First Draft of CM Prescribing Coalition’s Community Controlled Substance Policy Now Ready.

Please review before the August 18 meeting and be ready to critique and discuss this first draft of a Community Controlled Substance Policy. This is a multi-page document.  It would greatly facilitate our August 18 discussion if you can review this draft ahead of time and be ready with your comments or suggestions for additions, deletions, improvements, etc.  

Opioid and Controlled Substance Prescribing Policy Of the Central Minnesota Prescribing    Coalition and the Stearns Benton Medical Society, St. Cloud, Minnesota 2014

In April, 2014 the Stearns Benton Medical Society in St. Cloud, Minnesota convened the first meeting of the Central Minnesota Prescribing Coalition to begin the process of developing a uniform, community-wide prescribing policy for prescribing opioids and other controlled substances. This effort was initiated by the Medical Society in response to the current “opioid crisis” that has evolved and is evidenced by the rising rate of prescription drug addiction and the resulting and increasing degree of human suffering now happening throughout our Central Minnesota medical community.  Overdose deaths, increasing hospitalizations, and emergency room, urgent care and office visits arising from this problem have brought together a coalition of physicians, pharmacists, nurses, advanced practice providers, social workers, administrators and several other concerned community members resolved to not only develop a community prescribing policy, but also to work on a concerted, multi-faceted community campaign to find and implement solutions to this public health problem. This policy will be continuously updated as we progress towards full acceptance and implementation by our community’s health workers and their patients while hearing and acting on input from the various viewpoints of the Coalition participants.

The Coalition is well aware that no policy or clinical guidelines for that matter can be expected to cover each and every clinical encounter circumstance.  However, we hope to offer a useful consensus strategy that can provide a general treatment and management resource for health workers and their patients. We recognize and recommend that all clinicians will continue to rely upon their own experience and training when dealing with particular clinical circumstances as they occur.  Use of this policy cannot and should not take the place of clinicians’ sound clinical judgment.  Since there are several excellent clinical controlled substance guidelines already published for us to pick and choose from, we do not intend to reproduce yet another of these, but rather we can draft Policy that covers our common goals and the “why” part of standardized, quality controlled substance prescribing for our medical community.  Most published guidelines cover “opioid” prescribing with only occasional mention of other controlled substances.  We intend for our Policy to cover principles for prescription of any of the usual controlled substances that we use in daily practice including opioids.  Our experiences that we shared at our first two meetings tell us that opioid prescribing problems rarely occur in isolation from other controlled substances.  We therefore want to include consideration of all controlled substances with our Policy.  Also, we want to take a prescribing community approach.  Clinical guidelines tell us “what” and “when” for individual prescribers.  We prefer to take a community-of-prescribers approach for this significant community health problem which will require all of us in the Coalition to mitigate. 

We are grateful to the many health care and other professionals and concerned citizens who contributed so much to this effort.  The Coalition and the Medical Society are resolved to put the policy into action as soon as possible by informing the medical community and public not only of the Policy’s presence, but also about its content, strategy and goals.  We will need to achieve broad consensus among health care workers to be successful, but we are encouraged by the dramatically favorable results achieved by similar community efforts around the country and around the world in reducing death and suffering from non-prescription use and abuse of prescribed medications.  The Coalition and our community health providers in no way intend to withhold or promote the withholding of a controlled substance medication wherever its use would be appropriate according to standard, best practice medical care.  We wish to assure the patients of our community that our health care workers will continue to deliver compassionate, evidence-based personal care, including prescription of controlled substances where appropriate to those entrusting us with their treatment

Who will use the Policy?

We expect any and all health care providers including physicians, advanced practice providers, nurses, pharmacists, social workers, public health workers, emergency room and urgent care workers, and any medical personnel involved in the prescribing and refilling of prescriptions for controlled substances including opioids, tranquilizers and sedatives to take an active role in supporting and enacting the Policy offered here.  We also expect that the patients of our health care community will become aware of the Policy and recognize when providers are acting accordingly with the initiation of or follow up of treatment with these medications. 

What medical conditions will the Policy cover besides just chronic pain?

