009, 849 drug prescriptions were collected from 34 general practitioners in the Midi-Pyrénées region. Specialties with ASMR V were classified according to the anatomical therapeutic chemical (ATC) classification system. 58.8% of the prescriptions concerned female patients; 67.4% of the prescriptions contained at least one ASMR-V drug. Approximately 20% of the prescriptions in subjects over 65 years contained ASMR-V drugs. This study shows that older subjects are being prescribed a significant number of ASMR-V drugs. However, this classification combines several situations, including a product line extension, a fixed combination of preexisting drugs, an insufficient therapeutic benefit, the absence of additional therapeutic benefit versus a comparative drug, the absence of comparative study in some indications, or a less favorable benefit-risk ratio comparing to that of the reference drug.This classification includes as well the generic drugs prescribed using the international non proprietary names. This study did not analyze the influence of certain factors, such as treatment history, history of drug allergy or dose titration, which could influence the physician's decision. Following this study, it appears useful to extend this type of survey to other general practitioners in other French regions, and to analyze the reasons for prescribing ASMR-V drugs. These data would help increasing general practitioners' awareness of "proper drug use" to reduce the proportion of "inadequate" drugs prescribed to
Johnell, Kristina; Fastbom, Johan
Most previous studies about drug use in the elderly population have either investigated drug use in institutions or in the community-dwelling setting. Hence, very few studies have compared drug use in institutionalized and community-dwelling elderly, maybe because of a lack of sufficiently large databases. The aim of the study was to investigate differences in drug use patterns between community-dwelling and institutionalized elderly, after adjustment for age, gender and number of other drugs (used as a proxy for overall co-morbidity). We analysed data from individuals aged ≥65 years who filled at least one drug prescription between July and September 2008 and were consequently registered in the Swedish Prescribed Drug Register (n = 1,347,564; 1,260,843 community-dwelling and 86,721 institutionalized elderly). A list of current prescriptions was constructed for every individual on the arbitrarily chosen date 30 September 2008. Outcome measures were the 20 most common drug classes and the 20 most common individual drugs. Logistic regression analysis was used to investigate whether institutionalization was associated with use of these drugs, after adjustment for age, gender and number of other drugs. Institutionalized elderly were more likely than community-dwelling elderly to use antidepressants, laxatives, minor analgesics, opioids and hypnotics/sedatives, after adjustment for age, gender and number of other drugs. On the contrary, institutionalization was negatively associated with use of lipid modifying agents, angiotensin II antagonists, selective calcium channel blockers, β-blocking agents and ACE inhibitors, after adjustment for age, gender and number of other drugs. Our results indicate that institutionalized elderly are more likely than community-dwelling elderly to use psychotropics, analgesics and laxatives, but less likely to receive recommended cardiovascular drug therapy, which may indicate a need for implementation of evidence-based guidelines for
Kornfield, Rachel; Alexander, G Caleb; Qato, Dima M; Kim, Yoonsang; Hirsch, Jan D; Emery, Sherry L
TV accounts for more than half of pharmaceutical direct-to-consumer advertising (DTCA) spending in the U.S. The purpose of this study is to quantify average household exposure to branded and non-branded (help-seeking) televised prescription drug advertisements and describe variation over time and according to medication indication and geography. In 2013, Nielsen TV ratings were compiled for prescription pharmaceutical advertising that aired between 2003 and 2011 for the top 75 U.S. media markets. All advertisements were coded as branded or help-seeking. Advertisements were further coded for one of eight prevalent indications (allergies, arthritis, asthma, erectile dysfunction, high cholesterol, smoking cessation, depression, and sleep disorder) or as "other." Televised DTCA exposure increased from 2003 to 2007 and then declined 43% by 2011, to 111 monthly prescription drug advertisements per household. The examined indications were associated with varying amounts and patterns of exposure, with greatest declines among medications for allergies and sleep disorders. Help-seeking advertisements comprised 10% of total exposure, with substantial variation by indication. Considerations of DTCA's effects on health care should take into account the shifting concentration of advertising across indications. Copyright © 2015 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.
Cline, Richard R; Mott, David A
Several proposals for adding a prescription drug benefit to the Medicare program rely on consumer choice and market forces to promote efficiency. However, little information exists regarding: 1) the extent of price sensitivity for such plans among Medicare beneficiaries, or 2) the extent to which drug-only insurance plans using various cost-control mechanisms might experience adverse selection. Using data from a survey of elderly Wisconsin residents regarding their likely choices from a menu of hypothetical drug plans, we show that respondents are likely to be price sensitive with respect to both premiums and out-of-pocket costs but that selection problems may arise in these markets. Outside intervention may be necessary to ensure the feasibility of a market-based approach to a Medicare drug benefit.
Simonsen, Marianne; Skipper, Lars; Skipper, Niels
This paper investigates price sensitivity of demand for prescription drugs using drug purchase records for at 20% random sample of the Danish population. We identify price responsiveness by exploiting exogenous variation in prices caused by kinked reimbursement schemes and implement a regression ...... education and income are, however, more responsive to the price. Also, essential drugs that prevent deterioration in health and prolong life have lower associated average price sensitivity....... kink design. Thus, within a unifying framework we uncover price sensitivity for different subpopulations and types of drugs. The results suggest low average price responsiveness with corresponding price elasticities ranging from -0.08 to -0.25, implying that demand is inelastic. Individuals with lower...
Suneetha, A; Rajeswari, Raja K
As a polytherapy treatment, multiple sclerosis disease demands prescriptions with more than one drug. Polytherapy is sometimes rational for drug combinations chosen to minimize adverse effects. Estimation of drugs that are concomitantly administered in polytherapy is acceptable as it shortens the analytical timepoints and also the usage of biological matrices. In clinical phase trials, the withdrawal of biofluids is a critical issue for each analysis. Estimating all the coadminsitered drugs in a single shot will be more effective and economical for pharmaceuticals. A single, simple, rapid and sensitive high-performance liquid chromatography assay method has been developed with UV detection and fully validated for the quantification of 14 drugs (at random combinations) used in the treatment of multiple sclerosis disease. The set of combinations was based on prescriptions to patients. Separations were achieved on an X-Terra MS C18 (100 × 3.9 mm, 5 µm) column. The analytes were extracted from 50 µL aliquots of whole human blood with protein precipitation using acetonitrile. All the drugs were sufficiently stable during storage for 24 h at room temperature and for 23 days at 2-8°C. The percentage recoveries of all drugs were between 90 and 115%, with RSD values <10.6%. This method has been shown to be reproducible and sensitive and can be applied to clinical samples from pharmacokinetic studies and also a useful tool in studying the drug interaction studies. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: email@example.com.
Corroon, James M; Mischley, Laurie K; Sexton, Michelle
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
Background While extensive evidence suggests that the economic recession has had far reaching effects on many economic sectors, little is known regarding its impact on prescription drug utilization. The purpose of this study is to describe the association between state-level unemployment rates and retail sales of seven therapeutic classes (statins, antidepressants, antipsychotics, angiotensin-converting enzyme [ACE] inhibitors, opiates, phosphodiesterase [PDE] inhibitors and oral contraceptives) in the United States. Methods Using a retrospective mixed ecological design, we examined retail prescription sales using IMS Health Xponent™ from September 2007 through July 2010, and we used the Bureau of Labor Statistics to derive population-based rates and mixed-effects modeling with state-level controls to examine the association between unemployment and utilization. Our main outcome measure was state-level utilization per 100,000 people for each class. Results Monthly unemployment levels and rates of use of each class varied substantially across the states. There were no statistically significant associations between use of ACE inhibitors or SSRIs/SNRIs and average unemployment in analyses across states, while for opioids and PDE inhibitors there were small statistically significant direct associations, and for the remaining classes inverse associations. Analyses using each state as its own control collectively exhibited statistically significant positive associations between increases in unemployment and prescription drug utilization for five of seven areas examined. This relationship was greatest for statins (on average, a 4% increase in utilization per 1% increased unemployment) and PDE inhibitors (3% increase in utilization per 1% increased unemployment), and lower for oral contraceptives and atypical antipsychotics. Conclusion We found no evidence of an association between increasing unemployment and decreasing prescription utilization, suggesting that any
...The Food and Drug Administration (FDA) is reopening the comment period on specific data related to a proposed rule published in the Federal Register of March 29, 2010 (75 FR 15376), to establish standards that would be considered in determining whether the major statement in direct-to-consumer (DTC) television and radio advertisements relating to the side effects and contraindications of an advertised prescription drug intended for use by humans is presented in a clear, conspicuous, and neutral manner. FDA is announcing that it has added a document to the docket for the proposed rulemaking concerning a study entitled: ``Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to- Consumer Prescription Drug Television Advertisements'' (Distraction Study). This study was designed to investigate some advertising factors that could influence consumers' understanding of a drug's risks. This document reopens the comment period for the rulemaking proceeding to allow an opportunity for comment on the study as it relates to the proposed standards.
Sánchez, Diego P; Guillén, José J; Torres, Alberto M; Arense, Julián J; López, Ángel; Sánchez, Fernando I
In the past few decades, increasing pharmaceutical expenditures in Spain and other western countries led to the adoption of reforms in order to reduce this trend. The aim of our study was to analyze if reforms concerning the pharmaceutical reimbursement scheme in Spain have been associated with changes in the volume and trend of pharmaceutical consumption. Retrospective observational study. Region of Murcia. Prescription drug in primary care and external consultations. Records of prescribed medicines between January 1, 2008 and December 31, 2013. Segmented regression analysis of interrupted time-series of prescription drug consumption. Dispensing of all five therapeutic classes fell immediately after co-payment changes. The segmented regression model suggested that per patient drug consumption in pensioners may have decreased by about 6.76% (95% CI; -8.66% to -5.19%) in the twelve months after the reform, compared with the absence of such a policy. Furthermore the slope of the series of consumption increased from 6.08 (P<.001) to 12.17 (P<.019). The implementation of copayment policies could be associated with a significant decrease in the level of prescribed drug use in Murcia Region, but this effect seems to have been only temporary in the five therapeutic groups analyzed, since almost simultaneously there has been an increase in the growth trend. Copyright © 2014 Elsevier España, S.L.U. All rights reserved.
Campo, Katia; De Staebel, Odette; Gijsbrechts, Els; van Waterschoot, Walter
This paper provides an in-depth, qualitative analysis of the physicians' decision process for drug prescription. Drugs in the considered therapeutic classes are mainly prescribed by specialists, treating patients with obligatory medical insurance, for a prolonged period of time. The research approach is specifically designed to capture the full complexity and sensitive nature of the physician's choice behavior, which appears to be more hybrid and less rational in nature than is often assumed in quantitative, model-based analyses of prescription behavior. Several interesting findings emerge from the analysis: (i) non-compensatory decision rules seem to dominate the decision process, (ii) consideration sets are typically small and change-resistant, (iii) drug cost is not a major issue for most physicians, (iv) detailing remains one of the most powerful pharmaceutical marketing instruments and is highly appreciated as a valuable and quick source of information, and (v) certain types of non-medical marketing incentives (such as free conference participation) may in some situations also influence drug choices.
Full Text Available Drug-induced QT-interval prolongation is associated with occurrence of potentially fatal Torsades de Pointes arrhythmias (TdP. So far, data regarding the overall burden of QT-interval prolonging drugs (QT-drugs in geriatric patients are limited.This study was performed to assess the individual burden of QT-interval prolonging drugs (QT-drugs in geriatric polymedicated patients and to identify the most frequent and risky combinations of QT-drugs.In the discharge medication of geriatric patients between July 2009 and June 2013 from the Geriatrics in Bavaria-Database (GiB-DAT (co-prescriptions of QT-drugs were investigated. QT-drugs were classified according to a publicly available reference site (CredibleMeds® as ALL-QT-drugs (associated with any QT-risk or High-risk-QT-drugs (corresponding to QT-drugs with known risk of Torsades de Pointes according to CredibleMeds® and in addition as SmPC-high-risk-QT-drugs (according to the German prescribing information (SmPC contraindicated co-prescription with other QT-drugs.Of a cohort of 130,434 geriatric patients (mean age 81 years, 67% women, prescribed a median of 8 drugs, 76,594 patients (58.7% received at least one ALL-QT-drug. Co-prescriptions of two or more ALL-QT-drugs were observed in 28,768 (22.1% patients. Particularly risky co-prescriptions of High-risk-QT-drugs or SmPC-high-risk-QT-drugs with at least on further QT-drug occurred in 55.9% (N = 12,633 and 54.2% (N = 12,429 of these patients, respectively. Consideration of SmPCs (SmPC-high-risk-QT-drugs allowed the identification of an additional 15% (N = 3,999 patients taking a risky combination that was not covered by the commonly used CredibleMeds® classification. Only 20 drug-drug combinations accounted for more than 90% of these potentially most dangerous co-prescriptions.In a geriatric study population co-prescriptions of two and more QT-drugs were common. A considerable proportion of QT-drugs with higher risk only could be detected by
Limbu, Yam; Torres, Ivonne M
This article examines consumers' attitudes toward Direct-to-Consumer (DTC) advertising of prescription drugs that are influenced by the use different types of DTC ads and product involvement. Our findings suggest that product involvement and the type of DTC ad are significant predictors of consumers' attitudinal responses toward DTC advertising. High involvement consumers have more favorable attitudes toward the drug's price, DTC ad and brand name, and a higher intention to ask a doctor about the advertised drug than low involvement consumers. In contrast to Informational and Reminder DTC ads, Persuasive ads have more favorable effects on consumers' reactions to DTC prescription drug advertising.
Public/private partnerships for prescription drug coverage: policy formulation and outcomes in Quebec's universal drug insurance program, with comparisons to the Medicare prescription drug program in the United States.
Pomey, Marie-Pascale; Forest, Pierre-Gerlier; Palley, Howard A; Martin, Elisabeth
In January 1997, the government of Quebec, Canada, implemented a public/private prescription drug program that covered the entire population of the province. Under this program, the public sector collaborates with private insurers to protect all Quebecers from the high cost of drugs. This article outlines the principal features and history of the Quebec plan and draws parallels between the factors that led to its emergence and those that led to the passage of the Medicare Prescription Drug, Improvement and Modernization Act (MMA) in the United States. It also discusses the challenges and similarities of both programs and analyzes Quebec's ten years of experience to identify adjustments that may help U.S. policymakers optimize the MMA.
van der Gronde, T.; Uyl-de Groot, Carin A; Pieters, A.H.L.M.
Context. Recent public outcry has highlighted the rising cost of prescription drugs worldwide, which in several disease areas outpaces other health care expenditures and results in a suboptimal global availability of essential medicines. Method. A systematic review of Pubmed, the Financial Times,
Gronde, T.V. (Toon van der); C.A. Uyl-de Groot (Carin); Pieters, T. (Toine)
markdownabstractCONTEXT: Recent public outcry has highlighted the rising cost of prescription drugs worldwide, which in several disease areas outpaces other health care expenditures and results in a suboptimal global availability of essential medicines. METHOD: A systematic review of Pubmed, the
Lago, Paola; Bizzarri, Giancarlo; Scalzotto, Francesca; Parpaiola, Antonella; Amigoni, Angela; Putoto, Giovanni; Perilongo, Giorgio
Administering medication to hospitalised infants and children is a complex process at high risk of error. Failure mode and effect analysis (FMEA) is a proactive tool used to analyse risks, identify failures before they happen and prioritise remedial measures. To examine the hazards associated with the process of drug delivery to children, we performed a proactive risk-assessment analysis. Five multidisciplinary teams, representing different divisions of the paediatric department at Padua University Hospital, were trained to analyse the drug-delivery process, to identify possible causes of failures and their potential effects, to calculate a risk priority number (RPN) for each failure and plan changes in practices. To identify higher-priority potential failure modes as defined by RPNs and planning changes in clinical practice to reduce the risk of patients harm and improve safety in the process of medication use in children. In all, 37 higher-priority potential failure modes and 71 associated causes and effects were identified. The highest RPNs related (>48) mainly to errors in calculating drug doses and concentrations. Many of these failure modes were found in all the five units, suggesting the presence of common targets for improvement, particularly in enhancing the safety of prescription and preparation of endovenous drugs. The introductions of new activities in the revised process of administering drugs allowed reducing the high-risk failure modes of 60%. FMEA is an effective proactive risk-assessment tool useful to aid multidisciplinary groups in understanding a process care and identifying errors that may occur, prioritising remedial interventions and possibly enhancing the safety of drug delivery in children.
Karjalainen, Karoliina; Lintonen, Tomi; Hakkarainen, Pekka
Non-medical use of prescription drugs (NMUPD) is known to be associated with illicit drug use, but less is known about how illicit drug use has changed in NMUPD. We examined (1) the changes in illicit drug use among Finnish non-medical users of prescription drugs during the 2000s and (2) whether the trends of illicit drug use differ by non-medical use of prescription drugs in the general population. Data were derived from population-based (aged 15-69) Drug Surveys conducted in Finland in 2002, 2006, 2010 and 2014. The response rates varied between 63% and 48%. NMUPD during the last year was measured (n=252). Past-year illicit drug use among non-medical users of prescription drugs and the reference population not reporting NMUPD (n=10,967) was compared. Logistic regression was used to estimate the p-values for trends. Illicit drug use has increased notably among Finnish non-medical users of prescription drugs (from 21% to 70%, p for trendillicit drug use also increased statistically significantly, but much more moderately (from 2.5% to 5.4%). The difference between the trends was confirmed by an interaction test (p=0.022). NMUPD seems to be increasingly merging with illicit drug use. This indicates an increasing prevalence of polydrug use among non-medical users of prescription drugs, which may bring about more severe harms and worse health outcomes for users and more challenges in regard to treatment. Copyright © 2017 Elsevier B.V. All rights reserved.
Ford, Jason A; Arrastia, Meagan C
Data from the 2001 College Alcohol Study, a national sample of U.S. college students, were used to conduct multinomial logistic regression analysis examining correlates of substance use. Students were divided into three groups based on their lifetime substance use: non-users, non-medical prescription drug use only, and illicit/street drug use only. The purpose of this analytic strategy was to examine the similarities/differences in the correlates of non-medical prescription drug use and illicit/street drug use. Findings indicate that race, age, G.P.A., sexual activity, health, binge drinking, marijuana use, social bonding and social learning measures are correlates of non-medical prescription drug use. Correlates of illicit/street drug use include gender, Hispanic ethnicity, sexual activity, binge drinking, marijuana use, social bonding and social learning measures. Finally, the focus of the paper is a comparison of students who report only non-medical prescription drug use to students who report only illicit/street drug use. Findings indicate that gender, race, marital status, sexual activity, marijuana use, and social bonding measures significantly distinguish illicit/street drug use from non-medical prescription drug use. Important implications, limitations, and future research needs were discussed.
Hansen, Richard A; Schommer, Jon C; Cline, Richard R; Hadsall, Ronald S; Schondelmeyer, Stephen W; Nyman, John A
Previous research on the impact of various cost-sharing strategies on prescription drug use has not considered the impact of direct-to-consumer (DTC) advertising. To explore the association of cost-containment strategies with prescription drug use and to determine if the association is moderated by DTC prescription drug advertising. The study population included 288 280 employees and dependents aged 18 to 65 years with employer-sponsored health insurance contributing to the MEDSTAT MarketScan administrative data set. Person-level enrollment and claims data were obtained for beneficiaries enrolled continuously during July 1997 through December 1998. Direct-to-consumer advertising data were obtained from Competitive Media Reporting and linked to the MEDSTAT enrollment files. Localized DTC advertising expenditures for one class of medication were evaluated and matched with prescription claims for eligible MEDSTAT contributors. The association of various types and levels of cost-sharing incentives with incident product use was evaluated, controlling for the level of DTC advertising, health status, and other demographic covariates. The relationship of cost-sharing amounts with drug use was modified by the level of DTC advertising in a geographic market. This relationship was dependent on the type of cost-sharing, distinguishing between co-payments for provider visits and co-payments for prescription drugs. Compared with low-advertising markets, individuals residing in markets with high levels of advertising and paying provider co-payments of $10.00 or more were more likely to use the advertised product. In the same markets, higher prescription drug co-payments were associated with a decreased likelihood of using the advertised product. A similar relationship was not observed for the nonadvertised competitor. Among insured individuals, response to cost-sharing strategies is moderated by DTC prescription drug advertising. The relative ability of cost-sharing strategies to
Oliven, A; Zalman, D; Shilankov, Y; Yeshurun, D; Odeh, M
Computerized prescription of drugs is expected to reduce the number of many preventable drug ordering errors. In the present study we evaluated the usefullness of a computerized drug order entry (CDOE) system in reducing prescription errors. A department of internal medicine using a comprehensive CDOE, which included also patient-related drug-laboratory, drug-disease and drug-allergy on-line surveillance was compared to a similar department in which drug orders were handwritten. CDOE reduced prescription errors to 25-35%. The causes of errors remained similar, and most errors, on both departments, were associated with abnormal renal function and electrolyte balance. Residual errors remaining on the CDOE-using department were due to handwriting on the typed order, failure to feed patients' diseases, and system failures. The use of CDOE was associated with a significant reduction in mean hospital stay and in the number of changes performed in the prescription. The findings of this study both quantity the impact of comprehensive CDOE on prescription errors and delineate the causes for remaining errors.
Kreling, D H; Kirk, K W
Accurate payment for the acquisition costs of drug products dispensed is an important consideration in a third-party prescription drug program. Two alternative methods of estimating these costs among pharmacies were derived and compared. First, pharmacists were surveyed to determine the purchase discounts offered to them by wholesalers. A 10.00% modal and 11.35% mean discount resulted for 73 responding pharmacists. Second, cost-plus percents derived from gross profit margins of wholesalers were calculated and applied to wholesaler product costs to estimate pharmacy level acquisition costs. Cost-plus percents derived from National Median and Southwestern Region wholesaler figures were 9.27% and 10.10%, respectively. A comparison showed the two methods of estimating acquisition costs would result in similar acquisition cost estimates. Adopting a cost-plus estimating approach is recommended because it avoids potential pricing manipulations by wholesalers and manufacturers that would negate improvements in drug product reimbursement accuracy.
Jalbert, Jessica J; Quilliam, Brian J; Lapane, Kate L
The risk of adverse events among alcohol-interactive medication users can occur with one standard alcoholic drink. Research on the extent to which this occurs is scant. To examine the prevalence and correlates of concurrent alcohol and alcohol-interactive (AI) medication use across different levels of risk for an alcohol-related adverse event in a nationally representative sample of American adults. Cross-sectional analysis of past year, self-reported drinking history as well as past month, self-reported and visually inspected prescription drug use data from the 1999-2000 and 2001-2002 NHANES questionnaire section (n = 8,246). Medications were considered AI if concurrent use of alcohol and the prescription drug could intensify the effects of alcohol, resulting in increased sedation, drowsiness, or dizziness. Weighted prevalence estimates and polytomous logistic regression accounted for the complex survey design. Overall, 13.5% took prescription AI medications, of which 5.6% reported alcohol consumption of three or more drinks on each drinking occasion. Correlates of such use were being a man [adjusted odds ratio (AOR): 4.37; 95% confidence interval (CI): 1.84-10.35], between the ages of 20 and 54 (AOR=12.28; 95% CI: 3.12-48.25), and currently smoking (AOR: 2.61; 95% CI: 1.28-5.29), with alcohol-abstaining AI users as the referent group. Combining alcohol and AI medications is a common phenomenon, and the risk of alcohol-related adverse drug events may be nontrivial. Screening for alcohol use before prescribing AI medications would be prudent. Better communication regarding the dangers of mixing alcohol with AI medications is warranted.
Machado, Jorge Enrique; Moncada, Juan Carlos; Mesa, Giovanny
To determine patterns in antilipidemic drug prescriptions among a group of patients covered by the General Social Security System (Sistema General de Seguridad Social) in Colombia. A descriptive, observational study was conducted of 41 580 hyperlipidemics of both sexes, who were over 20 years of age, undergoing treatment from at least April to June 2006, and were residents of one of 19 cities in Colombia. A database was created to track prescription data collected by the pharmaceutical company that dispenses medications to the patients. The mean age was 58.4+/-13.5 years; 58.9% of the participants were women. Of the total number of patients, 95.6% were receiving monotherapy, while 4.4% were receiving two or more antilipidemics. Prescriptions were ranked as follows: statins (70.9%), fibrates (27.5%), bile acid sequestrant resins (0.9%), and others (0.7%), all at low dosage levels. The most common therapy combinations were lovastatin + gemfibrozil (n = 1 568), cholestyramine + gemfibrozil (n = 92), and cholestyramine + lovastatin (n = 78). Comedications most frequently prescribed were: antihypertensive (60.9%), antiinflammatory (56.5%), antiulcer (22.9%), and antidiabetes drugs (20.6%), and acetylsalicylic acid (ASA, 3.8%). Antianginals and ASA were being underused, while antiinflamatories and antiulcer drugs were being overused. Dyslipidemia is a primary risk factor for developing coronary heart disease and stroke, frequent causes of morbidity and mortality in Colombia and the world. All of the antilipidemics are being used at lower-than-recommended dosage levels. Clearly there is a need for creating educational strategies to address these prescribing habits and for exploring clinical results of the pharmaceuticals studied.
