Prescription opioids and pharmacist responsibility

Key Points

As pharmacists' responsibilities expand, so may some of their liabilities, a number of which may be related to controlled substances, according to speakers at a session that took place during this year's American Pharmacists Association meeting.

PDMPs and pharmacy liability

Pharmacists should pay attention to the status of the state prescription drug monitoring programs (PDMPs) and their related obligations, said Kimberly Burns, BS Pharm, JD, associate professor, department of pharmaceutical sciences, LECOM School of Pharmacy in Erie, Pa.

Although neither the issues nor the standards are clearly defined yet, Burns believes that as more states create these databases and as the programs become more committed to taking action based on the information gathered, it is likely that more questions will arise concerning whether pharmacists have an obligation to use such information if it is available to them.

Sanchez v. Wal-Mart: No duty of care

The only legal case published so far with which Burns was acquainted raised the question of whether, in the words of the court, "a pharmacy owes a duty of care to unidentified third parties who were injured by a pharmacy customer who was driving while under the influence of controlled prescription drugs," said Burns.

In the 2009 case of Sanchez v. Wal-Mart Stores East, LP, 8 pharmacies were sued after a customer hit 2 men on the roadside in 2004, killing 1 and seriously injuring the other.

The injured man and the family of the man who was killed learned that the Nevada PDMP had sent a letter to pharmacies and physicians in June 2003, stating that the customer had bought approximately 4,500 hydrocodone pills from 13 different pharmacies over the course of the previous year.

With 2 of the 7 justices dissenting, the state Supreme Court decided in 2009 that the pharmacies do not owe a duty of care to unidentified third parties.

A footnote in the decision noted that in 2004 Nevada pharmacists had no obligation to respond in any way after receiving the PDMP's letter and had only limited authority to refuse to fill prescriptions. [For more on this case and its ramifications, go to http://www.drugtopics.com/duty to see "Monitoring controlled substances" by Ken Baker, published in Drug Topics September 15, 2010.]

A shift in emphasis

Since that time, amendments to state Board of Pharmacy regulations have indicated that if pharmacists feel that prescriptions are, for example, fraudulent or harmful to the patient's health, and if they cannot resolve the issues by contacting the prescribing physicians, the pharmacists are mandated to retain the prescriptions and not to fill them.

In addition, Burns said, if the customer himself was the person injured, the suit's outcome might well have been different. Over time, she said, the nation may see more actions in which a patient essentially says, "Hey, you could have done something to help me and you didn't."

Elements of PDMPs that vary from state to state include which state office controls the programs, what schedules of controlled substances they cover, whether the data are available in real time, and whether pharmacists have access to the data. PDMPs also vary in whether they proactively investigate and send out unsolicited reports or are merely reactive and respond to requests for information.

Information is still limited, Burns contended, that might indicate whether these expensive PDMPs are effective in reducing prescription drug abuse or whether they will have a chilling effect on reducing legitimate access to pain medications. Nevertheless, she said, pharmacists should consider what will be expected in their states.

Dee v. Wal-Mart: Due and proper care

Of the leading cases that have expanded the legal duties of pharmacists beyond technical accuracy, one that is worthy of note, Dee v. Wal-Mart Stores East, LP, was decided in Florida in 2004, said Thomas Smith, PharmD, JD, clinical assistant professor, department of pharmaceutical outcomes and policy, College of Pharmacy, University of Florida, Gainesville, Fla.

According to the opinion, a woman filled a prescription for a 50-µg Duragesic patch at a Wal-Mart pharmacy because she was having pain from a broken ankle. The prescription she filled had been written more than 4 months earlier to treat surgical pain connected with a Cesarean section. After applying the patch, she died in her sleep from an overdose of fentanyl.

Her husband alleged that the pharmacist should have seen that the prescription was more than 4 months old, should have questioned whether the patient was opioid-naïve, and should have warned the patient about the danger or made inquries of the physician.

The District Court of Appeals, First District, allowed the suit to proceed, saying, "When a pharmacy fills a prescription which is unreasonable on its face, even though it is lawful as written, it may breach" its duty "to use due and proper care in filling a prescription."

The lack of further action published about the case, Smith said, suggests that the case was settled out of court.