“The moral test of a government is how it treats those who are at the dawn of life, the children; those who are in the twilight of life, the aged; and those who are in the shadow of life, the sick and the needy, and the handicapped.” – Hubert Humphrey
passionate pachyderms
Pharmacist Steve steve@steveariens.com 502.938.2414
The DEA made a surprise visit to my office yesterday. This apparently was prompted because a vendor reported a suspicious order – AN ORDER THEY DID NOT COMPLETE. I tried to order a vial of ketamine to do infusions for depression. I did this because the psychiatric hospital that was doing them, 1.5 hours away, abruptly stopped their ketamine clinic when the physician who ran the program resigned. The patient found me because I received my REMS certification for Spravato – a new FDA approved drug, a nose spray, a derivative of ketamine that is very expensive ($4700/month). He had had a fantastic response to ketamine, which was life altering for him, after 30 years of debilitating depression from bipolar disorder. He was now overdue for an infusion, and was spiraling down, becoming more depressed with suicidal ideation. He was being treated by a nurse practitioner who was only treating him with a single agent for his bipolar disorder, which I did not feel was adequate. I agreed to treat him and told him I wanted to take over all the treatment. I ended up ordering the ketamine from a pharmacy that also gets Spravato, we simply had the patient pay for it ($14 which covers several infusions) and they sent it to the office. The patient has had a fantastic response to the infusions. I am using the protocol most sites have used – twice weekly for one month then monthly infusions at 0.5mg/kg infused over about 1 hour. We monitor vitals (BP, 02sat, pulse). We do have an AED, ambu bags, ACLS meds, EKG, and between my RN and me are ATLS, ACLS, PALS and NALS certified, though at such a low dose, ketamine thus far has shown to be quite safe. The side effects in the studies of both ketamine and esketamine have been hypertension, dissociation and sedation. We monitor patients for 2 hours. We also have one patient recently started on Spravato and we are following the REMS protocol for that patient, who is also responding quite well.
The DEA agents came in, told me that this vendor had alerted them that I ordered ketamine, which they found “suspicious”. I laughed because the patient was upstairs in our infusion room. The agent then went on to state that she then investigated further, saw my consent agreement with the state Board and had questions about my methadone prescribing. She had allegations that were false, so I corrected her. Many notes were taken. I told them which controlled substances are on site, how we account for them, how we document, what procedures we do, and everything else. I offered to show them our narcotics cabinet and documentation, the agents declined stating that would require paperwork. I am fully aware they could come back with that exact paperwork, so their declination does not mean all is over. For those wondering, I called my attorney who was on speaker phone through all of this. I will never speak to anyone without an attorney present and advise the same for all others. No agency is your ‘friend’ in medicine. No call is innocent. Do not speak, do not answer without an attorney. Take it from those of us who made that mistake.
What really shocks me is that the vendor did not bother to contact me. If they had concerns why was there no communication? Why have they not assigned a sales person to my office? What has happened to customer service? Clearly for physicians there is none. I understand the need to report, and that everyone is doing their job but had there been any sort of communication, all of this would have been avoided.
This follows the adage of no good deed goes unpunished. The patient has offered to testify on my behalf should that become necessary. He jokingly said to bill his insurance company for a higher rate – oh if only I could. Yes indeed this is another unfunded nuisance. It happened during office hours, meant no lunch for me, and yes indeed I went and drank at the end of the day – being the lightweight that I am 2 drinks was all I needed to rid myself of the angst from the DEA showing up at my office. Law school cannot start soon enough.
Injured Workers Pharmacy LLC is under investigation by the Massachusetts attorney general, which is looking into the workers compensation mail-order pharmacy’s reportedly high numbers of opioids dispensed since 2006, a spokeswoman in the Massachusetts Office of the Attorney General confirmed Friday.
The investigation is centered on “whether Injured Workers Pharmacy properly dispensed controlled substances to its customers” – an investigation that began before the latest revelations concerning IWP dispensing went public, according to the spokeswoman in Attorney General Maura Healey’s office.