Applequist, Janelle; Ball, Jennifer Gerard
In 2015, the American Medical Association called for a ban of direct-to-consumer advertising (DTCA) for prescription drugs. Yet, the pharmaceutical industry spends more than ever on broadcast advertisements, with national health care costs largely driven by drug spending. An evaluation of these ads is critical, as these advertisements can impact the frequency which patients ask their doctors about medications. A content analysis of prime-time direct-to-consumer ads was conducted across 4 major cable television networks. The ad content (n = 61) was coded for factual claims made regarding target conditions, appeals used, portrayal of medications, and lifestyle characteristics shown. We found a substantial decrease in the percentage of ads that conveyed information about the conditions being targeted, such as risk factors (16%) and prevalence (16%). Positive emotional appeals (94%) continued to be emphasized; yet there was decreased use of negative emotional appeals (51%), pointing to an overall more positive portrayal of a patient's experience with a medication. The lifestyles portrayed in the sample largely featured how products can enable more recreational activities (69%) and fewer ads (7%) presented alternatives to product use. Direct-to-consumer advertising continued to promote prescription drugs above educating the population. Improvement in the educational value of DTCA is likely to require regulatory action rather than reliance on self-regulation by the pharmaceutical industry. © 2018 Annals of Family Medicine, Inc.
...The Food and Drug Administration (FDA) is reopening the comment period on specific data related to a proposed rule published in the Federal Register of March 29,, to establish standards that would be considered in determining whether the major statement in direct-to- consumer (DTC) television and radio advertisements relating to the side effects and contraindications of an advertised prescription drug intended for use by humans is presented in a clear, conspicuous, and neutral manner. In the Federal Register of January 27, 2012, FDA announced that it had added a document to the docket for the proposed rulemaking concerning a study entitled ``Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Television Advertisements'' (Distraction Study) and the public was given until February 27, 2012, to comment on this study as it relates to the proposed standards. FDA is reopening the comment period for the rulemaking proceeding in response to a request for more time to submit comments to the Agency.
Mackey, Tim K; Yagi, Nozomi; Liang, Bryan A
Pharmaceutical marketing in the United States had undergone a shift from largely exclusively targeting physicians to considerable efforts in targeting patients through various forms of direct-to-consumer advertising ("DTCA"). This includes the use of DTCA in prescription drug coupons ("PDCs"), a new form of DTCA that offers discounts and rebates directly to consumers to lower costs of drug purchasing. Our examination of PDCs reveals that the use and types of PDC programs is expanding and includes promotion of the vast majority of top grossing pharmaceuticals. However, controversy regarding this emerging form of DTCA has given rise to health policy concerns about their overall impact on prescription drug expenditures for consumers, payers, and the health care system, and whether they lead to optimal long-term utilization of pharmaceuticals. In response to these concerns and the growing popularity of PDCs, what we propose here are clearer regulation and regulatory guidance for PDC DTCA use. This would include review for appropriate disclosure of marketing claims, increased transparency in PDC use for pharmaceutical pricing, and leveraging potential positive benefits of PDC use for vulnerable or underserved patient populations. Copyright © 2014 Elsevier Inc. All rights reserved.
Devine, Joshua W; Trice, Shana; Spridgen, Stacia L; Bacon, Thomas A
Examine trends in U.S. Department of Defense (DoD) outpatient drug spending and utilization between 2002 and 2007. We analyzed pharmacy claims data from the U.S. Military Health System (MHS), using a cross-sectional analysis at the prescription and patient-year level and measuring utilization in 30-day equivalent prescriptions and expenditures in dollars. Pharmaceutical spending more than doubled in DoD, from $3 billion in FY02 to $6.5 billion in FY07. The largest increase occurred in the DoD community pharmacy network, where utilization grew from 6 million 30-day equivalent prescriptions in the first quarter of FY02 to more than 16 million in the last quarter of FY07. The smallest increase in annual spending occurred in FY07 (5.5%), down from a high of 27.5% in FY03. The MHS has experienced rapid growth in pharmaceutical spending since FY02. However, there are signs that growth in pharmaceutical spending may be slowing.
Calfee, John E
Two papers, by Joel Weissman and colleagues and by Robert Dubois, add to our limited knowledge of the effects of direct-to-consumer (DTC) advertising of prescription drugs. Their results reinforce the largely positive findings from consumer surveys, while adding valuable new data and insights. These suggest that DTC ads probably improve patients' health outcomes and do not tend to lead to inappropriate prescribing. DTC advertising is emerging as a positive force in health care markets, consistent with what is known about the effects of advertising in many other markets.
Aikin, Kathryn J; Sullivan, Helen W; Dolina, Suzanne; Lynch, Molly; Squiers, Linda B
US Food and Drug Administration (FDA) regulations state that any prescription drug promotion that presents drug benefits to consumers must also disclose certain information about the drug's risks in a similar manner. Nearly three-quarters of all US mobile phone subscribers use a smartphone, and over half report receiving mobile advertisements on their device. The objective of this project was to investigate how prescription drugs are being promoted to consumers using mobile technologies. We were particularly interested in the presentation of drug benefits and risks, with regard to presence, placement, and prominence. We analyzed a sample of 51 mobile promotional communications and their associated linked landing pages. We assessed the content and format of the mobile communications and landing pages with regard to presentation of drug benefits and risks. Of the 51 mobile communications we coded, 41% (21/51) were product claim communications (includes the drug name, benefits, and risks), 22% (11/51) were reminder communications (includes drug name only), and 37% (19/51) were help-seeking communications (includes information about the medical condition but not the drug name). Some of the product claim communications (5/21, 24%) required scrolling to see all the benefit information; in contrast, 95% (20/21) required scrolling to see all the risk information. Of the 19 product claim communications that presented both benefits and risks, 95% (18/19) presented benefits before risks and 47% (9/19) used a bigger font for benefits than for risks. Most mobile communications (35/51, 69%) linked to branded drug websites with both benefits and risks, 25% (13/51) linked to a landing page with benefits but no visible risks, and 6% (3/51) linked to a landing page with risks but no visible benefits. Few landing pages (4/51, 8%) required scrolling to see all the benefit information; in contrast, 51% (26/51) required scrolling to see all the risk information. Of the 35 landing pages
Full Text Available Daniel Asfaw Erku,1 Abebe Basazn Mekuria,2 Abdrrahman Shemsu Surur,1 Begashaw Melaku Gebresillassie3 1Department of Pharmaceutical Chemistry, 2Department of Pharmacology, 3Department of Clinical Pharmacy, School of Pharmacy, University of Gondar, Gondar, Ethiopia Purpose: This study was aimed at assessing the extent of dispensing prescription-only medications without a prescription in community drug retail outlets (CDROs of Addis Ababa, Ethiopia.Methods: A descriptive cross-sectional observational study design was used to sample 31 pharmacies, 25 drug stores, and two rural drug vendors from August 11, 2015, to October 21, 2015, through a simple random sampling method. A simulated-patient method of visit was implemented to collect data. Requests of six tracer prescription-only medicines (amoxicillin + clavulanic acid capsule, amitriptyline, captopril, glibenclamide [also known as glyburide], omeprazole capsule, and sildenafil citrate and upper respiratory tract infection were selected as the simulated clinical scenario.Results: Amoxicillin–clavulanic acid capsule was dispensed when requested in 87.93% of the dispensaries. All of the CDROs dispensed omeprazole upon request. Sildenafil citrate (Viagra was in stock in 96.55% of the CDROs, all of which issued the requested number of tablets without asking why or for whom the drug was needed. Amitriptyline, captopril, and glibenclamide (glyburide were dispensed in 84.48%, 89.65%, and 87.93% of CDROs upon the provision of an empty container. Antibiotics were obtained from 75.86% of CDROs for presentation of upper respiratory tract infection symptoms. Among the dispensed antibiotics, the most common was amoxicillin (93.18%, followed by amoxicillin–clavulanic acid capsule (72.72%, and azithromycin (50%. Only 4.5% of the dispensaries asked about drug allergies, and 15.9% of the CDROs informed the simulated patient about the possible side effects of the drugs.Conclusion: This study revealed a very high
Dyb, Grete; Tverdal, Aage; Jacobsen, Geir Wenberg; Schei, Berit
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
Lucas, Philippe; Walsh, Zach; Crosby, Kim; Callaway, Robert; Belle-Isle, Lynne; Kay, Robert; Capler, Rielle; Holtzman, Susan
Recent years have witnessed increased attention to how cannabis use impacts the use of other psychoactive substances. The present study examines the use of cannabis as a substitute for alcohol, illicit substances and prescription drugs among 473 adults who use cannabis for therapeutic purposes. The Cannabis Access for Medical Purposes Survey is a 414-question cross-sectional survey that was available to Canadian medical cannabis patients online and by hard copy in 2011 and 2012 to gather information on patient demographics, medical conditions and symptoms, patterns of medical cannabis use, cannabis substitution and barriers to access to medical cannabis. Substituting cannabis for one or more of alcohol, illicit drugs or prescription drugs was reported by 87% (n = 410) of respondents, with 80.3% reporting substitution for prescription drugs, 51.7% for alcohol, and 32.6% for illicit substances. Respondents who reported substituting cannabis for prescription drugs were more likely to report difficulty affording sufficient quantities of cannabis, and patients under 40 years of age were more likely to substitute cannabis for all three classes of substance than older patients. The finding that cannabis was substituted for all three classes of substances suggests that the medical use of cannabis may play a harm reduction role in the context of use of these substances, and may have implications for abstinence-based substance use treatment approaches. Further research should seek to differentiate between biomedical substitution for prescription pharmaceuticals and psychoactive drug substitution, and to elucidate the mechanisms behind both. [Lucas P, Walsh Z, Crosby K, Callaway R, Belle-Isle L, Kay B, Capler R, Holtzman S. Substituting cannabis for prescription drugs, alcohol, and other substances among medical cannabis patients: The impact of contextual factors. Drug Alcohol Rev 2016;35:326-333]. © 2015 Australasian Professional Society on Alcohol and other Drugs.
Schifano, Fabrizio; Chiappini, Stefania; Corkery, John M; Guirguis, Amira
Recently, a range of prescription and over-the-counter drugs have been reportedly used as Novel Psychoactive Substances (NPS), due to their potential for abuse resulting from their high dosage/idiosyncratic methods of self-administration. This paper provides a systematic review of the topic, focusing on a range of medications which have emerged as being used recreationally, either on their own or in combination with NPS. Among gabapentinoids, pregabalin may present with higher addictive liability levels than gabapentin, with pregabalin being mostly identified in the context of opioid, polydrug intake. For antidepressants, their dopaminergic, stimulant-like, bupropion activities may explain their recreational value and diversion from the therapeutic intended use. In some vulnerable clients, a high dosage of venlafaxine (‘baby ecstasy’) is ingested for recreational purposes, whilst the occurrence of a clinically-relevant withdrawal syndrome may be a significant issue for all venlafaxine-treated patients. Considering second generation antipsychotics, olanzapine appears to be ingested at very large dosages as an ‘ideal trip terminator’, whilst the immediate-release quetiapine formulation may possess proper abuse liability levels. Within the image- and performance- enhancing drugs (IPEDs) group, the beta-2 agonist clenbuterol (‘size zero pill’) is reported to be self-administered for aggressive slimming purposes. Finally, high/very high dosage ingestion of the antidiarrhoeal loperamide has shown recent increasing levels of popularity due to its central recreational, anti-withdrawal, opiatergic effects. The emerging abuse of prescription drugs within the context of a rapidly modifying drug scenario represents a challenge for psychiatry, public health and drug-control policies.
Al-Tayyib, Alia A; Rice, Eric; Rhoades, Harmony; Riggs, Paula
The nonmedical use of prescription drugs is the fastest growing drug problem in the United States, disproportionately impacting youth. Furthermore, the population prevalence of injection drug use among youth is also on the rise. This short communication examines the association between current prescription drug misuse (PDM) and injection among runaway and homeless youth. Homeless youth were surveyed between October 2011 and February 2012 at two drop-in service agencies in Los Angeles, CA. Prevalence ratios (PR) and 95% confidence intervals (CI) for the association between current PDM and injection behavior were estimated. The outcome of interest was use of a needle to inject any illegal drug into the body during the past 30 days. Of 380 homeless youth (median age, 21; IQR, 17-25; 72% male), 84 (22%) reported current PDM and 48 (13%) reported currently injecting. PDM during the past 30 days was associated with a 7.7 (95% CI: 4.4, 13.5) fold increase in the risk of injecting during that same time. Among those reporting current PDM with concurrent heroin, cocaine, and methamphetamine use, the PR with injection was 15.1 (95% CI: 8.5, 26.8). Runaway and homeless youth are at increased risk for a myriad of negative outcomes. Our preliminary findings are among the first to show the strong association between current PDM and injection in this population. Our findings provide the basis for additional research to delineate specific patterns of PDM and factors that enable or inhibit transition to injection among homeless and runaway youth. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.
Jin, Rui; Zhao, Kui-Jun; Guo, Gui-Ming; Zhang, Bing; Wang, Yu-Guang; Xue, Chun-Miao; Yang, Yi-Heng; Wang, Li-Xia; Li, Guo-Hui; Tang, Jin-Fa; Nie, Li-Xing; Zhang, Xiang-Lin; Zhao, Ting-Ting; Zhang, Yi; Yan, Can; Yuan, Suo-Zhong; Sun, Lu-Lu; Feng, Xing-Zhong; Yan, Dan
With the growth of number of Chinese patent medicines and clinical use, the rational use of Chinese medicine is becoming more and more serious. Due to the complexity of Chinese medicine theory and the uncertainty of clinical application, the prescription review of Chinese patent medicine always relied on experience in their respective, leading to the uncontrolled of clinical rational use. According to the traditional Chinese medicine (TCM) theory and characteristics of the unique clinical therapeutics, based on the practice experience and expertise comments, our paper formed the expert consensus on the prescription review of Chinese traditional patent medicine for promoting the rational use of drugs in Beijing. The objective, methods and key points of prescription review of Chinese patent medicine, were included in this expert consensus, in order to regulate the behavior of prescription and promote rational drug use. Copyright© by the Chinese Pharmaceutical Association.
In 2006, the National Inpatient Medication Chart (NIMC) was introduced as a uniform medication chart in Australian public hospitals with the aim of reducing prescription error. The rate of regular medication prescription error in the NIMC was assessed. Data was collected using the NIMC Audit Tool and analyzed with respect to causes of error per medication prescription and per medication chart. The following prescription requirements were assessed: date, generic drug name, route of administration, dose, frequency, administration time, indication, signature, name and contact details. A total of 1877 medication prescriptions were reviewed. 1653 prescriptions (88.07%) had no contact number, 1630 (86.84%) did not have an indication, 1230 and 675 (35.96%) used a drug's trade name. Within 261 medication charts, all had at least one entry, which did not include an indication, 258 (98.85%) had at least one entry, which did not have a contact number and 200 (76.63%) had at least one entry, which used a trade name. The introduction of a uniform national medication chart is a positive step, but more needs to be done to address the root causes of prescription error. © 2012 John Wiley & Sons Ltd.
Gee, Gilbert C; Delva, Jorge; Takeuchi, David T
We examined associations between self-reported unfair treatment and prescription medication use, illicit drug use, and alcohol dependence. We used data from the Filipino American Community Epidemiological Survey, a cross-sectional investigation involving 2217 Filipino Americans interviewed in 1998-1999. Multinomial logistic and negative binomial regression analyses were used in assessing associations between unfair treatment and the substance use categories. Reports of unfair treatment were associated with prescription drug use, illicit drug use, and alcohol dependence after control for age, gender, location of residence, employment status, educational level, ethnic identity level, nativity, language spoken, marital status, and several health conditions. Unfair treatment may contribute to illness and subsequent use of prescription medications. Furthermore, some individuals may use illicit drugs and alcohol to cope with the stress associated with such treatment. Addressing the antecedents of unfair treatment may be a potential intervention route.
van der Putten, M. J. G.; Wetzels, R. B.; Bor, H.; Zuidema, S. U.; Koopmans, R. T. C. M.
Objectives: To assess the differences in antipsychotic drug prescription rates in residents with dementia in dementia special care units (SCUs) of Dutch nursing homes, considering the differences in patient characteristics. Method: As part of the Waalbed-II study, the data on antipsychotic drug use
Ndyomugyenyi, Richard; Magnussen, Pascal; Clarke, Siân
actually using insecticide-treated nets. Many patients (25%) had received treatment prior to visiting a health facility, with drug shops and general stores being the main sources of treatment. Some shops dispensed quinine, a second-line drug recommended for complicated malaria. Prescription practices...
Full Text Available The opioid epidemic is the most significant modern-day, public health crisis. Physicians and lawmakers have developed methods and practices to curb opioid use. This article describes one method, prescription drug monitoring programs (PDMP, through the lens of how to optimize use for emergency departments (ED. EDs have rapidly become a central location to combat opioid abuse and drug diversion. PDMPs can provide emergency physicians with comprehensive prescribing information to improve clinical decisions around opioids. However, PDMPs vary tremendously in their accessibility and usability in the ED, which limits their effectiveness at the point of care. Problems are complicated by varying state-to-state requirements for data availability and accessibility. Several potential solutions to improving the utility of PDMPs in EDs include integrating PDMPs with electronic health records, implementing unsolicited reporting and prescription context, improving PDMP accessibility, data analytics, and expanding the scope of PDMPs. These improvements may help improve clinical decision-making for emergency physicians through better data, data presentation, and accessibility.
Szrek, Helena; Bundorf, M Kate
The Medicare Part D Prescription Drug Program places an unprecedented degree of choice in the hands of older adults despite concerns over their ability to make effective decisions and desire to have extensive choice in this context. While previous research has compared older adults to younger adults along these dimensions, our study, in contrast, examines how likelihood to delay decision making and preferences for choice differ by age among older age cohorts. Our analysis is based on responses of older adults to a simulation of enrollment in Medicare Part D. We examine how age, numeracy, cognitive reflection, and the interaction between age and performance on these instruments are related to the decision to enroll in a Medicare prescription drug plan and preference for choice in this context. We find that numeracy and cognitive reflection are positively associated with enrollment likelihood and that they are more important determinants of enrollment than age. We also find that greater numeracy is associated with a lower willingness to pay for choice. Hence, our findings raise concern that older adults, and, in particular, those with poorer numerical processing skills, may need extra support in enrolling in the program: they are less likely to enroll than those with stronger numerical processing skills, even though they show greater willingness to pay for choice. (c) 2011 APA, all rights reserved.
Sullivan, Helen W; Aikin, Kathryn J; Poehlman, Jon
Direct-to-consumer (DTC) television ads for prescription drugs are required to disclose the product's major risks in the audio or audio and visual parts of the presentation (sometimes referred to as the "major statement"). The objective of this content analysis was to determine how the major statement of risks is presented in DTC television ads, including what risk information is presented, how easy or difficult it is to understand the risk information, and the audio and visual characteristics of the major statement. We identified 68 DTC television ads for branded prescription drugs, which included a unique major statement and that aired between July 2012 and August 2014. We used subjective and objective measures to code 50 ads randomly selected from the main sample. Major statements often presented numerous risks, usually in order of severity, with no quantitative information about the risks' severity or prevalence. The major statements required a high school reading level, and many included long and complex sentences. The major statements were often accompanied by competing non-risk information in the visual images, presented with moderately fast-paced music, and read at a faster pace than benefit information. Overall, we discovered several ways in which the communication of risk information could be improved.
Carneiro, Mônica de Fátima Gontijo; Guerra, Augusto Afonso; Acurcio, Francisco de Assis
This retrospective study in Belo Horizonte, Minas Gerais, Brazil, aimed to provide indicators on the sale and consumption of anorexigenic substances. During the first stage, 2,906 of 168,237 prescriptions received by pharmacies in 2003 were analyzed, showing low quality of prescriptions. Projected consumption in defined daily doses was 19.75 DDD/1,000 inhabitants/day in 2003. Fenproporex (59.8%) was the most widely consumed drug. One pharmacy was responsible for 39.8% of the pharmaceutical sales. During the second stage, 14,554 sales records from this "blockbuster" pharmacy were analyzed, from April to August 2005; 9.2% of sales were for anorexigenic products, 91.8% of which prescribed in association with another substance. The data suggest irrational use of anorexigenic drugs by these consumers and highlight the need for proper regulation of these products. It is important to understand both the role of pharmacies in this regulation and that of physicians in the rational use of these substances.
Thorley, Emma; Kang, Isaac; D'Costa, Stephanie; Vlazaki, Myrto; Ayeko, Olaoluwa; Arbe-Barnes, Edward H; Swerner, Casey B
The 2015 Varsity Medical Ethics debate convened upon the motion: "This house believes nootropic drugs should be available under prescription". This annual debate between students from the Universities of Oxford and Cambridge, now in its seventh year, provided the starting point for arguments on the subject. The present article brings together and extends many of the arguments put forward during the debate. We explore the current usage of nootropic drugs, their safety and whether it would be beneficial to individuals and society as a whole for them to be available under prescription. The Varsity Medical Debate was first held in 2008 with the aim of allowing students to engage in discussion about ethics and policy within healthcare. The event is held annually and it is hoped that this will allow future leaders to voice a perspective on the arguments behind topics that will feature heavily in future healthcare and science policy. This year the Oxford University Medical Society at the Oxford Union hosted the debate.
Bellis, Jennifer R; Kirkham, Jamie J; Nunn, Anthony J; Pirmohamed, Munir
National Health Service (NHS) hospitals in the UK use a system of coding for patient episodes. The coding system used is the International Classification of Disease (ICD-10). There are ICD-10 codes which may be associated with adverse drug reactions (ADRs) and there is a possibility of using these codes for ADR surveillance. This study aimed to determine whether ADRs prospectively identified in children admitted to a paediatric hospital were coded appropriately using ICD-10. The electronic admission abstract for each patient with at least one ADR was reviewed. A record was made of whether the ADR(s) had been coded using ICD-10. Of 241 ADRs, 76 (31.5%) were coded using at least one ICD-10 ADR code. Of the oncology ADRs, 70/115 (61%) were coded using an ICD-10 ADR code compared with 6/126 (4.8%) non-oncology ADRs (difference in proportions 56%, 95% CI 46.2% to 65.8%; p codes as a single means of detection. Data derived from administrative healthcare databases are not reliable for identifying ADRs by themselves, but may complement other methods of detection.
Morgan, Steven; Mintzes, Barbara; Barer, Morris
According to economic theory, one might expect that the informational content of direct-to-consumer advertising of prescription-only drugs would improve consumers' welfare. However, contrasting the models of consumer and market behaviour underlying this theory with the realities of the prescription-only drug market reveals that this market is distinct in ways that render it unlikely that advertising will serve an unbiased and strictly informative function. A review of qualitative evidence regarding the informational content of drug advertising supports this conclusion. Direct-to-consumer prescription drug advertising concentrates on particular products, and features of those products, to the exclusion of others, and the information provided has frequently been found to be biased or misleading in regulatory and academic evaluations. Governments that have so far resisted direct-to-consumer advertising should invest in independent sources of evidence that could help consumers and professionals to better understand the risks and benefits of treating disease with alternative drug and non-drug therapies, rather than permitting direct-to-consumer prescription drug advertising.
Donohue, Julie M; Cevasco, Marisa; Rosenthal, Meredith B
Evidence suggests that direct-to-consumer advertising of prescription drugs increases pharmaceutical sales and both helps to avert underuse of medicines and leads to potential overuse. Concern about such advertising has increased recently owing to the withdrawal from the market of heavily advertised drugs found to carry serious risks. Moreover, the Food and Drug Administration (FDA) has been criticized for its weak enforcement of laws regulating such advertising. We examined industry-wide trends in spending by pharmaceutical companies on direct-to-consumer advertising and promotion to physicians during the past decade. We characterized the drugs for which such advertising is used and assessed the timing of advertising after a drug is introduced. Finally, we examined trends in the FDA's regulation of drug advertising. Total spending on pharmaceutical promotion grew from $11.4 billion in 1996 to $29.9 billion in 2005. Although during that time spending on direct-to-consumer advertising increased by 330%, it made up only 14% of total promotional expenditures in 2005. Direct-to-consumer campaigns generally begin within a year after the approval of a product by the FDA. In the context of regulatory changes requiring legal review before issuing letters, the number of letters sent by the FDA to pharmaceutical manufacturers regarding violations of drug-advertising regulations fell from 142 in 1997 to only 21 in 2006. Spending on direct-to-consumer advertising has continued to increase in recent years in spite of the criticisms leveled against it. Our findings suggest that calls for a moratorium on such advertising for new drugs would represent a dramatic departure from current practices. Copyright 2007 Massachusetts Medical Society.
