Codeine without a prescription?

“Will I finally be able to buy these codeine cough syrups without asking for a prescription?” Charles, a pharmacist in Liège is complaining: “For two days now, patients have been asking me for products they are used to purchasing but that are no longer sold over the counter as of May 1st. This is especially true of cough syrups that contain codeine or one of its derivatives. Other medicines, such as those containing guafenesin, an expectorant, are no longer available for children under 6 years of age. There are several dozen medications among which are very common products such as Touralynx Codeine, Eucalyptine or Bromophar.”

The explanation is that the Agency for medication safety had decided to make a number of restrictions on syrups after having reevaluated the possible risks and benefits. One of these restrictions is the requirement for a prescription for products containing codeine, allowing the physician to assess the potential for danger to the patient, especially of addiction, prior to prescribing. Codeine, as a matter of fact, is not harmless. It calms coughs by transforming into morphine and decreasing the body’s reactivity.

The agency had also decided to completely ban the use of codeine (and a series of related substances) for syrups for children under the age of six. Also, it will restrict the use of nasal decongestants containing phenylephrine, ephedrine, naphazoline or tramazoline to children over seven years old.

There is one concern. These regulations have just been vacated by the State council following a complaint filed by three companies, Qualiphar, Medgenix and Novartis, which have been able to establish that they had not been heard prior to the decision and had not been able to present their scientific arguments.

The companies appealed in February 2012, claiming that the government did not wait not wait do decide before legislating. As a result, new rules were applied as of May 1st.

The manufacturers have again put in place a new distribution system for older products. “Codeine-based cough medications are available for children from the age of 3 without a prescription,” a spokesperson for Qualiphar insists. Some patients, upset that they could no longer obtain the medicine on the pharmacist’ s advice alone, are glad to hear the news, as are parents seeking a solution for their child. “We often have little in the matter of choice to offer parents with children exhausted from coughing. Alternate products are often not as effective, even if they are less risky.” explains a family physician.

The Federal medication agency, however, vigorously protests this interpretation of the decision. “The State council does not contest the basis of the decision that balances risks and benefits. It simply favors the companies regarding a procedural issue. Age restrictions on children have effectively been lifted, but this does not mean in any way that the requirement for a prescription has also been lifted. One must be presented because it’s part of other legal provisions that were not contested by the companies. There should not be any changes made to the delivery method of codeine-based syrup. The messages issued by the manufacturers stating that cough syrups containing codeine or any of its derivatives are once again available over the counter are not correct.”

For Charles, it’s a real problem: “The firms are saying one thing, the medication agency another. I ask the customers who request them to first see their physician, but I know that some of my colleagues are selling the products without hesitation. This kind of contradiction seems very strange in view of the fact that we’re talking about patient safety. And I’ll just come out and say it: it’s really amateurish.”

FRÉDÉRIC SOUMOIS

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