Prescribing Controlled Substances: Primary Care Guidelines


1. Purpose

At HPSM, we want to ensure that members’ chronic conditions are treated according to evidence-based guidelines and that the benefits of prescription management outweigh the risks of the medications to the members. This is most salient when it comes to prescribing controlled substances. Evidence-based medicine supports best practices for prescribing controlled substances to ensure that the medication(s) meet(s) clinical criteria and to mitigate risk. This policy delineates medical standards of care for prescription management of all controlled substances, independent of underlying diagnosis, excluding testosterone for gender affirming hormone therapy.

2. Policy

  1. In accordance with the Medical Board of California, providers must consult CURES (see section 3 of this policy) prior to prescribing, ordering, administering or furnishing a Schedule II–IV controlled substance. 
  2. According to California Assembly Bill 2760, members who take more than 90 morphine milligram equivalents per day of opioids and/or combination opioids and benzodiazepines and/or present with an increased risk for overdose, including a patient with a history of overdose, a patient with a history of substance use disorder, or a patient at risk for returning to a high dose of opioid medication to which the patient is no longer tolerant, must have an active prescription for naloxone.  
  3. It is recommended that documentation for members’ prescribed controlled substances include all components delineated in section IV of this policy. 

3. Definitions

Chronic pain: Pain that persists beyond normal tissue healing time, which is assumed to be three months (according to the International Association for the Study of Pain).

Controlled substances: Prescription and non-prescription drugs whose manufacture, possession or use are regulated by law, due to their potential risk for dependence and abuse. 

CURES: Controlled Substance Utilization Review and Evaluation System (CURES) is California’s Prescription Drug Monitoring Program (PDMP). A PMDP is used to evaluate whether a patient is receiving dosages or dangerous combinations of controlled substances that increase risk of overdose. Maintained by the Department of Justice (DOJ), CURES stores Schedule II, III, IV and V controlled substance prescription information reported as dispensed in California and contains the following information: patient name, patient date of birth, patient address, prescriber name, prescriber DEA number, pharmacy name, pharmacy license number, date prescription was dispensed, prescription number, drug name, drug quantity and strength, and number of refills remaining.  

According to DOJ, providers must consult the CURES database no more than 24 hours prior or the previous business day before prescribing a controlled substance to the patient for the first time and then at least once every four months, as long as the medication remains part of the treatment plan.

Medication Assisted Treatment (MAT): The use of FDA-approved medications, in combination with behavioral therapy, to treat substance use disorders. MAT has been approved to treat Opioid Use Disorders, Alcohol Use Disorder and Smoking. 

Opioid Use Disorder (OUD): Defined in the DSM-5 by the 3C’s:  

  1. Control loss (out of control use).
  2. Compulsivity (devoting increasing mental/physical resources to obtaining, using, recovering from substances).
  3. Continued use despite adverse consequences.

The DSM-5 criteria exclude tolerance (diminished response to a drug with repeated use), physical dependence (adaptation to a drug that produces symptoms of withdrawal when the drug is stopped) and adverse medical consequences.

The prevalence of OUD is as high as 50% in patients receiving opioids. OUD is more likely in those on higher doses and/or longer duration.

Sedative/Hypnotics: Drugs that are often used to calm down people with anxiety or promote sleep (e.g., benzodiazepines like clonazepam or lorazepam, SOMA, trazodone, zolpidem “Ambien”). They act by suppressing the Central Nervous System. Sedative/hypnotics in combination with opioids increase risk of overdose, and are, therefore, not recommended/contraindicated. 

4. Procedure: Documentation Checklist for Prescribing Controlled Substances

Evaluation

History of present illness

  • As indicated for the underlying condition or complaint, including, but not limited to location, quality, severity, onset, duration, timing/frequency, context, modifying factors, associated symptoms

Functional impact (physical and psychological)

  • ADLs/physical activities/mobility
  • Social functioning (home/school/work)
  • Mood
  • Sleep
  • Enjoyment of life
  • Other

Prior evaluation and treatment

  • History of prior and current medications, including degree of relief and adverse events/side effects, (with attention to medications that increase risk of overdose, such as concurrent use of opioids and benzodiazepines and/or sedative-hypnotics)
  • History of prior and current non-pharmacologic treatment, degree of relief, and adverse events/side effects
  • Previous diagnostic tests/studies

Assessment of coexisting conditions

  • Medical history (with attention to comorbidities that increase risk of an adverse event, such as overdose, fatal or non-fatal, or opioid-induced respiratory depression (OIRD)
  • Mental health conditions
  • Substance use history (past and current)
  • Family history of alcohol or drug abuse

