Strict Compliance Is Needed When Assessing Opioid Prescriptions

MAY 17, 2019
Joseph L. Fink III, BSPharm, JD, DSc (Hon), FAPhA
ISSUE OF THE CASE
When a teenage patient presents numerous prescriptions for oxycodone during a 7-month period, along with orders for alprazolam, and then dies of multiple drug toxicity, can the lawsuit filed by the estate of the patient proceed? The main argument advanced by the plaintiff was that the staff at the pharmacy had as its role doing more than merely honoring legitimately issued prescriptions with scrupulous accuracy.

FACTS OF THE CASE
A man in a Southwestern state presented numerous valid prescriptions for oxycodone during 1 period May through November. Each bore the signature of the prescribing physician. However, on occasion, the patient arrived at the pharmacy with a prescription authorizing additional dispensing on a date prior to when the supply provided earlier should have been used up. Some of the prescriptions bore notations such as “OK to fill early.” During one 4-month period, pharmacy employees dispensed prescriptions early 7 times.

In addition, the patient’s prescription expenses were covered by the state’s Medicaid program. However, the Medicaid policies and claims database did not accommodate or authorize dispensing early. One time, the patient paid $1107 in cash for a prescription that Medicaid would have covered in full had he waited. The following month, he again offered to pay cash for early access to the medication a mere 3 days before Medicaid coverage would have been available. On that occasion, the staff members at the pharmacy contacted the prescriber to ensure that the dispensing in advance of the appropriate date was acceptable.

To make matters worse, the patient was also receiving prescriptions for alprazolam, a medication known to suppress respiration. Using that in combination with another central nervous system depressant such as oxycodone “can be toxic even in low concentrations” the court handling this matter noted.

The patient history recounted above transpired during the period that ended in November. On December 1, the 19-year-old died of multiple drug toxicity.

A lawsuit alleging negligence was filed against the pharmacy by the personal representative of the estate of the deceased man. The attorneys representing the defendant pharmacy made a motion for summary judgment, meaning that in their view, no factual issues were in dispute and the matter should be resolved summarily, ie, decided by the judge without a trial. The argument on behalf of the pharmacy was that “a pharmacist’s standard of care is to dispense appropriately prescribed medications to a patient in accordance with a proper medical doctor’s prescription.” Their view was that the pharmacy staff members had discharged that duty, so no issue remained to be considered at trial.

The trial court judge agreed and granted the motion, thereby dismissing all claims against the pharmacy. The representative of the estate did not agree with that disposition and appealed to the state’s court of appeals, arguing that the trial court judge’s decision was in error.

THE RULING
The appellate court reversed the decision of the trial court judge and sent the matter back for further proceedings at the level of the lower court.

THE COURT’S REASONING
The argument advanced on behalf of the pharmacy was that the pharmacist’s paramount professional responsibility was to dispense medication pursuant to a legitimate prescription with scrupulous accuracy. The prescriptions honored at the pharmacy were valid in every respect.

The representative of the estate argued that more was required from the pharmacy staff members. Emphasis was placed on regulations of the state board of pharmacy, which require that the pharmacist be alert for signs of “clinical abuse/misuse” of opioids. More specifically, the attention of the pharmacist should be attracted when a patient seeks early dispensing or offers to pay cash, despite the existence of insurance coverage. Both were present in this interaction between patient and pharmacy staff members.

Expectations of state regulators continued by specifying that once suspicions have been aroused by interaction with the patient, the pharmacist is required to obtain the patient’s medication history from the state’s prescription monitoring program (PMP). Following that, the pharmacist is to exercise professional judgment when deciding whether to consult the prescriber or counsel the patient. That decision making is to be documented.

The court of appeals agreed with the plaintiff that the standard of care applicable to pharmacists in that state includes strict compliance with the expectations of the regulations. The record before the courts, both the trial and appellate courts, did not address whether such compliance existed. The court of appeals concluded that the reason that information was unavailable was that the trial court judge had decided the matter by granting summary judgment based on an incomplete factual record. The case was returned to the trial court for proceedings to decide whether the pharmacy staff members had taken the various steps outlined in the relevant regulations. Further, the trial court needs to determine whether any lack of compliance with the regulatory expectations—if there indeed was no PMP report and attendant documentation—contributed in any meaningful way to the demise of the patient.
 
Joseph L. Fink III, BSPharm, JD, DSc (Hon), FAPhA, is a professor of pharmacy law and policy and the Kentucky Pharmacists Association Endowed Professor of Leadership at the University of Kentucky College of Pharmacy in Lexington.


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