Background.When considering health-related Web sites, issues of quality generally focus on Web content. Little concern has been given to attrition of Web sites or the "fleeting" nature of health information on the World Wide Web. Since Web sites may be available for an uncertain period of time, a Web page may not be a sound reference.Objective.To address the issue of attrition, a defined set of health-related Web sites was examined at two separate time intervals.Methods.To determine the degree of attrition, Web sites obtained and recorded from a previous study were revisited approximately three years later. From December 1998 to May 1999, 184 Web sites were collected from which health claims were identified. During May and June 2002, the previously recorded URL for each Web site was entered into the address field of the browser Netscape Navigator. It was documented whether the original Web site could not be found, moved to a different URL location, or the URL and site location was found unchanged from the original search. For a Web site whose URL remained unchanged, it was also noted whether the site had maintained currency, (i.e. updated) since the original posting. To ensure that inaccessibility may not be due to temporary server problems, another attempt was made to access the sites at different periods of time.Results.When each URL address from the original set of 184 Web sites was re-entered into the address field of the browser, 108 (59%) of the sites could not be found, 31 (17%) had moved to a new URL address, and 45 (24%) of the sites could be found from the original URLs obtained in the previous study. Of the Web sites that moved to a new URL address, 7 sites provided a link from the original URL to redirect the viewer to the new location. Of the Web sites still in existence, 17 (38%) provided update information from the original posting.Conclusions.It can be difficult to locate information that was previously found on the Web, and if a reference to an item is provided, there is no guarantee that viewers will be able to find the site at a later time. Enhancements in Web technologies such as the Internet Archive may improve this situation. Future research that is directed toward making sure Web site viewers know the site will be accessible at a later time will enhance the Web as a valuable medical information resource.

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Objectives To explore the issues involving generic versus brand antimicrobial drug products and provide an overview of assessments of equivalence and their potential relevance to health outcomes. Methods In April and May 2010, literature searches were performed in MEDLINE and EMBASE for studies involving antimicrobial drug products that convey equivalence or non-equivalence of generic and brand-name drugs. Key findings Sixty-six studies involving antibiotics, antifungals, antivirals and antimalarials were identified for analysis. The types of studies were categorized into microbial assays, pharmaceutical assays, bioequivalence and those that assess clinical endpoints. Studies varied markedly on equivalence measures between generic and brand drug products. Thirty-four of 66 (52%) were primarily bioequivalency studies with 30 of 34 (88%) demonstrating positive outcomes for equivalency. Two of 22 studies (9%) involved microbial and/or pharmaceutical assays for quality assurance testing and presented the largest disparity in equivalence. Ten studies compared outcomes of a clinical nature and concluded no significant difference in outcome between generic and brand products. Ten of 66 (15%) studies were published before 2000 and 11 (17%) were conducted in the USA. Conclusions In the USA, it is unlikely that use of generic antibiotics and antimicrobials pose a problem for patients with infectious diseases, where quality safeguards exist and patients are informed when generic substitution occurs. However, with expansion of international markets and questionable drug supply chains -particularly with the advent of the internet -consumers and providers should be aware of drug product quality differences that may impact patient outcomes.

Results of this study suggest comparable quality assurance manufacturing standards for the US innovator product and the Canadian generic drug products tested. These findings have clinical, legal, and economic implications that should be addressed by policy makers to safeguard consumers who choose to purchase Canadian-manufactured drugs via the Internet.

BackgroundFor patients, the prescription container label may be the only source of instructions on how to take their medicines. In the United States, the legal requirements for a prescription label are set by federal law and state statutes. The container should be comparable to that which manufacturers use to package drug products and should preserve a product’s identity, strength, quality, and purity and prevent contamination. Safety features such as a child-resistant closure should be provided. Pharmaceutical products purchased from international online pharmacies are not approved by the Food and Drug Administration (FDA) and may not meet US guidelines for labeling and packaging.ObjectiveThe study objective was to determine whether commonly purchased pharmaceutical products obtained from international online pharmacies are comparable to products dispensed in the United States with regard to labeling and packaging.MethodsDuring March 2006 through January 2007, 41 pharmaceutical oral dosage form samples were obtained from international Internet pharmacy websites for evaluation: 18 generic simvastatin samples, 18 generic amlodipine samples, and 5 generic sildenafil samples. Contents for each package were observed and recorded and comparison of the prescription labeling and packaging of these products was made with prescription labeling and packaging requirements in the United States.ResultsOf the 41 drug products obtained from online pharmacies from 12 different countries, only 1 product (from Canada) would meet both labeling and packaging guidelines for products dispensed in the United States. Of those not meeting the requirements, 7 were dispensed in paper envelopes with label affixed that was either handwritten or typed and contained missing information such as name and address of dispenser, name of prescriber, name of patient, and directions for use. Another 3 products did not have a label affixed to the drug product, but information was printed on a paper document enclosed in the shipping package, while 28 products did not have labels affixed to the drug product. In all, 39 of the 41 drug products’ packaging would not meet the US guidelines. Aside from the Canadian product, only 1 product from Mexico was dispensed in a container that would meet guidelines established in the United States. In total, 35 products were not dispensed in plastic vials but were dispensed in unit dose packages, paper envelopes with loose dosage forms, blister packs of drugs held together with rubber bands, or a combination of these packaging forms.ConclusionsResults suggest that labeling and packaging standards for international generic drug products are not equivalent to labeling and packaging standards in the United States. This suggests dissimilar and substandard distribution processes compared with those in the United States, which in turn presents a challenge to patient comprehension and health literacy and may affect patient adherence to drug treatment regimens. These findings have strong implications for drug product quality, ...

