The Packaging Awards focus on the quality of packaging for drugs evaluated during the previous year in the New Products section of our French edition (in 2011: issues 327 to 338).
> Rules governing the Prescrire Awards (in French, pdf)
PACKAGING AWARD
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• Mexilétine AP-HP° capsules Ageps-EPHP (mexiletine)
The labelling highlights information necessary to prevent medication errors, i.e. the international nonproprietary name (INN), the dosage, and the pharmaceutical form. The individual blister pockets of the blister packs are each labelled and precut (a).
The packaging promotes correct preparation of the drug in daily practice, whether in the hospital or not.
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"YELLOW CARDS"
In alphabetical order |
• Diarfix° capsules Cristers (racecadotril)
• Grazax° oral lyophilisates Alk Abelló (allergenic extract of Timothy grass pollen)
• Hexaquine° tablets Du Gomenol (quinine + thiamine)(b)
• Levofree° single-dose eyedrops Chauvin (levocabastine).
The printing on Levofree° single-dose units is easily rubbed off.
• Lovavulo° Gé tablets Codépharma (ethinylestradiol + levonorgestrel).
Lovavulo° Gé blister packs mention the INN but in tiny, poorly legible characters.
The primary packaging (blister pack or single dose units) for these products does not clearly mention the name of the active ingredient. |
• Septidose° Gé unit-dose cutaneous solution Neitum (chlorhexidine)
The route of administration is not clearly mentioned on the front of the box, even though confusion over the route of administration has been reported with other single-dose units containing various products used to treat infants. The packaging includes an obscure pictogram that is supposed to indicate the age of the patients. |
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"RED CARDS"
By type of packaging defect, and then in alphabetical order |
BULK BOTTLES WITH POTENTIALLY FATAL CONTENTS:
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• Imeth° 10-mg tablets Nordic Pharma (methotrexate)
• Méthotrexate Bellon° 2.5-mg tablets Sanofi Aventis (methotrexate)
• Novatrex° 2.5-mg tablets Pfizer (methotrexate)
Bulk bottles for these 3 products lack a child-proof safety cap, creating a risk of ingestion of a tablet that has accidentally fallen out of the bottle, and accidental ingestion of a lethal dose by a child (c). |
PATIENT LEAFLETS THAT FAIL TO PROVIDE ADEQUATE INFORMATION
TO PREGNANT WOMEN AND THUS ENDANGER THEIR UNBORN CHILDREN:
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• Adviltab rhume° tablets Pfizer Santé Familiale (ibuprofen + pseudoephedrine)
• Antarène Codéine° tablets Élerté (ibuprofen + codeine)
• Bi-Profénid° LP tablets Sanofi Aventis (ketoprofen)
• Compralfène° gel Gifrer Barbezat (diclofenac)
• Flector Tissugel Héparine° plasters Genévrier (diclofenac + heparin)
• Nifluril Enfants° suppositories Bristol-Myers Squibb (morniflumate)
• Profémigr° tablets Sanofi Aventis (ketoprofen)
• Tendol° gel Népenthès (diclofenac)
• Voltarène Enfant° suppositories Novartis Pharma (diclofenac)
The labelling of these nine nonsteroidal anti-inflammatory drug (NSAID)-containing products states that they are only contraindicated from the sixth month of pregnancy. The labelling fails to stipulate there is an increased risk of miscarriage and malformations with exposure in the first trimester, as well as life-threatening renal and cardiovascular fetal toxicity after NSAID exposure during the second trimester.
Paediatric suppositories examined in 2011 may be mistakenly used by pregnant women who are falsely reassured by their indication for paediatric use.
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| CONTRADICTORY DOSING SCHEDULES ON THE BOXES: |
• Colokit° tablets Mayoly Spindler (sodium phosphates)
The outer packaging includes a two-box treatment schedule with the words “date” and “hour” in the singular, whereas the 32 tablets must be ingested in eight sequences, each with 250 ml of water; this creates a source of confusion in the preparation and administration of this product, thus increasing the risk of adverse effects with this laxative
(including life-threatening electrolyte disorders (d)). |
| PAEDIATRIC PACKAGING UNSUITABLE FOR CHILDREN: |
• Picoprep° sachets of powder for oral solution Ferring (sodium picosulfate + magnesium oxide + citric acid)
There is no specific paediatric dosage or packaging: the labelling states that children under 9 years old should receive one-half or onequarter of a sachet, creating a risk of dosing errors and adverse effects of laxatives (including life-threatening electrolyte disorders) (e). |
• Cozaar° preparation for oral suspension Merck Sharp & Dohme (losartan)
Multiple sources of error during preparation of this product for hypertensive children, due to:
– The excess volume (273 ml) of solvent, and the excess capacity (40 ml) of the bottle provided for the reconstituted suspension;
– The need to "shake before use" is not mentioned on the bottle, but only on the patient leaflet; this can result in a solution that is not sufficiently homogeneous.
– The oral syringe is graduated in millilitres, representing a potential source of error when converting the prescribed dose (in mg) to the required volume (in ml). |
| ADULT MEDICINES TOO READILY ACCESSIBLE TO CHILDREN: |
• Humex toux sèche oxomémazine° syrup and oral solution Urgo (oxomemazine)
No child-proof safety cap is provided; the label represents what looks like a cream dessert, a starry night and a moon; and the graduated cups carry a risk of overdose.
The multiple flaws of this self-medication product, part of an umbrella brand, create a risk of preventable overdose and misuse (for insomnia), especially in children. |
• Bipreterax° tablets Servier (perindopril arginine 10 mg + indapamide 2.5 mg)
• Buccosoin° mouthwash solution Merck Médication Familiale (chlorhexidine + chlorobutanol, 42.8% ethanol)
• Célestamine° tablets Merck Sharp & Dohme (betamethasone + dexchlorpheniramine)
• Dolko° oral solution Therabel Lucien (paracetamol)
• Eludrilpro° mouthwash solution Pierre Fabre Médicament
(chlorhexidine + chlorobutanol, 42.8% ethanol)
• Euphonyll toux sèche dextrométhorphane° syrup Mayoly Spindler (dextromethorphan) (f)
• Flucalyptol toux sèche pholcodine° syrup Zambon (pholcodine)
• Primalan° syrup Pierre Fabre Médicament (mequitazine)
• Primpéran nourrissons et enfants° and Primpéran enfants° paediatric oral solutions Sanofi Aventis (metoclopramide)
There is no child-proof safety cap on the bottles of these 10 products, creating a risk of overdose in children. Overdose exposes them to the adverse effects of the drugs concerned or their excipients (high ethanol concentration), including cardiovascular, hepatic and neurological disorders, depending on the substance ingested. |
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NOTES :
a - A unit-dose blister pack is defined by the labelling of each blister pocket with the INN, the dosage, the pharmaceutical form (or the route of administration), as well as the batch number and the expiry date.
b - The company announced that a label including the INN but accompanied by a
much bigger brand name will be added, see Rev Prescrire n° 340 p. 156.
c - The company stated that the risk was negligible compared with that of overdose due to dosing error, see Rev Prescrire n° 340 p. 156.
d - According to the company, details about dosing schedules should be given during the visit prior to colonic investigation. Also a risk management plan is underway, see Rev Prescrire n° 340 p. 156.
e - The company announced that dosing spoon will be available in 2012, see Rev Prescrire n° 340 p. 156.
f - According to the company, a "feasibility study" for a safety cap will be conducted, see Rev Prescrire n° 340 p. 156.
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©Prescrire Février 2012
"The 2011 Prescrire Awards" Prescrire Int 2012; 21 (125): 78-82. (pdf, free)
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