Physicians in Canada are navigating difficult waters when it comes to the safe prescribing of opioid medications such as morphine, hydromorphone, oxycodone and fentanyl, and would be well advised to exercise caution in providing care for patients suffering from acute and chronic pain.

The medical community today understands that opioid medications are much more addictive than previously recognized. Tolerance to opioids is common, and physical dependence can occur in patients who take these drugs regularly for even a short period of time. Because of their addictive nature, opioids are also aggressively sought through the medical system by drug users who have no conditions that require pain management. As a consequence, we are in the midst of a crisis related to opioid addiction and abuse that the healthcare community is struggling to address. Canada ranks second only to the United States in the per capita consumption of prescription opioids. In 2015, physicians in this country wrote enough opioid prescriptions for one out of every two Canadians.

To be sure, this is not an easy matter for physicians to manage. Many Canadians suffer from chronic pain and there is a scarcity of proper pain management services in many communities. Traditional pain relievers such as acetaminophen and nonsteroidal anti-inflammatory drugs may not work adequately. As a result, well-meaning doctors who are trying to help patients reduce their pain may prescribe opioid drugs or escalate dosages and inadvertently support addiction. A small number of patients who are suffering from addiction may seek out multiple doctors to acquire opioids. Demanding or sometimes threatening behaviour towards physicians and prescription fraud can further complicate matters.

Yet it is in the interest of patients and physicians to find ways to ensure the safe and effective prescribing of opioid medications. At the Canadian Medical Protective Association (CMPA), we have observed that opioid prescribing is leading to increased medical-legal difficulties for doctors. Between 2010 and 2015, there were 151 medical-legal cases involving allegations of patient harm related to opioid prescribing. These cases mostly involved opioids prescribed for chronic pain. Most often physicians were criticized for their failure to assess patients appropriately for indications related to opioids. Inadequate assessments typically occurred at initiation, prescription renewal, and when increasing dosages. Also, the prescribing of opioids at the same time as other medications such as benzodiazepines and psychotropic medications has resulted in an increased rate of over sedation, respiratory failure and death.

Ensuring the proper use of opioid medications

While governments, medical regulatory authorities (Colleges), and law enforcement are becoming increasingly aware of the growing misuse of opioids, and are working to address the issue, physicians in all areas of medicine have an important role to play in reducing the harm caused by these medications. At the CMPA, we provide information and suggestions on the steps that physicians can take to properly use opioid medications. Taking these steps can help to ensure the proper care of patients, and also mitigate the risks posed to doctors in terms of legal actions, College complaints and reputational damage. Safeguards include the following:

1. Seek updated information on opioids: Physicians should regularly seek up-to-date information about opioid medications and non-medication pain relief options, including treatment indications, medication interactions and adverse effects. Stay current to allow you to take the right steps for a patient and comply with recognized clinical practice guidelines.

2. Perform careful and detailed patient assessments: Taking time to carefully and thoroughly assess a patient is always advisable. But this can be especially valuable in cases of chronic pain. Physicians should take a detailed history of the patient, obtain past medical records, and speak with other doctors who have treated the patient. Be mindful of other medications the patient is taking, any history of substance abuse, and any mental health conditions. This kind of detailed assessment will help determine whether an opioid medication would be beneficial to the patient.

3. Develop a well-defined treatment plan: Opioids, if used for chronic pain, should be one part of a comprehensive and well-defined treatment plan. Consider offering opioids on a trial basis and have a strategy to discontinue opioid therapy for cases where pain does not improve.

4. Obtain informed consent from patients: Given the risks involved in prescribing opioid drugs – both for the patient and the attending physician – it is important that the patient’s informed consent be obtained. Doctors should seek informed consent after they have had a fulsome discussion with the patient of the risks and benefits of pain management treatment using opioids. It is also good practice to warn patients to avoid driving or operating machinery while taking opioids. Document carefully all medication-related discussions, including informed consent discussions, and treatment decisions in the medical record. Ensure a copy of any treatment agreement signed by the patient is also retained in the medical record.

5. Conduct regular reassessments of patients taking opioids: Again, physicians should not consider their job done once they have written a prescription for a pharmaceutical. Patients who are taking opioid medications should be monitored and reassessed on a regular basis. How is the patient’s pain? Have the opioids helped? Can the dosage be reduced or discontinued? Are there pain management alternatives? Asking these questions and evaluating the patient on an ongoing basis are critical steps in the process.

6. Consult with other physicians or healthcare providers: Communication at every step of the process is important, and not just with the patient. Effective communication with other physicians, pharmacists and healthcare providers can help to better control a patient’s pain or manage addiction should it occur. Doctors who administer opioids should never feel they need to operate in a silo. Involving the full spectrum of care can be beneficial to the patient and physician.

