Medication Safety Program FAQs

For Pharmacies and Pharmacy Professionals – Program Operational Implementation

Overview and Program Requirements

What are the requirements of the Medication Safety Program?

The ultimate goal of the program is to reduce the risk of patient harm caused by medication incidents in, or involving, pharmacies. Consistent with the principles of a safety culture, there are four core elements of the medication safety program (please see the supplemental Standard of Practice (sSOP) related to the medication safety program for further details):

• Report: Medication incidents and near misses will be recorded by pharmacy professionals via a third-party platform in order to populate an aggregate incident database to identify issues and trends to support patient safety improvements at the pharmacy and broader system levels;

• Document: Pharmacy professionals will document appropriate details of medication incidents and near misses in a timely manner to support accuracy. Continuous quality improvement (CQI) plans and outcomes of staff communications and quality improvements implemented are also documented;

• Analyze: Pharmacy professionals will analyze the incident in a timely manner for causal factors and commit to taking appropriate steps to minimize the likelihood of recurrence of the incident;

• Share Learnings: Pharmacy professionals will ensure prompt communication of appropriate details of a medication incident or near miss, including causal factors and actions taken as a result, to all pharmacy staff.

Is the Medication Safety Program mandatory?

Yes, all Ontario community pharmacies will be required to participate in the mandatory, standardized Medication Safety Program.

What are the responsibilities of the Designated Manager?

The Designated Manager plays a critical role in the successful implementation of the AIMS mandatory Medication Safety Program. Along with ensuring pharmacy staff have access to the incident recording platform and associated tools and resources, the Designated Manager must also ensure the pharmacy’s operations are conducive to the principles of the AIMS Program and a safety culture, as well as satisfy the expectations outlined in the supplemental Standard of Practice.

What was the role of the ambassadors during the preliminary phase of the program roll out?

The program was initially tested during a successful nine-month ambassador program which started in February 2018. Pharmacy professionals at approximately 100 Ontario pharmacies received training and actively utilized the incident reporting platform prior to the formal program rollout. These ambassadors played a valuable role in providing critical input to fine tune the process and helped prepare the program for provide-wide implementation through feedback related to the incident recording platform, resources and tools and onboarding experiences.

Is there a fee for this program?

The AIMS Program, mandatory for all accredited community pharmacies, is paid for by the Ontario College of Pharmacists. The cost for the program, just as all other programs administered by the College as part of our regulatory responsibilities and public-protection mandate, are recovered through fees paid by registrants and accredited pharmacies.

Pharmacy Onboarding

When and how will pharmacies be expected to implement the program and be onboarded to the incident recording system?

The College is implementing the program over the next several months; we expect to have all 4,300 community pharmacies successfully onboarded to the program and incident recording system by mid-2019. The College and Pharmapod will notify the Designated Manager in advance of the targeted implementation date for his/her community pharmacy(ies) and will work with the DM to prepare their staff prior to being onboarded to Pharmapod’s platform.

Will there be any formal training on how to use the Pharmapod software? How much training will be provided?

A web-based training program will be available through the platform and can be completed once pharmacies have onboarded. Completion of the training modules is mandatory. Training modules will cover both the use of the platform for recording incidents and for continuous quality improvement (CQI) and provide guidance on how to implement CQI processes within your pharmacy. In addition to the web-based training on all components, you will be able to reach out to Pharmapod directly for one-on-one support as needed.

How will OCP support engagement with the mandatory requirements of the program?

The immediate priority for the College and its program partner Pharmapod will be to support a successful onboarding to the AIMS Program among all 4,300+ community pharmacies in the province. Once implementation has been completed, over time pharmacy professional engagement with the program and evidence of meaningful use will be reviewed as part of the College’s pharmacy and practice assessment processes.

Using the Incident-Recording System

Who is Pharmapod and what is its role in the College’s AIMS Program?

Pharmapod is the third party selected by the College following a formal request for proposals process, to create and manage the program incident-recording system. Their platform will be used by pharmacies to enter medication incident data. Pharmapod will also be providing training, resources and data analysis for pharmacies and the College.

What types of devices can we use to access the system?

The Pharmapod platform may be securely accessed from any internet enabled device including desktops, tablets or mobile devices, with the user interface optimized for each given device. The platform is cloud-based, therefore a device does not have to be inside the pharmacy location to access the platform.

My pharmacy already has a reporting system. Can the Pharmapod system integrate with other systems?

At this time, the Pharmapod platform is the required interface for the College’s Medication Safety Program. Over time, the option to build application program interfaces (API) to link with existing software may be explored, as the Pharmapod platform has the capability to integrate with other systems. The College and Pharmapod look forward to working with community pharmacies over the coming year to assess the challenges/opportunities.

What kind of a time commitment does the incident recording system require?

There has always been an expectation that pharmacies are engaging in continuous quality improvement, as illustrated in the NAPRA Model Standards of Practice. The Pharmapod platform has been designed to enable more streamlined, standardized, accurate and complete tracking of this information and minimize the time required to do so. It will support pharmacies to record and analyze medication incidents by:

• Using pre-populated drop downs to decrease the time required to enter information.

• Using standardize responses to support the analysis of medication incident trends.