The pharmacy made headlines this week following a Washington Post investigation, which included the newspaper and HD Media Co. LLC successfully suing the U.S. Drug Enforcement Administration to gain access to its database tracking opioid prescriptions known as ARCOS, or Automation of Reports and Consolidated Orders System.
A judge with the United States District Court for the Northern District of Ohio, Eastern Division, based in Cleveland on July 15 ruled that the records should be made public because “there is clearly no basis to shield from public view ARCOS data.” The district court’s order came after the 6th Circuit Court of Appeals in Cincinnati, Ohio, on June 20 vacated an initial ruling that the database could not be disclosed.
The attorney for IWP said the company is “fully cooperating” with the investigation and that the DEA data is “misleading.”
“The DEA data regarding opioids received by Massachusetts pharmacies presents a misleading comparison because the quantities received by IWP are dispensed to patients across the country, whereas at least the next seven largest recipients of opioids are retail pharmacies which dispensed in small areas within the state,” Greg Saikin, Houston-based partner for BakerHostetler LLC, said in an emailed statement.
IWP, a national home delivery pharmacy service based in Andover, Massachusetts, described itself on its website as a drug dispenser that provides quick turnaround and “hassle-free” prescriptions to the tune of more than 40,000 prescriptions each month for those hurt on the job.
The pharmacy did not respond to a request for comment on Friday.
CINCINNATI — Two top execs from a pharmaceutical wholesaler indicted this month. Two pharmacists indicted.
A federal agent tells WCPO that others passing prescription drugs and adding to the opioid crisis should take it as warning.
“We’re going to come after you. If we can do it, we’re going to do it,” said Mauricio Jimenez, DEA assistant special agent in charge.
Jimenez said the Drug Enforcement Administration is cracking down on pharmaceuticals distributors and pharmacists it believes are breaking the law, like those accused in the Miami-Luken case. The former Springboro wholesaler, two executives and two West Virginia pharmacists were charged in a conspiracy to flood rural Appalachia with millions and millions of painkiller pills, according to the U.S. Attorney’s Office.
“You’re breaking the law, you’re killing people, you’re putting this out on the street, we’re going to do everything we can to get you,” said Jimenez.
Jimenez said these investigations can take years, but they are happening. The DEA looks at the size of companies, ratio of pills to population, how payment is accepted and more.
“When it comes to these distributors … that are doing this to gain as much money as they can, and not caring about the public, that’s a significant issue that we all must face,” Jimenez said.
Speaking for pharmacists, Mimi Hart, owner of Hart Pharmacy in West Price Hill, said most take great care to avoid overfilling. She said every prescription comes with a checklist and pharmacists look for red flags before deciding to fill it.
“If it’s from a doctor out of the area, if it’s from a very large quantity,” Hart said for example.
“I don’t know a pharmacist that hasn’t said, ‘No, I cannot fill this prescription,’ that hasn’t called the doctor and said, ‘We’re really worried about this.’ “
Today’s opioid crisis makes that scrutiny even more important. But it’s not always cut and dried, Hart said.
“You know it’s a high dose, but it’s not necessarily a high dose for this patient,” Hart said.
“Everybody is trying really hard to make sure that people are getting the pain medication that they need, that they’re not getting too much, that it’s not diverted,” Hart said.
With clear evidence that restricting the number of prescriptions increased the death rate by driving non-medical users to heroin and fentanyl, the last thing one wants to hear about is a politician planning to double down on this deadly policy by calling for further prescription limits for patients in pain.
Yet Senator Robert Portman (R-OH) is proposing legislation that would impose a national 3-day limit on opioid prescriptions following surgeries. He will be kind enough to allow exceptions for people dealing with cancer, chronic pain, and “other serious matters”—whatever that means.
Government data show there is no correlation between the number of opioids prescribed and their non-medical use or the development of opioid use disorder. Overdose rates skyrocketed during the last 10 years while high-dose opioid prescriptions dropped more than 58 percent and total volume of dispensed opioids dropped more than 29 percent. Seventy-five percent of opioid-related deaths in 2017 involved fentanyl and heroin, and fewer than 10 percent involved prescription pain pills without also involving heroin, fentanyl, cocaine, tranquilizers, or alcohol.
