CVS Fined $535,000 for Filling Forged Opioid Prescriptions

By Pat Anson, PNN Editor

CVS Pharmacy has agreed to pay a $535,000 fine to resolve allegations that several of its Rhode Island stores filled dozens of forged prescriptions for Percocet, a potent opioid painkiller. It’s the latest in a series of fines the nation’s largest pharmacy chain has paid for violations of the Controlled Substances Act.

According to DEA investigators, CVS pharmacists filled 39 forged prescriptions for Percocet between 2015 and 2017 even though they “knew or had reason to know that the prescription in question was invalid or unauthorized.”

In a settlement agreement with the Department of Justice, CVS agreed to pay the fine while making no admission of any liability or wrongdoing. The company said it wanted to avoid the expense and uncertainty of going to trial. In return, the DOJ agreed to drop all civil or criminal prosecution of the case.

“DEA registrants like CVS have a corresponding responsibility to dispense controlled substances in accordance with the Controlled Substance Act,” said DEA Special Agent in Charge Brian Boyle. 

“Pharmacies put patients at risk when they dispense Schedule II narcotics, which have the highest potential for abuse, without a valid and legal prescription.  Today’s settlement demonstrates DEA’s commitment to work with our law enforcement and regulatory partners to ensure that these rules and regulations are followed.”

It’s not the first time CVS has been accused of lax or fraudulent behavior involving opioid medication.

In 2017, CVS agreed to pay a $5 million fine to settle allegations that several of its pharmacies in California failed to detect thefts of the opioid painkiller hydrocodone.

In 2016, CVS agreed to pay a $3.5 million fine to resolve allegations that 50 of its pharmacies in Massachusetts and New Hampshire filled forged prescriptions for opioids. One forger signed a dentist’s name on 131 prescriptions for hydrocodone and had them filled at eight different CVS stores.

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And in 2015, CVS paid a $22 million fine after two of its pharmacies in Florida were found to be routinely filling bogus prescriptions for painkillers, including some for customers as far away as Kentucky.

All of these cases were settled out of court.

In 2018, CVS angered pain patients when it began to limit the initial dose of opioids to 7 days’ supply for customers enrolled in CVS Caremark health plans. For both acute and chronic pain patients, CVS said daily doses of opioids should not exceed 90 MME (morphine milligram equivalent) and patients would be required to use immediate release formulations. CVS said it was making the CDC opioid guideline the “default approach” to prescribing opioids.

Last week, CDC Director Dr. Robert Redfield acknowledged for the first time the agency’s voluntary guideline was causing “unintended harms” and that patients should only be tapered to lower doses “if a patient would like to taper.”  

“The Guideline does not endorse mandated or abrupt dose reduction or discontinuation, as these actions can result in patient harm,” Redfield said. “The Guideline includes recommendations for clinicians to work with patients to taper or reduce dosage only when patient harm outweighs patient benefit of opioid therapy.”

Nothing in the guideline empowers pharmacists to set dose limitations. CVS operates 9,700 pharmacies and 1,100 walk-in medical clinics nationwide

Feds Warn CBD Marketers About False Medical Claims

By Pat Anson, PNN Editor.

The Food and Drug Administration and the Federal Trade Commission are tapping the brakes on the fast growing market for cannabidiol (CBD), warning companies not to make false claims that CBD products can be used to treat fibromyalgia, migraine, arthritis and other chronic illnesses.

The agencies sent warning letters to three companies — Nutra Pure, PotNetwork Holdings, and Advanced Spine and Pain — for making false and unsubstantiated health claims about a variety of CBD oils, extracts and edibles.

The FDA and FTC sent the warning letters on March 28 and gave the companies 15 days to respond.

Nutra Pure’s website, according to regulators, claimed that “CBD has demonstrated the ability to block spinal, peripheral and gastrointestinal mechanisms responsible for the pain associated with migraines, fibromyalgia, IBS and other related disorders.”

Claims were also made that CBD is “an effective and safe treatment alternative” for inflammatory conditions such as lupus, Celiac disease and rheumatoid arthritis.

Nutra Pure, which makes a line of hemp oil, has a small disclaimer on its website stating that “these products are not intended to diagnose, prevent, treat, or cure any disease.”

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PotNetwork has a similar disclaimer on its website, where it sells everything from CBD infused gummy bears and energy drinks to moisturizers and pet care products. According to the FDA, the company falsely claimed that CBD “blocked the progression of arthritis” and “has also shown the ability to kill cancer cells directly.”  

In addition to marketing CBD products, Advanced Spine and Pain also offers stem cell therapy, steroid injections, trigger point injections and ketamine infusions at its “Relievus” clinics in New Jersey and Pennsylvania.

‘Open Questions’ About CBD Safety

The federal crackdown on CBD marketing comes at a time when CBD products are starting to appear in mainstream stores. CVS Pharmacy and Walgreens started selling cannabis-based lotions, tinctures, edibles and lozenges in stores last month. The CBD products are being sold over-the-counter and without a prescription.  

The FDA and FTC announced no actions against CVS, Walgreens or other retailers selling CBD products, but they sent a clear message that the marketing of CBD will be closely watched.

