If you are a distance-selling pharmacy attached to a private high street-based, pharmacy, the GPhC may want to inspect your premises to ensure that you are not offering face-to-face NHS essential services to the public. In this case, a risk assessment of P medicine sales would be essential. Creating one requires a deep understanding of the local regulations, pharmacy operations, and the specific risks associated with the sale of Pharmacy Only (P) medicines. Here’s a simplified outline to guide you:

1. Identification of Risks:
   • Expiry date check
   • Incorrect Dispensing
   • Pharmacist Sale Approval
   • Miscommunication about medicine usage
   • Adverse reactions or interactions
2. Analysis of Risks:
   • Likelihood of occurrence
   • Potential impact
3. Evaluation of Risks:
   • Tolerability
   • Priority for addressing
4. Mitigation Strategies:
   • Staff training and certification
   • Clear procedures for the sale of P medicines
   • Patient counseling
   • Proper signage and information
   • Systems for verifying patient details and medicine details
5. Monitoring and Review:
   • Regular audits
   • Feedback collection from staff and patients
   • Review of adverse incidents
6. Documentation:
   • Recording all identified risks, analysis, mitigation strategies, and reviews
7. Compliance with GPhC Standards:
   • Ensuring all processes comply with the General Pharmaceutical Council (GPhC) standards and other relevant regulations.

This outline is quite general and should be tailored to the specific circumstances of the pharmacy in question. Consulting with a legal professional or a pharmacy consultant with experience in UK regulations is advisable for a thorough risk assessment. If you would like to get in contact with one please drop us a line.

Pharmacy near Edgware rd (1^st inspection)

Summary of GPhC findings:

• The pharmacy cannot clearly demonstrate how it manages the risks associated with the prescribing services it operates.
• It does not have comprehensive procedures explaining how this service operates and there is no evidence that it has been properly risk assessed.
• Its system for handling complaints is unclear
• The pharmacy’s record keeping does not always comply with the law and there is a lack of documentation supporting the pharmacist prescribing service.
• The team members keep people’s personal information secure and they understand the principles of safeguarding and how to support vulnerable people.
• The pharmacy SOPs had been recently updated but they did not cover some aspects of the pharmacy’s services, such as the private doctor and pharmacist prescriber consultation, so it was not totally clear how these operated or what the parameters for offering these services were.
• It was unclear if the private doctors’ service was registered with the Care Quality Commission.
• The superintendent explained he did use a prescribing framework and he would only prescribe for adult patients who were mainly from overseas and requested medication they had used before or for treating minor acute conditions.
• And some SOPs lacked detail; for example, the SOP for record-keeping did not explain how records were maintained.
• Some team members had signed SOPs to show they had read and agreed them, but others had not, so some they might not always fully understand their roles and responsibilities.
• A privacy notice was not displayed in accordance with the General Data Protection Regulation.
• Records relating to pharmacist prescriber consultations were not available although the superintendent said he did document all consultations.

Improvement action plan:

• Complete comprehensive procedures explaining how the prescribing services operate including SOPS and prescribing clinical framework
• Practice good risk management by providing staff training protocols for proper assessment triage and signposting for the prescribing service and other related medical services
• Review record keeping procedures to ensure full record keeping is maintained including new electronic patient records and review of complaints procedures.

2^nd inspection

• Prescribing framework reflecting therapeutic areas covered by the prescribing service included but not limited to high-risk drugs.
• Risk assessment does not identify all therapeutic areas covered by prescribing service, classes of meds included or key risks involved and a plan explaining how these are mitigated. Also does not routinely assess safety and quality of its prescribing service, does not hold consultation notes which means can not demonstrate that prescribing decisions are appropriate.
• Does not have appropriate safeguards in place to prescribe some higher risk categories of meds i.e. CDs.
• Prescribing framework that includes all conditions that medication is prescribed for i.e. mental health, weight loss.
• Pharmacy had a risk assessment which identified some areas of risks in prescribing service and how to mitigate them but not individual risk assessments.
• Not completed any clinical audits of prescribing to determine whether it was safe and appropriate.
• People asked to complete consultation form, ID was checked then consultation carried out by prescriber and any additional notes were added to form? IP were usually not initiating treatments, patients usually presenting with old medication packs or documentation which was double checked were possible and if necessary with their practitioner? If any CDs prescribed which they rarely are, a maximum of 30 days supply given? (Needs to be mentioned on prescribing SOPs)

