The Next Barriers to Care: Your Local Pharmacy
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.