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Shared Learning for Continuous Quality Improvement

Shared learning is a key element in continuous quality improvement. Most of the time, things run safely and smoothly in pharmacies across Manitoba; occasionally, things go wrong. Learning from incidents is the best thing we can do to improve care and safety for all Manitobans.

Case Studies from the Medical Examiner

Case Studies from the Medical Examiner are a deliverable of the collaborative work of the Adult Inquest Review Committee. The College of Pharmacists of Manitoba, the College of Physicians and Surgeons of Manitoba, and the Chief Medical Examiner’s Office work together to learn from deaths related to prescription drugs, focusing on opioids and other drugs of misuse.

On occasion, the College identifies that it is necessary to contact a pharmacist or pharmacy manager for further education to address dispensing practices that raise concern. It is an opportunity for the pharmacy manager and pharmacists working at the pharmacy, where appropriate, to review the practices in place within the pharmacy and is intended to be educational. All files are reviewed jointly with the College of Physicians and Surgeons of Manitoba (CPSM) for education of prescribers to facilitate and enhance collaboration.

Pharmacies involved are contacted and sent one of the following letters:

  • Educational letter: feedback is given using standardized evidence-based quality indicators (e.g., concomitant prescribing of opioids and benzodiazepines) based on concerns identified, including resources.
  • Letter requiring a response: requests additional information from the pharmacy team (e.g. overview of care provided to the patient, copies of prescriptions, pharmacist documentation and interventions, etc.), and operational changes instituted to prevent similar cases in the future. If the response received is satisfactory, pharmacies are then provided with education and resources for further reflection.

Thorough review of patient care through medical examiner files provides robust educational opportunities for pharmacy teams across the province. These specific learnings should be used as foundational components for implementing continuous quality improvement in practice, including ongoing practice review with reflection and the implementation of practice improvements when necessary. Use the case studies below to continuously improve quality and safety in your pharmacy.

Intentional Quetiapine Overdose Leads to Patient Death *New*

This patient died from an intentional quetiapine overdose. Quetiapine is commonly prescribed for its sedating and mood stabilizing properties; however, pharmacists must also consider the drug’s potential for harm in overdose. Learn more about the role pharmacist’s can play in promoting and providing mental health care here.

Accidental Mixed Drug Toxicity Contributes to Patient Death *New*

This patient was rapidly tapered off of hydromorphone-controlled release over 13 weeks; however, patients who are opioid dependent and given sudden rapid dose reductions can experience serious withdrawal symptoms that include uncontrolled pain, psychological distress, and potentially suicide. Learn more about the crucial role pharmacists play in preventing patient harm and what you can do to better serve patients who use opioids here.

Mixed-Drug Overdose Leads to Patient Death

Pharmacists have a role to play in ensuring that patients know the risks of using medication that are not prescribed to them and how to return unused medications. Read more about this case and learn how you can improve the quality and safety of your pharmacy here.

Mixed Drug Toxicity Contributes to Renal Failure and Patient Death

The prescribing and dispensing of medications for this patient warranted a reevaluation of the safety of long-term combination sedating medication and the use of high-dose long-acting morphine. Pharmacists can play a role in reducing the risk of opioid-related deaths by re-evaluating the use of combination sedating medications. Read more about this case and learn how you can improve the quality and safety of your pharmacy here.

Accidental Mixed Drug Toxicity Leads to Patient Death

A patient received multiple sedating medications, contributing to his death. Pharmacists can play a role in reducing the risk of opioid-related deaths by re-evaluating the use of combination sedating medications. Read more about this case and learn how you can improve the quality and safety of your pharmacy here.

Amitriptyline and Venlafaxine Intoxication Contributes to Patient Death

Amitriptyline and venlafaxine intoxication were contributing causes of this patient’s accidental death. Research has shown that patients on multiple sedating agents are at higher risk of experiencing an accidental opioid-related overdose. Read more about this case and learn how you can improve the quality and safety of your pharmacy here.

Uncoordinated Care Contributes to Accidental Drug Intoxication Death

This patient’s care was complicated and involved twelve different physicians, including multiple hospital prescribers from nephrology and internal medicine, as well as more than one primary care physician. Uncoordinated care can put patients at risk of prescription-related harm, and mitigation strategies should be implemented to support and protect the patient. Read more about this case and learn how you can improve the quality and safety of your pharmacy here.