Improvement action plan:

1. Create a risk mitigation plan for each therapeutic area. Develop risk assessments specifying each therapeutic areas the prescriber(s) will be prescribing within and the classes of medication included for each, and identify the likelihood of key risks for each, the likely impact and a written plan on how these risks are mitigated.
2. Consultation records will be updated, at minimum every week, using the digital patient management software. All clinic records will be available upon inspection.
   Clinical audits will be made on a regular basis, starting with high-risk therapeutic areas.
3. The prescribing framework will be updated to reflect the therapeutic areas covered by the prescribing service including but not limited to high-risk categories. Prescribing of CDs will follow UK guidelines. Prescribers will have access to the patient’s medical records or contact the person’s usual doctor before prescribing CDs. And no more than the recommended 30 days’ supply of CDs will be issued unless in exceptional circumstances.

All patients that are to receive medication from the pharmacy’s independent prescriber or private doctor will be consulted on the important maintenance of an up-to-date medical record with their regular doctor. Consent will be requested from the patient to inform their regular doctor of any medication prescribed on their behalf. In the instance that consent is not given for any reason from the patient, the patient should be asked if they wish to be provided with a copy of a letter that would otherwise be given directly to their regular doctor in order for the patient keep their doctor up to date with medication being prescribed.  From previous visit the year before, seems this has been ongoing issue hence led to the above improvement action plans.

The pharmacy would be expected to tell us within 5 days of the action they intend to take to meet the standards and improve practice in the pharmacy. We will consider some flexibility in this timescale if there are exceptional reasons why this deadline cannot be met.

We require improvement action plans to be filled in by the owner and superintendent pharmacist and returned to us. The inspector will already have identified whether the improvement action in relation to each standard, must be completed within 10, 20 or 60 working days

Then schedule another visit at 6 months after to make sure all changes have been sustained and inspector is happy, at which point new report is generated.

Pharmacy No.2

• Audited each others prescribing, however, audit was lacking number of prescriptions audited, which guidance they were working in line with, parameters they were auditing against, which guidance was used for people from abroad?
• Risk of this service, identify specific risks i.e. following up, monitoring, ensuring no interactions or contraindications, how would practitioners abroad be aware of what has been prescribed to patient etc.
• Which medications does the pharmacy consider as high risk give examples.
• SOP covering independent prescribing was reviewed and updated.
• Prescribing policy not comprehensive, state which guidance is being complied with, maximum supplies within any given time frame and monitoring required.
• Near misses need to be formally reviewed.
• Records for unlicensed specials dispensed were not always completed in line with MHRA guidance. Some certificates of conformity could not be found whilst others were not filled in.
• One dispenser was responsible for reviewing notes and prescriptions every month to check for missing items or information.
• Both prescribers were reviewing each other’s prescriptions every quarter, they checked each other’s notes were complete, monitoring parameters had been noted, counselling was provided and references used such as published guidance.
• A complaints procedure was in place. Members of the team said that they would refer people to the pharmacist if they wished to raise a complaint.
• All staff had completed online training and MCQs on GDPR. Staff briefed on safeguarding and told to raise any concerns directly to pharmacists
• Systems it uses to verify authenticity of overseas? Consultations were still conducted by the pharmacists even when a prescription from a doctor was seen. High-risk medications were never initiated, only prescribed if prescription from patient’s doctor was provided.
• IP did not routinely share information with the patient’s doctors as most were abroad. Example of refusing to supply Lithium to patient in Kuwait, then patient came back with up to date bloods which were documented at the pharmacy, before supply was made, how can you be sure it was there bloods done etc?
• Labelling and counselling points regarding sodium valproate
• Patients asked to do urine dipstick test before prescribing antibiotics for UTIs, example were they prescribed only three days worth of Nitrofurantoin to patient with recurring UTI (example to show that they know some stuff) spoke to her regular pharmacist to confirm previous supplies and referred her back to her GP (again example he knows hes doing diligence and also signposting back).

Improvement action plan:

1. Have proper insurance for prescribing
2. Revised Prescribing Policy
   – Revised Prescribing Audit template

Pharmacy 3

Below is a summary of the inspection report from the primary visit by the GPhC.

