Proper management of pain is a high priority in the United States. According to a recent Institute of Medicine Report on Pain, 100 million Americans suffer from pain, and treatment of pain costs the United States more than half a trillion dollars per year. Pain is one of the most common reasons people consult a physician, yet it frequently is inappropriately treated. In the last several years, health-policymakers, health professionals, regulators, and the public have become increasingly interested in the provision of better pain therapy and in the reduction of drug diversion and addiction. Earlier this month, two CVS locations in Florida resolved to pay 22 million as a result of their lax sale of powerful painkillers. The payment follows the revocation by the DEA of the CVS locations’ DEA licenses in 2012 for the alleged dispensing of more than 3 million oxycodone pills in 2011. In light of the above and similar cases, an important aspect of the regulation of pain medicine relates to the issuance and filling of prescriptions for pain medicine drugs.
Section 1306 of the Code of Federal Regulations (“CFR”) discusses the purpose of issuing a prescription for a controlled substance, stating that:
“A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription.”*
Authority for the determination of which healthcare activities constitute a “legitimate medical purpose,” and the implementation of regulatory dispensing procedures rests with state governments. Many states require pharmacists to enter prescriptions into an electronic database, and to review electronic databases to identify potential abuse or narcotic dependence prior to dispensing a controlled substance. Pharmacists are encouraged to educate themselves regarding the established safeguards and processes set in place in the states in which they practice, in order to ensure their practices comport with all applicable laws. Frier Levitt has substantial experience creating corporate compliance plans and pain management policy manuals, as well as educating professionals in the responsibilities related to their practice. Contact us to speak to an attorney.
*21 CFR 1306.04
