A Misguided Department of Justice Lawsuit Forces Pharmacists Between Patients and Their Doctors
FROM WALMART PHARMACY PRESS RELEASE
“ATTORNEY GENERAL MERRICK GARLAND MUST READ youarewithinthenorms.com AND
RESTORE THE CREDIBILITY OF THE JUSTICE DEPARTMENT
AGAINST DOJ/DEA CORRUPTION”
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, mischaracterization, 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 PrescriptionIf 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 PrescriptionOn 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.
In fact, a new class action lawsuit says pharmacies are harming patients and illegally discriminating against them by not filling needed opioid prescriptions.
The AMA writes JUNE 16. 2020
“We are concerned that such a careful approach to identifying the precise combination of pharmacologic options could be flagged on a prescription drug monitoring program as indications wrongly interpreted as so-called “doctor shopping” and cause the patient to be inappropriately questioned by a pharmacist. The AMA strongly supports a pharmacist carrying out his or her corresponding responsibility under state and federal law, but the past few years are rife with examples of patients facing what amounts to interrogations at the pharmacy counter as well as denials of legitimate medication. The AMA urges CDC to provide strong guidance and support for physicians and pharmacists to work together rather than jumping to conclusions about a patient’s PDMP report.”
”Clinicians are encouraged to have open and honest discussions with their patients so as to avoid stigmatizing the decision to start, continue, or discontinue opioids or non-opioid therapy. This discussion also must account for the treatment options accessible to the patient based on their health condition, social determinants of health (e.g. transportation, employment, childcare responsibilities, race, gender, age) and insurance coverage.”
Pete Giarrusso, who runs a Longwood motorcycle shop, is an expert at making things run better — except when it comes to his wife’s health. His wife’s doctor prescribed the muscle relaxer Soma after neck surgery, but he said Walgreens refused to fill it.
“They say, ‘We don’t feel comfortable filling the prescription,'” Giarrusso said. “They make us feel like drug addicts.”
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.
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’sstatement 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.
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.
- The Wall Street Journal Editorial Board – Scapegoating Walmart – Dec. 29, 2020
- Fox Business
- The Wall Street Journal – A Case Against Walmart Mocks Justice – Dec. 27, 2020
- The Wall Street Journal Editorial Board – Walmart’s Opioid Whipsaw – Oct. 29, 2020
- National Association of Chain Drug Stores (NACDS) and the American Pharmacists Association (APhA)
- The U.S. Chamber of Commerce, the Washington Legal Foundation (WLF), the National Retail Federation (NRF) and the Retail Litigation Center, Inc. (RLC)
- American Association of Physicians and Surgeons (AAPS)
FOR NOW, YOU’RE WITHIN
Statement from the Florida Department of Health:
“As you may know, in recent years, the Florida Legislature has made a number of changes in regard to the treatment of chronic, non-malignant pain. These changes were made as an effort to prevent the growing abuse of pain medications. When making these changes, the Legislature sought to balance the needs of patients with medical conditions and the safety of Florida’s general population. The Department remains committed to ensuring that the practice of pharmacy in Florida is conducted in compliance with Florida law. While pharmacists are encouraged to use their professional judgment when filling a prescription, the Florida Board of Pharmacy has urged them to always fill what they consider a valid prescription representing a legitimate patient-physician relationship. The Board remains in contact with the DEA’s Division Office of Diversion Control in its continuing effort to ensure that Florida pharmacists can practice their profession with confidence and compassion. Patients who do find it difficult to access their medications may find it beneficial to contact their physician and request that he/she reach out to their local pharmacist on their behalf to assist with getting prescriptions filled.”