Psychiatric, sleep disorders, neurologic and other medical conditions among others might call for the prescription of controlled substances.  We want our policy to cover prescribing principles that will also be useful toward achieving Coalition goals for any clinician prescribing or participating in the prescribing process for controlled substances for any of our community’s patients. Also, our early research into this issue indicates that our best opportunity for improvement on this issue may be that very first prescription moment when a clinician proposes to treat for an acute pain episode due to injury, surgery or some other immediate problem.  Setting clear expectations and scheduling careful follow up of these very first prescribing encounters will be central in our recommendations. 

Where will the Policy be posted?

The Policy will be posted on the Stearns Benton Medical Society website and also on the blog of the Central Minnesota Prescribing Coalition.  Most recent paper copies will be available upon request from the Medical Society, although the online versions will be more likely to be most current.  We willingly offer our policy to share and use if other communities, our state of Minnesota or other states express interest in this product of our coalition’s work.  Physicians and other prescribing providers and pharmacists may wish to keep a paper copy of the latest version on hand to share with patients or their loved ones when appropriate.


What are the goals of the Controlled Substance Prescribing Policy?

The goals of the Coalition include among others:

1) Improvement in the quality of care and care encounters (including standardized, complete clinical encounter documentation) for patients and medical providers involving prescription or refills of controlled substances in our medical community (Central Minnesota)

2) Reduction of the incidence of death, addiction, disability and suffering in our medical community population resulting from prescription and non-prescription use and abuse of controlled substances

3) Reduction of the incidence of adverse health consequences resulting from medication interactions of controlled substances with other medications or substances

4) Improvement of general access to medical care in our community by reducing the increased consumption of medical resources’ time and effort required for dealing with rising rates of adverse consequences of non-prescription and prescription use of controlled substance medication

5) Improvement in the availability of health care access for all citizens of our diverse community especially those most affected by adverse health consequences of prescription drug abuse

6) Increased use of the Minnesota Prescription Monitoring Program, medication agreements, informed consent, non-prescription and prescribed other modalities by community physicians and other health workers when indicated to improve the process of controlled substance prescribing in our health community

7) Maintain continuing educational opportunities for physicians and other health providers to maintain the highest standard of care for our community’s patients when the prescribing of controlled substances is indicated.  Education regarding use and documentation of alternative, non-controlled prescribing and non-medication modalities will be an important part of the Coalition’s campaign.

8) Maintain continuing education efforts for all patients in our health community to understand and participate in best practice principles for prescription of controlled substances as covered in the Policy.

9) Improvement of the general health of all persons living in our Central Minnesota health community

10) Reduce the incidence of non-prescription use, abuse, addiction, and diversion of controlled substance prescription medications in our health community.

11) Maintain the Policy with continuous reevaluations and revisions to keep it pertinent and up to date for the needs of our medical community

12) The Coalition will make every effort to avoid deterring physicians and other prescribing clinicians from prescribing controlled substance medications when clinically appropriate.  The Coalition will also strive to avoid allowing our community to stigmatize patients or their medical conditions where the need for use of controlled substances is indicated.

Guiding Principles of the Central Minnesota Prescribing Coalition Controlled Substance Prescribing Policy include:

Continuing broad community input and support will be necessary for acceptance and feasibility of this policy. The coalition will continue to expand and solicit participation by as many groups from among our citizens as possible.

The Coalition will encourage the medical community to choose from the mix of currently available clinical guidelines for controlled substance prescribing and  adapt them to fit the needs of their particular practice.  Several common practices found among the guidelines are reflected and referenced below in the section of this Policy that outlines prescriber and patient expectations.

The Coalition will promote among our medical community the expedited assimilation of the Policy principles and guidelines of choice into the pool of templates and forms of their electronic medical record systems.  This will promote a more universal medical record format for evaluations and follow up visits for managing medical problems that require the use of controlled substance prescriptions. 

Education of physicians, other health care workers and the citizens of our health community will be a prime focus of the Coalition.  We will need to educate about the problems and possible solutions for the medical and personal consequences of controlled substance abuse and prescribing problems. Participating Coalition members will make presentations to medical and non-medical groups to increase awareness of the policy and encourage its use throughout our medical community. We will bring the facts of the extent and seriousness of the problem to light as causative of the need for our Policy.

