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Prescription Drug Abuse

New Report Finds Gaps in Oversight for U.S. Drug Safety

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A new study by the Pew Health Group finds serious gaps in the oversight of U. S. drug safety.  The report says about 40% of finished drugs and 80% of active ingredients and the bulk chemicals in U. S. pharmaceuticals come from overseas.

Allan Couckell, director of medical programs for the Pew Health Group, says the vast majority of what’s on the shelves is not counterfeit or adulterated.  But he says the change in manufacturing toward increased globalization and outsourcing means there are new risks that need to be addressed.

Couckell says in developing countries, where our drugs increasing come from, often the products are made in facilities that have less oversight from their domestic regulators. He says they’re not being inspected by the Food and Drug Administration like a producer in the United States would be inspected.

Couckell says U.S. manufacturing facilities are inspected on a regular basis, but if the same product is coming from India or China, it may be going into the drug store without any inspections. He says that’s true for prescription and over-the-counter products.

Couckell says manufacturers themselves have to guarantee quality by looking outside the walls of their factories and going back up the supply chain.  He says we also need the FDA to be able to adapt to a globalized world.  He says the law that set up the FDA is 70 years old and the world has really changed since then.

He says the FDA and some manufacturers are taking steps already, but for the agency to be able to work with regulators in other countries and do the kind of international oversight that we need, the law needs to be updated. Couckell says we need to update the laws and the system to make sure we’re not at risk.

Prescription Drug Abuse

Testifiers: PA Needs RX Drug Monitoring Program

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Prescription drug abuse is an epidemic in Pennsylvania, according to State Rep. Gene DiGirolamo (R-Bucks).  In efforts to rein in the problem, the chairman of the House Human Services Committee has introduced legislation to create a Pharmaceutical Accountability Monitoring System to give doctors and pharmacists the ability to monitor people they suspect of doctor shopping or pharmacy shopping.  “Then they’ll be able to tell this person that – hey – I’m not going to write this prescription because you’ve been at Dr. so-and-so yesterday for the same thing,” DiGirolamo tells us.

The House and Human Services Committee held the first of two hearings on HB 1651 Thursday.  A litany of speakers urged lawmakers to act on the bill.  “Pennsylvania is awash in prescription drugs of addiction, and many of them are tragically lethal.  The streets are full of prescription drugs of addiction,” said Deb Beck, president of the Drug & Alcohol Service Providers Organization of Pennsylvania.  Others pointed to 2005 data that show nearly 1 in 20 Pennsylvanians used an opioid for non medical purposes in the past year. 

DiGirolamo says the cost to the state would be negligible because the bill gives pharmacists the responsibility of entering the information into the statewide database.  The Pennsylvania Pharmacists Association supports the initiative.  “Pharmacists probably more than anyone see the effects of diversion and abuse, and are put in the hard decision point of whether to dispense or not,” said Pat Epple, Association CEO.  Epple, however, did point out that the bill would not be without costs to pharmacies.  She also raised the point of “mail order” pharmacies, which would not be covered by the bill. 

DiGirolamo tells us 47 other states have already put similar tools in place.  A second hearing has been scheduled for next Thursday, because so many people expressed interest in testifying.  Details of the bill are still being hammered out.