What do I report?
All medication incidents must be promptly reported by pharmacy staff member(s) to the pharmacy’s medication incident reporting platform. Near-miss events, especially those that recur or could have caused harm if they had reached the patient, are also reported to the pharmacy’s medication incident reporting platform.
Who should report?
Any dispensary staff person— pharmacists, pharmacy technicians and pharmacy assistants— can make a medication incident or near-miss event report. Including all team members in reporting encourages a positive safety culture and ensures efficiency.
How do I report?
While there are a number of basic required reporting fields, the narrative quality of your report is the richest data source. Your greatest impact on shared learning is possible in the Incident Description/How the Incident was Discovered category. A rich, detailed, and clear description of the incident ensures that analysis at the pharmacy and NIDR level is as comprehensive as possible.
Ask yourself the following questions as you make and review your incident description:
- Does your description include the ‘What? When? Where? Why? and How?’ of the incident
- Is the incident description clear and concise?
- Have contributing factors been identified and are they included in the incident description?
- Is the action to be taken to prevent the incident from recurring included in the incident description?
- Is your description free from patient and/or provider information?
The CPhM ‘Quick Start to Reporting’ resource can be posted at workstations as a support for pharmacy staff.
Near-Miss Event Protocol
To Report or Not to Report? Establish a Near-Miss Event Protocol to Ensure Compliance and Efficiency
Pharmacy professionals excel at discovering potential medication incidents before they reach a patient. Near-miss event reporting and analysis is an opportunity to address gaps in existing pharmacy systems or procedures to improve the safety of your pharmacy.
Not all near-miss events are valuable from an improvement or learning perspective and pharmacy professionals juggle many tasks throughout the workday. Your pharmacy should consider the following points to increase the efficiency and quality of your pharmacy’s near-miss event reporting:
Establish a near-miss event protocol as part of your policy, procedure and training. When building a near-miss event protocol, your team should consider the following:
- Potential impact on the patient: would the patient harmed if they were given this medication? If yes, report the near-miss event.
- Recurring nature of the near-miss event: does the same near-miss happen repeatedly? If yes, report the near-miss event.
- The potential for shared learning: could learning from a near-miss event benefit colleagues and patients in other pharmacies? If yes, report the near-miss event.
Find ways to maintain near-miss event reporting when your pharmacy is busy. For example, use paper reports to quickly document near-miss event details to be entered into your reporting platform during a less busy time. Check if your reporting platform has a printable version of its reporting template or use the CPhM near-miss report form. Ideally, all pharmacy team members should be trained and encouraged to report medication incidents and near-miss events immediately. This can reduce the administrative burden.
Think of your documentation as a road-map to improving patient safety and professional accountability. Your documentation of medication incidents and improvement plans should demonstrate reflection, learning, and meaningful change.
In terms of measuring and monitoring safety improvements, your pharmacy must document the improvement plans created in response to individual incidents, trends or patterns detected by staff or managers, and in response to the pharmacy’s SSA. Without documentation of your plans, it is impossible to assess if your changes have reduced the chances of patient harm. Measuring and monitoring is a key component of continuous quality improvement.
Secondly, documentation is key to accountability and regulatory compliance. The College of Pharmacists of Manitoba (CPhM) inspection process is in place to protect the public interest and compliance with Safety IQ is a key component of CPhM’s accountability to the public. In the rare event CPhM must launch an investigation relating to a complaint by a member of the public, a colleague, or CPhM, documentation that you followed the requirements of the Medication Incident and Near-Miss Event Practice Direction is key evidence that will be collected.
What Needs to be Documented?
Pharmacy managers must ensure the following information is documented and available for regulatory review:
- medication incidents and near-miss events are reported (documented) to the medication incident reporting platform;
- all pharmacy communication with the patient, prescriber, and staff related to the incident;
- formal CQI meetings (at least one meeting annually) including date, staff present and topics discussed;
- action plans developed in response to incidents and near-miss events, SSAs, and shared learning; and
- Safety IQ engagement through your Pharmacy Portal.
Please see the CPhM Quick Guide to Documentation for a resource to support the pharmacy team.