• Offering a suite of pre-populated analytic reports that can be used to identify areas for improvement within your specific pharmacy processes.

• Integrating continuous quality improvement (CQI) tools within the platform to support the recording and management of continuous quality improvement activities.

• Creating an in-platform forum for communication regarding specific medication incidents or CQI initiatives.

The Pharmapod platform has an ease to-use, intuitive design that supports recording and analysis of medication incidents at your pharmacy.

Who in the pharmacy will need access to the incident recording system?

Designated managers are encouraged to engage all pharmacy staff in entering medication incidents into the Pharmapod platform, including pharmacists, pharmacy technicians and pharmacy assistants. All staff within the pharmacy need to be able to support the process and the program to ensure its success. Designated managers will have the control to assign levels of access to individuals within the pharmacy.

How are pharmacies expected to use the information in the incident recording system?

Other than the mandatory requirement to record all incidents and near misses, pharmacies will be expected to use the data available to them and the additional tools and resources developed in collaboration with Pharmapod and other partners to document, analyze, make improvements and to share learnings within their teams. This is a key component of the AIMS Program requirements.

When will all pharmacies be required to begin participating in the Medication Safety Program?

The Medication Safety Program will be in place by the end of 2018. Pharmacies will be on-boarded to the Pharmapod platform in waves throughout early 2019, to ensure smooth uptake. You will be contacted and notified by Pharmapod when it is time for you to receive an account.

What is the definition of an incident and near miss?

Medication incident: Any preventable event that may cause or lead to inappropriate medication use or patient harm. Medication incidents may be related to professional practice, drug products, procedures, or systems, and include prescribing, order communication, product labelling/packaging/nomenclature, compounding, dispensing, distribution, administration, education, monitoring, and use.

Near miss: An event that could have led to inappropriate medication use or patient harm but did not reach the patient. Near misses provide valuable insight into areas of risk, and may indicate where systems can be improved to prevent harm.

How can I determine when to record a near miss?

If a potential error is caught outside of the established processes and procedures at the pharmacy but before the prescription reaches the patient, then it should be recorded as a near miss. Established processes and procedures could include the technical and therapeutic signoffs and/or any other regular process in place to catch errors such as input or DIN errors.

Regardless of when a near miss or medication incident is caught, if you notice that similar incidents are reoccurring on a frequent basis, this may indicate that the processes and procedures you have implemented into the workflow are not effective and should be reviewed.

The extent to which near misses are recorded will be a professional judgment decision of the Designated Manager in consideration of the nature of the near miss, its implication for patient safety and the extent to which it is recurring.

Data Protection

How is patient confidentiality protected within the system?

Personal health information must not be entered into the Pharmapod platform. The only information entered in the platform that is related to the patient will be the patient’s month and year of birth and gender. The prescription number associated with the medication incident will also be an optional field, to allow pharmacy professionals working at the pharmacy the ability to cross-reference with the pharmacy’s practice management system (PPMS).

What data will OCP have access to and what will it do with it?

The College will not have the ability to view data at the level of a specific pharmacy, pharmacy professional or medication incident. OCP will only receive de-identified aggregate data for the purpose of reviewing medication incident trends to inform the development of resources to address gaps and issues identified, and to support shared learning across Ontario.

A Response Team of pharmacy professionals and patient safety experts will assist the College in analyzing the de-identified data and develop recommendations to the College on strategies for continuous quality improvement and reducing the risk of patient harm associated with medication incidents. The members of the Response Team are: Dr. Corey Lester (Research Assistant Professor at the University of Michigan), Dr. Nancy Waite (Associate Director at the University of Waterloo), Dr. Lisa Dolovich (Professor, Leslie Dan Faculty of Pharmacy, University of Toronto and Professorship in Pharmacy Practice, Ontario College of Pharmacists), Shelita Dattani (Director, Practice Development and Knowledge Translation, Canadian Pharmacists Association), Alison Bodnar (CEO of the Pharmacy Association of Nova Scotia), Dr. James Barker (Professor and the Herbert S. Lamb Chair in Business Education at the Rowe School of Business, Dalhousie University and Team Lead at SafetyNET-Rx), Deb Saltmarche (Senior Director Professional Affairs, Shoppers Drug Mart), Mark Naunton (Head of Pharmacy, Faculty of Health, University of Canberra, Australia).

The data will be made available directly to pharmacies and health-system stakeholders and will be shared publicly, along with improvement recommendations, on the College’s website on a quarterly basis. The analysis and sharing of this information will be key in providing helpful, actionable insights to pharmacy professionals and other healthcare stakeholders to reduce medication errors and improve patient safety.

How anonymous is the data I record on the platform?

Each pharmacy will only be able to view data they have entered. The central offices for organizations with groups of pharmacies will not have the ability to access data from the Pharmapod platform. Only local pharmacy staff with an authorized account at the pharmacy will be able to access their pharmacy’s platform. Each pharmacy (and their staff) will be provided with a unique login, and it is very important that this be kept confidential.

Will the public be able to see medication incident data reports?

In the future, OCP expects to make reports on aggregate medication incident trends accessible to the public to support patient safety in a transparent manner. Public reports will only contain information on de-identified aggregate trends.