Curbing The Epidemic of Drug Overdoses

Dr. Robert Califf, the new commissioner of the Food and Drug Administration, is focusing his energy on curbing the epidemic of drug overdoses. He told a panel of FDA advisors last week that abuse-deterrent formulations (ADFs) may be part of the solution.

However, many speakers at that panel warned the FDA that it would be a mistake to rely on ADFs to solve the problem.

The advisors are correct. Abuse deterrent formulations (ADFs) are not a magical cure to the problem of opioid abuse.

As New Jersey Governor Chris Christie pointed out, “The benefits of [ADFs] are still uncertain in the medical community, and are the subject of ongoing research.”

At least one medical journal, the New England Journal of Medicine, has concluded that “some drug abusers using abuse-deterrent OxyContin increase their use of other opioids, including heroin.”

Governor Christie is correct, too. There are no magical cures. There are only incremental steps towards reducing harm caused by opioids.

The enemy of good is perfection. If we demand that ADFs must be able to prevent all abuse before they can be adopted, then we will not make the advances we need.

There are only two ways to stop abuse of opioids

The first way is to eliminate demand. That will never happen. People have always searched for a way to feel better. Since the beginning of time, drugs have been used for this purpose. That is just an aspect of being human. If it isn’t an opioid that is being abused, it will be a different rewarding drug.

The second way to stop abuse is to replace opioids with non-addictive medications. One day, that may happen, but that day is not likely in the near future.

So that means we have to do what we can with the current technology.

Abuse-Deterrent Formulations will not prevent all abuse

However, ADFs can reduce the risk of harm for some people. We need to think of taking small steps forward when prevention or cures for all people are not possible.

Extended release formulations without abuse deterrent properties are responsible for a disproportionate number of overdose deaths^* and in-patient admissions for addiction.^**

Reducing the deaths and substance abuse treatment by using abuse deterrents (when the alternative is to do nothing and continue to use opioids without abuse deterrents) would be a small step forward. But it would be a step forward.

Experts often argue that ADFs do not prevent oral abuse. It’s true that ADFs do not prevent all oral abuse. However, they do prevent some forms of oral abuse.

The most common method of abusing extended release opioids is to crush the tablet into powder so it is more quickly absorbed in the stomach.

In other words, ADFs prevent oral dose dumping which can cause an overdose.

ADFs also prevent the crushed power from being simply snorted, or from being diluted into a solution so it could be easily injected. It also prevents the pills from being chewed or cut to create a quick, potent rush.

Safer Formulations

The FDA has urged Pharma to develop safer formulations. In fact, the FDA created an incentive for Pharma by offering preferred labeling in their package insert if they could demonstrate the drugs had abuse deterrent properties.

Pharma has stepped up to the challenge, and they are making progress. More than 30 products with abuse deterrent properties are being developed. But, despite the large number of drugs that may have ADF properties, the drugs are still not safe for everyone. They may be safer for some people, but they will not solve the problem.

Clearly, more work must be done. We still need safer and more effective therapies.

I’m grateful to Dr. Robert Califf for continuing to seek safer medications, but lawmakers and insurance companies must help, too. They must ensure that abuse deterrent formulations are the preferred option for patients. This means that ADFs cannot be more expensive for the patient than opioids without abuse deterrent properties. Patients must be able to afford the medication or, for them, the medication may just as well not exist.

One More Option

There is one more option, of course. We can prohibit opioids. This would reduce (not eliminate, because people always find a way to get what they need, but reduce) access to opioids.

However, it would ignore the needs of people in severe pain. It would disenfranchise a group of people who represent the most prevalent health problem in America: those who suffer from pain.

Tell me, does curtailing access to the only medicine that might help pain patients make it through another day seem like something that members of a moral society would do?

I don’t think so!

 

^* Fitzgibbon D, Rathmell J, Michna E, Stephens L, Posner K, Domino K. Malpractice Claims Associated with Medication Management for Chronic Pain. Anesthesiology 2010; 112:948-56

^** NAVIPPRO surveillance system (this is proprietary data)

 

Copyright 2016, Lynn Webster, MD