Risk factors for harm or misuse (including but not limited to):

  • Personal history of substance use, abuse
  • Family history of substance abuse
  • Heavy tobacco use
  • Co-occurring mental health conditions
  • History of childhood trauma
  • Poverty/unemployment

Relevant physical exam

  • Constitutional
  • Cardiovascular
  • Respiratory
  • Musculoskeletal
  • Neurologic
  • Psychiatric

Standardized screening tools (posted on HPSM website)

  • Depression: PHQ
  • Anxiety: GAD
  • Alcohol use: AUDIT
  • Drug use: DAST
  • Pain and Functional Assessment: PEG 
  • Opioid Risk Tool
  • Adverse Childhood Experience Questionnaire for Adults

Update problem list 

For any patient on controlled substances, the problem list should include:

  • ICD-10 Z79.899 Monitoring of Current, Long Term Drug Therapy  
    For patients with chronic pain on opioids, the problem list should include
  • ICD-10 G89.29 Chronic Pain 
  • ICD -10 Z79.891 Long-Term Current Use of Opiate Analgesic

Urine toxicology

Provider should send prior to starting any controlled substance(s) and at least annually during therapy to check to confirm presence of prescribed medications and for undisclosed prescription drug or illicit substance use.

Patients should be aware that these tests are administered to improve safety. The provider should explain the expected result and ask/document the last time the controlled substance(s) was/were taken and whether there might be any unexpected results.

The provider should review positive results with the patient and concerns for harm/misuse.

  • Depending on the clinical scenario, positive screens may include absence of the prescribed medication(s), presence of other (non-prescribed) controlled substances and failure/refusal to submit a urine drug test.
  • As with CURES, dismissing patients from care based on urine results could have adverse consequences for patient safety, including missed opportunity to facilitate treatment for SUD and/or to provide other potentially life-saving information and interventions.
  • Document finding and integrate into individualized treatment plan.
Additional recommendations for administering and interpreting urine drug toxicology

Urine samples

  • Laboratories may have specific specimen cups for drug screening. Each health center should consult with the respective lab to ensure proper handling.
  • If there is any suspicion that the urine sample is not valid (i.e., the sample is not warm to the touch), check a specific gravity and creatinine concentration. If the specific gravity is less than 1.003 and the creatinine is less than 20 mg/dl, it is likely an altered specimen. This is considered a positive screen.  

Interpreting results

  • Interpreting urine toxicology screen results is not always straightforward. Many opiates have expected metabolites that can appear to signify use of non-prescribed substances if the clinician is not aware. 
  • Call the lab prior to acting on a drug test that is negative for the prescribed drug to ensure it was included.
  • If there is a discrepancy, ask the patient first.

For more information, see resources below on Drug Testing and Monitoring.

Medication Reconciliation 

  • Providers should ensure that the medication list within the medical record is reconciled and updated at every relevant visit.
  • Providers must check CURES, California’s Prescription Drug Monitoring Program (PDMP),
    prior to initiating therapy with a controlled substance and ≥ every 4 months during therapy or with every prescription for controlled substance(s), whichever is more frequent (Resource: Interpreting the PDMP).  
  • For patients on combination opioids and benzodiazepines and/or sedative hypnotics:
    • Offer other treatments, including CBT and first-line anxiolytics
    • Refer to mental health
    • Begin tapering off at least one agent
  • As with drug testing, dismissing patients from care based on CURES data alone could have adverse consequences for patient safety, including missed opportunities to facilitate treatment for SUD and/or to provide other potentially life-saving information and interventions.

Medicine agreement 

Providers should complete and include in the medical record a management plan that is agreed upon by the provider and the patient. The plan should outline the expectations and responsibilities of the provider and patient in entering a management agreement that includes controlled substances and situations in which the plan may be reviewed, altered or discontinued. This agreement should assist in shared decision-making and patient education.  

