Proponents argue that limits reduce the risk of addiction, but are they keeping pharmacists from caring for their patients?
As the opioid crisis worsens, pharmacies, pharmaceutical manufacturers, and legislators are scrambling to help solve the problem. Recently, those efforts have focused on limiting opioid supplies. But in the effort to prevent unnecessary medications, are pain patients getting left behind?
Several major players in the pharmaceutical world have recently voiced their support for opioid limits. Express Scripts and CVS Caremark (CVS’s PBM) recently announced a seven-day supply limit, and PhRMA, the association representing pharmaceutical manufacturers, announced at a meeting of the President’s Commission on Combating Drug Addiction and the Opioid Crisis that it also supported a seven-day limit. The DEA recently announced that it is advocating for a 20% reduction in opioid production next year, which could affect the supply of available opioids.
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Most opioid limits are based on CDC guidelines released in March 2016, guidelines based on a review of available evidence and expert opinions. The recommendations cover patients facing long-term chronic pain (pain lasting more than three months), but not active cancer treatment, palliative care, or end-of-life care. The CDC recommends that clinicians prescribe immediate-release opioids instead of extended-release opioids, and avoid going over 90 MME/day. The guidelines say that three days or fewer of opioid supply “will often be sufficient” for acute pain, and that supplies for more than seven days “will rarely be needed.” However, the report does stipulate that “patients should receive appropriate pain treatment based on a careful consideration of the benefits and risks of treatment options.”
A spokesperson for PhRMA said that, while still needing to stay consistent with state guidelines, certain criteria conditions would “clearly” meet exemptions, such as cancer pain and hospice and palliative care.
Overall, pharmacy groups seem supportive of the effort, but wary of its implementation.
Chad Clinton, an APhA spokesperson, told Drug Topics that APhA is “generally supportive of the CDC Guideline, which are recommendations intended to drive safer prescribing for chronic pain patients, and are not suggested for active cancer treatment, palliative care, and end-of-life care, and efforts to address our nation’s opioid epidemic.”
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However, Clinton said that APhA has “concerns that payer decisions are a one-size fits all approach and will supplant providers’ clinical decision-making and the needs of patients who have legitimate need for these medications.” He added that payer limits restrict patients with legitimate pain management needs from accessing opioids. Those limitations, he said, will force patients not at risk of abuse or misuse to work with their prescriber and pharmacist-which will cost the health-care system and “significantly” impact patients with limited resources, physical restrictions, or transportation issues. He also added that more research still needs to be done on the impact these rules will have medications for legitimate patients.
As for how they will affect pharmacists, Clinton said that “APhA is concerned pharmacists and other providers will have additional administrative burdens due to the need to navigate these limitations on behalf of our patients in order for them to obtain the medications they legitimately need.”
Up next: More pharmacy groups weigh in
Deborah Pasko, PharmD, MHA, Director of Medication Safety and Quality at ASHP, echoed similar praises and concerns about the various policies. She said that there has been an “often been an imbalance” in the number of opioids prescribed versus what was actually needed, especially for acute pain patients. She gave the example of wisdom tooth extractions and broken bone resetting that may only require small quantities (fewer than 30 tablets), but that prescriptions frequently exceeded the necessary amount. The CDC guidelines, she said, “do allow some flexibility,” but noted that some patients do require higher than 90 MME/day doses.
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Pasko concluded that “the guidelines are a good starting point for providers, but the provider and pharmacist should still decide what is best for the patient and assess risks versus benefits.” She said that because opioid limits are still are relatively new domain and different states have been enacting different policies, it is difficult to gauge the effects of limits on how pharmacists operate. However, she did say that “some pharmacists involved in ambulatory care settings may be affected if patients are sharing struggles or discontent about ability to obtain opioids with them directly.”
NCPA recommended a maximum day limit on opioids, but added that they must take into consideration “certain patient populations.” They also stressed that any rules need to be consistent.
Pharmacists are struggling to fully understand what the implications of these limits will be for them and their patients. On one hand, pharmacists know that opioids are a problem, but they also know that some patients need access to pain medications. Pharmacists, like pharmacy groups, worry that hard limits could reduce a pharmacist’s decision-making abilities. Richard Logan, PharmD, Owner of two Missouri pharmacies and a certified police office and drug diversion investigator, summed it up this way: “Are we at the point where we need a corporate policy that supersedes professional judgment?”
