To combat rampant prescription opiate abuse, patients should be required to enter into behavioral agreements with physicians, a pair of healthcare professionals argue -- with measures including more frequent urine tests to backstop the pledges.
Under an approach advocated by two University of Pittsburgh health professionals in The American Medical Association's Ethics forum, patients taking opiates would enter such agreements that seek to curb abuse by placing standing restrictions, such as requiring police reports when patients claim medication has been stolen, or stepped-up monitoring, like increased urine tests or in-person prescription redemption, when a patient's behavior indicates a change is needed.
Although the writers, Robert Arnold, MD and Carol Heape, RN, conceded a lack of data supporting the approach, their prescription comes as public health officials and politicians grasp for a means of reining in abuse -- for example, New York Mayor Michael Bloomberg's proposal that hospital emergency rooms restrict opiate prescriptions to three-day supplies and refrain from issuing prescriptions for long-acting versions. It comes at a time when city ER visits related to opioid painkillers have nearly tripled over six years, rising from 55 people per 100,000 to 143 per 100,000.
Although New York's voluntary guidelines are for a finite area, the city trend is one that has a broader story: the most recent data from the CDC indicates that prescription painkillers are linked to 75% of prescription drug overdoses. The CDC also reports that about 2 million people first used prescription painkillers for nonmedical reasons in 2010. This comes down to approximately 5,500 first-time non-medical users a day. The CDC estimates that 20% of prescribers write 80% of all prescription medications (not just opioids).
In addition to NYC's efforts to keep opioid medications in check, national efforts are also underway. A recent back-and-forth between Representative Fred Upton (R-MI) and Department of Health and Human services officials about the FDA's power to restrict extended release opioids highlights the legal leverage the FDA says it currently has, including the ability to require generic manufacturers to create abuse-deterrent formulations of opioid analgesics if it available in the branded form. The FDA can also refuse to approve extended release opioids lacking a tamper-resistant formula if a tamper-resistant one is on the market.
Endo Pharmaceutical's crush-resistant formula of Opana ER is an example of such an attempt. The new formulation started surfacing in March 2012 and joined the FDA's orange book list of discontinued drugs in June. The company has seen sales fall during the transition, slipping 36% in the third quarter of 2012 compared to sales in Q3 of 2011, but expects sales efforts, couponing and education programs will help sales rebound.
At the same time, the FDA issued draft guidance in January that proposes drug makers test a drug's abuse potential by evaluating the benefits of bypassing abuse-deterrent measures through crushing, grinding or melting the product or how a formulation could make extracting the opiates difficult and thereby limit its desirability for intravenous injection. This is in addition to the REMS strategy the agency put in place in July 2012 that requires drug makers to supply CME programs about long-acting opioid drugs.
Arnold and Heape note that between 33% and 50% of patients will violate their behavioral agreements, and the preamble to the FDA's draft guidance notes that “most abuse-deterrent technologies developed to date . . . have not yet proven successful at deterring the most common form of abuse—swallowing a number of intact pills or tablets to achieve a feeling of euphoria.”