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Pharmacy inspections

Inspection reports and learning from inspections

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Effective use of risk assessments to identify potential patient safety risks.

Pharmacy type

Community

Pharmacy context

​This was a community pharmacy close to a GP practice in a town with a population of 50,000 of which the pharmacy served around 10,000. It had recently had a complete refit and was dispensing around 12,000 NHS items each month. The NHS items included supply to around 350 patients in monitored dose devices. Dispensing was highly automated using 2 robots. Other NHS services provided were the standard Scottish pharmacy contract services – CMS, eMAS, smoking cessation and the gluten free food prescribing service. A substance misuse service was provided An extensive range of other services were delivered including independent prescribing for respiratory conditions, pain management common clinical conditions.

Relevant standards

  • 1.1 - The risks associated with providing pharmacy services are identified and managed
  • 1.2 - The safety and quality of pharmacy services are regularly reviewed and monitored

Why this is notable practice

All services are risk assessed before commencing, and on an ongoing basis to ensure that risks are managed. There is awareness of potentially weaker areas in processes, so strategies including doublechecking and additional audits are in place to manage these. There is very thorough record-keeping and checking of high-risk activities. Improvements have been demonstrated by making comparisons after new services and technology are introduced with previous arrangements.

How the pharmacy did this

Most dispensing was using a robot with 3 chutes delivering medicines to the dispensing bench. This minimised the movement of people within the dispensary and was observed to be a very quick, accurate and efficient process. At least one dispenser was always on reception, and the pharmacist worked close by, but shielded from the public to minimise distractions, but allowing her to supervise the medicines counter and reception area.

Patient information (such as methotrexate and anticoagulant booklets) was highly visible and accessible in the dispensary to ensure supply to patients who required them. A rear dispensary was used for all other dispensing except compliance aids i.e. balances, queries and collection service prescriptions. There were usually 4 dispensers and a pharmacist working here, also using the robot with a dedicated chute into this area. All aspects of the prescription, medicine and label were thoroughly checked and packages marked to signify this before passing for the final accuracy check

Compliance aids were dispensed on a 4-weekly cycle in a dedicated room using an automated system. Patients were divided into different cohorts to ensure workload was even across the 4 weeks. A dispenser who was also qualified as an accuracy checker largely managed this with a colleague assisting her and a third dispenser competent to replace either of them in the event of absence.

When patients were started on compliance aids their medicines were synchronised, a decision made on the day of each week that the compliance aid started and this was recorded and packed in such a way that it was consistent. New patients were contacted by phone and the ‘pouch system’ described and demonstrated to them. Medicines for most of these patients were dispensed into pouches using a robot which was highly accurate. The risks identified were at points where humans were involved and were well managed. Tablet descriptions were automatically printed onto the pouches and they did not change for most medicines as the brands were specific to the robot. Some less commonly used items were placed into the robot immediately prior to dispensing and a dispenser was required to input the information using bar codes and this was doublechecked by a colleague and an audit trail of this kept.

A spreadsheet was kept with details for each patient such as additional medicines stored elsewhere e.g. controlled drugs, key safe codes if drivers had the authority to use these, and any special instructions such as ‘knock and enter’, deliver at a certain time and hospitalisation. A calendar of events for each cycle was kept showing when prescriptions were ordered, dispensed and delivered. Many of these patients had CMS serial prescriptions which assisted with the workload as the pharmacy was in control of when these could be assembled. Near misses were consistently and continually recorded and analysed for trends. Comparisons had been made of the number before and after the installation of the robot and a significant decrease had been observed. The robot had the facility to produce a label to put on split packs but it had been decided not to use these as there was the possibility that the wrong label could be placed on the packet resulting in the wrong product then being dispensed. Instead, a facility on the robot which allowed the number of tablets in the packet to be manually changed was used, again using the bar code, and the robot ‘knew’ where it positioned the packet. When this was manually input it was double checked by a second dispenser to ensure accuracy, and records and signatures of this were kept.

What difference this made to patients

Risks within the pharmacy are constantly assessed and strategies implemented to manage them, including the innovative use of automation for dispensing. Monitoring and review of all services is continual and ongoing with improvements made to services resulting in a reduction in errors and positive outcomes for patients.

Highlighted standards

We have identified the standards most likely and least likely to be met in inspections, and highlighted examples of notable practice for each of these standards; to help everyone learn from others and to support continuous improvement:

  1. 1.1 Risk management
  2. 1.2 Reviewing and monitoring the safety of services
  3. 4.2 Safe and effective service delivery
  4. 4.3 Sourcing and safe, secure management of medicines and devices
  5. 2.2 Staff skills and qualifications