Tag: prescriptions

Politicians Cannot Stop Punishing Patients for the Unintended Consequences of Drug Prohibition

It seems no amount of evidence can make political leaders disabuse themselves of the misguided notion that the nation’s opioid overdose crisis is caused by doctors getting patients hooked on prescription opioids. A group of eight senators unveiled the CARA(Comprehensive Addiction and Recovery Act) 2.0 Act on February 27, targeting the opioid crisis. It would impose a 3-day limit on all opioid prescribing for patients in acute and outpatient postoperative pain.

But the movement to restrict prescriptions is not evidence-based, as prominent experts have pointed out. The politicians base their proposal on the 2016 opioid guidelines put out by the Centers for Disease Control and Prevention. The guidelines stated:

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.

The guidelines pointed out that the above recommendations were based on “Type 4” evidence:

Type 4 evidence indicates that one has very little confidence in the effect estimate, and the true effect is likely to be substantially different from the estimate of the effect.

It further described Type 4 evidence as being based upon “clinical experience and observations, observational studies with important limitations, or randomized clinical trials with several major limitations.”

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Arizona Governor, Legislature, Rush Through Flawed “Emergency” Opioid Legislation

Late on the night of January 25, the Arizona legislature unanimously approved “The Arizona Opioid Epidemic Act,” introduced at the urging of Governor Doug Ducey (R) just 3 days earlier. The Governor and legislature were in such a hurry that they took no time to request testimony from representatives of the medical profession or from any other experts that might have differing views about the best ways to approach the overdose crisis. The overdose crisis is such an “emergency” that there was no time for that. Yet, most of the Act’s provisions are not scheduled to take effect until 2019.

Among the harmful features of the Act are strict restrictions on the amount and dose of opioids doctors can prescribe to new and postoperative patients. Prescriptions may be for only 5 days, and the dosages are capped. Doctors wishing to exceed these limits must first consult a board-certified pain management specialist which, of course, might take several days. This policy is not evidence-based. It will cause injured patients and those recovering from surgery to suffer needless and agonizing pain. In December, the Arizona Medical Association and the Arizona Osteopathic Medical Association wrote the state Department of Health Services warning of harmful “unintended consequences” that may ensue from one-size-fits-all 5-day limits on prescriptions and dosages for patients in acute pain.

This policy is not just inhumane, it’s dangerous. Desperate patients might seek to get better relief for their undertreated pain by supplementing their prescriptions with alcohol and/or other drugs, or by obtaining drugs through the illegal market, increasing the risk of overdose or death.

Another provision requires all providers to use a state-approved E-prescription system to prescribe opioids, placing a burden on health care providers in remote and rural areas of the state, where broadband internet access is inadequate and where some practitioners lack technological sophistication in their practices.

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Is The ACA Helping to Fuel the Opioid Overdose Rate?

Leaders at all levels of government and civil society are alarmed at the continued rise, year after year, in the death rate from opioid overdose. The latest numbers for 2015 report a record 33,000 deaths, the majority of which are now from heroin. Health insurers are not a disinterested party in this matter.

Cigna, America’s fifth largest insurer, recently announced it has made good progress towards its goal of reducing opioid use by its patients by 25% by mid-2019. To that end, Cigna is limiting the quantities of opioids dispensed to patients and requiring authorizations for most long acting opioid prescriptions. Cigna is encouraging its participating providers to curtail their use of opioid prescriptions for pain patients and is providing them with data from monitoring the opioid use patterns of their patients with an aim towards reducing abuse.

In a Washington Post report on this announcement Cigna CEO David Cordani said, “We determined that despite no profit rationale—in fact it’s contrary to that—that societally we needed to step into the void and we stepped in pretty aggressively.”

No profit rationale?

Paying for fewer opioids saves the insurer money in the short run. And opioids have become costlier as “tamper-resistant” reformulations, encouraged by the FDA, have led to new patents allowing manufacturers to demand higher prices.

There is growing evidence that, as doctors curtail their opioid prescriptions for genuine pain patients, many in desperation seek relief in the illegal market, exposing them to adulterated opioids as well as heroin. For the same reason, recent studies on the effect of state-based Prescription Drug Monitoring Programs (PDMPs) suggest they have not led to reductions in opioid overdose rates and may actually be contributing to the increase. It is reasonable to be skeptical that Cigna’s internal prescription drug monitoring program will work any differently.

Further research suggests the community rating regulations of the Affordable Care Act may be contributing to the problem. The ACA requires insurance companies to sell their policies to people who have very expensive health conditions for the same premiums they charge healthy people. At the same time, the ACA’s “risk-adjustment” programs systematically underpay insurers for many of their sickest enrollees. The overall effect is that the ACA penalizes insurers whose networks and drug formularies are desirable to those who are sick. Insurers respond to this disincentive by designing their health plans to have with provider networks, drug formularies, and prescription co-payment schedules that are unattractive to such patients, hoping they will seek their coverage elsewhere. This “race to the bottom” between the health plans results in decreased access and suboptimal health care for many of the sickest patients.

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Sorrell vs. IMS Health: Not a Privacy Case

The Supreme Court’s decision in Sorrell vs. IMS Health is being touted in many quarters as a privacy case, and a concerning one at that. Example: Senator Patrick Leahy (D-VT) released a statement saying “the Supreme Court has overturned a sensible Vermont law that sought to protect the privacy of the doctor-patient relationship.” That’s a stretch.

The Vermont law at issue restricted the sale, disclosure, and use of pharmacy records that revealed the prescribing practices of doctors if that information was to be used in marketing by pharmaceutical manufacturers. Under the law, prescription drug salespeople—“detailers” in industry parlance—could not access information about doctors’ prescribing to use in focusing their efforts. As the Court noted, the statute barred few other uses of this information.

It is a stretch to suggest that this is a privacy law, given the sharply limited scope of its “protections.” Rather, the law was intended to advance the state’s preferences in the area of drug prescribing, which skew toward generic drugs rather than name brands. The Court quoted the Vermont legislature itself, finding that the purpose of the law was to thwart “detailers, in particular those who promote brand-name drugs, convey[ing] messages that ‘are often in conflict with the goals of the state.’” Accordingly, the Court addressed the law as a content- and viewpoint-oriented regulation of speech which could not survive First Amendment scrutiny (something Cato and the Pacific Legal Foundation argued for in their joint brief.)

What about patients’ sensitive records? Again, the case was about data reflecting doctors’ prescribing practices, which could include as little as how many times per year they prescribe given drugs. (They probably include more detail than that.) The risk to patients is based on the idea that patients’ prescriptions might be gleaned through sufficient data-mining of doctors prescribing records (no doubt with other records appended). That’s a genuine problem, if largely theoretical given the availability and use of data today. Vermont is certainly free to address that problem head on in a law meant to actually protect patients’ privacy—against the state itself, for example. Better still, Vermonters and people across the country could rely on the better sources of rules in this new and challenging area: market pressure (to the extent possible in the health care area) and the (non-prescriptive, more adaptive) common law.

Whatever the way forward, Sorrell vs. IMS Health is not the privacy case some are making it out to be, it’s not the outrage some are making it out to be, and it’s not the last word on data use in our society.

“This cries out for a Jim Harper rant.”

… says a colleague. Or maybe it speaks for itself.

Sheriffs want lists of patients using painkillers

Assuming, for the sake of argument, that the War on Drugs is meant to help people: The helping hand of government strips away privacy before it goes to work.

My 2004 Cato Policy analysis on point is: “Understanding Privacy – and the Real Threats to It.”