Walmart Inc. filed a complaint seeking declaratory relief against the United States Department of Justice (DOJ) and the United States Drug Enforcement Administration (DEA) to clear up expectations and obligations of pharmacies and pharmacists under the Controlled Substances Act (CSA).
Walmart cited the difficulties pharmacists face when a patient presents a prescription for an opioid. “The pharmacist can accept the doctor’s medical judgment and fill the opioid prescription, or second-guess the doctor’s judgment and refuse to fill it — a decision the pharmacist must make without the benefit of a medical license, examining the patient, or having access to medical records,” according to the complaint.
The complaint cited the risks for pharmacists in both filling and refusing to fill opioid prescriptions. If the DOJ and DEA retroactively claim that an opioid prescription filled by a pharmacist should not have been filled, the pharmacist “risks federal investigation, civil liability, or even criminal prosecution,” according to the complaint. On the other hand, should a pharmacist refuse to fill a prescription based on their own judgment, they risk losing their license and potential harm to the patient.
According to the complaint, pharmacists at Walmart “have refused to fill hundreds of thousands of problematic opioid prescriptions, and Walmart has blocked thousands of concerning doctors from having their opioid prescriptions filled at any Walmart pharmacy,” which has made the company subject to investigations and lawsuits for “interfering in medical practice.” Despite Walmart’s efforts, the complaint said the DOJ and DEA have threatened to file a civil complaint against Walmart “for not going far enough in blocking doctors by refusing to fill their prescriptions.”
The complaint claimed that the DOJ’s expectations and guidance for pharmacies and pharmacists regarding judgment on filling opioid prescriptions are not in writing officially nor are they law and that the guidance is often inconsistent with other DEA, federal health agency and medical/pharmacy law guidance. Additionally, the complaint noted that Congress specifically tasked the DOJ and DEA with preventing opioid abuse through the CSA, at “every step in the opioid supply chain.”
Citing “profound failures” of the DOJ and DEA to prevent opioid abuse, the complaint claimed that the DEA has not done enough to regulate production of the drugs; has allowed “bad actors” to continue prescribing opioids and continued to renew these doctors’ registrations; has never articulated clear guidance for distributors on how to effectively report “suspicious orders”; and has often “ignored and discarded the reports with no investigation or follow-up.”
The DOJ and DEA, through the CSA, now expect pharmacists to “second-guess the doctor’s medical judgment,” despite pharmacist refusal to fill a prescription being a risky move and going against American Medical Association guidance that “doctors’ judgments should be paramount,” according to the complaint. The plaintiff contended that through the defendant’s contradictory and inconsistent expectations and threat of legal action, the defendant is attempting to transfer responsibilities to pharmacists and pharmacies that Congress originally placed on the DEA and that state law placed on state medical boards.
Walmart is seeking a declaration from the DOJ and DEA that will resolve the disputes with the agencies in order to clear up the inconsistent expectations and guidance under the CSA.
