Despite great efforts by the FDA and the industry, there still are 55 different drug products under shortage on the FDA’s list (here). While the number of drugs on the shortage list is much lower than we have seen in the past (100+), there is still cause for concern as products move on and off the list. Patient treatments must be adjusted or postponed, and delays in some treatments for which, in some cases, there may not be an alternative, especially for oncology patients or cardiac patients, could mean serious consequences.
The list contains many different dosage forms, including tablets. Capsules oral solutions, aerosols, but the biggest proportion of products still continue to be parenteral products. There has been much written about the causes of shortages, most of which involve cGMP problems at either drug product or active pharmaceutical ingredient manufacturers. The FDA has been working with manufacturers to help resolve shortage issues expeditiously. Just yesterday, there was an article regarding the ongoing sodium bicarbonate injection shortage, where one firm is working with the FDA to arrange for a temporary import of a foreign approved product until the shortage can be rectified. This is reminiscent of the FDA’s permission to import foreign approved Propofol a few years ago.
The issue of lack of multi-source products typically plays into the shortage problem and with current pending proposed legislation to help address this issue, perhaps the shortage numbers will further decline. Supply issues outside of the control of drug product manufacturers, especially in the case of a single worldwide API supplier, can also result in a severe shortage.
Drug shortage issues are oft times multifaceted, complex problems for which time and resources are the only fix. Assuring that multiple sources are available may ease the burden, but that alone won’t solve the problem.