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Since 2000, the opioid epidemic has claimed the lives of more than 400,000 Americans. Drug company marketing campaigns and the practices of the Drug Enforcement Administration (DEA) are responsible for over 100 related deaths per day.
Counties, cities and states started going after the drug manufacturers and wholesalers a few years ago, in an attempt to hold them financially responsible but more recent lawsuits have gone after a third entity: The pharmacies where these prescriptions were often filled.
Major chains have argued they simply served as middlemen, following the orders of a DEA-approved doctor. However, their role in the opioid epidemic is changing.
The Controlled Substances Act (CSA) and Pharmacies
The CSA went into effect in the early 1970s. Title 21, Part 1306 spells out the role of pharmacies in relation to the distribution of controlled substances. Specifically in relation to prescriptions:
- The primary responsibility falls on the prescribing doctor, in which he or she must issue a prescription for a legitimate condition in accordance with standard medical practices.
- The pharmacy plays a corresponding or secondary role. In this case, the pharmacy should note if the prescription does not appear to be part of a standard treatment plan or if the doctor issuing it is not DEA registered.
- Those who assist with issuing and filling one of these prescriptions may face penalties.
Within this relationship, pharmacies are supposed to identify and respond to certain red flags, including:
- A single patient has multiple prescriptions for a controlled substance from multiple physicians or the same doctor.
- A patient regularly requests early refills.
- The patient is not local to the pharmacy or the prescribing doctor.
- A patient has multiple prescriptions for the same issues or symptoms.
- The patient strictly pays in cash.
- A patient requests to fill a prescription that was denied by another pharmacy.
- The prescription isn’t from a DEA-registered doctor or it’s from a doctor whose registration was recently revoked.
Pharmacies that spot one or more of these red flags are expected to verify the prescription from the prescribing physician or reach out to the state prescription drug monitoring program (PDMP).
Pharmacies have paid the price for not following through or simply turning a blind eye. In March 2017, Rite Aid had to pay over $800,000 for not verifying a doctor’s revoked DEA registration before recording and filling prescriptions and for failing to maintain their database to identify this practitioner’s status.
Bellwether Case Against Pharmacies in Ohio
According to a January 2020 report from AP News, Summit and Cuyahoga counties in Ohio filed a claim against CVS, Rite Aid, Walgreens, HBC, Discount Drug Mart and Walmart, alleging these major chains failed to identify the signs of suspicious or illegal prescriptions and therefore, played a role in the local opioid epidemic.
As their counter argument, the pharmacies claim the prescriptions filled were from DEA-registered doctors and that the Ohio counties are ignoring the roles that pill mills, pain clinics and internet and independent pharmacies had in distributing opioids. Particularly, the chains allege these other entities often issued a greater number of opioids per patient than prescriptions dispensed by seemingly legitimate pharmacies.
Furthermore, the chains argue much of the responsibility should fall on the doctors, who were swayed by the drug companies and often did not thoroughly screen patients before writing out prescriptions. On this last point, the pharmacies claim that if they’re found liable, the drug companies and prescribers should contribute partially to the settlement.
The counties claim these major chains did not hold doctors and drug companies accountable and failed to follow CSA provisions, violating public nuisance laws in the process. The same argument was used against drug manufacturers and distributors in an earlier case that reached a settlement toward the end of 2019.
In response, the judge presiding over the case ordered pharmacies to supply over a decade’s worth of prescription data to be analyzed for patterns.
Not the Only Pending Claim Against Pharmacies
The pending case in Ohio, which is expected to begin in October 2020, is predicted to serve as a bellwether trial for over 2,000 cases filed by states, counties and cities across the nation.
As a precursor, Florida filed a lawsuit against Walgreens and CVS in 2018, alleging the two chain pharmacies knowingly fueled the opioid epidemic. Particularly, Walgreens sent 2.2 million opioid tablets over a six-month period to a single pharmacy in Hudson, FL in 2011 and CVS sent over 700 million opioid pills to the state between 2006 and 2014. The lawsuit claimed both companies should have realized how abnormal these orders appeared and halted distribution.
In response, both chains sued 500 anonymous physicians in the state of Florida, alleging the doctors are responsible for the state’s opioid epidemic; all they did was fill the prescription orders.
Making Internal Changes
In response to these lawsuits, pharmacies – particularly the major chains – have started changing procedures and implementing new prescription-tracking software to help identify at-risk patients. Among these changes:
- According to an NPR report, certain chains like Walmart plan to restrict the number of pills contained in acute painkiller prescriptions, capping single amounts to no more than seven pills, unless states specify a smaller supply. Prescriptions for morphine will also be capped at no more than 50 mg per day. New policies reflect the Center for Disease Control and Prevention’s 2016 recommendations for prescribing painkillers, which require doctors to supply no more than the lowest effective dose.
- Pharmacies have started carrying naloxone over-the-counter without a prescription to help counteract the number of opioid-related overdose deaths.
- To improve tracking, prescriptions for controlled substances can only be submitted electronically, preventing patients from making copies or writing their own.
- Pharmacies have started implementing NarxCare, an analytics software that integrates with a pharmacy’s prescription management system to offer better insight into prescription habits, pinpoint at-risk patients and compare their data against state figures. As a result, a pharmacy can better identify if an opioid prescription is being issued for chronic pain management or if a patient may be misusing these drugs.