The senator has determined that, “After the second or third [postoperative] day, other pain medications work just as effective (sic).” In my more than 35 years as a practicing general surgeon, I usually find that my patients recovering from major surgery require prescription opioids to control their pain for more than 2 or 3 days. It is bad enough that many states have imposed 5 or 7 day limits on opioid prescriptions, forcing many patients in severe pain to make multiple trips to the doctors office for refills. Imposing a national 3-day limit lacks an understanding of the science. It would be an unfounded and callous government intrusion into the practice of medicine.
Senator Portman, like so many other politicians untrained in medicine or pharmacology, is guilty of misinterpreting and misapplying the guidelines on opioid prescribing published in 2016 by the Centers for Disease Control and Prevention. He must still believe that today’s non-medical users are yesterday’s pain patients, even though, as mentioned above, there is no evidence of any correlation between the two.
He also seems to think there is a high risk of addiction in patients prescribed opioids for acute post-surgical pain. Yet a well-publicized study in the medical journal BMJ by researchers at Harvard and Johns Hopkins looked at 568,000 opioid “naïve” patients in the Aetna health insurance data base given prescription opioids for acute postoperative pain over the period of 2008-2016. The researchers found the “total misuse rate,” i.e., rate of all opioid misuse diagnoses among the 568,000 patients prescribed the opioids, was 0.6 percent.
Senator Portman told Ohio reporters, “After day four, five or six, the chances of becoming addicted are higher.” Maybe he is reacting to the statement by the researchers in the BMJ report that each refill and additional week of opioid use was “associated with an adjusted increase in the rate of misuse of 44%.” But a deeper look at their data shows the incidence of opioid misuse rose from 145 cases per 100,000 person years, or 0.15 percent per year, in patients who had no refills, to 293 cases per 100,000 person years, or 0.29 percent per year, for persons who had one refill. Indeed, that is nearly double. But if you nearly double a very low number, you still get a low number.
The fact is the overdose rate from the non-medical use of licit and illicit drugs has been on a steady exponential increase since the 1970s and shows no signs of slowing down. The only thing that has changed over the years is the particular drug in popular use at any given time. The reasons behind this are complex and multifactorial, and likely sociocultural and psychosocial. In the early part of this century the popular drugs for non-medical users were diverted prescription opioids. Next it became heroin. For the past several years it has been heroin and fentanyl. Methamphetamine related deaths are now surging to all-time high levels, and preliminary estimates from the CDC place the number of meth-related deaths at nearly 13,000 in 2018—eclipsing the number for prescription opioid-involved deaths.
Senator Portman is two or three drugs behind in his prosecution of the drug war.
To bring the death rate down, Senator Portman should learn a lesson from his home state of Ohio, where a recent embrace of harm reduction measures—expanding needle exchange programs, distributing the overdose antidote naloxone, and increasing access to Medication Assisted Treatment—has led to a 23.3 percent drop in overdose deaths in 2018 according preliminary CDC data. Harm reduction is a proven strategy for saving lives.
If Senator Portman wishes to craft legislation that can truly save lives, he should propose a repeal of the federal “Crack House Statute.” This law stands in the way of many of the country’s largest cities that wish to establish Safe Injection Facilities, which are preventing overdoses and saving lives in more than 120 cities throughout Europe, Canada, and Australia.
Josselyn Stevens called the KVUE Defenders after the medicine she received left her with a hole in her arm.
AUSTIN, Texas — Another pharmacy failure has a Leander woman wondering how long it will take the state and the federal government to investigate.
“I saw your previous story and it hit home that people don’t deserve to be hurt,” Josselyn Stevens said. “People deserve to be heard. And I don’t want anyone else hurt.”
Compounding pharmacies tailor medicine for patients. They’re needed for people who can’t take a standard manufactured drug.
There’s no FDA testing and approval for each tailored prescription. So, when things go wrong, patients can be scarred for life.
Now, Stevens’ health requires frequent visits to a doctor.
“I’d be like, ‘Where am I? What am I doing?’” Josselyn said.
She has a genetic disorder causing seizures. The seizures stopped in 2014 when doctors prescribed a specific B-12 shot, tailored at a compounding pharmacy. She can count more than 250 rounds over the years.
