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Advancing healthcare policy

Drug packaging and patient safety

The Prescrire Packaging Awards
The Prescrire Packaging Awards for 2011

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)


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.

Carton Jaune
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.
Carton Rouge
By type of packaging defect, and then in alphabetical order
• 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).
• 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.
• 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)).
• 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).
• 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.
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.

About the 2011 Packaging Awards

Throughout the year, the editorial staff systematically examines the packaging of several hundred pharmaceutical products. This provides us with an opportunity to identify high-quality packaging and to detect dangerous packaging that is a potential source of confusion and errors, in order to inform our readers.

Painstaking analysis
Every aspect of the packaging is examined: the labelling on boxes, blister packs, vials, syringes; any devices provided for drug preparation or administration; caps and stoppers, and the legibility and quality of the information provided in the patient leaflet regarding the conditions of use, adverse reactions and interactions, and any recommended non-drug measures.

Independent rating
At the end of each year, the Packaging Awards are granted following a review of the year’s standardised forms by the Prescrire Packaging Working Group, in total independence and with no input from drug or packaging manufacturers (See rules, above).

Too many red and yellow cards in 2011
Prescrire has been examining drug packaging for three decades, representing more than 5000 packages analysed. This activity contributes to various projects, including the articles published in Prescrire, actions aimed at improving professional practice (such as the Preventing the Preventable programme at evitable.prescrire.org), and contributions to European public consultations.

This year’s Packaging Awards highlight the poor overall quality of drug packaging in 2011
The method used to prepare the Awards has remained unchanged over the years, meaning that the steady increase in the number of yellow and red cards simply reflects the state of the market. High-quality packaging is now so rare that the product to which the Packaging Award was granted in 2011 does nothing but to bring together all the basic requirement for quality packaging. The packaging in question was designed by Établissement pharmaceutique of Assistance Publique- Hôpitaux de Paris (AP-HP) (EPHP) (a), which is no doubt more sensitive to the real needs of hospital practitioners than to the greed of BigPharma shareholders.

Even after France’s Mediator° (benfluorex) scandal, health authorities are still failing to pay sufficient attention to the quality of drug packaging.

EPHP is part of Ageps (Agence générale des équipements et des produits de santé) of APHP, Paris's public hospitals. Ageps provides various services, including evaluation and purchase of healthcare products, clinical research and development, and the manufacture and availability of drugs with marketing authorisations.

©Prescrire Février 2012

"The 2011 Prescrire Awards" Prescrire Int 2012; 21 (125): 78-82. (pdf, free)