Zopiclone Toxicity Contributes to Patient Death

This patient died as a result of blunt head trauma following a fall with zopiclone toxicity as a contributing factor. While ensuring appropriate prescribing and addressing consistent requests for early refills can be challenging, they are life-saving measures.

Read more about this case and learn how you can improve the quality and safety of your pharmacy here.

Multi-Drug Overdose Involving Carfentanil and Methadone Leads to Patient Death

While this patient died as a result of a multi-drug overdose involving carfentanil and methadone, the case revealed concerning prescribing and dispensing practices.

Read more about this case and learn how you can improve the quality and safety of your pharmacy here.

Over-the-Counter Drugs Contribute to Patient Death

This patient’s cause of death was determined to be probable cardiac arrhythmia, and mixed drug intoxication was a contributing factor. Learning from this case focuses on the harms of over-the-counter drugs when combined with other sedative prescription or street drugs.

Read more about this case and learn how you can improve the quality and safety of your pharmacy here.

Patient Death Reveals Concerning Prescribing and Dispensing Practices

This patient passed away of a carfentanil overdose, but many concerning issues with the prescribing and dispensing practices in this case were revealed by the Medical Examiner.

Read more about this case and learn how you can improve the quality and safety of your pharmacy here.

Benzodiazepines Near or Higher than Recommended Dose Leads to Overdose Death

An autopsy revealed that this patient died of an intentional multi-drug overdose. The case revealed concerning prescribing and dispensing practices and pharmacists are urged to review this case to evaluate their own work.

Read more about this case and learn how you can improve the quality and safety of your pharmacy here.

Accidental Mixed Drug Toxicity Contributes to Patient Death

This patient had recently started methadone that was witnessed daily by the pharmacist. Overdose from methadone in patients on opioid replacement therapy (ORT) is most likely to occur in the first two weeks of starting the medication.

Read more about this case and learn how you can improve the quality and safety of your pharmacy here.

Students raising their hands in a classroom.

Accredited Learning Activities

For additional learning from the Adult Inquest Review Committee, please see Trends and Learning from the Medical Examiner, From Script to the Medical Examiner: Resources for Pharmacy Intervention, and Overdose in the Era of COVID-19 & Approaching Mental Health in Pharmacy Practice professional development programs.

Learn more

Opioid Agonist Therapy and Patient Safety

In pharmacy practice, certain medications or processes are considered to be high-risk and medication incidents are more likely to occur. Due to the narrow therapeutic index of methadone and the complexity of the dispensing process, it is regarded as a high-risk pharmacy practice. It is important that pharmacy teams review their processes and have a consistent system in place to prevent medication incidents.

All patient and health care provider information has been de-identified to protect their privacy.

ISMP Canada Safety Bulletin Focuses on Methadone Harm Incidents in Community Pharmacies

The Institute for Safe Medication Practices (ISMP Canada) issued a recent safety bulletin that analyzed data from four Canadian Medication Incident Reporting and Prevention System (CMIRPS) databases between 2015 and 2020 and summarized the most frequent medications cited in harm incidents. Methadone was listed as the most frequent medication in community pharmacies to cause harm incidents, accounting for 6.3% of cases. Furthermore, methadone accounted for 4.5% of incidents that caused either severe harm or death across all health-care settings.

For incidents involving methadone, the safety bulletin underscored three contributing factors:

  • Insufficient patient identification processes,
  • The need for individualized dosing regimens, and
  • Complex preparation steps.

The risks that manifest can be reduced with policies and procedures fashioned from the guidance in the Opioid Agonist Therapy Guidelines for Manitoba Pharmacists.

Insufficient patient identification processes can often lead to errors that cause patients to receive a methadone dose meant for a different patient. In the context of the pandemic requirement to wear face masks, identification can be even more challenging. Patient identification processes to reduce errors should include:

  1. Asking for two patient identifiers such as their full name and a secondary identifier (e.g. date of birth or address) at each visit,
  2. Keeping a photo of the patient on file, and
  3. Confirming their dose before witnessing ingestion.