A review of the plan should include:

  • Goals of therapy  
    • Set realistic treatment goals for pain and function based on diagnosis
    • Review expectation that controlled substances are one part of a multi-modal treatment plan
    • Set expectations that therapy will only be continued if clinically meaningful improvement in symptoms and function and benefits of continuation outweigh risks
    • Review patient-specific risk factors for adverse effects, harm or misuse
  • How controlled substances will be prescribed and taken
    • Patients should receive prescriptions from one physician and pharmacy whenever possible
    • Dosage adjustments should only be made by the PCP unless PCP is on a prolonged leave of absence >4 weeks
    • Expectations for clinic follow-up and monitoring (i.e., office visits at specified minimum intervals, frequency of urine drug screens, use of pill counts if indicated)
  • Alternative therapies to controlled substances
  • Expectations regarding diagnostic tests and use of concomitant therapies
  • Criteria/potential indications for tapering or discontinuing controlled substance 
    • Failure to progress toward therapeutic goals
    • Intolerable adverse effects
    • Risks to patient safety outweigh benefits
    • Repeated or serious aberrant drug-related behaviors

Overdose prevention and naloxone 

At minimum, naloxone must be offered when factors that increase risk for overdose are present, including the following:

  • History of overdose 
  • History of substance use disorder
  • Opioid dosages ≥ 90 MME/d (Consider prescribing at 50 MME/d)
  • Concurrent opioid and benzodiazepine/sedative-hypnotic use

Naloxone Rx for suspected opioid overdose 

Use one of the following:

  • Narcan®: 1 pack of two 4 mg/0.1 ml intranasal devices, disp x 1; sig: if suspect overdose, call 911; spray naloxone in nostril; repeat after 3 minutes in other nostril if still unconscious. 
  • Single use 0.4 mg/1ml naloxone vial plus 3 ml syringe with 23–25-gauge 1 inch IM needle, disp x 2; administer as directed PRN for suspected opioid overdose.

Storage and safe disposal 

In an effort to protect family and visitors (and avoid loss, theft or diversion), encourage all patients to store their medications in spaces to which others will not have access. Also counsel patients on safe disposal of controlled substances that they no longer take.  

Individualized treatment plan

  • Treatment goals by which the plan will be evaluated, such as level of relief, improved physical and psychosocial functioning and/or improved quality of life
  • Planned diagnostic evaluations
  • Specialty consultation(s)/referral(s)
  • Prescribed therapeutic modalities
    • Pharmacologic treatment
    • Non-pharmacologic treatment (e.g., physical/occupational therapy, acupuncture, mindfulness, psychotherapy, substance use treatment)
  • Plan for follow up
  • Informed consent
    • Providers must document the discussion and offer the patient a copy of the plan, including:
      • Goals and expectations
      • Potential risks, benefits and side effects of prescribed treatment(s)
      • Alternatives to recommended therapy(ies) 

 

5. Follow-up and Monitoring

  • Members prescribed controlled substances should have periodic visits with the prescribing provider (no less than every 4 months) for evaluation and management. 
    • Scheduled reassessment should match quantity and duration of the prescription medication
    • Consider more frequent follow up/monitoring for those who are older; with unstable or dysfunctional social environment; in an occupation demanding mental acuity; and/or with comorbid medical conditions
  • For established patients on controlled substances, evaluation must be consistent with evidence-based medical guidelines and regulatory requirements, including but not limited to:  
    • Appropriate and applicable history review and physical exam (see Evaluation in Documentation Checklist above), including but not limited to response to treatment(s), changes in medical and/or psychiatric comorbidities
      • Utilize standardized screening instruments as indicated
    • Monitor for side effects, adverse reactions and safety 
      • For methadone, an ECG is required at baseline and recommended annually and/or with increase in doses
      • Consider periodic LFTs if on high-dose acetaminophen combinations
      • Document the presence of opioid-related adverse effects 
      • Observe for signs of over-sedation or overdose risk
      • Screen for misuse
      • Screen for substance use disorder and offer MAT as indicated
    • Reconcile medications, generate and review the CURES Patient Activity Report (PAR) and review most recent drug toxicology test
    • Based on the above evaluation, review multi-modal treatment plan objectives to determine appropriateness, continuation and/or modification of the treatment plan
      • Optimize management of co-morbidities as indicated
      • Offer or arrange medication-assisted treatment in combination with behavioral therapies for those with substance use disorder
    • In the assessment and plan, document clear justification for management including discussion about risks/benefits/alternatives to continued therapy (see Individualized Treatment Plan above).

