Home Delivery of Rx Opioids Would Help Chronic Pain Patients

By Pat Anson, PNN Editor

We hear almost every day from people in pain who say they can’t get an opioid prescription filled because their pharmacy is out of stock. Often, the pharmacist has no idea when the next shipment of pain medication is coming.

“Walgreens cannot fill my prescription. They say the drug is on back order with no ship date available,” a patient recently told us.

“20 years on the same Rx for Vicodin and now CVS says they are out of stock and no idea when it will be available,” another patient wrote.

“Just talked to a pharmacist today that said they are out of Percocet, Vicodin and morphine. They said that their supplier, Cardinal Health, wasn't sure when they would get more,” said another patient.

Now imagine, if you will, what it would be like to have a pharmacy that delivers opioid medication directly to your home. No more standing in line at the pharmacy. No more dirty looks from the pharmacist. No more excuses about being out of stock.

For about 1,000 patients in the Philadelphia area, most of them chronic pain sufferers, that fantasy is a reality. They are customers of a boutique pharmacy in the Delaware Valley that specializes in home deliveries of controlled substances – including high dose opioids.  Prescriptions and refills are delivered on a carefully managed schedule before a patient runs out, becomes disabled by uncontrolled pain, and goes into withdrawal.

“We hand deliver directly to the patient. I have a whole delivery team. They're our own drivers, our own vehicles,” says Brian Dunleavy, CEO of PMC Pharmacy. “Our customers get notified when their delivery is anticipated to arrive at their home. And then every patient has to sign for it. They have to be present or we can't leave it there. Or it has to be an adult that's been authorized to receive the medication.”

I first heard of PMC Pharmacy when it sent out a news release last month to address difficulties that some patients have getting opioids and other controlled medications from other pharmacies in the Delaware Valley. PMC said it could help those patients avoid gaps in drug therapy and was committed to keeping them “on schedule, at home, and independent.”

“We should really have every chronic pain management patient in the Delaware Valley under our care because of the way our program works,” Dunleavy told PNN.

While big chain pharmacies and their wholesale drug suppliers are under increased scrutiny from law enforcement and regulators, PMC flies under the radar because its customers’ medical conditions, prescriptions and insurance claims are carefully documented – reducing the risk of diversion or misuse.     

“We won't take patients from a typical primary care practice, we're only working with chronic pain specialists who give us (patient) chart notes and supporting documentation to satisfy our wholesalers’ desires that we're doing due diligence on all these doctors and all these patients, and making sure that there's a legitimate need for the medication,” Dunleavy explained. “The diversion isn't coming from the people that are legitimate chronic pain patients. Those people hold onto that medication as if it's their lifeline.”

Trifecta of Problems

The supply of opioids and other controlled substances is tight because of a trifecta of problems that have hamstrung the pharmaceutical industry.

First, the Drug Enforcement Administration has been aggressively cutting opioid production quotas for nearly a decade, reducing the supply of oxycodone by 65% and hydrocodone by 73% since 2013.

Second is the fallout from opioid litigation. The nation’s three largest drug wholesalers reached a $21 billion settlement with 46 states, requiring them to impose strict limits on opioid shipments to pharmacies. CVS, Walgreens and other pharmacy chains have also paid tens of billions of dollars to settle lawsuits that alleged they helped fuel the overdose crisis by dispensing too many opioids.  

The third reason for tight supplies is a retooling of the generic drug industry. There’s little money to be made in selling most opioids and there’s a risk of further liability, so drug makers are cutting back production of many generic opioids.  One of the world’s largest manufacturers of generics, Teva Pharmaceutical, recently notified the FDA that it was discontinuing production of oxycodone.

It all adds up to an increasing number of drug shortages, involving not just opioids, but medications used to treat cancer, anxiety and attention deficit disorder. Dunleavy thinks the shortages are a direct result of regulatory overreach.

“You have all these things going on and everybody's like, ‘Oh well, there's a shortage of oxycodone out there.’ And in actuality, there isn't. It's a regulatory created shortage, which is why there's a discrepancy between what we're hearing from patients versus what we see at the on the wholesalers’ shelves,” he explained. “The pharmacies can't get those drugs because they're quantity restricted by the wholesalers, based on the programs that the wholesalers have implemented to police the pharmacies.”

Dunleavy says PMC would like to add more patients to its customer base, provided they live in its delivery area in southeastern Pennsylvania and parts of New Jersey and Delaware that border Philadelphia. He’s confident he’ll be able to get the additional medication from suppliers.

