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Chronic non cancer pain (CNCP) is one of the top five reasons patients seek healthcare treatment. However, the treatment of CNCP has become more complex and more controversial in recent years; primarily due to the increased use of chronic opioid therapy (COT) to treat CNCP. Many medications used in the pharmacotherapy of chronic conditions, such as warfarin or insulin have dangerous adverse effects. The use of chronic opioid therapy is no different. With the increased use of COT, there has been an increase in the rate of accidental overdoses in patients prescribed COT. Our state, until recently, had the highest rate of accidental overdoses in the country. Due to the efforts of our state’s Board of Pharmacy & Board of Medicine, and the resulting changes in regulations guiding COT, New Mexico has moved from #1 in the country to #2 in the rate of accidental overdoses.

Walgreens Company has recently been fined $80 MILLION dollars for their lack of control for diversion while their pharmacies dispensed BILLIONS of doses of oxycodone. Walgreens has now been implementing their Good Faith Dispensing Policy across the country as part of an agreement with the DEA. However Walgreens is spinning this as a “trail blazing” program for public safety. This policy is the height of corporate self-interest, borne out of the height of corporate greed. It is being implemented by misinformation because the truth is to damaging to Walgreens. Remember Walgreens did not get fined a record amount for doing the right thing!!

For brevity’s sake I will address my concerns with the Walgreens Company’s GFD policy in bullet points.

1. A continued and repetitive pattern of misinformation on the reason for, and the implementation of, the GFD policy
   1. In the Walgreens “Dear Prescriber” letter, the second sentence in the first paragraph states to “satisfy DEA requirements”. The DEA does not make “requirements” and this letter does not give any qualifiers stating that fact or that these DEA requirements are specific to Walgreens pharmacies only.
   2. In repeated conversations that myself and other providers at UNMH have had with Walgreens pharmacists we were repeatedly told that the GFD policy was due to “new DEA requirements”. It was never clarified that the to “new DEA requirements” were specific to Walgreens pharmacies only
   3. In repeated conversations that myself and other providers at UNMH have had with Walgreens pharmacists we were repeatedly told that the GFD policy was due to “new Board of Pharmacy regulations”. I am on the NMBOP subcommittee that would have written any new requirements, and to my knowledge we have not done so.
   4. In repeated conversations that myself and other providers at UNMH have had with Walgreens pharmacists we were repeatedly told that the GFD policy was due to “new insurance limits.” In conversations with insurance companies when I asked about limits on opiate medication, many insurance companies stated that they were thinking of implementing limits on certain opiate medications, but had yet to do so.

      
      

   5. Education in Substance Abuse: without the needed education, the pharmacist cannot make an informed decision. Not having the ability to make an informed decision, can lead to incorrect decisions and negative outcomes
      1. Many of the pharmacists have not had any in depth education in recognizing and addressing substance abuse since before their graduation from pharmacy school.
      2. In discussion with Walgreens personnel responsible for the education of their staff pharmacists, this area of needed education was never explored.
      3. Many patients were given prescriptions for greater than 120 doses of their COT. The Walgreens pharmacist would then decrease this amount to #120 doses per the GFD policy. Patients unable to go to other pharmacies were therefore forced to go one or more months before the patient could see their provider and this could be addressed. In some instances the provider was contacted by the Walgreens pharmacist for an additional prescription to make up the balance of the first prescription. This required a second co pay at best or cash payment for the second prescription. The payment of cash for the second prescription could then be misinterpreted by anyone reading the PMP report as a DEA “Red Flag” and the patient could be unfairly stigmatized.
      4. Many patients had to return to the Walgreens pharmacy two to three times or more or were told to go to another pharmacy. However for many patients this is an undue hardship. Additionally, a patient going to multiple pharmacies can then be flagged as a “pharmacy shopper” and unfairly stigmatized.

         
         

