Abstract

BackgroundUnprecedented drug shortages announced by the US Food and Drug Administration (FDA) have severely affected therapeutic access, patient safety, and public health. With continued shortages, patients may seek drugs online.ObjectiveTo assess the prevalence of online marketing for current FDA shortage drugs and potential patient safety risks.MethodsWe performed a descriptive study of the prevalence of online marketing for shortage drugs—that is, offers for sale of each drug, including characteristics of online drug sellers and intermediary sites marketing these drugs.ResultsOf the 72 FDA shortage-listed drugs, 68 (94%) were offered for sale online. We found 291 offers for these drugs, the vast majority (n = 207, 71.1%) by online drug sellers selling direct to consumers. Intermediary sites included data aggregators (n = 22, 8%), forum links (n = 23, 8%), and personal page data links (n = 34, 12%), as well as Flickr social media links (n = 5, 2%), all advertising drugs without a prescription. Of the 91 online drug sellers identified, 31 (34%) had more than 1 shortage drug offered for sale, representing most (n = 148, 71%) of all online drug seller sales offers. The majority of these online drug sellers (n = 21, 68%) were on the National Association of Boards of Pharmacy (NABP) Not Recommended Sites list. Finally, for shortage drugs with an online drug seller (n = 58, 85%), 53 (91%) had at least one site on the Not Recommended list and 21 (36%) had only sites on the Not Recommended list.ConclusionsFDA shortage drugs are widely marketed over the Internet. Suspect online drug sellers and intermediaries dominate these sales offers. As a critical risk management issue, patients, providers, and policymakers should be extremely cautious in procuring shortage drugs through Internet sourcing.

Highlights

  • The US Food and Drug Administration (FDA), the American Hospital Association, and the American Society of Health-System Pharmacists have announced a growing crisis of drug shortages in critical areas such as cancer therapy, urgent care, infectious disease, hypertension, orphan disease, pediatric, and other key patient and disease treatment categories [1,2,3,4,5,6]

  • FDA shortage drugs are widely marketed over the Internet

  • We examined the prevalence of online drug seller sites and intermediary sites including those sites that sell shortage drugs direct to patients, sites that act as intermediaries for the purchase of drugs and market online drug seller sites, and user-generated content via forums and social media that link to online drug sellers

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Summary

Introduction

The US Food and Drug Administration (FDA), the American Hospital Association, and the American Society of Health-System Pharmacists have announced a growing crisis of drug shortages in critical areas such as cancer therapy, urgent care, infectious disease, hypertension, orphan disease, pediatric, and other key patient and disease treatment categories [1,2,3,4,5,6]. A survey by the American Hospital Association found dramatic results, including 99.5% of surveyed hospitals reporting a drug shortage in the prior 6 months and 41% reporting shortages of more than 21 medicines during the same time frame [3]. This crisis has hit a critical juncture, with shortages leading to loss of patient lives and gross overpricing. Hospitals have been forced to delay treatment or leave patients untreated, in unnecessary pain, or with suboptimal clinical care, leading to complications, adverse events, and increased overall burden and costs for the health care system [3,7].

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