Requirement

Purchasing for safety is an aspect of previous patient safety alerts that NHS England recommend should inform broader local safety initiatives.

Embedding the principles of purchasing for safety within practice supports the safe use of medicines.

Identifying products with inherent risk provides an opportunity

• to avoid purchasing them, so they are not available at point of use
• for risk minimisation strategies to be planned and implemented prior to product purchase

Patient harm

Inadvertent harms have occurred due to of poor product quality, design and/or purchase of a medicinal product unsuitable for the intended use.

Product selection, dosing and administration errors can occur as a result of:

• ‘Look Alike Sound Alike’ (LASA) products
• poor labelling and packaging
• inappropriate formulation/design

Harms have occurred from delayed administration of time critical medicines due to suitable medicines not being available.

The cumulative risk associated with poorly-informed procurement decisions varies depending on many factors including patient vulnerability, experience of clinical staff, the nature of individual products and frequency of their use.

Scope

Purchasing for safety principles and their application outlined within this article relate to UK licensed medicines.  Unlicensed medicines carry additional risks explained in our series of articles on Understanding unlicensed medicines.

Understanding purchasing for safety

‘Purchasing for safety’ is a systematic process that when embedded into practice, supports safe clinical use of medicinal products.

The process requires;

• systematic evaluation of packaging, labelling and presentation of products, to identify issues that may lead to patient safety concerns,
• evaluation of identified risks against other considerations during the purchasing decision process, giving preference to products whose properties support safe use,
• implementation of strategies to mitigate identified risks of products purchased.

Implementation

Successful embedding of principles of purchasing for safety requires collaboration. Good communication between pharmacy procurement, organisational procurement, clinical specialists and, wider patient safety teams will support an effective purchasing for safety process.

Policy

An organisational policy supports embedding purchasing for safety principles into practice. Compliance of practice against it supports assurance of standards related to medication safety.

The policy should identify and define the key roles and responsibilities within the purchasing process.

It should reflect the variable time pressures associated with purchasing 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.

Product safety assessment

Product assessment is one part of the process and identifies how closely a product meets specifications for safe use.

Standards related to quality and design of packaging and labelling, and considerations related to the product’s clinical use, will inform the product assessment and resultant safety categorisation of the product.  The product safety assessment outcome should inform the purchasing decision.

Product Risk Assessment Tools are available.

Quality

Quality standards that can give assurance of safety include medicines that:

• have a UK marketing authorisation
• are sourced from trusted and appropriate sources.

Design

Standards based on ‘good design for patient safety’ should be included; graphic design of medicines packaging can enhance safe use of medicines.

Where purchasing is made under contracts (further information below) there is opportunity for early assessment of packaging and labelling design.

Ready-to-use or ready-to-administer

Products in a ready to use or ready to administer presentation are examples of a design standard supporting safe use.

Labelling and packaging

Guidance from the MHRA on best practice in the area of labelling and packaging provides example standards.

The Design for patient safety: a guide to the labelling and packaging of injectable medicines (archived) was published by the NPSA as a reference guide for those involved in the procurement of medicines in the NHS.

The Design for patient safety: a guide to the graphic design of medication packaging (archived) published by the NPSA shows how graphic design on medicines packaging can enhance patient safety and details best practice.

Labelling and packaging of unlicensed medicines (Specials): best practice guidance for the NHS is available.

Clinical use

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

Consider:

• potential LASA confusion in medicine name(s) and packaging
• potential confusion or mis-selection resulting from the product’s appearance in electronic prescribing and dispensing systems, including its position in drop down lists.
• clinical requirements e.g. preservative-free, alcohol-free
• proposed use of the product e.g. connectors to delivery devices or administration consumables required
• the intended location of use, including storage considerations

Purchasing decision

The outcome of the product safety assessment should be considered when making purchasing decisions; noting and discussing any assessment outcomes at medicines safety / medicines optimisation groups.

Adherence to formularies

There are opportunities to give preference to products whose properties support safe clinical use when reviewing and agreeing organisational and regional formularies.

Contracts

Procurement of medicines and pharmaceutical products in acute care settings within the NHS is under framework agreements negotiated by NHS England or equivalent.  Arrangements for Procurement of Medicines and Pharmaceutical Products and Services support cost effective purchasing of medicines.  When available, details of packaging  and labelling of awarded injectable lines are submitted to SPS Quality Assurance and their assessment is shared to alert end users to potential in-use safety issues and support development of local risk mitigation measures.

Where a safety concern is identified through local product assessment or through reported incidents and near misses, purchasing alternative products off contract may be considered to support safe clinical use.  Escalation of safety concerns will inform future tenders.

Supply chain

Assurance of product availability may support avoidance of inadvertent harms associated with delayed supply of time critical medicines.

Shortages

Products can become unexpectedly unavailable.  Purchasing for safety policies and practice standards should outline the process for undertaking product safety assessments of alternative products and management of their safe introduction to use (further guidance below).

Local manufacture or preparation

Where a ready to use or ready to administer product is unavailable, consideration should be given to the feasibility and safety of making the product in pharmacy or sourcing from another licensed manufacturing unit.

Mitigation

For many reasons including the lack of choice in the market, purchasing for safety processes may identify risks which can’t be avoided through purchasing decisions.  Organisations need to locally manage risks.

Possible mitigations include,

• clear signage and segregation where products are stored, both in pharmacy and clinical areas,
• relabelling of products at receipt, to include ‘in use’ instructions,
• use of typographical interventions, such as Tall Man Lettering (TML) on locally generated labels and in electronic systems
• publicity and communication material highlighting new products and the risks, including how to address it in practice
• identification via barcodes
• processes to ensure products purchased on an individual patient basis (e.g. non-formulary items) are supplied promptly in full to prevent stockholding

Escalation of concerns

Safety concerns identified through product safety assessment or incident and near miss reporting after the product has been purchased should be reported via local systems and escalated to the most appropriate organisation or group:

• The Marketing Authorisation Holder (MAH)
• The Medicines and Healthcare products Regulatory Agency (MHRA)
• Local patient safety and clinical risk management groups
• Local/regional procurement groups or MPSC for future purchasing decisions
• Local/regional Medication Safety Officer networks for information

Safety concerns escalated through the learn from patient safety events service (LFPSE)  allows for new or under-recognised safety issues to be quickly identified and acted upon widely.

Introduction to clinical use

Introducing a new product may present unintended risks or result in unexpected consequences.  Managing the process of introduction may minimise the potential for harm.

Collaboration for safety will ensure all professional groups impacted by the introduction of a new product are consulted and, involved in the process.

Consider the need for:

• additional education and training for healthcare professionals and patients,
• additional patient held resources
• delivery support required for the medicine e.g. connectors to devices or administration consumables
• supplementary consumables required and, process for supply, e.g. administration syringes, sharps bins
• additional stockholding or storage requirements

Switching

Introduction of a new product to replace products already in use may result in a period of overlap, with both products in use at the same time, presenting additional risks.

Where a product is considered high risk, consideration should be given to undertaking the switch at a specified time point – ‘Big Bang approach’.  Where this is not possible, risks should be managed locally with timely and effective communication to all healthcare professionals involved in the product use.

Further resources

NHSE Purchasing for safety

World Health Organisation – Medication Safety for Look-Alike, Sound-Alike Medicines.