The FDA has reported that shortages of drugs in the United States during 2010 set an all-time record and that there have been increasing shortages during 2011. The shortage of sterile injectables represented 74% of the drug shortages during 2010: 54% of the shortages in sterile injectables during 2010 were due to contamination, particulates, and impurities; 21% were due to delays or manufacturing capacities; 11% due to discontinuation; 5% due to raw materials issues; 4% due to an increase in demand due to another shortage; 3% due to the loss of a manufacturing site; and, 2% due to component problems or shortages. Only 7 manufacturers make up a large portion of the manufacturers of sterile injectables, which are often less attractive economically to produce.
The shortages of certain drugs have become so severe that the FDA has temporarily allowed the importation of certain drugs from unapproved sources, including propofol during 2010 and foscarnet, ethiodol, thiotepa, norepinephrine, Xeloda, levoleucorovin, and leucorovin during 2011.
The FDA was able to assist in preventing 38 drug shortages during 2010 and 99 during 2011. Recent significant quality issues include sterility problems (including bacterial and mold contamination), particles of foreign matter such as glass, metal, and fibers in vials, crystallization of the active ingredient, precipitate formation due to reaction with raw materials or container/stopper with the drug, and newly identified impurities or degradants. The earthquake in Japan, volcanic activity in Iceland disrupting transportation, and fires at manufacturing or raw materials plants have also contributed to the shortages.
How serious is the problem? The FDA is considering allowing the release of medically necessary medications with extra testing and third party oversight, building in exemptions for medically necessary products into enforcement actions such as consent decrees, and allowing distribution of products with filters and alerts to health care providers.
The drugs that are currently in short supply are: acetylcysteine inhalation solution, alcohol dehydrated, amikacin injection, aminocaproic acid, ammonium molybdate injection, ammonul injection, amphetamine mixed salts (ER capsules), anadrol-50 tablets, aquasol A, avalide tablets, bleomycin injection, buprenorphine injection, calcitriol 1 mcg/mL injection, calcium chloride injection, calcium gluconate, cerezyme, cisplatin injection 1 mg/mL, cyanocobalamin injection, cytarabine injection, daunorubicin hydrochloride solution for injection, desmopressin injection, dexamethasone injection, digoxin injection, ditiazem injection, doxorubicin lyophilized powder, doxorubicin liposomal injection, doxorubicin solution for injection, ethiodol ampules, etoposide solution for injection, fabrazyme, fluorouracil injection, foscarnet sodium injection, fosphenytoin sodium injection, furosemide injection, haloperidol decanoate injection, intravenous fat emulsion, isoniazid tablets, leucovorin calcium lyophilized powder for injection, leuprolide injection, levoleucovorin 50 mg single use vials, lorazepam injection, magnesium sulfate injection, methylphenidate HCL, metoclopramide injection, mexiletine capsules, mitomycin powder for injection, mustargen injection, multi-vitamin infusion, nalbuphine injection, neoprofen injection, neostigmine methylsulfate injection, neupro, norepinephrine bitartrate injection, ontak injection, oxsoralen 1% topical lotion, oxsoralen-ultra 10 mg capsules, paclitaxel injection, phenylephrine HCL injection, potassium phosphate, procainamide HCL injection, propofol injection, sodium chloride 23.4%, sodium chloride 14.6% injection, sodium phosphate injection, streptomycin for injection, USP, sulfamethoxazole 80mg/trimethoprim 16/mg/ml injection, thiotepa for injection, thyrogen injection 1.1 mg/vial, thyrolar tablets, vasopressin injection, vecuronium injection, and vincristine sulfate injection.
Drug shortages can be due to many factors including manufacturers discontinuing certain drugs, problems with quality control during manufacture, difficulty in obtaining some of the ingredients of drugs, and increasing demand for the drugs.
Some parts of the United States may experience different shortages of certain drugs than in other parts of the country. Hospitals as well as retail pharmacies are experiencing drug shortages. Cancer drugs, anesthesia drugs, and other critical drugs are among the drugs that are in short supply.
When bad drugs cause bad injuries, visit our website to be connected with medical malpractice lawyers in your state who may be able to assist you with your claim. You may also reach us toll free 800-295-3959.
Turn to us when you don’t know where to turn.