Focus on the safe and effective management of medicines: our findings from inspections

With this series of Regulate articles, we aim to help pharmacy owners and the pharmacy team to continually improve the services they provide to patients and the public. This month we are revisiting the important issue of the management of medicines.

Analysis of GPhC inspections of registered pharmacies tells us that standard 4.3, relating to the management of medicines and medical devices, is the most commonly ‘not met’ standard.

In order to meet our standards for registered pharmacies [PDF 986 KB] and comply with all legal requirements, pharmacy owners are required to make sure that they effectively manage and identify the risks associated with the pharmacy services they provide, including the supply of medicines and medical devices.

The most common reasons for failing to meet this standard include:

• not being able to provide sufficient assurance that medicines and medical devices are safe and fit for purpose (either as a result of poor temperature control or being out of date)
• controlled drugs not being stored securely and not sufficiently safeguarded from unauthorised access

Below are some of the more common situations that cause pharmacies to fail this standard, improvements pharmacies have made, and some examples of good practice we have seen as part of the inspections we’ve carried out. You can find more of these examples in the knowledge hub section of the inspection publications website.

Storing medicines at the correct temperature 

Not being able to demonstrate that medicines that need to be refrigerated are stored within the correct temperature range is a common reason for failing standard 4.3. As part of its improvement action plan, a city centre pharmacy addressed this issue through simple steps to improve their record keeping and to train their staff.
The pharmacy strengthened its standard operating procedures (SOPs) and made sure that each fridge had a separate monitoring record by linking its fridges to its Patient Medication Record (PMR) system.

All staff received training on how to record and reset minimum and maximum fridge temperature readings, and on what steps should be taken if a reading was outside the correct range. The staff were tested on their understanding of the SOPs, and their result was recorded in their training files as evidence of their knowledge and skills.

The pharmacy team also carried out a cold chain fridge audit, which they scheduled to repeat annually.

Managing medicines left over from assembling prescriptions

Making sure that odd strips or part strips of foil blisters left over from assembling prescriptions, particularly those involving compliance aids, are managed safely and effectively is another frequent area where pharmacies have failed the standard.

One pharmacy addressed this issue as part of its improvement action plan by changing its procedures to make sure that left-over medication end strips were kept in their original manufacturers’ packaging, and that the stock for each individual compliance aid patient was kept in their own basket. This meant that:

• the left-over end strips were used whenever possible
• every product was stored with the relevant information readily available 
• in the event of a recall, the risk of missing some of the recalled products would be significantly reduced

Date checking SOPs

In order for pharmacies to meet Standard 4, they need to make sure that medicines are safe and fit for purpose, including that they are in date. One pharmacy demonstrated good practice by reviewing its standard operating procedures (SOPs) and making sure these were fully understood and actioned by all members of staff.

The pharmacy team followed a simple yet effective process of checking medicines, which included:

• weekly date checks performed using a matrix to record which sections had been checked and by whom
• marking all items approaching three months of their expiry date with a coloured dot and including them in a list
• checking the list each week to see if the items listed were still present on the shelf
• removing all items for disposal one month prior to expiry and noting the date on the list

In addition, the pharmacist checked the expiry date of every item as he dispensed them, to reduce the risk still further of supplying an out-of-date product.

The pharmacy also had FMD scanning equipment and software. Using the FMD scanners provided an additional safeguard against mistakenly supplying an expired medicine and against a dispensing error.

Meeting the standard

Think about how you can show that the medicines and medical devices you provide are:

• obtained from a reputable source
• safe and fit for purpose
• stored securely
• safeguarded from unauthorised access
• supplied to the patient safely 
• disposed of safely and securely
   

Management of controlled drugs

One pharmacy’s approach to the management of controlled drugs (CDs) was an example of good practice due to its simplicity and efficiency.

They had a robust procedure to prevent controlled drug prescriptions being handed out after their validity of 28 days. This included:

• highlighting all prescriptions for CDs, including Schedules 3 and 4, with a laminated card listing their expiry date
• checking the prescription retrieval shelves every month and removing any prescriptions for CDs exceeding their 28-day validity

The pharmacy team also had a robust procedure for the storage of controlled drugs. In particular:

• staff ensured that all CDs which were required to be stored under safe custody were kept in the CD cabinet at all times
• during the day, the keys were kept by the pharmacist
• overnight, the keys for the cabinet were kept in a sealed and signed bag in the pharmacy safe 
• there was a register to show who had signed for the keys

Disposal of unwanted medicines

One pharmacy displayed good practice in its proactive approach to reducing waste.

The pharmacy team followed a comprehensive yet simple process for accepting unwanted medicines back from people for disposal:

• they used a large tray, gloves and forceps to avoid handling the medicines
• they immediately recorded patient-returned CDs in a separate book kept for the purpose and placed them in a clearly labelled bag in a segregated section of the CD cabinet for subsequent disposal 
• they gave the contact details of the local council to patients for the safe disposal of any sharps
• there was a laminated list of hazardous medicines (e.g. cytotoxic and cytostatic preparations) to help identify any that may be present, and a separate hazardous waste bin for disposing of them safely
• the rest of the returned medicines were placed in a separate area of the pharmacy, away from other stock, before having any patient details removed and being placed in the approved containers for disposal

The pharmacy also took steps to ensure that people only requested what they needed.

Find out more:

The Royal Pharmaceutical Society has published professional guidance on the safe and secure handling of medicines.

The PSNC has published guidance on the disposal of unwanted medicines.