Bali, Vishal; Raisch, Dennis W; Moffett, Maurice L; Khan, Nasreen
Previous studies have found a negative association between health insurance and nonmedical use of prescription drugs (NMUPD), and abuse or dependence on prescription drugs (ADPD); and mixed associations between health insurance and use of substance abuse treatment (SAT). However, effect of health insurance in the specific subgroups of population is largely unknown. To estimate the relationship between health insurance and (1) NMUPD, (2) ADPD, and (3) use of SAT services among 12-64 years old, noninstitutionalized individuals and to see if these relationships are different in different subgroups of population. This study used cross-sectional survey data from 2007 National Survey on Drug Use and Health. Bivariate and multiple logistic regression analyses were conducted. In 2007, self-reported prevalence of NMUPD was approximately 10% (N=15,509,703). In multivariate analysis, NMUPD was negatively associated with health insurance, age, race other than non-Hispanic White, education, marital status, and income ($40,000-$74,999). Past year use of tobacco and alcohol were positively associated with NMUPD. Among those with private health insurance, Hispanics and individuals with family income less than $20,000 and $40,000-$74,999 were more likely prone to NMUPD than others. High school graduates with public health insurance were less likely prone to NMUPD. Approximately, 13% of nonmedical users reported ADPD (N=2,011,229). Health insurance and age were negatively associated with ADPD. However, people who were unmarried, reported fair/poor health, and used tobacco were more likely to report ADPD. Lastly, the use of substance abuse treatment programs was approximately 73% and 76% between NMUPD and ADPD population, respectively. Health insurance was not associated with use of substance abuse treatment. Individuals with high school education were 2.6 times more likely to use substance abuse treatment than the college graduates. Additionally, no significant interaction effects
DeLorme, Denise E; Huh, Jisu; Reid, Leonard N
This study investigates advertising skepticism in the context of consumers' prescription drug information seeking behavior. Results of a telephone survey found that: (a) the overall level of direct-to-consumer advertising (DTCA) skepticism among consumers was neutral; (b) DTCA skepticism was unrelated to age, positively related to education and income, and varied by race; (c) however, when all the antecedent variables were considered concurrently, only education emerged as a significant predictor (consumers with higher education were more skeptical of DTCA); (d) DTCA skepticism was not significantly related to perceived importance of prescription drug information; (e) DTCA skepticism was not associated with use of advertising and interpersonal sources of prescription drug information; and (f) DTCA skepticism was negatively related to perceived usefulness of advertising sources but unrelated to perceived usefulness of professional interpersonal sources (i.e., physicians and pharmacists). The article concludes with a discussion of findings and directions for future research.
Jarre, C; Bouchet, J; Hellot-Guersing, M; Leromain, A-S; Derharoutunian, C; Gadot, A; Roubille, R
The aim of this study was to assess a selection method for drug prescriptions developed at the hospital level that allows to target pharmacist-led medication order review for at-risk patients and drugs. A one-month study has been conducted on all targeted medication orders in 19 care units. Selection criteria have been identified: biological criteria, alert medications and drug interactions. Pharmacists' interventions proposed during medication order review were listed and the possible links to the selection criteria were determined. A total of 1612 prescriptions were analysed and 236 pharmacists' interventions were performed (14.6 interventions per 100 prescriptions). Physicians' acceptance rate was 60.6%. The percentage of pharmacists' interventions linked to the selection criteria was 35.6%. The relevance of the biological criteria was identified, particularly the one identifying patients with creatinine clearance below 30ml/min. Six alert medications were also relevant selection criteria: dabigatran, morphine, gentamicin, methotrexate, potassium chloride and trimethoprim sulfamethoxazole. Drug interactions criteria was irrelevant. This study allowed a first assessment of the selection criteria used. A largest study seems necessary to continue the analysis of this selection method for prescriptions, especially the assessment of the alert medications list, in order to refine the prescriptions targeting. Copyright © 2017 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.
Full Text Available Najla Dar-Odeh1, Soukaina Ryalat1, Mohammad Shayyab1, Osama Abu-Hammad21Department of Oral and Maxillofacial Surgery Oral Medicine and Periodontics, Faculty of Dentistry, University of Jordan, Jordan; 2Department of Prosthetic Dentistry, Faculty of Dentistry, University of Jordan, JordanObjectives: The aim of this study was to analyze clinical records of dental patients attending the Dental Department at the University of Jordan Hospital: a teaching hospital in Jordan. Analysis aimed at determining whether dental specialists properly documented the drug prescriptions and local anesthetic injections given to their patients.Methods: Dental records of the Dental Department at the Jordan University Hospital were reviewed during the period from April 3rd until April 26th 2007 along with the issued prescriptions during that period.Results: A total of 1000 records were reviewed with a total of 53 prescriptions issued during that period. Thirty records documented the prescription by stating the category of the prescribed drug. Only 13 records stated the generic or the trade names of the prescribed drugs. Of these, 5 records contained the full elements of a prescription. As for local anesthetic injections, the term “LA used” was found in 22 records while the names and quantities of the local anesthetics used were documented in only 13 records. Only 5 records documented the full elements of a local anesthetic injection.Conclusion: The essential data of drug prescriptions and local anesthetic injections were poorly documented by the investigated group of dental specialists. It is recommended that the administration of the hospital and the dental department implement clear and firm guidelines for dental practitioners in particular to do the required documentation procedure.Keywords: dental records, documentation, prescriptions, local anesthesia
West, Suzanne L; Squiers, Linda B; McCormack, Lauren; Southwell, Brian G; Brouwer, Emily S; Ashok, Mahima; Lux, Linda; Boudewyns, Vanessa; O'Donoghue, Amie; Sullivan, Helen W
Under the Food, Drug, and Cosmetic Act, all promotional materials for prescription drugs must strike a fair balance in presentation of risks and benefits. How to best present this information is not clear. We sought to determine if the presentation of quantitative risk and benefit information in drug advertising and labeling influences consumers', patients', and clinicians' information processing, knowledge, and behavior by assessing available empirical evidence. We used PubMed for a literature search, limiting to articles published in English from 1990 forward. Two reviewers independently reviewed the titles and abstracts for inclusion, after which we reviewed the full texts to determine if they communicated risk/benefit information either: (i) numerically (e.g., percent) versus non-numerically (e.g., using text such as "increased risk") or (ii) numerically using different formats (e.g., "25% of patients", "one in four patients", or use of pictographs). We abstracted information from included articles into standardized evidence tables. The research team identified a total of 674 relevant publications, of which 52 met our inclusion criteria. Of these, 37 focused on drugs. Presenting numeric information appears to improve understanding of risks and benefits relative to non-numeric presentation; presenting both numeric and non-numeric information when possible may be best practice. No single specific format or graphical approach emerged as consistently superior. Numeracy and health literacy also deserve more empirical attention as moderators. Copyright © 2013 John Wiley & Sons, Ltd.
Hollon, Matthew F
In the US and New Zealand, the past decade has seen tremendous growth in the marketing of prescription drugs directly to patients. The pharmaceutical industry has applied pressure in other countries to relax regulations governing such marketing although this has not yet been successful. While we still have much to learn about the potential impact on the public's health of direct-to-consumer (DTC) marketing, some data are available. This article summarises the current literature on the benefits and risks of DTC marketing. This marketing strategy has grown substantially in the US, but only select drugs are advertised. Whether there is net benefit or harm to the public's health as a result of DTC marketing depends critically on which drugs are advertised and the quality of the information provided in promotional material. Critical reviews of this promotional material suggest the information is of poor quality. Notably, 18% of the 50 drugs advertised most intensively in the US were medications used to treat psychiatric and neurological disorders. The impairments in decisional capacity often seen in psychiatric and neurological illness leave patients vunerable to the controlling influence of DTC marketing and, thus, undermine the patient autonomy that is said to be promoted by this marketing strategy. If there is any benefit from DTC marketing it is for significantly undertreated conditions. International restrictions on DTC marketing should remain in place until further evidence of net benefit or harm emerges from the DTC marketing experiment that is taking place in the US and New Zealand.
Li, Qian; Trivedi, Pravin K
This paper develops an extended specification of the two-part model, which controls for unobservable self-selection and heterogeneity of health insurance, and analyzes the impact of Medicare supplemental plans on the prescription drug expenditure of the elderly, using a linked data set based on the Medicare Current Beneficiary Survey data for 2003-2004. The econometric analysis is conducted using a Bayesian econometric framework. We estimate the treatment effects for different counterfactuals and find significant evidence of endogeneity in plan choice and the presence of both adverse and advantageous selections in the supplemental insurance market. The average incentive effect is estimated to be $757 (2004 value) or 41% increase per person per year for the elderly enrolled in supplemental plans with drug coverage against the Medicare fee-for-service counterfactual and is $350 or 21% against the supplemental plans without drug coverage counterfactual. The incentive effect varies by different sources of drug coverage: highest for employer-sponsored insurance plans, followed by Medigap and managed medicare plans. Copyright © 2014 John Wiley & Sons, Ltd.
Aagaard, Lise; Hansen, Ebba Holme
licensed for paediatric use. Setting Spontaneous ADR reports located in the European ADR database, EudraVigilance. Method ADRs reported for asthma medications licensed for paediatric use from 2007 to 2011 were analysed. The included substances were beclometasone, budesonide, fenoterol, fluticasone...... administered" and "respiratory failure". Conclusion Only a few ADRs from use of asthma medications in children were identified in the EudraVigilance ADR database, but a large majority of these were serious including fatal cases....
Fendrich, Michael; Bryan, Janelle K; Hooyer, Katinka
We sought to understand how pharmacists viewed and used a newly implemented prescription drug monitoring program (PDMP). We also sought to understand pharmacist orientation toward dispensing of controlled substances and the people who obtain them. We conducted three mini focus groups. The focus group findings were used to inform the design of a structured survey. We emailed a survey to 160 pharmacists who were employed in one statewide community chain store; we obtained 48 survey responses. Focus groups findings suggested that, in relation to the dispensing of scheduled prescription medication, pharmacists were either "healthcare" oriented, "law-enforcement" oriented, or an orientation that combined these two perspectives. Surveys suggested that pharmacists found PDMPs easy to use and that they used them frequently - often to contact physicians directly. Surveys suggested that pharmacists were typically either "healthcare" oriented or "mixed" (combined perspectives). Pharmacist orientation was associated with the frequency with which they counseled patients about medication risk and the frequency with which they used the PDMP as the basis for contacting prescribers. Ongoing tracking of pharmacists' use of PDMPs is important both at the implementation stage and as PDMPs develop over time. The orientation construct developed here is useful in understanding pharmacist behavior and attitudes towards patients potentially at risk for misuse of controlled substance medications. Further research on this construct could shed light on barriers and incentives for pharmacist PDMP participation and use and provide guidance for pharmacist training, ultimately enhancing patient care.
Wangia, Victoria; Shireman, Theresa I
While understanding geography's role in healthcare has been an area of research for over 40 years, the application of geography-based analyses to prescription medication use is limited. The body of literature was reviewed to assess the current state of such studies to demonstrate the scale and scope of projects in order to highlight potential research opportunities. To review systematically how researchers have applied geography-based analyses to medication use data. Empiric, English language research articles were identified through PubMed and bibliographies. Original research articles were independently reviewed as to the medications or classes studied, data sources, measures of medication exposure, geographic units of analysis, geospatial measures, and statistical approaches. From 145 publications matching key search terms, forty publications met the inclusion criteria. Cardiovascular and psychotropic classes accounted for the largest proportion of studies. Prescription drug claims were the primary source, and medication exposure was frequently captured as period prevalence. Medication exposure was documented across a variety of geopolitical units such as countries, provinces, regions, states, and postal codes. Most results were descriptive and formal statistical modeling capitalizing on geospatial techniques was rare. Despite the extensive research on small area variation analysis in healthcare, there are a limited number of studies that have examined geographic variation in medication use. Clearly, there is opportunity to collaborate with geographers and GIS professionals to harness the power of GIS technologies and to strengthen future medication studies by applying more robust geospatial statistical methods. Copyright © 2013 Elsevier Inc. All rights reserved.
Sullivan, Helen W; O'Donoghue, Amie C; Aikin, Kathryn J; Chowdhury, Dhuly; Moultrie, Rebecca R; Rupert, Douglas J
To determine whether visual aids help people recall quantitative efficacy information in direct-to-consumer (DTC) prescription drug advertisements, and if so, which types of visual aids are most helpful. Individuals diagnosed with high cholesterol (n=2504) were randomized to view a fictional DTC print or television advertisement with no visual aid or one of four visual aids (pie chart, bar chart, table, or pictograph) depicting drug efficacy. We measured drug efficacy and risk recall, drug perceptions and attitudes, and behavioral intentions. For print advertisements, a bar chart or table, compared with no visual aid, elicited more accurate drug efficacy recall. The bar chart was better at this than the pictograph and the table was better than the pie chart. For television advertisements, any visual aid, compared with no visual aid, elicited more accurate drug efficacy recall. The bar chart was better at this than the pictograph or the table. Visual aids depicting quantitative efficacy information in DTC print and television advertisements increased drug efficacy recall, which may help people make informed decisions about prescription drugs. Adding visual aids to DTC advertising may increase the public's knowledge of how well prescription drugs work. Published by Elsevier Ireland Ltd.
Tayem, Yasin I; Qubaja, Marwan M; Shraim, Riyad K; Taha, Omar B; Abu Shkheidem, Imadeddin A; Ibrahim, Murad A
We aimed to reliably describe the pattern of outpatient prescription of non-steroidal anti-inflammatory drugs (NSAIDs) and antibiotics (ATBs) at a central hospital in the West Bank, Palestine. This was a retrospective, cross-sectional study investigating a cohort of 2,208 prescriptions ordered by outpatient clinics and the emergency room over one year in Beit Jala Hospital in Bethlehem, West Bank. The orders were analysed for the rate and types of NSAIDs and ATBs utilised, and the appropriateness of these drugs to the diagnosis. Of the total prescriptions, 410 contained NSAIDs (18.6%), including diclofenac (40.2%), low dose aspirin (23.9%), ibuprofen (17.8%) and indomethacin (15.1%). A minority of these prescriptions contained a combination of these agents (2.5%). Only one prescription contained cyclooxyeganse-2 inhibitors (0.2%). The appropriateness of NSAID use to the diagnosis was as follows: appropriate (58.3%), inappropriate (14.4%) and difficult to tell (27.3%). The rate of ATB use was 30.3% (669 prescriptions). The ATBs prescribed were amoxicillin (23.3%), augmentin (14.3%), quinolones (12.7%), first and second generation cephalosporins (9.4% and 12.7%, respectively) and macrolides (7.2%). ATB combinations were identified in 9.4%, with the most common being second-generation cephalopsorins and metronidazole (4.3%). Regarding the appropriateness of prescribing ATBs according to the diagnosis, it was appropriate in 44.8%, inappropriate in 20.6% and difficult to tell in 34.6% of the prescriptions. These findings revealed a relatively large number and inappropriate utilisation of ATBs and NSAIDs. An interventional programme needs to be adopted to reinforce physicians' knowledge of the rational prescription of these agents.
Wall, Melanie; Cheslack-Postava, Keely; Hu, Mei-Chen; Feng, Tianshu; Griesler, Pamela; Kandel, Denise B
This study sought to specify (1) the position of nonmedical prescription opioids (NMPO) in drug initiation sequences among Millennials (1979-96), Generation X (1964-79), and Baby Boomers (1949-64) and (2) gender and racial/ethnic differences in sequences among Millennials. Data are from the 2013-2014 National Surveys on Drug Use and Health (n = 73,026). We identified statistically significant drug initiation sequences involving alcohol/cigarettes, marijuana, NMPO, cocaine, and heroin using a novel method distinguishing significant sequences from patterns expected only due to correlations induced by common liability among drugs. Alcohol/cigarettes followed by marijuana was the most common sequence. NMPO or cocaine use after marijuana, and heroin use after NMPO or cocaine, differed by generation. Among successively younger generations, NMPO after marijuana and heroin after NMPO increased. Millennials were more likely to initiate NMPO than cocaine after marijuana; Generation X and Baby Boomers were less likely (odds ratios = 1.4;0.3;0.2). Millennials were more likely than Generation X and Baby Boomers to use heroin after NMPO (hazards ratios = 7.1;3.4;2.5). In each generation, heroin users were far more likely to start heroin after both NMPO and cocaine than either alone. Sequences were similar by gender. Fewer paths were significant among African-Americans. NMPOs play a more prominent role in drug initiation sequences among Millennials than prior generations. Among Millennials, NMPO use is more likely than cocaine to follow marijuana use. In all generations, transition to heroin from NMPO significantly occurs only when both NMPO and cocaine have been used. Delineation of drug sequences suggests optimal points in development for prevention and treatment efforts. Copyright © 2017 Elsevier B.V. All rights reserved.
Greene, Jeremy A; Herzberg, David
Although the public health impact of direct-to-consumer (DTC) pharmaceutical advertising remains a subject of great controversy, such promotion is typically understood as a recent phenomenon permitted only by changes in federal regulation of print and broadcast advertising over the past two decades. But today's omnipresent ads are only the most recent chapter in a longer history of DTC pharmaceutical promotion (including the ghostwriting of popular articles, organization of public-relations events, and implicit advertising of products to consumers) stretching back over the twentieth century. We use trade literature and archival materials to examine the continuity of efforts to promote prescription drugs to consumers and to better grapple with the public health significance of contemporary pharmaceutical marketing practices.
Warnier, Miriam Jacoba; Rutten, Frans Hendrik; Souverein, Patrick Cyriel
PURPOSE: Monitoring of the QT duration by electrocardiography (ECG) prior to treatment is frequently recommended in the label of QT-prolonging drugs. It is, however, unknown how often general practitioners in daily clinical practice are adhering to these risk-minimization measures. We assessed...... the frequency of ECG measurements in patients where haloperidol was initiated in primary care. METHODS: Patients (≥18 years) with a first prescription of haloperidol in the UK Clinical Practice Research Datalink (2009-2013) were included. The proportion of ECGs made was determined in two blocks of 4 weeks......: during the exposure period when haloperidol was initiated, and during the control period, 1 year before. Conditional logistic regression analysis was applied to calculate the relative risk of having an ECG in the exposure period compared with the control period. Subgroup analyses were performed to assess...
DeLorme, Denise E; Huh, Jisu
This study provides insight into seniors' perceptions of and responses to direct-to-consumer prescription drug advertising (DTCA) usefulness, examines support for DTCA regulation as a type of uncertainty management, and extends and gives empirical voice to previous survey results through methodological triangulation. In-depth interview findings revealed that, for most informants, DTCA usefulness was uncertain and this uncertainty stemmed from 4 sources. The majority had negative responses to DTCA uncertainty and relied on 2 uncertainty-management strategies: information seeking from physicians, and inferences of and support for some government regulation of DTCA. Overall, the findings demonstrate the viability of uncertainty management theory (Brashers, 2001, 2007) for mass-mediated health communication, specifically DTCA. The article concludes with practical implications and research recommendations.
Although the public health impact of direct-to-consumer (DTC) pharmaceutical advertising remains a subject of great controversy, such promotion is typically understood as a recent phenomenon permitted only by changes in federal regulation of print and broadcast advertising over the past two decades. But today's omnipresent ads are only the most recent chapter in a longer history of DTC pharmaceutical promotion (including the ghostwriting of popular articles, organization of public-relations events, and implicit advertising of products to consumers) stretching back over the twentieth century. We use trade literature and archival materials to examine the continuity of efforts to promote prescription drugs to consumers and to better grapple with the public health significance of contemporary pharmaceutical marketing practices. PMID:20299640
Huh, Jisu; Shin, Wonsun
Direct-to-consumer (DTC) prescription drug brand websites, as a form of DTC advertising, are receiving increasing attention due to the growing number and importance as an ad and a consumer information source. This study examined consumer trust in a DTC website as an important factor influencing consumers' attitude toward the website and behavioral intention. Applying the conceptual framework of website trust, the particular focus of investigation was the effect of the website trust cue factor on consumers' perceived DTC website trust and subsequent attitudinal and behavioral responses. Results show a significant relation between the website trust cue factor and consumers' perceived DTC website trust. Perceived DTC website trust, in turn, was found to be significantly associated with consumers' attitude toward the DTC website and behavioral intention.
Ball, Jennifer G; Manika, Danae; Stout, Patricia A
Age is an important factor that can influence processing of and response to health messages. Many studies examining evaluations of and responses to direct-to-consumer prescription drug advertising (DTCA) have incorporated age as a predictor variable, moderating variable, or sample criterion. However, findings have been inconsistent. This study attempts to add clarity to this body of research by assessing age differences in the antecedent factors of various DTCA outcomes. A multigroup structural equation modeling analysis revealed several significant differences in variable relationships between older (50+) and younger (behavioral intentions among older adults while showing a straightforward positive association with attention among younger adults. Further analysis indicated that health status accounted for some but not all of the age differences. It is suggested that younger adults are more open to seeking additional information following DTCA exposure, whereas older adults remain ambivalent.
Stanley, Ava; Cantor, Joel C; Guarnaccia, Peter
The health care safety net in the United States is intended to fill gaps in health care services for uninsured and other vulnerable populations. This paper presents a case study of New Brunswick, NJ, a small city rich in safety net resources, to examine the adequacy of the American model of safety net care. We find substantial gaps in access to care despite the presence of a medical school, an abundance of primary care and specialty physicians, two major teaching hospitals, a large federally qualified health center and other safety net resources in this community of about 50,000 residents. Using a blend of random-digit-dial and area probability sampling, a survey of 595 households was conducted in 2001 generating detailed information about the health, access to care, demographic and other characteristics of 1,572 individuals. Confirming the great depth of the New Brunswick health care safety net, the survey showed that more than one quarter of local residents reported a hospital or community clinic as their usual source of care. Still, barriers to prescription drugs were reported for 11.0% of the area population and more than two in five (42.8%) local residents who perceived a need for specialty care reported difficulty getting those services. Bivariate analyses show significantly elevated risk of access problems among Hispanic and black residents, those in poor health, those relying on hospital and community clinics or with no usual source of care, and those living at or below poverty. In multivariate analysis, lack of health insurance was the greatest risk factor associated with both prescription drug and specialty access problems. Few local areas can claim the depth of safety net resources as New Brunswick, NJ, raising serious concerns about the adequacy of the American safety net model, especially for people with complex and chronic health care needs.
Frosch, Dominick L.; Krueger, Patrick M.; Hornik, Robert C.; Cronholm, Peter F.; Barg, Frances K.
PURPOSE American television viewers see as many as 16 hours of prescription drug advertisements (ads) each year, yet no research has examined how television ads attempt to influence consumers. This information is important, because ads may not meet their educational potential, possibly prompting consumers to request prescriptions that are clinically inappropriate or more expensive than equally effective alternatives. METHODS We coded ads shown during evening news and prime time hours for factual claims they make about the target condition, how they attempt to appeal to consumers, and how they portray the medication and lifestyle behaviors in the lives of ad characters. RESULTS Most ads (82%) made some factual claims and made rational arguments (86%) for product use, but few described condition causes (26%), risk factors (26%), or prevalence (25%). Emotional appeals were almost universal (95%). No ads mentioned lifestyle change as an alternative to products, though some (19%) portrayed it as an adjunct to medication. Some ads (18%) portrayed lifestyle changes as insufficient for controlling a condition. The ads often framed medication use in terms of losing (58%) and regaining control (85%) over some aspect of life and as engendering social approval (78%). Products were frequently (58%) portrayed as a medical breakthrough. CONCLUSIONS Despite claims that ads serve an educational purpose, they provide limited information about the causes of a disease or who may be at risk; they show characters that have lost control over their social, emotional, or physical lives without the medication; and they minimize the value of health promotion through lifestyle changes. The ads have limited educational value and may oversell the benefits of drugs in ways that might conflict with promoting population health. PMID:17261859
Frosch, Dominick L; Krueger, Patrick M; Hornik, Robert C; Cronholm, Peter F; Barg, Frances K
American television viewers see as many as 16 hours of prescription drug advertisements (ads) each year, yet no research has examined how television ads attempt to influence consumers. This information is important, because ads may not meet their educational potential, possibly prompting consumers to request prescriptions that are clinically inappropriate or more expensive than equally effective alternatives. We coded ads shown during evening news and prime time hours for factual claims they make about the target condition, how they attempt to appeal to consumers, and how they portray the medication and lifestyle behaviors in the lives of ad characters. Most ads (82%) made some factual claims and made rational arguments (86%) for product use, but few described condition causes (26%), risk factors (26%), or prevalence (25%). Emotional appeals were almost universal (95%). No ads mentioned lifestyle change as an alternative to products, though some (19%) portrayed it as an adjunct to medication. Some ads (18%) portrayed lifestyle changes as insufficient for controlling a condition. The ads often framed medication use in terms of losing (58%) and regaining control (85%) over some aspect of life and as engendering social approval (78%). Products were frequently (58%) portrayed as a medical breakthrough. Despite claims that ads serve an educational purpose, they provide limited information about the causes of a disease or who may be at risk; they show characters that have lost control over their social, emotional, or physical lives without the medication; and they minimize the value of health promotion through lifestyle changes. The ads have limited educational value and may oversell the benefits of drugs in ways that might conflict with promoting population health.
Sheingold, Steven; Nguyen, Nguyen Xuan
This study estimates the effects of generic competition, increased cost-sharing, and benefit practices on utilization and spending for prescription drugs. We examined changes in Medicare price and utilization from 2007 to 2009 of all drugs in 28 therapeutic classes. The classes accounted for 80% of Medicare Part D spending in 2009 and included the 6 protected classes and 6 classes with practically no generic competition. All variables were constructed to measure each drug relative to its class at a specific plan sponsor. We estimated that the shift toward generic utilization had cut in half the rate of increase in the price of a prescription during 2007-2009. Specifically, the results showed that (1) rapid generic penetration had significantly held down costs per prescription, (2) copayment and other benefit practices shifted utilization to generics and favored brands, and (3) price increases were generally greater in less competitive classes of drugs. In many ways, Part D was implemented at a fortuitous time; since 2006, there have been relatively few new blockbuster drugs introduced, and many existing high-volume drugs used by beneficiaries were in therapeutic classes with multiple brands and generic alternatives. Under these conditions, our paper showed that plan sponsors have been able to contain costs by encouraging use of generics or drugs offering greater value within therapeutic classes. It is less clear what will happen to future Part D costs if a number of new and effective drugs for beneficiaries enter the market with no real competitors.
