Drug Safety

State Boards of Pharmacy Missing in Action During Opioid Crisis

This post should serve as the beginning of a serious inquiry into the failure of U.S. state boards of pharmacy to properly regulate pharmacies that irresponsibly and too often illegally profited from opioid drug sales to patients. Sociologist Elizabeth Chiarello writes, “Boards have a duty to protect the public, but because they are mostly comprised of professionals whose common interests may conflict with those of the public, their ability to do so is questionable.” Indeed.

While the drug companies, wholesalers, pharmacies and doctors, and federal regulators, such as the FDA and DEA, all point fingers at each other, it seems that the state boards of pharmacy are getting a pass that they don’t deserve. This is a largely unexplored and under-investigated piece of the puzzle in the opioid crisis of the past two decades. But not entirely.

West Virginia’s Charleston Gazette-Mail did an incredible job of investigative reporting that in my opinion unequivocally found the West Virginia Board of Pharmacy grossly negligent in its regulatory role to protect the public’s health and safety. It’s really straightforward. According to the title of the Gazette-Mail’s article, “Suspicious’ drug order rules never enforced by state,” the board of pharmacy in West Virginia ignored thousands of suspicious drug order reports.

West Virginia, sadly, is the poster child of the opioid drug crisis in the United States. They have the record for the highest number of drug overdose deaths per 100,000 people in one year: 57.8 in 2017. Last year, the state ranked 5th in the rate of drug overdose deaths. From the Commonwealth Fund: “West Virginia had not only the highest state rate of “deaths of despair” in 2016 but the biggest increase in deaths from these causes since 2005.”

The big pharmacy wholesalers, AmerisourceBergen, Cardinal Health, and McKesson, have all been accused of failing to report huge increases in opioid orders and “turning a blind eye” to the opioid epidemic and agreed to settle to the tune of billions of dollars to avoid further litigation and prosecution. What did the law require them to do? In West Virginia, the law requires wholesale pharmacies to report suspicious orders of drugs to the pharmacy board, those “of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.” W. Va. Code R. § 15-2-5. So, where was the West Virginia Board of Pharmacy?

Despite the law requiring the reporting of suspicious orders, the Gazette-Mail reported that between 2001-2012 the board received only two reports, both from Cardinal Health. Arguably, that period represented the worst surge in opioid addiction to prescription drugs, when doctors were still flagrantly writing opioid prescriptions for patients with only moderate pain. By 2010, according to the CDC, nationally, opioid prescriptions began to decline but still remained far higher than in previous periods.

In West Virginia, by 2012 big wholesaler pharmacies were under investigation by the state attorney general: and then the suspicious order reports began to come in. After 2012, the West Virginia Board of Pharmacy received over 7200 suspicious drug order reports. What did the board of pharmacy do with those reports? Literally nothing, as reported in the Gazette-Mail:

The pharmacy board didn’t investigate. It never contacted the wholesalers or pharmacies. It didn’t pass the reports along to law enforcement authorities.

So pharmacies could order scores of powerful painkillers at will with no scrutiny — at least from state regulators.

There was no price to pay for the members of the board of pharmacy. Some members of the board remain on the board to this day.

The example of West Virginia may be an outlier, but I tend to doubt it. A couple of months ago, a federal jury in Ohio decided to hold large U.S. pharmacy chains, including Walgreens, Walmart and CVS accountable for the trail of addiction and death in Ohio communities. After I read about that case, I went to the Ohio Board of Pharmacy website to see who was on the board. I suspected I would find big chain pharmacies represented on the board, and that’s just what I found. Three out of eight board members work for CVS, Meijer, or Walgreens. The Ohio jury’s verdict was that CVS, Walgreens, and Walmart “recklessly distributed massive amounts of pain pills in two Ohio counties.” The lawsuit alleged that the pharmacies “engaged in intentional conduct to dispense opioids in a manner that caused an oversupply of highly addictive drugs in Plaintiffs’ communities.”

I’d like to know, what was the Ohio Board of Pharmacy doing to police the pharmacies’ opioid sales? Shouldn’t we be asking whether the public can continue to rely on board members to regulate the very companies they work for?

At the first West Virginia State Board of Pharmacy meeting to publicly discuss the issue of the reports of suspicious orders not being reported, one lawyer for a wholesale pharmacy said, “For many years, the board didn’t really want suspicious order reports.” We need to ask “why” and never let this happen again.

Gabriel Levitt

President of PharmacyChecker.com and Founder of Prescription Justice