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Delaware Health Law Blog

Shared Responsibility for Proper Prescribing and Dispensing of Controlled Substances

Delaware pharmacists have recently been reminded of their “corresponding responsibility” under Delaware and federal law. Regulations provide that while “the responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner… a corresponding responsibility rests with the pharmacist who fills the prescription.” 21 CFR § 1306.04; Delaware Controlled Substances Act Regulation 4.3.1

This responsibility can create tension between prescribing practitioners and pharmacists, who are at times obligated to confirm the validity and appropriateness of a controlled substance prescription. Many prescribing practitioners are reporting receiving frequent calls from pharmacists, who are asking questions about the reasons certain controlled substances have been prescribed.

Earlier this week, the federal government sent a significant remainder to the health care community that pharmacists and pharmacies can and will be held accountable for the failure to comply with these regulations. On June 11, 2013, the Walgreen Company (the nation’s largest pharmacy operator) agreed to pay $80 million to resolve DEA charges that several Walgreens pharmacies did not properly control oversight and handling of narcotic painkillers, particularly oxycodone. The $80 million settlement is the largest ever paid by a pharmacy chain.

According to the DEA, six Florida Walgreens pharmacies were responsible for “an unprecedented number” of record keeping and dispensing violations under the federal Controlled Substances Act, allowing prescription painkillers to be diverted for abuse or to the black market. The DEA alleged that the retail pharmacies knew or should have known that the prescriptions were not for legitimate medical use.

Delaware pharmacists and prescribers are partners in guarding against prescription drug diversion and misuse. As with any good partnership, open communication will benefit the partnership.

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