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 The leading web portal for pharmacy resources, news, education and careers November 22, 2017
Pharmacy Choice - Opioids Disease State Management - November 22, 2017

Opioids Disease State Management

Filling Opioid Prescriptions
by Ken Baker, BS Pharm, JD

James T. was in an automobile accident in December. His injuries were extensive. His treatment was just as extensive and at times aggressive. There were two surgeries. James was in the hospital for 17 days in almost constant pain. He was finally released a little after New Year Day.1

James had lost his job about six months before the accident. His savings were exhausted and he had no insurance. He had no way of paying the hospital bill. While still in the hospital he applied for Medicaid, but it had not been approved by the time he was released from the hospital. While in the hospital James was treated for his pain with opioids.

When he was released from the hospital his physician, a hospitalist employed by the hospital, wrote a prescription for the same opioid James had taken while he was hospitalized. James took the pain medication prescription to a large chain pharmacy near his home. He intended to pay for the medicine with cash he had borrowed from a relative. When the prescription was presented and said he would be paying in case, one of the pharmacy technicians told James they were out of this drug. It was obviously a well-practiced speech. The technician added, "all of our pharmacies in town are out of it." It was a town of over five million people. She was obviously lying. There was nothing James could say and he eventually left and took his prescription to another pharmacy. The second pharmacy noted the prescription was written on the hospital's prescription pad. After a short phone call the second pharmacy was satisfied the prescription and James were both legitimate.

The story of James was not an isolated incident. Across the country pharmacies have been turning down legal prescriptions. Real patients in real pain are not being treated. 2

There are certainly hundreds, if not thousands, of illegal opioid prescriptions being presented to pharmacies, which should not be filled. There are many more that are legal and need to be filled. The problem for the pharmacist is how to know which should be filled and which should be refused. The federal law provides a two-pronged test. Federal regulations §1306.04 (a) says:3

A prescription for a controlled substance to be effective must be:
  1. issued for a legitimate medical purpose
  2. by an individual practitioner acting in the usual course of his professional practice.
The question for the pharmacist – is this prescription (1) for a legitimate medical purpose and is the (2) prescriber acting in the usual course of his professional practice? The DEA suggests "Red Flags" should be considered and they should create questions the pharmacist must resolve before filling a controlled substance prescription.4 In the Jones Pharmacy case4 the pharmacist's liability was "largely based on evidence that Jones Pharmacy failed in its responsibility to address "red flags…" In that case the Administrative Law Judge listed five red flags the pharmacist ignored:
  1. Patients traveled long distances for filling prescriptions, often from out of state;
  2. Prescriptions were filled for common "cocktail medications," (i.e., short term pain relief);
  3. Prescriptions were issued by doctors prescribing outside their scope of practice;
  4. Prescriptions were dispensed on the same day to patients with the same out-of-state address for the same controlled substance; and
  5. Such prescriptions dispensed were paid for in cash.
Note, however, these red flags are not "stop signs" they are "warning signs." They do not say do not fill, but say questions are raised that must be resolved before filling. In James' case he tried to pay in cash, but had the pharmacist asked a couple of questions he could have determined the prescription was still legitimate. There was a reason James needed to pay in cash. A call to the hospital would have shown James' prescription was for a legitimate medical purpose written by a hospitalist "acting in the usual course of his professional practice."

Pharmacists should also consider "Green Flags"5 showing this is probably a legitimate patient in real pain. In James case, he lived in the neighborhood, as his driver's license would have shown. The prescription was written on a local hospital prescription pad. James had just been released from the hospital after an auto accident.

Pharmacists have an ethical and legal responsibility when dispensing opioids. It calls for judgement. As long as the pharmacist makes his or her decision based on professional judgement, it does not matter if the decision is ultimately proved correct. It is just as wrong to refuse a legitimate prescription as to fill a bad prescription.4

One other necessity is to document the reasons for the professional judgement,3 whether the prescription is refused or filled. Be able to prove months later why the actions were taken.

These articles are not intended as legal advice and should not be used as such. When a legal question arises the pharmacist should consult with an attorney familiar with pharmacy law in his or her state.

Ken Baker is a pharmacist and an attorney. He teaches ethics at Midwestern University, Glendale, Arizona, campus and risk management for the University of Florida. He consults in the areas of pharmacy error reduction, communication, and risk management. Mr. Baker consults with Pharmacists Mutual Insurance Company and is an attorney, of counsel, with the Arizona law firm of Renaud Cook Drury Mesaros, PA. Contact Ken Baker at ken@kenbakerconsulting.com.

References
  1. The story of James is true. The identity has been changed. The story is from the memory of the author, who was familiar with the real patient. The facts have been condensed for space.
  2. See, Fact Sheet on Changes to Walgreens Policy on Filling Prescriptions for Controlled Substances, California Medical Association, 2013. www.cmanet.org Rev. 5.13.13; also see WESH.org Special report: Pharmacies denying legitimate prescriptions, by Matt Grant, Orlando.
  3. Title 21 - Food and Drugs. CHAPTER II - DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE. PART 1306 - PRESCRIPTIONS; CFR §1306.04 Purpose of Issue of Prescription. "A pharmacist is required to exercise sound professional judgment when making a determination about the legitimacy of a controlled substance prescription. Such a determination is made before the prescription is dispensed. The law does not require a pharmacist to dispense a prescription of doubtful, questionable, or suspicious origin."
  4. DEA Decisions: Evidence of "Red Flags" of Drug Diversion, By Larry Cote, November 13, 2016, http://deachronicles.quarles.com/2016/11/dea-decisions-evidence-of-red-flags-of-drug-diversion/ Last Accessed 7/19/2017. See also, Holiday CVS, LLC d/b/a CVS Pharmacy Nos. 219 and 5195
  5. See, Baker, K; Diversion of Opioids - A Pharmacist's Dual Ethical Duties Red Flags and Green Flags, Drug Topics, April 2014.


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