“You're not going to have a better adherence and compliance program from a pharmacy than ours,” he said. “Because our program is pain management specific, once we start working with a practice, we start getting quite a few referrals. So it's very easy for us to start growing.”

Could PMC’s business model be adopted by other pharmacies? With pain management under so much scrutiny, Dunleavy says home deliveries to selected patients make sense.

“There's a legitimate need for a pharmacy that puts in a little bit more effort, that's a little bit more specialized. Because the regulatory environment requires it, the patients require it, and the physicians require it,” he said.

“This is a very interesting concept. It almost sounds too good to be true, but if it really works it would be tremendously helpful to many chronically ill people,” says Kristen Ogden, a patient advocate in Virginia. “I think this concept may be really helpful to house-bound patients and persons with limited access to transportation, especially those who don't have an engaged family member helping them.”  

For many years, Kristen and her husband Louis have traveled to California to get the high dose opioids he needs to treat severe pain from arachnoiditis and Ehlers-Danlos Syndrome. Not having to make that monthly cross-country trip for refills would be a welcome relief to the Ogdens.  

“It would be great to think this sort of service would be available to us as we get older, especially since we have no children and no other family members who live in our area to assist us. This could certainly be a big factor in enabling older adults to continue living in their own homes if that's what they prefer to do,” Kristen said. 

The American Society of Health-System Pharmacists put immediate release oxycodone on its list of drug shortages in March and added hydrocodone/acetaminophen tablets to the list in May.  Neither shortage has yet to be recognized by the FDA, although many patients are already well aware that both medications are in short supply. 

“I've been waiting for over a week for oxycodone to come in. Over the last weekend, I went to over 25 different pharmacies searching, until I couldn't drive anymore. It's not fair to any of us!” a pain patient recently told PNN

Algorithms Now Determine If You Get Medication

By Crystal Lindell, PNN Columnist

Did you know that secret algorithms are being used to determine whether your pharmacy is allowed to stock certain medications?

Algorithms are computer software programs designed to select, calculate and carry out certain actions – in this case the amount of opioids and other controlled substances that pharmacies can keep in stock to fill prescriptions with. And if an algorithm decides your pharmacy has used up its monthly allotment of a controlled drug, there’s almost no recourse for you as a patient.

The situation was recently brought into the spotlight by The New York Times article, “Opioid Settlement Hinders Patients’ Access to a Wide Array of Drugs.”

As The Times explains, the $21-billion opioid settlement brokered between the three largest U.S. drug distributors and 46 states includes a provision that forces the distributors to place strict limits on the drugs they supply to pharmacies. In addition to opioids, any medication labeled as a controlled substance is now subject to these restrictions, including Xanax, Adderall, muscle relaxants, and more.

“Before the settlement, pharmacists said, they could explain to a distributor the reason for a surge in demand and still receive medications past their limits. Now the caps appear to be more rigid: Drugs are cut off with no advance notice or rapid recourse. As a condition of the settlement, distributors cannot tell pharmacies what the thresholds are,” The Times reported.

So, like I said, secret algorithms are effectively deciding your medical treatment. And it’s not even based on you as an individual. It’s based on how many people in your region are taking the same medication.

Predictably, the situation is causing a lot of problems for a lot of people. The Times found that a number of groups have been affected, including:

1. “College students far from home trying to fill their Adderall prescription.”

2. “Patients in rural areas where it is customary to drive long distances for medical care.”

3. “Hospice providers that rely on local pharmacies for controlled substances.”

Let’s take a moment to truly absorb that last one. While the The Times used the term “hospice providers,” we all know what that actually means: hospice patients who are very sick or terminally ill.

So, it doesn’t even matter if you’re on your deathbed, you still might not get pain relief. And the decision for denial, to paraphrase how a pharmacist might explain it, is basically: “A bunch of your neighbors already got morphine, so you can’t have it.”

While the exact metrics used to deny shipments aren’t public, the drug distributors have addressed the issue on their websites, and explained how they’re tracking prescriptions.

“The algorithm will flag order lines of unusual size, frequency or pattern based on a pharmacy’s own order history or when compared to peers,” AmerisourceBergen explains. “Any order lines that are flagged by the algorithm will be automatically cancelled and reported.” 

Again, none of that is based on what any specific patient is experiencing.

All of this would be upsetting if it were only impacting opioid medication, but the fact that it’s been extended to other common prescriptions – that weren’t even part of opioid litigation -- is both enraging and scary.

