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Issue Background

Abuse Deterrent Formulations

SPPAN Position

SPPAN supports the development of abuse-deterrent formulations (ADF) and views them as one of many important components in a complex strategy to combat prescription drug abuse, misuse and diversion.  We encourage pain management advocates to support legislation and regulation that includes the following provisions:

• The decision to prescribe and use ADF should be made by the prescriber and the patient, based on a thorough risk assessment that considers not only the patient, but others in the patient’s social setting who may be seeking opioid analgesics for the purpose of abuse.

• Prescriptions specifically written for an ADF should be filled as written. Pharmacy benefit managers and individual pharmacists should not be allowed to substitute generic non-ADF products in these instances without first obtaining approval from the prescriber.

• Reimbursement for ADF prescriptions should be provided at a level that does not threaten patients’ ability to afford them. While plans vary somewhat with respect to their reimbursement tier structure, we believe that the rate of reimbursement for ADF prescriptions should be equal to or less than that provided for preferred brand-name medications.

• If a prescription is not written for an ADF, or if the prescriber notes on the prescription that substitution of a generic non-ADF is permissible, then such a substitution should be allowed. The patient should be charged the appropriate co-pay for the generic non-ADF, based on his or her pharmacy benefit plan.

Background

The misuse, abuse, and diversion of controlled substances, especially opioid pain relievers, is a public health crisis that produces tragic and sometimes fatal consequences. Pain management professionals, and the people with pain for whom they care, recognize this crisis and are eager to be involved in finding and implementing effective solutions. They seek solutions that do not restrict the ability of people who benefit from the use of opioid pain relievers to obtain them at a price that is appropriate and manageable. It is important to consider how to balance the needs of those who might be harmed by inappropriate medication use, as well as those who benefit from appropriate use of opioid pain relievers.

Many people who abuse opioid pain relievers do so by swallowing intact dosage units, but many others (as many as half in some studies) alter the original formulation by crushing, cutting, or melting it. This defeats the extended release mechanism and enables them to inhale or inject the active ingredients in order to obtain a faster and higher maximum concentration of the drug in the blood stream. This, in turn, produces a greater sense of feeling euphoric, or “high”.

To combat such tampering with their products, pharmaceutical manufacturers have begun developing new formulations of frequently-abused opioid pain relievers that deter such tampering. Some of these products are tamper-resistant, in that they are manufactured in ways that make it difficult to crush or cut them (e.g., OxyContin®). Others are made so that such tampering is discouraged, as it causes the release of an opiate receptor antagonist which, when injected or snorted with the opioid, blocks the euphorogenic effects of the opioid (e.g., Embeda®). Both can accurately be referred to as “abuse-deterrent”, the term used in the balance of this statement. Other abuse-deterrent mechanisms are under development, with the support of the US Food and Drug Administration.

Resources:

Commentary: Abuse-Deterrent Opioids: Who Needs Them, and at What Cost?  Partnership for Drug-Free Kids, February 4, 2015, by Bob Twillman, PhD, FAPM

Abuse-deterrent formulations show promising signs of reducing the incidence of the most dangerous and potentially deadly form of abuse. They should be available when needed, at a reasonable cost.