Pharmacists speak out

At its last House of Delegates meeting, the American Medical Association (AMA) introduced a resolution, “AMA Response to Drug Store Intrusion into Medical Practice, Resolution 218 (A-13).”  Representing AMA in a public statement, Orange County delegate Dr. Melvyn Sterling had a message for pharmacists: “Don’t call us, we’ll call you!”

While subsequent communications with AMA members and staffers indicate disagreement with Sterling’s comment, the situation set many pharmacists to gnashing their teeth and rattling their sabers against their physician colleagues.¹

Professional pharmacy organizations, pharmacists, and physicians alike have weighed in on this issue, stating the need for collaboration between our professions to provide the best patient care possible. Professional organizations have cited the central issue precipitating this communication crisis as one of prescription drug abuse and resultant deaths.²

However, the AMA resolution title is aimed at “drug store intrusion” and is specifically directed at Walgreens Corporation. for implementation of its Good Faith Dispensing (GFD) policy regarding opioid prescriptions for chronic pain. AMA Resolution 218 (A-13) is not directed at pharmacists per se, but at Walgreen Corp., which is using its pharmacists as pawns to satisfy internal requirements set forth in a deal with the Drug Enforcement Agency (DEA).³ Walgreens, the “drug store” that lit this fuse, has emerged remarkably unscathed.

The backstory

Walgreens and the U.S. Drug Enforcement Agency (DEA) entered into a Memorandum of Agreement (MOA) in the fall of 2011 as a result of dramatic increases in oxycodone doses dispensed by Walgreens pharmacies in Florida.⁴

It appears that as a result of this MOA, Walgreens implemented its Good Faith Dispensing (GFD) policy, but misinformation has accompanied the implementation of this policy. This is exemplified in a “Dear Provider” letter that attempts to explain why Walgreens pharmacists are compelled to call providers and ensure that “the necessary information to confirm the appropriateness of the prescription is documented to satisfy the DEA requirements”.⁵ However, the DEA has issued no such “requirements” for the filling of prescriptions, as the Walgreens “Dear Provider” letter plainly states.

The heart of the GFD policy is Title 21 of the Code of Federal Regulations, Section 1306.4, which states that pharmacists have a corresponding responsibility to ensure that when a prescription for a controlled substance is dispensed, the dispensing must be done for a legitimate medical purpose.⁶ This is appropriate, valid, justified, and part of a pharmacist’s responsibility. 

The consequences

However, Walgreens’ GFD policy has bastardized its pharmacists’ ability to make a free-will professional interpretation and, ironically places patient safety at risk.⁷

This policy obstructs the delivery of patient medications, as it requires the gathering of medical chart information above and beyond requirements set forth by any state or federal regulations, prior to the dispensing of an opioid prescription for chronic pain.

If Walgreens honestly believed in the validity of that policy, pharmacists would also be required to obtain routine laboratory monitoring tests prior to dispensing statins, hypoglycemic agents, and antibiotics, for example. The thought is absurd!

Absence of accountability

The most unsettling element of Walgreen’s GFD policy is that, while it promotes the concept of “corresponding responsibility,” there is no advocacy for “corresponding accountability” on the part of the Walgreens pharmacist. The question remains as to how a Walgreens pharmacist would be held accountable for “prescribing by omission” if an adverse event occurred through the withholding or delay of a patient’s opioid prescription resulting from Walgreens’ GFD policy.

Imagine a parallel situation, in which a patient becomes hyperglycemic because the pharmacist didn’t have glucose levels and refused to fill a prescription for an oral hypoglycemic agent.

Or consider this: As a result of Walgreens’ previous irresponsible dispensing behaviors, the GFD policy is stigmatizing chronic pain patients, through no fault of legitimate pain patients themselves or of the doctors and pharmacists caring for them.

The real issue

When the above facts are elucidated, it is quite clear that behind the rhetoric of AMA Resolution 218 (A-13), the issue is not that of physicians striking out at pharmacists¹; to the contrary, it is Walgreen Corp. itself that is being condemned.

