Research: Featured

Acri née Lybecker, Kristina M.L., State Pharmaceutical Importation Programs: An Analysis of the Cost Effectiveness (June 12, 2019). Colorado College Working Paper 2019-02 June 2019.

Abstract Recently proposed legislation in Colorado, Connecticut, Florida, Maine, Missouri, Oklahoma, Oregon, Utah, Vermont and West Virginia aims to reduce spending on pharmaceuticals by importing them from Canada. To examine the cost effectiveness of importation, this study analyzes 24 drugs from an online Canadian supplier, accounting for the cost savings, the cost of testing, the…

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Mackey, Tim K.*, and Bryan A. Liang*. “Pharmaceutical digital marketing and governance: illicit actors and challenges to global patient safety and public health.” Globalization & Health 9, no. 1 (November 2013): 1-21.

BackgroundDigital forms of direct-to-consumer pharmaceutical marketing (eDTCA) have globalized in an era of free and open information exchange. Yet, the unregulated expansion of eDTCA has resulted in unaddressed global public health threats. Specifically, illicit online pharmacies are engaged in the sale of purportedly safe, legitimate product that may in fact be counterfeit or substandard. These…

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Shepherd M*. Examination of Why Some Community Pharmacists Do Not Provide 72-Hour Emergency Prescription Drugs to Medicaid Patients When Prior Authorization Is Not Available. J Manag Care Pharm. 2013;19(7):523-33.

BACKGROUND: Existing federal law requires that a 72-hour emergency supply of a prescription drug be dispensed to Medicaid patients when prior authorization (PA) is not available and the medication is needed without delay. The pharmacist’s role is to contact prescribers and inform them that PA is needed. If the prescriber cannot be reached, the pharmacist can dispense a 72-hour emergency supply.

OBJECTIVES: To determine (a) the reasons why some community pharmacy owners/managers, staff pharmacists, and technicians are not compliant with the law; (b) how often the decision is made; and (c) estimate how often pharmacies do not dispense the 72-hour emergency supply when PA is not available.

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Mackey TK, Liang BA*. Global Reach of Direct-to-Consumer Advertising Using Social Media for Illicit Online Drug Sales. J.Med Internet Res. 2013 Sept 12; 15(5):e105.

Abstract

Background: Illicit or rogue Internet pharmacies are a recognized global public health threat that have been identified as utilizing various forms of online marketing and promotion, including social media.
Objective: To assess the accessibility of creating illicit no prescription direct-to-consumer advertising (DTCA) online pharmacy social media marketing (eDTCA2.0) and evaluate its potential global reach.

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Chambliss W. G, Carroll W. A, Kennedy D, Shepherd M*, et al. Role of the Pharmacist in Preventing Distribution of Counterfeit Medications. In: J Am Pharm Assoc. 2012;52(2):195-199.

Abstract Objective: To provide an overview of the counterfeit medication problem and recommendations of a joint American Pharmacists Association (APhA) Academy of Pharmaceutical Research and Science and APhA Academy of Pharmacy Practice and Management taskforce. Date sources: SciFinder and PubMed were searched from 1980 to March 2011 using the following keywords: counterfeit drug product, counterfeit…

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Hottinger M, Liang BA*. Deficiencies of the FDA in Evaluating Generic Formulations: Addressing Narrow Therapeutic Index Drugs. Am J Law Med. 2012. Forthcoming. Available at SSRN: http://ssrn.com/abstract=2121528.

Abstract: Generic drugs represent a significant portion of the medical arsenal in treating disease. As copies of originator drugs, these drugs have been permitted abbreviated approval under the Hatch-Waxman law. Yet with current drive toward lowering costs focusing upon generic formulation of drugs, potential safety issues have arisen. Although there is an established criterion of…

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Liang BA,* Mackey TK. Stem Cells, Dot-Com. Sci Transl Med. 2012 Sept 12; 4;151:151-9.

Abstract. Direct-to-consumer (DTC) advertising of suspect goods and services has burgeoned because of the Internet. Despite very limited approval for use, DTC stem cell–marketed “treatments” have emerged for an array of conditions, creating global public health and safety risks. However, it remains unclear whether such use of stem cells is subject to drugs or biologics…

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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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