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11 Articles in Volume 12, Issue #10
An Anti-inflammatory Diet For Pain Patients
Focus on the Foot
How to Use Adrenocorticotropin As a Biomarker in Pain Management
Iatrogenic Nerve Injury Following Dry Needling For Foot Pain: Case Challenge
Methamphetamine Urine Toxicology: An In-depth Review
Musculoskeletal Ultrasound: A Primer for Primary Care
November 2012 Letters to the Editor
Off-label Use of Pain Treatment No Longer Covered by Insurance
Proper Disposal of Fentanyl Patches: What Patients Need to Know
The Next Barriers to Care: Your Local Pharmacy
Why Podiatric Medicine Must Embrace Pain Management

The Next Barriers to Care: Your Local Pharmacy

Actions taken by wholesalers to curtail drug diversion and abuse may be hampering physicians and pharmacies, as well as harming legitimate pain patients.

Dring the Decade of Pain (2000-2010), we spent 10 years fighting for the rights of pain patients, educating practitioners, carefully crafting treatment regimens, titrating doses, and selecting multidisciplinary treatments. This has allowed patients living with pain to get out of bed in the morning and have a better quality of life. But the Decade of Pain also has changed the landscape for pain practitioners in two significant and diametrically opposed ways. On the one hand, intractable pain has been codified into various laws and regulations enabling pain patients to finally get the treatment they need. But on the other hand, the freedom to prescribe opioid therapy has allowed some bad actors to openly write prescriptions and dispense drugs with the sole intent of profit and diversion.

In their efforts to curb prescription drug abuse, however, the authorities have come perilously close to throwing the pain management baby out with the drug abuse bathwater. It is human nature to ignore the millions of Americans whose lives have been improved by careful opioid prescribing and focus on the small percentage of people who are misusing and abusing prescription medications. After all, which makes a better headline: “Iraqi Vet With Spinal Injuries Returns to Work Part Time” or “Driver High on Prescription Pills Kills Family of Five on Interstate”? Headlines like these have put pressure on the government to “do something” about the perceived increase in prescription drug abuse. 

That something is the newest battlefront in the war on drugs: your local pharmacy. Just because you prescribe the best medication regimen for your pain patient doesn’t mean that the pharmacy will be able to fill it. Under pressure from the Drug Enforcement Administration (DEA) and legislators, pharmacy suppliers (wholesalers like AmerisourceBergen, Anda, Cardinal Health, H.D. Smith, Letco Medical, McKesson, etc) are severely restricting the available quantities of opioids that are most commonly prescribed. The DEA, which is principally responsible for monitoring illegal drug use, and the Centers for Disease Control and Prevention felt that it was useful to make wholesale drug companies into de facto deputies in the war against illegal drugs. In reaction, a group of Congressmen sent a letter to DEA Administrator Michele Leonhart stating that pharmacy owners in Florida were having difficulty obtaining certain controlled substances because the supply from wholesalers has been severely limited or shut off.1

Without the real investigative authority of law enforcement, and with limited medical training, wholesalers have tried to find a one-size-fits-all method of monitoring their hundreds of clients (pharmacies) that are dispensing opioids. According to some wholesaler insiders, these companies are looking for diversion, but without guidelines from the DEA as to what that looks like or how to proceed once a “problem” is identified.1 Although suppliers have not disclosed their monitoring methods, the arrival of companies that use statistical algorithms to monitor drug purchases suggests that statistics are the wholesaler’s starting point for discovering diversion. Some wholesalers even require prospective clients (pharmacies) to pass muster with a statistics company before they will even look at their application. This means that any pharmacy specializing in pain management (as some independent pharmacies do, including our own) will show up as a glaring anomaly. The statistics do not allow for pharmacy specialization.

Supply Chain Squeeze

The next step in the war on drugs has been to limit the quantity of drugs available to individual pharmacies. It seems that by squeezing the drug supply from the top down, the regulators hoped to limit the national supply in total. The wholesalers do this by allocation. Each pharmacy is allowed a specific quantity of scheduled drugs per month that the pharmacy may not exceed—however, the pharmacy is not told exactly what this amount is. This may be why your favorite pharmacy can no longer accept new pain patients. Taking on a new pain patient may cause the pharmacy to go over their allowed amount of controlled drugs, which may result in their inability to fill prescriptions for established patients who arrive later in the month.

