DSB: Drug Shortages July 2015 Save

Several drugs continue to be in short supply, posing significant problems for patients. Foremost on this list is leflunomide (Arava) which is backordered for both 10 mg and 20 mg tablets.  

Leflunomide Shortage

There are several options available that should be considered:

• Use double the amount if 10 mg leflunomide tablets are available when 20 mg are not.
• Consider using 100 mg tablets and use a once a week dosing regiment. So instead of 20 mg qd, 100 mg once a week may be sufficient to achieve the same benefits. Leflunomide has a very long (>21d) half-life and can be successfully given once a week.
• Using branded Arava pills if available when the generic leflunomide is in short supply.  This will be 3-5 times more expensive, but nevertheless may be a short term solution.
• I've check several Canadian pharmacies, and they still have generic leflunomide (10mg, 20 mg) tablets available in 30, 90 or 100 pill lots.

Drug Shortages Reviewed

Drugs.com has published a short review of the origins of supply shortages and what the FDA is doing to head off or limit the impact of drug shortages.

FDA prioritizes drugs that are medically necessary. A medically necessary drug product is a product that is used to treat or prevent a serious disease or medical condition for which there is no alternative drug, available in adequate supply, that medical staff has determined to be an acceptable substitute. Although the agency focuses on medically necessary drugs, all potential shortages are evaluated to help determine the possible public health impact.

Reasons for Drug Shortages

• Raw Materials 27%
• Quality Manufacturing Issues 37%
• Quality: Delays/Capacity 27%
• Loss of Manufacturing Site 2%
• Increased Demand 5%
• Discontinuation 2%

FDA Works to Prevent Drug Shortages. FDA works to find ways to mitigate drug shortages. However, there are a number of factors that can cause or contribute to drug shortages that are outside of FDA's control. Sometimes manufacturers have an unforeseen breakdown in manufacturing line that affects their production. Other times, shortages are caused by longstanding quality manufacturing issues.

FDA cannot require a pharmaceutical company to: make a drug, even if it is a medically necessary drug, OR make more of a drug, OR change how much and to whom the drug is distributed.

FDA responds to potential drug shortages by taking actions to address their underlying causes and to enhance product availability. FDA determines how best to address each shortage situation based on its cause and the public health risk associated with the shortage.

Reported Drug Shortages as of July 24, 2015

RESOLVED Shortages: Colchicine, Cyclosporine, DTaP vaccine, Cyclophosphamide injection