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Pharmacy inspections

Inspection reports and learning from inspections

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Weaknesses in governance arrangements, including an absence of standard operating procedures and appropriate insurance.

Pharmacy type

Closed

Pharmacy context

This is a closed pharmacy offering internet and mail order services only. The pharmacy is located within a business unit occupied by the parent company. The parent company provides services connected to the sale and distribution of small low cost items not necessarily related to health or personal care. The pharmacy does not have an NHS contract and does not propose to supply medicines against prescription. The business model is based around the sale and supply of a limited rage of Pharmacy only and GSL medicines via a website. Pharmacy activity currently takes place only between 3pm and 4pm each day when a Responsible Pharmacist is present. The company was run by a non-pharmacist director and a pharmacist director who was also the Superintendent and regular pharmacist.

Relevant standards

  • 1.1 - The risks associated with providing pharmacy services are identified and managed
  • 1.5 - Appropriate indemnity or insurance arrangements are in place for the pharmacy services provided
  • 4.2 - Pharmacy services are managed and delivered safely and effectively

Why this is poor practice

The pharmacy has basic governance arrangements in place but does not have procedures in place to ensure that online sales of Pharmacy medicines are safe and appropriate. There is no professional indemnity and public liability insurance. As the non-pharmacy trained director has access to the pharmacy in the absence of a pharmacist there should be greater clarity with regard to roles and responsibilities under the Responsible Pharmacist regulations.

What the shortcomings are

Staff roles were not yet clearly defined. Currently there was only the non-pharmacist director and the Superintendent pharmacist at the premises on a regular basis. There were no Responsible Pharmacist (RP) SOPs to clearly identify what could and could not occur in the absence of the RP. The business model was based on the sale and supply of GSL and Pharmacy only products however at the time of the inspection there had been no governance procedures in place to ensure the safe supply of Pharmacy medicines against on line orders. Governance procedures in that regard extended only to attempts at frequent purchases or where volumes were deemed too high. There was no assessment of the appropriateness of a pharmacy medicine for an individual customer. Indemnity arrangements were not in place at the time of the inspection, although this was rectified later the same day.

What improvements are required

Clear governance arrangements, including SOPs with clear roles for staff are required, along with insurance prior to a pharmacy commencing operations.

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