The Man-made Opioid Epidemic: Part 3 – Opioids Are The Tip of the Iceberg.

Posted on | November 23, 2015 | Comments Off on The Man-made Opioid Epidemic: Part 3 – Opioids Are The Tip of the Iceberg.

NOAA

Mike Magee

The Man-made American Opioid Epidemic represents a supply chain failure and a management challenge if system flaws are to be corrected. In its simplest terms, the process involves approval, production, distribution, prescribing, dispensing, and consuming. For all pharmaceuticals, the goal should be to personalize and customize the prescription with the intent of maximizing benefit and minimizing risk. For opioids specifically, the goal should be to appropriately and wisely meet the requirements of patients with pain, while maintaining a series of safeguards to prevent, correct and treat misuse, abuse, disability and potential intentional or accidental death from overdose.

Process analysis and oversight require real time access to data. Up till now, the only ones who have had it, through a cooperative arrangement that has included the AMA, were the pharmaceutical companies. Clearly, the lack of coordinate access to information has been a well-known, and not infrequent, fatal flaw in America’s fiercely independent and dis-integrated health care system. This system has placed the highest value on professional autonomy, featuring largely self-regulating physicians, empowered to make independent decisions for, and sometimes with, patients. Since World War II, the profession’s most potent instrument, and most jealously guarded right, has been the license to prescribe medications.

This highly vaulted system has now allowed a level of abuse in consumption of opioids sufficient to bend the survival curve of white middle aged males in America. As laid out in Part 2 of this series, automated Prescription Drug Monitoring Programs (PDMPs), where utilized, as in Kentucky, have proven effective in stemming abuse, saving lives, and saving money.

The need for PDMPs, which rely on real time downloads from multiple databases, reflects existing deficiencies in the system of medical regulation and oversight. For example, large nationwide pharmacy chains electronically track and survey controlled substance prescriptions to detect prescriber or consumer abuse. But they only have access to those prescriptions filled in one of their own stores. Similarly, insurers or their agents, Pharmacy Benefit Management (PBM) companies, track claims data for abuse, but they can not detect prescriptions paid for with cash. Federal programs, like Medicaid, Medicare, VA, DOD, and Indian Health Service are unable to track purchases made in cash outside their benefits programs, and usually do not share data with the new PDMPs. Finally, state PDMP’s are not yet fully integrated with each other forming a seamless, reliable network nationally for analysis and oversight.

Though certainly imperfect and incomplete, PDMP’s, which exist in 49 states, as well as existing databases controlled by insurers, PBMs and pharmacy chains, maintain moderately effective programs to detect the most egregious opioid abusers. For example Oregon zeroed in on just 4% of the state’s prescribers because they were generating 60% of the prescriptions for controlled substances. And one national pharmacy chain uncovered 42 prescribers, each on average generating some 5000 scripts for controlled substances per month.

While criminal “pill mills” certainly do exists, the issues that have generated the current opioid crisis are far more systemic and involve long-standing, generalized, widespread, and inappropriate overprescribing of powerful pharmaceutical agents with and without high abuse potential. These insights, long suspected, will increasingly be revealed by newly established PDMPs, and shine a glaring light on the dysfunctional relationship between producers of pharmaceuticals and prescribers of pharmaceuticals.

A Johns Hopkins consensus paper revealed that proactive investigatory data analysis is now conducted by PDMPs in 26 states. Only four of those states are currently distributing algorithm driven analytics to prescribers, pharmacists, professional licensing boards and law enforcement agencies without request. But this aggressive approach is likely to spread rapidly to include most states within the next 12 to 24 months. In 32 states, some insurers are permitted to access PDMP databases, and licensing boards currently have unimpeded access in 46 states. Five states are analyzing Medicare prescribing data as well. A PDMP Center of Excellence has been established with joint funding from the CDC, FDA, and Justice Department.

While the careful tracking and analysis of prescription patterns is a relatively new capability among insurers, regulators, and law enforcement agencies, it is old hat to pharmaceutical companies. Some 60 years ago, the enterprising leadership of IMS Health began to collect raw data from pharmacies to spreadsheet and resell to pharmaceutical sales teams. The broad numbers of products sold in a region were valuable, but what the sales teams really needed was the number of scripts for each of their products written by each specific physician.

To achieve that level of granularity, the IMSs of the world needed identifier numbers for the physicians. As it turns out, the AMA possessed those numbers in what was termed the Physician Masterfile, and were willing to sell the database. The identifiers were controlled by the Liaison Committee on Medical Education (LCME) and the Accreditation Council for Graduate Medical Education (ACGME) which agreed to provide them to the AMA years ago. When physicians enter medical school or enroll in a residency program anywhere in the US, they receive a ME (medical education) number. That number is a lifelong tracker and the key to identifying future prescriptions written by those physicians in real time.

For the pharmaceutical industry, such information is a gold mine. That’s why, by 2005, as sales of Oxycontin (the premier prescriptive opioid at the center of this epidemic) exploded, IMS Health had revenues of $1.75 billion, and why the AMA charted a profit of $44 million that same year from the licensing of their Physician Masterfile to a wide range of interested parties. In the wake of criticism, the AMA created a set of voluntary guidelines for manufacturers and a process for physicians to opt-out of the Physician Masterfile on request.

The clear purpose of the pharmaceutical industry’s purchase of refined prescriber data from IMS Health and others was to inform their sales detailing, and sell more drugs. They have no vested interest in critiquing the appropriateness of prescribing practices. Over the past two decades, pharmaceutical prescribing has markedly liberalized with deliberate widening of indications, expanded use of pharmaceuticals in children, medicalization of behaviors to achieve “disease status”, and creation of pharma-funded medical research and CME organizations and patient advocacy groups who, in return for funding, willing support industry goals. These industry actions have had a single, consistent over-arching purpose – to sell more drugs.

What the PDMPs have revealed for opioids, and will soon reveal quite glaringly for a range of other agents, most notably psychiatric drugs, is that industry, in partnership with many physicians and medical institutions and member organizations, have been fabulously successful in expanding profitability and patient risk over benefit. In response, the PDMP empowered regulatory bodies will increasingly push back.

What might be expected policy wise, at minimum in the near future? Expansion of the scope of practice of pharmacists; elimination of DTC advertising which has little/no value in this modern era; the end of detailing and physician prescriber level data mining; and expanded strategies to disrupt the six decade old, self-enriching financial relationship within the Medical-Industrial complex in America.

In Part 4 of this 5-part series, I’ll explore the origins of this relationship in the immediate post-WWII period, and share the story of a single widely celebrated physician who was responsible for modern day pharmaceutical advertising tactics, facilitated drug reliance in behavioral health care, and created an addictive agent (by manipulating a WWI vintage generic product), which ignited the current opioid epidemic.