Supporting the patient and following the standards of practice
Baclofen is a skeletal muscle relaxant indicated for use in spasticity. By acting on pre-and post-synaptic gamma-aminobutyric acid (GABA)-B receptors, baclofen causes membrane hyperpolarization and inhibits excitatory neurotransmitter release1. Off-label uses include management of chronic hiccups and treatment of muscle spasm and musculoskeletal pain (with use generally recommended only intermittently).
Another off-label use is in the treatment of alcohol use disorder, despite inconclusive evidence2, 3 and potential for harm4. Baclofen’s target receptors are found within several brain regions, including those related to the mesolimbic reward system5, often linked to the development of substance use disorders. Clinically, baclofen can create sensations of relaxation or sedation, explaining why some patients might be at risk of using more than prescribed.
While baclofen is not monitored by TPP Alberta, it carries a potential for overuse and associated harms, and as such falls within CPSA’s standard of practice, Prescribing: Drugs Associated With Substance Use Disorders or Substance-Related Harm. Below, we describe a clinical case related to an Alberta patient, with a history of escalating baclofen use and a pattern of attending multiple care providers for prescriptions. The case details have been modified for confidentiality.
A middle-aged man presented to the emergency department with visual hallucinations and insomnia, apparently related to baclofen withdrawal. The patient’s medical history included generalized anxiety disorder, fibromyalgia, hypertension, benzodiazepine use disorder in sustained remission and a 30 pack year history of smoking. Prescribed medications included zopiclone 7.5 mg QHS, quetiapine XR 100 mg daily, ramipril 5mg daily and baclofen 10 mg BID. Per the patient, he was on a biweekly dispense interval for all his medications. The patient acknowledged taking baclofen in higher-than-prescribed doses and running out of the medication 3 days prior (last dispensed 5 days before presentation).
The patient was alert but speech was pressured and thought process appeared to be disjointed. Diaphoresis and mild tachycardia were noted during physical exam and other vital signs were normal. The patient had one similar admission to acute care in the previous year, with identical symptoms.
Attending multiple prescribers
Upon inquiry into the previous hospitalization and baclofen use, the patient disclosed a pattern of seeing multiple physicians to secure an adequate supply of baclofen to support his escalating needs. The patient’s PIN profile showed multiple prescribers for baclofen, with overlapping prescription durations. The patient explained that in addition to getting prescriptions from walk-in clinics, from time to time he would also receive a 2-3 day supply of baclofen as a pharmacist-authorized bridging prescription. He tended to approach pharmacies and physicians other than his primary pharmacy and physician for such requests, picking busy times of day for these visits. The patient had been using baclofen daily for over two years.
Chronic oral baclofen therapy can lead to physical dependence where abrupt cessation of the medication can lead to a withdrawal syndrome. This can occur with regular daily use of prescribed doses, even without greater or more frequent use than prescribed. Baclofen withdrawal can present as similar to alcohol or benzodiazepine withdrawal. Symptoms may be mild (e.g. irritability, nausea, diaphoresis, agitation, insomnia) or severe with delusions, psychosis, hallucinations and seizures that can rarely lead to rhabdomyolysis, multi-organ system failure and death6. As such, if changes in treatment are indicated, chronic drug therapy with baclofen should be tapered down gradually over 1-2 weeks, or longer if withdrawal symptoms occur7.
For the case patient, a treatment plan (including a slow taper of baclofen) was initiated. The detailed assessment and plan was communicated to the patient’s primary care physician and his pharmacist. The patient participated in the decision-making about his care. The treatment plan also included exploring other treatments for his chronic pain related to fibromyalgia and anxiety disorder.
Expectations under the prescribing standard of practice
CPSA’s Prescribing: Drugs Associated With Substance Use Disorders or Substance-Related Harm can apply in a greater context than recognized initially. The standard is deliberately broad for the purpose of patient safety—any medication linked to a substance use disorder or substance-related harm falls within its scope. In the case described, the patient had a presentation consistent with a potential baclofen use disorder, along with a history of a benzodiazepine use disorder in sustained remission. Both would be classified as a sedative, hypnotic, or anxiolytic use disorder under DSM-5 criteria.
When prescribing medications with a potential of causing dependence or a substance use disorder, whether for short-term use or on a longer-term basis, it is expected the major elements of a sound clinical practice be followed. These are outlined in the standard and related Advice to the Profession. In short, before prescribing for a patient, physicians should:
- Check the Pharmaceutical Information Network (PIN)/Netcare to identify current prescribed medications, potential risk factors or indicators for a developing or existing substance use disorder (e.g., evidence of use more frequently or in greater amounts than prescribed) and any drug interactions;
- Approach prescribing with a full understanding of the individual health context, including co-morbid substance use disorder, and identifying the use of other psychoactive drugs, including alcohol and other prescribed or non-prescribed drugs;
- Engage in shared decision-making with the patient through candid discussions around risks, benefits, alternatives and goals of the prescribed therapy; and,
- Ensure that prescribing decisions are supported by clinical indication, which is then reassessed on an ongoing basis for the duration of the treatment.
For positive patient outcomes and to ensure continuity of care, collaborating with colleagues and other health professionals within the patient’s circle of care can go a long way in achieving these goals.
- Chang E, Ghosh N, Yanni D, Lee S, Alexandru D, Mozaffar T. A review of spasticity treatments: pharmacological and interventional approaches. Crit Rev Phys Rehabil Med. 2013;25:11–22. doi: 10.1615/CritRevPhysRehabilMed.2013007945.
- Rose AK, Jones A. Baclofen: its effectiveness in reducing harmful drinking, craving, and negative mood. A meta-analysis. Addiction. 2018;113(8):1396‐1406. doi:10.1111/add.14191
- Minozzi S, Saulle R, Rösner S. Baclofen for alcohol use disorder. Cochrane Database Syst Rev. 2018;11(11):CD012557. Published 2018 Nov 26. doi:10.1002/14651858.CD012557.pub2
- Jamshidi N, Morley KC, Cairns R, Dawson A, Haber PS. A Review of Baclofen Overdoses in Australia: Calls to a Poisons Information Centre and a Case Series. Alcohol Alcohol. 2019;54(1):73‐78. doi:10.1093/alcalc/agy082
- Colombo G, Addolorato G, Agabio R, et al. (2004) Role of GABAB receptor in alcohol dependence: reducing effect of baclofen on alcohol intake and alcohol motivational properties in rats and amelioration of alcohol withdrawal syndrome and alcohol craving in human alcoholics. Neurotox Res 6:403–14
- Baclofen Drug Information. UpToDate.[Accessed June 2, 2020]
- Committee on Safety of Medicines (CSM), Medicines Control Agency. Reminder: severe withdrawal reactions with baclofen. Curr Probl Pharmacovigilance. 1997;23:1-4
Authors and reviewers:
- Fizza Gilani, BSc. Pharm, CPSA Program Manager, Prescribing & Analytics
- Dr. Karine Meador, MD CCFP (AM), Assistant Director, Inner City Health and Wellness Program and Addiction Recovery and Community Health (ARCH)
- Dr. Monica Wickland-Weller, MD, CPSA Senior Medical Advisor
- Dr. Mark Godel, MD, CPSA Senior Medical Advisor