reasons cited for drug shortages

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" Whatever the cause, drug shortages have become a key patient safety concern

in healthcare today. The urgency of this situation suggests that the current

" business as usual " approach is woefully inadequate in every respect; this

issue requires a disaster-type response. "

Some of the more common reasons for drug shortages include the following *

..Unavailability of bulk and raw materials used to produce pharmaceuticals,

of which 80% come from outside the US

..A delay or halt of production in response to an FDA enforcement action

regarding noncompliance with good manufacturing practices identified during

an inspection

..Voluntary recall of a drug after the manufacturer discovers a problem with

the medication, such as inadvertent bacterial or fungal contamination

..Change in the manufacturer or product formulation (e.g., inhalers without

chlorofluorocarbons) that delays production

..Unexpected increases in demand for a drug when a new indication has been

approved, usage changes due to new therapeutic guidelines, or a substantial

disease outbreak occurs

..Natural disasters that involve manufacturing facilities or that lead to

demands for certain classes of medications to treat disaster victims.

=== For me, the following are unacceptable / unethical reasons:

..Manufacturer's business decision to halt production of a drug due to

availability of generic products, patent expiration, market size, drug

approval status, regulatory compliance requirements, anticipated clinical

demand, and/or reallocation of resources to other products (FDA does not

have authority to require a company to continue manufacturing a medically

necessary product)

..Manufacturer mergers that narrow the focus of product lines, causing

discontinuation of certain products, or move production of a drug to a new

facility, causing production delays

..Poor inventory ordering practices, stockpiling before price increases, and

hoarding caused by rumors of an impending shortage

*. Fox ER, Birt A, KB, et al. ASHP guidelines on managing drug product

shortages in hospitals and health systems. Am J Health-Syst Pharm. 2009;

66:1399-406.

Source: http://www.medscape.com/viewarticle/727958

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