6. Best Practices

Office/organization-wide policies

  • After Hours policy: Refills of any controlled medicines should not be provided after hours. To limit weekend calls, consider writing 28-day prescriptions instead of 30-day, so that medications will always be due the same day of the week.  
  • Coverage policy: In the event that a patient’s PCP is out of the office, limit prescriptions from covering physicians to a standard one-month refill if the patient is due. No early refills should be given by covering providers.
  • Refill requests between PCP visits: When a patient presents for a refill without an appointment, the following should be obtained/reviewed/documented:
    • Date of last relevant clinician visit 
    • Last dose of the medication(s) 
      • If last dose of medication was taken more than 30 days ago, controlled substances should not be refilled outside of a provider visit. Arrange follow up to reevaluate and manage underlying diagnoses. 
    • Review CURES PAR
    • Calculate MME (morphine milligram equivalents) for opioids
    • Review medication list for benzodiazepines/sedative/hypnotics
      • If total opioid dose is greater than 90mme and/or patient is on combination opioids and sedative/hypnotics, review case with medical director or another provider prior to prescribing
    • Confirm urine drug toxicology screen (within last year) 
    • If deemed appropriate, provide sufficient refills until a follow-up appointment can be arranged (no more than one month supply)
    • Doses should not be escalated outside of a provider visit
    • Ensure active prescription for naloxone if opioid prescription is ≥90MME/d (recommended at ≥50MME/d) and/or concurrent use of benzodiazepines/sedative/hypnotics, history of OUD, or use of illicit drugs
    • Ensure medication list within the health record is updated with today’s prescription
    • Notify PCP

7. Clinical Case Review, Consultation and Referral

  • Situations or conditions that would benefit from internal clinical case review (consultation with Medical Director as applicable):
    • Prior to any new prescriptions for any controlled substances for more than seven days of use for new patients or for established patients newly requesting controlled substances 
    • Prior to (re)initiating opioids in patients at risk for overdose or opioid misuse
    • Patients receiving ≥90MME daily
    • Switching/transitioning to an alternative regimen of the same drug class (e.g., opioids)
    • Tapering controlled substances (consider specialist involvement for higher doses and/or longer durations of use)
    • Patients with a positive urine drug toxicology screen
    • Patients with fatal or non-fatal overdose or sudden death with opiates as a potential cause/contributing factor 
    • As requested by PCP or another clinical staff member for the following: 
      • Concerns about polypharmacy, suspected diversion and co-occurring illicit substance use, optimization of pain management, challenging patient-provider interactions and/or problem behaviors
  • Situations or conditions that are indications for referral to a mental health provider, pain specialist, addiction medicine and/or substance abuse specialist:
    • Patients taking opioids with underlying pulmonary or cardiac conditions who are at higher risk for respiratory depression
    • Initiating methadone for treatment of chronic pain
    • Patients on medication assisted treatment (MAT)
      • Prescribing long-acting/chronic opioids for chronic non-malignant pain to patients on MAT should be carried out in partnership with the MAT provider or Medical Director from the patient’s MAT clinic
    • Patients with history of or current substance abuse and/or mental health disorder 
    • Females who are pregnant and plan to continue the pregnancy 
    • Patients with aberrant, drug-related behaviors 
    • The concomitant use of benzodiazepines is strongly discouraged/contraindicated  
      • If a patient is on benzodiazepines and opiates, a mental health provider should be involved in the care of the patient
    • Medication assisted treatment for Opioid Use Disorder or other substance disorder if cannot be managed within the primary care practice

8. Job Tools and Resources

General

Evaluation

Risk of harm or misuse

Medication reconciliation and management

Assessment and plan

Patient education

9. References

Coffa D, Snyder H. Opioid Use Disorder: Medical Treatment Options. Am Fam Physician. 2019;100(7):416-425.

Dowell D, Haegerich T, Chou R. CDC guideline for prescribing opioids for chronic pain - United States, 2016. JAMA 2016;315(15):1624-1645.

Jackman RP, Purvis JM, Mallett BS. Chronic nonmalignant pain in primary care. Am Fam Physician. 2008 Nov 15;78(10):1155-62.

Krebs EE, Lorenz KA, Bair MJ, Damush TA, Wu J, Sutherland JM, Asch SM, Kroenke K. Development and initial validation of the PEG, a 3-item scale assessing pain intensity and interference. Journal of General Internal Medicine. 2009 Jun;24:733-738.

Lembke A, Humphreys K, Newmark J. Weighing the Risks and Benefits of Chronic Opioid Therapy. Am Fam Physician. 2016 Jun 15;93(12):982-90.

Webster LR.  Chronic Pain Medicine: Risk Factors for Opioid-Use Disorder and Overdose. Anesthesia & Analgesia. 2017 Nov;125(5):1741-1748.

10. Appendix

Additional tools for evaluating and managing patients with chronic, non-malignant pain:

Opioids Initiated for Acute Pain

Long-term opioid use often begins with treatment of acute pain. To reduce risk, opioids started for acute pain should be prescribed in a time-limited fashion. Clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less is often sufficient; more than seven days is rarely needed. Do not prescribe ER/LA opioids for acute pain.


