Dec. 22, 2020
Walmart is helping fight the opioid crisis. We are proud of our pharmacists, who help patients understand the risks about opioid prescriptions. And our pharmacists have refused to fill hundreds of thousands of opioid prescriptions they thought could be problematic.
On top of that, Walmart has blocked thousands of questionable doctors from having their opioid prescriptions filled by any of our pharmacists, as part of our good-faith efforts to help address the opioid crisis and to satisfy the Drug Enforcement Administration (DEA).
As a result, many health regulators, medical groups, doctors and patients say that Walmart is going too far in refusing to fill opioid prescriptions—and even say we are improperly interfering in the doctor-patient relationship.
Which is a big reason a new lawsuit brought by the Department of Justice (DOJ) and DEA against Walmart is so misguided and misleading.
There are a lot of problems with the lawsuit—as we will explain in court, it is wrong on the law and riddled with factual inaccuracies, mischaracterizations and cherry-picked documents taken out of context. And it is outrageous the Department is trying to shift blame for DEA’s own well-documented failures in policing the very doctors it gave permission to prescribe opioids.
One serious and big-picture problem with the Department’s attempt to turn pharmacists and pharmacies into DEA’s own “doctor police” is that it forces them to come between doctors and their patients in a way Congress never intended, and federal and state health regulators say isn’t allowed. And many patients say that pharmacies are preventing them from getting needed medicine.
The Department’s Lawsuit: Putting Pharmacists Between a Rock and a Hard Place
Think about what happens when a patient brings an opioid prescription from a doctor into a pharmacy to fill.
Pharmacists aren’t doctors and don’t write opioid prescriptions. Instead, when a patient hands an opioid prescription written by a DEA-approved doctor to a pharmacist, a pharmacist has to decide whether to fill it. No one disputes that if a pharmacist knows a prescription is fake or forged, she shouldn’t fill it.
The Department’s lawsuit raises a different issue: what a pharmacist should do with a prescription that is valid on its face and written by a state-licensed and DEA-approved doctor.
For a prescription like that, should a pharmacist accept the doctor’s medical judgment and fill the prescription? Or should a pharmacist second-guess the doctor and not fill it, leaving the patient without the medicine prescribed by her doctor? Remember, a pharmacist must make this decision without the benefit of a medical degree, without examining the patient, and without access to the patient’s medical records.
Either decision carries risks.
If a Pharmacist ...
Fills a Prescription
If a pharmacist accepts a doctor’s judgment and fills a valid-looking prescription written by a DEA-approved doctor, then under the Department’s theory, she and the pharmacy still risk federal investigations, civil liability, or even criminal prosecution if the Department and DEA later say they believe the prescription should not have been filled.
One reason the Department’s lawsuit is wrong-headed is because no law tells a pharmacist how to decide whether to fill a prescription. Instead, under the Department’s lawsuit, government lawyers second-guess pharmacists for not second-guessing doctors. That moves health care decisions further and further away from patients and doctors.
Refuses to Fill a Prescription
On the other hand, if a pharmacist refuses to fill the same prescription, state boards could investigate her for the unauthorized practice of medicine, and even take away her license. And patients and doctors could sue her for not filling opioid prescriptions. And she could harm patients who need the medicine.
These aren’t hypothetical risks—they are happening all over the country. And pharmacies are also sued, investigated and criticized for instructing pharmacists not to fill any opioid prescriptions from certain doctors.
Patients
In fact, a new class action lawsuit says pharmacies are harming patients and illegally discriminating against them by not filling needed opioid prescriptions.
Even DEA has expressed concern that “legitimate patients” are sometimes unable to “get their prescription for pain medications filled at large retail pharmacies.”
State Medical and Pharmacy Boards
In addition to patient criticisms, state medical and pharmacy boards all over the country have criticized, investigated and threatened Walmart and our pharmacists for going too far in refusing to fill opioid prescriptions.
Complaints against Walmart and its pharmacists for refusing to fill opioid prescriptions have also been filed with, or pursued by, many Boards of Pharmacy or Medicine across the country, including those in dark blue above.
Below are just a few examples:
- A Georgia legislator proposed a bill to punish Walmart for blocking questionable doctors from having their opioid prescriptions filled, saying Walmart is “interfering with the doctor patient relationship.”
- The President of the Texas Medical Board threatened cease-and-desist orders against Walmart and our pharmacists for interfering in the practice of medicine by not filling certain opioid prescriptions.
- Citing Tennessee law, the Tennessee Pharmacy Board launched inspections of Walmart pharmacies and opened a months-long investigation after a doctor complained Walmart wouldn’t allow its pharmacists to fill the doctor’s opioid prescriptions.
The list goes on, and you can read more examples in this news story or in this legal filing by Walmart.
Federal Health Agencies
Pharmacists and pharmacies also get contradictory guidance from federal health agencies that often disagree with the Department’s view that pharmacists should interfere with a doctor’s individualized medical judgment. And, the DEA itself has taken positions contrary to the one it is now pushing. Here are just a few examples, but there are many more.
- Medical associations cite the Health and Human Services Department’s statement that doctors and patients—not pharmacists—should be the ones making the decisions.