   6. Delay in delivery of prescribed COT or a decrease in the amount of doses prescribed for COT
      1. In multiple discussions with Walgreens pharmacists between myself and/or other UNMH providers the message was clearly conveyed that the dispensing of the COT prescription will be held until information such as the ICD-9 code, previous therapies tried and failed, other options for pain therapy, and expected duration of COT were obtained. The gathering of the above information is above and beyond any state or federal regulations and is unique to Walgreens internal policy only. The time delay involved in obtaining this information specific to Walgreens pharmacies may take 2-3 days. In that 2-3 day delay the patient is exposed to morbidity from increased pain and/or opiate withdrawal
2. Patient Safety
   1. Education in COT: without the needed education, the pharmacist cannot make an informed decision. Not having the ability to make an informed decision, can lead to incorrect decisions and negative outcomes
      1. The use of COT for the treatment of CNCP is complex. Many of the pharmacists have not had any in depth education in COT for CNCP since before their graduation from pharmacy school.
      2. It is clear after discussions with Walgreens personnel responsible for the education of their staff pharmacists that they do not possess the needed expertise in the area of COT for CNCP. The Walgreens personnel did not know what the current recommended ceiling daily dose for COT therapy is (100mg-120 MED), why that dose is being used as a marker (patients on doses greater than 100-120 MED have an accidental overdose rate 8-9 times higher than those that are prescribed a lower dose), what the most dangerous combinations of medications used with COT therapy are (benzodiazepines and/or carisprodol), or what the term MED means (Morphine Equivalent Dose).
      3. Walgreens personnel responsible for the education of their staff pharmacists are utilizing UNM College of Pharmacy students to help develop their education program and possibly the College of Pharmacy itself, but are not utilizing local, state or national experts in this area to help develop their education program for pharmacists
3. Corresponding Accountability
   1. The cornerstone of the GFD is the “Corresponding Responsibility” that is described in Title 21 of the Code of Federal Regulations, Section 1306.4 (2). This is appropriate. This defines part of our role as a pharmacist and helps fulfill our profession’s societal covenant to protect the public. However, with Corresponding Responsibility comes a corresponding accountability. When the Walgreens pharmacist delays the dispensing or withholds a prescription for COT based on the guidelines for the GFD policy, they are making a unilateral decision to hold a prescribed therapy. This unilateral decision amounts to “prescribing by omission” and exposes the patient to adverse events from increased pain and/or opiate withdrawal. The only person responsible for any adverse event at this point is the Walgreens pharmacist. How will this pharmacist be held accountable for their actions?
4. NMBOP definition of unprofessional activity by regulation
   1. New Mexico Code of Regulations. 16.19.4.9 states that unprofessional activity 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”. The development and implementation of the GFD by Walgreens Company was a planned activity. By the examples above, the implementation of the GFD has decreased the quality of professional services provided by Walgreens pharmacists. The GFD is the example of regulation 16.19.4.9 in action

Walgreens Company is America’s largest retail pharmacy chain. Whatever business model they choose to operate is their business and theirs alone. That is the consistent message Walgreens Company has sent as it marches across the country implementing their GFD policy. And it is the correct message…..up until the point that patient safety is compromised. And at the point that corporate policy collides with the pharmacy profession’s societal covenant to “First Do No Harm”, then it is imperative that our profession’s covenant take precedence. This is no different than the recurring discussion of the pharmacist:technician ratio that regularly surfaces. And when you have a policy where the first directions of implementing that policy state that if you do not implement said policy that your job and career are at risk, it is human nature that the corporate policy will take precedence over our societal covenant for public safety. At such a place the door opens for the slippery slope of pharmacy professionalism being defined by corporate policies.

From Walgreens Company you will hear articulate, well crafted, well planned statements as to why the GFD policy has been and continues to need to be implemented. You will hear articulate, well crafted, well planned statements declaring that Walgreens Company is a “patient-first” business and that the GFD policy is a “trail blazing”, “cutting edge” policy developed to protect the public. What you may not hear is why if those statements are true, was the GFD policy not put in place before the DEA began its investigation into the sales of oxycodone from Walgreens Company’s pharmacies. What you will not hear are statements that I and other practitioners hear daily. Statements from patients that have been Walgreens customers for years and cannot understand why they are being treated like a drug addict, why they are being interrogated by the Walgreens staff and embarrassed as other nearby customers hear the questions they are being asked. Statements from CNCP patients that could not find a ride to the Walgreens pharmacy for the third time to pick up a prescription that will not be dispensed until information that is not required by any state or federal law, only dictated by Walgreen’s internal policy is obtained. Statements from elderly patients whose joints are too painful to walk to the pharmacy because of severe osteoarthritis, to ask the Walgreens staff why their prescription for their pain medication has been reduced to #120 doses when they have routinely received #150 doses of their COT for the past 5 years. What you will not hear is the collision of corporate policy and pharmacy’s societal covenant colliding, and the lowering of Pharmacy’s professional line if the champion of that collision is corporate policy.

I have tried to outline my concerns involving the Walgreens GFD policy and its implementation. The length of this document was guided by the depth of the problem. In an effort to have the GFD policy investigated as engaging in unprofessional 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 (http://lujangrisham.house.gov/media-center/in-the-news/rep-lujan-grisham-sends-letter-to-nm-board-of-pharmacy).

I realize the length of this paper and thank you for your patience in reading and considering its points. There are so many explanations to rationalize why a wrong decision is reached, and so few opportunities to correct that path once it is set. 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 that is on her web page and the New Mexico Medical Society Reporting Forms that are on their web page.

Web sites

1. Rep. Lujan Grisham Sends Letter to NM Board of Pharmacy to Address Concerns of Constituents
2. New Mexico Medical Society