Michael A. Veronin

Comparison of Simvastatin Tablets from the US and International Markets Obtained via the Internet

Background: Convenient access to prescription drugs produced outside the US has been facilitated by the Internet. Of greatest concern to clinicians and policy-makers is product quality and patient safety. The Food and Drug Administration has issued warnings to potential buyers that the safety of drugs purchased through the Internet cannot be guaranteed and may present consumers with a health risk from substandard products. Objective: To determine whether generic simvastatin tablets and capsules obtained via the Internet from international markets are equivalent to the US innovator product regarding major aspects of pharmaceutical quality. Methods: Twenty simvastatin tablets and capsules were obtained for pharmaceutical analysis: 19 generic samples from international Internet pharmacy Web sites and the US innovator product. Tablet samples were tested according to US Pbarmacopeial (USP) guidelines where applicable, using high-performance liquid chromatography, disintegration, dissolution, weight variation, hardness, and assessment of physical characteristics. These tests are often used to detect formulation defects of drug products during the manufacturing process. Results: Several international samples analyzed were not comparable to the US product in one or more aspects of quality assurance testing, and significant variability was found among foreign-made tablets themselves. Five samples failed to meet USP standards for dissolution and 2 for content uniformity. Among all samples, variability was observed in hardness, weight, and physical characterization. Conclusions: Results suggest that manufacturing standards for the international generic drug products compared with the US innovator product are not equivalent with regard to quality attributes. These findings have implications for safety and effectiveness that should be considered by clinicians to potentially safeguard patients who choose to purchase foreign-manufactured drugs via the Internet.

Open-access publishing for pharmacy-focused journals.

PURPOSE Pharmacy-focused journals that are available in open-access (OA), freely accessible, hybrid, or traditional formats were identified. METHODS Relevant journals were accessed from PubMed, International Pharmaceutical Abstracts, EMBASE, and the Pharmacology and Pharmacy category of Thomson Scientific Journal Citation Reports. Criteria were established to select journals that satisfied the definition of pharmacy focused. Journals were assessed based on accessibility, copyright transfer requirements, and restrictions. If tracked, the journals impact factor (IF) was identified according to classification, and medians were calculated for each journal category. RESULTS A total of 317 pharmacy-focused journals were identified. The majority of pharmacy-focused journals identified were traditional/non-OA (n = 240). A smaller number of journals were freely accessible/ non-OA (n = 37), freely accessible/non-OA with content restrictions (n = 20), or freely available/non-OA with date restrictions (n = 18). The fewest number of journals were completely OA (n = 2). The median IF for the 185 journals whose IF was tracked was 2.029. The median IF for freely accessible and hybrid journals (n = 42) was 2.550, whereas the median IF for traditional journals (n = 143) was 1.900. CONCLUSION A very small number of pharmacy-focused journals adhere to the OA paradigm of access. However, journals that adopt some elements of the OA model, chiefly free accessibility, may be more likely to be cited than traditional journals. Pharmacy practitioners, educators, and researchers could benefit from the advantages that OA offers but should understand its financial disadvantages.

Packaging and labeling of pharmaceutical products obtained from the internet.

Background For 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. Objective The 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. Methods During 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. Results Of 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. Conclusions Results 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, patient outcomes, therapeutic effectiveness, and safety.

“Insight” into Drug Quality: Comparison of Simvastatin Tablets from the US and Canada Obtained via the Internet

Background: Recently, there has been much debate in the US concerning drug importation from Canadian Internet pharmacies. The Food and Drug Administration and US drug manufacturers assert that drugs obtained from international markets via the Internet present a health risk to consumers from substandard products. The publics perception is that drugs from Canada are as safe as those from the US. Objective: To determine whether simvastatin tablets obtained via the Internet from Canadian generic manufacturers are comparable in blend uniformity, a major attribute of tablet quality, with the US innovator product. Methods: Generic simvastatin tablets from 4 Canadian Internet pharmacy Web sites and the US innovator product were obtained for pharmaceutical analysis, Tablet samples were analyzed using near-infrared spectroscopic imaging techniques, which are designed to detect formulation defects of drug products during the manufacturing process. Digital images were created, revealing the tablets’ internal structures. Results: The blend uniformity of the active pharmaceutical ingredient in the tablet samples from Canada was determined and compared with that of the US innovator product. Results indicated that there is little significant difference in blend uniformity among US innovator and Canadian generic tablets. Conclusions: 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.

