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Pharmacy inspections

Inspection reports and learning from inspections

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Management of controlled drugs

Pharmacy type

Community

Pharmacy context

Located within a residential area which included a number of high-rise flats. A range of services were provided to a mixed population with a significant number of elderly residents and a significant demand for Methadone and MDS dispensing. A prescription collection and delivery service was provided to local residents. Activity was 2000 items per month, including 70 Methadone patients and 65 MDS patients; e-MAS; CMS; and smoking cessation service.

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
  • 1.6 - All necessary records for the safe provision of pharmacy services are kept and maintained

Why this is poor practice

There are inadequate governance arrangements particularly in respect of controlled drugs (CDs) . A range of standard operating procedures define the processes and procedures at the pharmacy, however most of these are out of date and a review is needed to ensure they reflect current pharmacy practices and are adhered to by staff. Not all near-misses and errors are recorded and reviewed to ensure that all of the emerging risks are managed. Not all of the necessary records are being maintained and CDs are not properly managed.

What the shortcomings are

A range of SOPs were in place, however only a few of the SOPs had been recently reviewed, updated and read by all of the relevant staff. Most of the SOPs were past their review date, such as the ‘Assembly and supply of CD prescriptions’. Not all of the SOPs had been signed by the relevant staff to confirm their understanding and to ensure compliance.

Most of the records needed to provide the pharmacy services had been kept and maintained, however the electronic responsible pharmacist record was not up to date with full days not accounted for and the time the RP period ended not always recorded. A significant number of CD register entries had been crossed out but no footnotes had been used to supplement records. For example, an Oxycodone 5mg capsules register had been opened, with subsequent entries scored through, and the register then used for Tapentadol M/R 250mg tablets. Methadone balances had not been checked to take account of the overages that were normally present. A standard CD register was being used to record destructions of patient returned CDs, however records were messy and difficult to read and the register header stated MST 10mg tablets. Information had been scored through and there were big gaps and blank rows between records. There was a buid up of patient returned CDs and expired CDs and an authorised destruction was overdue.

What improvements are required

The management of CDs requires improvement to ensure safe practice including associated record keeping requirements.

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