• Did not have proper SOPs.
• Pharmacy cannot demonstrate that the private Dr service that it works with is meeting the regulatory requirements.
• Pharmacy’s information governance and safeguarding procedures lack formality.
• Most SOPs overdue review and out of date might not reflect current legal requirements or best practice, some duplicated or not relevant to Pharmacy’s current activities
• No policies or procedures explaining how they work with private Dr or the scope of pharmacist prescribing services.
• Pharmacy currently working with a private Dr but he was not working for the pharmacies CQC registered service.
• Pharmacy did not have any record of dispensing incidents, the last entry in near-miss log in 2018.
• Dispensing labels not always signed by pharmacist.
• Complaints procedures not always promoted in pharmacy or on website, so people may not know how to raise concern,
• Pharmacy did not always use mechanisms to actively seek feedback about pharmacy’s services, so it might miss opportunities to make improvements. Also give examples of what we have done as a result, this can be used to kill time.
• Unlicensed medicines were sometimes supplied on prescription and the pharmacy maintained appropriate records.
• Team members briefed on principles of data protection and confidentiality
• There were no formal information governance policies so risk as staff may not fully understand their responsibilities.
• SI stated they had completed safeguarding training some years ago but had no evidence of this.
• Pharmacy’s website did not include GPhC no. or superintendent’s details, promoted clinic with GMC Drs but did not provide any details, absence of information did not support people to make informed decisions when opting to access the pharmacy’s services.

Improvement action plan

1. The pharmacy cannot demonstrate that its pharmacist prescribing service is operating safely. It does not have SOPs or a prescribing framework covering this activity. And it hasn’t completed risk assessments for this service identifying the therapeutic areas and classes of medication included, or the key risks involved, with a plan explaining how these risks are mitigated.
2. The consultation records for the pharmacist prescribing service do not contain enough information to support prescribing decisions.
3. The pharmacy’s prescribing service does not have sufficient safeguards in place to provide assurance that medicines are always prescribed safely. It cannot demonstrate how it verifies information about the patient and their existing health conditions or communicates with their usual doctor to ensure the continuity of their care. And it cannot show that prescribing of CDs in line with UK guidelines.

Action taken by pharmacy – Pharmacist prescribing service suspended

The objectives of an online prescribing audit may include:

• Assessing the safety and effectiveness of the online prescribing process
• Evaluating the compliance of the online prescribing process with relevant laws and regulations
• Identifying any potential risks to patient safety or quality of care
• Making recommendations for improving the online prescribing process

During an online prescribing audit, the auditor may review the policies and procedures that are in place for prescribing medications online, as well as the systems and tools that are used to facilitate the prescribing process. They may also review records and data related to online prescribing, and may conduct interviews with relevant staff and stakeholders. The findings of the audit may be used to identify any areas of concern or improvement, and to develop recommendations for improving the online prescribing process.

We offer professionally written, high-quality template packages for conducting an online prescribing audit. Below is a simple excerpt from the package:

Methodology

Population:                              Users of the website: www.yourwebsitename.com

Sampling:                                  Ten prescriptions and associated documents should be selected or more if required

Frequency of Audit:          As determined by health service providers audit process for prescribing practice and medicine management

Method:                                     This is a retrospective audit

Part 1: Demographic Details

Part 2: Audit Tool

Part 3: Audit Tool for Prescription Writing for MDA Schedule 8 Medicinal Products

Calculation of Compliance Rate Percentage

The audit tool calculates the score for the audit. The score, expressed as a percentage, is calculated by dividing the number of “yes” answers by the total of “yes” and “no” answers. “Not applicable” answers are excluded from the calculation of the percentage score.

Example:

If there are 18 “yes” and 2 “no” answers, the score is calculated as follows:

18 (yes answers) divided by 20 (total of yes and no answers) multiplied by 100. The score in this example would be 90%.

A clinical governance framework is a structured approach to clinical governance that outlines the roles, responsibilities, and processes that are involved in ensuring the quality of healthcare services. The framework may include:

• Standard Operating Procedures and procedures for the delivery of healthcare
• Standards for the training and competency of healthcare professionals
• Quality improvement processes to identify and address problems with the delivery of care
• Risk management processes to identify and mitigate potential risks to patient safety
• Mechanisms for gathering and analyzing data on the quality of care
• Communication and collaboration among healthcare professionals and organizations to ensure the coordination of care

The purpose of a clinical governance framework is to ensure that patients receive safe, high-quality care, and that healthcare professionals are held accountable for the care they provide. It is an important part of the overall system of healthcare regulation and oversight.

We provide a wide range of off-the-shelf and custom solutions, if you need help just contact us.