Prescription medicines are important therapeutic options which can be prescribed in order to prevent, treat or cure diseases and symptoms.

Appropriate prescription of these medicines is necessary to ensure medicines are used correctly in the right clinical situations, where the benefits outweigh the risks to the patient.  Appropriate prescribing requires many aspects of the health system to function effectively, including industry fulfilling certain obligations.

ABPI companies are committed to fulfilling their obligations by complying with regulatory requirements for accurate product information and packaging and labelling of medicines.

ABPI companies are committed to abiding by the Code of Practice in both the spirit and the letter.

We are committed to working with stakeholders and members to ensure that the industry plays its role in support of the appropriate prescription of medicines.

Policy position: The use of ‘Unlicensed Specials’ to treat NHS patients

The ABPI recognises that there are occasions where the use of unlicensed medicines is required in the best medical interests of individual patients.

Download the Policy position paper

Principles

The process of appropriate prescribing is based on the following principles:

  • Medicines should be prescribed only when they are necessary as part of a patient management plan, and in all cases the benefit of administering the medicine should be considered in relation to the risk involved.
  • There must be a discussion between the patient and Health Care Professional (HCP) to determine the most appropriate or right treatment choice for the patient.
  • The prescription of any medicines should be in line with the Summary of Product Characteristics (SmPC) legal document; HCPs are permitted to prescribe outside of the SmPC in certain circumstances
  • Prescribed medicines must be continually reviewed in order to make decisions on whether to adjust the dose or to stop the prescription, as appropriate.
  • Stopping medicines requires careful counselling and shared decision-making with patients and should be considered part of routine clinical care.

Professional Guidance

There is professional guidance on appropriate prescribing:

  • The General Medical Council (GMC) has issued Good practice in prescribing and managing medicines and devices This refers HCPs to the electronic Medicines Compendium for Summaries of Product Characteristics and Patient Information Leaflets.
  • The Royal Pharmaceutical Society (RPS) has published a Prescribing Competency Framework that includes a common set of competencies that form the basis for prescribing, regardless of professional background. The competencies have been developed to help HCPs to be safe and effective prescribers, with the aim of supporting patients to get the best outcomes from their medicines.

Pharmaceutical companies

Pharmaceutical companies play a key part in appropriate prescribing in 3 areas:

1. Licensing of medicines

  • Medicines are developed and authorised for a specific indication(s) through a robust process of regulatory review and scrutiny. This is to protect patient safety and public health. The medicines licencing regime exists as a bridge between the pharmaceutical industry and patients to provide the assurance that medicinal products are of high quality, safe and efficacious.
  • The SmPC is agreed by the regulatory authorities based on the research and development evidence generated and an assessment of the benefit:risk ratio.
  • The SmPC and Patient Information Leaflet set out the specific indication (i.e. disease) to be treated and the specific patients who may and may not be treated, as well as important safety warnings and interactions with foods and other medicines.
  • Companies must support the safe and effective use of their products; at the time of applying for a licence to the European Medicines Agency (EMA), companies must submit a risk-management plan, including any risk-minimisation measures which will be taken.
  • There must be ongoing monitoring (pharmacovigilance) to ensure that the product information continually reflects how to use the product and the expected therapeutic and side effects.

ABPI companies are committed to complying with regulatory requirements for preparing accurate product information.

2. Product information and packaging

The Medicines and Healthcare products Regulatory Agency (MHRA) approves all packaging and labelling information for medicines sold in the UK and has clear guidelines on the information that should be included.

The right information about medicines must be provided to prescribers, so medicines are managed appropriately and only used for the right patients for the right length of time.

ABPI companies are committed to complying with regulatory requirements for packaging and labelling.

3. ABPI Code of Practice

The ABPI Code of Practice states that the pharmaceutical industry in the UK is committed to benefiting patients by operating in a professional, ethical and transparent manner to ensure the appropriate use of medicines and support the provision of high quality healthcare and that patient safety is the priority.

The Code of Practice sets standards for the promotion of medicines to HCPs and other relevant decision makers in the UK.  It includes requirements for the provision of information to patients and the public and relationships with patient groups. The Code of Practice also applies to a number of areas that are non-promotional.

In addition to the Code there is extensive UK and European law relating to the promotion of medicines. The Code of Practice reflects and extends beyond the relevant UK law. In accordance with UK and European law, and the ABPI Code of Practice, pharmaceutical companies can only promote indications that are covered by the marketing authorisation of that medicine, promotion must not be inconsistent with the medicine’s SmPC and information must be accurate, fair and balanced.

ABPI companies are committed to abiding by the Code of Practice in both the spirit and the letter.