As I travel across the county speaking to clients on prescription medications and how they affect Medicare Set-Aside arrangements, I am invariably asked “Why are there so many Pharmacies being built?” Many different reasons can be given, from access to care, competition, economics, to even the prominence prescription drug medications play in the United States Healthcare System. In 2009, prescription drugs sales topped $300 billion dollars (IMS Health).
On the flip side, however, is the dark side and opposite intentions prescription drug medications create. One only needs to do a Google search to find all kinds of stories on the crisis our communities face today concerning the increasing drug abuse and accidental deaths through overdose with prescription medications. The one story I read with the most shock is that 1 person from Staten Island, New York dies every 13 days due to a prescription drug overdose, with opioids as the leading cause (NY Dept. Health/Mental Hygiene 2011). Recent deaths of celebrities Heath Ledger, Michael Jackson, and Anna Nicole Smith, have put the spotlight back on this “hidden” problem.
Recently, the White House released a report entitled “Epidemic: Responding to America’s Prescription Drug Abuse Crisis.” The report acknowledges that prescription drugs are the second most-abused category of drugs after marijuana and that 70% of abusers are not those for whom the original prescription was written for. As opioids are very prominent in the worker compensation arena, these issues are of concern. The report also cites four areas that can potentially reduce abuse. These areas include education, monitoring, proper disposal, and enforcement.
Although this report is encouraging as potential solutions to the problem are addressed, it still comes with many questions and concerns. Think about this- the United States of America represents ~ 4% of the world’s total population, and consumes ~ 80% of the world’s opioid supply (Sciame 2010). Where do we start in all of this?
As a practicing healthcare professional, I agree with the notion that more education is an important first step. The Risk Evaluation and Mitigation Strategy REMS is a plan which arose from the Food and Drug Administration Amendments of 2007 for biologics or drugs which pose a safety risk to the general public. The REMS program was designed to allow patients continued access to medications, while lowering the potential to abuse, overdose, misuse and addiction.
Maybe the economics of medications is a prescription for a dilemma. Will programs, such as REMS, actually curb inappropriate drug use and subsequent deaths or create a barrier for those who truly need medications? Can states, such as Florida, impose some strong language and regulation to stop “pill mills” or can electronic drug monitoring programs help curtail diversion and misuse?
Prescription drug abuse is a dilemma all healthcare professionals and medical boards must recognize. However, there is some light at the end of the tunnel and one worth watching in the months and years to come.
It is still too early to tell the relative impact REMS will have upon the prescription drug abuse problem.
Going forward, REMS will play a part in addressing prescription drug abuse. But REMS can only examine the risk/benefit tradeoff of therapies in relative isolation. Increasing protection and overside on the most easily abused drugs may only serve to divert abuse to other compounds. REMS class-wide treatments such as the long-acting opioid REMS program need to allow information sharing across compounds and companies so that clinicians can better understand the usage-patterns and risk-profiles of their patients.
REMS may end up meaning “real encouragement for MORE short+acting” prescriptions. I’m afraid that regulations requiring education to prescribers of long-acting or extended release opioids, or fast-actings such as effervescent/sublingual fentanyl will result in an explosion or prescribed IR combination scheduled III products such as hydrocodone and schedule II such as oxycodone IR. The problem is likely going to remain the same or get worse unless prescribers are required to be educated on all opioids…unfortunately, even data on practitioner education outcomes are bleak. But, to think that by segregating IR’s from long-acting will help the problem is short-sited.