Why design matters
Well-designed medicines packaging can help reduce risk and support better patient outcomes.
The safe use of all medicines relies on users (whether a healthcare professional, carer, or patient) to read, understand, and act on the information presented. While users remain responsible for interpreting this information, effective design can significantly reduce the likelihood of errors, particularly in high-pressure or high-risk environments.
Although healthcare professionals are not responsible for designing medicines packaging, they are key stakeholders in how that design is used and interpreted in practice. Understanding the principles of good graphic design can help healthcare professionals identify potential safety risks, support safer medicines use, and provide informed feedback to manufacturers.
Good packaging and labelling are designed to support:
- accurate product selection
- correct dose calculation and administration
- differentiation between similar products or formulations
The physical form and delivery method of a medicine directly affects how safely it can be prepared and administered. Good presentation reduces the need for manipulation, supports accurate dosing, and increases confidence in use.
Design decisions should reflect how medicines are handled in real-world settings. The responsibility for incorporating these safety features lies with Marketing Authorisation Holders (MAHs) and manufacturers.
Regulations and best practice
Medicines packaging and labelling must meet defined legal standards and are further supported by national guidance to promote safe design. The key documents that shape regulatory expectations and best practice in the UK are shared below. These documents help to ensure medicines are presented in ways that support safe and effective use.
Human Medicines Regulations 2012
The Human Medicines Regulations 2012 set out the minimum legal requirements for labelling and packaging of medicinal products in the UK. Requirements include:
- clear presentation of critical information (medicine name, strength, pharmaceutical form, and route of administration)
- legibility, comprehensibility, and indelibility of all information
- inclusion of storage conditions and special warnings, where applicable
- application to both outer and immediate packaging, with specific provisions for blister packs (if placed in compliant outer packaging) and small containers (where space is limited)
Medicines and Healthcare products Regulatory Agency (MHRA) best practice guidance
The MHRA best practice on the labelling and packaging of medicines expands on the legal requirements and promotes design principles to reduce medication errors. It groups these into three categories, discussed below.
Information
This includes key details essential for the safe use of the medicine.
Format
The medicine should be presented in a way that supports legibility and understanding.
Style
Attention to style is essential to avoid confusion due to similar names or packaging.
National Patient Safety Agency (NPSA) design for patient safety guides
These documents, though archived, are still widely referenced for practical design advice and include digital examples.
- Design for patient safety: A guide to the graphic design of medication packaging (NPSA, 2007, NHS National Archives)
- Design for patient safety: A guide to labelling and packaging of injectable medicines (NPSA, 2008, NHS National Archives)
Unlicensed Medicines
Different regulations and guidance apply to unlicensed medicines, but the general principles of good packaging and labelling should be applied wherever possible.
Labelling and packaging of unlicensed medicines (Specials): best practice guidance for the NHS (SPS Page) provides guidance for NHS Specials manufacturing units.
For imported unlicensed medicines the article on evaluating the quality of imported Specials (SPS Page) provides more background information.
Graphic design considerations
The graphic design of medicines packaging plays a crucial role in how safely and effectively products are identified, selected, and used. Good design supports usability, reduces the risk of error, and enhances user confidence across care settings.
This section explores key graphic design features and offers practical considerations for healthcare professionals working in both acute and community environments.
Instructions for use and storage
Where healthcare professionals, patients or carers are required to prepare or administer a medicine, instructions should be clear, well-structured, and easy to follow. These should consider the needs of the intended user and, where appropriate, be tested with representative users in real-life scenarios.
Storage instructions, such as “store in a refrigerator” or “protect from light” should be clearly displayed so that they can be easily followed.
Layout and structure
A standardised layout can help users locate important information. Font size, layout, and structure all contribute to readability. Overly dense or unstructured labels may obscure required information.
Critical information such as medicine name, strength, form, and route of administration should be given due prominence, and should be clearly and consistently presented to aid readability.
Where possible, the generic name should be given appropriate prominence to support consistent identification across care settings. Whether a medicine is known by a brand, invented name, or generic name, labelling should align with naming used in prescribing systems, hospital stock lists, and reference sources such as the BNF.
Differentiation between medicines
Packaging should use layout, size, or other design elements to help users distinguish between products. This is especially important where multiple strengths, formulations, or brands exist that could lead to selection errors.
The use of colour should support, not replace, clear labelling. Colour can aid identification but should not be the sole means of differentiation, nor be relied upon to select medicines. Lighting conditions, vision deficiencies and personal perception can affect how packaging is perceived.
Container and presentation considerations
The way a medicine is presented affects how safely it can be prepared and administered. Good presentation reduces the need for manipulation, supports accurate dosing, and increases user confidence.
Presentation should reflect the needs of the intended user, whether a healthcare professional in a clinical setting or a patient or carer in the community. This section explores key presentation features and offers practical considerations for healthcare professionals working in clinical and community settings.
Product protection, security and ease of access
Medicines are designed to be stored in their original packaging to support product stability and protect from damage.
Packaging should be easy to open while maintaining essential safety features and product stability. Child-resistant closures (CRCs) should be used where appropriate but must not create barriers for users with reduced hand strength or dexterity.
Container differentiation
Products presented in similar-looking containers may pose a risk of confusion.
Deliberate design differences in container shape, size, or texture, along with clear and legible labelling can support safer handling and selection. However, the physical appearance of containers cannot be relied upon when selecting and storing medicines, as they may otherwise appear identical despite containing different medicines.
Dosing accuracy
Ready-to-administer forms, such as pre-filled syringes or single-dose oral liquids, reduce the need for calculations or reconstitution, and help minimise the potential for error. Where these are not available, dosing information should be clearly presented and expressed in appropriate units of strength, to aid calculations.
Minimising preparation steps
Where preparation is required (for example, dilution or volume measurement), the risk of error increases. This risk increases further when multiple steps are required. Presentation formats that simplify these steps such as dual-chamber devices or fixed-dose formulations may improve safety, although practical constraints and cost may limit their use.
Managing the risks
It is essential to understand that even the best designs of medicines can present challenges that must be overcome with local working practices. Our articles on managing medicines safely in pharmacy (SPS Page) and managing medicines safely in clinical areas (SPS Page) provide further information and advice.