Once again, we welcome Dr. Dole’s expert opinion and insight, but this time on an important topic of pharmacy ethics. and Opioid Therapy.
Dr. Ernest Dole is Clinical Pharmacist at University of New Mexico Hospitals (UNMH), Department of Clinical Pharmacy/Pain Consultation and Treatment Center (PCTC); and Clinical Associate Professor at University of New Mexico Health Sciences College of Pharmacy. A comprehensive biosketh appears beneath blog post.
Dr. Dole writes…
Please take a few minutes and read this. It is much longer than the usual blogs posted here, but addresses an important issue to our profession.
Money doesn’t talk it swears
Bob Dylan; It’s Alright Ma, I’m Only Bleeding
Pharmacy has struggled with the nature of its duality; trying to balance the two agendas of being a patient care profession, or a profession driven by business interests. This duality is about to be exposed on a national stage with the business side of pharmacy being epitomized by Walgreens Pharmacy’s newly implemented, “Good Faith Dispensing” (GFD) policy.
Appearing as a result of Walgreens selling BILLIONS of doses of opiates in Florida, Walgreens and the Drug Enforcement Agency (DEA) entered into a Memorandum of Agreement (MOA) in 2011. Additionally, on fall 2012, the DEA issued an Immediate Stop Order (ISO) at Walgreens Distribution Center Jupiter, Florida because their business constituted an imminent danger to the public safety (1). In response, Walgreens has resurrected a policy that they allege has always been on their books, their GFD policy. Their current enforcement of the GFD policy is an attempt to shift the payment of their sins to the DEA, over to the patient and provider, and to insulate Walgreens by employing the verbiage of patient care. Walgreens maintains that it is a business with patient safety as their main concern. The closest that Walgreens’ GFD policy comes to patient safety and patient care is that these words are used in a maneuver to provide the needed window dressing so that their GFD policy appears as if patient safety is the organzations primary goal.
The heart of this policy is Title 21 of the Code of Federal Regulations, Section 1306.4 (2) which explains that a pharmacist has a corresponding responsibility to ensure that any prescription for a controlled substance that is dispensed is done so for a legitimate medical purpose (3). This is totally appropriate, valid and justified. This is part of a pharmacist’s role. However, Walgreens has warped this concept into a clever marketing action designed to give the illusion of this company’s commitment to patient care. Ironically, this policy places patient safety at risk by obstructing the delivery of patients’ medication as it requires the gathering of information above and beyond requirements set forth by state and federal regulations before an opiate prescription for chronic non cancer pain (CNCP) may be dispensed to the patient.
It is standard practice for a business to educate its employees on new initiatives prior to implementation of that initiative in order to optimize successful execution of the agenda. Walgreens has, at best, performed sub-optimally in educating their pharmacists as to the goals and objectives of the GFD policy. At worst, their efforts could be construed as a deliberate attempt at mis-information. Walgreens is apparently misinforming patients and providers for the reasons this additional information needs to be collected by telling them any combination of the following: that the DEA has issued new guidelines; that and/or the Board of Pharmacy has enacted new regulations; that the patient’s insurance company is requiring this.
Further confusion exists as to the “guidelines given by the DEA” to limit quantities of certain opiates to #120 doses. Per the Deputy Assistant Administrator, Office of Diversion Control, DEA, (in a personal discussion) the DEA does not issue therapy “guidelines”. Additionally, there are reports that Walgreen pharmacies are not only limiting the quantity of an opioid prescription to 120 doses, but then requesting from the provider a second prescription for the remaining balance of the first prescription. It is unclear how this protects the patient, however it does allow the Walgreens pharmacy to collect copay for the first prescription and then requires the patient to pay cash for the second prescription. By implementing such a policy, Walgreens is giving the appearance of protecting the public and fulfilling its obligations to the DEA, and at the same time profiteering in their implementation of a policy that obstructs the delivery of prescribed medication to the public. As a business, Walgreens wins on all accounts. As a company that states patient care is its primary goal, there is a level of hypocrisy.
The most disturbing element of Walgreen’s GFD policy is that while promoting the concept of “corresponding responsibility”, there is no advocacy for “corresponding accountability” of the Walgreens pharmacists. There can be no responsibility without accountability. The question exists as to how a Walgreens pharmacist is to be held accountable for “prescribing by omission” if there were an adverse event that occurred because a patient’s opiate prescription being dispensed was delayed due to their GFD policy.
You’ve left it for somebody other than you to be the one to care
Jackson Browne; Rock Me on the Water
Walgreens’ implementation of its GFD policy and the subsequent risks to the public is a pharmacy profession issue. It is deeply concerning that no State Board of Pharmacy, or pharmacy professional organization has deemed that Walgreens is participating in unprofessional conduct. The ethics of this speaks to the Oath of the Pharmacist that states, “A pharmacist acts with honesty and integrity in professional relationships “ and “A pharmacist promotes the good of every patient in a caring, compassionate, and confidential manner”(4). In Virginia, the State Board of Pharmacy ruled that Walgreens’ actions appeard to violate no rules or regulations of that state. In New Mexico, the State Board of Pharmacy (NMBOP) defines unprofessional conduct as, “Participation in a plan or agreement which compromises the quality or extent of professional services, or facilities at the expense of public health or welfare”(5). By this very definition it seems clear that Walgreens is engaging in unprofessional activity in New Mexico; just by reading this regulation, the issue seems cut and dry. In an effort to have the GFD policy investigated as engaging in unprofessonal conduct, New Mexico Congress-woman, Michelle Lujan Grisham has sent a letter to the NMBOP outlining her concerns and requesting that the GFD policy be put on hold until these concerns can be addressed. (6).
