Practice Insight explores concerns reported to the College as part of the complaints and reports process that present learning opportunities for pharmacists and pharmacy technicians. This close up on a complaint highlighted below reminds Designated Managers of their responsibilities, including for staff training and oversight, policies and procedures, and management of medication incidents.
A Missed Medication Refill Results in Patient Harm
A patient telephoned the pharmacy to request a refill of anti-epileptic medication and was told to pick it up a couple of days later. When the patient attended the pharmacy, they were told by the pharmacy assistant that the medication was not available. As a result of missing several doses of medication, the patient suffered a seizure that resulted in a dislocated shoulder requiring surgery and the loss of their driver’s license.
Outcome from the Inquiries, Complaints and Reports Committee
Upon reviewing the complaint, a panel of the College’s Inquiries, Complaints and Reports Committee noted that the pharmacy assistant did not follow the procedures in place regarding what should happen when a medication is unavailable. In particular, the pharmacist was not informed about the lack of medication.
The panel observed that the Designated Manager of a pharmacy is responsible for ensuring that policies and procedures are in place, and that staff receive adequate training and are consistently following those policies and procedures. Therefore, this complaint focused on the responsibilities of the Designated Manager of the pharmacy at the time of incident.
The panel highlighted the expectation that a Designated Manager takes an active role in conducting an investigation following a medication incident, including performing a root cause analysis, following up with the patient and formulating an action plan to prevent future occurrences. In this case, the panel noted that the Designated Manager, in her response to the complaint, did not show insight into the seriousness of the incident, her own role and responsibilities, and how the incident could have been prevented.
The panel provided the Designated Manager with advice/recommendations to assist her in how she may be more thoughtful in her practice when supervising unregulated staff and when addressing medication incidents.
Learnings for Designated Managers
As defined in the Drug and Pharmacies Regulation Act, 1990, it is the Designated Manager’s responsibility to ensure that the pharmacy conforms to the requirements set out in legislation.
The Standards of Practice require that pharmacists who are managing a pharmacy develop policies and procedures that ensure a safe and effective system of medication supply is maintained at all times. In addition, all pharmacists must ensure that staff for whom they are responsible competently perform delegated pharmacy-related activities.
One of the key principles of the College’s Designated Manager – Professional Supervision of Pharmacy Personnel Policy is that the Designated Manager must provide staff members with the appropriate tools and resources to deliver safe and effective patient care. Designated Managers must ensure that appropriate risk assessment and management systems are in place to mitigate risks to patient safety and prevent medication incidents. The Designated Manager must establish job descriptions and a performance measurement and improvement system for pharmacy employees, and also ensure that, at all times, staffing in the pharmacy supports the pharmacist(s) in their cognitive and patient care functions.
The supplemental Standard of Practice (sSOP) and Standards of Operation require Designated Managers to integrate continuous quality improvement into the pharmacy’s work processes and establish a safety culture such that pharmacy professionals and staff can be successful in meeting the requirements of the Assurance and Improvement in Medication Safety (AIMS) Program. The sSOP expect pharmacy professionals to record and analyze all medication incidents, document quality improvement plans and share learnings from the incident with the pharmacy team to prevent recurrence and support shared accountability and patient safety.
The recent Pharmacy Connection article “Understanding, Managing and Responding to Complaints,” explains the College’s expectation that the Designated Manager trains unregulated staff to a degree in which they can provide high quality pharmacy services. To prevent concerns regarding unregulated pharmacy staff, Designated Managers are expected to develop and facilitate a training program for new staff.
All Designated Managers are encouraged to complete the College’s new Designated Manager e-Learning module, which provides an overview of many of their key responsibilities, including those related to managing the premises, the equipment and systems, and personnel.