Doctors do not give prescriptions for any controlled substances out easily, so if a patient is being prescribed any of the meds, then they need them.

Now, you may assume that at the very least, pharmacies are calling doctors once they hit these new thresholds so that the doctor can at least try to prescribe something else or send the prescription to another pharmacy.

You’d be wrong.

As the The Times reports:

“Psychiatrists in California were so alarmed by patients’ stories of unfilled prescriptions that they sent a survey to colleagues in December. They received reports of dozens of such problems, said Dr. Emily Wood, chairwoman of the government affairs committee of the California State Association of Psychiatrists.

Dr. Wood said that patients who take a stimulant for A.D.H.D. sometimes need anti-anxiety pills or a sedative at night to sleep — but that pharmacists now tell them they cannot have the combination.

“Pharmacists aren’t calling the doctors to work it out,” Dr. Wood said. “They’re just not filling the prescriptions.”

Pharmacists are being put in an impossible position, being forced to essentially serve as police agents without any say in what they’re enforcing. And it’s upsetting that the task of reaching a doctor to ask for a different prescription is now falling on patients with conditions like ADHD, a disorder that makes tasks like that especially difficult.

I couldn’t find much about how these algorithms were created, so it’s unclear if doctors were involved in creating them. But one thing we do know is that your personal doctor definitely wasn’t involved. And your personal needs were not a factor.

Your medical treatment is now being determined by drug distributors, state attorneys general, lawyers and computers — none of whom have ever met you or your doctor.

The thing that most people in the United States don’t seem to understand — but may be about to learn — is that to the DEA anyone who uses a controlled substance above a certain level must be abusing them. This is evidenced by the fact that this policy is even leading to restrictions for hospice patients and none of the parties involved are trying to fix that.

As the The Times reports, “Although the tighter restrictions have been in place for months, the government has offered little remedy for patients.”

It’s easy to believe the myth that restrictions on controlled substances are there to help keep us safe. That they are only meant to keep these medications from people who might misuse or abuse them.  But how is it safe to make a patient quit Adderall cold turkey, even when they have a valid prescription for it? How is it safe to tell rural patients that they need to drive hundreds of miles to another pharmacy? How is it safe to deny pain relief to a dying cancer patient? It’s not.

Everything about this situation is so inhumane. We’ve had incredible medical breakthroughs and finally have medications available for health conditions once considered untreatable. But it doesn’t matter. The masses still can’t have them. We must continue to suffer for whatever time we have left.

And for what? What is the reward for our suffering? Apparently, just more suffering.

Crystal Lindell is a freelance writer who lives in Illinois. After five years of unexplained rib pain, Crystal was finally diagnosed with hypermobile Ehlers-Danlos syndrome. She and her fiancé have 3 cats: Princess Dee, Basil, and Goose. She enjoys the Marvel Cinematic Universe, Taylor Swift Easter eggs, and playing the daily word game Semantle. 

Kolodny Clarifies His Conflicts of Interest

By Pat Anson, PNN Editor

Dr. Andrew Kolodny has revised his conflict of interest statements for two articles he co-authored in the Journal of the American Medical Association (JAMA) to include his work in malpractice lawsuits involving opioid medication.

Kolodny, the founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP), is a longtime critic of opioid prescribing. He recently testified as the “star witness” for Oklahoma in its opioid negligence lawsuit against Johnson & Johnson, a case the state won with a $572 million judgement against J&J.

“I am writing to provide additional information to clarify conflict of interest disclosures in 2 articles I published in JAMA in 2017 and 2018.  During this time, I received compensation for work as an expert in malpractice litigation involving opioid prescribing,” Kolodny wrote in a Sept. 4 letter to JAMA’s editors.

“When the articles were first published, I did not believe this work could be perceived as a potential conflict of interest. My view has since changed. In the spirit of full transparency, I am requesting a correction to my disclosure statements.”

The two JAMA articles in question, which were co-authored by former CDC director Thomas Frieden, MD, both dealt with the opioid crisis and the federal policy response to it.

JAMA disclosure policy is very clear and requires authors to list “all relevant financial interests, activities, relationships and affiliations,” including payments for employment, consultancies and expert testimony.

During the Oklahoma trial, Kolodny admitted under questioning by J&J lawyers that he was being paid $725 an hour by Nix Patterson & Roach, one of three law firms hired by Oklahoma to handle the case against J&J. Kolodny anticipated being paid up to $500,000 by the end the Oklahoma trial.

