PHARMACIST STEVE

A long-awaited report from the President’s Commission on Combating Drug Addiction and the Opioid Crisis, with strategies to combat it, was just issued by The White House. The document is over 130 pages long and consists of 56 recommendations designed to get a handle on what should more accurately be called “the fentanyl crisis.”

Some of the recommendations are no-brainers, such as better training of emergency personnel in the use of Narcan (Naloxone) to block the effects of opioids, expansion of electronic record keeping, and fast-tracking technological alternatives that would treat pain without the downside of opioids. 

But some of the recommendations are controversial; some are good and others are terrible. Let’s grade a few of the recommendations that may have the greatest impact – good or bad – on pain patients and addicts, the groups with the most to gain or lose. If you have read it as well, you can add your own in the comments section.

RECOMMENDATION # 7 – ONE-SIZE-FITS-NONE

“The Commission recommends that HHS coordinate the development of a national curriculum and standard of care for opioid prescribers. An updated set of guidelines for prescription pain medications should be established by an expert committee composed of various specialty practices  to supplement the CDC guideline that is specifically targeted to primary care physicians.” 

As I have written before, it is impossible to establish standards of care that will apply to the general population, especially with regard to opioid drugs. Standardized doses will fail because they do not account for two critical variables. One is the large variation in patient weight. A 100-pound woman will have a very different response to set opioid dose than that of a 350-pound man, based on size alone. But size is only one variable. Metabolism is another. This already-impossible job of determining a standard drug dose or regimen for the public becomes even “more impossible” when the difference in opioid metabolism is included.

Some people, independent of weight, are much more efficient in metabolizing opioids because of their liver oxidase enzymes. Can government identify a “standard dose” that provides the same pharmacological response in a 350-pound man who is a slow metabolizer, as it does in a 100-pound woman who is fast metabolizer? No, it can’t because the differences in metabolism between two people can be as large as 15-times.

When both these factors are taken together it becomes obvious why a fixed-dose approach to a diverse will fail. It may be easy for the government to establish a maximum dose of a drug, but this number is not only a guess but a poor one at that. 

Grade: F

RECOMMENDATION # 10- EDUCATING DOCTORS WHO DON’T NEED TO BE EDUCATED

“Recommends the Administration work with Congress to amend the Controlled Substances Act to allow the DEA to require that all prescribers desiring to be relicensed to prescribe opioids show participation in an approved continuing medical education program on opioid prescribing.”

On the surface, this may seem like a fine idea, but it is really a mixed bag. While a few physicians may benefit from more training in opioid prescribing, this recommendation suggests that doctors were to blame for today’s crisis and that “educating” them (1) will help reverse the harm done. This is false. Although there are pill mill doctors who did enormous damage, the overwhelming majority of doctors have not. The fact that pain patients become addicted only a very small percentage of the time (about 1%) clearly demonstrates that physicians who were caring for their patients ethically and responsibly were helping patients, not harming them.

There is a “blame the doctor” mentality built into this recommendation, which is unfair. Ethical doctors did not create today’s fentanyl epidemic. A few unethical doctors, and people who use opioids to get high did.

GRADE: C

RECOMMENDATION # 11- PHARMACISTS CAN OVERRULE DOCTORS

“The Commission recommends that HHS, DOJ/DEA, ONDCP, and pharmacy associations train pharmacists on best practices to evaluate the legitimacy of opioid prescriptions, and not penalize pharmacists for denying inappropriate prescriptions.”

Recently, CVS took a “bold,” but atrocious step of establishing restrictions that limit the dose, number of days of the prescription, and even the type of drug (time release vs immediate release). (See: CVS’s Transparent Opioid PR Stunt).  This will mean that the pharmacist will have the power to overrule a physician.

This is wrong on many levels. Pharmacists should (and do) consult with physicians when there is a question about a drug or its dose, or when it might be dangerous when taken with another drug, but pharmacists cannot be permitted to unilaterally overrule the wishes of the physician. It is not their job to do so. 

Grade: F

RECOMMENDATION # 17- DISPOSING OF UNUSED OPIOIDS

“The Commission recommends community-based stakeholders utilize Take Back Day to inform the public about drug screening and treatment services. The Commission encourages more hospitals/clinics and retail pharmacies to become year-round authorized collectors and explore the use of drug deactivation bags.”

In a perfect world (even sane) world, disposing of unused opioids would be entirely appropriate. Whenever excess pills are kept around there is always a chance that children or (more likely teens) will get their hands on them, so it is better not to have them lying around.

GRADE (in a perfect world): A

But, we are not in a perfect world; we are in the middle of a war on pain medications, which is really a war on pain patients. If you are counting on getting some Vicodin when you really need it, for example, a toothache or a migraine headache, you will probably be seriously disappointed. The opioid jihad, which is aimed at persecuting pain patients will touch all of us at some point in our lives. It is inevitable.