- At the same time the Department’s lawsuit says Walmart should have been blocking more doctors and prescriptions. Just last year DEA said that the agency has no legal authority to regulate “the general practice of medicine” and that federal law doesn’t include specific number limits on prescriptions.
Doctors
And it’s not just state and federal health regulators saying pharmacists and pharmacies are going too far in refusing to fill opioid prescriptions as they try to satisfy DEA—doctors are also weighing in.
For example, the American Medical Association said Walmart “disrupted legitimate medical practices” by refusing to fill opioid prescriptions from certain doctors.
The AMA has also accused the company of creating a physician “blacklist.”
Many doctors have sued pharmacists and pharmacies—including Walmart—for blocking their prescriptions, saying they have tarnished their professional reputations.
There are many other examples, but you get the picture: the Department is putting pharmacists and pharmacies between a rock and a hard place by demanding they go further in second-guessing doctors, while state health regulators are saying they are going too far. Ultimately, patients are caught in the middle.
A Better Path: Clarity for Doctors, Patients and Pharmacists
Walmart is proud of our pharmacists, and we intend to defend against the Department’s lawsuit. We also need a real solution to the rock-and-a-hard-place problem. In working toward the best policy answer for this problem, each branch of government has a role to play in providing clarity for doctors, patients and pharmacists on how to handle opioid prescriptions.
What DOJ and DEA Can Do
For starters, DOJ and DEA could go through the proper rulemaking channels to clarify going forward what the agencies expect of pharmacies and pharmacists, rather than make them guess what DEA wants by looking at DEA’s scattered letters and PowerPoints (that have no legal authority, anyway). In fact, Walmart has filed a petition asking DEA to propose a rule-making to provide this much needed clarity.
And according to the Department’s own Inspector General, DEA needs to do a better job using the tools and legal authority Congress gave it to keep bad doctors from prescribing opioids. Right now, the Department’s current lawsuit tries to turn pharmacists and pharmacies into the prescriber police—even though they lack DEA’s authority and tools to do their job, and states say that they can’t under state law.
What Legislatures Can Do
Legislatures—state and federal—also have an important role. That’s why Walmart has been pressing for much-needed legislative reforms to help fix the opioid crisis. For example, legislatures could help protect pharmacists when they properly refuse to fill prescriptions, so they do not face retaliatory investigations and lawsuits—protections we have asked for in Georgia, for example.
What Courts Can Do
And the courts need to clarify what existing law says. That is why in October, Walmart proactively brought its own lawsuit, asking a court for clarification on what the law says pharmacists and pharmacies should do when a patient presents an opioid prescription that looks legitimate.
Our pharmacists and patients deserve better than the current bramble patch of inconsistent, conflicting and outright contradictory guidelines from federal and state regulators. Let’s work together to fix this.
Walmart is not alone. Read what others are saying.
“DEA needs to do its job and crack down on doctors abusing their privileges, not target pharmacies for not doing the job DEA failed to do.”
“The opioid addiction crisis has been crying out for leadership by our government agencies and it's time [to] put an end to their blame games and hold them accountable for real action.”
“The Justice Department alleges Walmart isn't rigorous enough in checking facially valid opioid prescriptions written by DEA-authorized physicians. If this is a problem, let the DEA propose specific regulations requiring pharmacies to conduct increased diligence before filling any opioid prescription... Until this happens, it's a travesty to blame Walmart for complying with state law.”
“Companies are finding themselves either being sued for filling opioid prescriptions or being threatened with prosecution if they don’t fill the prescriptions.”
“Pharmacies, though, are a curious place to assign blame for the opioid epidemic. They don’t make the drugs: Controlled substances are manufactured by heavily regulated producers. Nor do pharmacies sell opioids on their own authority: They dispense meds prescribed by licensed medical practices.”
“[The Government’s] overreach threatens not only the livelihoods of [NACDS and APhA]’s members but, most important, the lives and health of their patients.”
“To that end, pharmacies and pharmacists need and deserve clarity regarding their obligations when filling prescriptions for controlled substances, so that they can practice their profession without the threat of liability on all sides.”
“Compliance programs are frustrated, not furthered, when agencies enforce subregulatory guidance, created without notice, as if it were binding law. When burdensome obligations stem from loose policymaking, even businesses with robust compliance programs are left guessing.”
“Facing potentially crushing liability, many companies acquiesce and settle, seeming to validate the subregulatory guidance and encouraging further aggrandizement by government. … This is a case where a company did not acquiesce and has not settled. This gives the Court an all-too-rare opportunity to stop the otherwise inexorable trend toward regulation by post-hoc enforcement.”
"Pharmacists do not examine patients. Nor do they spend equivalent time evaluating the needs of a patient who seeks to fill a valid prescription. [The Government] should not be insisting that pharmacies be penalized unless they profile patients in some kind of one-size-fits-all approach to medical care.”
“The practice of private, ethical medicine depends heavily on the prompt filling of physicians’ prescriptions by pharmacists without second-guessing, delays, or bureaucratic red tape.”
“Physicians and particularly their patients would be the ones harmed most if [the Government] succeed[s] in interfering with the filling of prescriptions based on a profiling-like “red flag” approach as sought by distant regulators located in Washington, D.C., who are unfamiliar with the practice of rural medicine.”