“We treat products containing cannabis or cannabis-derived compounds as we do any other FDA-regulated products. Among other things, the FDA requires a cannabis product (hemp-derived or otherwise) that’s marketed with a claim of therapeutic benefit to be approved by the FDA for its intended use before it may be introduced into interstate commerce,” FDA commissioner Scott Gottlieb, MD, said in a statement. “Additionally, it is unlawful to introduce food containing added CBD, or the psychoactive compound THC, into interstate commerce, or to market CBD or THC products as dietary supplements.”

The 2018 Farm Bill removed hemp – a less potent strain of marijuana – from the Controlled Substances Act. That made hemp products legal to sell, but left the FDA in charge of regulating dietary supplements containing CBD. The agency is still trying to figure out how to regulate a product for which there is growing consumer demand, but little scientific evidence to support its use.

“While the availability of CBD products in particular has increased dramatically in recent years, open questions remain regarding the safety considerations raised by their widespread use,” Gottlieb said. “There are also unresolved questions regarding the cumulative exposure to CBD if people access it across a broad range of consumer products, as well as questions regarding the intended functionality of CBD in such products.”

Gottlieb has announced plans to hold a public hearing on May 31 to review the safety and effectiveness of CBD products. The FDA is also forming an internal working group within the agency to explore what regulatory changes would be needed for CBD products to be marketed legally.  

CVS Begins Selling Cannabis Products

By Pat Anson, PNN Editor

You may not be able to get your opioid prescription filled at a CVS pharmacy, but you can stock up on medical marijuana. The nation’s largest drug store chain has begun selling cannabis-based products in eight states, despite lingering concerns about their effectiveness and legal status.

The move was announced by cannabis retailer Curaleaf Holdings, which carries a line of cannabis lotions, tinctures, edibles and lozenges that CVS started carrying in its stores last week. The CBD products are being sold over-the-counter without a prescription.

(Update: Walgreens has also announced plans to sell CBD products in 1,500 of its stores.)

CBD stands for cannabidiol, a chemical compound in marijuana that does not produce euphoria but is believed to reduce symptoms of chronic pain and other health conditions.  

“We have partnered with CBD product manufacturers that are complying with applicable laws and that meet CVS’s high standards for quality,” a CVS spokesman said in an email to MarketWatch.  

CVS said that it was selling CBD products in Alabama, California, Colorado, Illinois, Indiana, Kentucky, Maryland and Tennessee. Curaleaf executives said CVS would eventually carry its products in 800 stores in ten states.

“We’re going to walk slowly, but this is something we think our customers will be looking for,” CVS Health CEO Larry Merlo told CNBC.

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‘Treated Like Criminal’ at CVS

The move is somewhat puzzling for CVS, which was one of the first pharmacy chains to crackdown on opioid prescriptions due to concerns about addiction and overdose. In 2017, CVS began restricting initial opioid prescriptions to 7 days’ supply and aligned its polices with the CDC opioid guideline.

Pain sufferers now complain they’re treated like drug addicts by CVS pharmacists.

“I submit to monthly drug tests and do everything I am supposed to do and I am treated like a criminal at the doctor and CVS pharmacy. My two pills a day barely touches the pain, but I need to work,” one patient recently told us.

“Some pharmacies, such as CVS, have taken it upon themselves to deny my prescriptions that I have been having filled there for 15 years. They first took it upon themselves to adjust my dosage. I didn’t realize that pharmacist were allowed to change a prescription,” said another patient.

“Why does CVS, a drug store that sells NSAIDs without restriction, have control of how I treat my patient?” asked one practitioner.

Although most Americans now support the use of medical marijuana and it is legal in dozens of states, the safety, effectiveness and legality of CBD is still very much up in the air.  Marijuana remains classified as a Schedule I controlled substance by the DEA, alongside heroin and LSD.

“Societies have jumped far, far ahead of science,” Dr. Margaret Haney, a professor of neurobiology at Columbia University Medical Center, told NBC News. “So it’s showing up in lotions and pretty much any form of product one can use. There’s a lot of different ways one could use CBD, but the ways we have studied CBD is much more limited.”

According to MarketWatch, Curaleaf only list its shares on the Canadian Securities Exchange because major exchanges in the U.S. and Canada will not list shares of marijuana companies due to their hazy legal status.

How Has CDC Opioid Guideline Affected You?

By Lynn Webster, MD, PNN Colomunist

The controversial CDC Guideline for Prescribing Opioids for Chronic Pain was released on March 15, 2016 in an effort to curb the opioid crisis. While “largely supportive” of the guideline at the time, the American Medical Association had concerns about how it would be implemented.

“We remain concerned about the evidence base informing some of the recommendations; conflicts with existing state laws and product labeling; and possible unintended consequences associated with implementation, which includes access and insurance coverage limitations for non-pharmacologic treatments, especially comprehensive care; and the potential effects of strict dosage and duration limits on patient care,” said Patrice Harris, MD, then board chair-elect of the AMA.

Dr. Harris proved to be prescient. In the last three years, insurance companies, healthcare systems and dozens of states have imposed limits – based on the CDC guideline -- on the quantity and dose of opioids dispensed to people with pain.

