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Published on 17 September 2009

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Assessing the impact of drug packaging and labelling on patients

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Innovative research based at Cambridge University has revealed a need to improve packaging and labelling, underscoring pharmacist’s importance in helping patients to take their medicines correctly

James Ward
Janet Watkinson
P John Clarkson
Peter Buckle
Janet Anderson
Shelly Jeffcot


Knowing the user is a basic tenet of good engineering design. Ask a designer of medicines packaging who the user is and traditionally the reply has tended to be “the pharmacist”. However, at the risk of stating the obvious, pharmacists are not the only users of such packaging. From a safety perspective, the patient is at least as important, but for various reasons patient needs do not seem to have been high on designers’ priority lists. Possible reasons are a general lack of knowledge about how patients actually get on with using packaging and labelling at home, and a failure to realise the importance of getting the design right.

Investigating the patient’s perspective
To begin to fill this knowledge gap, the authors conducted interviews with patients, along with observations, as they used solid oral medicines in their homes. They also undertook further interviews with patients in community pharmacies. The views of 44 patients on medicines packaging and labelling were assessed.

This preliminary research found patients generally experienced difficulties in two areas: accessing medicines and identifying medicines correctly. Further research on a much larger scale is ongoing to investigate and quantify these issues more robustly.

Opening packaging and accessing medicines
The vast majority of the patients cited difficulties in accessing medicines due to packaging issues, with frustration over blister packs being more prevalent than that over bottles. Many users found it difficult or impossible to open standard medicines bottles with pushdown-and-turn, child-resistant closures, and had to rely on assistance from third parties. Many were unaware that alternative closures existed, or if they did they were unwilling to use them. Statements typical of patients include: “Medicines bottles are childproof and ageproof” and “(Blister packs are) slightly easier than screw caps, but…it’s fairly tedious pressing out six pills.’

Given these difficulties, many patients adopted coping strategies. One such was to only partially secure bottle closures-defeating the aim of childproofing. Other patients decanted their medicines into alternative easier-to- open containers. Sometimes these were unlabelled or labelled with the name of another medicine. Such “latent errors” may later resurface and cause harm, particularly if a third party unwittingly becomes involved in incorrectly administering the medicine.

To speed access, a significant proportion of users of blister strips also disposed of the outer packaging, thus also dispensing with critical information about what their medicines were and when they should be taken.

It was also noted that as tablets were extracted from blister strips the foil became progressively more damaged, which made correct identification of the medicines increasingly difficult.

Correct identification of medicines
All patients in the research, received multiple prescription medicines-on average, seven different medicines-regularly. Typically, patients would store medicines in large containers such as that illustrated in Figure 1. It was noted that, often, patients received different medicines in similar-looking packaging, particularly with medicines provided by pharmacies.

Given the range of medicines administered and the similarities in packaging, patients were asked whether they had ever confused one package with another. Although few patients did declare such errors, two out of 12 methotrexate users had confused their medicine with folic acid tablets. Such an error could have serious consequences, and was perhaps made more likely by the similarity in appearance of the tablets (see Figure 2) Figure 1. A typical container for storing medicines at home as well as that of the outer packaging.

Patients were also asked whether they had difficulties understanding pharmacy label instructions. Few highlighted such difficulties, but some patients noted legibility problems when low ink levels in pharmacy dotmatrix printers had resulted in poor print contrast.

Some other potential problem areas were not identified by patients. One was that of pharmacy labels obscuring manufacturer information (often due to the manufacturer providing insufficient free space for this) and an inability or unwillingness on the part of pharmacists to provide patient information leaflets, especially when packs were split. A similar problem arose from the fact that sometimes pharmacy bottles were too small for the dispensing label: this could create difficulties in reading critical information at a glance due to the
label being wrapped around two or three sides of the container and/or damage to the label (see Figure 3).

[[HPE45.69]]

Discussion
Many medicines users suffer from some degree of impairment due to age and/or medical condition. It is questionable whether current packaging and labelling design sufficiently takes such patients’ needs into account. We suggest addressing this on two fronts. First, guidance from the UK National Patient Safety Agency[1] can help designers make significant progress on improving packaging and labelling design. It is pleasing to see that many manufacturers have already modified their designs since this guidance was issued. However, while such guidance does address many identification issues, it only provides “bolt-on” solutions for addressing difficulties in accessing medicines. With the number of arthritic patients running into the millions in the UK alone, a more radical overhaul of packaging design may be needed.

Regarding the second front, there are many “interim” ways in which community pharmacists can help drive change and improve the experience for patients:

  • Using community pharmacy review to ask patients about whether they experience problems with packaging and labelling.
  • Providing feedback to manufacturers (including congratulations when design has been done well).
  • Providing easy-open tops (eg, winged tops, tops with a larger diameter) for patients who have problems opening child-resistant closures.
  • Providing a pill-press for patients who have difficulties using blister packs.
  • Considering the provision of larger containers in cases where labels are too big and likely to become damaged and hard to read.
  • Being prepared to purchase only patient-friendly packaging, with clear and distinct labelling, to help limit the chances of mixups.
  • Minimising use of generic pharmacy packaging (ie, white boxes), to reduce the chance of mixups between medicines, particularly when a patient is being issued several medicines at once.
  • Avoiding placing labels over other information.
  • Ensuring that printer ribbons always produce labels with sufficient contrast.

Conclusions
Cambridge University is undertaking a much larger study to try to quantify the scale of the problems patients experience. More details can be found via a website.[2] It is hoped that such work, and the growing list of NPSA guidance documents,[1] will help support designers in their bid to continually improve packaging, providing benefits to both pharmacist and patient.

References
1. UK National Patient Safety Agency. Design for patient safety: a guide to the graphic design of medication packaging. London: NPSA; 2007. Available online at: http://www.npsa.nhs.uk/nrls/ improvingpatientsafety/design/dispensedmedicines
2. Engineering DesignCentre. Healthcare design: design for patient safety. Cambridge: Engineering Design Centre, University of Cambridge; 2006. Available online at: www-edc.eng.cam.ac.uk/research/healthcaredesign

 



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