It is important to ensure that the procedures are clear, consistent, and put in force and patients are aware as well as staff.

When multiple patients receive their methadone from the same pharmacy, the pharmacy must prepare individualized dosing regimens for each patient which can be a contributing factor leading to harm incidents. Routines and procedures that support organization will be helpful in managing significant variability in doses, witnessing schedules, and other components of the dosing regimen. Some examples of policies that can be useful in these circumstances include using the same unit of measure for all OAT medications (i.e. “mg”), marking the witnessing schedule on the administration log, and establishing an organized and secure method of preparing and storing doses for multiple patients.

At times the complex steps of preparing methadone can lead to harm incidents. Confusion can occur when converting doses in “mg” to stock solution in “mL”. This is especially dangerous since the stock solution is 10mg/mL. A calculation error can easily lead to a ten times dose error, which can be fatal. A careful analysis of the dose on a new prescription by the pharmacist, and having two staff members, including the pharmacist, observing the preparation process can be useful towards preventing this error. The preparation of methadone doses can also involve stock solution being transferred between multiple containers and this increases the risk of exposure to the potent substance. Segregation and security of the stock solution is imperative.

Proper training of staff to administer opioid agonist treatment will further cement their skills in managing the risks associated with methadone dispensation. The College requires that at least one pharmacist must be extensively knowledgeable at each pharmacy that provides opioid agonist therapy, and one of the required courses listed in the guidelines must be completed within 6 months of initiating care. This pharmacist is expected to train any other pharmacist at that pharmacy who will be dispensing OAT. While the guidelines only require one pharmacist at a pharmacy to receive the specialized training in OAT, it is strongly recommended that all pharmacists who are dispensing OAT receive the training as well. A pharmacy that is waiting for availability of the specialized training and is dispensing OAT must have a trained/knowledgeable pharmacist acting as a mentor at another pharmacy until such training is complete.

Each pharmacy dispensing OAT must have their own written policies and procedures to ensure that OAT guidelines and relevant legislation are followed as well to ensure safe patient care. A policy and procedures manual should cover topics such as:

  • Staff education and training,
  • Dispensing procedures (preparation, measuring devices, labelling, storage),
  • Witnessing process (patient identification, diversion),
  • Documentation (witnessed dose logs, patient agreements),
  • Patient assessment (patient under influence),
  • Communication with patient, caregivers and prescribers,
  • Take-home doses,
  • Harm reduction (naloxone, accidental overdose), and
  • Security and disposal.

Proper training combined with explicit policies and procedures are essential components of dispensing methadone in a safe and effective manner.

ISMP Canada’s analysis reveals the elevated occurrence of harm incidents involving methadone over the last half decade. This evidence is a clear reason to focus on improving procedures and training with methadone dispensation and administration, and ensuring that safety will remain uncompromised.

Dose Mix-Up Leads to Methadone Overdose

Introduction

KC was on a stable dose of methadone (45mg), once daily for opioid agonist therapy (OAT) for several months. She was also using puffers for asthma, antidepressants, and muscle relaxants regularly. KC attended a busy pharmacy that had numerous OAT patients and prepared methadone doses ahead of time.

One day, KC arrived for her dose near the end of the day, and the pharmacist erroneously selected
a bottle that contained 115mg of methadone for another patient. KC ingested the incorrect dose and handed her empty bottle back. The pharmacist then saw the incorrect label and immediately realized that an error had been made. The pharmacist suggested that KC could try to vomit the dose, but emesis made KC uncomfortable and she declined. The pharmacist suggested going to the emergency room if she felt side effects in 2 to 4 hours (e.g. drowsiness, trouble breathing). KC accepted this suggestion and decided to leave and go home without any further consultation.

The pharmacist was able to make contact with the prescribing physician and reported the incident. The next day, KC described to the pharmacist some unexpected drowsiness and loss of balance the previous evening as she was preparing dinner for her kids, but she tried to stay awake until the effects sufficiently wore off.