Oregon has even drafted a plan to stop opioid prescribing for many Medicaid patients and require that they use alternative treatments. Here was my response to Oregon's plan, in which I warned that “forcing opioid tapers is not an appropriate or compassionate solution” and could drive some patients to suicide.

Pharmacies are also imposing limits. In 2017, CVS announced it would limit the number of pills for new patients with acute pain to 7 days’ supply, saying “the CDC Guideline should become the default approach to prescribing opiates.”

That same year, the giant prescription benefits manager Express Scripts also started limiting new opioid prescriptions and set a dosage limit “based on CDC prescribing guidelines.” 

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This January, the Centers for Medicare and Medicaid Services made it more difficult for over a million Medicare patients to receive doses above 90 MME (morphine milligram equivalent) which they consider a high dose. CMS also imposed a seven-day limit on all patients receiving a new opioid prescription. The CMS rules are based on evidence “cited in the CDC Guideline.”  

‘Revisit This Guideline’

When it first published its recommendations, CDC pledged to “revisit this guideline as new evidence becomes available” and said it was “committed to evaluating the guideline to identify the impact of the recommendations on clinician and patient outcomes, both intended and unintended, and revising the recommendations in future updates when warranted.” 

In a recent statement to PNN, the CDC said there are “several studies underway with external researchers” evaluating the impact of its guideline on opioid prescribing and patient outcomes. The agency also said it recently commissioned a review by Agency for Healthcare Research & Quality (AHRQ) “to determine what new scientific evidence has been released” on the effectiveness of opioid and non-opioid pain relievers.

In the meantime, no revision of the guideline is being planned.    

The CDC guideline was well-intentioned and included many wise principles of opioid prescribing. But it appears to be more about limiting the supply of opioids than improving clinical care for pain patients. Limiting opioid access may be good for some patients, but for many it means more pain and a worsened quality of life.  

There is little evidence that limiting supply reduces opioid addiction and overdoses. Opioid prescribing in the United States has significantly declined since 2012, yet opioid overdoses continue rising – primarily due to illicit fentanyl, heroin and counterfeit drugs, not prescription opioids. The CDC's reevaluation of the guideline should take this into consideration.  

In 2018, the National Institutes of Health’s Interagency Pain Research Coordinating Committee recommended that the CDC "engage with advocates and patients, who have been negatively impacted by the unintended consequences of the CDC guideline." It also called on the FDA and the CDC to work together to "update and improve" the guideline.  

Rather than seeing the CDC guideline as a resource or helpful tool, many prescribers live in fear of it. The DEA now routinely monitors prescription drug databases, looking for “red flags” that indicate a doctor is prescribing opioids at doses above those recommended by the CDC. The AMA last year took a stand against this “inappropriate use” of the guideline, and passed a resolution stating that doctors should not be subject to criminal prosecution or other penalties solely for prescribing opioids at higher dosages.

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Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is a former president of the American Academy of Pain Medicine and the author of “The Painful Truth.”

You can find Lynn on Twitter: @LynnRWebsterMD. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Walmart to Limit Rx Opioids for Acute Pain

By Pat Anson, Editor

Walmart has announced plans to restrict opioid prescriptions for short-term acute pain to no more than a 7-day supply.

The new policy, which is similar to one already adopted by CVS, will begin “within the next 60 days” and be implemented at all Walmart and Sam’s Club pharmacies in the United States and Puerto Rico.

“We are taking action in the fight against the nation’s opioid epidemic,” Marybeth Hays, executive vice president of Health & Wellness and Consumables for Walmart U.S. said in a statement.

“We are proud to implement these policies and initiatives as we work to create solutions that address this critical issue facing the patients and communities we serve.”

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In addition to the 7-day limit on opioids for acute pain, Walmart and Sam’s Club pharmacists will also limit the dose to no more than 50 morphine milligram equivalent (MME) units per day. The company said its policy was “in alignment” with the Centers for Disease Control and Prevention’s opioid guidelines.

However, those 2016 guidelines are voluntary and only intended for primary care physicians who are treating chronic pain. They say nothing at all about pharmacists being required to limit the dose or duration of opioid prescriptions for acute pain:

“When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less will often be sufficient; more than seven days will rarely be needed.”

Several states have already adopted policies that limit opioid prescriptions for acute pain to seven days or less. Walmart said when state law limits prescriptions to less than seven days, Walmart and Sam’s Club pharmacists will follow state law.

The company’s pharmacists will also be trained and required to counsel patients about the CDC’s guidelines, while “focusing on using the lowest effective dose for pain management for the shortest time possible.”

In 2020, Walmart and Sam’s Club will also require e-prescriptions for controlled substances such as opioids. The company said e-prescriptions are less prone to errors, cannot be altered or copied, and are electronically trackable.

By the end of August 2018, Walmart and Sam’s Club pharmacists will also have access to a controlled substance tracking system called NarxCare. NarxCare analyzes a prescription database to provide pharmacists with a patient’s “risk score” for potential drug abuse.

Opioid Limits: Means, Medians or Madness?