The policy will continue to be a work in progress as enhancements and revisions will be expected as need arises after the Policy is in place and accepted.

Certain areas of the policy might be expected to need particular enhancements or changes for the specialized clinical care provided by various specialties of our medical community

The Prescribing Coalition does not in any way intend to deter physicians or other health care workers from prescribing or refilling controlled substances where reasonable clinical evaluation determines that such medication is indicated, nor do we intend to make patients requiring these medications after suitable evaluation feel reluctant to obtain or refill them

Physicians and other health care workers through this and other cooperative efforts will continue to strive to provide the best quality of care possible using accepted best practices.  Patients of our medical community can continue to expect compassionate personal care for any medical condition that warrants the prescription of controlled substances among other modalities.

 The Coalition will collaborate and share successes or shortcomings of our Policy with any other community or governing entity taking on a similar project and seeking collaboration or information sharing.

Patient information confidentiality will be maintained as is now the standard of practice in our health care community

The policy will serve to improve the quality and value of clinical encounters involving the prescription or refills of controlled substances for both patients and health care workers. We expect there to be an improvement and standardization of clinical encounter documentation.

The Coalition and the Stearns Benton Medical Society will not act in any way to process or adjudicate any claims of failure to comply with the policy originating from patients, providers or their representatives. Prevailing Federal, local and State legal statutes and the Minnesota Board of Medical Practice will continue to serve in this capacity. 

Policy for Controlled Substance Prescribing

Physicians and other health care workers who prescribe or refill controlled substances will

Strive to keep current on the risks vs. benefits of all the controlled substances that they prescribe or refill in their practice at all locations. This would include for each drug knowledge of side effects, signs of abuse or addiction, drug interactions, risks for overdose injury or death, risks for addiction potential, addiction-deterrent formulations, maximum effective doses, tolerance, risks of tolerance reduction, antidotes and how to administer them, first aid and supportive care for overdose situations, and pharmacology. 

Take extra care at the time of initial prescription.  After fully evaluating the clinical problem and discussion of all treatment options, and a trial of treatment with other options, clinicians will strive to fully inform the patient and/or their entrusted loved ones about treatment.  This would include discussion of proposed medication risks vs. benefits, side effects, drug or other substance interactions, and expectation of the duration of use anticipated for the controlled substance being prescribed.  Patients and their loved ones should be informed at the time of the first prescription of the possibility of abuse, addiction, overdose and other adverse consequences that are possible with the use of any proposed medication.  If the controlled substance medication need is likely to be long term, then the possible need for regular monitoring, medication prescribing agreements, random pill counts, or random urine testing should be discussed at this time where appropriate.  Patients should be informed of and give permission to all members of the treatment team for the use of the Minnesota Prescription Monitoring Program at this time if long term need is anticipated. 

Prescribing health workers should also consider written rules for obtaining refill authorizations, use of a single pharmacy, working with the same provider for follow up visits or refills, and the need for regular office visits to monitor the patient’s status while being treated.  These rules should be included in a written treatment agreement which patient, clinician and a witness should sign after informed consent is obtained.  Providers will ask about history of mental health problems, use of alcohol, smoking, street drugs, history of addiction, chemical dependency or treatments, family history of addiction or drug abuse and other risks.  The problem for which the patient is being treated should be fully documented and evaluated and first treated with non-controlled substance prescriptions or other modalities like physical therapy or counseling before controlled substances are prescribed.  Consultation with appropriate specialists for the clinical problem should be arranged if needed and followed up on as treatment progresses.  An opioid treatment trial period should be discussed and undertaken before entering any treatment agreement for a longer period.  If a patient’s situation worsens, even with increasing doses of the controlled substance medication, then referral to pain management or addiction treatment resources should be considered as soon as possible. This would be preferable to waiting for the occurrence of serious consequences such as a motor vehicle accident, an injury, a law violation or violence. 

Prescribers will become adept at accessing the Minnesota Prescription Monitoring Program website and creating drug use reports when appropriate.  Busy practices can train treating health team co-practitioners to use the program under their direction to save time when needed.

Strive for full support of the policy and suitable guidelines implementation among all their partners at their place of practice such as their clinic, hospital, emergency room, nursing home or urgent care center in order to improve the quality and standardization of medical records.

