Liang BA.*, Mackey TK. Promoting online drug safety: Using Public–Private Partnerships to Deter Illicit Online Drug Sales. J Commer Biotechnol. (2011) 17, 266–271

Illicit online pharmacies selling counterfeit drugs in a global virtual marketplace remain a critical problem in global health. Yet they continue to operate with little regulation while growing numbers of consumers access the Internet for health information that may lead them to purchase dangerous drugs online. This global social problem requires immediate action to protect…

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Liang B A*, Mackey T. Direct-to-Consumer Advertising With Interactive Internet Media. JAMA. 2011 2 23; 305 (8): 824-825.

Direct-to-consumer advertising (DTCA) is legal only in the United States and New Zealand and has been linked with drug overutilization, public health concerns, and higher costs. 1 Despite global proscriptions, DTCA is the most rapidly increasing form of pharmaceutical marketing, with approximately $4 billion in US expenditures, outpacing physician marketing and research and development. Liang…

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Liang BA.*, Mackey T. Searching for Safety: Addressing Search Engine, Website, and Provider Accountability for Illicit Online Drug Sales. Am J Law Med. 2009;35:125-184.

Abstract.
Online sales of pharmaceuticals are a rapidly growing phenomenon. Yet despite the dangers of purchasing drugs over the Internet, sales continue to escalate. These dangers include patient harm from fake or tainted drugs, lack of clinical oversight, and financial loss. Patients, and in particular vulnerable groups such as seniors and minorities, purchase drugs online either naïvely or because they lack the ability to access medications from other sources due to price considerations. Unfortunately, high risk online drug sources dominate the Internet, and virtually no accountability exists to ensure safety of purchased products.

Importantly, search engines such as Google, Yahoo, and MSN, although purportedly requiring “verification” of Internet drug sellers using PharmacyChecker.com requirements, actually allow and profit from illicit drug sales from unverified websites. These search engines are not held accountable for facilitating clearly illegal activities. Both website drug seller anonymity and unethical physicians approving or writing prescriptions without seeing the patient contribute to rampant illegal online drug sales. Efforts in this country and around the world to stem the tide of these sales have had extremely limited effectiveness. Unfortunately, current congressional proposals are fractionated and do not address the key issues of demand by vulnerable patient populations, search engine accountability, and the ease with which financial transactions can be consummated to promote illegal online sales.

To deal with the social scourge of illicit online drug sales, this article proposes a comprehensive statutory solution that creates a nocost/low-cost national Drug Access Program to break the chain of demand from vulnerable patient populations and illicit online sellers, makes all Internet drug sales illegal unless the Internet pharmacy is licensed through a national Internet pharmacy licensing program, prohibits financial transactions for illegal online drug sales, and establishes criminal penalties for all parties—including websites, search engines, and health care providers— who engage in and facilitate this harmful activity.

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Gavaza P, Shepherd MD*, Shcherbakova N, Khoza S. The state of health economics and pharmacoeconomics research in Russia: a systematic review. Journal of Pharmaceutical Health Services Research. 2010 Sept; 1(3):113-21.

Abstract.
Objectives To investigate the state of health economic research in Russia available in the English language by describing the number and characteristics of the articles, and assessing the quality of these articles.

Methods The study assessed the state of health economics and pharmacoeconomics research in Russia. We conducted a literature search to identify health economics articles pertaining to Russia. Each article in the final sample was scored by two reviewers independently using the data-collection form designed for the study.

Key findings In total, 16 studies investigating a wide variety of diseases were included in the study. These articles were published in 15 different journals all based outside of Russia between 1994 and 2009. On average, each article was written by seven authors. Most first authors had medical/clinical training and resided in the USA (n = 8) at the time of publication of the study. Based on a scale of 1–10, with 10 indicating the highest quality, the mean quality score for all studies was 8.09 (SD = 1.29) and 25% of the articles were of fair quality (score 5–7). The quality of articles was statistically significantly related (P < 0.05) to the primary health intervention (pharmaceuticals > non-pharmaceuticals) and primary training of the first author (medical > non-medical).

Conclusions The conduct of health economics and pharmacoeconomics research in Russia in the English language is limited and, on average, the published articles were of good quality. However, about one-quarter of published articles were of fair quality. More health economics research in English is warranted in Russia.