Discussion
In this case, pharmacy staff did not:

  • Use an adequate method to double check that the correct dose was being given to the correct
    patient
  • Take sufficient measures to ensure the safety of the patient after the incorrect dose was ingested, especially considering the higher dose and her other medical conditions.

Preparation of methadone or buprenorphine-naloxone doses ahead of time can improve workflow in a busy pharmacy, but it can lead to a higher risk of dose mix-ups between patients. When administering OAT to a patient, stating their name and dose in a confidential manner can reduce this risk. For example, using open-ended questions (“What dose are you on?”) is recommended. Methadone and buprenorphine-naloxone can have peak effects in 1-2 hours (buprenorphine is usually faster) and can last for several hours. When an OAT overdose occurs, adverse effects will be most apparent during these peak times, which can include drowsiness, intoxication, and respiratory depression at higher doses (which can lead to death).

Overdose Pharmacy Protocol

In the event of an accidental OAT overdose, quick decisions need to be made by the pharmacy team, and a succinct protocol should be in place to manage these situations. An overdose protocol should cover, but is not limited to, the following steps:

  • make every reasonable effort to contact, inform, and follow up with the patient about the overdose;
  • promptly contact the physician;
  • assess the risk to the patient and make an appropriate recommendation to go to emergency or urgent care;
  • stress to the patient the reasons for seeking medical attention,
  • involve a trusted person to care for the patient, especially if they refuse to go to the hospital;
  • management of other current medications;
  • supply a naloxone kit; and
  • document the incident.

A pharmacy may consider creating a checklist that is to be used by the pharmacist-on-duty if this type of event occurs. Certain risk factors can contribute to a higher incidence of harm/death with an OAT overdoses including:

  • Any type of overdose during the initiation phase of OAT (i.e. first 2-3 weeks). All attempts should be made to ensure the patient receives medical attention immediately
  • If an overdose is 50 per cent higher than the patient’s usual dose
  • Other sedating medications
  • Contributing medical conditions (e.g. asthma)
  • The patient is stable at a lower dose (e.g. below 40mg)
  • The patient receives more carry-home doses
  • Patients with an uncertain level of opioid tolerance

All patients who experience an OAT overdose should be advised to consider and/or seek medical attention. Using an assessment of the risk factors, along with consultation from the prescriber, the pharmacist should use their professional judgment in determining and recommending the level of medical attention required (e.g. emergency room). The pharmacy staff should be actively involved with ensuring that the patient receives the appropriate medical intervention, which may include finding transportation or calling an ambulance.

The pharmacist can make other recommendations to mitigate harm, especially in the event where the patient refuses to go to the hospital. Involving a trusted, knowledgeable person known to the patient (e.g. spouse) who can oversee and monitor for adverse effects during the peak times can be critical to preventing harm. Managing current medications, such as reducing the consumption of sedating drugs, can reduce the risk of additional drug-drug interactions. Supplying a naloxone kit
to the patient or a trusted person coming for the patient is also recommended.

Pharmacists should use caution when advising on the induction of emesis. Pulmonary aspiration is a risk of inducing emesis, and the risk is higher in the presence of CNS depression. Emesis may also create a false sense of resolution for the patient because there may only be a partial expulsion of the contents of the stomach. Emesis might be used only as a first aid measure if medical help is not readily available, there is no apparent CNS depression, and the pharmacist or another person with first-aid training is available to assess the patient post-emesis.

Keep up-to-date contact information for each patient on OAT (including alternate phone numbers) so that you can contact them quickly in the event of an emergency, like discovery of an accidental overdose. Ensure that the patient also has the contact information for the pharmacy readily available.

Conclusions

Pharmacists play a crucial role with ensuring that OAT is administered in a safe and effective manner. An OAT administration error can result in an accidental overdose, therefore preventative measures to reduce the risk of OAT administration errors should be a top priority for all pharmacists and pharmacy managers. In the event of an accidental overdose, a knowledgeable pharmacist who follows a readily available protocol is the best line of

Dose Error and Unclear Policy and Procedure Contributes to Methadone Overdose

Introduction

Patient AJ receives methadone 22mg once daily for opioid agonist therapy from a Winnipeg pharmacy. He is traveling to Victoria, B.C. and his prescriber gives him a prescription to fill there on a daily basis. The pharmacy in Victoria is unfamiliar with the Manitoba M3P form and erroneously prepared one dose for 22ml of methadone 10mg/ml stock solution (220mg of methadone). The methadone was dispensed without confirming the dose with the patient or the previous pharmacy. The patient had concerns about the dose but left without questioning the pharmacist. After 20 minutes, while driving on the highway, the patient began to feel unwell and believed he was given the wrong dose. The patient did not have the contact information for the dispensing pharmacy, so called
his pharmacy in Winnipeg.

