Analysis Of The Prevalence Of Shortages Of Oncology Drugs In The United States (2000-2014)

Shortages of oncology drugs adversely impact health outcomes, healthcare costs and lifesaving treatments availability. This study assessed the prevalence and characteristics of shortages of oncology drugs in the United States (US) for the period 2000-2014. Oncology drug shortages data were provided by the Drug Information Service, University of Utah. Drug regulatory data were collected from [email protected] Medical devices, non-therapeutic biologics, vaccines, and non-FDA approved drugs were excluded from analysis. The prevalence of shortages was estimated as a percentage of the total number of active ingredients marketed in the US during the study period. A logistic regression analysis was conducted to assess the association between the prevalence of drug shortages and the FDA approval date, generic availability, orphan designation, FDA review process (i.e., standard or priority), and route of administration for drugs in shortage on December 31, 2014. A total of 201 oncology active ingredients were marketed in the US during the period 2000-2014; 72 of them were in shortage at least once resulting in 35.8% shortage prevalence. There were 25 active shortages as of December 31, 2014. Additionally, 17 active ingredients were discontinued from the market by the same date. Injectable oncology active ingredients had the highest (46.3%) level of shortages. FDA approval date [OR=1.18 (95%CI:1.02-1.07)(p=0.001)], FDA priority review process [OR=3.1 (95%CI:1.3-7.7)(p=0.015)], and injectable form [OR=3.6 (95%CI:1.5-8.2)(p=0.003)] were associated with an increase in the prevalence of shortages among oncology drugs. Conversely, orphan drug status was associated with a reduction in the prevalence of shortages [OR=0.4 (95%CI:0.16-0.99) (p=0.0480)]. Generic availability was not significantly associated with the prevalence of shortages [OR=2.3 (0.99-5.33)(p=0.0520)]. Over one-third of oncology drugs were reported in shortage anytime during the study period posing an enduring challenge to patient care. Injectable, older drugs, subject to FDA priority review had higher odds of experiencing a shortage.