“I don’t think it should be a secret that I’m being compensated,” he said.  

Kolodny also acknowledged working for the law firm of Cohen Milstein Sellers & Toll in a similar capacity, also for $725 an hour. Cohen Milstein is heavily involved in opioid litigation in New Jersey, Indiana, Vermont, California and Illinois. 

Kolodny’s work in opioid litigation was disclosed in the April 2018 JAMA article.

DR. ANDREW KOLODNY

His revised disclosure statement for that article is vague, stating that he worked as “a medical expert for states and counties that have filed suits against opioid manufacturers and as an expert witness in malpractice cases involving opioid prescribing.” It does not identify which states, counties and law firms he worked for or what companies were being sued. 

JAMA policy calls for “complete disclosure of all potential conflicts of interest” covering a three-year period prior to an article being submitted. If an author received funding from the pharmaceutical industry, for example, he or she would be expected to identify the company involved.   

“It is encouraging that Dr. Kolodny has recognized that his very profitable work supporting plaintiffs in opioid lawsuits might constitute a conflict of interest when he writes about opioid policy and clinical practice,” said Bob Twillman, PhD, a healthcare policy consultant and former Executive Director of the Academy of Pain Management. “Of course, these aren't the only two articles Dr. Kolodny has co-authored, and he has done numerous presentations at professional meetings as well, so I wonder if he will seek to correct all the rest of those relevant disclosure statements.

“I think it's also interesting that, when I disclose my conflict, I am always required to specifically name the entity involved, yet Dr. Kolodny names neither the jurisdictions nor the law firms for which he was working. It seems a little like a double standard to me, and I wonder how the editorial boards of the relevant journals feel about that.”

In March 2017, Kolodny co-authored a research letter in JAMA Internal Medicine on a study he designed that looked into funding that patient advocacy groups and professional organizations received from opioid manufacturers. Many of those organizations publicly opposed the CDC’s controversial opioid prescribing guideline, which Kolodny and other PROP members helped draft.

“The CDC did not prompt or require organizations to disclose their financial associations as part of their comments. Disclosure, however, is one means of managing conflicts of interest,” Kolodny and his co-authors wrote. “Our findings demonstrate that greater transparency is required about the financial relationships between opioid manufacturers and patient and professional groups.”

Kolodny’s disclosure statement for the 2017 article states that he was a member of PROP and Chief Medical Officer for the addiction treatment chain Phoenix House (which he has since left). It makes no mention of his work in opioid litigation or malpractice lawsuits, which may have begun at a later date.

Lucrative Sideline

Kolodny is not the only critic of opioid prescribing to develop a lucrative sideline as a medical expert or paid witness. Dr. Adriane Fugh-Berman, Director of PharmedOUT, a program at Georgetown University that seeks to expose deceptive healthcare marketing practices, has also been paid handsomely for her testimony.

In August, Fugh-Berman testified in California that she was paid $500 an hour for her work in a pelvic mesh liability trial of Johnson & Johnson. She received about $120,000 for her work on the case, according to Northern California Record.

Fugh-Berman has written several op/eds claiming that “industry-funded attacks” on the CDC guideline by physician and patient advocacy groups were part of a “coordinated attempt by opioid manufacturers to use third parties to undermine, discredit, and smear the guideline.”

Fugh-Berman discloses on PharmedOUT’s website that she is a paid expert witness, but she won’t say who funds her organization.

“(We) are funded primarily by individual donations, mostly small donations but we have several major donors. We do not provide the names of our individual donors,” she said in an email to PNN.  

Dr. Timothy Munzing, a Kaiser Permanente family practice physician in California, has also stoutly defended the CDC guideline and warned against excessive opioid prescribing.

“Most prescribing physicians feeding the opioid epidemic are well meaning, naïve, or just too busy to recognize the dangers,” he wrote in a physician guide for opioid prescribing published by Kaiser Permanente.

Over the past decade, Munzing has established a profitable career as an expert witness for the Medical Board of California, DEA, FBI and DOJ, working mostly on cases that involve doctors flagged for overprescribing opioids.

According to GovTribe.com, which tracks payments to federal contractors, Munzing has been awarded nearly $1.3 million in DOJ contracts since 2017 and is currently working on over two dozen DEA investigations.

After he left Phoenix House, Kolodny became the co-director of an opioid research program at Brandeis University that is funded with over $8.5 million federal grants, according to GovTribe.com.