According to the Centers for Disease Control and Prevention, the amount of pain that Americans report has not increased significantly since 1999. Yet in the same time period, the quantity of prescription opioids sold in the United States has nearly quadrupled, as has the number of deaths resulting from prescription opioid overdoses. In an effort to stem the tide of opioid-related deaths, lawmakers in Massachusetts have increased their focus of late on regulating and monitoring the prescription and dispensation of legal painkillers. To that end, in March 2016 the Massachusetts legislature overhauled the Controlled Substances Act, M.G.L. c. 94C, as it applies to prescription opioids. As Julia Monack McLetchie explained in an earlier blog post, one major impact of these statutory changes was to revamp the Massachusetts Prescription Awareness Tool, an online database that allows prescribers to track their patients’ opioid prescription histories and law enforcement to identify problematic prescribing trends and potential drug diversion. A second, equally significant component of the March 2016 legislation imposes new requirements on prescribers with respect to patient requests for partial fills of prescriptions for Schedule II opioids. These requirements are intended to empower patients to manage their own prescriptions, so as to reduce the number of unused painkillers that linger in medicine cabinets and thereby eliminate a major source of prescription opioids for people who may abuse them.
In a recent Circular Letter, the Massachusetts Department of Public Health explained that the revised Controlled Substances Act (1) provides patients with the right to request that the pharmacist dispense less than the prescribed amount of an Schedule II opioid and (2) requires that prescribers include a notation indicating to the dispensing pharmacist that the patient has this right on each Schedule II opioid prescription. The statute also makes clear that if a patient requests and receives less than the full number of pills prescribed, any amount remaining under the initial prescription is void. That is to say, the patient must obtain a new prescription in order for the pharmacist to legally dispense an additional quantity of the drug to the patient.
The Circular Letter also provides guidance to prescribers and pharmacists on what constitutes compliance with these statutory changes. With respect to prescribers, the Letter explains that DPH considers the notation “Partial fill upon patient request” to satisfy the new statute. This notation must appear on every prescription for a Schedule II opioid either in writing or electronically. The Letter further advises that a dispensing pharmacist who receives a Schedule II opioid prescription without this notation must contact the prescriber for confirmation that a partial fill is indeed authorized and must document such confirmation on the prescription before filling it. Notably, this is true whether or not the patient has in fact requested a partial fill.
Massachusetts’ requirements regarding patient requests for partial fills of opioid prescriptions are some of the first of their kind and it remains to be seen whether they will fulfill their intended purpose. Nonetheless, in light of the continued focus of lawmakers and regulators on the seemingly intractable opioid epidemic, prescribers and pharmacists should anticipate strict enforcement of these new requirements.