By Roger Chriss, Columnist

CVS recently announced it would impose a 7-day limit on opioid prescriptions for short-term acute pain for customers in its pharmacy benefit management program.  A pharmaceutical industry trade group also supports a 7-day limit and so does the U.S. Pain Foundation, a patient advocacy group.

Maine, New Jersey, Massachusetts and other states are also limiting prescriptions to a week or less, justifying the time frame by saying that’s what patients need on average.

But this represents a misunderstanding of how statistics work and ignores emerging research about opioid analgesia in the world of acute pain care.

In statistics, we have three values of fundamental importance: the mean, median, and variance.

The mean, also known as the “arithmetic mean,” is the sum of a collection of numbers divided by the number of numbers in the collection. The average height or weight of a group of people is the mean.

The median is the “middle value” of a data set that is ordered from lowest to highest. The mean is found in “median income” or “median price of a new home.” Importantly, the mean and median are not necessarily the same. In the set of numbers 2, 3, 3, 5, 7, 17 and 313, the median value is 5, but the mean value is 50.

The variance is the tendency of a set of numbers to cluster around the mean, or how spread out the numbers are. We know from experience that the height of adults is closely clustered around average height: Most people are over five feet tall and under seven feet tall. No one is 2 inches or 20 feet tall. But variance can also be significant, as is the case with annual income, home prices or family size.

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The significance of these three values cannot be understated. In his essay “The Mean Isn’t the Message,” biologist Stephan J. Gould explains that a “median mortality of eight months” does not mean that a person will probably be dead in eight months. Some people, including Gould himself, live many times more than the median survival time for a disease. 

So when talking about opioid analgesia for acute pain, we cannot rely on just an “average” value. Physicians know this, but legislators, corporations and even some patient advocates do not seem to.

JAMA Surgery recently reported on the post-surgical acute pain needs of over 200,000 patients who had one of eight common surgical procedures. The results showed median values from 4 days for an appendectomy or gallbladder surgery to 7 days for a discectomy.  

The authors then used these values and the variance to calculate the range of time a patient would typically need opioids for acute pain after surgery:

  • 4 to 9 days for general surgery procedures
  • 4 to 13 days for women's health procedures
  • 6 to 15 days for musculoskeletal procedures

In other words, there is substantial variance, with the optimal length extending to as much as two weeks. And there is no way to know ahead of time where in this range an individual will fall.

To address this uncertainty, the Opioid Prescribing Recommendations for Surgery were developed at the University of Michigan. They list the recommended numbers of tablets of hydrocodone, codeine, tramadol, or oxycodone for a range of common surgical procedures, including laparoscopic cholecystectomy, open colectomy, and several types of biopsy.

This resource gives amounts that “represent the actual maximum opioid use reported by three-quarters of actual surgery patients.” Those amounts range from 10 to 40 pills, depending on the procedure, noting that “prescribers are encouraged to use their best judgment.”

The Opioid Prescribing Recommendations for Surgery also advise recovering unused pills to reduce the risk of diversion, which is a much more sensible policy than forcing people recovering from trauma or surgery to seek refills if they happen not to fit a mandated average.

In sum, the medical profession is offering evidence-based recommendations for pain management that include not just a simplistic mean, but the real-world variance found in individuals. This approach is likely to provide better results than blanket policies geared toward a statistical mean that does not capture vital features of medical care.

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Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society.

Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

PNN Survey Shows Strong Support for CVS Boycott

By Pat Anson, Editor

There is widespread support for a boycott of CVS for planning to have its pharmacists impose strict limits on the supply and dosage of opioid pain medication, according to a PNN survey of over 2,500 pain patients, caretakers and healthcare providers.

Nine out of ten (93%) said they would support a boycott of the pharmacy chain, which has nearly 10,000 retail locations nationwide.

“I already have to jump through multiple hoops to get my pain medication prescriptions. It is not the place of CVS to monitor or alter my prescriptions. That is my doctor's job,” one patient told us.

“My Rx needs have been determined by my physician and my case history,” another patient wrote. “CVS does not have my history, nor have they been seeing me as a patient. Therefore, they have no business dictating or changing the regimen my physician has set to try to help me control my chronic pain.”

CVS Health announced last month that its pharmacists would only provide a 7-day supply of opioids for acute, short-term pain. CVS will also limit the dose of opioid prescriptions – for both acute and chronic pain -- to no more than 90mg morphine equivalent units (MME). 

The policy begins February 1 and applies to about 90 million customers enrolled in CVS Caremark’s pharmacy benefit management program, which provides pharmacy services to over 2,000 health and insurance plans.

Many of the healthcare providers who responded to the online survey resent the idea of a pharmacist changing a doctor’s prescription or refusing to fill it.

WOULD YOU SUPPORT A BOYCOTT OF CVS?

“It is no one’s business how I prescribe but mine and the patient,” one doctor wrote.

“It is wrong on all levels. As a health care provider I am appalled by it,” said another.

“Pharmacies should not be interfering in doctor patient relationship and treatment. There are more and more rules and regulations, and where does it stop before you have tyranny? Their rule basically will accomplish nothing positive. I would also encourage others to boycott,” a healthcare provider wrote.

