Diversion of opioids: Red flags and green flags

April 10, 2014

Things aren't as simple as the DEA would have us believe.

Ken BakerIn the February issue of Drug Topics [http://bit.ly/bakerfeb2014], I wrote about the problem of real pain patients being refused their medications because the pharmacists thought the prescription might be from a “pill-mill” doctor. In that article I said that pharmacists have a tough job and it is getting tougher. Pharmacists are being pressured into taking a “Do not fill” attitude, often toward legitimate pain treatments. I talked about real patients being turned away from the pharmacy without their pain medications.

The question arises, however, of how the pharmacist is to know when a prescription is real and when it is not? No pharmacist wants to be tricked into allowing controlled substances to head to the streets for sale.

Pharmacists have an ethical and legal obligation to prevent prescription drugs from being diverted to nonmedical uses. Pharmacists also have an obligation not to leave a patient in tears, holding an unfilled, legal prescription written by a licensed physician, who is acting in the usual course of his or her professional practice and trying to treat the patient’s legitimate medical condition.

 

Red flags

The DEA says that the pharmacist is to look for red flags, and if they are present and not resolved, the pharmacist should refuse to fill the prescription. That is too simplistic.

In the revocation case of the CVS pharmacy in Florida, the government’s expert talked about “unresolvable red flags.”1

There cannot be “unresolvable” red flags. In each real case, a real pharmacist in real practice must resolve every flag and must make a real decision on each prescription - to fill or not fill.

The law says that a pharmacist must not “knowingly” fill a prescription that was written for other than a “legitimate medical purpose by a practitioner acting in the usual course of professional practice."2 Knowingly includes “should have known.”3

Red flags are useful in telling the pharmacist when a prescription should not be filled. Red flags are only half the equation, however. Red flags must be balanced with GREEN FLAGS.

 

Green flags

Green flags are the factors that indicate the prescription is valid. In an article I wrote recently, I enumerated 25 green flags. Every pharmacist reading this could list at least as many.

The following is a list of five green flags. It is an incomplete sample. These are only some of the factors pharmacists can use, along with red flags, to answer the basic question of whether the prescription be filled.

1.     The patient is known to the pharmacists or pharmacy staff.

2.     The physician is known to the pharmacists or pharmacy staff.

3.     The patient is believed by the pharmacist to suffer from chronic pain (or from the condition being treated).

4.     Another physician prescribed the same medication previously. This indicates that two physicians concurred on the diagnosis and made same or similar risk assessments.

5.     The physician sees other patients for whom the pharmacy fills prescriptions, and they appear to be legitimate patients being treated for legitimate medical needs.

 

Ethical duty

The Code of Ethics for Pharmacists says that we have an ethical duty to our patients and also to society as a whole.

As pharmacists, we can do much to reduce the very real problem of prescription-drug diversion, but we must also care for patients.

Sometimes we will be wrong. The law does not demand that the pharmacist be perfect, only that he or she think before coming to a decision.

References

1. Holiday CVS, L.L.C., d/b/a CVS/Pharmacy Nos. 219 and 5195, Registrant Actions-2012, Decision and Order, Federal Register Volume 77, Number 198, Pages 62315-62346], (Friday, October 12, 2012)

2. 21 CFR §1306.04

3. U.S. v. Leal, 75 F.3d 219 (1996)

Ken Bakeris a pharmacist and an attorney. He teaches ethics at the Glendale, Arizona, campus of Midwestern University, and risk management for the University of Florida. He consults in the areas of pharmacy error reduction, communication, and risk management. Mr. Baker is an attorney of counsel with the Arizona law firm of Renaud Cook Drury Mesaros, PA. E-mail him atken@kenbakerconsulting.com.