Become familiar with and be able to utilize all the non-pharmacologic modalities available for treatment of pain, anxiety and other psychiatric disorders and sleep problems. Providers would benefit from getting to know their local practitioners of these alternative modalities like physical therapy, acupuncture, massage, yoga, pool therapy, counseling, health coaching, meditation and others. Close collaboration with these alternative modality providers can facilitate minimizing the dose and use of controlled substances.

Become familiar with community treatment resources for pain management, counseling, psychiatric treatment, and addiction treatment in order to facilitate timely and effective referrals for these services when indicated. 

Establish treatment protocols and develop medication treatment agreements, informed consent forms and written rules for patient interaction that work throughout their place of practice for all the providers to use in a standardized fashion for prescribing controlled substances. 

Work to ensure availability of alternative treatment resources and insurance coverage for these services in their community

Maintain controlled substance prescribing clinical competency with continuing medical education modalities to maintain skills and effectiveness in this area of clinical practice.

Contribute to the maintenance and upgrading of the Policy by participating at some level with the Central Minnesota Prescribing Coalition, whether it might be through meeting attendance, educational presentations or just keeping up with the online presence of the Coalition.

Work with large medical institutions and insurers to remove patient satisfaction pay policies that penalize conscientious providers who decline improper drug seeking requests by patients filling out their patient satisfaction surveys

Physicians and other health care workers will not refill controlled substance medications for patients calling for refills outside of regular office or clinic hours such as when on call for the practice of the prescribing provider. Prescribing clinicians will clearly indicate to patients how and when to obtain any medication refills describing the rules that their practice follows in a standard fashion for prescription and refills of controlled substance medications.

Physicians and other health care workers will not prescribe controlled substances to patients whose medical situation cannot be thoroughly evaluated for any reason such as time urgency, lost medication, or unavailable medical records

Prescribing clinicians will not refill long acting pain medication or methadone for patients seeking care at an acute care facility like an urgent care center or emergency room. They will be directed to obtain these chronic, long acting meds exclusively from their regular prescribing clinician.

Physicians and other prescribing health care workers will not provide hospitalized chronic pain patients with higher doses of their chronic pain medication than what they were prescribed as an outpatient and will not change from the oral route of administration unless dire clinical circumstances indicate otherwise

Physicians and other prescribing health care workers when discharging patients from hospitals or acute treatment centers will discharge patients home with new controlled substance medications in quantities sufficient only enough to last until the expected follow up visit with the patient’s primary provider.  With post-op patients, surgeons or their designees will consider prescribing only enough controlled substance medication quantity to last until the first post-op follow up visit. This will minimize the possibility of patients subsequently having large quantities of unused controlled substance medications in their home medicine cabinets without an easy way to safely dispose of them.

Physicians and other providers working in acute care centers like emergency rooms, surgical centers, and urgent care centers will minimize controlled substance prescription quantities sent home with acute care outpatients and wherever possible. If possible, they should call the primary provider to discuss the best course of action with regard to medication choice and quantity for patients who frequently seek care in the acute setting and often request controlled substance prescriptions.

Physicians and other prescribing providers will work to establish several convenient unused medication drop-off centers and events in their community in order to minimize diversion leading to addiction and abuse originating from unused medication stored at home.  Prescribers will promote the use of the permanent unused medication drop-off sites at local law enforcement centers.

Pharmacists can collaborate with physicians and other prescribing providers to identify potential prescribing problems with individual patients where the pharmacist has reason to believe that a patient is overusing or diverting controlled substance medication to the detriment of themselves or others.

Psychiatrists, counselors and other therapists can collaborate with physicians and other prescribing providers to identify deteriorating clinical status or other concerns in a particular patient in common that they both see where controlled substance abuse might be aggravating the patient’s overall status.

Prescribing physicians and other providers will consider whether patients taking controlled substance medication should be allowed to drive commercial or private vehicles or operate machinery while taking the medication and will discuss their recommendations at the initial and subsequent office visits.