Nielsen, Lars Hougaard; Løkkegaard, Ellen; Andreasen, Anne Helms
of this misclassification for analysing the risk of breast cancer. MATERIALS AND METHODS: Prescription data were obtained from Danish Registry of Medicinal Products Statistics and we applied various methods to approximate treatment episodes. We analysed the duration of HT episodes to study the ability to identify......PURPOSE: Many studies which investigate the effect of drugs categorize the exposure variable into never, current, and previous use of the study drug. When prescription registries are used to make this categorization, the exposure variable possibly gets misclassified since the registries do...... not carry any information on the time of discontinuation of treatment.In this study, we investigated the amount of misclassification of exposure (never, current, previous use) to hormone therapy (HT) when the exposure variable was based on prescription data. Furthermore, we evaluated the significance...
Vissman, Aaron T.; Bloom, Fred R.; Leichliter, Jami S.; Bachmann, Laura H.; Montano, Jaime; Topmiller, Michael; Rhodes, Scott D.
Background: Little is known about access to medicine among immigrant Latinos in the United States (US). This study explored access to, and use of, prescription drugs obtained from nonmedical sources among recently arrived, Spanish-speaking immigrant Latinos in rural North Carolina (NC). Methods: Our community-based participatory research…
... average drug cost for all prescriptions dispensed. The revised formula for calculating reasonable charges... collections, and includes dispensing costs, such as costs of the labor of the pharmacy department, packaging... economy, a sector of the economy, productivity, competition, jobs, the environment, public health or...
Lavigne, Jill E.; McCarthy, Michael; Chapman, Richard; Petrilla, Allison; Knox, Kerry L.
Prescription drugs for many indications are labeled with warnings for potential risk of suicidal ideation or behavior. Exposures to prescription drugs labeled for adverse effects of suicidal behavior or ideation among 100 Air Force personnel who died by suicide between 2006 and 2009 are described. Air Force registry data were linked to…
Menon, Ajit M; Deshpande, Aparna D; Perri, Matthew; Zinkhan, George M
The proliferation of both manufacturer-controlled and independent medication-related websites has aroused concern among consumers and policy-makers concerning the trustworthiness of Web-based drug information. The authors examine consumers' trust in on-line prescription drug information and its influence on information search behavior. The study design involves a retrospective analysis of data from a 1998 national survey. The findings reveal that trust in drug information from traditional media sources such as television and newspapers transfers to the domain of the Internet. Furthermore, a greater trust in on-line prescription drug information stimulates utilization of the Internet for information search after exposure to prescription drug advertising.
Scheen, A J
Clinical pharmacology and therapeutics are two complementary disciplines which should lead the medical student, through an optimized training, to a rational prescription of drugs, ultimate and important step of the medical approach. Such a learning should occur progressively throughout the medical education, focusing, first, on the therapeutic reasoning ("why?") and, second, on the practical application leading to the prescription ("how?"). The medical student should learn the difficult task of integrating disease, drug and patient, in order to optimize the benefit/risk ratio, while being informed about new concepts such as "Evidence-Based Medicine" and pharmacoeconomics.
Kesselheim, Aaron S; Choudhry, Niteesh K
In response to increasing prescription drug costs, more U.S. patients and policymakers are importing less-expensive pharmaceutical products from other countries. Large-scale prescription drug importation is currently illegal, but the U.S. Food and Drug Administration permits individuals to bring in 90-day supplies of drugs for personal use. As patient use of foreign-bought drugs has increased, federal legislators have continued to debate the full legalization of importation. Three factors help guide whether U.S. patients and policymakers can rely on other countries as sources of imported prescription drugs: whether the safety of the product can be ensured, how the import price compares with domestic prices, and how importation might affect the exporting country's pharmaceutical market. In wealthier countries with active regulatory systems, drug safety can be adequately ensured, and brand-name products are usually less expensive than in the United States (although generic drugs may be more expensive). However, implementing large-scale importation can negatively impact the originating country's market and can diminish the long-term cost savings for U.S. consumers. In low- and middle-income countries, prices may be reduced for both brand-name and generic drugs, but the prevalence of unauthorized products on the market makes ensuring drug safety more difficult. It may be reasonable for individual U.S. consumers to purchase essential medicines from certain international markets, but the most effective way to decrease drug costs overall is the appropriate use of domestic generic drugs, which are available for almost every major therapeutic class.
Mohamad Reza Khodaei Ardakani
Full Text Available Objectives: Psychotropic drug use in the elderly with chronic schizophrenia is an important issue in the field of psychiatry. The main goal of this study was to clarify the pattern of such drug use in these patients, in order to consider such therapy plan and focus on its cost attributing measures, for a more reasonable quality of care program. Methods: In this descriptive study, participants included 52 elderly patients at Tehran’s Razi Mental Hospital who had chronic schizophrenia in the residual phase. Selected patients were taking at least two psychotropic drugs equivalent to 500mg Chlorpromazine. We prepared the list of the drugs used by completing the pre-designed questionnaire charts. Data were analyzed with SPSS 17. Results: In one case (1.92% the entries were Risperidone, Chlorpromazine, Fluphenazine Decanoate, & Thiothixene. In 11 cases (21.2% there were three entries and in 40 cases (76.8% there were two. The Chlorpromazine equivalent dose in each group ranged from the lowest dose (750 mg to the highest (5600 mg. The highest Chlorpromazine dose (5600 mg equivalent per milligram belonged to the four entries of (Risperidone, Chlorpromazine, Fluphenazine Decanoate & Thiothixene. The lowest Chlorpromazine dose (750 mg was seen in 3 entries of Risperidone, Chlorpromazine & Fluphenazine Decanoate. Discussion: There was a high prevalence of using more than two psychotropic medications from the first atypical antipsychotic category. Less frequently, the second and the third typical antipsychotics were used. We recommend further research into more feasible patterns of psychotropic prescriptions, lowering the amount of medication use and considering their cost-benefits in the elderly with chronic schizophrenia.
When a new drug is labelled, before deciding its integration in the therapeutic strategy, the doctor has to know the degree of innovation of the drug, i.e. its actual benefit and the improvement of actual benefit, also called added value over other available drugs. For each new medicine in France, after drug approval by the French Drug Agency, the French National Authority for Health thought its "Commission de transparence" (Transparency Commission) issues an opinion about the degree of innovation of the drug, which is independent of the marketing authorization. The added value over other available drugs is quantified by five levels of improvement: level I, major progress to level V, no progress. The complete opinion of the Transparency Commission and its synthesis (one page) is online http://www.has-sante.fr/. Between 2006 and 2008, no paediatric drug has obtained a level I of improvement (major progress), ten have obtained a level II (significant progress), 11 a level III (moderate progress), 12 a level IV (minor progress) and for 38 drugs, no progress has been retained. The need to know and to follow therapeutic recommendations is the evidence based medicine. The opinions of the Transparency Commission are one of those recommendations. Copyright (c) 2010 Elsevier Masson SAS. All rights reserved.
Fahim, Germin; Toscani, Michael; Barone, Joseph A; Wang, Chris; Gandhi, Shivani
The FDA's Presenting Risk Information draft guidance from May 2009 states that the time of risk versus benefit is a factor taken into consideration when evaluating audio and video direct-to-consumer (DTC) broadcasts. The objective of the study is to evaluate the proportion of risk narration on television (TV) advertisements in comparison to the actual proportion of serious adverse effects findings across select therapeutic areas. The study reviews prescription drug TV advertisements between the years 2010 and 2015 separated by therapeutic class. Indicators to assess risk versus benefit are as follows: total benefit time, total risk time, total ad time, percentage proportion of risk, and number of serious adverse effects (SAEs) listed in the package insert. The objective is establishing proportion of risk-to-benefit narration across therapeutic areas and the proportion of risk narration compared to the number of SAEs in the package insert. These outcomes will reflect whether TV advertisements abide by the "fair balance" rule and if the time spent on risk narrations is proportional to the number of SAEs across therapeutic areas. An analysis of risk versus benefit showed that there was a vast range of percentage differences in risk versus benefit narration across the products selected. The majority of the products narrated showed a 40% to 60% risk-to-benefit ratio. Six out of the 10 products evaluated communicated applicable black box warnings. There was variability among the SAE percentages presented between products. Lack of consistency exists between risks versus benefit proportions among different drug products.
Bapat, Shweta S; Patel, Harshali K; Sansgiry, Sujit S
In this study, we evaluate the role of information anxiety and information load on the intention to read information from prescription drug information leaflets (PILs). These PILs were developed based on the principals of information load and consumer information processing. This was an experimental prospective repeated measures study conducted in the United States where 360 (62% response rate) university students (>18 years old) participated. Participants were presented with a scenario followed by exposure to the three drug product information sources used to operationalize information load. The three sources were: (i) current practice; (ii) pre-existing one-page text only; and (iii) interventional one-page prototype PILs designed for the study. Information anxiety was measured as anxiety experienced by the individual when encountering information. The outcome variable of intention to read PILs was defined as the likelihood that the patient will read the information provided in the leaflets. A survey questionnaire was used to capture the data and the objectives were analyzed by performing a repeated measures MANOVA using SAS version 9.3. When compared to current practice and one-page text only leaflets, one-page PILs had significantly lower scores on information anxiety ( p information load ( p Information anxiety and information load significantly impacted intention to read ( p < 0.001). Newly developed PILs increased patient's intention to read and can help in improving the counseling services provided by pharmacists.
Phillips, Elyse; Gazmararian, Julie
To determine whether specific state legislation has an effect on opioid overdose mortality rates compared to states without those types of legislation. Ecological study estimating opioid-related mortality in states with and without a prescription drug monitoring program (PDMP) and/or medical cannabis legislation. Opioid-related mortality rates for 50 states and Washington DC from 2011 to 2014 were obtained from CDC WONDER. PDMP data were obtained from the National Alliance for Model State Drug Laws, and data on medical cannabis legislation from the National Organization for the Reform of Marijuana Laws. The relationship between PDMPs with mandatory access provisions, medical cannabis legislation, and opioid-related mortality rates. Multivariate repeated measures analysis performed with software and services. Medical cannabis laws were associated with an increase of 21.7 percent in mean age-adjusted opioid-related mortality (p cannabis (p = 0.049) and 5.8 percent for states with a PDMP (p = 0.005). Interaction between both types of legislation produced a borderline significant decrease of 10.1 percent (p = 0.055). For every year states had both types of legislation, interaction resulted in a 0.6 percent decrease in rate (p = 0.013). When combined with the availability of medical cannabis as an alternative analgesic therapy, PDMPs may be more effective at decreasing opioid-related mortality.
de Mulder, M; York, V A; Wiznia, A A; Michaud, H A; Nixon, D F; Holguin, A; Rosenberg, M G
With the advent of combined antiretroviral therapy (cART), perinatally HIV-infected children are surviving into adolescence and beyond. However, drug resistance mutations (DRMs) compromise viral control, affecting the long-term effectiveness of ART. The aims of this study were to detect and identify DRMs in a HIV-1 infected paediatric cohort. Paired plasma and dried blood spots (DBSs) specimens were obtained from HIV-1 perinatally infected patients attending the Jacobi Medical Center, New York, USA. Clinical, virological and immunological data for these patients were analysed. HIV-1 pol sequences were generated from samples to identify DRMs according to the International AIDS Society (IAS) 2011 list. Forty-seven perinatally infected patients were selected, with a median age of 17.7 years, of whom 97.4% were carrying subtype B. They had a mean viral load of 3143 HIV-1 RNA copies/mL and a mean CD4 count of 486 cells/μL at the time of sampling. Nineteen patients (40.4%) had achieved undetectable viraemia (40.5% had a CD4 count of > 500 cells/μL. Most of the patients (97.9%) had received cART, including protease inhibitor (PI)-based regimens in 59.6% of cases. The DRM prevalence was 54.1, 27.6 and 27.0% for nucleoside reverse transcriptase inhibitors (NRTIs), PIs and nonnucleoside reverse transcriptase inhibitors (NNRTIs), respectively. Almost two-thirds (64.9%) of the patients harboured DRMs to at least one drug class and 5.4% were triple resistant. The mean nucleotide similarity between plasma and DBS sequences was 97.9%. Identical DRM profiles were present in 60% of plasma-DBS paired sequences. A total of 30 DRMs were detected in plasma and 26 in DBSs, with 23 present in both. Although more perinatally HIV-1-infected children are reaching adulthood as a result of advances in cART, our study cohort presented a high prevalence of resistant viruses, especially viruses resistant to NRTIs. DBS specimens can be used for DRM detection. © 2013 British HIV Association.
Hardt, Nancy; Wong, Tit D; Burt, Martha J; Harrison, Ross; Winter, Will; Roth, Jeffrey
Abuse of prescription and illicit drugs has been rapidly increasing. This study examines the prevalence of drug use in the non-natural deaths of pregnant or recently pregnant women. Records from Florida's Pregnancy Associated Mortality Review conducted between 1999 and 2005 (n = 415) were linked to 385 toxicology reports obtained from Florida medical examiners' offices. The final study sample consisted of 169 drug-positive, pregnancy-associated non-natural deaths. Of these, 86 were positive for both blood and urine, 64 were positive for blood only and five for urine only, and the remainder were positive for some other specimen. Among these deaths, 91 cases (54%) involved prescription drugs, 78 cases (46%) involved illicit drugs, and 69 cases (41%) involved alcohol. Opioids constituted the majority of deaths associated with prescription drugs. Substantial co-use of opioids and benzodiazepines was seen. Pregnant or recently pregnant women may have more interactions with healthcare providers, which may present more opportunities for intervention and prevention. © 2013 American Academy of Forensic Sciences.
Hyosun Kim’s report "Trouble Spots in Online Direct to Consumer Prescription Drug Promotion: A content Analysis of FDA Warning Letters" aims to teach marketers how to avoid breaching current Food and Drug Administration (FDA) guidelines in their online drug promotion. While Kim hopes to minimise the potential for online promotion to misinform consumers and the study is carefully conducted, teaching drug marketers how to avoid the common mistakes in online drug promotion is more likely to make marketers more adept at spinning information than appropriately balancing it PMID:27239884
Full Text Available This thesis is part of the studies of gender bias in health which together with the paradigm of evidence-based medicine shares the empirical assumption that there are inaccuracies in medical practice, in addition to a lack of rigour and transparency. It worked with the distinction between the concepts of sex and gender and between the concepts of sex-related differences and gender inequalities, in terms of applying a gender perspective in the study design and the subsequent analysis. This PhD review presents the research process conducted in Spain, which can provide an example for future research. Study I described a review of 58 clinical trials (CTs of etoricoxib to assess its compliance with the Recommendations of Evaluation of Gender Differences in the Clinical Evaluation of Drugs. In Study II, key informants from professions related to different areas in drug development and pharmacovigilance held a working meeting to reach a consensus document on recommendations for the study and evaluation of gender differences in CTs in Spain. In Study III, the websites of the eight best-selling hormone replacement therapy drugs in Spain on Google first page of results were analysed. In Study IV, a logistic regression analysis was performed to compare analgesic prescription by sex in regions with a higher or lower Gender Development Index (GDI than the Spanish average. Gender biases identified in this thesis limited the legitimacy of medicine, which is not based on the best possible evidence. The results also demonstrate the existence of inequalities between men and women that are not due merely to biological differences, but are gender inequalities stemming from the social differences that exist between both sexes.
This thesis is part of the studies of gender bias in health which together with the paradigm of evidence-based medicine shares the empirical assumption that there are inaccuracies in medical practice, in addition to a lack of rigour and transparency. It worked with the distinction between the concepts of sex and gender and between the concepts of sex-related differences and gender inequalities, in terms of applying a gender perspective in the study design and the subsequent analysis. This PhD review presents the research process conducted in Spain, which can provide an example for future research. Study I described a review of 58 clinical trials (CTs) of etoricoxib to assess its compliance with the Recommendations of Evaluation of Gender Differences in the Clinical Evaluation of Drugs. In Study II, key informants from professions related to different areas in drug development and pharmacovigilance held a working meeting to reach a consensus document on recommendations for the study and evaluation of gender differences in CTs in Spain. In Study III, the websites of the eight best-selling hormone replacement therapy drugs in Spain on Google first page of results were analysed. In Study IV, a logistic regression analysis was performed to compare analgesic prescription by sex in regions with a higher or lower Gender Development Index (GDI) than the Spanish average. Gender biases identified in this thesis limited the legitimacy of medicine, which is not based on the best possible evidence. The results also demonstrate the existence of inequalities between men and women that are not due merely to biological differences, but are gender inequalities stemming from the social differences that exist between both sexes.
Jayawardene, Wasantha Parakrama; YoussefAgha, Ahmed Hassan
This study aimed to identify the sequential patterns of drug use initiation, which included prescription drugs misuse (PDM), among 12th-grade students in Indiana. The study also tested the suitability of the data mining method Market Basket Analysis (MBA) to detect common drug use initiation sequences in large-scale surveys. Data from 2007 to 2009 Annual Surveys of Alcohol, Tobacco, and Other Drug Use by Indiana Children and Adolescents were used for this study. A close-ended, self-administered questionnaire was used to ask adolescents about the use of 21 substance categories and the age of first use. "Support%" and "confidence%" statistics of Market Basket Analysis detected multiple and substitute addictions, respectively. The lifetime prevalence of using any addictive substance was 73.3%, and it has been decreasing during past few years. Although the lifetime prevalence of PDM was 19.2%, it has been increasing. Males and whites were more likely to use drugs and engage in multiple addictions. Market Basket Analysis identified common drug use initiation sequences that involved 11 drugs. High levels of support existed for associations among alcohol, cigarettes, and marijuana, whereas associations that included prescription drugs had medium levels of support. Market Basket Analysis is useful for the detection of common substance use initiation sequences in large-scale surveys. Before initiation of prescription drugs, physicians should consider the adolescents' risk of addiction. Prevention programs should address multiple addictions, substitute addictions, common sequences in drug use initiation, sex and racial differences in PDM, and normative beliefs of parents and adolescents in relation to PDM.
Kenne, Deric R; Hamilton, Kelsey; Birmingham, Lauren; Oglesby, Willie H; Fischbein, Rebecca L; Delahanty, Douglas L
Since the early 1990s, the United States has seen a significant increase in the prevalence of prescription opioid misuse. Despite benefits prescription opioids provide, misuse can be fatal. The current study was designed to investigate the prevalence of prescription opioid misuse, perceived harm of misuse, and reasons for misuse for physical or emotional pain instead of seeking professional medical or mental health treatment. Survey data were collected in the fall of 2013 via an online survey to a random sample of 668 students from a public Midwestern university. Lifetime prevalence of prescription opioid misuse was 9.5%. Misusers of prescription opioid drugs generally reported lower ratings of perceived harm as compared to individuals not reporting misuse of prescription opioid drugs. Primary reasons for misuse of prescription opioid drugs was to relieve pain (33.9%), "to feel good/get high" (23.2%) and experimentation (21.4%). Lifetime misuse of a prescription opioid drug for physical or emotional pain was reported by 8.1% and 2.2% of respondents, respectively. Primary reasons for misuse for physical pain included because pain was temporary, immediate relief was needed, and no health insurance/financial resources. Primary reasons for misuse for emotional pain included not wanting others to find out, embarrassment and fear. Conclusions/Importance: Reasons for misuse of prescription opioid drugs vary by type of prescription opioid drug. Reasons for not seeking treatment that ultimately lead to misuse, vary by type of pain being treated and may be important considerations in the effort to stem the misuse of prescription opioid drugs among college students.
... using VA's managerial cost accounting system. Under this accounting system, the national average... the professional activity of reviewing and dispensing a prescription. Based on this accounting system...
Full Text Available Preetinder S GillCollege of Technology, Eastern Michigan University, Ypsilanti, MI, USABackground: Health literacy impacts health outcomes. Health literacy is a measure of a person's competence to find, access, contextualize, and understand the information needed to make health decisions. Low levels of health literacy have been associated with poor health status. Health literacy can be enhanced by improving the readability of health literature. Misuse and abuse of prescription medicines and controlled substances is rising. It could be argued that improving the readability of the drug-information documents associated with these medicines could serve to alleviate this situation in a small, albeit incremental, manner. This paper provides a readability assessment of 71 such documents.Methods: The readability of drug-information documents associated with 12 commonly misused and abused painkiller medicines and controlled substances published by the top six US pharmacies was assessed. The Flesch-Kincaid Grade Level, Flesch Reading Ease, and Simple Measure of Gobbledygook (SMOG indices were used to assess the readability of these drug-information documents. One-way analysis of variance (ANOVA was used to compare the readability of the documents.Results: The average Flesch-Kincaid Grade Level index score was found to be 11.16. The average Flesch Reading Ease index score was found to be 45.94. The average SMOG index score was found to be 13.60. Pharmacies C and E had the best average readability scores, whereas pharmacies A and B had the worst average readability scores.Conclusion: Access, contents, and formatting of the documents were qualitatively analyzed to make recommendations to improve readability. Pharmacies C and E were used as benchmarks to identify the seven best practices. Good drug-information documents should have: (1 clear purpose, (2 limited scope, (3 summary/brief review, (4 well-placed graphics, (5 informative illustrations, (6 clean
Reisinger, Kelsy B.; Rutledge, Patricia C.; Conklin, Sarah M.
The role of beliefs about academic integrity in college students' decisions to use nonmedical prescription drugs (NMPDs) in academic settings was examined. In Spring 2012 the authors obtained survey data from 645 participants at a small, undergraduate, private liberal arts institution in the Northeastern United States. A broadcast e-mail message…
Lanier, Christina; Farley, Erin J.
Objective: Although prior recent research has revealed a significant relationship between the nonmedical use of prescription drugs, demographic characteristics, college-specific risk factors, and other substance use among college students, there remains a need to conduct a comparative analysis on the differential impact these factors may have on…
Khalil Zadeh, Neda; Robertson, Kirsten; Green, James A
The factors determining individuals' self-reported behavioural responses to direct to consumer advertising of prescription drugs were explored with an emphasis on 'at-risk' individuals' responses. Nationally representative cross-sectional survey. Community living adults in New Zealand. 2057 adults (51% women). Self-reported behavioural responses to drug advertising (asking a physician for a prescription, asking a physician for more information about an illness, searching the internet for more information regarding an illness and asking a pharmacist for more information about a drug). Multivariate logistic regressions determined whether participants' self-reported behavioural responses to drug advertising were predicted by attitudes towards advertising and drug advertising, judgements about safety and effectiveness of advertised drugs, self-reported health status, materialism, online search behaviour as well as demographic variables. Identifying as Indian and to a less extent Chinese, Māori and 'other' ethnicities were the strongest predictors of one or more self-reported responses (ORs 1.76-5.00, Ps advertising (ORs 1.34-1.61, all Psadvertising and may make uninformed decisions accordingly. The outcomes raise significant concerns relating to the ethicality of drug advertising and suggest a need for stricter guidelines to ensure that drug advertisements provided by pharmaceutical companies are ethical. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
Ju, Ilwoo; Park, Jin Seong
The literature shows that the prominence of risk disclosure influences consumer responses to direct-to-consumer advertising of prescription drugs. However, little is known about the psychological process whereby disclosure prominence exerts its influences on health beliefs and behavior. Based on a review of the literature on health cognition and behavior, the current study proposed and tested a model to show that risk disclosure prominence affects consumers' drug choice intention through the mediating roles of awareness of drug adverse reactions (ARs), perceived control over ARs, and perceived risk of ARs. The findings were discussed in terms of their theoretical and managerial implications.
Full Text Available The increasing prominence of new Internet and social media technologies and their growing importance as a source of health information are pushing the pharmaceutical industry towards digital channels. This paper explores the potential impacts of the pharmaceutical industry’s increasing interest in online marketing and considers how the existing regulatory framework in Canada translates into the social media sphere. Direct-to-consumer advertising (DTCA of prescription drugs is prohibited in Canada, as it is in most industrialized countries. Although Health Canada has reaffirmed that the existing DTCA regulations apply to new Internet and social media technologies, new dynamics such as user-generated content, consumer propagation, and targeted marketing make applying the existing regulations an uncertain process. Moreover, certain problems often associated with DTCA may be exacerbated in the social media context. Finally, there is skepticism around whether government regulators have the resources or political will to effectively monitor new digital media. As such, this paper considers not only the role of direct government regulation in monitoring and enforcing the regulation of DTCA, but also the role of third party oversight and industry self-regulation—both of which may play an important role in filling the gaps in the regulation of the Internet and social media.
Hwang, Monica J; Young, Henry N
The educational value of direct-to-consumer advertising (DTCA) of prescription drugs hinges on its ability to convey important benefit and risk information to consumers. However, the literacy level required to understand some of the information presented in print advertisements may hinder DTCA's ability to educate consumers. The objective of this study was to compare the comprehension and retention of benefit and risk information between consumers who viewed an original print DTCA and those who viewed an advertisement modified according to health literacy principles. An experimental design was used to conduct the study. Participants were randomly assigned to view a modified print advertisement (experimental group) or the original print advertisement (control group) for an antidepressant medication. Study participants were recruited from the University of Wisconsin Kidney Clinic. Ten true-false and 10 multiple-choice questions were developed to assess participants' comprehension and retention of benefit and risk information. A total of 120 participants were randomized to view either the original or the modified version of the advertisement. Regarding the comprehension and retention of only the benefit information, no significant differences were observed between the 2 groups. Significant differences were observed for comprehension and retention of only the risk information. The experimental group had significantly higher scores in comprehension (U = 1224; P advertisement were successful in enhancing both consumers' comprehension and their retention of information presented in a print DTCA. This was especially apparent for the risk information. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.