Velva L. Price District Clerk Travis County D-1-GN-19-004106 D-1-GN-19-004106 CAUSE NO. _______________ Ruben Tamez TREVOR STEVENS § §V. § TRAVIS COUNTY, TEXAS §STONEGATE PHARMACY, LP., §RENE GARZA, PHARM.D. and § 200THANDRES RUIZ, PHARM.D. § ____ JUDICIAL DISTRICT PLAINTIFFS’ PETITION CONTAINING REQUESTS FOR DISCLOSURE PHARM.
A surgeon performed a debridement to remove the damaged skin.
Josselyn also has Stage 3 breast cancer. So going under anesthesia for surgery for the chemical burn could contaminate her central line needed for receiving chemotherapy drugs – an infection could kill her.
“So, I did the procedure awake in the surgeon’s office,” Josselyn said.
The chemo rounds continue, and so do the debridement sessions.
“It was devastating,” she said. “It was devastating to have another hurdle to have to overcome. It’s devasting to worry.”
When moms go through this much pain, the family feels it, too.
“I can’t even pump soap without it hurting,” Josselyn said.
“Having three kids running around the house, bumping into everything, bumping into her,” said her husband, Trevor.
“Bumping into me is hard,” Josselyn added.
Josselyn’s specialized B-12 came from Stonegate Pharmacy, the same pharmacy the KVUE Defenders told you about in May when a specially mixed thyroid medicine nearly killed Lorena Lopez-Gonzalez. Records show it was 54,000% percent higher than her prescribed dosage.
“It’s a miracle that I did not die,” Lorena said in May.
Last year, the Texas State Board of Pharmacy fined Stonegate for several mistakes from 2014 through 2016. The board required the pharmacy to implement a corrective action plan and put Stonegate on probation for five years.
“I think just one person, one person with an injury to my extent should at least call for a recall,” Josselyn said.
The pharmacy board director, Allison Benz, said it’s mandatory.
“We require pharmacies to institute recalls on their compounded medications if they become aware of a problem with one of their products,” Benz said.
The KVUE Defenders tried asking Stonegate if they recalled the B-12. They quickly referred KVUE to their attorney, who is out of the country until August.
“My purpose for contacting you was to help people, even if there is just one person,” Josselyn said.
Josselyn filed complaints with the FDA and the State Board of Pharmacy.
As evidenced by Lorena’s case, it can take years for the state to investigate and take enforcement action.
“I couldn’t believe it,” attorney Sean Breen said.
Breen represents Josselyn in a lawsuit filed last week against Stonegate claiming negligence.
“They’re not going to wait around for the pharmacy board for two years,” Breen said. “They’re not going to wait around for the FDA. They’re going to exercise their rights in court, to have 12 people in Travis County say enough is enough.”
Josselyn has two more rounds of chemo left and eight more wound-scraping visits.
“Everything that I’ve had to go through over the last eight months has been devastating,” she said. “It just felt like the odds were against me.”
To top it all off, Josselyn had her gall bladder removed a month before her mastectomy. That’s three different surgeries this year.
The pharmacy board wants compounding pharmacies inspected every two years.
The legislature recently provided money to hire more people and bring the total to 14 compliance inspectors for the entire state – eight field investigators.
Two House members (Foster& Kelly) have added an amendment to HR 2470 #20 amendment – which would assign a “unique number” to every person getting chronic pain meds
Two Senate members ( Manchin & Braun) has a bill S. 2089: FDA Opioid Labeling Accuracy Act that would prohibit the FDA from labeling any opiate for long term pain use – with a few exceptions – until studies have been done to “prove” that they work for treating long term pain. I guess the couple of millenium that they have been used to treat pain in insufficient ?
They claim that global warning is caused by an excessive amount of CO2 and our increasing national debt is caused by the cost of supporting our Social Security, Medicare & Medicaid programs. A part of the solution to this problem can be brought by using the carbon footprint calculator which helps in calculating the consistency of damage to the environment over millions of years.
