Michael Montagne

MASS MEDIA REPRESENTATIONS AS DRUG INFORMATION FOR PATIENTS: THE PROZAC PHENOMENON

Results of a 20-year study of mass media representations of antidepressant medications and their use are presented. The recent Prozac phenomenon stands out as a primary example of media-generated drug information for patients. Various forms of mass media are important in providing perceptions of the effects, benefits, and safety of these new antidepressant drugs. Clinical research, however, suggests that the latest generation of antidepressant medications is no more effective in treating depressive symptoms than the first generation, tricyclic antidepressants. Yet, these new antidepressants have become the model drug not only for treating depression, but also for cosmetic psychopharmacology. [Translations are provided in the International Abstracts Section of this issue.]

Pharmaceutical pictograms: a model for development and testing for comprehension and utility.

BACKGROUND With concerns about the medication literacy skills of patients comes the need to develop various types of information materials that will enhance understanding and drug use. OBJECTIVES To review pictogram development projects and to propose a model for pharmaceutical pictogram development and testing for comprehension and use. METHODS Previous efforts in developing specific types of pictograms in engineering and safety as well as in health care and pharmacy are collected and summarized in terms of level of comprehension and recall. The impact of pictogram-enhanced medication information materials on knowledge acquisition, information retention, and adherence is assessed. RESULTS AND CONCLUSIONS Pictograms are a key component in re-designing medication information to improve comprehension, recall, and adherence. Many types of pictograms still produce low levels of comprehension and the impact of pictograms on medication knowledge is inconsistent. Prior training through patient counseling on the intended meaning and use of pictograms greatly increases their effectiveness. A model for the development and testing of pictograms and pictogram sequences for comprehension and use in medication information is presented and discussed.

APPRECIATING THE USER'S PERSPECTIVE: LISTENING TO THE ''METHADONIANS''

Researchers have long neglected the users perspective and experiences in assessing drug effects and drug use. With increased interest in Canada directed at prescribing heroin in place of methadone, researchers took the relatively unique approach of gathering data and information from methadone users to determine their views and experiences with methadone programs and alternative treatment choices. The results of that research portrayed very interesting and useful notions of users regarding methadone maintenance and the prescribing of heroin.

Drugs on the Internet. I: Introduction and Web Sites on Psychedelic Drugs

The Internet has greatly expanded access to information about all types of drugs. Web sites devoted to psychedelic drugs are proliferating. These sites vary considerably in terms of the quality and objectivity of information, financial support (non-profit vs. commercial), ideological stance, and the identification of creators and maintainers. Representative sites are reviewed and assessed on criteria of credibility and quality.

Prevention of Substance Use Problems: Models, Factors, and Processes

The use of substances for medical or nonmedical reasons occurs in most cultures. Regardless of the reason for use, however, most types of substance use (or drug-taking behaviors) have their associated problem states. The prevention of substance use problems is an important issue and need in every society. In this review we present and discuss various models and factors that purport to describe and predict patterns of drug use, and we discuss various strategies to prevent the occurrence of substance use problems.

The prevalence of pharmaceutical shortages in the United States

Shortages of drugs, vaccines, and other biologics are a perennial problem of the U.S. health care system. The objectives of this study were to assess the prevalence of these shortages of drugs, vaccines, and other biologics, and to characterize the products in short supply as reported in the United States by several public agencies and private organizations on June 1, 2011. Reported shortages of pharmaceuticals were obtained from the FDA, the CDC, the American Society of Health-System Pharmacists (ASHP), and the Brigham and Women’s Hospital (BWH). A list of approved drugs and licensed vaccines and other biologic products were obtained from the FDA. The units of analyses were the active ingredient(s) and the route of administration. The study included descriptive analyses of the characteristics of products experiencing shortages and an estimation of the prevalence of shortages as the proportion of non-discontinued FDA-approved products that were listed by the FDA in June 1, 2011. The most frequent characteristics of shortages included: reported by ASHP, referred to a drug approved under the NDA/ANDA system, contained only one active ingredient, was a drug administered by injection, required a prescription, was part of one of six main therapeutic classes, and was marketed by three or less companies. The overall prevalence of drug shortages was estimated at 11.0% of all the FDA-approved and marketed drugs, vaccines, and other biologics. Vaccines had the highest prevalence of shortage. The prevalence varied from 9.9% reported by the ASHP to 4.0% reported by public agencies and to 2.0% reported by BWH. Differences in the reporting of shortages can be attributed to variations in defining shortages and how they were characterized within each reporting organization. The highest prevalence rate was found among active ingredients with injection routes of administration (23.1%). Shortages are prevalent in the U.S. health care system. Several definitions of shortage are currently in use in the United States. Additional research is needed to develop a standard definition for a pharmaceutical shortage and to standardize the criteria used to characterize a pharmaceutical shortage.

