May 31, 2018

Dennis E. Smith, Esq., Executive Director

Board of Licensure in Medicine

137 State House Station

Augusta, ME 04332-0137

RE: Applicability of Chapter 21 Rules to Certain Settings

Dear Dennis:

Thank you for agreeing to accept our comments on the applicability of the recent changes to the joint Chapter 21 rules regarding opioid prescriptions. While we all agree that opioid misuse is a serious problem and that we should be doing all we reasonably can to address it, parts of this rule have applicability specifically for the outpatient setting and will either be extremely difficult to comply with, or just irrelevant to long term care.

The term “long term care (LTC)”, as used in these comments specifically refers to nursing homes, acute/subacute rehabilitation facilities, and assisted living facilities that control and administer medications to the patients. The fact that patients in these settings do not handle or self-administer their own medications makes these settings very different from outpatient settings in terms of the risks associated with opioid medications.

The following are the sections of most concern: 

C. Informed Consent

“Before prescribing any controlled substances to a patient for 90 days or more for chronic pain, the clinician shall discuss and obtain a written signed consent on the risks and benefits of the use of controlled substances with the patient, or, if the patient lacks the capacity to provide informed consent, from the patient’s legal representative…”

This language is problematic because the moment a patient is admitted to a LTC setting, the receiving clinician becomes the “prescriber”. Some patients coming from hospital or home are already on chronic opioid therapy, and many of these admissions occur after hours or on weekends when there is no clinician present to “discuss and obtain” consent. However, the orders must be approved (usually by telephone) at the time the patient arrives (and sometimes are approved in advance of the patient’s arrival) to ensure that the medications can be dispensed by the facility’s pharmacy to that patient in a timely manner.

In the LTC setting, informed consent can be obtained at the time the clinician performs the admission history and physical. If the patient lacks capacity to provide consent, verbal consent can be obtained from the legal representative at the time of the H&P with written consent to follow. Furthermore, the application of the rule’s requirements to all controlled substances (for chronic pain) extends its effects far beyond the Legislature’s focus on opioids.

Informed consent is part of the standard of care that applies to all clinicians for all prescriptions, orders, and treatment options. Informed consent, in order to be truly informed, must be tailored to the individual patient and based upon sound clinical judgment. For example, it makes no sense to warn a patient with dementia who resides in a nursing home that the medication under consideration will affect the ability to operate a motor vehicle, that sudden discontinuation may result in withdrawal symptoms (described with specificity), or that there is a risk of fatal overdose resulting from accidental exposure, especially by children. The specific, mandatory terms of this part of the rule are unnecessary and unhelpful in most instances.

E. Treatment Agreement

While a written treatment agreement is a practical and useful tool for monitoring compliance with controlled substances in the outpatient setting, required elements of the agreement as outlined in the chapter 21 rule are largely irrelevant in settings where all medications are prescribed by a single clinician or clinical team and administered by licensed staff.  For example:

(a)       "The patient agrees to tell the clinician about all of their medical conditions and all medication they are taking." In the postacute and long-term nursing home setting, all medications are prescribed by the attending clinician(s). If the patient goes out for a consultation or follow-up appointment with a specialist, any medication or treatment recommendations must be ordered by the attending clinician who is credentialled at the facility. Orders or prescriptions coming back with the patient are not valid unless reordered or prescribed by credentialled clinicians. Additionally, any medications, supplements, or over-the-counter remedies brought in by family must likewise be ordered through the attending clinician(s). 

(b)       “The responsibility of the patient to be discrete about possessing narcotics and keeping them in an inaccessible place that they may not be stolen.”  Patients in nursing homes and skilled rehabilitation facilities do not possess controlled substances at any time. Many assisted living facilities also prohibit patients from possessing controlled substances, though this varies according to the facility. 

(c)       “The patient agrees to take their medications only as prescribed, not to use any illegal substances or use alcohol in excess.” Again, in the nursing home, skilled nursing, and many assisted living facilities, each dose of every medication is administered by licensed staff as prescribed. Patients have very limited, if any, access to illegal substances and may not use alcohol in the facility without a clinician order. Even when alcohol is permitted (generally limited to assisted living and occasionally long-term nursing home patients), the prescribing clinician must indicate the quantity of alcohol allowed. 

