It is worth mentioning the progress resulting from the regulatory measures that required labelling to include the INN and Braille. These measures went into effect in France on 7 May 2009 (3).
In 2009, with only a few exceptions, INNs were displayed, after the brand name, on the box and on the primary packaging (although rarely prominently). Braille was present on almost all of the boxes examined. And recalcitrant pharmaceutical companies no longer have the right to refuse access to Braille leaflets to associations for the visually impaired. Improvements were made in the clarity of the labelling of ampoules containing certain dangerous injectable drugs, following Afssaps’ recommendations (see opposite).
More blister packs that were examined in 2009 carried full labelling on each unit dose; most of these were for outpatient use. Blister packs with a safety film designed to delay access to the contents of the blisters were also less of a rarity: dabigatran - Pradaxa° Rev Prescrire 306; oxycodone - OxyNormOro° Rev Prescrire 313; ambrisentan - Voli-bris° Rev Prescrire 303; fentanyl - Abstral° Rev Prescrire 313. Two oral syringes that used to be marked with two graduation scales (one corresponding to weight of drug and one in ml), which was a source of confusion, now only have graduations corresponding to weight of drug: sodium oxybate - Xyrem° Rev Prescrire 307 and valproic acid - Dépakine° syrup (Rev Prescrire 315).
Another dosing device we examined in 2009, the oral syringe for Rovalcyte° oral solution (valganciclovir; Rev Prescrire 311) meets two criteria that are essential for quality care: it is graduated in mg and labelled with the INN.
Overall, the content of patient information leaflets has continued to improve, thanks to comprehension tests conducted on patients. Most of the high quality package leaflets were those authorised by the European Medicines Agency (EMA). Medical terms are explained. Certain information, such as the therapeutic indications, is presented in a concise manner.
Examples of real progress include bortezomib - Velcade° Rev Prescrire 308, doripenem - Doribax° Rev Prescrire 304 and lacosamide - Vimpat° Rev Prescrire 307 + 311 inside front cover and 314 p. 899-900.
In practice. Improvement in drug packaging has been too slow. Healthcare professionals must therefore continue to remain vigilant, to report shortcomings and inform patients. Errors, suspected errors and dangerous packaging must be reported to Afssaps. Subscribers to Prescrire can also submit reports to its "Preventing the Preventable" programme for the prevention of treatment-related errors.
© Prescrire June 2010
"Drug packaging in 2009: a few advances" Prescrire Int 2010; 19 (107): 135-137
Notes:
a- In January 2009, the European Commission finally updated its guidelines on labelling and packaging leaflets (ref. 4). This new version includes useful recommendations such as displaying the INN in a prominent way. As of late 2009, it was still too soon to evaluate their impact. We will return to this issue in the future.
b- In 2009, the European Medicines Agency (EMA) released draft guidelines for public consultation on the expression of concentrations and strengths on packaging. The comments Prescrire sent to EMA are presented in reference 5. Selected references from Prescrire’s literature search.
References:
1- Prescrire Editorial Staff "Drug packaging in 2008: not enough progress" Prescrire Int 2009; 18 (101): 134-135.
2- Prescrire Editorial Staff "Packaging of pharmaceuticals: still too many dangers but several encouraging initiatives" Prescrire Int 2007; 16 (89): 126.
3- Prescrire Editorial Staff "European Directive: drug packaging provisions finally transposed into French law" Prescrire Int 2009; 18 (102): 183-1.
4- European Commission "Guideline on the readability of the labelling and package leaflet of medicinal products for human use. Revision 1" 12 January 2009: 27 pages.
5- Prescrire Editorial Staff "Preventing errors related to the expression of strength on drug packaging" Comments on draft guidelines EMEA/208304/2009 28 May 2009: 9 pages.