Drugs and the Media: An Introduction

Mass media accounts of drugs and drug use are a daily occurrence and the focus of much inquiry and debate. In this special issue, nine articles consider the role and impact of a specific type of mass medium in the depiction of drugs, drug use, and drug users. Media include television programs, newspapers, films, public service advertising and product-specific marketing campaigns, and the world of the Internet, including YouTube and message boards. Media accounts of alcohol, tobacco, marijuana, and prescription drugs such as antidepressants, and more broadly, drug abuse and addictions are examined through a variety of methods from the humanities and social sciences.

Drugs on the Internet, Part IV: Google's Ngram Viewer Analytic Tool Applied to Drug Literature

Google Inc.s digitized book library can be searched based on key words and phrases over a five-century time frame. Application of the Ngram Viewer to drug literature was assessed for its utility as a research tool. The results appear promising as a method for noting changes in the popularity of specific drugs over time, historical epidemiology of drug use and misuse, and adoption and regulation of drug technologies.

Drugs on the internet, part III: tobacco and smoking on the web.

This study examines the types of tobacco- and smoking-related websites that are available on the Internet. The search terms used were nicotine, tobacco, and cigarette. These terms were searched in the engines Google and Yahoo as well as video-sharing website YouTube and analyzed based on the search engine results pages (SERPs) that were produced. The results returned the following categories of websites: health information and news, smoking cessation, product ads/sales, history of tobacco and smoking, prosmoking/pleasure, smoking prevention/control, and miscellaneous. Results showed fluctuations in the number of search engine results by search term and date. There also was variable quality and availability of informative resources for Internet users due to lack of quality control criteria and regulation.

Changes in FDA enforcement activities following changes in federal administration: the case of regulatory letters released to pharmaceutical companies

BackgroundThe United States (US) Food and Drug Administration (FDA) is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA) and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and notice of violation) to pharmaceutical companies. A regulatory letter represents the FDA’s first official notification to a pharmaceutical company that the FDA has discovered a product or activity in violation of the FDCA.This study analyzed trends in the pharmaceutical-related regulatory letters released by the FDA during the period 1997–2011 and assessed differences in the average number and type of regulatory letters released during the last four federal administrations.MethodsData derived from the FDA webpage. Information about the FDA office releasing the letter, date, company, and drug-related violation was collected. Regulatory letters were classified by federal administration. Descriptive statistics were performed for the analysis.ResultsBetween 1997 and 2011 the FDA released 2,467 regulatory letters related to pharmaceuticals. FDA headquarters offices released 50.6% and district offices 49.4% of the regulatory letters. The Office of Prescription Drug Promotion released the largest number of regulatory letters (850; 34.5% of the total), followed by the Office of Scientific Investigations (131; 5.3%), and the Office of Compliance (105; 4.3%). During the 2nd Clinton Administration (1997–2000) the average number of regulatory letters per year was 242.8 ± 45.6, during the Bush Administration (2001–2008) it was 120.4 ± 33.7, and during the first three years of the Obama administration (2009–2011) it was 177.7.0 ± 17.0. The average number of regulatory letters released by the Office of Prescription Drug Promotion also varied by administration: Clinton (122.3 ± 36.4), Bush (29.5 ± 16.2) and Obama (41.7 ± 11.1).ConclusionsMost regulatory letters released by FDA headquarters were related to marketing and advertising activities of pharmaceutical companies. The number of regulatory letters was highest during the second Clinton administration, diminished during the Bush administrations, and increased again during the Obama administration. A further assessment of the impact of changes in federal administration on the enforcement activities of the FDA is required.