Focus on risk management in pharmacy
This is the second in a series of articles focusing on key topics to help prompt discussion and share examples of what we are seeing through our inspections of registered pharmacies.
This month we are focusing on risk management, which is a crucial part of effective governance. It underpins the pharmacy’s day to day practice and ensures that the health, safety and wellbeing of patients are safeguarded and risks are minimised.
Risk is the chance or probability, high at one extreme and low at the other, that a person could be harmed or experience an adverse health outcome if something goes wrong, together with an indication of how serious the harm could be.
Risk management in the context of registered pharmacies is about more than near misses and dispensing errors. It involves:
- Having the necessary systems, processes and skilled staff in place to minimise the likelihood of providing poor quality care
- Having mechanisms to learn from situations where, despite having those systems something has gone wrong
- Identifying and minimising the potential for harm or adverse health outcomes if something goes wrong as a result of a pharmacy’s activities and services
As a pharmacy owner or member of the pharmacy team, it’s useful to ask yourself what the greatest risks are in your pharmacy.
By carefully considering what in your work could cause harm to patients and users of pharmacy services, you can think about what you and other members of your pharmacy team need to do in order to keep the risk as low as possible, and what you could do to reduce it further. You and your team should take account of the individual circumstances in your pharmacy and understand the factors central to managing risk and providing person-centred services. These include:
- The services the pharmacy provides
- The staff working there and their knowledge and experience
- The scale and nature of the activity
- The number of people potentially affected by it
- The likelihood of something going wrong
- The likely impact on the patient or service user, taking into consideration their health and vulnerability
You and your team may not always be able to foresee all the risks and deal with them in advance. But by continually using risk assessments for different activities and services, and collecting information about patients and from concerns and other feedback, pharmacy owners can show how they have identified and managed those risks appropriately. There is the potential for new risks to be introduced before starting a new service or before making changes in technology.
Our inspections consider governance arrangements across all the pharmacy activities, including the systems and processes in the pharmacy. They look at whether pharmacy services are delivered safely. We are also interested in assessing how pharmacies manage the risks associated with different models of service delivery, such as pharmacy services provided via the internet. There may not necessarily be greater risks in, for example an internet pharmacy service, but different risks to consider.
The case studies below are examples of what we have seen through our inspection of registered pharmacies.
- The owner of an internet pharmacy demonstrated that he had identified and managed the risks associated with the supply of GSL and P medicines over the internet. The entire process had been designed by the owner and superintendent to minimise the risk of making inappropriate or excessive supplies of medicines liable to abuse. The sale of P medicines was tightly controlled, with orders for medicinal products assessed for appropriateness by a pharmacist on receipt. As part of this assessment, purchasers were contacted by email or telephone to clarify any queries on their online questionnaires before the order was assembled. Additionally, all orders received were electronically logged using a number of parameters such as the name of the person placing the order, the delivery address and the payment method used. These parameters were automatically monitored and cross-checked within the system to identify whether the same or similar medicine had been previously ordered by the same purchaser or had been previously delivered to the same delivery address. In the case of multiple purchases of the same or similar medicines, an enquiry was raised with the pharmacist who would then contact the purchaser to resolve any issues prior to supply. Orders were assembled by trained staff and checked by a pharmacist against the order and online questionnaire responses. Each order was identified by a unique barcode repeated for internal tracking processes to identify the pharmacist responsible for checking the assembled order and label for delivery.
- A busy pharmacy had identified its large care home dispensing business as high risk. As well as being well organised and methodical, the pharmacy had a range of checks and accurate records in place to mitigate the risk of errors. The pharmacy had good relationships with the care homes it served, and effective, frequent communication supported this. Each care home had an allocated dispenser or technician, who would respond to queries and communicated frequently with the care home staff. Each care home had a well organised communication book, where actions which needed to be taken were recorded. Care homes were visited regularly, and a pharmacist spent one and a half days per week on this task. Visits were more frequent if additional support was required. The care home services manager was involved in training staff and nurses at the homes. Progress logs were maintained for each home so it was always clear what stage of the process all homes were at. Delivery sheets were used to record how many bags or boxes were being delivered to each home. The care home staff signed this when they received a delivery, and a copy was kept in the pharmacy. Frequent phone calls and discussions between staff members, with patients, care homes and prescribers were professional, decisive and effective.
We saw many different ways pharmacy owners highlighted and learned from the errors and near misses recorded, to minimise the risk and avoid repetition of mistakes. These included:
- Recording and analysing errors and near misses as an integral part of what the pharmacy did and not just as an add-on to its other activities.
- Reviewing near misses each week to identify patterns, common themes, trends and significant risks and visually displaying these using pie charts in the dispensary. For example, one pharmacy owner carried out an analysis of the total near misses and errors over the previous 30 months and categorised these into system, quantity, selection and dosage errors, and then examined why the errors were occurring. (For instance, many of the dosage errors related to staff pressing the repeat button and not checking the current prescription.)
- Giving staff members individual tailored feedback, to support them and address any issues identified on an ongoing basis with follow-up audits to monitor progress.
- Keeping details of how previous adverse incidents were handled and the action taken to prevent recurrence. For example, a dispensing incident had shown that the handover notes between different pharmacists were not always secured with each client’s paper record, which had led to a client not starting a reduced dose as planned. As a result, patient files were reorganised and the team was briefed to ensure that handover information was firmly attached to the records.
- Providing examples of changes made following dispensing incidents to demonstrate the pharmacy’s culture of transparency and openness.
- Using case studies relating to errors as training opportunities – to learn how to manage the error, how to communicate with the patient, for example. Carrying out the root-cause analysis, provided staff with relevant experience and the confidence to deal with a similar incident if it happened for real.
Find out more
Here are some of the resources available to help you and your team find out more about risk management.
- The Health and Safety Executive’s website hosts risk management resources, such as ALARP “at a glance” and risk assessment case studies
- The Royal Pharmaceutical Society has produced Clinical Governance - a quick reference guide. Section 7 includes a section on risk management.
- Pharmacy Voice have produced a Community Pharmacy Medication Safety Risk Assessment Tool
- We produced Guidance for registered pharmacies preparing unlicensed medicines and Guidance for registered pharmacies providing pharmacy services at a distance, including on the internet, which provide information on what to consider when carrying out risk assessments in these settings.
- We also produced Responding to complaints and concerns guidance
- Monitor has produced an updated Risk assessment framework
CPPE launched an e-learning programme on Risk Management.
- Health Improvement Scotland have produced a national framework Learning from adverse events through reporting and review.