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Labelling and packaging practices: A summary of some of the evidence

Version 1.0, January 2013

21 January 2013

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Blister strip labelling

Ambiguous labelling of blister strips has been implicated in medication errors (Guchelaar, Kalmeijer & Jansen, 2004, Rev Prescrire, 2011;). Guchelaar et al (2004) discussed how a section of a blister strip containing two tablets labelled with 'Zelitrex 500' (valaciclovir) caused confusion among health care professionals, with many being unclear whether the 500 referred to the amount of active ingredient in a single tablet or the total amount of active ingredient in the two tablets together. It was reported that a patient being treated with medication packed in this manner was given two tablets twice a day, equating to 1000 mg twice a day, instead of 500 mg twice a day). It was found that the labelling of the blister and the packaging of two tablets together contributed to the misadventure. Similar examples were cited in Rev Prescrire (2011).

In a paper proposing a packaging design blister strips for optimal compliance, Weiss (2009) identified discarding of packaging containing directions, warnings and dosing instructions as one of the contributory factors to the misuse of OTC medicines. Weiss (2009) suggested that optimal compliance packaging should:

  • keep the instructions, warnings and dosing directions attached to the blister strip at all times
  • increase the surface area of the packaging without adding bulk
  • organise the pills into logical, unit-of-use sets or rows (for example per-dose maximum or per-day maximum)
  • limit the number of pills in a unit-of-use package to coincide with the instructed maximum dose and maximum days of use for a specific product.

An article in Rev Prescrire (2011) noted a new packaging design where the box, blister pack and information leaflet for a paracetamol OTC product could not be separated. This design ensured that the patient leaflet remained on hand throughout the use of the product, and that a blister pack containing another drug could not accidentally be put into this box.

References

Guchelaar HJ, Kalmeijer MD & Jansen MEP, Medication error due to ambiguous labelling of a commercial product. Pharm World Sci, 2004;26:10-11.

2010 drug packaging review: identifying problems to prevent errors. Rev Prescrire 2011;31:142-145.

Weiss S, Compliance packaging for over-the-counter drug products. J Public Health, 2009;17:155-164.

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