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Scrutiny Of Painkiller Distributors Harms Patients

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Anyone following the opioid problem knows about the delinquent practices of some drug distributors, the companies that deliver painkillers from manufacturers to pharmacies.  By transporting “suspicious orders” – regulatory code for unrealistically large shipments — to rogue pharmacies, they helped fuel the crisis of addiction and overdose. A crackdown was long overdue. But there’s an important untold story: distributors are now so spooked by class action lawsuits against them and the possibility of federal fines and even criminal action, that they are reducing the supply of pills available to patients in pain.

Consider the story of James DeMicco, pharmacist-in-charge at J and J State Street Pharmacy in Hackensack, New Jersey. On November 1, he learned that his distributor, AmerisourceBergen, would no longer supply his store with opioids.

A month earlier, J and J participated in an on-site compliance visit mandated by AmerisourceBergen. Because DeMicco fills many prescriptions from pain specialists and from physicians who treat addiction with buprenorphine (also an opioid) he is no stranger to oversight.

Together with the on-site reviewer, a former DEA agent contracted by AmerisourceBergen, DeMicco pored over thirty patient cases that the company had flagged as suspicious. Irregularities included his dispensing more than one controlled drug to a given patient and the numbers of out-of-state patients who patronized J and J, signals that perhaps the pharmacy was supplying pills to patients who were abusing them.

As DeMicco explained to the reviewer, many of his patients suffered “high impact pain syndromes” and required complex dosing regimens. Thus, some patients were prescribed two or more classes of controlled (addictive) substances, such as an opioid with a benzodiazepine (e.g. Valium) for muscle relaxation and/or a stimulant (e.g. Desoxyn) for chronic fatigue. And some of his patients traveled considerable distances to see the pain specialist in the adjoining office building – one of the increasingly few pain specialists who still prescribed opioids long term and in high doses for patients whose pain did not respond to other interventions.

The review went well, or so DeMicco thought. He’d been through many on-site evaluations in his ten years at J and J and had passed them all. But the compliance officer at AmerisourceBergen, who had the final say in whether the company would remain DeMicco’s supplier, told him that shipments would stop. “She said our pharmacy was a risk to the company,” the pharmacist told me.

The problem is widespread. “Distributors are fearful of being held liable for patients becoming addicted or overdosing,” according to attorney Steven Cava, so they set limits on how much a pharmacy can order. Oddly, those limits are confidential so pharmacies only discover they have breached them after the fact.

Cava is consulting to a pharmacy in eastern North Carolina that recently began serving a facility caring for ailing elderly people. The added demand pushed the pharmacy’s orders over the undisclosed threshold so its distributor terminated the supply of morphine for the last twelve days of October.

Granted, distributor monitoring was egregiously lax in many cases between 2005 and 2016, according to an  expose  in the Washington Post. In court settlements, distributors have admitted delivering huge quantities of opioids to pharmacies that colluded with shady physicians and that shipped directly to pill mills (bogus pain clinics prescribing opioids to virtually anyone who paid) and internet pharmacies.

A 2018 House Energy and Commerce Committee bipartisan report on rural West Virginia found distributors derelict in reporting “suspicious” pharmacy orders to the DEA, a civil violation. That same report criticized the agency’s failure to “identify diversion trends” by certain distributors and to “target enforcement actions” against them.

Many lawsuits are pending. The National Prescription Opiate Litigation, unfolding in a U.S. District Court in Cleveland, encompasses 3,000 civil lawsuits filed by city, county and tribal representatives against distributors, as well as drug makers and pharmacies. States are suing separately. In October, federal prosecutors initiated a criminal investigation into whether distributors and others allowed opioid painkillers to flood communities, potentially charging violation of he Controlled Substances Act, a laws normally used to go after drug traffickers, according to the Wall Street Journal.

And it is not just distributors who are trying to shield themselves from penalties.  

Walmart and Sam’s Clubs’ pharmacies, for example, have imposed daily limits per patient of 50 morphine milligram equivalents, or MMEs (which translates to 50 mg of Vicodin or about 35 mg of Percocet) for chronic pain. For people suffering extreme pain from, for example, diabetic peripheral neuropathy (severe nerve pain caused by diabetes) or fibromyalgia, 50 MMEs can be far too low.  

As for doctors, the story of their retreat from treating chronic pain patients has been well documented. Physicians worry about losing their licenses lest they prescribe opioids and attract the attention of the DEA or their state medical boards. This summer, Quest Diagnostics, a lab testing company, surveyed 500 primary care physicians and found that 81 percent are reluctant to care for chronic pain patients who take opioids. Another recent study found that two in five primary care clinics sampled in Michigan refuse to accept new patients already treated with opioids.

Shortly before AmerisourceBergen was going to be cut off his supply on December 12, DeMicco found a small distributor whose name he won’t disclose. “It’s a band-aid on a bullet hole,” DeMicco told me. He can no longer get brand name opioids such as Nucynta and Xtampza and what he does obtain comes only in small volumes.  

One patient called him in tears because five other pharmacies could not fill his prescription for buprenorphine, an anti-addiction medication that DeMicco would normally have in stock.

All agree that judicious oversight and accountability are imperative. But under intense scrutiny, distributors are practicing defensive medicine and unintended casualties –patents in pain — will surely mount.

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