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      Our response to opioid lawsuit

      A female pharmacists advises an older female patient about her mediation at the pharmacy counter.

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      We have cooperated with the DOJ’s investigation for more than four years, and we strongly disagree with the allegations and false narrative within this complaint. We will defend ourselves vigorously against this misguided federal lawsuit, which follows on the heels of years of litigation over these issues by state and local governments — claims that already have been largely resolved by a global agreement with the participating state Attorneys General. 

      The government’s lawsuit seeks to impose a shifting standard for pharmacy practice. Many of the litigation theories laid out in the complaint are not found in any statute or regulation, and relate to topics on which the government has declined to provide guidance. Each of the prescriptions in question was for an FDA-approved opioid medication prescribed by a practitioner who the government itself licensed, authorized and empowered to write controlled-substance prescriptions.

      CVS Health has been an industry leader in developing innovative programs to fight opioid misuse. As one example, 12 years ago CVS Pharmacy pioneered a first-of-its-kind program to block controlled-substance prescriptions written by doctors of potential concern. To date, we have blocked more than 1,250 practitioners, including nearly 600 prescribers who the government continues to license. This program is not required by any statute or regulation, and CVS Health repeatedly has defended lawsuits from those alleging we go too far in blocking opioid prescribers.

      The government’s lawsuit intensifies a serious dilemma for pharmacists, who are simultaneously second-guessed for dispensing too many opioids, and too few. 

      Fill this opioid prescription. No, wait, actually you can’t do that. Or, maybe, you can: The dilemma for community pharmacists

      Community pharmacy is the most accessible part of the U.S. health care system. Here at CVS Pharmacy®, more than 27,000 pharmacists do their part in helping to keep America healthy. They are highly trained in the safe and appropriate use of all medications, as well as in the state and federal laws governing the dispensing of medicines. 

      Part of this role includes filling legitimate prescriptions for opioid medications for patients requiring pain relief. In doing so, our pharmacists help to care for and educate patients on the proper use and misuse of opioid medications.
       

      When it comes to filling opioid prescriptions, pharmacists are held to vague, undefined, and ever-changing standards of practice.

      Opioids are approved and regulated by the U.S. Food and Drug Administration (FDA), and opioid prescriptions can only be written by a licensed physician authorized by the U.S. Drug Enforcement Administration (DEA) to do so. With the knowledge that opioids are often vital to patients enduring relentless pain, community pharmacists are challenged to assess if a prescription written by a licensed physician should not be filled.   

      Whichever decision they make, community pharmacists know they can—and will—be second-guessed later. Too often, we have seen government agencies and trial lawyers question the good-faith decisions made by pharmacists while a patient waits at the pharmacy counter, often in pain. While simultaneously being accused of dispensing too few opioids1 and too many, pharmacists and pharmacies face threats of liability no matter their actions.

      Caught between these conflicting demands from government agencies and trial attorneys, we have implemented best-in-class and first-of-its-kind programs to help our pharmacists make the best decisions on behalf of patients and in compliance with the law.

      DEA Declines to Give Guidance

      Even the DEA has said repeatedly that there is no simple rule to apply. The DEA published in 2006 a policy statement in the Federal Register saying that “one cannot provide an exhaustive and foolproof list of ‘dos and don’ts’ when it comes to prescribing controlled substances for pain or any other medical purpose.”  When again asked in 2019 to help pharmacists caught in this difficult moment, the DEA said in a letter to the National Association of Chain Drug Stores:

      • It lacks authority to issue “guidelines that constitute advice” as to the practice of medicine, which includes the appropriate prescribing of opioids.

      • Federal law does not “impose a specific quantitative minimum or maximum limit on the amount of medication that may be prescribed on a single prescription, or the duration of treatment intended with the prescribed controlled substance.”

      • “The DEA has consistently emphasized and supported the prescriptive authority” of individual doctors.
      • We've voluntarily blocked dispensing of controlled substances written by certain doctors whose prescribing patterns have raised concerns.
      • We've developed cutting-edge algorithms to help pharmacists identify forged prescriptions, a task which can be extraordinarily difficult because of the sophistication of the forgeries.
      • Our systems check that the prescriber has an active DEA registration that permits them to prescribe opioids.
      • Our systems provide pharmacists with safety alerts for certain opioid prescriptions, such as those written for particularly high dosages.
      • We provide our pharmacists access to state prescription drug monitoring databases and encourage our pharmacists to use them.
      • We train our pharmacists about appropriate opioid dispensing multiple times each year.
      • We have a longstanding policy of supporting — at all levels of management — the judgments of our pharmacists when they refuse to fill a prescription.

      Even after taking these actions, we've been met with state investigations and lawsuits for allegedly second-guessing doctors’ medical judgment and refusing to fill opioid prescriptions. Whatever decision pharmacists make, it will not be good enough for some interest group.

      This after-the-fact scrutiny places our pharmacists in an unenviable position. Our past efforts to work with the DEA to improve this situation have been routinely and flatly rebuked by bureaucrats that have no interest in disrupting the status quo.

      How we're keeping communities safer

      Our comprehensive approach includes designing programs and collaborating with community leaders, policymakers, law enforcement, health care professionals and others to increase community-based educational programs related to opioid misuse, create safe prescription drug disposal sites, expand access to life-saving antidotes and advocate for targeted and effective policies, locally and nationally. 

      Our opioid response includes:

      • Safe medication disposal program includes units in more than 3,900 CVS Pharmacy locations and donations of more than 1,000 units to local police departments which together have removed more than 8 million pounds of unwanted medications from communities
      • Pharmacist counseling for patients filling their first opioid prescription
      • Community investments to support addiction recovery and prevention
      • Opioid misuse prevention education2 for teens and parents impacting more than 2.6 million individuals
      • Access to both prescription and over the counter (OTC) opioid-overdose reversal medication and OTC fentanyl-testing strips where allowed by law
      • Patients and colleagues can report suspected inappropriate or illegitimate dispensing, prescribing or diversion of controlled substances, violations of CVS policies and/ or procedures, other applicable law, or the terms of any  agreement between CVS Health® and any state or federal entity by calling the CVS Health Ethics Line anonymously and toll-free at 1-877-CVS-2040 (1-877-287-2040; TTY:711) or visit the Ethics Line page3.
      • A commitment from our Company and its Board of Directors to support the development and implementation of solutions aimed at reducing prescription opioid abuse and misuse in our communities. Our Board has made our commitment to help address prescription opioid abuse an important priority of CVS Health. Learn more about the Board’s role.