Knowledge article: Independent Prescribing Principles: ensuring appropriate assurance and governance of prescribing activities + professional indemnity requirements

15th March 2024

Disclaimer: All information, content, and materials available in this document is for general informational purposes only. The information published is, to the best of our knowledge, correct at the time of publication. However, no responsibility will be accepted by the NPA for any consequences and/or decisions made using this information.

In this knowledge article we discuss key independent prescribing and prescribing service operating principles in community pharmacy, to ensure pharmacy contractors and Pharmacist Independent Prescribers (PIPs) meet the expectations of NPAI and GPhC/PSNI standards when delivering prescribing services, including:

 

  1. Prescribing to only be undertaken by a PIP in agreement with, and in the knowledge of the pharmacy owner and superintendent pharmacist
  2. PIPs to only prescribe within their scope of practice
  3. PIPs to only prescribe within the scope of practice declared to the indemnity provider
  4. Thorough risk assessment of the prescribing service completed and regular audits of a PIPs prescribing activity
  5. Clear records of all consultations related to prescribing in the community pharmacy are documented and stored in line with record keeping requirements
  6. PIPs to make every effort to gain consent from a patient to access their medical records and share the outcome of the consultation with their regular prescriber
  7. Community pharmacy prescribing services should be delivered by prescribers based in, and registered with an appropriate regulatory body in the UK
  8. A list of references and further reading can be found at the end

PIPs are responsible for ensuring they are competent in assessing, diagnosing, prescribing and monitoring the patient within their scope of competency and practice. PIPs must only prescribe within the clinical areas they are competent in and within their scope of practice.

Recent inspections conducted by the GPhC identified prescribing activities and services within community pharmacies that do not meet the standards expected by the GPhC, which the GPhC has shared with the NPA. Examples of sub-standard prescribing activity and prescribing services include:

  • Lack of governance of the prescribing service, such as no SOPs and protocols relating to prescribing/prescribing services in place
  • Cases where no records of patient consultations and prescribing are documented/retained
  • Individual PIPs operating outside of service specifications, SOPs and protocols relating to prescribing/prescribing services
  • PIPs undertaking high-risk prescribing, outside the terms of individual indemnity insurance policies and agreements
  • PIPs undertaking prescribing activity without the knowledge of superintendents and/or pharmacy owners

The above examples of poor practice have been identified during GPhC inspections and many PIPs and pharmacy owners remain unaware that such activity may invalidate existing professional indemnity policies. Where an appropriate level of governance and procedures are not in place or policies/SOPs are not followed, pharmacy contractors and PIPs are left vulnerable and liable to claims, as well as risking patient safety. Below are the key independent prescribing and prescribing service operating principles, to ensure PIPs and pharmacy contractors meet the expected standards when delivering prescribing services.

PROFESSIONAL INDEMNITY

NPA Members and Customers wishing to offer an independent prescribing service (NHS or private) must have their professional indemnity policies endorsed to cover independent prescribing and pay the additional premium owing to cover each independent prescriber. This is because independent prescribing is not automatically covered under the professional indemnity policies provided to NPA Members, but policies may be endorsed to cover this activity for an additional fee depending on where prescribing takes place. NPA Members must contact the membersupprt@npa.co.uk to arrange the additional cover, or to check if they are covered, for independent prescribing.

