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Legal Obligations and Implications of Prescription Opioid Abuse:
Pharmacists' Role and Responsibilities

INTRODUCTION

Prescription opiates are among the most frequently prescribed classes of medications nationwide. Since 1999, the number of prescription opioids sold in the United States has nearly quadrupled, with more than 250 million prescriptions written for opiate analgesics in 2012 alone.1-2 Unfortunately, opioid-related deaths have risen in parallel; from 1999 to 2012, the number of overdose deaths involving opioid analgesics nearly quadrupled, leading to what is now considered a public health crisis and epidemic according to the Centers for Disease Control (CDC).3-4 Of the 41 500 drug overdose deaths in 2012, 38% were attributed to prescription opiates while an additional 14% were due to heroin.3 Perhaps what is most concerning is the fact that prescription medications are known to be a major source of diverted opioids and that 4 out of 5 new heroin users start out by misusing prescription opiate drugs.2,5

Treatment for pain is one of the most common reasons patients seek healthcare, and as a result, pharmacists are faced with the challenge of balancing appropriate treatment of patients with legitimate pain against the risks of opiate-related complications such as addiction, abuse, and diversion.6 The Drug Enforcement Administration (DEA) has referred to pharmacists as the "last line of defense" in the fight against opioid abuse, and a corresponding responsibility rests upon the pharmacist to ensure proper prescribing and dispensing of a controlled substance.7-8 Due to the large increase in opioid-related deaths, the DEA has become more aggressive in its enforcement of the Controlled Substances Act (CSA) and has been taking legal action against large retail pharmacy chains, long-term care facilities, and prescription drug wholesalers in 2012, which is a shift from their historical focus on independent community pharmacies.9 State Boards of Pharmacy, such as California, have also taken action against pharmacists for their role in improper opiate dispensing.10 In a recent case, a pharmacist's license was revoked after he failed to comply with corresponding responsibility requirements in the distribution of opioid drugs, eventually resulting in overdose deaths of 4 patients. Pharmacists must exercise their professional judgement when dispensing controlled substances, a duty that entails much more than the act of simply filling a prescription.10


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