The first action of pharmacy staff following a medication incident is to ensure the immediate safety of the patient. 

While medication incidents tend to be rare in community pharmacy, the do happen. Handling a medication incident properly is of the utmost importance to protect the patient and promote healing.

When an incident is discovered, the pharmacist and/or pharmacy manager must ensure the safety of the patient by

• determining if the patient has experienced or is at risk of experiencing harm and provide care for the patient to best of their ability;
• ensuring the patient receives the correct medication in a timely matter;
• taking reasonable steps to ensure the incorrect medication is quarantined and/or returned to the pharmacy; and
• notifying the pharmacy manager, prescriber, and any other personnel deemed necessary of the medication incident.
  
  

While a pharmacist must complete the above steps, it is critical that all pharmacy staff know and understand the pharmacy’s policy on managing medication incidents.

Once the patient’s immediate safety has been addressed, the pharmacy professional and/or pharmacy manager must disclose and apologize for the medication incident.

The proper disclosure of a medication incident offers many benefits to patients, loved ones, and the pharmacy professionals involved. An empathetic and sincere disclosure and apology can

• build a culture of safety through open, honest, and effective communication;
• serve, in part, to heal the patient and/or family and pharmacy professional involved in the incident; and
• help the pharmacy team to learn from mistakes to prevent recurrence.

A sincere apology should be communicated with open and active listening that allows the patient to speak and ask questions before the pharmacy professional makes a judgement or tries to explain what happened.

Please see the “Suggested Framework” tab on this page for additional information about disclosure and apology following a medication incident.

Disclosure and Apology Requirements

Your pharmacy’s disclosure and apology process must include the following:

• Acknowledging to the patient that a medication incident has occurred and an apology for the distress the incident has caused
• Listening to the patient (express empathy and concern, do not minimize what happened)
• Advising the patient of the potential consequences (both short- and long-term) from the incident
• providing the patient with a description of the facts that are known about the incident and updating the patient as new information is obtained
• notifying patient of any changes to systems or processes made after analysis of the incident and informing the patient that:
  • the medication incident will be reported to pharmacy manager
  • the pharmacy will anonymously report the medication incident to a national medication incident database to enable other pharmacies to learn from this incident
  • an investigation will take place and based on the investigation, that changes to systems or processes will be developed and implemented to minimize recurrence of a similar medication incident or near miss.

At first, you may not know all the details of how the incident occurred, but you must still provide an explanation to the patient including the following:

• The pharmacy will conduct an investigation of the incident and analyze the contributing factors;
• Staff will discuss the incident and develop changes in processes to prevent a similar incident from happening in the future;
• The incident will be anonymously reported to a national medication safety database to share learning with other healthcare providers; and
• You will follow-up with the patient to tell them what changes you have made to prevent a recurrence. The Medication Incident and Near-Miss Event Practice Direction requires this step which can restore trust with your patient.

Pharmacists have a trusted relationship with their patients. When an incident occurs, communication with the patient or caregiver must be empathetic and transparent. Genuine and open communication of the pharmacy’s actions during and after an incident can help to restore the patient’s trust. For additional information on properly disclosing a medication incident to a patient, please see the Canadian Disclosure Guidelines.

Additional CPhM resources include:

• Conflict and Communication Resolution Tool: additional guidance on constructively and respectfully communicating with patients and caregivers.
• Responding to an Incident Quick Guide: short overview of the disclosure process and requirements.
• Facts for Patients and the Public About Safety IQ: a patient-friendly resource to explain the Safety IQ program including tips about medication safety.

Manitoba’s Apology Act allows health care providers, including pharmacists, to apologize to patients who have experienced a medication or patient incident that may or not have resulted in harm. The Apology Act empowers pharmacists to express empathy and compassion to their patients without the worry that an apology could be used against them in court.