Pharmacy cases in Second Life: an elective course

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.

Tools to investigate how interprofessional education activities link to competencies.

Integrating interprofessional education (IPE) activities and curricular components in health professions education has been emphasized recently by the inclusion of accreditation standards across disciplines. The Interprofessional Education Collaborative (IPEC) established IPE competencies in 2009, but evaluating how activities link to competencies has not been investigated in depth. The purpose of this project is to investigate how well two IPE activities align with IPEC competencies. To evaluate how our IPE activities met IPEC competencies, we developed a checklist and an observation instrument. A brief description of each is included as well as the outcomes. We analyzed Disaster Day, a simulation exercise that includes participants from Nursing, Medicine, and Pharmacy, and Interprofessional Healthcare Ethics (IPHCE), a course that introduced medical, nursing, and pharmacy students to ethical issues using didactic sessions and case discussions. While both activities appeared to facilitate the development of IPE competencies, Disaster Day aligned more with IPEC competencies than the IPHCE course and appears to be a more comprehensive way of addressing IPEC competencies. However, offering one IPE activity or curricular element is not sufficient. Having several IPE options available, utilizing the tools we developed to map the IPE curriculum and evaluating competency coverage is recommended.

‘URL 404 File Not Found’: dealing with the transient nature of the Web

The ‘URL File Not Found’ message is all too familiar to users seeking biomedical information on the Web, and occurs when a requested Web‐site is no longer available. The complex and dynamic nature of information flow is grounded in computer server technologies and makes the Web difficult to preserve. Enhancements in Web‐technologies are helping to improve the problem of Web‐site transience. Some initiatives to manage Web‐site loss include Googles memory cache, the Internet Archive with Wayback Machine, and Web‐site recording tools such as Internet Researcher.

Attrition of Canadian Internet pharmacy websites: what are the implications?

Background The unavailability of Internet pharmacy websites may impact a consumer’s drug purchases and health care. Objective To address the issue of attrition, a defined set of Canadian Internet pharmacy websites was examined at three separate time intervals. Methods In February to March 2006, 117 distinct, fully functional “Canadian Internet pharmacy” websites were located using the advanced search options of Google and the uniform resource locator (URL) for each website was recorded. To determine website attrition, each of the 117 websites obtained and recorded from the previous study was revisited at two later periods of time within a 4-year period. Results After approximately 4 years and 5 months, only 59 (50.4%) sites were found in the original state. Thirty-four sites (29.1%) had moved to a new URL address and were not functioning as the original Internet pharmacy. For 24 sites (20.5%) the viewer was redirected to another Canadian Internet pharmacy site. Conclusion Of concern for patients if Internet pharmacy sites were suddenly inaccessible would be the disruption of continuity of care.

One step forward, two steps back: The World Wide Web as aninformation resource

The World Wide Web offers the potential for comprehensive shared access of reliable and valid health information and educational resources; hence a major step towards enriching pharmacy education. However, educators and students must now consider web site information that may change, move, expire and disappear with no record. Also, many web sites lack key indicators of quality such as the source of the material presented, authorship, or how current the information is. In a sense, these issues may be viewed as major “steps backward” toward using web-based information to enrich education. Although no comprehensive, organized strategy exists to ensure high quality and availability of web sites at all times, several initiatives exist to assist viewers in dealing with web site disappearance and evaluating the quality of information presented. Awareness of these issues is necessary for the World Wide Web to be useful as a valid information and educational resource.

Medication Access through the Internet: Legal and Safety Considerations for Pharmacists

Today, it is common for patients to order prescription drugs via their home computer through an Internet pharmacy. Because of this, pharmacists may be faced with having to evaluate a patients drug regimen that may include foreign-made imported drugs obtained through the Internet. This article addresses major issues involving drug importation via this mechanism. Topics discussed include types of Internet pharmacies, patient access to prescription drugs, self-medication, legal issues, and potential health risks. The current level of activity of Internet drug sales has reached record volume and does not appear to be subsiding; pharmacists should be aware of these emerging influences on their practice.