Peralta, Robert L; Stewart, Breanna C; Steele, Jennifer L; Wagner, Fernando A
Male-female variations in health-behavior continue to be of national and international significance with men generally being more likely to be engaged in behaviors that enhance risk across an array of preventable diseases and injuries as well as premature deaths. The literature has identified non-medical use of prescription drugs (NMUPD) as a developing and particularly dangerous substance use behavior among college students. The literature has reported sex differences (male; female) in NMUPD but has yet to explain how gender-orientation (e.g., masculine, feminine) might impact NMUPD. The purpose of this study is to address this gap by examining the influence of gender-orientation on NMUPD. Using survey data collected during the 2013-2014 academic year from a convenience sample of college students at a mid-sized Midwestern university, we examine the association of gender-orientation with NMUPD (N=796). To do this, we separate masculine and feminine scales from the BEM Sex Role Inventory and use logistic regression to test whether masculine or feminine gender characteristics influence the likelihood of NMUPD (lifetime measure of any use and by category). This analysis shows that self-identified characteristics associated with masculinity increase the odds of NMUPD while femininity is associated with lower odds of NMUPD. Findings from this study increase our knowledge of gender-orientation and sex interactions as factors that might influence NMUPD thus demonstrating the importance of differentiating sex from gender-orientation.
Mackey, Tim K; Liang, Bryan A; Strathdee, Steffanie A
The tragic death of 18-year-old Ryan Haight highlighted the ethical, public health, and youth patient safety concerns posed by illicit online nonmedical use of prescription drugs (NUPM) sourcing, leading to a federal law in an effort to address this concern. Yet despite the tragedy and resulting law, the NUPM epidemic in the United States has continued to escalate and represents a dangerous and growing trend among youth and adolescents. A critical point of access associated with youth NUPM is the Internet. Internet use among this vulnerable patient group is ubiquitous and includes new, emerging, and rapidly developing technologies-particularly social media networking (eg, Facebook and Twitter). These unregulated technologies may pose a potential risk for enabling youth NUPM behavior. In order to address limitations of current regulations and promote online safety, we advocate for legislative reform to specifically address NUPM promotion via social media and other new online platforms. Using more comprehensive and modernized federal legislation that anticipates future online developments is critical in substantively addressing youth NUPM behavior occurring through the Internet.
Mamo, C; Farina, E; Cicio, R; Fanì, M
The aim of the study was to obtain local estimates of the prevalence of anxiety and dysthymic disorders among attendees of primary care at local level, useful to pursue a better management of the health care services. The study was conducted in the Health District no. 2 of Turin (industrial town in northwest Italy). The criteria for identification of cases were based on the drugs prescriptions made by general practitioners (GPs), selected in order to assure high specificity. The study involved 86 physicians (with 87,885 attendees). As expected, the crude and standardized prevalences were higher in women (anxiety: 2.9% vs 1.3% in men; dysthymia: 3.8% vs 1.7% in men), with a peak in women aged over 75 yrs (anxiety: 4.8%; dysthymia: 6.2%). In comparison to male GPs, female GPs had an higher prevalence of patients with anxious disorders, whereas the prevalences of dysthymia were similar. Despite the discussed limitations, the used methodology allows to obtain sufficiently reliable estimates of prevalence of common mental disorders at local level, providing informations useful for organizing the primary care in the Health district.
Lepeytre, Fanny; Cardinal, Héloise; Fradette, Lorraine; Verhave, Jacobien; Dorais, Marc; LeLorier, Jacques; Pichette, Vincent; Madore, François
Background: The aim of this study was to assess the impact of follow-up in renal protection clinics on the prescription of and adherence to cardioprotective drugs in patients with chronic kidney disease (CKD). Methods: We studied stage 4 and 5 CKD patients who initiated follow-up in three renal protection clinics. The prescription pattern of antihypertensive agents (AHA) and lipid-lowering agents (LLAs) was measured as the percentage of patients who are prescribed the agents of interest at a given time. Adherence to drug therapy was defined as the percentage of days, during a pre-defined observation period, in which patients have an on-hand supply of their prescribed medications. Results: A total of 259 CKD patients were enrolled and followed for up to 1 year after referral to renal protection clinics. There was a significant increase in the prescription of angiotensin-converting enzyme inhibitors (34-39%), angiotensin II receptor blockers (11-14%), beta-blockers (40-51%), calcium channel blockers (62-74%), diuretics (66-78%) and LLAs (39-47%) during follow-up in the renal protection clinic compared with baseline (P-values protection clinics. Conclusion: Our results suggest that referral and follow-up in a renal protection clinic may increase the prescription of cardioprotective agents in CKD patients, but does not appear to improve adherence to these medications.
Full Text Available To describe trends, patterns, and determinants of prescription drug use during pregnancy and postpartum.This is a retrospective, population-based study of all women who gave birth between January 2002 and 31 December 2011 in British Columbia, Canada. Study population consisted of 225,973 women who had 322,219 pregnancies. We examined administrative datasets containing person-specific information on filled prescriptions, hospitalizations, and medical services. Main outcome measures were filled prescriptions during pregnancy and postpartum. We used logistic regressions to examine associations between prescription drug use and maternal characteristics.Approximately two thirds of women filled a prescription during pregnancy, increasing from 60% in 2002 to 66% in 2011. The proportion of pregnant women using medicines in all three trimesters of pregnancy increased from 20% in 2002 to 27% in 2011. Use of four or more different types of prescription drug during at least one trimester increased from 8.4% in 2002 to 11.7% in 2011. Higher BMI, smoking during pregnancy, age under 25, carrying multiples, and being diagnosed with a chronic condition all significantly increased the odds of prescription drug use during pregnancy.The observed increase in the number of prescriptions and number of different drugs being dispensed suggests a trend in prescribing practices with potentially important implications for mothers, their neonates, and caregivers. Monitoring of prescribing practices and further research into the safety of most commonly prescribed medications is crucial in better understanding risks and benefits to the fetus and the mother.
Colleen Anne Dell
Full Text Available The intentional misuse of psychotropic drugs is recognized as a significant public health concern in Canada, although there is a lack of empirical research detailing this. Even less research has been documented on the misuse of prescription drugs among First Nations in Canada. In the past, Western biomedical and individual-based approaches to researching Indigenous health have been applied, whereas First Nations’ understandings of health are founded on a holistic view of wellbeing. Recognition of this disjuncture, alongside the protective influence of First Nations traditional culture, is foundational to establishing an empirical understanding of and comprehensive response to prescription drug misuse. We propose health promotion as a framework from which to begin to explore this. Our work with a health promotion framework has conveyed its potential to support the consideration of Western and Indigenous worldviews together in an ‘ethical space’, with illustrations provided. Health promotion also allots for the consideration of Canada's colonial history of knowledge production in public health and supports First Nations’ self-determination. Based on this, we recommend three immediate ways in which a health promotion framework can advance research on prescription drug misuse among First Nations in Canada.
Full Text Available Background For the purpose of understanding the Food and Drug Administration’s (FDA’s concerns regarding online promotion of prescription drugs advertised directly to consumers, this study examines notices of violations (NOVs and warning letters issued by the FDA to pharmaceutical manufacturers. Methods The FDA’s warning letters and NOVs, which were issued to pharmaceutical companies over a 10-year period (2005 to 2014 regarding online promotional activities, were content-analyzed. Results Six violation categories were identified: risk information, efficacy information, indication information, product labeling, material information issues, and approval issues. The results reveal that approximately 95% of the alleged violations were found on branded drug websites, in online paid advertisements, and in online videos. Of the total 179 violations, the majority of the alleged violations were concerned with the lack of risk information and/or misrepresentation of efficacy information, suggesting that achieving a fair balance of benefit versus risk information is a major problem with regard to the direct-to-consumer advertising (DTCA of prescription drugs. In addition, the character space limitations of online platforms, eg, sponsored links on search engines, pose challenges for pharmaceutical marketers with regard to adequately communicating important drug information, such as indication information, risk information, and product labeling. Conclusion Presenting drug information in a fair and balanced manner remains a major problem. Industry guidance should consider addressing visibility and accessibility of information in the web environment to help pharmaceutical marketers meet the requirements for direct-to-consumer promotion and to protect consumers from misleading drug information. Promotion via social media warrants further attention, as pharmaceutical manufacturers have already begun actively establishing a social media presence, and the
For the purpose of understanding the Food and Drug Administration's (FDA's) concerns regarding online promotion of prescription drugs advertised directly to consumers, this study examines notices of violations (NOVs) and warning letters issued by the FDA to pharmaceutical manufacturers. The FDA's warning letters and NOVs, which were issued to pharmaceutical companies over a 10-year period (2005 to 2014) regarding online promotional activities, were content-analyzed. Six violation categories were identified: risk information, efficacy information, indication information, product labeling, material information issues, and approval issues. The results reveal that approximately 95% of the alleged violations were found on branded drug websites, in online paid advertisements, and in online videos. Of the total 179 violations, the majority of the alleged violations were concerned with the lack of risk information and/or misrepresentation of efficacy information, suggesting that achieving a fair balance of benefit versus risk information is a major problem with regard to the direct-to-consumer advertising (DTCA) of prescription drugs. In addition, the character space limitations of online platforms, eg, sponsored links on search engines, pose challenges for pharmaceutical marketers with regard to adequately communicating important drug information, such as indication information, risk information, and product labeling. Presenting drug information in a fair and balanced manner remains a major problem. Industry guidance should consider addressing visibility and accessibility of information in the web environment to help pharmaceutical marketers meet the requirements for direct-to-consumer promotion and to protect consumers from misleading drug information. Promotion via social media warrants further attention, as pharmaceutical manufacturers have already begun actively establishing a social media presence, and the FDA has thus begun to keep tabs on social media promotions of
Pedan, Alex; Wu, Hongsheng
This article examines the impact of direct-to-physician, direct-to-consumer, and other marketing activities by pharmaceutical companies on a mature drug category which is in the later stage of its life cycle and in which generics have accrued a significant market share. The main objective of this article is to quantitatively estimate the impact of pharmaceutical promotions on physician prescribing behavior for three different statin brands, after controlling for factors such as patient, physician and physician practice characteristics, generic pressure, et cetera. Using unique panel data of physicians, combined with patient pharmacy prescription records, the authors developed a physician level generalized linear regression model. The generalized estimating equations method was used to account for within physician serial correlations and estimate physician population averaged effects. The findings reveal that even though on average the marketing efforts affect the brand share positively, the magnitude of the effects is very brand specific. Generally, each statin brand has its own trend and because of this, the best choice of predictors for one brand could be suboptimal for another.
Sullivan, Helen W; O'Donoghue, Amie C; Gard Read, Jennifer; Amoozegar, Jacqueline B; Aikin, Kathryn J; Rupert, Douglas J
Direct-to-consumer (DTC) promotion of prescription drugs can affect consumer behaviors and health outcomes, and Internet drug promotion is growing rapidly. Branded drug websites often capitalize on the multimedia capabilities of the Internet by using videos to emphasize drug benefits and characteristics. However, it is unknown how such videos affect consumer processing of drug information. This study aimed to examine how videos on prescription drug websites, and the inclusion of risk information in those videos, influence consumer knowledge and perceptions. We conducted an experimental study in which online panel participants with acid reflux (n=1070) or high blood pressure (n=1055) were randomly assigned to view 1 of the 10 fictitious prescription drug websites and complete a short questionnaire. On each website, we manipulated the type of video (patient testimonial, mechanism of action animation, or none) and whether the video mentioned drug risks. Participants who viewed any video were less likely to recognize drug risks presented only in the website text (P≤.01). Including risk information in videos increased participants' recognition of the risks presented in the videos (P≤.01). However, in some cases, including risk information in videos decreased participants' recognition of the risks not presented in the videos (ie, risks presented in text only; P≤.04). Participants who viewed a video without drug risk information thought that the website placed more emphasis on benefits, compared with participants who viewed the video with drug risk information (P≤.01). Compared with participants who viewed a video without drug risk information, participants who viewed a video with drug risk information thought that the drug was less effective in the high blood pressure sample (P=.03) and thought that risks were more serious in the acid reflux sample (P=.01). There were no significant differences between risk and nonrisk video conditions on other perception
Full Text Available While the number of studies of the non-medical use of prescription drugs to augment cognitive functions is growing steadily, psychological factors that can potentially help explain variance in such pharmaceutical cognitive enhancement (CE behavior are often neglected in research.This study investigates the association between the Big Five personality traits and a retrospective (prior CE-drug use as well as a prospective (willingness to use CE drugs measure of taking prescription drugs with the purpose of augmenting one’s cognitive functions (e.g. concentration, memory, or vigilance without medical necessity. We use data from a large representative survey of German employees (N= 6,454, response rate= 29.8%. The Five Factor Model (FFM of Personality was measured with a short version of the Big Five Personality Traits Inventory (BFI-S, which includes: openness to experience, conscientiousness, extraversion, agreeableness, and neuroticism. Together with this, demographic variables such as gender, age, education, and income were used as potential confounders in multiple logistic regression models. Our results show a 2.96% lifetime prevalence of CE-drug use and a 10.45% willingness to (reuse such drugs in the future. We found that less conscientious and more neurotic respondents have a higher probability of prior CE-drug use and a greater willingness to use CE drugs in the future. No significant effects were found for openness, extraversion, or agreeableness. Prior CE-drug use was strongly associated with a greater willingness to take such drugs in the future.This study shows that specific personality traits are not only associated with prior enhancement behavior, but also affect the willingness to (reuse such drugs. It helps increase understanding of the risk factors of CE-drug use, which is a health-related behavior that can entail severe side-effects for consumers. The knowledge gathered can thus help improve interventions aimed at minimizing
Sattler, Sebastian; Schunck, Reinhard
While the number of studies of the non-medical use of prescription drugs to augment cognitive functions is growing steadily, psychological factors that can potentially help explain variance in such pharmaceutical cognitive enhancement (CE) behavior are often neglected in research. This study investigates the association between the Big Five personality traits and a retrospective (prior CE-drug use) as well as a prospective (willingness to use CE drugs) measure of taking prescription drugs with the purpose of augmenting one's cognitive functions (e.g., concentration, memory, or vigilance) without medical necessity. We use data from a large representative survey of German employees (N = 6454, response rate = 29.8%). The Five Factor Model (FFM) of Personality was measured with a short version of the Big Five Personality Traits Inventory (BFI-S), which includes: openness to experience, conscientiousness, extraversion, agreeableness, and neuroticism. Together with this, demographic variables such as gender, age, education, and income were used as potential confounders in multiple logistic regression models. Our results show a 2.96% lifetime prevalence of CE-drug use and a 10.45% willingness to (re)use such drugs in the future. We found that less conscientious and more neurotic respondents have a higher probability of prior CE-drug use and a greater willingness to use CE drugs in the future. No significant effects were found for openness, extraversion, or agreeableness. Prior CE-drug use was strongly associated with a greater willingness to take such drugs in the future. This study shows that specific personality traits are not only associated with prior enhancement behavior, but also affect the willingness to (re)use such drugs. It helps increase understanding of the risk factors of CE-drug use, which is a health-related behavior that can entail severe side-effects for consumers. The knowledge gathered can thus help improve interventions aimed at minimizing health
Tungol, Alexandra; Starner, Catherine I; Gunderson, Brent W; Schafer, Jeremy A; Qiu, Yang; Gleason, Patrick P
In 2006, pharmacies began offering select generic prescription drugs at discount prices (e.g., $4 for a 30-day supply) through nonmembership and membership programs. As part of the contract in membership generic drug discount programs, the member agrees to forgo submission of the claim to the insurance company. Claims not submitted for insurance adjudication may result in incomplete pharmacy benefit manager (PBM) and health plan data, which could negatively influence adherence reporting and clinical programs. To address potentially missing claims data, the Centers for Medicare Medicaid Services (CMS) encourages Medicare Part D sponsors to incentivize network pharmacies to submit claims directly to the plan for drugs dispensed outside of a member's Part D benefit, unless a member refuses. The extent of PBM and health plan claims capture loss due to generic drug discount programs is unknown. To identify changes in levothyroxine utilizers' prescription claims capture rate following the advent of generic drug discount membership and nonmembership programs. This retrospective concurrent cohort study used claims data from 3.5 million commercially insured members enrolled in health plans located in the central and southern United States with Prime Therapeutics pharmacy benefit coverage. Members were required to be 18 years or older and younger than 60 years as of January 1, 2006, and continuously enrolled from January 1, 2006, through December 31, 2010. Members utilizing generic levothyroxine for at least 120 days during January 1, 2006, through June 30, 2006 (baseline period) from the same pharmacy group with supply on July 1, 2006, were placed into 1 of 3 pharmacy groups: (1) nonmembership (Walmart, Sam's Club, Target, Kroger, City Market, and King Soopers pharmacies), (2) membership (Walgreens, CVS, Albertsons, and Savon pharmacies), or (3) the reference group of all other pharmacies. The index date was defined as July 1, 2006. The levothyroxine claim providing
Popova, Svetlana; Patra, Jayadeep; Mohapatra, Satya; Fischer, Benedikt; Rehm, Jürgen
Medical prescriptions for opioids as well as their non-medical use have increased in Canada in recent years. This study aimed to estimate the number of non-medical prescription opioid (PO) users in the general and street drug using populations in Canada. The number of non-medical PO users among the general population and the number of non-medical PO users, heroin users, or both among the street drug using population was estimated for Canada and for the most populous Canadian provinces. Different estimation methods were used: 1) the number of non-medical PO users in the Canadian general population was estimated based on Canadian availability data, and the ratio of US availability to non-medical PO use from US survey data; 2) numbers within the street drug using population were indirectly estimated based on overdose death data, and a key informants survey. Distribution and trends by usage of opioids were determined by using the multi-site Canadian OPICAN cohort data. Between 321,000 to 914,000 non-medical PO users were estimated to exist among the general population in Canada in 2003. The estimated number of non-medical PO users, heroin users, or both among the street drug using population was about 72,000, with more individuals using nonmedical PO than heroin in 2003. Based on data from the OPICAN survey, in 2005 the majority of the street drug using population in main Canadian cities was non-medical PO users, with the exception of Vancouver and Montreal. A relative increase of 24% was observed from 2002 to 2005 in the proportion of the street drug using population who used non-medical POs only. There is an urgent need to further assess the extent and patterns of non-medical prescription opioid use, related problems and drug distribution channels in Canada.
Kellams, Joni R; Maye, John P
Nurse practitioners (NPs) now have prescriptive authority for controlled substances in all 50 states in the United States. Florida, the last state to grant NPs DEA licensure, has been wrought with prescription diversion practices for a number of years as pill mills, doctor shopping, and overprescribing proliferated. Prescription Drug Monitoring Programs (PDMPs) help curb drug diversion activity and play a key role in reducing the abuse of controlled substances. The primary objective of this education improvement initiative was to increase knowledge of actively licensed NPs in the state of Florida regarding the state's PDMP. The main themes included the drug abuse problem, description and progression of the PDMP, and how to use the Florida PDMP. Upon approval from the institutional review board, this education improvement initiative gauged NP knowledge of the PDMP and main themes before and after an educational PowerPoint intervention. A pretest/posttest questionnaire was administered for assessment of all knowledge questions. One hundred forty-five NPs with active advanced registered NP licenses in Florida completed both the pretest and posttest questionnaires. Descriptive statistics and paired t tests were used for statistical significance testing. Knowledge of the PDMP and the main themes of the education improvement initiative significantly increased (p < .001) from pretest to posttest results. This education improvement initiative had positive effects for NPs on the knowledge of the Florida PDMP and the main themes. This indicated that Florida NPs are able to acquire greater comprehension of the PDMP by an education intervention.
Glintborg, Bente; Hillestrøm, Peter René; Olsen, Lenette Holm
inspected, and patients were interviewed about their drug use. Additional blood samples were drawn for drug analysis. The median age of included patients was 72 years, and 298 patients (60%) were women. Patients reported use of 3 (median) prescription-only medications (range, 0-14) during the structured...... interview. The congruence between self-report and drug analysis was high for all 5 drugs measured (all kappa >0.8). However, 9 patients (2%) reported use of drugs that were not detected in their blood samples. In 29 patients (6%), the blood samples contained drugs not reported during the structured...... to an acute medical department at a Danish university hospital were interviewed on the day of admission about their recent medication use. Blood samples drawn immediately after admission were screened for contents of 5 drugs (digoxin, bendroflumethiazide, amlodipine, simvastatin, glimepiride), and the results...
Frakt, Austin B; Pizer, Steven D; Hendricks, Ann M
Medicare and the Veterans Health Administration (VA) both finance large outpatient prescription drug programs, though in very different ways. In the ongoing debate on how to control Medicare spending, some suggest that Medicare should negotiate directly with drug manufacturers, as the VA does. In this article we relate the role of interest groups to policy differences between Medicare and the VA and, in doing so, explain why such a large change to the Medicare drug program is unlikely. We argue that key policy differences are attributable to stable differences in interest group involvement. While this stability makes major changes in Medicare unlikely, it suggests the possibility of leveraging VA drug purchasing to achieve savings in Medicare. This could be done through a VA-administered drug-only benefit for Medicare-enrolled veterans. Such a partnership could incorporate key elements of both programs: capacity to accept large numbers of enrollees (like Medicare) and leverage to negotiate prescription drug prices (like the VA). Moreover, it could be implemented at no cost to the VA while achieving savings for Medicare and beneficiaries.
Piovani, Daniele; Clavenna, Antonio; Cartabia, Massimo; Bonati, Maurizio
The aim of the study was to evaluate the trend of paediatric psychotropic drug prescriptions in Italy. Data sources were regional, outpatient prescription databases. Seven Italian regions, covering 50 % of the Italian population, provided data from 2006 to 2011. Prevalence and incidence of prescriptions by age and gender were evaluated for psychotropic, antidepressant, antipsychotic, and attention-deficit/hyperactivity disorders (ADHD) medications. The hospital admission rate for psychiatric conditions was calculated, also at the local health unit (LHU) level. The presence of trends in prescription prevalence and incidence during the 6 year period was assessed. Finally, the correlation between prevalence, prescription, hospital admission rates, latitude, longitude, and average annual income at the LHU level was also investigated. In 2011, 8834 youths received at least one psychotropic drug prescription, with a prevalence of 1.76 ‰ (95 % CI 1.72-1.80). The incidence of new psychotropic drug users was 1.03 ‰ (1.00-1.06). The prevalence of antidepressants was 1.02 ‰ (0.99-1.04), while that of antipsychotics was 0.70 ‰ (0.68-0.72), and that of ADHD medications 0.19 ‰ (0.18-0.21). The psychotropic drug prevalence increased with increasing age. Males were more exposed to psychotropic drugs than females (AUC0-17 male/female = 1.23). Antipsychotics were the most prescribed psychotropic drugs in males, while antidepressants were in females. Between-region prevalence ranged from 1.56 to 2.17 ‰. The overall prevalence of psychotropic drug from 2006 to 2011 was stable (χ(t)2 ≤ 0.001, p = 0.97). No correlation was found between prevalence and the variables investigated. Psychotropic drug prescription was very limited and stable. No geographical patterns were found.
Ho, Joel; DeBeck, Kora; Milloy, M-J; Dong, Huiru; Wood, Evan; Kerr, Thomas; Hayashi, Kanna
Nonmedical use of prescription opioid and illicit opioid has been increasing at an alarming rate in North America over the past decade. We sought to examine the temporal trends and correlates of the availability of illicit and prescription opioids among people who inject drugs (PWID) in Vancouver, Canada. Data were derived from three prospective cohort studies of PWID in Vancouver between 2010 and 2014. In semiannual interviews, participants reported the availability of five sets of illicit and prescription opioids: (1) heroin; (2) Percocet (oxycodone/acetaminophen), Vicodin (hydrocodone/acetaminophen), or Demerol (meperidine); (3) Dilaudid (hydromorphone); (4) Morphine; (5) oxycontin/OxyNEO (controlled-release oxycodone). We defined perceived availability as immediate (e.g., available within 10 minutes) versus no availability/available after 10 minutes. The trend and correlation of immediate availability were identified by multivariable generalized estimating equations logistic regression. Among 1584 participants, of which 564 (35.6%) were female, the immediate availability of all illicit and prescribed opioids (except for oxycontin/OxyNEO) increased over time, independent of potential confounders. The Adjusted Odds Ratios of immediate availability associated with every calendar year increase were between 1.09 (95% confidence interval 1.05-1.12) (morphine and Dilaudid) and 1.13 (95% confidence interval 1.09-1.17) (Percocet/Vicodin/Demerol) (all p-values illicit and prescription opioid use among PWID that could potentially increase the risk of overdose.