This is not simply an issue of “prescription drug abuse.” More precisely, it is the result of corporate “drug store intrusion” into patient’s therapy. The pharmacist’s healthcare role in this instance is not being defined by our knowledge, collaboration, clinical expertise, and direct patient care attributes, but rather by irresponsible and selfish corporate policy arising from an effort to satisfy previous misgivings and corporate greed, in an escalating lack of due diligence.

The issue of advance information required before the safe dispensing of an opioid prescription is distracting from a deeper conflict.

The business model

Walgreens’ actions here are not based on the contemporary clinical role of pharmacists; they are focused on a singular business model that exudes patient neglect, not safety, as Walgreens claims.

This distinction is critically important. It speaks to a duality the pharmacy profession has struggled with for decades.

The practice of pharmacy based on a healthcare model places the patient first, incorporates clinical knowledge, and enables the pharmacist to act in a fully collegial, collaborative manner with other healthcare providers in order to deliver the best patient care possible.

The pharmacy profession needs to realize the uncomfortable truth: that in this particular case, Walgreens reflects the worst that the pharmacy business model has to offer.

Before we see further erosion between medical and pharmacy colleagues and further decline of the societal covenant between pharmacy and our patients, there must be careful and heartfelt examination of this crisis. 

Today we call upon our professional organizations to support our colleagues who are Walgreens pharmacists, on the front lines and caught in the corporate crossfire, as well as all pharmacy colleagues nationwide and, most important, the patients who heretofore confidently relied on pharmacist professionalism and integrity.

[Editor's note: WTHR.com in Indianapolis has investigated Walgreens' Good Faith Policy and obtained a detailed "secret checklist" that pharmacists must use in determining whether to fill opioid prescriptions. To see the checklist and the accompanying article, go to "Walgreens' 'secret checklist' reveals controversial new policy on pills."]

References

AMA House of Delegates, Resolution 218 ( A-13), “AMA Response to Drug Store Intrusion into Medical Practice,” May 17, 2013. http://bit.ly/ama2013res.

“Pharmacists feeling pain over AMA resolution. Physician group blasts profession’s ‘intrusion into medical practice.’” Pharmacy Practice News, August 2013, Vol. 40. http://bit.ly/pharmsrespond. Accessed August 12, 2013.

Houck LK. “AMA tells pharmacists: ‘Don’t call us, we’ll call you.’” http://bit.ly/dontcallus. FDA Law Blog; Hyman, Phelps, & McNamara, PC. Accessed August 12, 2013.

U.S. DEA. “DEA serves a suspension order on Walgreens distribution center in Jupiter, Florida.” http://bit.ly/wagsuspend. Accessed April 26, 2013.

Walgreens Corp. Good Faith Dispensing provider letter. http://bit.ly/wagletter. Received April 27, 2013.

Code of Federal Regulations, Title 21, section 1306.4. http://bit.ly/CFR1306. Accessed April 26, 2013.

Walgreens Corp. Controlled Substance Prescriptions & Good Faith Dispensing Policy. Revised June 11, 2012. http://bit.ly/wagpolicy.

Ernest Dole, PharmD, PhC, FASHP, BCPS, is clinical pharmacist, Department of Clinical Pharmacy/Pain Consultation and Treatment Center, University of New Mexico Hospitals; and clinical associate professor, University of New Mexico Health Sciences College of Pharmacy. Dr. Dole is on the speaker’s bureau for Millennium Laboratories. Contact him at edole@salud.unm.edu.

Jeffrey Fudin, BS, PharmD, DAAPM, FCCP, is clinical pharmacy specialist, Stratton V.A. Medical Center, Albany N.Y., and adjunct assistant professor, University of Connecticut School of Pharmacy. He holds several academic affiliations in New York and is owner and managing editor of PainDr.com. Dr. Fudin is on the speakers’ bureau for Janssen Pharmaceuticals Inc., Millennium Laboratories, and Purdue Pharma. Contact him at jeff@paindr.com.

This commentary is the sole opinion of the authors and does not reflect the opinion of employers, employee affiliates, and/or pharmaceutical companies listed. It was not prepared as part of Dr. Fudin’s official government duties as clinical pharmacy specialist.