(d)       “The clinicians prescribing policies and expectations, including:

(i)        The patient will only obtain prescription opioids from 1 clinician or practice, except in the case of emergency for a new and severe pain.

(ii)       The use of a single designated pharmacy.

(iii)      The clinician’s policy on early refills, after our refills, replacement of lost or stolen pills.”

As previously described, patients in nursing homes and rehabilitation facilities have all medications prescribed by a single clinician or practice. These facilities are serviced by a single pharmacy and all refills are handled by licensed staff, not the patient. Therefore “lost or stolen” pills are not the fault of the patient.

(e)       “The patient’s responsibility to inform the clinician if they do receive opioids from another clinician, and likewise to inform those clinicians that they have an opioid treatment agreement in place.” Again, patients in these facilities do not receive any medications from other clinicians, only the clinician(s) who are credentialed to provide care at that facility.

(f)        “An agreement that the patient will keep scheduled appointments and will comply with random pill counts and or random urine/blood testing to determine compliance.” Patients in nursing homes and rehabilitation facilities are visited by the clinician on site, so keeping scheduled appointments is not an issue. Controlled substances are counted each shift by licensed staff. Compliance in these settings is documented dose by dose by the staff member administering the medication.

(g)       “A statement that if the clinician becomes concerned that there has been illegal activity, the clinician may notify proper authorities, and it may specify that local episodic care facilities, other healthcare providers and pharmacies can be made aware of the treatment agreement.”  While diversion of controlled substances by staff can in the long-term care setting, this is an administrative issue between the employee and the facility. The patient has no role.

(h)       “A statement that violation of the contract may result in opioids being reduced or discontinued, and that the patient may risk discharge from the practice.” This statement simply does not apply to the relationship between a provider and his or her patient in the LTC setting.

Since the majority of the required elements of the treatment agreement are not relevant for the majority of long-term care patients, it is our recommendation that there be an exception for long-term care facilities with regard to the treatment agreement.

F. Toxicological Drug Screens and Random Pill Counts

“Clinicians who prescribe controlled substances to a patient for 90 days or more for chronic non-cancer/non-hospice/non-end-of-life pain shall ensure that the patient undergoes a toxicological (e.g. urine or serum) drug screen prior to the initiation of treatment and then periodic random screening during the course of treatment to ensure that the patient is adhering to the prescribed treatment regimen…”

It has been suggested by one Assistant Attorney General that the reason to do urine drug screens in LTC settings is to monitor for diversion by staff. This argument is problematic for two reasons; first, the law states that the purpose of the testing is to monitor compliance on the part of the patient, not for monitoring caregivers; second, laboratory testing is billed to the patient or the patient’s insurance, or MaineCare. Using the patient’s resources, or state resources designated for patient benefit, to monitor staff is inappropriate and unethical. It is the facility’s responsibility to monitor the behavior of their staff, not the patients’. It is improper to bill a patient for services designated for a purpose other than the patient’s health care needs. In LTC facilities, each dose of every medication is documented by a licensed health care professional as given, held or refused on the medication administration record (MAR). It is therefore not necessary to perform a urine test to check the patient’s compliance because ingestion is witnessed by staff. 

Proposal:

This entire issue could be dealt with easily by a clarification from the Boards. That clarification would state that the Chapter 21 opioid prescribing requirements apply to any opioid medications prescribed or dispensed for the patient to take into possession. They would not apply to any medications ordered for administration by licensed health care professionals. Such a provision would deal with not only the LTC situation but also any opioids administered in an inpatient setting. The Legislature has clearly indicated its intention to differentiate between ordering and prescribing, and the Boards should make it clear that they are acting within the directions of the Legislature and not beyond them.

Respectfully submitted,

Karen E. Saylor, M.D., F.A.C.P.

Board of Directors

Maine Medical Association

Peter P. Michaud, J.D., R.N.

Associate General Counsel

Maine Medical Association