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Pharmacy inspections

Inspection reports and learning from inspections

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Insufficient staffing level and weaknesses in monitoring and review mechanisms

Pharmacy type

Community

Pharmacy context

The pharmacy was located close to a city centre and dispensed approximately 11 000 NHS prescription items each month with the majority of these being repeats and for nursing and care home patients whose medicines were dispensed via monitored dosage system (MDS). Few private prescriptions were dispensed. NHS advanced and enhanced services offered by the pharmacy were medicine use reviews (MURs), new medicine service (NMS), and supervised consumption of methadone and buprenorphine

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
  • 1.3 - Pharmacy services are provided by staff with clearly defined roles and clear lines of accountability
  • 1.6 - All necessary records for the safe provision of pharmacy services are kept and maintained
  • 1.7 - Information is managed to protect the privacy, dignity and confidentiality of patients and the public who receive pharmacy services
  • 1.8 - Children and vulnerable adults are safeguarded
  • 2.1 - There are enough staff, suitably qualified and skilled, for the safe and effective provision of the pharmacy services provided
  • 2.2 - Staff have the appropriate skills, qualifications and competence for their role and the tasks they carry out, or are working under the supervision of another person while they are in training
  • 2.4 - There is a culture of openness, honesty and learning
  • 3.2 - Premises protect the privacy, dignity and confidentiality of patients and the public who receive pharmacy services
  • 3.5 - Pharmacy services are provided in an environment that is appropriate for the provision of healthcare
  • 4.1 - The pharmacy services provided are accessible to patients and the public
  • 4.2 - Pharmacy services are managed and delivered safely and effectively
  • 4.3 - Medicines and medical devices are: obtained from a reputable source; safe and fit for purpose; stored securely; safeguarded from unauthorized access; supplied to the patient safely; and disposed of safely and securely
  • 4.4 - Concerns are raised when medicines or medical devices are not fit for purpose
  • 5.3 - Equipment and facilities are used in a way that protects the privacy and dignity of the patients and the public who receive pharmacy services

Why this is poor practice

There are poor governance procedures in place and an insufficient level of staff for the services provided. Overall, there is inadequate assurance that risks are identified and managed and that procedures are reviewed and monitored. Stock is haphazardly and unsafely stored. Schedule 2 controlled drugs are delivered against faxed prescriptions with no assurance that these have not also been supplied by local pharmacy. There are insufficient employed staff to safely provide the services offered by the pharmacy. Many of the staff are newly employed, unsure of their responsibilities and unable to make professional judgements. The trainees are not supported with their learning and there is no overall culture of learning at the pharmacy. Record-keeping is poor and some staff do not understand safeguarding issues. Patient-sensitive information is not kept securely. Some areas are in need of routine maintenance and repair and the temperature in parts of the dispensary is too high for the safe storage of medicines.

What the shortcomings are

Few processes were in place to identify and manage risks and staff were overstretched. The dispensary stock was not stored in an organised fashion. Loose tablets such as prochlorperazine 5mg and Ditropan 2.5 mg were seen. Split boxes were stored under full boxes and there were mixed batches of amoxicillin. Unlicensed medicines such as vitamin B compound strong were on the shelves. All the regular staff employed by the pharmacy, except for an accuracy checking technician (ACT), were trainees. There were no audit trails of clinical checking by the pharmacist prior to assembly. The pharmacy had no procedures to alert the person checking prescriptions to any changes in dose or new items. No checks were done to ensure that care home patients prescribed high-risk drugs such as lithium and warfarin were receiving regular blood tests. Up-to-date and signed Standard Operating Procedures (SOPs) were in place but these were highly generic with no local additions specific to the pharmacy business added. Several patient-returned controlled drugs (CDs) including diamorphine injection had not been entered in the patient returned CD records. The specials records were not legally complaint with no patient details recorded. There were no formal date-checking records and out-of-date stock was stored with in-date stock. Patient sensitive information was stored in the consultation room in cupboards that were not locked. A large quantity of stock was stored in this room which prevented it from being used by patients. Not all the staff were clear about the services on offer. Most of services offered by the pharmacy were the assembly of prescriptions into MDS trays for nursing and care home patients. The person largely responsible for the management of these services was a NVQ2 trainee dispenser. Discontinued items were recorded but there was no record of any changes to dose or new drugs. When required items, that may only be needed infrequently, were seen to be routinely included on the medicine administration (MAR) charts and not supplied as an acute interim item. This could be confusing for the nursing staff and increased the risk of errors. Most prescriptions were ordered by the homes but sent electronically to the pharmacy. Very few of these were double-checked by the staff at the homes.

What improvements are required

The pharmacy needs to ensure that it employs sufficient numbers of trained staff to safely provide the services offered by the pharmacy and implement appropriate governance arrangements to ensure all risks are identified and managed, including the layout and design of the premises.

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