The Winnipeg pharmacist uncovered the error and advised the patient to pull over immediately and to have someone take him to the nearest hospital immediately. Fortunately, with medical supervision, the patient did not experience any severe adverse effects, and resumed his treatment shortly thereafter.

Discussion

Several factors contributed to the medication incident and its associated risk, including:

  • The Victoria pharmacy staff was not familiar with the Manitoba M3P form, and misread the dose as milliliters (mL) instead of milligrams (mg). (The prescriber had omitted the unit of measure when he filled out the “interval” boxes)
  • The previous dispensing pharmacy was not contacted to verify the previous dose. The prescriber was not contacted for clarification or confirmation of the dose or unit measure when the prescription did not indicate it
  • The methadone dose was not confirmed with the patient when it was administered
  • The patient did not receive documentation with the dispensing pharmacy’s contact information which likely delayed a positive intervention

The requirements for prescriptions for methadone and buprenorphine-naloxone vary in each province and territory. This can lead to uncertainty and can increase the risk of misinterpretation when prescriptions are filled in other provinces or territories.

When a new prescription for a patient that had methadone or buprenorphine-naloxone is presented to a pharmacy and was previously filled at another pharmacy in Manitoba or elsewhere, the previous dispensing pharmacy must be contacted for information on the time and amount of the last witnessed dose as well as any carries. Pharmacists should also confirm the prescriber’s authority to prescribe methadone or buprenorphine-naloxone in their province. In Manitoba, this information must be documented on the original prescription by the receiving pharmacist. This can prevent:

  • double-dosing;
  • initiating treatment after too many missed doses; and
  • dosing errors, like in the above-mentioned case.

The unit of measure must be clearly indicated on the prescription and if it is omitted or unclear, then the pharmacist must verify the unit of measure with the prescriber. This is especially important for methadone as pharmacies typically measure methadone in mL and prescribers typically note the dose of methadone in mg, which can lead to confusion about the intended dose.

When administering methadone or buprenorphine-naloxone to a patient, stating their dose in a
confidential manner is a good practice to ensure that the patient is receiving the correct dose. Using open-ended questions (e.g. “What dose are you on?”) during the confirmation process is recommended. Educating the patient to always read the prescription label before ingesting methadone can also be useful.

Patients should be provided with the pharmacy’s contact information such as a medication information handout, and/or a business card, especially in the case of witnessed doses, as they may not have a pharmacy label with this information.

A pharmacy that dispenses methadone or buprenorphine-naloxone should have a clear protocol for their staff on how to handle an accidental overdose. This protocol should include but is not limited to the following:

  • make every reasonable effort to contact, inform, and follow up with the patient about the overdose;
  • contact the prescriber immediately;
  • encourage the patient to visit the emergency department of the hospital and be accompanied by someone knowledgeable of the incident; stress to the patient the reasons for going to the hospital;
  • if the patient refuses to go the hospital, ensure that they are observed by someone for at least the first four hours for signs and symptoms of overdose; and
  • document the incident.

Consider providing naloxone kits to patients on methadone or buprenorphine-naloxone, since this can provide an additional measure of safety against the risk of an opioid overdose.

Conclusions

Prescriptions for methadone and buprenorphine-naloxone can pose additional challenges for pharmacists since they have unique characteristics when compared to other prescriptions. For this reason, standardized protocols for prescription intake, processing, and administration can help reduce errors.

Consider implementing a standardized template for all new prescriptions for methadone or buprenorphine-naloxone so that no critical steps are missed, such as contacting the previous pharmacy. Additionally, pharmacies should also consider implementing protocols for handling medication incidents related to methadone and buprenorphine-naloxone, such as in the case of an accidental overdose. Pharmacists play an essential role in ensuring patient safety when dispensing medication. This role can be fulfilled by establishing and implementing additional protocols for specific situations, such as dispensing methadone and buprenorphine-naloxone.