Independent prescribing principles

Independent Prescribing Principle NPA guidance
1. Prescribing is only undertaken by a PIP in agreement with, and in the knowledge of the pharmacy owner and superintendent pharmacist
  • PIPs are only to conduct a prescribing service or undertake prescribing activity within the community pharmacy with the knowledge of, and in agreement with the pharmacy owner and superintendent
  • PIPs are to only prescribe within the clinical area/scope of practice agreed in advance with the pharmacy owner and superintendent
  • PIPs should not prescribe for any condition outside of the agreed therapeutic areas, without the prior knowledge of, and in agreement with both the pharmacy owner and superintendent
2. PIPs to only prescribe within their scope of practice
  • PIPs must only prescribe within their competence
  • We advise PIPs to use the NPA Independent Prescribing Competency Assessment and Declaration resource, which is approved by NPAI, to review their competence within defined scope(s) of practice
  • PIPs should not engage in prescribing activity (including patient assessment, investigations and diagnosis of conditions) outside of their scope of practice
  • PIPs must recognise when a patient case/condition is outside of their competence and is not suitable for them to assess, investigate, diagnose or prescribe
  • Recognising scenarios that are outside of your competence and identifying when it is safer to refer/signpost than prescribe, is key to being a proficient prescriber
  • When developing and designing a prescribing service, or when employing a PIP to deliver a prescribing service, pharmacy owners should consult with the PIP to identify the clinical/prescribing areas within their competence to ensure the PIP is suitable and competent to deliver the service
  • It is common that prescribers may need to prescribe outside of recognised guidelines, where appropriate; however this must still be within a PIPs competence and the PIP must clearly justify the reason for prescribing outside of clinical guidelines in the patient’s consultation notes
  • For NHS prescribing services, PIPs must only prescribe for clinical conditions and medicines outlined in the service specification
3. PIPs to only prescribe within the scope of practice declared to the indemnity provider
  • Prior to engaging in prescribing activity, PIPs are required to obtain an appropriate level of professional indemnity insurance; PIPs will be required to declare to NPAI their scope of practice and clinical area(s) they will prescribe for
  • PIPs must not prescribe in a clinical area that has not been declared to NPAI; if a PIP has expanded their scope of practice into a new clinical area, this must be declared to NPAI prior to conducting any consultations or prescribing within the new scope of practice
  • If a PIP prescribes within a clinical area that was not declared to NPAI, this may invalidate their policy
  • Pharmacy owners must also ensure the proposed prescribing service is covered under their NPA Membership and insurance; if the service is expanded to cover new clinical conditions, pharmacy owners must inform NPAI to ensure cover will be provided
  • PIPs and pharmacy owners should contact the NPA Member Support department at membersupport@npa.co.uk to confirm or arrange appropriate cover before delivering the service
4. Undertake a thorough risk assessment of the prescribing service and regular audits of a PIPs prescribing activity
  • As part of governance, it is expected that a full risk assessment of the prescribing service is completed, in order to identify any associated risks and therefore to help design and implement ways to mitigate the risks
  • The risk assessment should be specific to the prescribing service on offer and the clinical area covered by the service; if multiple conditions are covered, a separate risk assessment should be undertaken for each clinical area to consider risks to specific to different assessments, investigations and treatments related to that area
  • The NPA Independent Prescribing Risk Assessment template is available and the following high risk activities should be covered in the risk assessment:
    • Remote consultations
    • The scenario where consent to access medical records and/or share the consultation outcome with the regular prescriber is declined
    • Medicines with associated risks or where monitoring is required
    • Assessing capacity and obtaining valid consent, particularly if a patient representative is involved or there are communication barriers
    • Prescribing outside of clinical guidelines or off-label/unlicensed prescribing
    • Prescribing, dispensing and administration of a medicine by the same PIP (with no second individual involved in the process)
    • Asynchronous prescribing (where prescribing decisions are made based on a questionnaire completed by a patient, with no direct patient contact)
    • Using prescribers operating outside of the UK to deliver the prescribing service (see next section below)
  • Audits of the prescribing service and of an individual PIPs prescribing are recommended to be undertaken on a regular basis; this should include reviewing whether a PIPs prescribing is in line with guidelines or whether required ongoing monitoring is undertaken, in order to identify areas for improvement and ensure patient safety
  • In addition, if a PIP is involved in the prescribing and dispensing of a medicine, without the intervention of a second, suitable trained individual, audits of this activity should be completed at regular intervals
5. Clear records of all consultations related to prescribing in the community pharmacy are documented and stored in line with record keeping requirements
  • All consultations related to prescribing/prescribing services must be documented and stored securely
  • The NPA Independent Prescribing Service SOP outlines the information that should be recorded as part of every prescribing consultation
  • It is recommended that consultation notes should also be made in the following scenarios:
    • If following the assessment of a patient and diagnosis, the decision not to prescribe is made and the patient is referred/signposted; records should include the PIPs reasoning for not prescribing treatment
    • If a patient does not consent to, or part of the service; record reason why and action taken
    • If a patient declines to consent to the PIP accessing their medical record; if the PIP decides to continue with service without accessing the patient medical record, record the reason/justification for this decision