My personal opinion: You have to be out of your mind to give back a single pill. Instead store them safely, because at some point they will come in mighty handy. (See the article that my colleague Alex Berezow and I wrote for the Boston Globe website STAT: “Why we are hoarding our opioid pills.”) You may be less likely to return them.

GRADE (in the real world): D

RECOMMENDATION # 23- ENHANCED CRIMINAL PENALTIES FOR FENTANYL TRAFFICKING AND SALE

The harsh enforcement of drug laws, (e.g.’ The Rockefeller Laws’) which have resulted in absurdly lengthy prison sentences for people who were caught selling marijuana and other illegal drugs, has now been recognized as an abject failure. Prisons are full of non-violent offenders, while the flow of drugs continued unabated.

Except it is different this time. Fentanyl is both a drug and a murder weapon; there has never been a drug like it. As it continues to replace heroin (2), it is almost inevitable that “heroin” addicts will eventually die from an accidental fentanyl overdose. It is perfectly reasonable to apply severe penalties to people who knowingly are involved in trafficking fentanyl.

That said, it is unlikely that even the most fervent prosecution of dealers or traffickers will stop the deaths from overdoses. At best it will slow them.

GRADE: B

RECOMMENDATION # 19: FINANCIAL INCENTIVES TO DISCOURAGE PROPER MEDICAL CARE

“The Commission recommends CMS review and modify rate-setting policies that discourage the use of non-opioid treatments for pain, such as certain bundled payments that make alternative treatment options cost prohibitive for hospitals and doctors, particularly those options for treating immediate post-surgical pain.” 

Of the 56 recommendations, this one may be the worst. If doctors and hospitals are incentivized to avoid giving patients the opioid pain medications that they need after surgery, be prepared for a world of suffering. This is not to say that viable alternatives are not sometimes available, such as nerve blocks or the use of long-acting local anesthetics in repaired wounds. (See: Surviving Post-Op Pain Without Opioids, Thanks To Chemistry). But the assumption that a few days of morphine or Percocet for post-surgical pain will lead to addiction is ludicrous. If hospitals will make more money giving post-op patients Tylenol (which doesn’t even work, See: Tylenol Isn’t So Safe, But At Least It Works, Right?) instead of something stronger, surgical wards are going to become very noisy places. From patients screaming in pain because the Tylenol did nothing.

GRADE: F-

RECOMMENDATION: KEEP FENTANYL OUT OF THE US 

“Fentanyl defies detection at our borders, as the small quantities involved for psychoactivity of fentanyl and fentanyl analogs challenge Customs and Border Protection, USPS, and express consignment carriers’ ability to detect and interdict. We are miserably losing this fight to prevent fentanyl from entering our country and killing our citizens. We are losing this fight predominately through China. This must become a top-tier diplomatic issue with the Chinese.” 

Of all the recommendations in the Commission’s report, this may be the most important, but it won’t be easy. By being less than vigilant about illegal fentanyl manufacturing, the Chinese government has been, in effect, waging a pharmacological war against the US. But there are signs that this may be changing. As I wrote last month, two large fentanyl factories in China were shut down and the owners indicted. (See: How Chinese Organic Chemists Get Away With Murder – Literally). The Chinese must understand that it is in their best interest to put a stop to this one-sided war. 

GRADE: A

CONCLUSION:

The Commission’s report is a mixed bag. Many of the recommendations deal with funding initiatives, a topic I have not included. Many are common sense and noncontroversial. But the recommendations I have covered are controversial and will have a great impact on pain patients. Some are harmful in that they reinforce the false narrative about pain patients becoming addicted, further inserting government into the already-growing gap between patients and physicians, and creating financial incentives that will result in bad medicine and more suffering. On the other hand, the report does show a glimmer of understanding about what the real problem is (and has always been)—heroin and fentanyl—and concrete steps have been proposed to address this. Because without identifying the real problem, all “solutions” will be misguided and ultimately harmful. This is a good start.

NOTES:

(1) Why is the Orwellian-sounding “re-education” limited to doctors who prescribe opioids? Why not antidepressants, antibiotics, ADHD drugs, or sedatives?

(2) There is no longer any doubt what is killing Americans. It’s fentanyl, not pills. A recent DEA report revealed that of the drugs seized and analyzed by the agency, fentanyl was identified 65% of the time and furanyl fentanyl (even worse) 9% of the time.

Yes, three-quarters of the drugs accounted for by the agency were deadly poisons, yet we worry about how many days of pain medication can be prescribed to surgical patients. Insane.