The proposed House bill – as I remember – has been tried before by a dictator of a country that in the late 1930’s – early 1940’s – assigned a “unique number” to a subset of the country’s population. In fact they wanted the unique number to be “permanent” so they tattooed them to the inside of their forearms… As I remember, that numbering system did not work out so well and a lot of people died
The Senate bill would deny most chronic pain pts long term pain management, and we all know that chronic pain pts that get denied adequate pain management… some end up committing suicide and others will end of dying of “natural causes” because under/untreated pain will cause their other co-morbidity issues to become life threatening. Maybe even a premature… see chart below
How would all of this help solve global warning and our national debt problem ? If these proposed bills make it to law and cause more chronic painers to commit suicide or die prematurely… there would be less CO2 being generated … since every time that one of us exhales.. we exhale CO2.
Most of the chronic painers consume a lot of healthcare dollars in treating their numerous medical issues and many are on Medicare disability or Medicaid or maybe both..
Many talk about a “covert genocide” and perhaps there is a “end game” to help address global warming and our growing national debt.
Congress doesn’t seem to be capable of directly dealing with these two issues… so … maybe there is a hidden agenda here… because if they tried to create a direct solution… probably HALF of the country would not be happy… and maybe many in Congress would not get re-elected ?
The Swiss people took drastic measures to reduce the number of people dying from opioid overdose. Their approach is effective – and unorthodox. The first in a series describing how Europeans have tackled their overdose issues.
By Taylor Knopf
ZURICH and GENEVA, Switzerland — Today, Platzspitz Park serves as a peaceful respite for those meandering along the Limmat River and past the Swiss National Museum. But it’s best known by the nickname “Needle Park.”
That’s because in the 1980s the park was hijacked by thousands of heroin users and dealers. The space, despite being in the heart of downtown Zurich, became one of the most famous examples of Switzerland’s “open drug” scenes.
Local police were tired of trying to control and disperse large groups of users, so Needle Park became one of the spots law enforcement left alone.
Rates of HIV infection soared from the sharing of needles. And the number of drug overdose deaths climbed.
People were injecting and dying outside one of the most beautiful hotels in Zurich. The same thing happened near political buildings in Bern, the nation’s capital, said Rita Annoni Manghi, director of the opioid substitution and heroin-assisted treatment programs at Hôpitaux Universitaires Genève.
Platzspitz Park, nicknamed “Needle Park,” sits next to a river by the National Swiss Museum in downtown Zurich. It’s a clean, peaceful space now, but in the 1980s was filled with heroin users and dealers. Photo credit: Taylor Knopf
It was the equivalent of people dying on the White House lawn, she said.
“So you are obliged to see the problem,” she said. “And Switzerland is not so modern, but it’s very pragmatic. And Swiss politics is very pragmatic.”
The rise in HIV infections, drug overdose deaths and the public nature of the drug problem led the Swiss to make major changes in how they approached illegal drugs and treated people who use drugs.
And in 1994, Switzerland went on to pass one of the most progressive and controversial drug policies in the world, which included the dispensing of heroin.
“Its famous tradition of protecting bank secrets, its having granted women the right to vote only in the 1970s, and its referendum-based rejections of minarets on mosques and decriminalization of cannabis illustrate its quirky conservatism,” Csete wrote.
But the Swiss are pragmatic. Instead of endlessly fighting drugs, they took a new approach and began supporting drug users through new treatment options.
The majority of Swiss citizens supported the measures, despite some pushback inside and outside the country.
The nation cut its drug overdose deaths significantly. HIV and Hepatitis C infection rates dropped. And crime rates also dropped.
The Four Pillars
To address the Swiss drug problem, elected officials, community members, law enforcement and medical experts all worked together to create the “four pillars” drug policy.
Those four pillars of the Swiss law are harm reduction, treatment, prevention and repression (or law enforcement).
“The goal was not to fight drugs anymore. It’s completely ridiculous to fight drugs,” said Jean-Félix Savary, secretary general of the Romand Group of Addiction Studies in Geneva. “We came to this conclusion and decided to change.”
