The role of outsourcing facilities in overcoming drug shortages

Abstract

Background: The Drug Quality and Security Act passed in 2013 created a new voluntary category of compounders, referred to as outsourcing facilities. The regulatory landscape allows these facilities to compound on a larger scale in comparison with the typical compounding pharmacies, which positions them to potentially serve a role in overcoming drug shortages. Objective: The purpose of this article is to identify the number of drug products on shortage as reported by the Food and Drug Administration (FDA) that were also compounded by outsourcing facilities. Methods: All current and resolved drug shortages through January 27, 2020, as reported by FDA, were compared with the 503B product reports from July 2018 through June 2019 submitted to FDA by outsourcing facilities. The active pharmaceutical ingredient (API) and dosage form for each product on shortage were compared with the 503B product reports to identify similarities. Results: There were 344 unique APIs on the FDA drug shortage list and 774 unique APIs on the 503B product reports. After comparison of the APIs on the drug shortage list with those on the product reports, 27% of unique APIs (74 of 272) were included on both lists, and of these, 18% (50 of 272) of the APIs on the drug shortage list were compounded by outsourcing facilities in the same dosage form as what was on shortage. Conclusion: The regulatory landscape positions outsourcing facilities to play an important role in providing access to medications while on shortage. However, when comparing the drugs on shortage as reported by FDA with the 503B product reports, there was minimal overlap. Additional research into why outsourcing facilities are not taking on a larger role in overcoming drug shortages should be explored.

Special Report: Potential Strategies for Addressing GLP-1 and Dual GLP-1/GIP Receptor Agonist Shortages

“…Regardless of the method selected to overcome the current limited access to GLP-1 receptor agonists, educating patients and setting expectations during the transitional period is time well spent. Caution patients to consider the credibility and reliability of online sources and explain the concerns related to compounded products ( 4 , 5 ).…”

“…Many social media sites and online clinics claim to offer commercially available GLP-1 receptor agonist medications or even compounded versions at a discounted price. Although compounded medications are regulated and generally considered safe ( 4 ), compounded GLP-1 receptor agonists are unique. Each GLP-1 receptor agonist is only available as a branded medication manufactured by a single company.…”

Stress and strain on the U.S. drug supply: The intersection of shortages, globalization, counterfeit products, and throw in a global COVID-19 pandemic

“…This theme issue also contains 2 articles on 1 potential solution to the drug shortage problem, the use of outsourcing facilities. Mattingly 14 performed an investigation to determine the extent to which 503B outsourcing facilities were able to compound products for those reported as shortages by FDA. Data from July 2018 through December 2019 listed 64 outsourcing facilities, which compounded products matched only 27% of the API on the shortage list.…”

Coping with drug shortages: A study of government-enterprise option cooperation stockpiling strategies for drugs in shortage considering API surrogate stockpiling subsidies

“…For example, Hu verified the effectiveness of option contracts in the supply chain coordination process under demand uncertainty [ 37 ]; Aghajani et al used option contracts to derive the optimal production and purchasing quantities for supply chain decision makers under output and demand uncertainty [ 38 ]; Liu et al suggested that option contracts can increase the level of joint government-enterprise physical and production capacity stockpiles of emergency supplies and improve the response level of disaster relief [ 39 ]. However, while existing research confirms that option pacts can coordinate government-enterprise cooperation to carry out physical and production capacity stockpiling of emergency supplies, drugs in shortage belong to special emergency supplies, and the primary prerequisite for promoting the security of supply of medicines through enterprise production capacity stockpiling is an adequate stockpile of APIs [ 40 , 41 ]. The current shortage of APIs has become one of the main reasons for drug shortages in China, which is contrary to the reality of China as the world’s second-largest producer of APIs and the first-largest exporter of APIs [ 4 , 5 , 42 ].Various realities suggest that strengthening the API stockpile is the best way to realize the physical and production capacity of pharmaceuticals.…”