Pharmacists and other pharmacy staff can provide a sincere apology to a patient without the fear that it will create legal liability or impact their malpractice insurance coverage. A genuine apology to a patient who has experienced a medication or patient incident is an act of human connection that can contribute to healing both patient and practitioner. Pharmacy staff should know the following facts about Manitoba’s Apology Act:

• Apologizing does not create legal liability
• Apologizing does not impact malpractice or liability insurance
• Apologies are not admissible in courts, tribunals, arbitrations, disciplinary hearings, civil litigation, or “any other person who is acting in judicial or quasi-judicial capacity”

Disclosure of Medication Incidents: A Suggested Framework and Case Example

Every patient has the right to be informed about their healthcare. This includes the right to be promptly notified when a medication incident happens. According to the Medication Incident and Near-Miss Event Practice Direction¹ (MINME), your pharmacy must have a documented policy and procedure for providing appropriate apologies and disclosures to patients following a medication incident. You are required to disclose medication incidents to patients, regardless of the level of harm caused by the incident. Even when a ‘no harm’ incident occurs, you must disclose it to the patient including all of the steps outlined in the MINME.

Pharmacy managers and professionals must use their professional judgement when deciding the appropriate depth of a disclosure because some medication incidents will be more straightforward than others. This will mean that certain disclosures may only require a fifteen-minute conversation with the patient; other medication incidents that cause severe harm or death will require greater commitment from pharmacy leadership and staff.

In addition to disclosure, there can be other challenges in responding to medication incidents. The Safety IQ patient safety initiative relies on pharmacy professionals to share details of medication incidents when they are discovered. However, this requires an environment in which staff feel comfortable reporting medication incidents without undue consequences to their self-image, status, or career².

Very often, healthcare providers, including pharmacy professionals who are involved in medication incidents experience psychological and physical consequences which include extreme sadness, difficulty sleeping, and intrusive memories³. Recognizing these responses and the need to support pharmacy professionals are often overlooked in the aftermath of a medication incident.

The following framework and case example for disclosing medication incidents to patients or their agents was adapted from the HealthCare Excellence (formerly Canadian Patient Safety Institute) Canadian Disclosure Guidelines⁴and a previously-published eQuipped article, Disclosure of Medication Incidents: A Suggested Framework.⁵

If you have questions or concerns about a difficult disclosure, please contact the Safety IQ team by email at safetyiq@cphm.ca.

Medication Incident Disclosure: A Suggested Framework

1. Take Immediate Action to Ensure the Patient’s Safety^1,4,6

When you discover a medication incident or an incident is brought to your attention, the pharmacist and/or pharmacy manager must ensure the safety of the patient by:

• determining if the patient has experienced or is at risk of experiencing harm and provide care for the patient to best of their ability;
• ensuring the patient receives the correct medication in a timely matter, if applicable;
• advising the patient of the potential health consequences (both short and long term) from the incident, if applicable;
• taking reasonable steps to ensure the incorrect medication is quarantined and/or returned to the pharmacy, if applicable; and
• notifying the pharmacy manager, prescriber, and any other personnel deemed necessary of the medication incident.

Take immediate steps to reduce the risk of a similar incident harming another patient.

If the patient is physically and emotionally well enough, advise them that you would like to schedule an appointment (in-person is ideal, but over-the-phone is an option) to provide them with additional information about the incident and the steps for prevention the pharmacy is taking (as required by the MINME).

Document the steps you have taken and the conversations you have had with the patient, pharmacy manager, and prescriber.

If you have questions or concerns about a difficult disclosure, please contact the Safety IQ team by email at safetyiq@cphm.ca.

2. Prepare for the Initial Disclosure^4,6

Once the immediate safety of the patient is assured, you should prepare for the initial disclosure:

• Organize your thoughts and gather the current facts

• Determine which personnel will be participating – pharmacy manager, pharmacist. The most responsible healthcare provider who is involved should facilitate the disclosure. All others who played a role in the incident should be prepared to discuss relevant events with the patient and family.
• If you have not done so already, schedule a disclosure meeting (in-person is ideal, but over-the-phone is an option), at the earliest practical opportunity. Select a time that is convenient for the patient and family and a place that is private and free of interruptions. Allow adequate time for a complete discussion about the incident.

• Anticipate emotions; both the patient and pharmacy professionals should have supports available at the disclosure meeting if needed. When an incident occurs, patients want the pharmacy staff to:

• • Ensure their safety – what effects may occur, what should they do;
  • Apologize in a sincere and open manner – do not assign blame to others, be forthright and genuine; and,
  • Take action – investigate the incident and implement changes to prevent a similar occurrence for another individual or family.
• Assign a staff member as the primary contact for the patient and family throughout this process.

