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REMS and Opiates— A New Beginning?

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The FDA’s decision to require manufacturers to develop Risk Evaluation and Mitigation Strategies (REMS) for their new or improved prescription opiates has had a widespread effect on these companies and their plans for distributing their pain relievers. As these companies scramble to develop REMS that will receive FDA approval and allow their products to be approved for distribution, many questions are generated as to exactly what the federal agency wants them to achieve and how to do it.

Of course, REMS for opiates have been mandated due to the continued rise in prescription drug abuse in our country. Some of this abuse is intentional, and some of it is accidental; nonetheless, the FDA is requiring some new ideas and strategies in an attempt to reduce this diversion problem in America. For the first time, generic pharmaceutical companies are also included in this mandate; branded companies feel that this is long overdue. [Read more…]

Health Facility Nightmare

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An issue that has been addressed in this column on more than one occasion is the diversion of controlled substances from health facilities. I am usually discussing not only the horrors that can occur in our nation’s health facilities, but the common practice of those criminal acts not being reported to law enforcement or even regulatory boards. Unfortunately, many times the practice is to dismiss or accept the resignation of the violating health professional. This opens the door for abuse at the employee’s next facility and fails to address the underlying cause—addiction.

A June 2009 report of a Colorado hospital, however, provides an example of a health facility acting properly, resulting in a federal indictment. In November 2008, Boulder Community Hospital announced its discovery— over just a 1-month period—of 108 instances of theft and tampering with fentanyl vials taken from automated dispensing equipment for patients undergoing surgery. [Read more…]

A Pharmacist’s Dilemma?

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Recently, on a list server in which I participate, a pharmacist was posing a question to the health professionals, law enforcement officers, and regulators as to the course of action needed in a dispensing issue. It seems a local doctor was prescribing extra-strength hydrocodone and acetaminophen combination to the tune of 120 pills every 9 to 10 days, creating the intake of at least 9 g of acetaminophen per day for the patient!

The physician had been warned twice by the pharmacy, yet he continued to prescribe the medication, and the patient continued to have it filled at the complaining pharmacy. Understandably, the pharmacist was feeling very uncomfortable being involved in filling these prescriptions, and offered the situation to the group for input. [Read more…]

Identifying Legitimate Patients Revisited

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In my December 2008 column, I discussed the idea of patients providing positive photo identification when picking up controlled substance prescriptions at the retail pharmacy. In that article, I asked for input from you—the reader—on the pros and cons of making this mandatory in any one state or on a national level. I probably received more responses from that article than any other article I have written over the past few years.

One reader indicated that the pharmacy technician in his store wrote the patient’s driver’s license or state identification number directly on the prescription for CII drugs only. This took very little time, but the reader felt that it was a very effective way to curb drug diversion. [Read more…]

How BIG is the problem?

Year after year, state and local law enforcement statistics indicate that pharmaceuticals are almost 30% of the overall drug problem in the United States, running a close second only marijuana abuse. However, until recently, law enforcement, health care professionals, and the general public have placed little emphasis on this huge problem.

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About PDE

Pharmaceutical Diversion Education (PDE) is designed to assist a wide range of the population in understanding the potential abuse and addiction that can be associated with prescription medication.

Drug Diversion:
Any Criminal Act Involving a Prescription Drug.

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