Rx Integrative Solutions blog

On December 28, 2011 Pfizer recalled one million Lo/Ovral-28 and Norgestrel generic tablets.  The company states that only 30 packs were known to have packaging problems, the reason for the recall, including having the active (white) and inactive tablets (pink) out of order or lacking the correct number of each kind of tablet.  A savvy consumer notified the company of the problem on October 19, 2011.  Expiration dates on the recalled products range from July 31, 2013 to March 31, 2014 and you can find the lot numbers of these products online at www.pfizer.com.  The FDA will continue investigations and monitor any reports of unwanted pregnancies. If you have taken or are taking either of these products, please contact your medical doctor for directions on how best to proceed.  Dr. Cathy

Managing prescription medication shortages in hospitals and physician offices across the country has become quite complex and requires a multidisciplinary team of creative healthcare professionals to keep up with the changing supply chain.

For perspective, the number of new medication shortages per year rose from 130 in 2007 to nearly 180 as of July 31, 2011.  Current shortages include, but are not limited to, generic sterile injectables, anti-cancer medications, anesthetics, pain medications, and nutritionals creating an estimated annual impact on USA hospitals of $216 million from the purchase of therapeutic substitutions.

I am frequently asked, ‘Why is this happening?’  There are multiple contributing factors in the supply chain that affect these medication shortages.  1) Raw material shortages, 2) Quality issues (product bacterial contamination), 3)  Manufacturing difficulties or production decisions, 4)  Change in product formulation, 5) Regulatory issues, 6) Industry consolidation and company mergers, 7) Restricted drug distribution and allocation, 8 ) Just-In-Time inventory, 9) Changes in product demand and shifts in clinical practice, and 10) Natural disasters (manufacturing plant fires).

I believe Congress should expand FDA authority requiring drug manufacturers to notify FDA of medication supply interruptions/product discontinuations sooner than later.  Congress should allow FDA to require manufacturers to develop continuity of supply plans.

On October 31, 2011 President Obama issued an executive order directing the FDA to expand its reporting of prescription medication shortages to end users and speed up regulatory review to respond to medication shortages.  This is a step in the right direction.

How do you feel about this significant healthcare situation?  Send me your feedback.  Dr. Cathy

Cut & paste this URL into your web browser to learn more about building your integrative health team. http://www.momcentral.com/articles/General/Health/building-your-integrative-health-medicine-team/            Dr. Cathy - www.rxintegrativesolutions.com