As the Walgreens GFD policy is a pharmacy issue, it is further distressing that state and local medical groups have moved forward to take action against Walgreens. The California Medical Association, in cooperation with the American Medical Association (AMA), has expressed outrage regarding the GFD policy, yet no action has been taken to date by any California pharmacy organizations (7). Further, the New Mexico Medical Society (NMMS), in cooperation with the AMA, has placed on their website a form for reporting problems with Walgreens handling of patients’ opiate prescriptions and a letter to providers outlining the efforts that NMMS has performed to address this issue. (8).
Which side are you on
Florence Reese, Which Side Are You On
There are obviously multiple layers to this issue. There is the fact that there is an epidemic of abuse of prescription opioids; one that is hitting our teenage population especially hard. There is the fact that Walgreens is in a tough position by needing to fulfill the terms of an MOA they made with the DEA. There is the issue of a retail pharmacists having corresponding responsibility with no corresponding authority. But in the end, as a definition of unprofessional conduct, as defined by the NM BOP is,” Participation in a plan or agreement which compromises the quality or extent of professional services, or facilities at the expense of public health or welfare”, then Walgreens is engaged in unethical practice as evidenced by:
- The delay in dispensing opiate medication to a patient in order to gather data per their internal GFD policy that is above and beyond any state or federal requirements, which exposes patient’s to safety risk and compromises the quality of professional services.
- The fact that patients, against their preference, had to change pharmacies in order to get the prescribed amount of opiate medication dispensed to them has compromised the quality of care that Walgreens pharmacies are able to deliver.
- The fact that Walgreens has done at best a sub optimal performance in educating their pharmacists’ as to the goals and objectives of the GFD policy, and at worst a deliberate attempt at mis-information as evidenced by the fact that Walgreen’s personnel are apparently misinforming patients and providers for the reasons this additional information needs to be collected. This compromises Walgreens’ integrity and credibility which compromises the quality of professional services.
- The fact that Walgreens may be profiteering from implementation of their internal GFD policy by asking providers for a second opiate prescription to make up the balance of the original prescription that is greater than #120 doses requiring the patient to pay cash for the second prescription has negatively impacted on Walgreen integrity and credibility and decreased the quality of professional services.
- The fact that there is no “corresponding accountability” for a Walgreens’ pharmacist for “prescribing by omission” if there was an adverse event that occurred because a patient’s opiate prescription being dispensed was delayed due to their GFD policy has compromised the quality of care.
There is no other health care profession that would allow this. If pharmacy wishes to maintain its integrity both within and outside the profession, it cannot mutually support the position that pharmacists should be federally recognized providers and support the GFD policy Walgreens Corporation is implementing. If the profession of pharmacy wishes to continue its covenant with society, it cannot both support provider status for pharmacists and have pharmacists “prescribing by omission” as Walgreen pharmacists are doing. We are either who we say were are, or we’re not. Our words and policies mean something or they don’t. Please take some time and act to stop Walgreens Corporation from defining what pharmacy professionalism is! If this is happening in your area, please feel free to copy and utilize Congress-woman Lujan-Grisham’s letter to the New Mexico Board of Pharmacy and the New Mexico Medical Society Reporting Forms.
I know that this is a long blog post, but I sincerely thank you for taking the time to read this.
- 1. DEA Serves a Suspension Order on Walgreens Distribution Center in Jupiter, Florida. http://www.justice.gov/dea/divisions/mia/2012/mia091412.shtml. Accessed 4.26.13
- Title 21, Code of Federal regulations, section 1306.4.http://www.deadiversion.usdoj.gov/21cfr/cfr/1306/1306_04.htm. Accessed 4.26.13
- Good Faith Dispensing provider letter. Walgreens Company. Received 4.27.13
- Oath of a Pharmacist.www.pharmacist.com. Accessed 4.24.13
- New Mexico Code of Regulations. 188.8.131.52
Ernest Dole, PharmD, PhC, FASHP, BCPS
Dr. Dole is Clinical Pharmacist at University of New Mexico Hospitals (UNMH), Department of Clinical Pharmacy/Pain Consultation and Treatment Center (PCTC); and Clinical Associate Professor at University of New Mexico Health Sciences College of Pharmacy. At UNMH PCTC, Dr. Dole manages ambulatory care patients with chronic pain, as well as participating on an inpatient Pain Service. He received his B.S. in Pharmacy from Colorado, with honors, and his Doctor of Pharmacy degree from Tennessee. He completed an ASHP accredited Clinical Pharmacy Practice residency at Memphis VAMC, 1988. Dr. Dole was the ninth Pharmacist Clinician in New Mexico in 1996, was recognized as an ASHP fellow in 1997, passed the Board of Pharmaceutical Specialties Pharmacotherapy exam in 1997, and Certified Diabetes Educator exam in 2000. Dr. Dole has twice been nominated for the NMSHP Pharmacist of the Year. He has been the Chair of American Society of Health-System Pharmacists Section of Home, Ambulatory and Chronic Care Practitioners and has served as a member on ASHP Councils and Task Forces. He has been president of the New Mexico Society of Health-System Pharmacists in 2008-2009. Dr. Dole received the Volunteer Faculty of the Year Award and Preceptor of the Year Award from University of New Mexico Health Sciences College of Pharmacy in 2009. In 2012, Dr. Dole received the Dorothy Dillon Memorial Lecture Award from the New Mexico Society of Health System Pharmacists. This is the organization’s highest honor. His research interests include the impact of culture on pharmaceutical care, substance abuse in the elderly, and obtaining federal recognition of pharmacists as healthcare providers. His research interests with respect to chronic pain control include the effect of high opiate doses on testosterone levels, the effect of opiates on sleep apnea, and the use of non-opiate medications in the therapy of chronic non-cancer pain.