Penazzato, Martina; Lewis, Linda; Watkins, Melynda; Prabhu, Vineet; Pascual, Fernando; Auton, Martin; Kreft, Wesley; Morin, Sébastien; Vicari, Marissa; Lee, Janice; Jamieson, David; Siberry, George K
Despite the coordinated efforts by several stakeholders to speed up access to HIV treatment for children, development of optimal paediatric formulations still lags 8 to 10 years behind that of adults, due mainly to lack of market incentives and technical complexities in manufacturing. The small and fragmented paediatric market also hinders launch and uptake of new formulations. Moreover, the problems affecting HIV similarly affect other disease areas where development and introduction of optimal paediatric formulations is even slower. Therefore, accelerating processes for developing and commercializing optimal paediatric drug formulations for HIV and other disease areas is urgently needed. The Global Accelerator for Paediatric Formulations (GAP-f) is an innovative collaborative model that will accelerate availability of optimized treatment options for infectious diseases, such as HIV, tuberculosis and viral hepatitis, affecting children in low- and middle-income countries (LMICs). It builds on the HIV experience and existing efforts in paediatric drug development, formalizing collaboration between normative bodies, research networks, regulatory agencies, industry, supply and procurement organizations and funding bodies. Upstream, the GAP-f will coordinate technical support to companies to design and study optimal paediatric formulations, harmonize efforts with regulators and incentivize manufacturers to conduct formulation development. Downstream, the GAP-f will reinforce coordinated procurement and communication with suppliers. The GAP-f will be implemented in a three-stage process: (1) development of a strategic framework and promotion of key regulatory efficiencies; (2) testing of feasibility and results, building on the work of existing platforms such as the Paediatric HIV Treatment Initiative (PHTI) including innovative approaches to incentivize generic development and (3) launch as a fully functioning structure. GAP-f is a key partnership example enhancing
Deb, Partha; Trivedi, Pravin K; Zimmer, David M
In this paper, we estimate a copula-based bivariate dynamic hurdle model of prescription drug and nondrug expenditures to test the cost-offset hypothesis, which posits that increased expenditures on prescription drugs are offset by reductions in other nondrug expenditures. We apply the proposed methodology to data from the Medical Expenditure Panel Survey, which have the following features: (i) the observed bivariate outcomes are a mixture of zeros and continuously measured positives; (ii) both the zero and positive outcomes show state dependence and inter-temporal interdependence; and (iii) the zeros and the positives display contemporaneous association. The point mass at zero is accommodated using a hurdle or a two-part approach. The copula-based approach to generating joint distributions is appealing because the contemporaneous association involves asymmetric dependence. The paper studies samples categorized by four health conditions: arthritis, diabetes, heart disease, and mental illness. There is evidence of greater than dollar-for-dollar cost-offsets of expenditures on prescribed drugs for relatively low levels of spending on drugs and less than dollar-for-dollar cost-offsets at higher levels of drug expenditures. Copyright © 2013 John Wiley & Sons, Ltd.
Olugbenga O. Oluwagbemi
Full Text Available Malaria is one of the infectious diseases consistently inherent in many Sub-Sahara African countries. Among the issues of concern are the consequences of wrong diagnosis and dosage administration of anti-malarial drugs on sick patients; these have resulted into various degrees of complications ranging from severe headaches, stomach and body discomfort, blurred vision, dizziness, hallucinations, and in extreme cases, death. Many expert systems have been developed to support different infectious disease diagnoses, but not sure of any yet, that have been specifically designed as a voice-based application to diagnose and translate malaria patients’ symptomatic data for pre-laboratory screening and correct prescription of proper dosage of the appropriate medication. We developed Malavefes, (a malaria voice-enabled computational fuzzy expert system for correct dosage prescription of anti-malarial drugs using Visual Basic.NET., and Java programming languages. Data collation for this research was conducted by survey from existing literature and interview from public health experts. The database for this malaria drug informatics system was implemented using Microsoft Access. The Root Sum Square (RSS was implemented as the inference engine of Malavefes to make inferences from rules, while Centre of Gravity (CoG was implemented as the defuzzification engine. The drug recommendation module was voice-enabled. Additional anti-malaria drug expiration validation software was developed using Java programming language. We conducted a user-evaluation of the performance and user-experience of the Malavefes software. Keywords: Informatics, Bioinformatics, Fuzzy, Anti-malaria, Voice computing, Dosage prescription
Franchi, Carlotta; Tettamanti, Mauro; Djade, Codjo Dgnefa; Pasina, Luca; Mannucci, Pier Mannuccio; Onder, Graziano; Gussoni, Gualberto; Manfellotto, Dario; Bonassi, Stefano; Salerno, Francesco; Nobili, Alessandro
The aim of the study was to evaluate the effect of an e-learning educational program meant to foster the quality of drug prescription in hospitalized elderly patients. Twenty geriatric and internal medicine wards were randomized to intervention (e-learning educational program) or control (basic geriatric pharmacology notions). Logistic regression analysis was used in order to assess the effect of the intervention on the use of potentially inappropriate medication (PIM, primary outcome) at hospital discharge. Secondary outcomes were a reduced prevalence of at least one potential drug-drug interaction (DDI) and potentially severe DDI at discharge. Mortality rate and incidence of re-hospitalizations were other secondary outcomes assessed at the 12-month follow-up. A total of 697 patients (347 in the intervention and 350 in the control arms) were enrolled. No difference in the prevalence of PIM at discharge was found between arms (OR 1.29 95%CI 0.87-1.91). We also found no decrease in the prevalence of DDI (OR 0.67 95%CI 0.34-1.28) and potentially severe DDI (OR 0.86 95%CI 0.63-1.15) at discharge, nor in mortality rates and incidence of re-hospitalization at 12-month follow-up. This e-learning educational program had no clear effect on the quality of drug prescription and clinical outcomes in hospitalized elderly patients. Given the high prevalence of PIMs and potential DDIs recorded in the frame of this study, other approaches should be developed in order to improve the quality of drug prescription in this population. © 2016 The British Pharmacological Society.
Yao, Qiang; Liu, Chaojie; Ferrier, J Adamm; Liu, Zhiyong; Sun, Ju
To assess the impact of the National Essential Medicines Scheme (NEMS) with respect to urban-rural inequalities regarding drug prescriptions in primary care facilities. A stratified two-stage random sampling strategy was used to sample 23,040 prescriptions from 192 primary care facilities from 2009 to 2010. Difference-in-Difference (DID) analyses were performed to test the association between NEMS and urban-rural gaps in prescription patterns. Between-Group Variance and Theil Index were calculated to measure urban-rural absolute and relative disparities in drug prescriptions. The use of the Essential Medicines List (EML) achieved a compliance rate of up to 90% in both urban and rural facilities. An overall reduction of average prescription cost improved economic access to drugs for patients in both areas. However, we observed an increased urban-rural disparity in average expenditure per prescription. The rate of antibiotics and glucocorticoids prescription remained high, despite a reduced disparity between urban and rural facilities. The average incidence of antibiotic prescription increased slightly in urban facilities (62 to 63%) and reduced in rural facilities (67% to 66%). The urban-rural disparity in the use of parenteral administration (injections and infusions) increased, albeit at a high level in both areas (44%-52%). NEMS interventions are effective in reducing the overall average prescription costs. Despite the increased use of the EML, indicator performances with respect to rational drug prescribing and use remain poor and exceed the WHO/INRUD recommended cutoff values and worldwide benchmarks. There is an increased gap between urban and rural areas in the use of parenteral administration and expenditure per prescription.
Aikin, Kathryn J; Southwell, Brian G; Paquin, Ryan S; Rupert, Douglas J; O'Donoghue, Amie C; Betts, Kevin R; Lee, Philip K
Prescription drug television advertisements containing potentially consequential misinformation sometimes appear in the United States. When that happens, the U.S. Food and Drug Administration can request that companies distribute corrective advertisements to address misinformation and inaccurate claims. Previous research has demonstrated effectiveness in corrective advertising for various products. The present article builds on that work with a randomized experimental study (n = 6454) of corrective advertising investigating the extent to which visual similarity matters between violative and corrective ads and the extent to which time delay matters between violative and corrective advertisement exposure. Our study sample included overweight or obese U.S. adults recruited from an existing online consumer panel representative of the U.S. adult population. We created a brand for a fictitious prescription weight-loss drug and produced corresponding direct-to-consumer (DTC) television ads. All participants viewed the same violative ad, but were randomly assigned to view corrective ads with different levels of visual similarity and exposure time delay using a 4 × 4 between-subjects factorial design. Results suggest corrective ad exposure can influence consumer perceptions of drug efficacy, risks, and benefits previously established by violative ads that overstated drug efficacy, broadened drug indication, and omitted important risk information. Corrective ads also can weaken consumer intentions to consider and investigate a drug. However, ad similarity does not appear to affect consumer perceptions and preferences. Although we found that the effects of violative ad exposure tend to diminish over time, the length of the delay between violative and corrective ad exposure has limited influence. An exception to this was observed with regard to recall of drug benefits and risks, where the impact of corrective ad exposure increases with greater time delay. These results
Lee, Annisa Lai
A popular perception holds that physicians prescribe requested drugs to patients influenced by mass mediated direct-to-consumer prescription drug advertising. The phenomenon poses a serious challenge to the two-step flow model, which emphasizes the influence of opinion leaders on their followers and their legitimating power over the informing power of the mass media. This study investigates a 2002 Food and Drug Administration (FDA) survey and finds that patients searching for drug information through mass and hybrid media in newspapers and magazines' small print, the Internet, and toll-free numbers are more likely to seek information through interpersonal communication channels like health care providers. Patients using small print, toll-free numbers, one's own physician, and other physicians are associated with influencing their physicians with various drug-requesting behaviors. But physicians only prescribe requested drugs to patients who are influenced by other health care providers, such as pharmacists and other physicians, not the mass media. The influence of expert opinion leaders of drugs is so strong that the patients even would switch from their own unyielding physicians who do not prescribe drugs as advised by the pharmacists. Physicians and patients all are influenced more by other expert opinion leaders of drugs than by the mass media and therefore still uphold the basic tenet of the two-step model.
Charlotte Jane Houldcroft
Full Text Available Human cytomegalovirus (HCMV is a significant pathogen in immunocompromised individuals, with the potential to cause fatal pneumonitis and colitis, as well as increasing the risk of organ rejection in transplant patients. With the advent of new anti-HCMV drugs there is therefore considerable interest in using virus sequence data to monitor emerging resistance to antiviral drugs in HCMV viraemia and disease, including the identification of putative new mutations. We used target-enrichment to deep sequence HCMV DNA from 11 immunosuppressed paediatric patients receiving single or combination anti-HCMV treatment, serially sampled over 1-27 weeks. Changes in consensus sequence and resistance mutations were analysed for three ORFs targeted by anti-HCMV drugs and the frequencies of drug resistance mutations monitored. Targeted-enriched sequencing of clinical material detected mutations occurring at frequencies of 2%. Seven patients showed no evidence of drug resistance mutations. Four patients developed drug resistance mutations a mean of 16 weeks after starting treatment. In two patients, multiple resistance mutations accumulated at frequencies of 20% or less, including putative maribavir and ganciclovir resistance mutations P522Q (UL54 and C480F (UL97. In one patient, resistance was detected 14 days earlier than by PCR. Phylogenetic analysis suggested recombination or superinfection in one patient. Deep sequencing of HCMV enriched from clinical samples excluded resistance in 7 of eleven subjects and identified resistance mutations earlier than conventional PCR-based resistance testing in 2 patients. Detection of multiple low level resistance mutations was associated with poor outcome.
Arnott, Janine; Hesselgreaves, Hannah; Nunn, Anthony J; Peak, Matthew; Pirmohamed, Munir; Smyth, Rosalind L; Turner, Mark A; Young, Bridget
There is little research on parents' experiences of suspected adverse drug reactions in their children and hence little evidence to guide clinicians when communicating with families about problems associated with medicines. To identify any unmet information and communication needs described by parents whose child had a suspected adverse drug reaction. Semi-structured qualitative interviews with parents of 44 children who had a suspected adverse drug reaction identified on hospital admission, during in-patient treatment or reported by parents using the Yellow Card Scheme (the UK system for collecting spontaneous reports of adverse drug reactions). Interviews were conducted face-to-face or by telephone; most interviews were audiorecorded and transcribed. Analysis was informed by the principles of the constant comparative method. Many parents described being dissatisfied with how clinicians communicated about adverse drug reactions and unclear about the implications for their child's future use of medicines. A few parents felt that clinicians had abandoned their child and reported refusing the use of further medicines because they feared a repeated adverse drug reaction. The accounts of parents of children with cancer were different. They emphasised their confidence in clinicians' management of adverse drug reactions and described how clinicians prospectively explained the risks associated with medicines. Parents linked symptoms to medicines in ways that resembled the established reasoning that clinicians use to evaluate the possibility that a medicine has caused an adverse drug reaction. Clinicians' communication about adverse drug reactions was poor from the perspective of parents, indicating that improvements are needed. The accounts of parents of children with cancer indicate that prospective explanation about adverse drug reactions at the time of prescription can be effective. Convergence between parents and clinicians in their reasoning for linking children
Full Text Available There is little research on parents' experiences of suspected adverse drug reactions in their children and hence little evidence to guide clinicians when communicating with families about problems associated with medicines.To identify any unmet information and communication needs described by parents whose child had a suspected adverse drug reaction.Semi-structured qualitative interviews with parents of 44 children who had a suspected adverse drug reaction identified on hospital admission, during in-patient treatment or reported by parents using the Yellow Card Scheme (the UK system for collecting spontaneous reports of adverse drug reactions. Interviews were conducted face-to-face or by telephone; most interviews were audiorecorded and transcribed. Analysis was informed by the principles of the constant comparative method.Many parents described being dissatisfied with how clinicians communicated about adverse drug reactions and unclear about the implications for their child's future use of medicines. A few parents felt that clinicians had abandoned their child and reported refusing the use of further medicines because they feared a repeated adverse drug reaction. The accounts of parents of children with cancer were different. They emphasised their confidence in clinicians' management of adverse drug reactions and described how clinicians prospectively explained the risks associated with medicines. Parents linked symptoms to medicines in ways that resembled the established reasoning that clinicians use to evaluate the possibility that a medicine has caused an adverse drug reaction.Clinicians' communication about adverse drug reactions was poor from the perspective of parents, indicating that improvements are needed. The accounts of parents of children with cancer indicate that prospective explanation about adverse drug reactions at the time of prescription can be effective. Convergence between parents and clinicians in their reasoning for
Arnott, Janine; Hesselgreaves, Hannah; Nunn, Anthony J.; Peak, Matthew; Pirmohamed, Munir; Smyth, Rosalind L.
Background There is little research on parents' experiences of suspected adverse drug reactions in their children and hence little evidence to guide clinicians when communicating with families about problems associated with medicines. Objective To identify any unmet information and communication needs described by parents whose child had a suspected adverse drug reaction. Methods Semi-structured qualitative interviews with parents of 44 children who had a suspected adverse drug reaction identified on hospital admission, during in-patient treatment or reported by parents using the Yellow Card Scheme (the UK system for collecting spontaneous reports of adverse drug reactions). Interviews were conducted face-to-face or by telephone; most interviews were audiorecorded and transcribed. Analysis was informed by the principles of the constant comparative method. Results Many parents described being dissatisfied with how clinicians communicated about adverse drug reactions and unclear about the implications for their child's future use of medicines. A few parents felt that clinicians had abandoned their child and reported refusing the use of further medicines because they feared a repeated adverse drug reaction. The accounts of parents of children with cancer were different. They emphasised their confidence in clinicians' management of adverse drug reactions and described how clinicians prospectively explained the risks associated with medicines. Parents linked symptoms to medicines in ways that resembled the established reasoning that clinicians use to evaluate the possibility that a medicine has caused an adverse drug reaction. Conclusion Clinicians' communication about adverse drug reactions was poor from the perspective of parents, indicating that improvements are needed. The accounts of parents of children with cancer indicate that prospective explanation about adverse drug reactions at the time of prescription can be effective. Convergence between parents and
Grenard, Jerry L; Uy, Visith; Pagán, José A; Frosch, Dominick L
To conduct a pilot study exploring seniors' perceptions of direct-to-consumer advertising (DTCA) of prescription drugs and how the advertisements might prepare them for making informed decisions with their physicians. We interviewed 15 seniors (ages 63-82) individually after they each watched nine prescription drug advertisements recorded from broadcast television. Grounded Theory methods were used to identify core themes related to the research questions. Four themes emerged from the interviews about DTCA: (1) awareness of medications was increased, (2) information was missing or misleading and drugs were often perceived as more effective than clinical evidence would suggest, (3) most seniors were more strongly influenced by personal or vicarious experience with a drug - and by their physician - than by DTCA, and (4) most seniors were circumspect about the information in commercial DTCA. DTCA may have some limited benefit for informed decision making by seniors, but the advertisements do not provide enough detailed information and some information is misinterpreted. Physicians should be aware that many patients may misunderstand DTCA, and that a certain amount of time may be required during consultations to correct these misconceptions until better advertising methods are employed by the pharmaceutical industry. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.
Still the Great Debate - "Fair Balance" in Direct-to-Consumer Prescription Drug Advertising Comment on "Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters".
Rollins, Brent L
The above titled paper examined the Food and Drug Administration's (FDA's) warning letters and notice of violations (NOV) over a 10-year period. Findings from this content analysis reinforced what has been the primary issue for prescription direct-to-consumer advertising (DTCA) since its beginning, the fair balance of risk and benefit information. As opposed to another analysis in 2026 about this still being an issue, is there anything that can be done to prevent this problem from continuing? © 2016 by Kerman University of Medical Sciences.
Still the Great Debate – “Fair Balance” in Direct-to-Consumer Prescription Drug Advertising; Comment on “Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters”
Brent L. Rollins
Full Text Available The above titled paper examined the Food and Drug Administration’s (FDA’s warning letters and notice of violations (NOV over a 10-year period. Findings from this content analysis reinforced what has been the primary issue for prescription direct-to-consumer advertising (DTCA since its beginning, the fair balance of risk and benefit information. As opposed to another analysis in 2026 about this still being an issue, is there anything that can be done to prevent this problem from continuing?
Ohlsson, Henrik; Merlo, Juan
Therapeutic traditions at health care practices (HCPs) influence physicians' adherence to prescription guidelines for specific drugs, however, it is not known if such traditions affect all kinds of prescriptions or only specific types of drug. Our goal was to determine whether adherence to prescription guidelines is a common trait of HCPs or dependent on drug type. We fitted separate multi-level logistic regression models to all patients in the Skåne region who received a prescription for a statin drug (ATC: C10AA, n = 6232), an agent acting on the renin-angiotensin system (ATC: C09, n = 7222) or a proton pump inhibitor (ATC: A02BC, n = 11 563) at 198 HCPs from July 2006 to December 2006. There was a high clustering of adherence to prescription guidelines at HCPs for the different drug types (MOR(agents acting on the renin-angiotensin system) = 4.72 [95% CI: 3.90-5.92], MOR(Statins) = 2.71 [95% CI: 2.23-3.39] and MOR(Proton pump inhibitors) = 2.16 [95% CI: 1.95-2.45]). Compared with HCPs with low adherence to guidelines in two drug types, those HCPs with the highest level of adherence for these two drug types also showed a higher probability of adherence for the third drug type. Physicians' decisions to follow prescription guidelines seem to be influenced by therapeutic traditions at the HCP. Moreover, these therapeutic traditions seem to affect all kinds of prescriptions. This information can be used as basis for interventions to support rational and cost-effective medication use. Copyright 2009 John Wiley & Sons, Ltd.
Bell, R A; Kravitz, R L; Wilkes, M S
We conducted a content analysis of consumer-targeted prescription drug advertisements to explore trends in prevalence, shifts in the medical conditions for which drugs are promoted, reliance on financial and nonmonetary inducements, and appeals used to attract public interest. We collected the drug advertisements appearing in 18 consumer magazines from 1989 through 1998. Two judges independently coded each advertisement and placed it in a category pertaining to the target audience, use of inducements, and product benefits (mean kappa=0.93). We employed descriptive statistics, cross-tabulations, and curve estimation procedures. A total of 320 distinct advertisements were identified, representing 101 brands and 14 medical conditions. New advertisement and brand introductions increased dramatically during this decade. Advertisements for drugs used for dermatologic, human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS), and obstetric/gynecologic conditions were most common. Almost all of the advertisements were aimed at the potential user of the drug, not third-party intermediaries such as parents and spouses. Although most advertisements were gender-neutral, women were more likely to be exclusively targeted. One eighth of the advertisements offered a monetary incentive (eg, a rebate or money-back guarantee), and one third made an offer of additional information in printed or audio/video form. The most common appeals used were effectiveness, symptom control, innovativeness, and convenience. Consumer-directed prescription drug advertising has increased dramatically during the past decade. The pharmaceutical industry is turning to this type of advertising to generate interest in its products. Our data may be useful to physicians who want to stay abreast of the treatments that are being directly marketed to their patients.
Full Text Available Direct-to-consumer advertising (DTCA of prescription drugs is illegal in Canada as a health protection measure, but is permitted in the United States. However, in 2000, Canadian policy was changed to allow 'reminder' advertising of prescription drugs. This is a form of advertising that states the brand name without health claims. 'Reminder' advertising is prohibited in the US for drugs that have 'black box' warnings of serious risks. This study examines spending on DTCA in Canada from 1995 to 2006, 12 years spanning this policy shift. We ask how annual per capita spending compares to that in the US, and whether drugs with Canadian or US regulatory safety warnings are advertised to the Canadian public in reminder advertising.Prescription drug advertising spending data were extracted from a data set on health sector spending in Canada obtained from a market research company, TNS Media Inc. Spending was adjusted for inflation and compared with US spending. Inflation-adjusted spending on branded DTCA in Canada grew from under CAD$2 million per year before 1999 to over $22 million in 2006. The major growth was in broadcast advertising, accounting for 83% of spending in 2006. US annual per capita spending was on average 24 times Canadian levels. Celebrex (celecoxib, which has a US black box and was subject to three safety advisories in Canada, was the most heavily advertised drug on Canadian television in 2005 and 2006. Of 8 brands with >$500,000 spending, which together accounted for 59% of branded DTCA in all media, 6 were subject to Canadian safety advisories, and 4 had US black box warnings.Branded 'reminder' advertising has grown rapidly in Canada since 2000, mainly due to a growth in television advertising. Although DTCA spending per capita is much lower in Canada than in the US, there is no evidence of safer content or product choice; many heavily-advertised drugs in Canada have been subject to safety advisories. For governments searching for
Mintzes, Barbara; Morgan, Steve; Wright, James M
Direct-to-consumer advertising (DTCA) of prescription drugs is illegal in Canada as a health protection measure, but is permitted in the United States. However, in 2000, Canadian policy was changed to allow 'reminder' advertising of prescription drugs. This is a form of advertising that states the brand name without health claims. 'Reminder' advertising is prohibited in the US for drugs that have 'black box' warnings of serious risks. This study examines spending on DTCA in Canada from 1995 to 2006, 12 years spanning this policy shift. We ask how annual per capita spending compares to that in the US, and whether drugs with Canadian or US regulatory safety warnings are advertised to the Canadian public in reminder advertising. Prescription drug advertising spending data were extracted from a data set on health sector spending in Canada obtained from a market research company, TNS Media Inc. Spending was adjusted for inflation and compared with US spending. Inflation-adjusted spending on branded DTCA in Canada grew from under CAD$2 million per year before 1999 to over $22 million in 2006. The major growth was in broadcast advertising, accounting for 83% of spending in 2006. US annual per capita spending was on average 24 times Canadian levels. Celebrex (celecoxib), which has a US black box and was subject to three safety advisories in Canada, was the most heavily advertised drug on Canadian television in 2005 and 2006. Of 8 brands with >$500,000 spending, which together accounted for 59% of branded DTCA in all media, 6 were subject to Canadian safety advisories, and 4 had US black box warnings. Branded 'reminder' advertising has grown rapidly in Canada since 2000, mainly due to a growth in television advertising. Although DTCA spending per capita is much lower in Canada than in the US, there is no evidence of safer content or product choice; many heavily-advertised drugs in Canada have been subject to safety advisories. For governments searching for compromise
Mintzes, Barbara; Morgan, Steve; Wright, James M.
Background Direct-to-consumer advertising (DTCA) of prescription drugs is illegal in Canada as a health protection measure, but is permitted in the United States. However, in 2000, Canadian policy was changed to allow ‘reminder’ advertising of prescription drugs. This is a form of advertising that states the brand name without health claims. ‘Reminder’ advertising is prohibited in the US for drugs that have ‘black box’ warnings of serious risks. This study examines spending on DTCA in Canada from 1995 to 2006, 12 years spanning this policy shift. We ask how annual per capita spending compares to that in the US, and whether drugs with Canadian or US regulatory safety warnings are advertised to the Canadian public in reminder advertising. Methodology/Principal Findings Prescription drug advertising spending data were extracted from a data set on health sector spending in Canada obtained from a market research company, TNS Media Inc. Spending was adjusted for inflation and compared with US spending. Inflation-adjusted spending on branded DTCA in Canada grew from under CAD$2 million per year before 1999 to over $22 million in 2006. The major growth was in broadcast advertising, accounting for 83% of spending in 2006. US annual per capita spending was on average 24 times Canadian levels. Celebrex (celecoxib), which has a US black box and was subject to three safety advisories in Canada, was the most heavily advertised drug on Canadian television in 2005 and 2006. Of 8 brands with >$500,000 spending, which together accounted for 59% of branded DTCA in all media, 6 were subject to Canadian safety advisories, and 4 had US black box warnings. Conclusions/Significance Branded ‘reminder’ advertising has grown rapidly in Canada since 2000, mainly due to a growth in television advertising. Although DTCA spending per capita is much lower in Canada than in the US, there is no evidence of safer content or product choice; many heavily-advertised drugs in Canada have
Heck, Nicholas C; Livingston, Nicholas A; Flentje, Annesa; Oost, Kathryn; Stewart, Brandon T; Cochran, Bryan N
Previous research suggests that lesbian, gay, bisexual, and transgender (LGBT) youth are at elevated risk for using illicit drugs and misusing prescription drugs relative to heterosexual youth. Previous research also indicates that LGBT youth who attend high schools with a gay-straight alliance (GSA) report having fewer alcohol problems and lower levels of cigarette smoking. The present study investigates whether the absence of a GSA is associated with risk for illicit drug use and prescription drug misuse in a sample of 475 LGBT high school students (M age=16.79) who completed an online survey. After controlling for demographic variables and risk factors associated with illicit drug use, the results of 12 logistic regression analyses revealed that LGBT youth attending a high school without a GSA evidenced increased risk for using cocaine (adjusted odds ratio [adjOR]=3.11; 95% confidence interval [95% CI]=1.23-7.86), hallucinogens (adjOR=2.59; 95% CI=1.18-5.70), and marijuana (adjOR=2.22; 95% CI=1.37-3.59) relative to peers attending a high school with a GSA. Youth without a GSA also evidenced increased risk for the misuse of ADHD medication (adjOR=2.00; 95% CI=1.02-3.92) and prescription pain medication (adjOR=2.00; 95% CI=1.10-3.65). These findings extend the research base related to GSAs and further demonstrate the importance of providing LGBT youth with opportunities for socialization and support within the school setting. Important limitations of the present study are reviewed. Copyright © 2014 Elsevier Ltd. All rights reserved.