Tracking and Cross-Referencing Medication Incidents
Because pharmacies are using a variety of reporting platforms each with different capabilities, there is a potential to miss a step in the documentation process. It is imperative that you understand your reporting platform’s capabilities.
Reporting platform providers are responsible for providing training resources and tools as well as ongoing support and communication to pharmacies. Pharmacy managers must ensure that all staff are trained on the reporting platform and the tools available.
Your pharmacy’s policy and procedures on documentation must ensure that the entire history of an incident can easily be tracked and cross-referenced. If your incident reporting platform does not allow entry of patient identifiers or prescription numbers, you must create a process or procedure to ensure that all required documentation can be traced back to the specific incident and patient. This might include, for example, noting the incident number from the reporting platform directly in the patient record or using an incident log.
CQI Meetings and SSA Improvement Plans
There will be variation in what reporting platforms offer for documenting CQI meetings and SSA improvement plans, so pharmacy managers must ensure pharmacy documentation policy and procedure meet documentation requirements for these Safety IQ elements. Please see the Continuous Quality Improvement Meeting and Safety Self-Assessment pages for more information.
Safety IQ Engagement
The pharmacy manager must self-declare the following information in the Pharmacy Portal on cphm.ca*:
- The pharmacy’s medication incident reporting platform and date the pharmacy was subscribed
- The date the pharmacy’s SSA is complete and the product used
- The date the pharmacy’s formal CQI meeting is complete
*Note: Filling out the self-declarations in the pharmacy profile does not meet documentation requirements set out in the Medication Incident and Near-Miss Event Practice Direction for SSAs and CQI Meetings.
Frequently Asked Questions
What is a medication incident?
A medication incident is a preventable occurrence or circumstance that may cause or lead to inappropriate medication use or patient harm. Medication incidents may be related to human factors, environmental factors, procedures, and systems, and include prescribing, order communication, product labelling/packaging/ nomenclature, compounding, dispensing, distribution, administration, education, monitoring and use.
What is a near-miss event?
A near-miss event is an event or circumstance that took place and could have resulted in an unintended or undesired outcome(s) but was discovered before reaching the patient.
What is the NIDR and how is incident data used?
Community pharmacy teams report medication incidents and near-miss events to a reporting platform of their choice. De-identified reports are automatically forwarded to the National Incident Data Repository for Community Pharmacies (NIDR). The NIDR is a component of Canadian Medication Incident Reporting and Prevention System (CMIRPS), a collaborative pan-Canadian program designed to reduce and prevent harmful medication incidents. CMIRPS is hosted by the Institute for Safe Medication Practices Canada (ISMP Canada).
The NIDR creates a cohesive information-sharing system that facilitates the understanding of medication incidents and the development of robust strategies to prevent patient harm.
Information from the NIDR, including healthcare facility, practitioner, and consumer reporting programs of CMIRPS, is analyzed and targeted recommendations are shared with all healthcare professionals.
The data reported to the NIDR by community pharmacies is at an arm’s length from CPhM. CPhM only receives de-identified (anonymous) aggregate data summaries for the development of tools or resources that will help pharmacies close gaps in patient safety.
What is a medication incident reporting platform?
A medication incident reporting platform is a software program that pharmacy teams use to record data on medication incidents and near-miss events and that exports the de-identified (anonymous) data to the NIDR. The software program must meet the data standards and platform criteria set by CPhM Council.
How do pharmacies choose a reporting platform?
In Manitoba, each pharmacy chooses a medication incident reporting platform that fulfills CPhM criteria.
Allowing pharmacy choice eliminates the potential for redundant reporting to both a CPhM mandated program and the pharmacy’s internal program.
It is the pharmacy manager’s responsibility to choose a medication incident reporting platform that meets CPhM criteria on reporting capabilities, intelligence capability and data access, training capability, interface design, data security and privacy, and reporting fields.
I am opening a new pharmacy. How do I implement Safety IQ?
Owners and/or managers of new pharmacies should use the Safety IQ Implementation Toolkit for New Pharmacies to start a CQI program. The Toolkit supports pharmacy managers and owners to understand Safety IQ and put the technical requirements of the program in place when opening a new pharmacy.
The Toolkit is available at the following link: https://cphm.ca/resource/siq-new-pharm-toolkit/