Research: By Our Experts

Report: Counterfeit Medications Containing Deadly Fentanyl Have Been Found in 40 States

A newly-released report on counterfeit medicines is placing the spotlight on a problem that may be far worse than is commonly believed. According to the review conducted by The Partnership for Safe Medicines, counterfeit prescription drugs containing the deadly ingredient fentanyl, most often illegally imported, have been found in as many as 40 states and are tied to deaths in more than a dozen states.

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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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Nemlekar P, Shepherd M*, Lawson K, and Rush S. Web-Based Survey to Assess the Perceptions of Managed Care Organization Representatives on Use of Copay Subsidy Coupons for Prescription Drugs. J Manag Care Pharm. 2013;19(8):602-08.

ABSTRACT BACKGROUND: Promotion of prescription drug coupons and vouchers by pharmaceutical manufacturers has increased in recent years. These coupons and vouchers usually subsidize patients’ cost-sharing obligations. In other words, drug companies pay for a patient’s portion of the drug cost, and the remaining cost is paid by the patient and the patient’s health plan. This…

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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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Liang BA*, Mackey TK, Lovett KM. Illegal “No Prescription” Internet Access to Narrow Therapeutic Index Drugs. Clin Ther. 2013 Apr 15; S0149-2918(13)00167-7.

Abstract BACKGROUND: Narrow therapeutic index (NTI) drugs, because of proximity of therapeutic amounts to toxic amounts, require close professional oversight, particularly when switching formulations. However, safe use may be compromised by unsupervised switching through access to online "no prescription" Web sites. OBJECTIVE: We assessed no prescription online availability of NTI drugs, using an academically published…

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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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