Purchasing for safety

Understanding purchasing for safety

‘Purchasing for safety’ is a systematic process that ensures purchased medicines comply with the product specification and are available when needed.

The process involves:

• evaluation of licensed status and licensed indications
• evaluation of packaging, labelling, and presentation of medicines, to identify issues that may present a risk to patients
• evaluation of the identified risks against other considerations
• where practicable, avoiding purchasing medicines with labelling and packaging that may lead to patient harm
• implementation of strategies to mitigate identified risks for the medicines that are to be purchased

Refer to NHS England’s guidance on aspects of previous patient safety alerts that should inform broader local safety initiatives for additional information.

Purchasing for safety assessment

Introducing a new medicine, a new presentation or a new brand may present a new risk of selection difficulty or error. These risks may be relevant to both the pharmacy setting and clinical areas.

A purchasing for safety assessment identifies whether a medicine meets the product specification and best practice guidance and standards for packaging and labelling. It also assesses the potential for misidentification or incorrect use. Considering both the product’s design and its use in practice informs the decision to purchase and helps identify risk mitigation measures.

Product Specification

Before purchasing a medicine, ensure it will meet your requirements. Considerations may include:

• formulation, for example whether the excipients are appropriate for the intended patient group or administration route
• licensed routes
• licensed indications
• presentation, for example modified release
• compatibility with delivery devices
• compatibility with robots, including presence of a bar code

It is also important to understand the status of the product as this may affect risks in use and the risk mitigation measures needed. The use of unlicensed medicines, medical devices or food supplements may increase the likelihood of error. For more information refer to our articles on explaining the licensed status of medicines (SPS page), understanding unlicensed medicines (SPS page) and understanding food supplements (SPS page).

Design

Packaging and labels for medicines with a UK Marketing authorisation (licensed medicines) have been approved by the Medicines and Healthcare products Regulatory Agency (MHRA). These should comply with the best practice guidance, however, this does not mean there is no risk of misidentification.

Parallel Imported medicines, while being UK licensed medicines, are usually over-labelled, which means they do not comply with best practice guidance. The SPS article explaining the licensed status of medicines includes further details on parallel imports. The labelling of unlicensed medicines may not meet the best practice guidance. Imported medicines are often not labelled in English, and UK Specials often have plain labels with poor differentiation between products.

The article on understanding design for safety in medicines packaging and labels (SPS page) discusses best practice in packaging and labelling in more detail.

Use in practice

A review of the intended purpose will support identification and assessment of potential risks and possible mitigation strategies. It should consider the product’s use in the ‘real world’, including human factors.

During supply disruption, contract changes, or when switching from brands to generic medicines, there may be a period of overlap, with both products in use at the same time. This may exacerbate risks.

Further details can be found in our articles managing medicines safely in pharmacy (SPS page) and managing medicines safely in clinical areas (SPS page).

Purchasing decision

The product safety assessment should be considered, in collaboration with medicines safety or medicines optimisation groups, before purchasing decisions are taken.

Formularies

Consider the outcome of product safety assessments when reviewing and agreeing organisational and regional medicines formularies.

National contracts

Procurement of medicines and pharmaceutical products in acute care settings within the NHS is under framework agreements negotiated by NHS England. The article on arrangements for procurement of medicines and pharmaceutical products and services (SPS page) provides more information about cost-effective purchasing of medicines.

Medicines Procurement and Supply Chain (MPSC) undertakes a range of due diligence checks before medicines are awarded to a framework. These include pricing and contractual terms, supplier verification, licensing and regulatory compliance, supply chain resilience, product availability and compliance with the product specification and the framework.

SPS undertakes packaging and labelling assessments for injectable medicines on generics contracts. The assessments are shared with Trusts to alert end users to potential in-use safety issues and to support development of local risk mitigation measures. Issues identified during the assessments are also fed back to the MHRA or Marketing Authorisation Holder (MAH), or both, to drive improvement.  However, the outcome of these assessments cannot influence framework award decisions.

Trusts are responsible for the safe implementation of contracts including conducting local risk assessments. These are informed by MPSC and SPS findings, ensuring medicines are used safely in practice and concerns or incidents are reported through appropriate channels.

Regional contracts

Where a national framework does not exist medicines can also be purchased through local regional contracts or on a Trust by Trust basis.

Shortages

Managing shortages often involves introduction of new products. Your shortages management process should include a purchasing for safety assessment and identification of risk mitigation measures. This is particularly important if unlicensed medicines are to be introduced.

Managing Residual Risks

For many reasons, including limited choice in the market, purchasing for safety processes may identify risks which cannot be avoided through purchasing decisions. Organisations need to manage risks locally. Considerations will include:

• additional education and training for healthcare professionals and patients
• additional resources for patients
• new consumables and ancillaries for use with the new product
• additional stockholding or storage requirements
• minimising overlap of different stocks by switching on a specified date

Further good practice risk mitigation measures are provided in our articles on managing medicines safely in pharmacy (SPS page) and managing medicines safely in clinical areas (SPS page).

Policy

An organisational policy should embed purchasing for safety principles into practice. It should identify key roles and responsibilities and define when products require a safety assessment.

The policy should specify timescales for purchasing for safety decisions. Quick decisions may be required when dealing with unexpected shortages or clinical demands, whereas managing long term formulary and contracts may be less time sensitive.

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