Rita Annoni Manghi, medical director of the opioid substitution and heroin-assisted treatment programs at Hôpitaux Universitaires Genève (left) sits a heroin injection spot inside the facility with Christel Ding (right), a nurse who supervises the program. Photo credit: Taylor Knopf
“It was a big revolution. We don’t try to ask people not to take drugs, but take care of problems generated by the situations around people being addicted to drugs.”
The policies became as much about public order as public health, Savary said.
There was some resistance among some Swiss civil groups. Their push ultimately forced a national referendum in 1997 challenging the four pillars policy. But 70 percent of Swiss citizens voted in favor of the law. The four pillars have withstood other challenges as well, as the majority of Swiss voters continue to support it.
The multi-pronged approach included some controversial measures — such as legalized drug consumption rooms and heroin-assisted treatment facilities — but ultimately, the statistics show it has been successful.
Sponsored
Over the past two decades, the number of opioid-related deaths in Switzerland has decreased by 64 percent.
The number of new HIV infections also dropped significantly. In 1986, more than 3,000 people tested positive for HIV in Switzerland. In 2017, there were fewer than 500 new positive tests in a country of 8.4 million.
Switzerland began mandatory Hepatitis C reporting in 1988. The number of reported cases peaked between 1999 and 2002, declining since then.
Harm reduction
Harm reduction strategies aim to lessen the damage caused to a person by their use of drugs. Needles exchange programs fall under this category, as do legalized drug consumption rooms.
Offering drug users clean needles and other supplies reduces their use of dirty needles, therefore reducing the spread of HIV and Hepatitis C infections.Drug consumption rooms go one step further by providing users with a safe place to use under medical supervision, which reduces the chance of an overdose.
(What’s a drug consumption room like? More on that later in our series.)
Swiss drug experts said the public also benefits: passersby no longer see people injecting in the streets or come in contact with many used syringes.
Harm reduction staff workers make a point not to judge people who come through their doors. And many build relationships with frequent visitors. Resources are available to drug users at these facilities as well to connect them to anything they might need, from a place to sleep, eat, do laundry, or find addiction treatment.
The Swiss are also very deliberate when it comes to placing their drug consumption rooms.
For example, in Geneva, a lot of people gathered and injected near the main train station. So now, around the corner, a drug consumption room is housed in a modern green building that stands out among the backdrop of the traditional Swiss architecture.
Lowering barriers to treatment
“The goal in this field is to get as many users as possible into treatment,” said Thilo Beck, addiction psychiatrist and medical director of the heroin-assisted treatment program in Zurich.
The drug consumption room in Geneva is around the corner from the train station and was placed there because so many users gathered together and injected heroin. Now, they use inside with clean supplies and medical staff. Photo credit: Taylor Knopf
He said that 75 percent of active users in Switzerland are in treatment on a given day, and about 95 percent have been in treatment at some point.
This is medication-assisted treatment, using methadone or buprenorphine. It also includes slow-release morphine or heroin, which aren’t used to treat people with substance use disorder in the United States.
“Treatment is available and accessible,” Beck said. “I think that’s how it should be in every country.”
There are circumstances in Switzerland that make treatment so accessible. First, the country has universal health care, so everyone has health insurance.
The four pillars law also expanded opioid substitution therapy (or medication-assisted treatment) and lowered the threshold for entry. Someone can walk into a clinic for the first time and start treatment 20 minutes later, Beck said.
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Before the 1990s, this type of treatment was viewed as the first step toward abstinence. Beck said that people were supposed to stay on the treatment for six months to stabilize them, then taper off and stop.
“But this was not happening. Some people might do that, but the majority will not,” he said. “What we learned is you have to be pragmatic and take the problems as they are and think of the most feasible solution.
“It doesn’t help to think of goals that are not achievable.”
People in drug treatment programs no longer need to visit a treatment center every day to receive methadone, buprenorphine or morphine. Stable patients receive take-home doses. Physicians can also write prescriptions for these same treatments. And there’s no expectation of abstinence from street drugs and no mandatory drug-screening tests.
“By offering opioid substitution therapy almost unconditionally to virtually anyone willing to change their consumption from heroin to another product, the health care system became a viable competitor among those supplying people addicted to opioids in Switzerland,” wrote Christian Schneider, a drug analyst who works at the Swiss Federal Office of Police.
