Drug recalls

According to the FDAICenter for Drug Evaluation and Research the leading causes for drug recall in fiscal year 2001 were ... 

Validation provides confidence in the quality of products manufactured as the over quality of a particular process cannot be established due to the limited sample size. Validation leads to less troubleshooting within routine production. As a result, it reduces the number of customer complaints and drug recalls. 

FIGURE 4 Drug recalls. One firm had over 100 recalls in 2005, which caused a spike in the 2005 recall figures. (Source CDER 2005 Report to the Nation.)... 

Labeling Correctly labeled product in incorrect carton or package FIGURE 5 Top 10 reasons for drug recalls in fiscal year 2005. (Source FDA.)... 

Drug Recalls Declined for 1998. The Gold Sheets. Vol. 33. February 1999. 

That s not all. The Merck Manual—a massive compendium of descriptions and treatments for probably every known human ailment—is a staple of doctors bookshelves. Merck could boast of never having a drug recalled in the United States (unlike some other pharmaceutical makers it could name). It was the first company to volunteer under the 1983 Orphan Drug Act to manufacture a product that was desperately needed by only a handful of people—the drug industry s version of pro bono work. It was one of the first two companies to sign up with the Council of Institutional... 

In the last 30 years there have been continued instances of drug recalls or precautionary statements due to pharmacovigilance reports and some more notable examples include benoxaprofen and hepatic disorders/ deaths in the elderly and temafloxacin associated hemolytic anemia. Other recent examples are cardiac valve disorders from fenfluramine and phentermine (Fen-Fen), anaphylaxis from zomepirac, rhabdomyoly-sis associated with ceiivastatin and cardiac arrests from drug interactions with terfenadine and drugs which inhibit P450 3A4 like ketoconazole and erythromycin... 

A complete progressive recording system for the distribution of drug products should be readily available and easily followed, information should be readily available to conduct a prompt, accurate and efficient drug recall whenever necessary. 

A drug recall where use or exposure to a drug product may cause temporary or medically reversible adverse health consequences or where probability of serious harm is remote is classified as what class recall ... 

Which level of drug recall can affect the patient or the physician depending on the extent of the distribution of the product ... 

Which level of drug recall affects the pharmacy, dispensing physicians, clinics, hospitals, and long-term care facilities ... 

Which level of drug recall affects retailers and wholesalers ... 

Inclusion of material not intended for inclusion in the product such as dirt, plastic, animal parts is an example of which class drug recall ... 

A subpotent drug product is an example of which class drug recall ... 

Figure 8.10 shows a simple model of two types of pressures in this system that militate against drugs being recalled. The loop on the left describes pressures within the pharmaceutical company related to drug recalls while the loop on the right describes pressures on the FDA related to drug recalls. 

In February 2009, the British Broadcasting Corporation (BBC) reported that the Medicines and Healthcare Products Regulatory Agency (MHRA) recalled a number of medicines because counterfeit products had been introduced to the market that were found to contain between 50 and 80% of the required dose. The drugs recalled were Casodex , which is used for the treatment of prostate cancer Plavix , which is used to treat heart conditions and strokes and Zyprexa , which is used to control symptoms of schizophrenia (chemical structures are shown in Figure 11.1). 

The preparing pharmacist must have procedures in place to handle drug recalls from two different perspectives. Firstly as a manufacturer the preparing pharmacist may have to initiate a recall on a product that has been prepared in the pharmacy. Secondly there must be a procedure to handle recalls initiated from outside the pharmacy. This latter procedure is usually the responsibility of the main pharmacy. However the preparing pharmacist must be part of the team which acts on recalls if the recalled product is associated with a prepared medicine because of the legal responsibilities held by the individuals in the preparing section. This may initiate a recall as a manufacturer ... 

A successful example of bidirectional communication in public health informatics is when, in January 2011, the United States Centers for Disease Control and Prevention issued a drug recall for the antibiotic metronidazole. The central information system connecting 400 medical practices EHRs was able to identify 62 patients who had been prescribed the drug during the previous year. A secure message was then sent to the providers EHRs with instructions on how to use the system to identify patients for notification [79]. 

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