Wholesalers have now taken allocation to a whole new level. We have seen that pharmacies exceeding their allocation, whose opioid use was a statistical anomaly, or that requested an increase in allocation, found their supplies of controlled medication cut off completely. Cardinal Health, one of the “big three” wholesalers, stated that it cut off controlled medications to more than 300 pharmacies2 across the country in the 4 years preceding the DEA issuance of an immediate suspension order at their Lakeland, Florida, distribution center in February 2012.3 It is believed that nearly all the pharmacies whose supplies were stopped were independent pharmacies, despite the fact that some of the biggest alleged offenders (of possible misuse and diversion) were a couple of CVS Pharmacies in Florida.4

Word spread quickly among independent pharmacies. “Don’t increase your ordering!” While 300 independent pharmacies may have been cut off, their patients did not disappear. More likely, patients simply transferred their prescriptions to big chain store pharmacies, or other independents in the area. This would increase the new pharmacy’s use of controlled substances, causing wholesalers to cast a doubtful eye in their direction. (Most of those 300 pharmacies were able to remain in business.)

This highlights the inability of the wholesalers to adequately vet a pharmacy. They simply don’t have the tools or the training. From the wholesaler’s point of view, independent pharmacies are seen as more susceptible to intentional diversion than the chain stores, which are presumed to be monitored by their corporate offices. Just recently, the DEA revoked the registrations of two CVS Pharmacies in Sanford, Florida. This is the first time the DEA has ever revoked a chain pharmacy registration.3

Don’t demonize the wholesalers for this top-down supply limit. After Cardinal Health had their registration to distribute controlled substances suspended in Lakeland, the penalties for wholesalers’ failures to monitor their customers became clear. In September, a Walgreens distribution center also was issued an immediate suspension order by the DEA, halting the sale and distribution of controlled substances from their Jupiter, Florida, facility.5 It is not clear whether the shift of former CVS patients to Walgreens had an effect on this.

Hurting Legitimate Patients

This supply chain squeeze has had some effect. With smaller quantities of prescription medication available, heroin and cocaine use is once again on the rise.6,7 Unsubstantiated Internet blogs tend to indicate that counterfeit prescription pills also are more available. And worse yet, legitimate patients are going without. It seems the tragically flawed theory behind these limits was that a smaller drug supply would be enough to treat patients but not enough to supply diverters. It turned out that both diverters as well as legitimate patients lost access.8,9 The supply chain squeeze was a blunt force blow that didn’t discriminate between legitimate patients and misusers.

One of our older barriers to care also has resurfaced: prescriber fear of regulatory prosecution. But there is a new twist; law enforcement and prosecutors are going after individual prescribers directly rather than waiting for a medical board review. United States v. Roggow was such a case.10 We have seen an increasing number of physicians being accused of murder or involuntary manslaughter when their patients have died. Once it was unthinkable to hold the prescriber responsible for the illicit actions of his properly treated patients. Now, it’s happening with greater frequency and with bigger headlines.

In the end, none of the tools to reduce the misuse of prescription opioids has been ideal. Limiting the supply of one abusable concoction simply moves abusers to other concoctions. Preventing the prescribing or dispensing of large amounts of opioids has hampered legitimate physicians and pharmacies and possibly increased the supply of counterfeit pills, while often depriving real patients of their needed medications. 

Proposed Solutions

We propose a different solution. Rather than trying to limit supplies or the prescribing habits of all physicians, we recommend that high-dose or chronic opioid patients be streamed into a well-monitored pain management specialty conduit. This would consist of a multidisciplinary method, which would include:

  • Specialty DEA diversion investigative teams to work with (not against) licensed prescribers and pharmacies. The DEA teams should be comprised of experienced law enforcement officers and board-certified pain specialists with real-world experience in both intervention and medication
  • Local pharmacies that have no financial relationship with prescribers and that are specially trained to identify diversion and identify patients face to face
  • The prevention of mail-order pharmacies from processing schedule Class-II (C-II) medications for the safety of common carriers and to prevent mass diversion
  • Eliminate direct-to-patient physician dispensing of C-II medications (this appears to be working very well in Florida)
  • Increase the availability of addiction treatment

In the meantime, the best physicians can do for their patients is to prescribe a variety of medications in order to keep any one drug, no matter how effective, from dominating the landscape. Prescribe multimodal treatments and therapies, even if third-party payors won’t cover them. Have your front office staff request valid identification for every patient, then use the identification to access your state’s prescription drug monitoring program (PDMP)—if your state has one—and keep a copy of the patient’s PDMP report in their chart. For patients on high-dose opioids, use genetic testing to help validate their use. Find a couple of local pharmacies you can trust and answer them when they call. Finally, keep detailed records of your ongoing examinations and efforts to prevent each patient from diverting their medications or becoming victims of diversion.

Last updated on: November 30, 2012
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