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Shepherd MD.* The effect of US pharmaceutical drug importation on the Canadian pharmaceutical supply. Can Pharm J. 2010 Sept/Oct; 143(5):226-33.

Abstract.
Background and objectives: For over a decade, many US politicians have advocated that the US allow personal and commercial drug importation. Currently, the only entities that can legally import a pharmaceutical in the US are pharmaceutical manufacturers. Our objective was to compare the number of prescriptions dispensed in Canada with the US and estimate the effect US drug importation from Canada will have on the Canadian drug supply.

Methods: A model was created to measure the potential effect on the Canadian drug supply. The model uses the number of US prescriptions being sourced from Canada and the number of prescriptions dispensed in Canada in 2007 as the baseline. The number of days to exhaust the 2007 Canadian drug supply was calculated.

Results: The model found that if 10% of the US prescriptions were fi lled from Canadian sources (manufacturer, wholesale or retail), Canada’s 2007 drug supply would be exhausted in 224 days. If the demand from the US reached 20%, the 2007 supply would be exhausted in 155 days. The model was redone focusing on brand name drugs, with generic drugs removed. It was found that with a US demand of 10% and 20%, the 2007 Canadian supply for brand name drugs would be exhausted in 268 and 201 days, respectively.

Conclusion: US drug importation is a threat to Canada’s drug supply. Even if the US demand were 10%, Canada would need to dramatically increase manufacturing, triple drug importation, or most likely control or halt pharmaceutical shipments to the US.

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Shepherd MD*, The effect of US pharmaceutical importation on the Canadian drug supply. CPJ. 2010 Sept/Oct; 143(5):226-33.

Abstract. Background and objectives: For over a decade, many US politicians have advocated that the US allow personal and commercial drug importation. Currently, the only entities that can legally import a pharmaceutical in the US are pharmaceutical manufacturers. Our objective was to compare the number of prescriptions dispensed in Canada with the US and estimate the effect US drug importation from Canada will have on the Canadian drug supply.

Methods: A model was created to measure the potential effect on the Canadian drug supply. The model uses the number of US prescriptions being sourced from Canada and the number of prescriptions dispensed in Canada in 2007 as the baseline. The number of days to exhaust the 2007 Canadian drug supply was calculated.

Results: The model found that if 10% of the US prescriptions were filled from Canadian sources (manufacturer, wholesale or retail), Canada’s 2007 drug supply would be exhausted in 224 days. If the demand from the US reached 20%, the 2007 supply would be exhausted in 155 days. The model was redone focusing on brand name drugs, with generic drugs removed. It was found that with a US demand of 10% and 20%, the 2007 Canadian supply for brand name drugs would be exhausted in 268 and 201 days, respectively.

Conclusion: US drug importation is a threat to Canada’s drug supply. Even if the US demand were 10%, Canada would need to dramatically increase manufacturing, triple drug importation, or most likely control or halt pharmaceutical shipments to the US.

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Shepherd, MD*. Black medicine. AQ. 2010 Summer; 4(3):82-5.

The exploring Internet trade in counterfeit medicine.

When you’re sick, taking the right medicine is almost as important as finding a good doctor. But what if the medicine is fake? A black market in counterfeit or low-quality drugs is fast becoming the world’s newest health hazard.

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Shepherd M.* Beef up international cooperation on counterfeits. Nat Med. 2010;16(4):366.

Counterfeit drugs are a menacing and deadly problem worldwide. The proliferation of fake drugs is astounding, with over 100 countries reporting incidents of fake drugs, according to a 2008 report from the Pharmaceutical Security Institute. And incidents of drug counterfeiting show no evidence of declining: some industry insiders suggest that the number of counterfeit medicines…

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Dai XM, An N Wu JM, Li HY, Zhang QM. Development and Validation of HPLC-UV-MS method for the control of four anti-diabetic drugs in suspected counterfeit products. Yao Xue Xue Bao. 2010 Mar; 45(3):347-52.

An HPLC-UV method has been developed for the determination of valibose, miglitol, voglibose and acarbose, the four anti-diabetic drugs. The separation was accomplished successfully by using reversed phase chromatography (Prevail carbohydrate column, 250 mm x 4.6 mm, 5 microm) with a gradient acetonitrile-phosphate buffer solution (pH 8.0) at a wavelength of 210 nm. Furthermore, the…

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