In 2009, the self-medication market, coveted by certain drug companies, saw the introduction of very few truly useful products.
"Over the counter": not the best choices
In 2009, more drugs were added to the list of products available over the counter for the treatment of mild disorders, but few represented the best available choice. Examples included: guaifenesin, a mucolytic agent for productive cough (Rev Prescrire 306); pheniramine (combined with paracetamol and vitamin C in Fervex°), a sedative atropinic antihistamine for runny nose (Rev Prescrire 306); and trolamine for mild burns and uninfected wounds (Prescrire Int 106).
Drugs "switched" to non-prescription status : a slight advantage with pantoprazole
In 2009, 3 drugs were "switched" from prescription-only to non-prescription status. Two were authorised through a European procedure: orlistat for weight loss (Prescrire Int 101); and pantoprazole for gastroesophageal reflux (Prescrire Int 104). Racecadotril for acute diarrhoea was authorised through the French national procedure (Rev Prescrire 304). Only pantoprazole provided a benefit for patients.
In 2009, the European Committee for Medicinal Products for Human Use (CHMP) refused an application to switch sildenafil to non-prescription status in erectile disorders, because of its potentially serious adverse effects. This deprived the company of an opportunity to publicise its product, as direct-toconsumer advertising is only authorised for non-prescription drugs in the European Union (Rev Prescrire 308).
Proliferation of umbrella brands: danger
So-called umbrella brands gather various products with different compositions, and sometimes, different licensing status, under the same brand name. This is essentially a marketing ploy, based on the choice of easily recognised names. However, umbrella brands can be dangerous, especially when the same drug is available under different brand names (Rev Prescrire 307).
Some umbrella brands were expanded in 2009, including: Humex° for sore throat, colds and allergies (Rev Prescrire 308, Rev Prescrire 312, Rev Prescrire 313, Rev Prescrire 314); Imo° and Imodium° for diarrhoea (Rev Prescrire 307, Rev Prescrire 312); and Vicks° for colds and sore throat (Rev Prescrire 306, Rev Prescrire 311). Self-medication: we need highquality products only! Self-medication is useful for treating some mild disorders, provided a pharmacist is on hand to rule out a more serious ailment. And provided patients have access to high-quality products, with more benefits than harms; proper packaging, including a fully informative patient leaflet; labelling highlighting the international nonproprietary name (INN, "a drug’s true name"); precise, practical measuring devices for multidose oral solutions; etc. (see the June issue).
A survey conducted by the Toulouse Pharmacovigilance Centre identified a number of errors parents made when treating their children with non-prescription drugs, including administration of the same drug under two fancy names, and use of a measuring device intended for another product (Prescrire Int page 28). The regulatory agencies must carefully select the drugs they authorise for self-medication, and ensure that drug companies market only high-quality products.
©Prescrire April 2010
Source: "A look back at 2009: one step forward, two steps back" Prescrire Int 2010; 19 (106): 89-94.
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