 Patients who obtain health care service involving the prescription of controlled substances will

Provide their prescribing physician or health care worker with full disclosure of all the medical details of their treatment condition including complete treatment history, a list of all their previous and current treating providers, all pharmacies used, all medications, drug allergies and adverse reaction history, history of addiction or treatments for it, risks for addiction or abuse potential including use of alcohol and psychiatric conditions or treatment, and other medical history that is pertinent. 

Agree to take only the dose of controlled substance medication that is prescribed for them

Not share or sell their controlled substance or other medication to anyone else

Store their controlled substance and other medications in a secure place to prevent diversion or accidental ingestion by children or others in their home

Properly dispose of any unused, unneeded or outdated controlled substance medication.  The Coalition recommends using the drop-off sites at law enforcement centers in their community or participating in unused drug drop-off events.  The Coalition will work to sponsor drug drop off events and encourage pharmacies to provide in-store drug take-back receptacles when this becomes legally feasible.

Learn about the Minnesota Prescription Monitoring Program and give permission for the treating team providers to access this website for their prescription information when deemed necessary. 

Agree to sign and adhere to medication treatment agreements and agree to random pill counts or random urine testing when considered appropriate by the prescribing provider

Expect to sign an informed consent when a treatment agreement is created and signed

Agree to prescribing rules that may or may not be in the medication treatment agreements at the discretion of the prescribing provider such as using only one pharmacy, getting all refills from the prescribing provider, no replacement for lost or stolen medications, not changing dosage without consulting with the treating provider, not sharing the medication with any other person, not taking prescription drugs from other providers without informing the controlled substance prescribing provider, no early refills, calling for refills according to provider’s rules, maximum allowable missed or late appointments and others as considered necessary by the prescribing provider. 

Learn about their medication, its risks vs. benefits, possible side effects, drug to drug or other interactions and learn about risk potential for abuse, overdose or addiction.  Keep a list of all medications, dosages and their prescribing providers.

Keep the prescribing physician or other health provider up to date with any other medical treatments or prescriptions from consultants, emergency rooms, urgent care centers and others. 

Present for regular office appointments with the treating provider as necessary to properly monitor the treatment condition and the use of controlled substance medication.

Participate fully with specialist consultations for the treating condition, psychiatric comorbid conditions, counseling, addiction management or others if these are considered necessary by the prescribing provider.

Seek treatment for addiction if concerned about this possibility or on the recommendation of their prescribing health provider.

Expect that their care with the prescribing provider may be terminated for failure to comply with the medication treatment agreement or the agreed upon treatment rules, or lack of cooperation with the recommendations of the treating provider.  Disrespectful behavior in person or by phone may also result in termination of treatment. 

Discuss with their prescribing provider at the onset of treatment the expected duration of treatment and dosage of the controlled substance medication and a proposed course of action to take if the apparent treatment duration goes on longer than planned or if dosage limits are exceeded

Refrain from driving a motor vehicle, operating potentially dangerous machinery or doing any potentially hazardous activity if not at full operational skill while taking controlled substance medication

Enlist a loved one or other responsible person to help them self-monitor their status while taking controlled substance medication to watch for side effects, addiction or abuse behavior, diversion, drug or other substance interaction, and signs of impending overdose consequences.

Patients suspecting or experiencing impending overdose symptoms will know to call 911 when appropriate.  Patients taking chronic higher doses of controlled substances should consider wearing a Med-Alert tag indicating use of the medication they take. Loved ones should know when to call 911 and should be trained in basic first aid for treating suspected controlled substance overdose.

Patients receiving prescriptions for controlled substances should obtain for future reference a copy of the signed treatment agreement including the prescribing provider’s prescription rules for controlled substance prescriptions and a list of patient expectations for initial evaluation and ongoing care and management.  Patients should review the prescribing rules and prescription policy with their provider if needed at follow up visits.  Patients should share the practice’s rules and policy with their loved ones with whom the patient has entrusted knowledge of their medical status.

Patients agree to allow their prescribing clinician to contact any health care professional, family member, pharmacy, legal authority, or regulatory agency to obtain or provide information about their behavior or clinical situation if their provider finds that it is necessary.

Patients would be expected to agree to a family conference or a conference with a friend, loved one or significant other if the physician believes that it is necessary.

End of draft of CM Prescribing Coalition’s Community Controlled Substance Policy

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