Six A’s for Monitoring Patients on Chronic Opioid Therapy


Using the PEG Scale to monitor pain and function:

The three-item Pain Average, Interference with Enjoyment of Life, and Interference with General Activity (PEG) Assessment Scale is a validated screening instrument derived from the Brief Pain Inventory that can be used to assess pain and function. The PEG score is the average of the three individual item scores. For clinical use, round to the nearest whole number. Results from baseline and then at follow up can be compared to assess the impact of therapy. Clinically meaningful improvement has been defined as a 30% improvement in scores for both pain and function.


Algorithm for Determining Mechanism of Pain 


Setting Treatment Goals for Pain and Function:

The goal of chronic pain management is to help improve the individual’s ability to function and quality of life. It is important to explore expectations and personal goals that may bring normalcy back to their pained lives.  

In addition to questions about pain level, ask questions that help assess quality of life and impact of pain on function, such as:

  • “What do you believe is causing this symptom?”
  • “How is this symptom affecting you and/or your family?”
  • “How are we improving your life?”
  • “How is the medication affecting your ability to function at home/school/work? (Be specific by naming an activity important to the patient.)
  • “Are there any other views or feelings about this symptom that are important to you or your family?”

Although it is important to explore their comfort goal or acceptable level for the symptom, individuals should be aware that their pain may not go away completely and thus the total elimination of pain is rarely a realistic goal. Rather goals to increase pleasurable activities may be achievable.  


Treatment Options for Chronic Non-Malignant Pain

Non-pharmacologic therapy and non-opioid pharmacologic therapy are preferred for all chronic pain disorders (including, but not limited to, headaches, fibromyalgia, low back pain, osteoarthritis and neuropathic pain disorders). Opioids should not be used as routine therapy outside of active cancer treatment, palliative care or end-of-life care. When opioids are used, they should be combined with other therapies to improve benefits for patients, and they should be prescribed at the lowest effective dosage for the shortest duration of time (NTE 90MME). See individual evidence-based guidelines for treatment of specific chronic pain disorders.


Encourage Smoking Cessation

Quitting smoking decreases pain.


Tapering Opioids

Patients who do not demonstrate progress toward therapeutic goals, who experience intolerable adverse effects or who exhibit symptoms/signs of harm/misuse should be tapered off chronic opioid therapy.

  • Tapering/discontinuing prescriptions for controlled substances is a vulnerable time in a patient-provider relationship, and having a trusted, supportive provider is key to a successful taper and the patient not feeling abandoned in the management of their pain condition (and at risk of potentially fatal consequences)
  • Taper dose to limit withdrawal symptoms in opioid-dependent patients
  • Recommend rehabilitation setting for patients unable to reduce opioid dose in less structured settings (e.g., severe medical or psychiatric co-morbidities)
  • The rate of the opioid taper depends on the clinical situation, the starting dose, and the occurrence of withdrawal symptoms once the taper is initiated
    • May use a range of approaches from slow 20% dose reduction per month to 10% dose reduction per week to more rapid 25%-50% reduction every few days.  
    • Slow tapers may be useful for minimizing withdrawal symptoms and for the patient-provider relationship in restructuring the interaction around something other than opioids 
  • Remain engaged with the patient through the tapering process to monitor their pain and any withdrawal symptoms, and provide psychosocial support as needed
    • Consider weekly prescriptions to limit the use of taper medications inappropriately and to make it easier for the patient and provider to manage the taper
    • Increase frequency of visits per patient preference

Managing Opioid Withdrawal

Patients who are withdrawn from opioid therapy should continue to be treated for their painful conditions, as well as for substance abuse or psychiatric conditions as indicated.

Discontinuing opioids may require a taper to minimize withdrawal symptoms. However, in the case in which the prescribed medication is not found in the urine toxicology screen, the medication can be discontinued immediately.

Symptoms of opioid withdrawal are uncomfortable, but they will not cause serious harm and are not life-threatening. Symptoms include stomach pain or discomfort, diarrhea, nervousness, palpitations, shakiness and/or rhinorrhea.

Symptom

Sympathetic hyperactivity (e.g., Lacrimation, rhinorrhea, yawning, sweats, chills, restless legs) 

Diarrhea 

Gastrointestinal cramping

Insomnia 

Nausea 

PRN Medication

Clonidine

Loperamide

Dicyclomine

Trazodone or diphenhydramine

Prochlorperazine or ondansetron (avoid promethazine due to abuse potential)