Unused First-Fill Prescriptions: Cause for Concern?
Published Online: August 16, 2013
Kimberly A. Burns, RPh, JD; Janene M. Madras, BS Pharm, PharmD, BCPS, BCACP; Mary E. Ray, BS Pharm, PharmD; Daniel P. O’Neil, PharmD; Andrew L. Bruinsma, PharmD; Emily Ferrare, PharmD, MS, RD, LDN; and Michael M. Madden, PhD
The accumulation of unused medications has the potential for negative consequences, including drug diversion and unintended poisonings, wasted healthcare resources, and harm to the environment.1 The topic of drug diversion and prescription drug abuse has recently received heightened attention at a national level. In 2011, the White House released a document and action plan titled Epidemic: Responding to America’s Prescription Drug Abuse Crisis, in which data from various studies highlighted the fact that abuse of prescription medications is the nation’s fastest growing drug problem.2 Although the document recognized that multiple classes of prescription medications are currently being abused, the action plan focused on opioid abuse.2 Sales of opioid pain relievers quadrupled between 1999 and 2010, opioid-related deaths accounted for more than 40% of drug poisoning deaths in 2008, and substance abuse treatment admissions increased 6-fold from 1999 to 2009.3,4 These sobering statistics indicate that multiple approaches are needed to combat this problem.
Access to prescription medications may occur through methods such as doctor shopping, acquiring early refills, medication resale from legitimate patients, and pill mills.5 Although national efforts to address this problem should continue to evaluate all points of access, this study focuses on accumulation of medications from everyday households.
The accumulation of unused medications may occur as a result of a myriad of factors such as patient nonadherence, expiration dates that occur too soon to enable use of a given initial quantity, overpurchase by the consumer, and overprescribing.1 A large source of the national prescriptiondrug abuse problem is a direct result of unused medications remaining in medicine cabinets.2 More than 70% of the persons who abuse prescription pain relievers obtain them for free, purchase them, or simply take them from the medicine cabinets of friends or relatives.6 The Prescription Drug Abuse Prevention Plan proposed by the White House callsfor a variety of approaches, including education, monitoring, proper disposal, enforcement, and changes in prescribing and dispensing practices to help minimize the abuse of prescription medications, while ensuring access for legitimate use.2
In focusing on the issue of medication accumulation, state agencies, federal agencies, and insurance companies have taken a proactive approach to limit the quantity for first-fill prescriptions. The Centers for Medicare & Medicaid Services (CMS) encourages patients to obtain a trial amount for first fills on prescriptions for chronic conditions at a prorated cost.7 CMS Prescription Drug Event data for Medicare Part D suggest that approximately 32% of first fill prescriptions for chronic conditions are not refi lled by enrollees.8,9 Based on data such as these, proposed changes to Medicare Advantage and the Medicare Prescription Drug Benefit Program require that Part D sponsors create and utilize a cost-sharing rate, where an enrollee wouldbe eligible to request a partial “trial fill” of a medication at a prorated cost equal to the days of supply dispensed, as recommended by the prescriber.9 The rationale for these efforts is to decrease environmental waste, discourage illegal drug diversion, replace samples given by physicians, allow patients to determine whether they will tolerate the medication, and promote savings to Medicare and Part D sponsors of more than $1.8 billion by 2018, assuming 32% of first fills are discontinued as predicted.8,9
Similar to the limit on days of supply issued through CMS, the Office of MaineCare Services, also known as Medicaid for the state of Maine, issued a 45-day supply limit on new narcotic prescriptions written for adults except those receiving cancer or human immunodeficiency virus infection/acquired immunodeficiency syndrome treatment, or hospice care. Patients receiving opioids for chronic pain due to other conditions for longer than 1 year are also subject to this restriction.10
Implementing a similar policy, private insurer Blue Cross Blue Shield of Massachusetts limits physicians to prescribing a 15-day supply of short-acting opioids with 1 additional refill within 60 days. For long-acting opioids, a cancer diagnosis must be present, the prescription must be written by an oncology prescriber, or the opioids must be used in end-of-life care. Outside of the aforementioned guidelines, prior authorization is necessary, by which physicians are required to certify an active treatment plan, acquire informed consent regarding the risks and benefi ts of opioid use along with an addiction risk assessment, and use a written agreement (ie, behavioral contract or pain contract). Furthermore, patients are limited to obtaining opioid prescriptions from a single prescribing group and preferred pharmacy chain.11
National Drug Take-Back Day events are 1 of the required actions set forth in the Prescription Drug Abuse Prevention Plan to increase proper disposal of prescription drugs, prevent diversion and abuse, and assist in reducing the introduction of drugs into the environment.2 The Lake Erie College of Osteopathic Medicine (LECOM) School of Pharmacy partnered with the US Drug Enforcement Administration (DEA) for a National Drug Take-Back Day event for the purpose of obtaining data regarding unused first-fill prescriptions in Northwest Pennsylvania. A first-fill prescription was defi ned as a prescription filled by a pharmacy only 1 time but then not finished, refilled, or reacquired via a new prescription for the patient.
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