Getting meds: why does government make it so hard?
Take a medication called buprenorphine, approved by the FDA in 2002. Buprenorphine's profile has risen within the last few years. It suppresses drug cravings and quells withdrawal symptoms like muscle aches, sweating, anxiety, agitation, and diarrhea--also called "dope sickness." The drug is a less potent substitute for the classic opiate replacement drug, methadone, and has less of a potential for abuse. Some patients dose daily over weeks or months as a way to slowly detox from abused opiates. Others stay with buprenorphine for years.
In order to prescribe buprenorphine, Congress requires that doctors undergo special training and certification from the Substance Abuse and Mental Health Services Administration, or SAMHSA. The eight-hour course is not particularly onerous (I did it in three days at my computer, and it was an excellent refresher on opiate psychopharmacology). Nor is it expensive. Yet, according to SAMHSA, fewer than 32,000 doctors are certified. Worse, most doctors with the buprenorphine certification seldom administer the drug--40 percent of physicians allowed to prescribe it never do so, according to SAMHSA. Also, many doctors who prescribe buprenorphine don't accept insurance. In fact, physicians routinely find that patients who make appointments to begin buprenorphine treatment have already initiated the medication on their own after buying it on the street, an indicator of how hard it can be to find a doctor who prescribes it.
What's more, federal law limits certified doctors to treating only thirty patients at any given time during their first year of prescribing buprenorphine and a maximum of 100 patients thereafter. (If buprenorphine is prescribed by a doctor in a licensed clinic devoted to the treatment of opiate dependence, then there is no limit per doctor.) "Removing this barrier to buprenorphine is particularly critical in rural and underserved areas, where the growing need for [medication-assisted treatment] often outstrips the number of physicians licensed to supply it," according to the National Governors Association.
To be fair, the point of the limit is to keep doctors' offices from turning into "film mills" (the drug is administered in a sublingual "film") that hand out buprenorphine without providing counseling and monitoring for abuse. But in some regions of the country so few doctors prescribe the drug, and so many patients could benefit, that some politicians and public health workers have urged raising the limit or lifting the cap altogether and allowing nurse practitioners to prescribe it. While President Obama proposed allowing doctors to treat up to 200 patients at a time after the second year of buprenorphine practice, some observers believe this won't make much of a difference because so few doctors prescribe buprenorphine to a large number of patients in the first place. Soon an implantable form of buprenorphine lasting up to six months is expected to be approved by the FDA. With this, concerns about abuse should decline.
The buprenorphine limit has been only one of several obstacles standing in the way of providing effective drug treatment for addicts more widely, but, fortunately, a bill called the Comprehensive Addiction Recovery Act (CARA) can remove a number of them. The broad intent of the legislation is to promote treatment of addicts over punishment. In service of that mission, it authorizes an expansion of pharmacological treatment for addiction. Using the catch-all phrase "medication-assisted treatment," or MAT, the bill refers to several kinds of medications that address opiate addiction.
One of these drugs is methadone, a synthetic substitute for heroin and narcotic painkillers that prevents opiate withdrawal symptoms and reduces cravings. I work as a part-time psychiatrist in a methadone clinic near George Washington University Hospital. My main job is to adjust the doses of methadone that patients drink daily in front of a nurse--methadone is addicting in its own right, and must therefore be carefully managed. The methadone is pink and cherry flavored; the lives of the patients are often far less sweet. The average age of our clientele is fifty-seven. Most are unemployed or disabled, and many have prison records. They are old-school addicts: people who started using three to four decades ago, took heroin as their first opiate, and quickly moved to injecting.
Today, by contrast, 75 percent of all heroin users started with painkillers that they bought on the street or from pill mills run by unscrupulous doctors, or stole from the medicine chests of unwitting relatives and friends who were prescribed the narcotics to treat pain. It is this new generation of opiate addict that's galvanized public health officials and politicians. According to the National Survey on Drug Use and Health, the number of first-time heroin users nearly doubled between 2006 and 2013. Ninety percent of that group comprised whites living outside of urban areas who began using opiates in their early twenties. The heroin surge of the 1970s, by contrast, comprised mainly inner-city minorities who initiated use in their mid-teens.
Today most methadone clinics cater to a subset of opiate users: those who have been treated with methadone on and off over the years; those who have failed other medications and counseling; and young users with habits too heavy for treatment with buprenorphine. CARA funds could indeed be used to establish more methadone and buprenorphine treatment, but the most valuable aspect of the legislation with regard to methadone is that it promotes the use of MAT within the criminal justice system. This is an important provision, because many judges, prosecutors, and prison officials still believe that opiate addiction can only be treated with counseling and group therapy.
Another drug covered under CARA is naloxone. Commonly known by its trade name, Narcan, naloxone is the subject of an entire section of the bill. It is basically an antidote; it saves lives by interrupting a potentially fatal overdose. It binds to the same sites in the brain as heroin and most other opioids, notably the breathing center in the brain stem. But it has a tighter grasp, so it can "kick" the opioid drugs off the receptors even after the drugs have taken effect. Pharmacologically speaking, naloxone is an opiate "antagonist." It is delivered as an intramuscular shot, intravenous injection, or nasal spray. Timing is essential: the medication must get to the brain stem as quickly as possible after opioid ingestion.
For decades following its approval by the FDA in 1971, naloxone had been used almost exclusively by emergency room doctors and first responders. CVS now sells Narcan kits to anyone with a doctor's prescription (patients can simply ask their doctors to prescribe it), and in twenty-three states it can be bought without a prescription. Narcan is also sold online and is available at needle exchanges or public health clinics. Some communities provide kits free to anyone who asks.
Another antagonist, naltrexone (Revia, Vivitrol), blocks abused opioids from producing euphoria or a high by binding tightly to opioid receptors. It is not a substitute for heroin or painkillers--it will precipitate withdrawal in people who are opiate dependent. To avoid dope sickness, a patient must first be opiate free for at least one week before taking naltrexone. There is a small group of people for whom the drug works well, however--patients with stable social situations, a lot to lose, and motivation to succeed, such as impaired physicians or nurses. Naltrexone is primarily used as an extended-release injection that has to be taken only once monthly. A pellet-like naltrexone implant, which is surgically inserted under the skin and lasts between three and six months, is also available, but it is used rarely and not approved by the FDA. (Unlike buprenorphine and methadone, naloxone and naltrexone are not addictive, and will have no effect on a person who does not use opiates regularly.)
Medication is indeed a critical element in the treatment of opiate addiction in many patients. But it rarely does enough, by itself, to solve an addict's problems: absent serious motivation to recover, no medication will work. Full recovery requires new, more constructive habits, identities, relationships, and a sense of one's future. Ideally, however, the medications can provide an extra dose of stability upon which addicts can rebuild their lives.
Sally Satel is an addiction psychiatrist, a resident scholar at the American Enterprise Institute, and a lecturer at Yale University School of Medicine.
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|Title Annotation:||Special Report on Mental Health|
|Date:||Jun 1, 2016|
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