    • If a patient declines to consent to their regular prescriber being informed of the consultation/treatment issued by the PIP; if the PIP decides to continue with the service without informing the patient’s regular prescriber, record the reason/justification for this decision
  • Consultation notes must be retained in line with record keeping requirements; see the NPA Independent Prescribing Service SOP for more detail
6. PIPs to make every effort to gain consent from a patient to access their medical records and share the outcome of the consultation with their regular prescriber
  • In order to ensure safe prescribing, PIPs should always review a patient’s medical record (if consent is provided); a patient’s medical record will provide additional information, to be used in conjunction with the history obtained from the patient, to support safe prescribing decisions
  • A patient’s medical record will provide PIPs information on a patient’s medical history, current and past medications, allergies, intolerances, co-morbidities and relevant pathology that may impact a PIPs prescribing decision
  • If consent is not provided by a patient for the PIP to access their medical records, PIPs must weigh up the risks of prescribing or not prescribing a treatment without sight of the medical records and consider what is in the patient’s best interest; this should be recorded in the patient consultation notes
  • It is important to note that for remote/online prescribing consultations the GPhC Guidance for registered pharmacies providing pharmacy services at a distance, including on the internet states that PIPs (and other prescribers delivering a pharmacy prescribing service) “must only prescribe when they have adequate knowledge of the person’s health” and “must not prescribe controlled drugs or medicines that are liable to abuse, overuse or misuse or when there is a risk of addiction and monitoring is important, if they don’t have access to relevant information from the patient’s medical records”
  • To ensure patient safety and continuity of care, a patient’s regular prescriber should be informed each time a prescription is issued by the PIP/under the prescribing service; this includes if this a repeat prescription or regular treatment
  • A key example where patient safety may be compromised when information is not shared, was a case where a patient was regularly prescribed opioids by a PIP in a community pharmacy, however the patient’s GP was not informed and therefore continued to also prescribe opioids; the patient was overusing and at risk of addiction and overdose
  • It is vital that a patient’s regular prescriber is made aware if a patient is receiving treatment elsewhere, as this may impact their current or future treatment; sharing this information with a patient’s regular prescriber ensures their medical records are up to date, which may be vital in an emergency situation
  • If a patient does not consent to this information being shared with their regular prescriber or they do not have a regular prescriber, PIPs must consider what is in the patient’s best interest, the risks of not sharing this information if they decide to continue with the service and the risks if they decide not prescribe a treatment if the PIP does not have consent to share the information; justification for the decision made should be recorded in the patient consultation notes
  • The GPhC Guidance for registered pharmacies providing pharmacy services at a distance, including on the internet stipulates that when prescribing medicines in the following categories as part of a remote/online consultation, that “the person has provided the contact details of their regular prescriber, such as their GP, and their consent to contact them about the prescription” and “the prescriber will proactively share all relevant information about the prescription with other health professionals involved in the care of the person (for example their GP)”:
    • Antimicrobials
    • Medicines liable to abuse, overuse, misuse or where there is a risk of addiction (such as opioids, laxatives, gabapentinoids)
    • Medicines where ongoing monitoring is required (such as medicines with a narrow therapeutic index (i.e. lithium), high risk medicines (i.e. methotrexate), treatment for long term conditions (i.e. hypertension/diabetes))
7. Community pharmacy prescribing services should be delivered by prescribers based in, and registered with an appropriate regulatory body in the UK
  • The use of prescribers operating outside of the UK to deliver a community pharmacy prescribing service poses an increased risk to patient safety
  • Prescribers based outside of the UK must be registered with the relevant body in the country where the prescription is issued and must lawfully be authorised to issue prescriptions (online) to patient’s in the UK; for the prescription to be dispensed in the UK, this means the prescriber must be registered with the relevant regulatory body in an EEA member state or Switzerland only
  • Prescriptions issued by prescribers registered in countries outside of the EEA and Switzerland cannot be dispensed in the UK
  • Prescribers based outside of the UK must work and prescribe with UK guidelines only
  • Prescriptions for unlicensed medicines and Controlled Drugs (Schedule 1, 2 or 3 to the Misuse of Drugs Regulations 2001 or in schedule 1, 2 or 3 to the Misuse of Drugs Regulations (Northern Ireland) 2002) issued by prescribers in EEA states and Switzerland, cannot be dispensed in the UK
  • If prescribers based outside of the UK are used to deliver the prescribing service, ensure this activity is covered by the indemnity insurance provider; contact the NPA Member Support department at membersupport@npa.co.uk to confirm or arrange appropriate cover

* Please note, the PSNI standards are currently being rewritten and updated. Members are therefore advised to contact PSNI directly on info@psni.org.uk, with any queries in relation to the standards discussed.

NPA support and resources

The NPA has developed the following resources, available from the NPA IP Hub, to support Member’s in developing and delivering prescribing services:

  • Independent Prescribing Service SOP
  • Prescribing Incident Protocol
  • Prescribing competency assessment and declaration
  • NPA Medical history consultation checklist template
  • NPA Independent Prescribing Risk Assessment template
  • Pharmacy First Plus SOP (Scotland)
  • Independent Prescribing and Prescribing Service FAQs

We are here to support you. Contact the NPA Pharmacy Advice & Support Team at pharmacyservices@npa.co.uk if you have any enquiries.

References and further reading