Switzerland’s low-threshold opioid substitution program allows stable patients to receive take-home doses of methadone, buprenorphine or morphine. Here, a worker at a substitution program in Geneva prepares a week of doses for a patient. Photo credit: Taylor Knopf
The treatments are safer than street drugs because the consumer knows exactly what’s in it. Switzerland doesn’t have the same fentanyl problem as the United States, but there are other unwanted substances in their street drugs. Drug check sites help with this problem. These are places a user can take their drug to be checked, and it’s given back to them with a list of what is inside it.
And because a person in treatment is spending less time and money finding and buying drugs, they can focus on other things in their life, such as housing, work or family.
“Prescribed in a way tailored to fit the needs of consumers, opioid substitution therapy not only offered a much safer and much cheaper substitute but also ensured availability and access to products in a way that street dealers could never match,” Schneider concluded.
Law enforcement
The role of law enforcement changed under the four pillars approach. As more and more users went into treatment, the demand for opioids on the black market fell, as did the purity of the products.
The purity of heroin taken by Swiss police over the last decade or so is poor, averaging between 15 and 20 percent purity. The purity and price were much higher before the four pillars law.
The police are focusing less on the users and more on big time dealers.
“You have to help the consumer and fight the criminal,” Manghi said. “And the consumer may deal a little, but they are not organized enough to do high-level crime.”
Savary, a Swiss drug and harm reduction expert, explained that getting law enforcement support was essential to gaining public support for the four pillars law. From what Savary has seen, one supportive police officer has more influence than 100 medical experts.
The Swiss are prosecuting fewer opioid-related crimes. In 1993, the country had about 20,000 cases a year. Today, the Swiss average about 5,000 opioid-related cases annually.
Prior to the four pillars law, house break-ins were common in Switzerland, Savary said. After the law was adopted, there was a huge drop in burglaries.
“We reduced theft by 98 percent. We never had a security figure like this,” he said, referring to crime statistics. “With health measures, you can have a very big security impact… You can do both. It’s cheap and effective. It sounds like a miracle, but you can do it.”
They’re essentially a “middle man” between drug makers, health care plans, and patients, negotiating the prices most of us pay for prescription drugs.
The flowchart below explains the way it works. It’s from The Commonwealth Fund, a private foundation that supports independent research on health care issues.
Independent Pharmacies Losing Business
In the last two years, health insurance companies, which set deductibles and co-pays, have bought up the three main PBMs: Express Scripts, CVS Caremark, and Optum RX.
A number of independent pharmacies have told Spectrum News they are now losing business and revenue because of PBMs, including Five Points Pharmacy in Cocoa, a pharmacy that has been welcoming customers since 1958.
Louella McCormick Edwards started coming to 5 Points Pharmacy with her mother. But now, Edwards says most of her family can no longer get their medication filled at 5 Points after their health plans dropped the pharmacy from their networks.
“We have nowhere to go and people are running around for days and days trying to find places to get medicine,” Edwards said.
5 Points Pharmacy owner Dr. James Wright says he wants customers to understand that insurance companies and PBMs are the entities responsible for removing 5 Points Pharmacy from their networks.
“I usually show people the notice or rejection notice when we try and run the claim that says ‘med not covered here’,” he said.
Express Scripts, CVS Caremark, and OptumRX are the three largest PBMS, controlling 75 percent of the market, according to Fortune Magazine.
All have their own pharmacies. And all are now owned by insurance companies.
Calls for Transparency at State, Federal Levels
Florida Rep. Anna Eskamani, D-Orlando, is now calling for more transparency about whether PBMs actually save consumers money.
“Everyone is impacted by the cost of drugs and medication,” said Eskamani. “Our seniors, especially here in Florida, are going to feel that pinch. Folks on a fixed income. I think there is something to be said about the monopoly control of PBMs and how that is the anti-thesis of the free market principal.”
It’s a concern also being voiced at the federal level. In April, the Senate Finance Committee questioned PBM CEOs about their negotiation process with drug manufacturers.
At the hearing, Sen. Ron Wyden, D-Oregon, described his concerns involving PBMs.