3. Disclose the Medication Incident to the Patient^4,6

During the medication incident disclosure, you must include the following steps:

1. Acknowledge the incident and the patient’s distress resulting from the incident. Do not minimize the incident. Although a patient may not have ingested the medication, they may be concerned or distressed about what could have happened and their trust in the pharmacy may be shaken;
2. Provide the patient with contact information (in writing) including which designated staff person (manager or pharmacist) they can contact if they have any questions;
3. Give the patient a sincere apology. Effective apologies should
   • • communicate genuine sincerity about the medication incident;
     • use a personal tone including terms such as “I” or “We;”
     • use appropriate non-verbal gestures (body language, tone of voice, facial expressions); and
     • assure that harm did not result from anything the patient or family did or did not do.
       
       For additional information on what makes a good apology, please see the “Full Disclosure: What Makes a Good Apology” blog post.
4. Explain the medication incident to the patient. Focus on the events that led to the medication incident, using clear and understandable terminology. Avoid speculation and assigning blame. Encourage the patient and family to ask questions and discuss the incident from their point of view. Actively listen to the patient and remember that they can make valuable contributions to your improvement plan.
   
   Although you may not know all the details about how the incident happened, you must still provide an explanation of what has and/or will happen including the following:

• • The pharmacy will conduct an investigation of the incident and analyze the possible contributing factors. Advise the patient that the purpose of the investigation is to improve the system and prevent a similar incident from happening again rather than assigning blame;
  • Staff will discuss the incident and develop changes in processes to prevent a similar incident from happening in the future;
  • The incident will be anonymously reported to a national medication safety database to share learning with other healthcare providers; and
  • You will follow-up with the patient that in an effort to be transparent to tell them what changes you made to prevent a recurrence. The MINME requires this step which can restore trust with your patient. Ask the patient for contact information for the follow-up.

4. Disclose the Details of the Investigation and the Steps Taken to Prevent a Recurrence^1,4,6

The disclosure process requires continued dialogue with the patient and family rather than a single discussion. After the initial disclosure meeting and when the medication incident has been fully reviewed and analyzed:

• Check on the health of the patient;
• Communicate any new facts about the incident and any learnings from analysis;
• Discuss any improvements or changes made to prevent recurrence because of the pharmacy’s investigation and analysis;

• Reinforce, update, or correct information provided in previous meetings; and

• Provide continued practical and emotional support to the patient and family.

5. Document the Disclosure Discussion¹

According to the MINME, you must document communication with the patient related to the medication incident. Your disclosure documentation should include:

• The date of all disclosure discussions and who participated
• The facts provided to the patient
• Information, suggestions, and questions raised by the patient and answers given
  
  

Medication Incident Disclosure: A Case Example

Mr. Patel, a patient of your pharmacy, states that he has been feeling nauseated and has had a few episodes of diarrhea ever since he picked up his new prescription two days ago. Upon examining his pharmacy profile and the medication vial he has brought in, it becomes apparent that he has received another patient’s metformin prescription by accident, instead of his intended medication, atorvastatin.

Application of the Suggested Framework

1. Take Immediate Action to Ensure the Patient’s Safety

• Determine if Mr. Patel has experienced or is at risk of experiencing harm and provide care to him to the best of your ability;
• Ensure Mr. Patel receives the correct medication in a timely matter;
• Take reasonable steps to ensure the incorrect medication is quarantined and/or returned to the pharmacy;
• Advise Mr. Patel of the potential consequences (both short and long term) from the incident; and
• Notify the pharmacy manager, prescriber, and any other personnel deemed necessary of the medication incident.
  
  

Document the steps you have taken and the conversations you have had with the patient, pharmacy manager, and prescriber.

2. Prepare for the Initial Disclosure

The pharmacy should make every effort to schedule an in-person disclosure meeting with Mr. Patel as soon as possible. The pharmacy manager will facilitate communication with Mr. Patel and oversee the disclosure process as the pharmacy manager is the most responsible healthcare provider involved in the patient’s care in this case. The staff member who gave the medication to Mr. Patel at pick-up should also be prepared to discuss the incident with him.