CVS Customers Support Boycott

Patients, caretakers and healthcare providers all support a boycott about equally. So did nearly 92 percent of those who identified themselves as current CVS customers.

“Treating patients like they are drug-seeking criminals is just plain cruel. Our lives are hard enough without having to jump through hoops to get even a few minutes of relief. I will never fill another prescription at CVS pharmacy,” one patient wrote.

“I have gone to the local CVS for my scripts for years because they had the best prices,” wrote another patient. “But since I heard about this new policy I refuse to even set foot in a CVS.”

“They (CVS pharmacists) think they are my doctor with rude comments to me and other customers. They are too big for their britches. I am switching to Walgreens,” another patient wrote.

“A boycott will happen whether organized or not. Patients who need more than 90 morphine equivalent mgs will have to take their business elsewhere,” said another patient.

“Boycotting solves nothing. A letter writing campaign or calls to corporate to voice our opinions would be a better way to explain why we disagree with the new policy,” another patient suggested.

There is still a fair amount of confusion about the CVS policy. Many chronic pain patients are worried the 7-day limit on opioids applies to them (it does not) and others believe a pharmacist doesn’t have the legal right to refuse to fill a doctor’s prescription (they do).  

CVS says “the prescriber can request an exception” if a patient needs a larger dose or more than a 7-day supply, but hasn’t released details on how that would work or how long it would take.

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The pharmacy chain says its opioid policy is designed to “give greater weight” to the Centers for Disease Control and Prevention's opioid guideline, which discourages primary care physicians from prescribing opioids for chronic pain. But the CVS policy actually goes far beyond the voluntary recommendations of the CDC, making them mandatory for all physicians and for all types of pain.  

As PNN has reported, preventing abuse and addiction may not be the only reason behind CVS’ decision. In recent years, the company has been fined hundreds of millions of dollars for violations of the Controlled Substances Act and other transgressions, many of them involving opioid medication.

“Corporate self-interest is impetus for this policy. This CVS ploy is to avoid further scrutiny by the DEA and avoid additional monetary penalties,” one patient wrote.

“Money and bad press is the only thing that large companies like CVS pay attention to. Until the leadership and major investors feel some considerable financial pain themselves, they will continue to make or support decisions that hurt and endanger the lives of people in pain,” said another.

U.S. Pain Foundation Endorses 7 Day Limit

CVS is not the first pharmacy to adopt policies that limit the dispensing of opioids, but it is the first major chain to set a 7-day limit on opioids for acute pain. Several states have already adopted laws that limit new prescriptions to a few days' supply. The Pharmaceutical Research and Manufacturers of America (PhRMA), an industry trade group,  recently announced its support for a 7-day limit, as did a patient advocacy group.

“We are on board with limiting new prescriptions for acute pain, but we do believe there should be a specific, written exemption for chronic pain, palliative pain, and cancer pain in order to ensure they are protected,” said Paul Gileno, founder and president of the U.S. Pain Foundation, which lists CVS Health and PhRMA as corporate sponsors on its website.

“A number of states, including Massachusetts, have adopted laws limiting first-time opioid prescription to seven days, and this part of the new CVS policy is consistent with these restrictions” said Cindy Steinberg, U.S. Pain’s national director of Policy and Advocacy. “We are in agreement with this limit for new, acute conditions; however instituting dosage limits for all patients is troubling.”

Not all of the comments in our survey were negative about CVS. Some patients expressed appreciation for CVS pharmacists who helped them save money with discounts or by suggesting cheaper medications. Others are happy to see any kind of action aimed at reducing opioid addiction. 

“It may anger some, but there is a major opioid problem in my area and sometimes it takes making a bold decision to create change, even at the risk of losing customers,” wrote one patient. “Notice nobody complains about CVS not selling cigarettes. They have lost billions in revenues since, but it was for the greater good of peoples’ health.” 

One healthcare provider is worried what will happen when her patients can’t get the pain medication they need.

“When that happens, we as providers become part of the problem because these patients will go to the street for help. They will do anything to get pain relief - not to get high. I won't boycott them but I think they ought to rethink what they are doing and the impact it will have,” she wrote.

“I have children with horrific chronic pain issues and other children who have had addiction issues that were not started with pain meds. I know both sides of this issue.”

Would You Support a Boycott of CVS?

By Pat Anson, Editor

One of the most talked about issues in the pain community over the last two weeks has been CVS Health’s announcement that its pharmacists would soon start restricting doses of opioid pain medication and limit the supply of opioids for acute pain to 7 days.

The policy only applies to customers enrolled in CVS Caremark’s pharmacy benefit management program, but it quickly triggered an online backlash from pain patients – including many who called for a boycott of CVS.

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“I refuse to patronize companies that practice medicine without a license,” wrote Jeannette on PNN’s Facebook page.

“Don’t go there anymore. Hit them in their pocketbook,” wrote Lauren.

“I very rarely use a CVS and will never go there for prescriptions or anything else,” said Jackie.

“I left CVS years ago for Walgreens and I’m guessing many more will be doing so,” wrote Amanda.