Thank you to Mike Sloan for his help with this article.

Safety IQ Academy

Continuous quality improvement (CQI) to reduce the chances of patient harm from medication incidents is an ongoing process that requires a preoccupation with safety. Safety IQ Academy offers additional resources and Manitoba-based case studies to support CQI In your pharmacy. When it comes to safety, there is always room for improvement.

Learn more

ISMP Canada Safety Bulletins and SMART Medication Safety Agenda

Safety Bulletins

The Institute for Safe Medication Practices Canada (ISMP Canada) publishes Safety Bulletins to share information about medication incidents reported through the programs of the Canadian Medication Incident Reporting and Prevention System (CMIRPS).

Safety Bulletins offer medication system improvement strategies for improving patient safety on a wide variety of practices, processes, and medications. The bulletins will also share alerts and warnings specific to the Canadian market place. You can sign-up to receive Safety Bulletins here.

SMART Medication Safety Agenda

ISMP Canada created SMART (Specific, Measurable, Attainable, Relevant, Time-based) Medication Safety Agenda to share learnings on common medication incidents reported to them from across Canada through the Community Pharmacy Incident Reporting (CPhIR) program. This data forms the foundation for continuous quality improvement (CQI) resources like SMART Medication Safety Agenda to support pharmacy practice enhancements for patient safety.

The SMART Medication Safety Agenda encourages pharmacy teams to learn about medication incidents that have happened in other pharmacies and create assessments or action plans to reduce the chances of patient harm.

The following YouTube video (4:16 Minutes) is a step-by-step guide for pharmacy professionals to learn how to use the SMART Medication Safety Agendas listed below: https://youtu.be/zFTwL-mt0Xw

 

Logged Prescriptions *NEW*

Lack of standardized, formal processes for logged prescriptions can lead to medication incidents.

Learn more about how your pharmacy team can reduce the chances of patient harm involving logged prescriptions with the SMART Medication Safety Agenda here.

Direct Oral Anticoagulants

Drug-drug interactions, transitions of care, and complex dosing can all contribute to medication incidents involving direct oral anticoagulants.

Learn more about how your pharmacy team can reduce the chances of patient harm involving direct oral anticoagulants with the SMART Medication Safety Agenda here.

Methadone

Methadone treatment can involve highly individualized dosing and confirmation bias is a risk factor when preparing this medication.

Learn about this and other contributing factors to medication incidents involving methadone with the SMART Medication Safety Agenda here.

Potentially Inappropriate Medication Use in Older Adults

Learn about the contributing factors and recommendations for improvement to pharmacy care for older adults with the SMART Medication Safety Agenda here.

Insulin

Insulin is a common medication with a potential for medication incidents during product selection, therapeutic regimen change, prescription calculations, and storage. Learn more about how your pharmacy team can reduce the chances of patient harm with this SMART Medication Safety Agenda on Insulin.

Blister Pack Preparation

Given the complexity and vulnerability of blister packing, pharmacy teams should consider how they can reduce the chances of patient harm in this process.

Learn more about preventing patient harm with this SMART Medication Safety Agenda about Blister Pack Preparation.

Fentanyl

Learn how independent double-checks and monitoring and follow-up can reduce the chances of patient harm related to medication incidents involving fentanyl with the SMART Medication Safety Agenda here.

Drug Shortage

Learn how independent double-checks, patient counselling, and monitoring and follow-up can be used to reduce the chances of patient harm or confusion related to drug shortages with the SMART Medication Safety Agenda here.

Hospital Discharge

Learn how implementing medication reconciliation and patient counselling can reduce the chances of a medication incident after hospital discharge with the SMART Medication Safety Agenda here.

Warfarin

This SMART Medication Safety Agenda examines how the limitations of computerized systems for identifying drug-drug interactions and copying instructions from previous prescriptions contribute to medication incidents involving Warfarin.

Learn more about these incidents and recommendations for system improvement here.