Pain-Pill Abuse Can Be Curbed Through Private-Sector Innovation

Picking the proper medication for our patients is a delicate nuance that is part of the art of medicine.  Cook book medicine does not often make a very good cake. Of late, government regulations have made it more difficult to find the right recipe for our patients particularly when they need pain relief.

Pain is a common problem.  Pain may be chronic or acute and may take on a life of its own particularly if it is not managed properly   I have seen patients with the kind of pain that makes living a normal life nearly, if not completely, impossible. Simple daily functions that most of us take for granted, such as walking or sleeping, can become insurmountable tasks.  Many of these patients unquestionably require the use of pain medication.  For them it is not a choice, it is a necessity.

Opioid pain relievers are almost never a first choice. The side effects are overwhelming particularly for the elderly. But, they can literally be lifesaving for these patients.  Unfortunately, the opioid abuse is a billion dollar industry and the government has decided to come in with an iron fist and impose regulations that neither curb the abuse or establish a means of reasonable accessibility for those who need the medication.

More than 60 people die every day in the United States from prescription drug overdoses.  6.5 million people abused prescription drugs in 2013, more than double that of heroin, cocaine and hallucinogens, combined.

According to a 2010-2011 government survey almost 1.5 million Californians, ages 12 and over, were estimated to have abused painkillers in the previous year. Seven percent of adolescents ages 12 to 17 in California used pain relievers for nonmedical reasons in the previous year, according to 2009-2010 figures.

Taxpayers are left on the hook for increased medical and policing costs, and abuse can also wreak economic devastation by reducing productivity.  Misuse and abuse of opioids is estimated to cost the U.S. $56 billion annually.

The opportunity to find a better means of administering opiods opened the door to the American entrepreneurial spirit and private industry has answers. By utilizing “abuse deterrent formulations” for opioid painkillers, we can significantly reduce the abuse of these drugs.

Breakthrough abuse deterrent formulations provide patients with the same pain relief as conventional opioid medications, but protect against abuse by making crushing, cutting and dissolving for injection extremely difficult and blocking the euphoric effect of the pills when manipulated.

While there are many contentious issues among those in the healthcare field, the facts in this situation are clear: pain management is a necessity for millions of people and non-medical use of these drugs is a medical, ethical and public safety problem that must be addressed.

The Food and Drug Administration considers the development of abuse deterrent formulations a high public health priority, and those of us in the medical community, along with policymakers in the Capitol, should as well.

Research on the relatively new abuse deterrent formulation of OxyContin, the first opioid approved by the FDA to make abuse deterrent claims, found that inhalation and injection abuse dropped from 70 percent to 40 percent, and poison control center calls declined by 32 percent.

It is estimated that utilizing abuse deterrent formulas can save hundreds of millions of dollars in medical and criminal justice costs.   These are dollars that would be far better spent elsewhere, as we struggle to rebound from the worst economic downturn most of us have ever seen.

Abuse deterrent formulations have received widespread support as part of a comprehensive effort to combat prescription drug abuse and promote appropriate pain management, including from the Office of National Drug Control Policy, the Community Anti-Drug Coalitions of America, members of Congress and the National Association of Attorneys General.

The California Medical Association approved a resolution in December 2014, supporting the FDA’s ongoing efforts to evaluate and label abuse deterrent technology and opposing the imposition of administrative deterrents that decrease access to and coverage of prescription drugs with abuse deterrent properties.

Our regulators need to open the doors for these new formulations rather than developing regulations that only hurt those patients who legitimately need these meds.  It is time that healthcare professionals, patient advocates, stakeholders and policymakers move forward to improve access to this new technology.  I welcome this rare opportunity where private industry can work productively with government to help America’s patient find a productive pain-free day.

Marcy Zwelling, MD, is Vice Chair, American College of Private Physicians