Helpful resources

The Canadian Medical Protective Association has published several articles on the safe prescribing of opioid medications, all of which can be found on our organization’s website (www.cmpa-acpm.ca). These include “Opioid prescribing for chronic non-cancer pain;” “Preventing the misuse of opioids;” “The challenges of relieving chronic pain with opioids;” and “Adverse events: Physician-prescribed opioids.” These resource materials have been published between 2009 and today, and provide helpful guidance to physicians on the issues they may encounter with opioids, as well as steps that can be taken to protect themselves.

The U.S. Centers for Disease Control and Prevention’s (CDC) 2016 recommendations on the use of opioids in treating chronic pain outside of active cancer treatment, palliative care, and end-of-life care also contains beneficial information. Additionally, physicians may want to consult the Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain (currently being updated) which is available on the McMaster University website. This resource outlines approaches for initiating and monitoring opioid therapy, ways to manage opioid addiction, steps to reduce prescription fraud, and how to work collaboratively with pharmacists.

Physicians with questions about opioid prescribing or managing medications can also consult their regulatory College, a pharmacist, or review information from the Institute for Safe Medication Practices (ISMP Canada).

Working together to tackle opioid misuse  

While physicians are a key part of the solution to opioid prescription abuse, other organizations are accountable too. Federal, provincial and territorial governments can provide increased funding for research. Communities need more consistent access to effective pain management and addiction resources. Healthcare monitoring systems are required to allow physicians to easily understand the amount of opioid medications patients are taking, and which other providers may be prescribing. Regulators should look at outliers in practice and support these providers to help them develop better prescribing patterns. Medical schools and professional development organizations should include more training on pain management and safe opioid prescribing practices. And pharmacists should work more closely with physicians to manage opioid prescriptions.

Patients are encouraged to also take an active interest in their medical care and pain management. Patients should discuss the advantages and disadvantages of opioid medications with their doctor, as well as alternatives to these powerful pharmaceuticals. Physicians can support these discussions by referring to reputable online information. Ongoing communication among all parties involved – physicians, pharmacists other healthcare professionals, patients and families – is key to the safe and effective use of opioid medications.

Dr. Gordon Wallace, FRCPC is Managing Director of Safe Medical Care at the Canadian Medical Protective Association.

USEFUL INFORMATION FOR HEALTH PROFESSIONALS

Safe use of opioid analgesics in the hospital setting

Preventing opioid-related events is a leading patient safety concern. Although there is increased focus on improper use and management of opioids in the community, the hospital setting is also where many patient safety incidents involving these drugs occur. These events take place across different settings within the hospital and involve various members of the healthcare team.

The CMPA identified 36 medical-legal cases in which a patient was harmed following the administration of an opioid in hospital. In the majority of these cases (78%), peer experts criticized the care related to the incident. More than half of the patients involved in these cases died.

In the cases with expert criticism, morphine was most frequently involved in an event, followed by hydromorphone and fentanyl. A few cases involved concomitant use of more than one opioid or sedative. The most common mode of administration was intravenous (IV).

Breaking down the medication process by phase — assessment, ordering, dispensing, administering, and monitoring — found administering to be the most problematic phase, representing half of the cases. In some cases, more than one phase may have been involved in each event. For example, an inadequate assessment of a patient could lead to an inappropriate dose being ordered and administered to that patient. This finding speaks to the complexity of some of the cases as well as the shared responsibility of healthcare providers to prevent opioid-related events.

Factors contributing to patient harm after opiod administration in hospital

Provider factors

-poor clinical judgment and inadequate training

-mishandling of available dosage forms

(e.g. crushing time-released tablet)

-failure to consider patient risk factors:

-advanced or young age

-comorbidities (e.g. obstructive sleep apnea)

-opioid naivety

-concurrent use of other opioids or medications with sedative effects (e.g. benzodiazepines)

System factors

-equipment issues

-lack of, inadequate, or unclear protocols and processes for:

-epidural opiate treatment

-patient assessment and monitoring

-naloxone administration

Strategies to support appropriate use and monitoring

For front-line care providers

Consider the patient’s relevant medical and medication history, including previous opioid use (e.g. naivety); co-morbid conditions (e.g. sleep apnea); and factors (e.g. age) that may require additional consideration when prescribing opioids.

Review and verify the medication concentration, dosage (dose calculation), rate of administration, and route of administration before prescribing. For children, calculate individual doses based on the child’s weight or body surface area and condition.

Consider whether non-medication analgesia options are appropriate or adjunctive, and whether non-opioid analgesics should be prescribed.

Ensure the patient with a high risk of respiratory depression is appropriately monitored for adequate vital signs, respiratory status, pulse oximetry, and level of consciousness.

For healthcare leaders

Encourage regular reviews and updates of policies and processes for the administration and monitoring of opioids. Periodically evaluate adherence to such policies and quality improvement activities.

Making opioid use safer in the hospital setting requires strategies to safeguard patients from opioid-related harm and must involve all members of the healthcare team