Justice Department sues Walgreens over illegal opioid prescribing

The Department of Justice filed a civil suit against Walgreens which operates more than 8,000 pharmacies across the United States, alleging that they dispensed millions of illegal prescriptions in violation of the Controlled Substances Act (CSA).

According to First Deputy Assistant Attorney General Brian M. Boynton, head of the civil department of the Ministry of Justice. “Our complaint alleges that Walgreens pharmacists filled millions of prescriptions for controlled substances with clear red flags indicating that the prescriptions were likely illegal, and that Walgreens systematically pressured its pharmacists to fill prescriptions, including for controlled substances without spending the time necessary to confirm their validity. This practice has allowed millions of pills of opioids and other controlled substances to flow illegally out of Walgreens stores.”

Centers for Disease Control (CDC) records indicate that from 1999 to 2022, nearly 727,000 Americans died of opioid overdoses, with approximately 82,000 people dying of opioid overdoses in 2022 alone. The overdose death rate has quadrupled since 2002.

Complaint of the Ministry of Justice alleges that between August 2012 and the present, Walgreens knowingly filled millions of prescriptions for controlled substances without a legitimate medical purpose, were invalid, and were not issued in the ordinary course of business, including prescriptions for dangerous and excessive amounts of opioids, improper prescriptions for early opioid refills, and prescriptions for a dangerous combination of drugs of abuse, described as the “trinity” of opioids, benzodiazepines and muscle relaxants, which abusers take because of their enhanced euphoric effect.

The complaint alleges that in some cases, patients died of opioid overdoses shortly after receiving invalid prescriptions from Walgreens.

Justice Department indicts Walgreens pharmacists filling these prescriptions despite clear red flags indicating that the prescriptions were likely illegal. Walgreens is also accused of pressuring its pharmacists to write prescriptions without taking the time necessary to verify the validity of each prescription.

The law requires all pharmacists to evaluate prescriptions for controlled substances and investigate any signs of possible prescription invalidity, known in the industry as “red flags.”

Among the red flags Walgreens is accused of failing to investigate are:

1. Prescriptions for high doses and quantities of opioids;

2. Prescriptions for combinations of controlled substances, such as trinities, that are unlikely to serve a legitimate purpose or that are commonly abused;

3. Prescriptions for patients who have prescriptions for controlled substances from multiple physicians;

4. Prescriptions for early refills before their previous prescription has expired;

5. Prescriptions for controlled substances, if the patient traveled a long distance to the subscriber or pharmacy;

6. Prescriptions issued by doctors under the scheme of prescribing the same drugs, quantity and strength for several patients.

According to the Ministry of Justicewhen such red flags are encountered, it is the pharmacist’s responsibility to confirm that the drug is appropriate for the patient’s condition, review the patient’s or physician’s discharge history at the pharmacy, contact the physician, or check the state’s Prescription Drug Monitoring Program (PDMP). ) database to see all the patient’s prescriptions.

Walgreens has also been accused of depriving its own pharmacists of vital information by preventing pharmacists from alerting each other to doctors known to routinely write invalid opioid prescriptions. In addition, Walgreens is accused of reprimanding its pharmacists, who diligently tried to verify the legitimacy of prescriptions for controlled substances. The complaint also alleges that Walgreens for years refused to implement a system to block its pharmacies from filling prescriptions written by doctors Walgreens already knew were regularly filling illegal opioid prescriptions, even when some of their own pharmacists asked the company to do so .

The complaint also alleges that Walgreens took corporate actions that it knew prevented bona fide pharmacists from fulfilling their legal obligations to check for red flags before dispensing such prescriptions. Specifically, the complaint alleges that for most of the time since 2012, Walgreens had a policy that required all prescriptions to be filled within 15 minutes, regardless of the volume of prescriptions being filled and other duties required of pharmacists. such as vaccinations, receiving phone calls from patients. and confirmation of insurance coverage. Pharmacists who did not comply with the 15-minute rule were subject to disciplinary action or dismissal.

The complaint further alleges that Walgreen pharmacists were pressured by managers, including store managers who were not pharmacists, to write prescriptions for controlled substances rejected by pharmacists.

As with many corporate crimes, this case began with the actions of four whistleblowers who used to work for Walgreens, including Elmer Mosley, who retired from Walgreens after 42 years in the pharmaceutical industry. The four whistleblowers initially filed suit under the qui tam provisions of the False Claims Act (FCA), which allows private individuals to sue on behalf of the United States for false claims and share in any money recovered through their lawsuit. The FCA also provides for the Department of Justice to step in and take over the litigation, which the Department of Justice did in all four lawsuits.

For its part, Walgreens has yet to file a legal response to the complaint, but has issued one short answer denying any wrongdoing.