Safety Concerns About Adulterated Drug Ingredients

Pharma Industry / Biotech Industry News

Main Category: Pharma Industry / Biotech Industry
Also Included In: Regulatory Affairs / Drug Approvals;  Public Health
Article Date: 18 May 2011 – 3:00 PDT
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Government regulators and pharmaceutical companies are moving to address a major new risk for the global supply of medicines: The possibility that unsafe ingredients are entering the supply chain as pharmaceutical companies increasingly outsource the production of drug ingredients to third parties. That’s the topic of the cover story in the current edition of Chemical & Engineering News (C&EN), ACS’ weekly newsmagazine.

C&EN Senior Editor Rick Mullin explains that the jolt for action came from several incidents. One incident – a major 2008 recall of contaminated heparin that likely caused 81 deaths in the U.S. In another incident, more than 300 people died in Panama after taking cough medicine manufactured with diethylene glycol that was shipped by a supplier as glycerin.

The story describes awareness within the U.S. Food and Drug Administration (FDA) that rampant globalization in drug manufacturing has outstripped the agency’s resources for inspecting foreign facilities. FDA has responded by establishing an information sharing network with European, Japanese, and Australian regulators and has opened regional offices in Asia and elsewhere.

Source:
Michael Bernstein
American Chemical Society

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Lack Of ADHD Med Ingredients Make Patients Jumpy; FDA, DEA Involved

Editor’s Choice
Main Category: ADHD
Also Included In: Pharma Industry / Biotech Industry
Article Date: 11 May 2011 – 2:00 PDT
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It seems there is a shortage of the ingredients needed to produce attention deficit hyperactivity disorder (ADHD) medications, and has sent some patients into a panic. The Food and Drug Administration discovered in March that they did not authorize enough of the active ingredients needed to produce medications such as Adderall and Ritalin to pharmaceutical manufacturers. These ingredients are highly regulated for their potential of abuse.

The shortages affect drugs that generated a combined 24.2 million prescriptions in 2010, according to data provided by IMS Health.

The Drug Enforcement Adminstration (DEA) regulates the active ingredients of some ADHD drugs as controlled substances. Shortages of drugs for attention deficit hyperactivity disorder have sent patients and their families on a hunt for pharmacies with drugs in stock or they are simply extending the dosages.

DEA spokesman Lawrence Payne said the agency has newly approved enough supply to allow for uninterrupted distribution of the drugs and it’s up to manufacturers to allocate the ingredients among their various products.

Erin Fox, manager of the drug-information service at the University of Utah Hospital & Clinics explains:

“It’s a huge inconvenience. Parents and patients are running around and calling pharmacies to see who has their product.”

Attention deficit hyperactivity disorder, known as ADHD, causes children and adults to have difficulty focusing, controlling their actions and remaining still or quiet. ADHD drugs generally act as a stimulant to alleviate symptoms but can be habit-forming and associated with side effects such as increased heart rate and loss of appetite.

What is the pharma industry’s response to this shortage?

Matt Cabrey, spokesman for Shire PLC, the maker of Adderall and generic versions, said rising demand for the drugs due to increased diagnoses of ADHD, which in turn may be fueled by greater awareness of the disorder, can make it difficult to forecast ingredient needs.

UCB SA’s Brenda Varney, director of UCB’s established-brands unit, said the company lifted production but recently ran out of immediate and extended release Metadate products, although it has a combination type in stock. UCB expects the products to be available by about May 20.

Novartis AG, who makes Sandoz and generic versions of methylphenidate, said it is manufacturing at capacity and trying to increase its supply. Spokesman Eric Althoff said the marketplace shortage has led to higher demand for its products.

A record 211 medications became scarce in 2010, triple the number in 2006, and at least 89 new shortages have been recorded through the end of March, putting the nation on track for far more scarcities.

Gordon Johnston, vice president for regulatory sciences at the Generic Pharmaceutical Association adds:

“We’ve certainly reached a very global supply chain for drug products, with the active ingredients typically made outside of the United States. It could be Europe, India and in some cases China. If there’s a problem at a facility in Italy or India, it leads to disruption of the drug supply in the United States.”

Although ADHD begins in childhood, sometimes it’s not diagnosed until a person is a teen, and occasionally not even until someone reaches adulthood. Because ADHD is a broad category covering different things including attention, activity, and impulsivity, it can show up in different ways in different people.

Sources: The U.S. Food and Drug Adminstration, The Generic Pharmaceutical Association and The U.S. Drug Enforcement Adminstration

Written by Sy Kraft

View drug information on Adderall XR; Metadate CD; Ritalin LA.

Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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