Use your professional judgement to arrange an uninterrupted meeting. A possible arrangement would be: The disclosure meeting is scheduled next Sunday when the pharmacy is closed to allow for privacy and the time needed for a thorough discussion. Mr. Patel is advised that he may bring his family for support if desired.

Gather the facts about the medication incident by reviewing the incident report, interviewing the staff involved if needed, reviewing relevant policy and procedure, and any other source material that will give you an idea of what happened beyond the most obvious answers.

3. Disclose the Medication Incident

Here is a potential disclosure: “Mr. Patel, I want to take some time to discuss the events that have led up to you receiving the wrong medication. When you picked up the prescription, we neglected to ask you for an additional patient identifier or information besides your name, such as your address or date of birth. You share a very similar name to one of our other patients and we didn’t ask for more information like your date of birth to confirm your prescription was correct. These factors contributed to you receiving the wrong prescription. We want to be clear that you did nothing wrong and the pharmacy will make changes to prevent this from happening again. I have contacted your family physician who agrees that no changes to your current care are needed. Again, we are very sorry about what happened. Would you like to share your thoughts on this incident with us or ask us any questions? Do you have any suggestions about how we might improve our processes?”

Give Mr. Patel specific contact information (including a person he can ask for and a phone number) in case he has any additional questions or concerns. Advise him that you will contact him if there are any new discoveries or additional process changes.

4. Disclose the Details of the Investigation and the Steps Taken to Prevent a Recurrence

While reviewing and analyzing the medication incident, the pharmacy team discovered that Mr. Patel had refused counselling when he picked up his medication as he was in a rush. As a result of this incident, the pharmacy has changed its processes related to prescription pick-up:

• All staff will request a minimum of two secondary patient identifiers upon prescription pick-up. Preferred identifiers, in addition to the patient’s name, will include the person’s address and date of birth.
• Counselling will be given for all prescriptions (new prescriptions and refills).
• Staff will open the bag containing the prescription for each patient to ensure that each prescription label bears the intended patient’s name and medication using a ‘show-and-tell’ or ‘teach-back’ method during patient counselling. This is the last opportunity to verify the appropriateness of each medication and confirm patient understanding.
  
  

These process improvements and workflow changes are shared with Mr. Patel along with any new findings the pharmacy discovers.

Document the Disclosure Discussion³

• The date of all disclosure discussions and who participated
• The facts provided to the patient
• Information, suggestions, and questions raised by the patient and answers given
  
  

References

1. College of Pharmacists of Manitoba. Medication Incident and Near-Miss Event Practice Direction. Winnipeg, MB. From: https://cphm.ca/resource-library/?_sft_resource_category=practice-directions-and-standards&_sf_s=Medication
2. Edmondson AC, Lei Z. Psychological safety: The history, renaissance, and future of an interpersonal construct. Annu Rev Organ Psychol Organ Behav2014; 1: 23-43.
3. Burlison JD, Quillivan RR, Scott SD, Johnson S, Hoffman JM. The Effects of the Second Victim Phenomenon on Work-Related Outcomes: Connecting Self-Reported Caregiver Distress to Turnover Intentions and Absenteeism. Journal of Patient Safety2016 Nov. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5413437/pdf/nihms-788857.pdf
4. Disclosure Working Group. Canadian disclosure guidelines: being open and honest with patients and families. Edmonton, AB: Canadian Patient Safety Institute; 2011. Available from: https://www.patientsafetyinstitute.ca/en/toolsResources/disclosure/Pages/default.aspx
5. College of Pharmacists of Manitoba. eQuipped: Safety IQ eNewsletter Vol 7. Available from: https://cphm.ca/wp-content/uploads/Resource-Library/SafetyIQ/eQuippedVol07.pdf
6. Ho C, Kawano A. How to handle a medication error. TECH talk CE 2013;May:4-10. Available from: http://www.canadianhealthcarenetwork.ca/files/2013/05/TechTalkMay-2013.pdf