The State of Washington, plagued by record opiate overdose deaths, drew national attention recently with the announcement of an initiative to address the problem by formulating guidelines for physicians treating pain. I offer my comments on the August 26, 2010 draft proposed rules submitted to the Pain Management Workgroup by the Medical Quality Assurance Commission's subcommittee on pain management as an outsider with no direct stake since I do not treat pain.
In fairness this is only a draft, so perhaps we can excuse the duplications, typos, and misplaced items. But better writing will not make for better policy, nor will more documentation by doctors, which seems to be the goal. Overall the effort is misguided and constitutes a waste of state funds during a budget crisis.
One rule requires the provider to "screen for risk" by looking for history of addiction, "aberrant behavior and underlying psychiatric conditions." Aberrant behavior could cover a lot of territory. Without a definition this requirement fails to advance the cause. I find the term "underlying" psychiatric condition offensive and stigmatizing. Absent evidence that any psychiatric condition causes chronic pain or addiction the committee should substitute co-morbid or coexisting.
Another rule addresses informed consent. This rule states that the provider should discuss with the patient the "risks and benefits of the use of controlled substances." Providers should probably discuss the risks and benefits of any treatment, certainly any drug, even if it is not a controlled substance.
One Provider, One Pharmacy
This rule goes on to suggest the patient should "receive prescriptions from one provider and one pharmacy" if possible, a nice idea but hardly within the control of the prescriber. I am not sure I see the connection to informed consent. Another loosely related rule suggests that the provider should document indication for opioid usage on the prescription. Perhaps this is so the pharmacist will know that the patient wants that OxyContin for pain rather than to get high. It will not prevent overdose deaths.
Also included under this section is the suggestion of use of a written agreement "outlining patient responsibilities." I welcome this wording as in medicine in general I believe there is far too little focus on the responsibilities of the patient and too much on the responsibilities of the physician. Ultimately overdose death results when a patient takes too much drug on a single occasion. The physician cannot prevent such an occurrence. However, the committee could do us all a great service by providing at least a prototype agreement. Such agreements often fail to live up to their promise and frequently add to confusion. For example, the committee suggests requiring the patient to agree to "medication levels screening when requested." This may work well if the sample is collected when the patient is already in the office, but if the patient must provide a sample when ordered to do so at a random time between office visits, the physician must assume the role of arbiter when the patient delays appearance at the lab or office, forced to make judgments about the validity of the excuse. This is not an appropriate role for a physician.
The committee suggests a requirement that the patient provide consent to allow coordination of treatment between the prescribing physician and local emergency departments and pharmacies. Such authorizations, however, expire in 90 days in the state of Washington, so when such communication is required the physician must have access to the date of the authorization in order to confirm its continued validity in order for this provision to work. This problem also makes for difficulty and adherence to another provision of the proposed rules. In this provision is suggested that the patient must consent to reporting by the physician of "concern" that there may have been "illegal activity." Again, vague language limits usefulness.
Of course such an agreement or contract must specify consequences, most likely discontinuation of the drug, when the patient fails to adhere to its terms. The proposed rules also alludes to "tapering" before discontinuation, but this implies control over what the patient takes when the physician can only control what she prescribes, and, other than the unenforceable "one prescriber" notion nothing prevents the patient from seeking another physician.
Safekeeping of Drugs
The suggestion that responsibility for safekeeping of the drugs rests with the patient admonishes the patient to use "discretion" and keep medications in an "inaccessible" place. The only feasible way of addressing the issue of potential theft is to make it clear to the patient that replacement prescriptions will not be issued when the patient claims to not have enough to last until the next planned refill, regardless of the reason given, except perhaps if the drug has been confiscated by law enforcement and the patient can provide a receipt proving this to the physician.
One proposal suggests that the provider should be "willing" to refer to the patient. I can imagine a prescriber documenting his "willingness" in a progress note. Willingness alone will not help. Not only must the consultation actually take place, but patient and prescriber must alter the treatment in response to the consultants recommendations.
The draft discourages provision of narcotic prescriptions for chronic noncancer pain without objective evidence of acute injury. I applaud this principle as well as inclusion of the statement, "The treatment of patients with chronic pain is not considered an acute health service." I believe emergency physicians far too readily prescribe controlled substances.
The suggestion that providers should write prescriptions for controlled substances "to require photo identification in order to fill" should apply to all controlled substance prescriptions, not just those for pain. But the best way to effect such a change should start with pharmacies, not physicians.
The committee suggests that physicians may have "an obligation" to report illegal acts by patients to law enforcement. The committee should also however admonish providers to do this only consistent with applicable statutes and ethics guidelines relating to confidentiality.
Opiate deaths result from too much drug not from too little documentation. These new rules will likely discourage many doctors from prescribing for pain, and will make it easier to discipline doctors who ignore them.
Overall these guidelines will likely fall short. There is little real substance here but much to make the prescribers who care want to avoid treating this population with narcotics. Perhaps most unfortunate is the fact that we have in buprenorphine a much safer drug which the committee does not even mention, perhaps only because the FDA has approved no oral formulation for treating pain. (Treat Physical Pain Safely with Buprenorphine) The committee, rather than demanding more documentation, should encourage prescribing of safer drugs like buprenorphine.