Unapproved Drugs—The Drug Information Pharmacists’ Perspective

Abstract

Pharmacists in all areas of practice frequently dispense or recommend drugs without realizing that some commonly used medications have never received Food and Drug Administration (FDA) approval. Most of these medications have been available for many years and are usually misconceived as generic drugs, when in fact they never went through the required quality, safety, and efficacy testing required by FDA. As a result, unapproved drugs can pose serious safety risks to patients and create uncertainty in the market. FDA established the "Unapproved Drugs Initiative" to protect public health by decreasing the number of available unapproved drugs with minimal disruptions to the market. Unapproved drugs remain in the market for various historical reasons. It is important for health care providers, particularly pharmacists, to be knowledgeable about unapproved products and consider switching patients to FDA-approved alternatives if possible when selecting drug therapy. Several resources are available on the FDA Website to determine approval status. Although FDA is working to remove unapproved drugs from the market, there will be circumstances when the use of unapproved drugs is medically necessary and appropriate. In these cases, pharmacists can monitor for and report adverse events and stay informed regarding any changes in approval status.

Effects of Modified Simiao Decoction on IL‐1β and TNFα Secretion in Monocytic THP‐1 Cells with Monosodium Urate Crystals‐Induced Inflammation

“…Colchicine's toxicity was wildly reported [5] and Food and Drug Administration exercised enforcement action against companies illegally marketing unapproved single-ingredient oral colchicine [6]. Therefore, it is urgent to explore new available antigout agents, especially herbal medicine.…”

Potential Association between Drug Shortages and High‐Cost Medications

“…Many drugs on the market have never gone through the FDA approval process . The 1962 Kefauver‐Harris Amendment to the Federal Food, Drug, and Cosmetic Act required proof of efficacy as well as safety and resulted in the Drug Efficacy Study Implementation (DESI) program, which reviewed over 3400 medications marketed between 1938 and 1962 . The FDA established the Prescription Drug Wrap‐Up program in the mid‐1980s to review products marketed prior to 1938.…”

“…This process has unintentionally created shortages by limiting manufacturing capacity to a single supplier or by creating uncertainty in the market for other suppliers concerned about enforcement actions by the FDA. Another type of drug shortage related to unapproved drugs occurred with emergency drug syringes in 2009 when Amphastar Pharmaceuticals (Rancho Cucamonga, CA) made a business decision to discontinue their emergency syringes of unapproved drugs (e.g., atropine sulfate injection, calcium chloride injection, dextrose, epinephrine, lidocaine 2%, and sodium bicarbonate) . The abrupt discontinuation contributed to a national shortage of emergency syringes because other suppliers could not keep pace with the increased demand for the products.…”

The FDA Unapproved Drugs Initiative: An Observational Study of the Consequences for Drug Prices and Shortages in the United States

“…Once the FDA takes action against an unapproved drug, fewer manufacturers remain in the market, potentially enabling drug price increases and greater susceptibility to drug shortages. Previous articles have explored the historical background for the UDI 3,8,9 and characterized the experience of individual unapproved drugs, 3,[8][9][10][11][12] including the finding that prices and shortages of specific drugs increased after they were targeted by the UDI. [13][14][15][16][17] However, to…”