The current direct-to-consumer advertising (DTCA) guidelines were developed with print, television, and radio media in mind, and there are no specific guidelines for online banner advertisements. This study evaluates how well Internet banner ads comply with existing Food and Drug Administration (FDA) guidelines for DTCA in other media. A content analysis was performed of 68 banner advertisements. A coding sheet was developed based on (1) FDA guidance documents for consumer-directed prescription drug advertisements and (2) previous DTCA content analyses. Specifically, the presence of a brief summary detailing the drug's risks and side effects or of a "major statement" identifying the drug's major risks, and the number and type of provisions made available to consumers for comprehensive information about the drug were coded. In addition, the criterion of "fair balance," the FDA's requirement that prescription drug ads balance information relating to the drug's risks with information relating to its benefits, was measured by numbering the benefit and risk facts identified in the ads and by examining the presentation of risk and benefit information. Every ad in the sample included a brief summary of risk information and at least one form of adequate provision as required by the FDA for broadcast ads that do not give audiences a brief summary of a drug's risks. No ads included a major statement. There were approximately 7.18 risk facts for every benefit fact. Most of the risks (98.85%, 1292/1307) were presented in the scroll portion of the ad, whereas most of the benefits (66.5%, 121/182) were presented in the main part of the ad. Out of 1307 risk facts, 1292 were qualitative and 15 were quantitative. Out of 182 benefit facts, 181 were qualitative and 1 was quantitative. The majority of ads showed neutral images during the disclosure of benefit and risk facts. Only 9% (6/68) of the ads displayed positive images and none displayed negative images when presenting risks
Weiss, Roger D; Potter, Jennifer Sharpe; Griffin, Margaret L; Provost, Scott E; Fitzmaurice, Garrett M; McDermott, Katherine A; Srisarajivakul, Emily N; Dodd, Dorian R; Dreifuss, Jessica A; McHugh, R Kathryn; Carroll, Kathleen M
Despite the growing prevalence of prescription opioid dependence, longitudinal studies have not examined long-term treatment response. The current study examined outcomes over 42 months in the Prescription Opioid Addiction Treatment Study (POATS). POATS was a multi-site clinical trial lasting up to 9 months, examining different durations of buprenorphine-naloxone plus standard medical management for prescription opioid dependence, with participants randomized to receive or not receive additional opioid drug counseling. A subset of participants (N=375 of 653) enrolled in a follow-up study. Telephone interviews were administered approximately 18, 30, and 42 months after main-trial enrollment. Comparison of baseline characteristics by follow-up participation suggested few differences. At Month 42, much improvement was seen: 31.7% were abstinent from opioids and not on agonist therapy; 29.4% were receiving opioid agonist therapy, but met no symptom criteria for current opioid dependence; 7.5% were using illicit opioids while on agonist therapy; and the remaining 31.4% were using opioids without agonist therapy. Participants reporting a lifetime history of heroin use at baseline were more likely to meet DSM-IV criteria for opioid dependence at Month 42 (OR=4.56, 95% CI=1.29-16.04, popioid abstinence. Eight percent (n=27/338) used heroin for the first time during follow-up; 10.1% reported first-time injection heroin use. Long-term outcomes for those dependent on prescription opioids demonstrated clear improvement from baseline. However, a subset exhibited a worsening course, by initiating heroin use and/or injection opioid use. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.
Distribution of blood derivatives by registered blood establishments that qualify as health care entities; Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; delay of applicability date. Final rule; delay of applicability date.
The Food and Drug Administration (FDA) is further delaying, until December 1, 2008, the applicability date of a certain requirement of a final rule published in the Federal Register of December 3, 1999 (64 FR 67720) (the final rule). The final rule implements the Prescription Drug Marketing Act of 1987 (PDMA), as modified by the Prescription Drug Amendments of 1992 (PDA), and the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The provisions of the final rule became effective on December 4, 2000, except for certain provisions whose effective or applicability dates were delayed in five subsequent Federal Register notices, until December 1, 2006. The provision with the delayed applicability date would prohibit wholesale distribution of blood derivatives by registered blood establishments that meet the definition of a "health care entity." In the Federal Register of February 1, 2006 (71 FR 5200), FDA published a proposed rule specific to the distribution of blood derivatives by registered blood establishments that qualify as health care entities (the proposed rule). The proposed rule would amend certain limited provisions of the final rule to allow certain registered blood establishments that qualify as health care entities to distribute blood derivatives. In response to the proposed rule, FDA received substantive comments. As explained in the SUPPLEMENTARY INFORMATION section of this document, further delaying the applicability of Sec. 203.3(q) (21 CFR 203.3(q)) to the wholesale distribution of blood derivatives by health care entities is necessary to give the agency additional time to address comments on the proposed rule, consider whether regulatory changes are appropriate, and, if so, to initiate such changes.
Tsai, Yi-Wen; Wen, Yu-Wen; Huang, Weng-Foung; Kuo, Ken N; Chen, Pei-Fen; Shih, Hsin-Wei; Lee, Yue-Chune
This study used Taiwan's National Health Insurance claim database (years 2000-2005) to examine how thiazolidinediones (TZD), a new class of drugs for diabetes, penetrated into Taiwan's hospitals, and its association with the concentration of all diabetes drugs at the hospital level. We collected 72 monthly summaries of diabetes prescriptions from all hospitals in Taiwan. Hospital-level pharmaceutical concentration was measured by penetration of TZD, defined as monthly market share of TZD in each hospital. Concentration of diabetes drugs was measured by Herfindahl-Hirschman indices. We found a negative association (coefficient = -0.3610) between TZD penetration and concentration of diabetes drug but a positive association between penetration of TZD and the volume of prescribed diabetes drugs (coefficient = 0.4088). In conclusion, hospital characteristics and volume of services determined the concentration of pharmaceuticals at the institution level, reflecting the heterogeneous competition between pharmaceutical companies within each hospital. Institution-level pharmaceutical concentration influences the adoption and penetration of new drugs.
Sajid, Ayesha; Whiteman, Aaron; Bell, Richard L; Greene, Marion S; Engleman, Eric A; Chambers, R Andrew
Fourfold increases in opioid prescribing and dispensations over 2 decades in the U.S. has paralleled increases in opioid addictions and overdoses, requiring new preventative, diagnostic, and treatment strategies. This study examines Prescription Drug Monitoring Program (PDMP) tracking as a novel measure of opioid addiction treatment outcomes in a university-affiliated integrated mental health-addiction treatment clinic. Repeated measure parametrics examined PDMP and urine drug screening (UDS) data before and after first injection for all patients (N = 68) who received at least one long-acting naltrexone injection (380 mg/IM) according to diagnostic groupings of having either (i) alcohol (control); (ii) opioid; or (iii) combined alcohol and opioid use disorders. There were no group differences post-injection in treatment days, injections delivered, or treatment service encounters. UDS and PDMP measures of opioid exposures were greater in opioid compared to alcohol-only patients. Post-first injection, UDS's positive for opioids declined (p opioid prescriptions (p Opioid patients without alcohol disorders showed the best outcomes with 50% to 80% reductions in PDMP-measures of opioids, down to levels of alcohol-only patients. This study shows PDMP utility for measuring opioid addiction treatment outcomes, supporting the routine use of PDMPs in clinical and research settings. These findings demonstrate that opioid addiction in patients with complex addictions and mental illnesses comorbidities can show effective treatment responses as measured by PDMP tracking of decreases in opioid prescriptions to those patients. (Am J Addict 2016;25:557-564). © 2016 The Authors. The American Journal on Addictions Published by Wiley Periodicals, Inc. on behalf of The American Academy of Addiction Psychiatry (AAAP).
Prescription drug direct-to-consumer advertising (DTCA) has been a subject of controversy in recent years. Though government regulations require equivalent prominence of risks and benefits, there is concern about the ability of consumers with limited health literacy to fully comprehend the risks and benefits associated with drug use. Evaluating…
Thorell, Kristine; Skoog, Jessica; Zielinski, Andrzej
There is a great variability in licit prescription drug use in the population and among patients. Factors other than purely medical ones have proven to be of importance for the prescribing of licit drugs. For example, individuals with a high age, female gender and low socioeconomic status are more...... and socioeconomic status after adjustment for multi-morbidity level....
I. O. Shchederkina
Full Text Available Among drug-resistant epilepsies, epileptic syndromes, characterized by combination of several types of seizures, are considered to be the most difficult in terms of treatment. Lennox–Gastaut syndrome is one of them. It manifests with polymorphic seizures (tonic axial, myatonic, atypical absence seizures, status epilepticus of minor motor seizures, myoclonic, generalized convulsive, and focal seizures. This is a heterogeneous disease, represented by a complex of clinical and electroencephalographic manifestations with various etiology. Current review is devoted to a novel antiepileptic drug rufinamide, which has a new mechanism of action. The drug has been registered in Russia in 2015. The authors also describe their own experience of rufinamide usage in the treatment of drug-resistant focal epilepsy as a part of multicomponent therapy for polymorphic seizures. One patient achieved clinical remission for 16 months; the second one had more than 50 % decrease in seizures frequency with a remission of drop-attacks.
Full Text Available We examine how consumers react to direct-to-consumer advertising (DTCA by investigating the role of goal compatibility between motivation to process advertisements and consumer self-concept. Specifically, we examine the interaction between self-regulatory (prevention versus promotion focus and self-construal orientation (independent versus interdependent and find that prevention (versus promotion focused consumers form stronger intentions to speak with physicians and are more likely to discuss an advertised drug, when the ad uses an interdependence self-construal theme, whereas promotion (versus prevention focused consumers form stronger intentions to speak with physicians and are more likely to discuss an advertised drug, when the ad uses an independent self-construal theme. The above two-way interaction was further found to be governed by attitudes toward DTCA. Under goal compatibility, consumers who had positive or neutral attitudes toward DTCA (versus negative had stronger (a intentions to speak with physicians about the advertised drug, (b stronger intentions to speak with physicians about high cholesterol, (c greater likelihood of discussing the drug with health professionals, and (d greater likelihood of requesting a prescription, yet did not differ in perceptions of drug benefits and risks. Hypotheses were tested on a sample of 197 female staff and retirees (aged 40–80 years at a large university.
the prescribing behaviour of physicians. ... Keywords: Physician prescription behaviour, Pharmacist factor, Collaboration, Trustworthiness ... provide information relating to drug prescription, ... processing , which takes into consideration.
Chang, Hsien-Yen; Murimi, Irene; Faul, Mark; Rutkow, Lainie; Alexander, G Caleb
We quantified the effects of Florida's prescription drug monitoring program and pill mill law on high-risk patients. We used QuintilesIMS LRx Lifelink data to identify patients receiving prescription opioids in Florida (intervention state, N: 1.13 million) and Georgia (control state, N: 0.54 million). The preintervention, intervention, and postintervention periods were July 2010 to June 2011, July 2011 to September 2011, and October 2011 to September 2012. We identified 3 types of high-risk patients: (1) concomitant users: patients with concomitant use of benzodiazepines and opioids; (2) chronic users: long-term, high-dose, opioid users; and (3) opioid shoppers: patients receiving opioids from multiple sources. We compared changes in opioid prescriptions between Florida and Georgia before and after policy implementation among high-risk/low-risk patients. Our monthly measures included (1) average morphine milligram equivalent per transaction, (2) total opioid volume across all prescriptions, (3) average days supplied per transaction, and (4) total number of opioid prescriptions dispensed. Among opioid-receiving individuals in Florida, 6.62% were concomitant users, 1.96% were chronic users, and 0.46% were opioid shoppers. Following policy implementation, Florida's high-risk patients experienced relative reductions in morphine milligram equivalent (opioid shoppers: -1.08 mg/month, 95% confidence interval [CI] -1.62 to -0.54), total opioid volume (chronic users: -4.58 kg/month, CI -5.41 to -3.76), and number of dispensed opioid prescriptions (concomitant users: -640 prescriptions/month, CI -950 to -340). Low-risk patients generally did not experience statistically significantly relative reductions. Compared with Georgia, Florida's prescription drug monitoring program and pill mill law were associated with large relative reductions in prescription opioid utilization among high-risk patients. Copyright © 2018 John Wiley & Sons, Ltd.
G.W. 't Jong (Geert); I.A. Eland (Ingo); M.C.J.M. Sturkenboom (Miriam); J.N. van den Anker (John); B.H.Ch. Stricker (Bruno)
textabstractMany respiratory drugs are not available in formulations suitable for infants and toddlers. Efficacy and safety research is mostly restricted to older children. However, respiratory drugs are frequently used in children for common diseases like asthma, upper and
Zosel, Amy; Bartelson, Becki Bucher; Bailey, Elise; Lowenstein, Steven; Dart, Rick
To describe the characteristics and health effects of adolescent (age 13-19 years) prescription drug abuse and misuse using the Researched Abuse Diversion and Addiction-Related Surveillance (RADARS(®)) System. Secondary analysis of data collected from RADARS System participating poison centers was performed. Data for all intentional exposures from 2007 through 2009 were used to describe adolescent prescription opioid (oxycodone, fentanyl, hydrocodone, hydromorphone, morphine, methadone, buprenorphine, and tramadol) and stimulant (methylphenidate and amphetamines) exposures. A total of 16,209 intentional adolescent exposures to prescription drugs were identified, 68% to opioids and 32% to stimulants. The mean age was 16.6 years (SD ± 1.7 years). Slightly more than half (52.4%) of drug mentions involved females. The five most frequently misused or abused drugs were hydrocodone (32%), amphetamines (18%), oxycodone (15%), methylphenidate (14%), and tramadol (11%). Of all exposures, 38% were classified as suspected suicidal. Of adolescents who intentionally exposed themselves to prescription drugs, 30% were treated in a health care facility, 2,792 of whom were admitted to the hospital, including 1,293 to the intensive care unit. A total of 17.2% of intentional exposures were associated with no effect, 38.9% minor effects, 23.3% moderate effects, 3.6% major effects, and 0.1% were associated with death. Oxycodone and methadone were associated with the most deaths. No deaths were associated with exposures to stimulants. Prescription drug misuse and abuse poses an important health problem and results in thousands of hospitalizations of adolescents per year. Further work is needed to develop focused interventions and educational programs to prevent prescription drug abuse and misuse by adolescents. Copyright © 2013 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.
... Advertisements AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... drug advertisements. DATES: Submit written or electronic comments on the collection of information by... approval from the Office of Management and Budget (OMB) for each collection of information they conduct or...
Background The current direct-to-consumer advertising (DTCA) guidelines were developed with print, television, and radio media in mind, and there are no specific guidelines for online banner advertisements. Objective This study evaluates how well Internet banner ads comply with existing Food and Drug Administration (FDA) guidelines for DTCA in other media. Methods A content analysis was performed of 68 banner advertisements. A coding sheet was developed based on (1) FDA guidance documents for consumer-directed prescription drug advertisements and (2) previous DTCA content analyses. Specifically, the presence of a brief summary detailing the drug’s risks and side effects or of a “major statement” identifying the drug’s major risks, and the number and type of provisions made available to consumers for comprehensive information about the drug were coded. In addition, the criterion of “fair balance,” the FDA’s requirement that prescription drug ads balance information relating to the drug’s risks with information relating to its benefits, was measured by numbering the benefit and risk facts identified in the ads and by examining the presentation of risk and benefit information. Results Every ad in the sample included a brief summary of risk information and at least one form of adequate provision as required by the FDA for broadcast ads that do not give audiences a brief summary of a drug’s risks. No ads included a major statement. There were approximately 7.18 risk facts for every benefit fact. Most of the risks (98.85%, 1292/1307) were presented in the scroll portion of the ad, whereas most of the benefits (66.5%, 121/182) were presented in the main part of the ad. Out of 1307 risk facts, 1292 were qualitative and 15 were quantitative. Out of 182 benefit facts, 181 were qualitative and 1 was quantitative. The majority of ads showed neutral images during the disclosure of benefit and risk facts. Only 9% (6/68) of the ads displayed positive images and
Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: Teaching Drug Marketers How to Inform Better or Spin Better? Comment on "Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters".
Hyosun Kim's report "Trouble Spots in Online Direct to Consumer Prescription Drug Promotion: A content Analysis of FDA Warning Letters" aims to teach marketers how to avoid breaching current Food and Drug Administration (FDA) guidelines in their online drug promotion. While Kim hopes to minimise the potential for online promotion to misinform consumers and the study is carefully conducted, teaching drug marketers how to avoid the common mistakes in online drug promotion is more likely to make marketers more adept at spinning information than appropriately balancing it. © 2016 by Kerman University of Medical Sciences.
Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: Teaching Drug Marketers How to Inform Better or Spin Better?; Comment on “Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters”
Full Text Available Hyosun Kim’s report “Trouble Spots in Online Direct to Consumer Prescription Drug Promotion: A content Analysis of FDA Warning Letters”aims to teach marketers how to avoid breaching current Food and Drug Administration (FDA guidelines in their online drug promotion. While Kim hopes to minimise the potential for online promotion to misinform consumers and the study is carefully conducted, teaching drug marketers how to avoid the common mistakes in online drug promotion is more likely to make marketers more adept at spinning information than appropriately balancing it.
Tomas, Ana; Tomić, Zdenko; Milijasević, Boris; Ban, Milica; Horvat, Olga; Vukmirović, Sasa; Sabo, Ana
Hypertension is one of the leading causes of cardiovascular morbidity and mortality and more than a half of all health insurance expenditures for reimbursed medicines are allocated to antihypertensive drugs in Serbia. The aim of this study was to identify the antihypertensive drug utilization patterns among hypertensive outpatients in the city of Novi Sad, Serbia, determine the adherence to clinical guidelines and address the economic aspects of current prescribing practices. This retrospective observational study was conducted in Novi Sad over a period of six months. The data on the number of packages, size their, and retail price of antihypertensives issued on prescription in outpatients with the diagnosis of essential arterial hypertension was collected from all state-owned pharmacies in Novi Sad. Drug consumption was analyzed using the Anatomical Therapeutic Chemical (ATC)/ defined daily dose (DDD) methodology. Total consumption of antihypertensives issued on prescription over a 6-month period in the city of Novi sad, Serbia was 283.48 DDD per 1,000 inhabitans per day (DID). Angiotensin converting enzyme inhibitors (ACEi) were most commonly prescribed drugs, and were used 3 times more often than calcium channel blockers and 5 times more than beta-blockers. The consumption of diuretics and angiotensin receptor antagonists was low within all the groups of outpatients. Both national and international guidelines state superiority and effectiveness of diuretics in treatment of hypertension in the elderly, but their consumption was unreasonable low despite the fact that over 70% of all antihypertensive drugs in the city of Novi Sad were dispensed in people aged > 60. The use of more expensive ACEi was observed despite the guidelines deeming all the drugs of this class equally effective in treatment of hypertension. Large differences in utilization of different groups of antihypertensive agents were noted in this study. Underutilization of valuable, efficacious, and
Norris, Rebecca L; Bailey, Rachel L; Bolls, Paul D; Wise, Kevin R
This experiment explored how the emotional tone and visual complexity of direct-to-consumer (DTC) drug advertisements affect the encoding and storage of specific risk and benefit statements about each of the drugs in question. Results are interpreted under the limited capacity model of motivated mediated message processing framework. Findings suggest that DTC drug ads should be pleasantly toned and high in visual complexity in order to maximize encoding and storage of risk and benefit information.
Mortensen, Jens T; Olesen, Anne V; Bøggild, Henrik
with slightly more male top managers using cardiovascular drugs. People in the upper half of the socioeconomic scale were somewhat less likely to redeem prescriptions for treating muscle, joints and bone, and central nervous system. CONCLUSION: Social or economic barriers in buying medicine are generally small......INTRODUCTION: In the public health system we study medical treatment which is ideally provided according to need and independently of economic means. We report use of prescription drugs according to socioeconomic classifications in North Jutland County in Denmark in 1999. METHOD: We conducted...
Suh, Hae Sun; Lee, Donghyun; Kim, Sang Yong; Chee, Dong Hyun; Kang, Hye-Young
To examine consumers' attitudes toward direct-to-consumer advertising (DTCA) for prescription drugs in Korea. We conducted a survey of 350 patients visiting community pharmacies to fill their prescriptions. Consumers' attitudes toward DTCA were assessed in terms of whether they felt DTCA was necessary, their trust in the information provided by DTCA, and their intention to use the information provided by DTCA. We examined consumers' preferences regarding the regulation of DTCA and their expectations of the effects of DTCA. About 60% of the respondents responded that DTCA is necessary and that they intended to use the information from DTCA. Less than half of the respondents reported that they would trust DTCA information. About 70% of the participants expressed the need for prior vetting of the DTCA content. Respondents had the highest expectation on the effect of DTCA as an information source for patients. Positive consumer expectations regarding the effects of DTCA were significantly associated with positive consumer attitudes toward DTCA (odds ratio=4.70, 95% confidence interval: 2.25-9.82). This study provides evidence that consumers in South Korea generally have positive attitudes toward DTCA. However, most of the respondents wanted a prior examination system of DTCA content to ensure that the information conveyed to them via DTCA was trustworthy. Policy-makers should be cautious and well-prepared if they decide to introduce DTCA in Korea. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.
Blangiardo, Marta; Finazzi, Francesco; Cameletti, Michela
Exposure to high levels of air pollutant concentration is known to be associated with respiratory problems which can translate into higher morbidity and mortality rates. The link between air pollution and population health has mainly been assessed considering air quality and hospitalisation or mortality data. However, this approach limits the analysis to individuals characterised by severe conditions. In this paper we evaluate the link between air pollution and respiratory diseases using general practice drug prescriptions for chronic respiratory diseases, which allow to draw conclusions based on the general population. We propose a two-stage statistical approach: in the first stage we specify a space-time model to estimate the monthly NO2 concentration integrating several data sources characterised by different spatio-temporal resolution; in the second stage we link the concentration to the β2-agonists prescribed monthly by general practices in England and we model the prescription rates through a small area approach. Copyright © 2016 Elsevier Ltd. All rights reserved.
Feldman, Roger; Lobo, Félix
We take on two subjects of controversy among economists-advertising and trademarks-in the context of the market for generic drugs. We outline a model in which trademarks for drug names reduce search costs but increase product differentiation. In this particular framework, trademarks may not benefit consumers. In contrast, the generic names of drugs or "International Nonproprietary Names" (INN) have unquestionable benefits in both economic theory and empirical studies. We offer a second model where advertising of a brand-name drug creates recognition for the generic name. The monopoly patent-holder advertises less than in the absence of a competitive spillover.
Gentili, Marta; Pozzi, Marco; Peeters, Gabrielle; Radice, Sonia; Carnovale, Carla
Knowledge of drugs safety collected during the pre-marketing phase is inevitably limited because the randomized clinical trials (RCTs) are rarely designed to evaluate safety. The small and selective groups of enrolled individuals and the limited duration of trials may hamper the ability to characterize fully the safety profiles of drugs. Additionally, information about rare adverse drug reactions (ADRs) in special groups is often incomplete or not available for most of the drugs commonly used in the daily clinical practice. In the paediatric setting several highimpact safety issues have emerged. Hence, in recent years, there has been a call for improved post-marketing pharmacoepidemiological studies, in which cohorts of patients are monitored for sufficient time in order to determine the precise risk-benefit ratio. In this review, we discuss the current available strategies enhancing the post-marketing monitoring activities of the drugs in the paediatric setting and define criteria whereby they can provide valuable information to improve the management of therapy in daily clinical practice including both safety and efficacy aspects. The strategies we cover include the signal detection using international pharmacovigilance and/or healthcare databases, the promotion of active surveillance initiatives which can generate complete, informative data sets for the signal detection and systematic review/meta-analysis. Together, these methods provide a comprehensive picture of causality and risk improving the management of therapy in a paediatric setting and they should be considered as a unique tool to be integrated with post-marketing activities. Copyright© Bentham Science Publishers; For any queries, please email at firstname.lastname@example.org.
... for the process for the review of human drug applications (see section 736(c)(2) of the FD&C Act... provide for not more than 3 months of operating reserves of carryover user fees for the process for the... establishment fees will be exempted this year based on the orphan drug exemption in FDAAA (see section 736(k) of...
..., shall be further adjusted to reflect changes in workload for the process for the review of human drug... year based on the orphan drug exemption in FDAAA (see section 736(k) of the act). Subtracting 30 establishments (15 waivers plus the estimated 15 establishments under the orphan exemption) from 445 leaves a net...
