Improve Mandatory National Standards for Drug Packaging


Improve Mandatory National Standards for Drug Packaging
The issue
There is currently a multitude of similarly packaged drugs with very different clinical effects available in both Australia and New Zealand. This increases the risk of significant drug error and the potential for serious patient harm.
Whilst clinician vigilance and pharmacy purchasing practices are important strategies, they are not able to provide a robust, permanent solution to these issues.
Incorporation of human factors strategies into manufacturer drug packaging & labelling to maximise distinctiveness of different medications and consistency between similar medications, could help to reduce this risk. Whilst work has already been done in this area there are no mandatory national standards to prevent pharmaceutical manufacturers producing medications with dangerously similar packaging.
Manufacturer drug packaging including the external box, labels, ampoules, vials, caps, stoppers, blister packs & other elements should be subject to mandatory standards. In addition to previously proposed/implemented strategies this should include colour coding of these packaging elements according to the class of drug, based on the existing coding system in place for intravenous medications & fluid therapy. This coding system could be extended to include other classes of intravenous & oral medications.
Standardisation of the type of packaging (vials, glass or plastic ampoules) for different classes of intravenous drugs should also be considered where practical.
Irrespective of the manufacturer, the type & colour of pharmaceutical packaging should be subject to a mandatory national standard, so that it's appearance maximises consistency between similar drug types and distinctiveness between different classes of drug.
The ultimate goal is to reduce the risk of drug error and minimise patient harm.
Dr Nicholas Chrimes, Anaesthetist, Australia
There are many examples of drugs which look very similar but have very different clinical actions in New Zealand. In an emergency or other stressful situation, this could prove to be catastrophic for the patient. Examples are being collected.
Dr Cara Thomson, Anaesthetic Registrar, Dunedin, NZL
The issue
There is currently a multitude of similarly packaged drugs with very different clinical effects available in both Australia and New Zealand. This increases the risk of significant drug error and the potential for serious patient harm.
Whilst clinician vigilance and pharmacy purchasing practices are important strategies, they are not able to provide a robust, permanent solution to these issues.
Incorporation of human factors strategies into manufacturer drug packaging & labelling to maximise distinctiveness of different medications and consistency between similar medications, could help to reduce this risk. Whilst work has already been done in this area there are no mandatory national standards to prevent pharmaceutical manufacturers producing medications with dangerously similar packaging.
Manufacturer drug packaging including the external box, labels, ampoules, vials, caps, stoppers, blister packs & other elements should be subject to mandatory standards. In addition to previously proposed/implemented strategies this should include colour coding of these packaging elements according to the class of drug, based on the existing coding system in place for intravenous medications & fluid therapy. This coding system could be extended to include other classes of intravenous & oral medications.
Standardisation of the type of packaging (vials, glass or plastic ampoules) for different classes of intravenous drugs should also be considered where practical.
Irrespective of the manufacturer, the type & colour of pharmaceutical packaging should be subject to a mandatory national standard, so that it's appearance maximises consistency between similar drug types and distinctiveness between different classes of drug.
The ultimate goal is to reduce the risk of drug error and minimise patient harm.
Dr Nicholas Chrimes, Anaesthetist, Australia
There are many examples of drugs which look very similar but have very different clinical actions in New Zealand. In an emergency or other stressful situation, this could prove to be catastrophic for the patient. Examples are being collected.
Dr Cara Thomson, Anaesthetic Registrar, Dunedin, NZL
Petition Closed
Share this petition
The Decision Makers
Petition created on 11 December 2014