"CVS has some nerve. The use of opioids, or any other drug, really, is up to the doctor and his or her patients, not a pharmacist. This is a terrible precedent, which will drive an even bigger wedge between physicians and patients,” cardiologist Arthur Kennish, MD, told the American Council on Science and Health.

The CVS boycott soon had its own hashtag on Twitter.

“Wrong way to handle, CVS! I will join the #BoycottCVS. You make it more difficult for the sick w/ no impact on the crisis,” Stephanie tweeted.

The online outrage even spilled over onto CVS’ Facebook page, where many negative posts were apparently deleted by the company.

“CVS Pharmacy, why did you take down all your Posts and comments regarding your big announcement over overriding doctor's orders and limiting patients' rights to their pain medication?” asked Lauri. “Where did they all go?”

People are so passionate about this issue that we started an online poll asking if they would support a boycott of CVS. Click here if you’d like to participate.

Would a Boycott Work?

But while there’s plenty of online enthusiasm for a boycott, it’s unlikely to be effective without the support of patient advocacy groups.  An informal survey of pain organizations by PNN found most were critical of CVS’ decision, but opposed to a boycott.

“I think boycotting CVS is not a good idea. I think a better idea is working with them for better care and finding the good in what they are doing and amplifying the bad.  They want better education, they want better disposal, and many other things we all fight for,” said Paul Gileno, President of the U.S. Pain Foundation.  “I don't think a boycott would work or be effective and can come across in a negative way. We need a loud conversation with CVS.”

“I don’t typically like boycotts” said Barby Ingle, President of the International Pain Foundation and a PNN columnist. “But if enough people have a bad experience or don’t like the CVS policies, they will see a drop in the market and will have to reevaluate what their policies will be.

“I wouldn’t call it a boycott, I would call it a shift in patients understanding that we have power and that we can choose to go to the healthcare places that fulfill our needs. Unless CVS changes their practices, I can see them continuing to lose business.”

Penney Cowan of the American Chronic Pain Association did not respond to a request for comment.

One patient advocate who gave full support for a boycott was Cynthia Toussaint, the founder of For Grace, a non-profit that supports women in pain.

“The lack of patient advocacy support for the boycott is totally surprising,” Toussaint wrote in an email. “We’ve all been beating the ‘don’t get between a doctor and a patient’ drum for years, and now that we can put our names behind that, we’re being sheepish.

“For Grace is ON BOARD with the boycott! This is chilling news for the pain world - and I hope our support helps many people. We understand CVS’s very real concern about the opioid crisis, but this new policy is too heavy handed and will greatly harm the chronic pain community!”

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CVS is not the first pharmacy to restrict access to opioid medication. In 2013, Walgreens gave its pharmacists a “secret checklist” to help them screen patients with opioid prescriptions. Any red flags, such as a prescription written by a new doctor or a patient paying in cash, could result in a prescription not being filled. The policy was implemented after Walgreens was fined $80 million by the Drug Enforcement Agency for violating the rules for dispensing controlled substances.

CVS has also been fined hundreds of millions of dollars for violations of the Controlled Substances Act and other transgressions, many of them involving opioid medication.

A Florida pharmacist who was fired this year by Sam’s Club for not following the company's opioid policy says pharmacies are driven by profit, not patient care, and a boycott is unlikely to change their bottom line. 

“Patients won't need to boycott. CVS doesn't want the business anyway,” says Karl Deigert, who was fired after complaining that patient rights were being violated at Sam’s Club, which is owned by Walmart.  “Corporations are only acting in their own best interest and have no concern for the patient. Patients can save their breath and energy as any complaints filed will fall on deaf ears. 

“Overzealous corporate policy makers have no desire or interest to protect the patients' well-being. Their policy making is self-serving to protect their assets from DEA scrutiny and monetary penalties. The corporations and the majority of retail pharmacists simply do not care to help the chronic pain patient population.”

The new opioid policy at CVS doesn’t go into effect until February 1, 2018. But CVS Caremark is already tightening the rules for some opioid prescriptions. 

A Caremark client who has been getting fentanyl pain patches at CVS for years was recently notified by letter that new limits are being placed on the patches “to help ensure that your use of opioid medication for pain management is safe and appropriate.” 

But is it really about safe and appropriate use?

The letter goes on to say the patient will still be able to get the fentanyl patches, but without prior authorization they “will have to pay 100 percent of the cost.”

CVS Defends Rx Opioid Policy

By Pat Anson, Editor

CVS Health has released new details about its plan to limit the dose of opioid pain medication and restrict new prescriptions for acute pain to a 7-day supply.

The new policy, which was announced last week, immediately sparked an online backlash from chronic pain patients, who fear they will no longer be able to refill their opioid prescriptions at CVS or will have to do it weekly.

“It's crazy what's going on. Every week going to doctors and pharmacists paying that extra money. This is a crime on the sick,” wrote Amy in a Facebook post.

“Even for new patients, this doesn't make sense,” wrote Jennifer in another online post. “After surgery some patients need these medications for longer than 7 days. Driving to the doctor to get a new script, then to the pharmacy to get more medication is not conducive to healing.”