Logan said that he sees challenges and benefits to opioid limits. If opioid limits work, he said, they will be as part of a “multifaceted approach,” not just one effort. But he did stress that pharmacy is a common point in the issue. “Pharmacy is the common touchpoint for every single opioid,” he said. “Pharmacy needs to be in this.”
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The problem, Logan said, is how limits are enforced and treated. He said the opioid crisis was a population problem and wondered, “What happens to an individual patient when they run up against a population-held issue?” He said that “It’s hard to treat people on the average, because I have yet to meet an average person.” He said that logistical elements, such as the number of phone calls that need to be made, how preauthorization would work, or how rules would be implemented across the spectrum of opioid patients, have the potential to be very challenging.
“I’m sure it’s going to make an impact,” he said. “My fear is that it’s also going to make an impact on patients who need those meds.”
When asked how patients were responding to limits, he simply laughed. “How do you think they’re going to react if we tell them they have to be in pain for four more hours while we contact their physician?” he asked.
Karl Deigert, BSPharm, a Florida-based pharmacist (where the governor recently announced a three-day limit on opioid prescriptions), was more direct in his disagreement with opioid limits. Deigert said that he first became familiar with pain management during a short time working as a home infusion pharmacist dealing with end-of-life HIV patients more than 20 years ago. During this time, he was trained to choose dosages based on an individual patient’s needs, and that “physical dependence and tolerance was to be expected and accepted as part of good pain management.” He added that during this time he also became familiar with what someone could handle with daily dosing, citing one patient who was taking nearly 800 MME/day but who “carried on as normally as any opioid-naive patient.”
Since that time, Deigert worked in several retail locations and continued to advocate for pain patients. He alleges that “corporations and the majority of retail pharmacists simply do not care to help the chronic pain patient population.” This is due to worries about increased DEA scrutiny, fear of having a patient overdose, a lack of pain management experience, prejudices surrounding patient’s medication use, and the extra workload with no benefit or compensation, he said.
He said that he has seen pharmacies unwilling to even stock opioids to make it easier to refuse patients and prevent the pharmacy from coming under increased scrutiny. He said that this creates a situation where patients are forced into what he called a “pharmacy crawl,” where they are forced to go from pharmacy to pharmacy searching for one with both a supply of medication and a pharmacist “with empathy and care for their patients.”
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When asked how patients will be affected, he was sure that the impact would be negative. Patients, he said, “are inconvenienced beyond any reasonable measure. Opioid limits will “reduce access to needed care for chronic pain patients.” They “will be forced now to see the same doctor for the same medication multiple times a month, to pay multiple office visits, waste inordinate amounts of time traveling and waiting to be seen, only then to be forced to spend more hours and expense traveling to seek the medications.”
Beyond his worries about the effects on patients, Deigert was also worried that strict guidelines interfere with a pharmacist’s ability to make decisions based on an individual patient.
“My objection is not with establishing a guideline; but rather, lies in the fact that pain management is subjective, amorphous, and must be individualized to each patient. What works for one is not good for all,” he said. “The guideline removes all ability of the pharmacist to think critically and make good professional judgments based on good patient assessment and due diligence to weed out potential abusers of narcotics while providing care to those most in need.”
Just as pharmacists and pharmacy organizations worry about patient reactions, so do pharmacy chains.
Erin Shields Britt, a spokesperson for CVS Health, echoed the call for increased collaboration between health-care stakeholders, saying that addressing the issue “will require a multi-pronged effort-from physicians and pharmaceutical companies to pharmacies and government officials.”
“We recognize that there are patients with a legitimate need for pain medication, and our approach is carefully designed to ensure that those patients can access their medication in an appropriate manner. We are dedicated to ensuring our retail and PBM approaches do not negatively affect patients who, for example, have cancer or palliative care needs, and are in need of their medication,” she said. “In implementing our utilization management edits, we review our available information to understand if the patient is being treated for cancer; if we find a cancer medication in their history over the past year, we immediately bypass our edits and the medication will be approved as written.”
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CVS also pledged to strengthen its counseling for patients filling an opioid prescription, including education on CDC guidelines, the risk of dependence, the importance of securing medications, and proper disposal methods.
When asked about how exceptions will be handled, the she said that as a PBM, CVS has experience in handling those types of requests. She also added that prior to the changes going to effect on February 1, 2018, affected members and prescribers will be notified “well in advance” to “ensure time for patients and providers to take appropriate action prior to any changes taking effect.”