“The deals they strike with drug makers and insurers are a mystery, how much they’re pocketing out of the rebates they negotiate is a mystery…,” Wyden said.
Currently, PBMs are not required to disclose their financial negotiations.
Would it Help?
Spectrum News 13 Watchdog Reporter Stephanie Coueignoux flew to Washington D.C. to speak with JC Scott, president and CEO of the Pharmaceutical Care Management Association, which represents PBMs.
While Scott supports transparency, and believes PBMs are one of the most transparent aspects in the health care system, he believes making negotiations public would ultimately hurt instead of help consumers.
“If you think about playing a game of cards, it would be the PBMs showing their cards to the drug company across the table in a way that lets the drug company raise prices even higher,” Scott said.
Dr. Wright at 5 Points Pharmacy does not agree. He showed us paperwork his pharmacy received for one prescription — paperwork he says patients never see.
Wright explains:
The customer’s co-pay is $60.
$1.23 is how much the medication costs, which the pharmacy pays.
$58.70 is how much the insurance company and PBM take from the total transaction.
“It’s just a strange, strange situation,” Wright said. “[They’re] passing on the cost to [me] and the patient. And patients would not know about it. It’s like a tax that no one is aware of.”
We asked Scott for his response to pharmacies claiming PBMs are putting them out of business.
“There is always going to be a tension point between negotiators when you’re trying to drive costs down, and that’s some of what you’re seeing,” Scott said.
An infographic from PCMA showing what they would like to see in terms of transparency. (PCMA)
Eskamani argues that’s where the issue of transparency comes in, that PBMs are inflating prices for out-of-network pharmacies, instead of lowering costs for everyone.
Scott says that’s simply not the case.
“I think that’s a conversation to have with them, and perhaps we need to do a better job of educating them on all the ways PBMs are already transparent, and willingness to engage with them in that important dialogue,” Scott said.
Scott said PCMA understands there is an affordability problem, but says his industry is ready to find a solution.
For Edwards, as her family scrambles to find affordable medication, talk is cheap.
Visibly upset, Edwards told Spectrum News, “It’s like extortion to me, that’s what it is. You extorting us. That’s exactly what it is.”
Eskamani says she’s working on legislation for the upcoming session that would require PBMs in Florida to be more transparent when it comes to drug pricing and availability.
MINNEAPOLIS (WCCO) — Curbing Minnesota’s opioid crisis means owners of sick pets will make more trips to their pharmacies. The state’s new opioid law went into effect at the beginning of the month, and parts of it have forced veterinarians to clear up confusion.
For eight years, Boo Boo has been by Bobby Wilbur’s side. A degenerative disc disease often has the cocker spaniel out of commission.
“It gets to the point where he can’t go up steps,” Wilbur said.
A prescription for Tramadol helps with the pain, which Wilbur would fill a few times a year. During his last visit stop at the pharmacy, that changed.
Part of Minnesota’s new opioid law places a time limit on when prescriptions for people and pets can be filled.
“They wouldn’t refill my medication because it had been more than 30 days since his last refill,” Wilbur said. “This doesn’t make any sense to me it means I will have a larger quanity on hand than I normally would.”
Minnesota’s Board of Pharmacy has fielded questions in the last few weeks from doctors, veterinarians, patients and pet owners — all trying to better understand the new pain pill law and the long list of provisions that comes with it.
“An opioid prescription needs to be filled within 30 days of the time it’s issued for the first fill, and then if it can have refills it needs to be filled every 30 days after that,” Board of Pharmacy executive director Cody Wiberg said.
Wilerg explains the 30-day rule is meant to bring patients back in to be re-evaluated to see if an opioid is still necessary. Since, sadly some have accessed medicine for themselves through their vet office.
“There’s still way too many people dying from opioid abuse,” Wiberg said.
The board has questioned some of the language and plans to make changes next session, meaning, at least for now, Wilbur will be back at his pharmacy every month to make sure Boo Boo finds help when it is needed.
A prescription for Tramadol can be phoned into a pharmacy by a vet so it wouldn’t require another appointment. But some stronger drug classes will before a refill is granted.
Click here for answers of frequently asked questions of Minnesota’s new opioid law.