“How can they single out medications and refuse when the doctor writes them for 30 days?” wrote Hazel. “Everyone should boycott them, not only for prescriptions but shopping there for anything. This is getting ridiculous!”

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Asked to comment on these and other concerns, CVS Health emailed a statement to PNN answering a series of questions we had about its new opioid policy. We were not allowed to interview anyone at CVS directly.

The questions and answers below were edited for clarity:

PNN: Many of your customers with chronic pain believe they'll have to go to a CVS pharmacy four times a month to get their refills. Can you clarify that for them? 

CVS: The seven day quantity limit on opioid prescriptions, going into effect on February 1, 2018 for CVS Caremark's pharmacy benefit management (PBM) clients, applies only to prescriptions written for acute conditions, such as a minor surgery or dental procedure, that generally last only for a short duration. 

We recognize that there are patients with a legitimate need for pain medication, and our approach is carefully designed to ensure that those patients can access their medication in an appropriate manner.  We are dedicated to ensuring our retail and PBM approaches do not negatively affect patients who are in need of their chronic pain medication.   

PNN: What happens when a patient recovering from surgery needs opioid medication for more than 7 days? Do they go back to their doctor and get a new prescription?

CVS: Our program encourages safe and appropriate utilization of opioids by managing utilization in a manner consistent with the Guideline set forward by the CDC.  Our efforts to ensure safe and appropriate opioid use are designed to improve the quality of care and health outcomes for patients.  If a prescriber feels patient care should exceed these limits, the prescriber can request an exception. 

PNN: What about limiting opioid prescriptions to 90mg morphine equivalent (MME) doses? Some pain patients are prescribed more than that.

CVS:  The CDC recommends that clinicians prescribe the lowest effective opioid dose and use caution when prescribing opioids at any dosage.  Further, the Guideline indicates physicians should carefully reassess evidence of individual benefits and risks when considering increasing dosage to ≥50 morphine milligram equivalents (MME)/day, and should avoid increasing dosage to ≥90 MME/day or carefully justify a decision to titrate dosage to ≥90 MME/day. 

We are aligning our standard utilization to these limits for all patients who are not in active cancer treatment, palliative care, or hospice care.  However, if a prescriber feels patient care should exceed these limits, the prescriber can request an exception. 

PNN: You say you are following the CDC guideline, but the guideline is voluntary and only intended for primary care physicians treating chronic pain. You are making them mandatory for all doctors and all patients for all types of pain.

CVS: Given the toll opioid misuse has taken on our country, we believe it is appropriate to align our utilization management of opioids for our members with the Guideline set by the CDC.  Our efforts to ensure safe and appropriate opioid use are designed to improve the quality of care and health outcomes for patients.  Notably, if a prescriber feels patient care should exceed these limits, the prescriber can request an exception. 

PNN: Many patients complain that there's already a tendency by some pharmacists to refuse to fill opioid prescriptions to avoid hassles, extra work, etc. and to send them away without their medication. How will CVS make sure its pharmacists abide by your rules and not invent new ones?

CVS: Our opioid utilization management program will be consistently executed as a coverage determination across all pharmacies in our PBM retail network.  Pharmacists at CVS Pharmacy, or any of the other retail pharmacies in our network, will not be making independent medical judgments about the appropriateness of opioid prescribing or the length of such prescribing. Additionally, the program we have recently announced does not impact prescriptions filled for CVS Pharmacy retail customers who are not covered by the CVS Caremark PBM.   

Our pharmacists are committed to providing the highest level of care for their patients.  At our retail pharmacies, we are also strengthening counseling for patients filling an opioid prescription with a robust safe opioid use education program highlighting opioid safety and the dangers of addiction. 

'Cookie Cutter' Approach to Pain Care

CVS is not the first pharmacy to adopt rules that limit the dispensing of opioids, but it is the first major chain to set a 7-day limit on prescriptions for acute pain. Given recent trends, it is probably not the last.

Several states have already adopted laws that limit opioids to a few days' supply for acute pain. And yesterday a major pharmaceutical organization announced its support for a 7-day limit on new opioid prescriptions.  

Critics say this “cookie cutter” approach to pain care ignores the fact that when acute pain is poorly treated or untreated, it can turn into chronic pain in a matter of months or even weeks.

And chronic pain can worsen or cause other life-threatening health problems, including high blood pressure, stroke, heart attack, depression and suicide ideation.

Each patient is also different. A large new study published this week in JAMA Surgery looked at the different lengths of time patients needed opioid medication while recovering from 8 common surgical procedures.

While a 7-day supply of opioids was adequate for most patients recovering from an appendectomy, hysterectomy, hernia repair and other common surgeries, an analysis of over 215,000 surgery patients found that about 20 percent of them needed at least one refill of their prescription. Orthopedic and neurological procedures were the most likely to require a refill, and Medicare patients were the most likely group to need opioids for more than 7 days after a surgery.

“Although 7-day limits on initial opioid pain medication prescriptions are likely adequate in many settings, and indeed also sufficient for many common general surgery and gynecologic procedures, in the postoperative setting, particularly after many orthopedic and neurosurgical procedures, a 7-day limit may be inappropriately restrictive," wrote lead author Louis Nguyen, MD, of Brigham and Women’s Hospital, Harvard Medical School.