BackgroundThe U.S. Food and Drug Administration Adverse Event Reporting System (FAERS), contains information on adverse drug events and medication error reports submitted to the FDA through the MedWatch program. A significant number of adverse events reported in the FAERS database have been for opioid use. The objective of this study was to determine the frequency counts and associated deaths of opioid drug names in the FAERS database.MethodsDrug data were obtained from the DRUG and OUTCOME files in the database. Drugs identified included: morphine, fentanyl, oxycodone, hydrocodone, tramadol, hydromorphone, methadone, codeine, oxymorphone, meperidine, propoxyphene, diphenoxylate, and heroin. Frequency counts and concomitant deaths of opioid drug names were determined via the MySQL database management system.ResultsFifteen different opioid drugs identified in the FAERS database were associated with ADEs, including death, and 3 drugs (oxycodone, hydrocodone, fentanyl) accounted for more than half of the reports. The highest frequency count value was 158,181 for oxycodone, which represents approximately 20.2% of the frequency counts for the opioids. The lowest frequency count value was 2,161 for dextromethorphan, which represents approximately 0.3% of the total. The opioid with the highest proportion of deaths to drug count was heroin (71.8%), followed by dextromethorphan (55.6%), methadone (37.2%), morphine (26.8%), and propoxyphene (23.7%).ConclusionThe FAERS database represents an important source for detection and reporting of adverse drug events (ADEs), in particular the opioids and related drugs. It remains a challenge to estimate the true incidence of ADEs for this class of drugs in the general population.

Interactive pharmacy case studies are an essential component of the pharmacy curriculum. We recently developed an elective course at the Rangel College of Pharmacy in pharmacy case studies for second- and third-year Doctor of Pharmacy students using Second Life® (SL), an interactive three-dimensional virtual environment that simulates the real world. This course explored the use of SL for education and training in pharmacy, emphasizing a case-based approach. Virtual worlds such as SL promote inquiry-based learning and conceptual understanding, and can potentially develop problem-solving skills in pharmacy students. Students were presented ten case scenarios that primarily focused on drug safety and effective communication with patients. Avatars, representing instructors and students, reviewed case scenarios during sessions in a virtual classroom. Individually and in teams, students participated in active-learning activities modeling both the pharmacist’s and patient’s roles. Student performance and learning were assessed based on SL class participation, activities, assignments, and two formal, essay-type online exams in Blackboard 9. Student course-evaluation results indicated favorable perceptions of content and delivery. Student comments included an enhanced appreciation of practical issues in pharmacy practice, flexibility of attendance, and an increased ability to focus on course content. Excellent student participation and performance in weekly active-learning activities translated into positive performance on subsequent formal assessments. Students were actively engaged and exposed to topics pertinent to pharmacy practice that were not covered in the required pharmacy curriculum. The multiple active-learning assignments were successful in increasing students’ knowledge, and provided additional practice in building the communication skills beneficial for students preparing for experiential clinical rotations.

Purpose. The World Wide Web has become a significant source of health information for the public, but there is concern that much of the information is inaccurate, misleading, and unsupported by scientific evidence. To explore this issue, the validity of health claims for the herb Opuntia on the World Wide Web was analyzed. Data Sources. From December 1998 to May 1999, health claims were identified from Web sites utilizing nine search engines. A corresponding search was conducted of the scientific literature. Search terms included common and botanical names for Opuntia. Inclusion and Exclusion Criteria. Nutritional support guidelines for herbs were used to identify claims from relevant sites. Scientific studies included established methodological designs with no restrictions on source, language, type of subjects, or dosage forms for Opuntia. Data Extraction Methods. A checklist of significant information was prepared for Web sites and scientific studies. The quality of scientific studies was assessed with two instruments, the Jadad and the Journal of the American Medical Association (JAMA) scales. Data Synthesis. Validity of health claims on Web sites was compared with scientific reports. Searches retrieved 184 Web sites, 98 with health claims and 51 with research studies. Only 34% of the claims were addressed in the scientific literature, and evidence was conflicting or contradictory. For human studies, none met the criteria for high quality as determined by the Jadad and JAMA scales. Major Conclusions. The majority of health claims were based on folklore or indirect scientific evidence and could not be validated by scientific research. This suggests a need to check the validity of herbal information on the World Wide Web.