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
... biologics approvals, drug supply chain, and other topics related to human pharmaceuticals. The draft PDUFA V... . Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration....gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to...
... U.S. postal money order payable to the order of the Food and Drug Administration. Please include the user fee identification (ID) number on your check, bank draft, or postal money order. Your payment can be mailed to: Food and Drug Administration, P.O. Box 979107, St. Louis, MO 63197-9000. If checks are...
..., or U.S. postal money order payable to the order of the Food and Drug Administration. Please include the user fee identification (ID) number on your check, bank draft, or postal money order. Your payment can be mailed to: Food and Drug Administration, P.O. Box 979107, St. Louis, MO 63197-9000. If checks...
Almarsdóttir, Anna Birna; Björnsdóttir, Ingunn; Traulsen, Janine Morgall
the consequences of the Human Genome Project over the next 40 years, and asked to give advice to politicians and the pharmaceutical industry. A dominating theme in the focus groups was the expectation that drugs developed based on pharmacogenomics will be more expensive than conventional mass produced drugs...
Over the past two decades, courts have consistently ruled that the manufacturer of a brand-name prescription drug cannot be liable for injuries suffered by those taking generic imitations of its product. This meant that a patient injured by a generic drug could have no remedy at all because in many instances the generic drug manufacturer would escape liability on the ground that it did not produce any information on which the patient's doctor relied. It was a perplexing dilemma. The generic drug manufacturer made the product that the plaintiff received, the brand-name manufacturer produced all of the information the patient's doctor saw, and neither manufacturer could be held liable even if each acted negligently. The California Court of Appeal recently issued a stunning decision in which it concluded that a brand-name drug manufacturer could be liable to a plaintiff who took a generic version of its product. The reaction to the decision has been overwhelmingly negative. Commentators have condemned the decision as one of the worst rulings made by any court in recent years. Judges around the country have dismissed it as a misguided aberration from the otherwise strong judicial consensus on the issue. Although the decision has been the subject of scathing criticism, this Article argues that the California court's ruling actually represents the first time that a court has properly examined this issue. In addition, the Article points out some weaknesses in the California court's reasoning and proposes a novel general framework for analyzing the liability of brand-name and generic drug manufacturers.
Vélez-Díaz-Pallarés, Manuel; Delgado-Silveira, Eva; Carretero-Accame, María Emilia; Bermejo-Vicedo, Teresa
To identify actions to reduce medication errors in the process of drug prescription, validation and dispensing, and to evaluate the impact of their implementation. A Health Care Failure Mode and Effect Analysis (HFMEA) was supported by a before-and-after medication error study to measure the actual impact on error rate after the implementation of corrective actions in the process of drug prescription, validation and dispensing in wards equipped with computerised physician order entry (CPOE) and unit-dose distribution system (788 beds out of 1080) in a Spanish university hospital. The error study was carried out by two observers who reviewed medication orders on a daily basis to register prescription errors by physicians and validation errors by pharmacists. Drugs dispensed in the unit-dose trolleys were reviewed for dispensing errors. Error rates were expressed as the number of errors for each process divided by the total opportunities for error in that process times 100. A reduction in prescription errors was achieved by providing training for prescribers on CPOE, updating prescription procedures, improving clinical decision support and automating the software connection to the hospital census (relative risk reduction (RRR), 22.0%; 95% CI 12.1% to 31.8%). Validation errors were reduced after optimising time spent in educating pharmacy residents on patient safety, developing standardised validation procedures and improving aspects of the software's database (RRR, 19.4%; 95% CI 2.3% to 36.5%). Two actions reduced dispensing errors: reorganising the process of filling trolleys and drawing up a protocol for drug pharmacy checking before delivery (RRR, 38.5%; 95% CI 14.1% to 62.9%). HFMEA facilitated the identification of actions aimed at reducing medication errors in a healthcare setting, as the implementation of several of these led to a reduction in errors in the process of drug prescription, validation and dispensing.
Park, Jin Seong; Ju, Ilwoo
This study aims to broaden the scope of knowledge on the role of direct-to-consumer prescription drug advertising (DTCA) in the construction of consumers' optimistic bias regarding health issues and their intentions for coping actions. Based on an online survey of U.S. adults aged 65 years or older (N = 622), this study revealed that (a) respondents were optimistically biased in estimating their future risk of Alzheimer's disease (AD); (b) exposure to DTCA for AD medicine related negatively to optimistic bias when respondents had a low level of knowledge about AD, while the relationship disappeared when knowledge was high; (c) optimistic bias was negatively associated with intentions to seek information about AD and professional help to discuss it; and (d) optimistic bias mediated the relationship between the DTCA exposure × AD knowledge interaction and information- and help-seeking intentions. Implications for the theory and practice of DTCA are discussed.
Ju, Ilwoo; Park, Jin Seong
This study addresses a void in the literature on direct-to-consumer prescription drug advertising (DTCA) with a theory-based content analysis. The findings indicate that Taylor's communication strategy wheel provides insight into what and how pharmaceutical marketers communicate with consumers by means of DTCA. Major findings are summarized as follows: (a) In most DTC ads, informational and transformational message themes and creative approaches were simultaneously used, indicating a combination strategy; (b) DTCA message themes were associated with creative strategies in alignment with Taylor's framework; and (c) message themes and creative strategies varied across therapeutic categories and DTCA categories with different levels of ad spending. Theoretical and practical implications of the findings are discussed.
Strang, John; Sheridan, Janie
We charted changes in the prescriptions issued to opiate addicts in treatment at a London clinic over the first 15 years of operation of one of the new National Health Service (NHS) drug clinics established in 1968. Having located the original handwritten ledger records of prescriptions issued by the drug addict treatment clinic, an SPSS data file was created of the prescriptions given to each of the clinic patients each month over the period 1968-1983 to permit examination of changes over this 15-year period in the drugs prescribed (e.g., heroin, methadone), the form (e.g., injectable or oral), the daily doses, and the extent of multiple items for single patients (e.g., both injectable ampule and oral forms). For each month, a list was available of all current patients detailing which drug(s) they had received during that month, in what form(s) and what dose(s). These items were the basic units of study. We report changes over the 15-year period for which the data were available. For the first 5 years, more than half of the prescriptions were for heroin (diamorphine hydrochloride), with the remainder of the prescriptions mostly comprising oral methadone. After 1973, methadone ampules for injection were increasingly commonly prescribed and thereafter remained at about a quarter of the prescriptions for the remaining 10 years for which data are available, whereas heroin prescriptions declined over the mid-1970s to only 20%. From 1973 onward, oral methadone was increasingly prescribed, rising from approximately one third of prescriptions in the early 1970s to more than two thirds by the early 1980s. Individual patients often received more than one drug or form of drug: From 1969 onward, oral methadone was commonly prescribed as a supplement to heroin prescriptions. This same practice was widespread with prescriptions for methadone ampules prescribed as a supplement to heroin prescriptions. Daily doses of heroin were at a mean of from 160 to 540 mg, in contrast with
... Availability. SUMMARY: The Food and Drug Administration (FDA) is announcing the selection of disease areas to... selection criteria, which were published in the September 24, 2012, Federal Register notice: Disease areas... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0967...
... disease areas to consider. FDA also welcomes public comment on the criteria for disease area selection... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0967...: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. SUMMARY: The...
... children under 6 years of age, except as directed by a physician, and against driving a car or operating... other drugs, in an aqueous vehicle suitable for administration in self-medication as nose drops, and..., and against driving a car or operating machinery while using the drug, since it may cause drowsiness...
... comply with an FDA over-the-counter (OTC) drug final monograph, before marketing. DATES: This notice is... the drug products covered by this notice contain active ingredients that were introduced into the... the firm marketing the product has received approval for additional indication(s). In the early 1970s...
In this study, we examined the impact of the Pharma Economic Act, which was introduced in Hungary in 2007. We used detailed data on the Hungarian prescription drug market, which had been made publicly available by the authorities. We evaluated the effect of the Pharma Economic Act on both dynamic and static efficiencies and also on equity, which has been historically a controversial issue in Hungary. We analyzed the overall prescription drug market and statin and atorvastatin markets; as a proxy for determining dynamic efficiency, we examined the oncology drug market for some specific products (e.g., bortezomib) and the long-acting atypical antipsychotic drugs market. There is no denying that the authorities managed to control the overall prescription drug costs; however, they were still paying excessive rents for off-patent drugs. Examples of oncology and long-acting atypical antipsychotic drugs showed that the diffusion of innovation was on per-capita basis at least comparable to G-5 countries. While the share of out-of-pocket co-payments markedly increased and the reimbursement was lowered, the concurrent price decreases often meant that the co-payment per milligram of a given dispensed drug was actually lower than that before the Act, thereby benefiting the patient. It appears that strong mechanisms to control volume rather than price on the supply side (marketing authorization holders) contained the drug expenditure, while offering enough room to strive for innovation. Making data on prescription drug expenditures and associated co-payments publicly available is an item that should be definitely followed by the surrounding jurisdictions. Copyright © 2013, International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc.
Bhutada, Nilesh S; Rollins, Brent L; Perri, Matthew
A randomized, posttest-only online survey study of adult U.S. consumers determined the advertising effectiveness (attitude toward ad, brand, company, spokes-characters, attention paid to the ad, drug inquiry intention, and perceived product risk) of animated spokes-characters in print direct-to-consumer (DTC) advertising of prescription drugs and the moderating effects of consumers' involvement. Consumers' responses (n = 490) were recorded for animated versus nonanimated (human) spokes-characters in a fictitious DTC ad. Guided by the elaboration likelihood model, data were analyzed using a 2 (spokes-character type: animated/human) × 2 (involvement: high/low) factorial multivariate analysis of covariance (MANCOVA). The MANCOVA indicated significant main effects of spokes-character type and involvement on the dependent variables after controlling for covariate effects. Of the several ad effectiveness variables, consumers only differed on their attitude toward the spokes-characters between the two spokes-character types (specifically, more favorable attitudes toward the human spokes-character). Apart from perceived product risk, high-involvement consumers reacted more favorably to the remaining ad effectiveness variables compared to the low-involvement consumers, and exhibited significantly stronger drug inquiry intentions during their next doctor visit. Further, the moderating effect of consumers' involvement was not observed (nonsignificant interaction effect between spokes-character type and involvement).
The purpose of this poster is to present the application and assessment of advanced technologies in a real-world environment - wastewater effluent and source waters - for detecting six drugs (azithromycin, fluoxetine, omeprazole, levothyroxine, methamphetamine, and methylenedioxy...
... Fee Act. The document was published with four errors. This document corrects those errors. FOR FURTHER INFORMATION CONTACT: David Miller, Office of Financial Management (HFA-100), Food and Drug Administration...
Atherly, Adam; Rubin, Paul H
In this paper we use published information to analyze the economic value of Direct to Consumer Advertising (DTCA). The reviewed research finds that DTCA leads to increased demand for the advertised drug and that the effect of the drug tends to be class-wide rather than product specific. There is weak evidence that DTCA may increase compliance and improve clinical outcomes. However, there is little research on the effect of DTCA on inappropriate prescribing or on the characteristics of patients who respond to treatment. On net, if the advertised drugs are cost effective on average and the patients using the drugs in response to the advertisement are similar to other users, DTCA is likely cost effective. Overall, the literature to date is consistent with the idea that DTCA is beneficial, but further research is needed before definitive conclusions can be drawn.
Mintzes, Barbara; Barer, Morris; Lexchin, Joel; Bassett, Ken L
Canada is strongly influenced by US cross-border direct-to-consumer advertising (DTCA) and has held consultations to discuss introduction of DTCA since 1996. This article describes a survey of Canadian drug policy experts carried out in 2001, during one such legislative review. The survey results are compared to more recent DTCA policy developments. We recruited key informants on pharmaceutical policy to complete a faxed questionnaire that queried their opinions on DTCA information quality, effects on drug and health care use, and regulatory issues. Respondents were asked about the evidence they had used to back their opinions. Analysis was descriptive. Of 79 identified potential participants, 60 (76%) participated, 40% of whom were from federal and provincial government; 3% were private insurers; 18%, 15%, and 8% were from health professional groups, consumer groups, and patient groups, respectively; 8% and 7% were from pharmaceutical and advertising industries, respectively. Opinions were highly polarized on the effects of DTCA on drug and health care use. Advertising and pharmaceutical industry respondents were generally positive, public sector, health professional and consumer groups generally negative. Over 80% believed DTCA leads to higher private and public drug costs and more frequent physician visits. Fewer judged billboards or television to be appropriate media for DTCA than magazines or the Internet, and most believed that children and adolescents should not be targeted. Given the polarization observed within this survey, we examined how DTCA policy has evolved in Canada since 2001. The federal government has legislative authority over DTCA, but bears few of the additional costs potentially incurred through policy change. These fall to the provinces, which provide an eroding patchwork of public coverage for prescription drugs in the face of rapidly increasing costs. No new federal legislation has been tabled since 2001. However, considerable shifts in
O'Donoghue, Amie C; Williams, Pamela A; Sullivan, Helen W; Boudewyns, Vanessa; Squire, Claudia; Willoughby, Jessica Fitts
Although pharmaceutical companies cannot make comparative claims in direct-to-consumer (DTC) ads for prescription drugs without substantial evidence, the U.S. Food and Drug Administration permits some comparisons based on labeled attributes of the drug, such as dosing. Researchers have examined comparative advertising for packaged goods; however, scant research has examined comparative DTC advertising. We conducted two studies to determine if comparative claims in DTC ads influence consumers' perceptions and recall of drug information. In Experiment 1, participants with osteoarthritis (n=1934) viewed a fictitious print or video DTC ad that had no comparative claim or made an efficacy comparison to a named or unnamed competitor. Participants who viewed print (but not video) ads with named competitors had greater efficacy and lower risk perceptions than participants who viewed unnamed competitor and noncomparative ads. In Experiment 2, participants with high cholesterol or high body mass index (n=5317) viewed a fictitious print or video DTC ad that had no comparative claim or made a comparison to a named or unnamed competitor. We varied the type of comparison (of indication, dosing, or mechanism of action) and whether the comparison was accompanied by a visual depiction. Participants who viewed print and video ads with named competitors had greater efficacy perceptions than participants who viewed unnamed competitor and noncomparative ads. Unlike Experiment 1, named competitors in print ads resulted in higher risk perceptions than unnamed competitors. In video ads, participants who saw an indication comparison had greater benefit recall than participants who saw dosing or mechanism of action comparisons. In addition, visual depictions of the comparison decreased risk recall for video ads. Overall, the results suggest that comparative claims in DTC ads could mislead consumers about a drug's efficacy and risk; therefore, caution should be used when presenting
Shaparin, Naum; Mehta, Neel; Kunkel, Frank; Stripp, Richard; Borg, Damon; Kolb, Elizabeth
Interpretation limitations of urine drug testing and the invasiveness of blood toxicology have motivated the desire for the development of simpler methods to assess biologically active drug levels on an individualized patient basis. Oral fluid is a matrix well-suited for the challenge because collections are based on simple noninvasive procedures and drug concentrations better correlate to blood drug levels as oral fluid is a filtrate of the blood. Well-established pharmacokinetic models were utilized to generate oral fluid steady state concentration ranges to assess the interpretive value of the alternative matrix to monitor steady state plasma oxycodone levels. Paired oral fluid and plasma samples were collected from patients chronically prescribed oxycodone and quantitatively analyzed by liquid chromatography tandem mass spectrometry. Steady state plasma concentration ranges were calculated for each donor and converted to an equivalent range in oral fluid. Measured plasma and oral fluid oxycodone concentrations were compared with respective matrix-matched steady state ranges, using each plasma steady state classification as the control. A high degree of correlation was observed between matrices when classifying donors according to expected steady state oxycodone concentration. Agreement between plasma and oral fluid steady state classifications was observed in 75.6% of paired samples. This study supports novel application of basic pharmacokinetic knowledge to the pain management industry, simplifying and improving individualized drug monitoring and risk assessment through the use of oral fluid drug testing. Many benefits of established therapeutic drug monitoring in plasma can be realized in oral fluid for patients chronically prescribed oxycodone at steady state. © 2017 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: email@example.com
Beyer, Andrea R; Fasolo, Barbara; Phillips, Lawrence D; de Graeff, Pieter A; Hillege, Hans L
Experts are perceived to be veridical and to focus only on objective data when evaluating risk. Only a few research studies have attempted to characterize the subjectivity in risk evaluation among experts. The hypothesis of this study is that expert evaluation of a pharmaceutical drug can be partly explained by dimensions that describe the drug and by individual characteristics. Seventy-five medical assessors in 9 EU countries evaluated a list of 28 pharmaceutical drugs using 4 scales: risk, benefit, seriousness of harm, and patients' knowledge of the risk. They were also given a mock "clinical dossier" and asked to rate it on 8 dimensions: risk, benefit, worry, magnitude of the exposure, scientific knowledge of the risk, familiarity of the risk, ethical concerns, and risk acceptability. Female assessors perceived significantly higher benefits than men for a large number of the 28 drugs. Principal component analysis of the ratings for the clinical dossiers revealed 2 underlying components: seriousness of harm and scientific evidence. A regression model predicting the risk perception of the drug showed that the variables seriousness of harm (benefit, worry, magnitude of exposure, ethical concerns, and risk acceptability), years of regulatory experience, gender, and type of drug explained 54% of the variability among assessors. Assessors' view of the risks associated with pharmaceutical drugs is influenced by worry for patient safety, magnitude of patient exposure, and ethical concerns. These dimensions may influence their perceptions of benefit and risk acceptability. Senior assessors are more risk averse than junior assessors, and female assessors seem to be sensitive to the promise of benefit from medicines and consequently may be less risk averse than male assessors.
Development of a Web-Based Clinical Decision Support System for Drug Prescription: Non-Interventional Naturalistic Description of the Antipsychotic Prescription Patterns in 4345 Outpatients and Future Applications.
Berrouiguet, Sofian; Barrigón, Maria Luisa; Brandt, Sara A; Ovejero-García, Santiago; Álvarez-García, Raquel; Carballo, Juan Jose; Lenca, Philippe; Courtet, Philippe; Baca-García, Enrique
The emergence of electronic prescribing devices with clinical decision support systems (CDSS) is able to significantly improve management pharmacological treatments. We developed a web application available on smartphones in order to help clinicians monitor prescription and further propose CDSS. A web application (www.MEmind.net) was developed to assess patients and collect data regarding gender, age, diagnosis and treatment. We analyzed antipsychotic prescriptions in 4345 patients attended in five Psychiatric Community Mental Health Centers from June 2014 to October 2014. The web-application reported average daily dose prescribed for antipsychotics, prescribed daily dose (PDD), and the PDD to defined daily dose (DDD) ratio. The MEmind web-application reported that antipsychotics were used in 1116 patients out of the total sample, mostly in 486 (44%) patients with schizophrenia related disorders but also in other diagnoses. Second generation antipsychotics (quetiapine, aripiprazole and long-acting paliperidone) were preferably employed. Low doses were more frequently used than high doses. Long acting paliperidone and ziprasidone however, were the only two antipsychotics used at excessive dosing. Antipsychotic polypharmacy was used in 287 (26%) patients with classic depot drugs, clotiapine, amisulpride and clozapine. In this study we describe the first step of the development of a web application that is able to make polypharmacy, high dose usage and off label usage of antipsychotics visible to clinicians. Current development of the MEmind web application may help to improve prescription security via momentary feedback of prescription and clinical decision support system.
Frosch, Dominick L; May, Suepattra G; Tietbohl, Caroline; Pagán, José A
Direct-to-consumer advertising (DTCA) of prescription drugs is the most common form of health communication Americans are exposed to. The effects of DTCA on prescription requests and utilization are well established, but little is known about the effects of advertisements on health behaviors. Many advertisements, especially those promoting drugs to prevent or treat cardiovascular disease, refer to lifestyle change as a way to improve health. However, no studies have examined how consumers interpret these frequently ambiguous messages. We used in-depth interviews with 45 participants, recruited in Los Angeles, USA between April 2007 and July 2008, to explore perceptions of 5 advertisements for drugs that prevent or treat cardiovascular disease (Lipitor(®), Vytorin(®), Zetia(®), Caduet(®), Plavix(®)). We found that participants interpreted advertising messages within their own life context and identified four trajectories for enacting behavior change versus taking prescription drugs: Negotiators, Avoiders, Embracers and Jumpstarters. Underlying these four typologies were beliefs about whether lifestyle change was something an individual could do or was willing to do. Our results also show how an advertisement narrative could potentially shift perceptions of causality by suggesting that high cholesterol is primarily hereditary, thereby obviating the need for lifestyle change. Some participants stated that they would prefer lifestyle change to a particular prescription drug, but felt that others would be more likely to embrace taking a prescription drug. This "Third Person Effect" may be masking participants' intentions by identifying a more socially desirable route to therapeutic change. These findings raise questions about how the typologies are distributed in the population and how advertising may shift consumers' beliefs over time, thereby contributing to new forms of medicalization. Effective regulation of DTCA may require expanding scrutiny beyond the
Saha, Lekha; Kaur, Sharonjeet; Khosla, Pratibha; Kumari, Sweta; Rani, Alka
The cost of antibiotic therapy for the treatment of pneumonia in the inpatient paediatric population can have a major impact on the healthcare expenditure. We planned to assess the direct and indirect costs of diagnosis and medical treatment of paediatric patients with community acquired pneumonia who are hospitalized in a tertiary care hospital in India. 125 children with a diagnosis of pneumonia who were admitted to the inpatient department of a paediatric hospital receiving antibiotic treatment were observed. Data on clinical presentation and resources consumed were collected and the costs of pneumonia treatment were calculated. Descriptive statistics (mean ± standard deviation (SD)) were used to evaluate data regarding demographics, drugs prescribed and cost (direct and indirect cost). Multivariate regression analysis was used to find out predictors of direct and indirect cost. Among all pneumonia admissions, mild-to-moderate pneumonia constitutes 76.8%, and 23.2% children were admitted with severe pneumonia; 105 children out of 125 (84%) were suffering from associated disorders along with pneumonia. The majority of antibiotics prescribed belonged to beta lactams (52%) followed by aminoglycosides (19%), macrolides (13%) and peptides (11%). Parenteral routes of administration were used in a majority of patients as compared to oral. The average cost per patient in management of pneumonia was 12245 ± 593 INR ($187.34 ± 9.07).
Full Text Available Aims and objectives: The cost of antibiotic therapy for the treatment of pneumonia in the inpatient paediatric population can have a major impact on the healthcare expenditure. We planned to assess the direct and indirect costs of diagnosis and medical treatment of paediatric patients with community acquired pneumonia who are hospitalized in a tertiary care hospital in India. Methods: 125 children with a diagnosis of pneumonia who were admitted to the inpatient department of a paediatric hospital receiving antibiotic treatment were observed. Data on clinical presentation and resources consumed were collected and the costs of pneumonia treatment were calculated. Descriptive statistics (mean ± standard deviation (SD were used to evaluate data regarding demographics, drugs prescribed and cost (direct and indirect cost. Multivariate regression analysis was used to find out predictors of direct and indirect cost. Results: Among all pneumonia admissions, mild-to-moderate pneumonia constitutes 76.8%, and 23.2% children were admitted with severe pneumonia; 105 children out of 125 (84% were suffering from associated disorders along with pneumonia. The majority of antibiotics prescribed belonged to beta lactams (52% followed by aminoglycosides (19%, macrolides (13% and peptides (11%. Parenteral routes of administration were used in a majority of patients as compared to oral. The average cost per patient in management of pneumonia was 12245 ± 593 INR ($187.34 ± 9.07.
van der Velde, R Y; Wyers, C E; Teesselink, E; Geusens, P P M M; van den Bergh, J P W; de Vries, F; Cooper, C; Harvey, N C; van Staa, T P
INTRODUCTION: Given the expected increase in the number of patients with osteoporosis and fragility fractures it is important to have concise information on trends in prescription rates of anti-osteoporosis drugs (AOD). METHODS: We undertook a retrospective observational study using the UK Clinical
Zosel, Amy; Bartelson, Becki Bucher; Bailey, Elise; Lowenstein, Steven; Dart, Rick
Objective: To describe the characteristics and health effects of adolescent (age 13-19 years) prescription drug abuse and misuse using the Researched Abuse Diversion and Addiction-Related Surveillance (RADARS[R])) System. Method: Secondary analysis of data collected from RADARS System participating poison centers was performed. Data for all…
McCauley, Jenna L.; Danielson, Carla Kmett; Amstadter, Ananda B.; Ruggiero, Kenneth J.; Resnick, Heidi S.; Hanson, Rochelle F.; Smith, Daniel W.; Saunders, Benjamin E.; Kilpatrick, Dean G.
Background: Building on previous research with adolescents that examined demographic variables and other forms of substance abuse in relation to non-medical use of prescription drugs (NMUPD), the current study examined potentially traumatic events, depression, posttraumatic stress disorder (PTSD), other substance use, and delinquent behavior as…
... diverted to the clandestine manufacture of a controlled substance. Most of the ephedrine, pseudoephedrine... for-profit. Other: Not-for-profit, government agencies. Abstract: The Domestic Chemical Diversion... may be diverted in the United States for the production of illicit drugs must register with DEA...
... fees. CMS may impose user fees on Part D plans for the transmittal of information necessary for benefit...) Provides supplemental drug coverage to individuals based on financial need, age, or medical condition, and... effective exchange of information and coordination between such plan and SPAPs and entities providing other...