But not everyone finds fault in the cookie cutter approach. In an editorial also published in JAMA Surgery, a leading surgeon wrote that “any effort” to reduce the frequency of opioid prescriptions was a good thing.

“Unfortunately, we have reached a point that 100% elimination of pain has become not only the goal but the expectation. If a surgeon allows a patient to expect a pain-free recovery, he or she will see refill requests increase,” wrote Selwyn Rogers, MD, chief of surgery at the University of Chicago Medicine Trauma Center.

“Alternatives to narcotics should be recommended and incorporated as the foundation of pain management. It does not take much time to explain the use of acetaminophen and ibuprofen and then follow up with a stronger option if the pain is not adequately relieved. It is also useful to prepare the patient to expect some discomfort, realize that complete relief of all pain is impossible, and that the cost of trying is not worth it.”

CVS to Limit Opioid Prescriptions

By Pat Anson, Editor

CVS Health has announced plans to further restrict the filling of opioid prescriptions at its pharmacies by limiting the dose and supply of opioids for acute pain to seven days. The new policy only applies to customers enrolled in the CVS Caremark pharmacy benefit management program, which provides pharmacy services to over 2,000 health and insurance plans.

CVS said its opioid policy would “give greater weight” to the Centers for Disease Control and Prevention's opioid prescribing guideline, which discourages doctors from prescribing opioids for chronic pain.

“The CDC Guideline should become the default approach to prescribing opiates, a scenario in which physicians would have to seek exceptions for those patients who need more medication or longer duration of therapy,” Troyen Brennan, MD, CVS’ Chief Medical Officer wrote in a post on Health Affairs Blog.

But the new CVS policy actually goes beyond the voluntary recommendations of the CDC guideline, which was only intended to give advice to primary care physicians who treat chronic pain.

Beginning February 1, CVS will limit all opioid prescriptions for acute pain to seven days. For both acute and chronic pain, opioid doses must not exceed 90mg morphine equivalent units and patients will be required to try immediate release formulations, before using extended release opioids.

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The policy will apply to all 90 million CVS customers enrolled in commercial, employer or Medicaid health plans. CVS operates 9,700 pharmacies and 1,100 walk-in medical clinics nationwide.

In announcing the policy, CVS rejected complaints that it and other healthcare providers were adopting a “heavy-handed, cookie cutter” approach to patient care – decisions best left between a patient and their doctor.

“To be sure, prescriber autonomy and respect for the physician-patient relationship are of paramount importance. However, there is little evidence to show that past opioid prescribing habits are necessary or appropriate, and there is a great deal of evidence that they have produced significant harm,” said Brennan.

“We see firsthand the impact of the alarming and rapidly growing epidemic of opioid addiction and misuse,” said Larry Merlo, CEO of CVS Health. 

“With this expansion of our industry-leading initiatives, we are further strengthening our commitment to help providers and patients balance the need for these powerful medications with the risk of abuse and misuse.”

 

Opioids Have Been Costly for CVS

Patient safety may not be the only factor behind CVS’ decision to limit opioid prescriptions. In recent years, the company has been fined hundreds of millions of dollars for violations of the Controlled Substances Act and other transgressions, many of them involving opioid medication.

As PNN has reported, CVS recently agreed to pay a $5 million fine to settle allegations that several CVS pharmacies in California failed to detect thefts of the painkiller hydrocodone by employees.

In 2016, CVS also paid a $3.5 million fine to resolve allegations that 50 of its pharmacies in Massachusetts and New Hampshire filled forged opioid prescriptions. One forger signed a dentist’s name on 131 prescriptions for hydrocodone and had them filled at eight different CVS stores. Another forger obtained over 200 prescriptions for hydrocodone and methadone by forging the name of an emergency room physician.

And in 2015, CVS paid a $22 million fine after two of its pharmacies in Florida were found to be routinely filling bogus prescriptions for painkillers, including some for customers as far away as Kentucky.

As a result of these and other fines, CVS pharmacists were already under pressure to be wary of filling opioid prescriptions. Many started calling doctors to make sure the prescriptions were legitimate and some even refused to fill the prescriptions of longtime customers.

Alcohol Sales Continue

CVS was widely praised for its decision to stop selling cigarettes a few years ago, a move that cost the company $2 billion in lost tobacco sales.  According to Marketplace, the company has also removed transfats from its branded food products and reduced displays of candy near its cash registers.

The healthier offerings apparently do not apply to alcohol, however, a substance that causes far more addiction, death and health problems than opioid medication. This week an advertising flier for CVS stories in California prominently displays a selection of inexpensive beer, wine and hard liquors.

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CVS did not respond to a query from PNN about whether it intends to limit the amount and frequency of alcohol purchases, as it is planning to do for opioid pain medications.    

CVS Health (NYSE: CVS) stock has fared poorly in the past year and company insiders have sold nearly $100 million in shares. Among the sellers, according to Barrons, was CEO Merlo – who has sold $26 million in shares so far in 2017, including $20 million in September alone.