French regulators provide guidance to prevent confusion between medicines and food supplements

Earlier this summer, the French National Agency for Medicines and Health Products Safety (ANSM) and the French National Agency for Food, Environmental and Occupational Health & Safety (ANSES) published recommendations to help healthcare professionals and patients distinguish medicines from food supplements. The recommendations follow pharmacy reports about a risk of confusion between the medicinal product Lytos® and the food supplement Lithos®.

While these products' brand names are pronounced identically in French and have similar spellings, they are different from a regulatory perspective:

• Lytos® (sodium clodronate tetrahydrate) is a medicinal product marketed by Riemser Pharma GmbH for the treatment of hypercalcaemia and certain bone disorders.
• Lithos® (potassium and magnesium citrate) is a food supplement marketed by Biohealth India and used in the event of significant loss of fluid related to excessive perspiration, substantial diuresis or diarrhoea.

To limit the risk of confusion between these two products, the ANSM and ANSES have provided fact-specific recommendations that can be extended to apply more generally to help distinguish medicinal products from food supplements:

• Physicians should: (i) prescribe medicinal products by their international non-proprietary name (INN) in addition to their brand name; (ii) include the terms "food supplement" and "recommended" ("à titre de conseil") when prescribing a food supplement; and (iii) separate medicines from food supplements on the prescription.
• Pharmacists, when in doubt, should confirm with physicians which product is being prescribed by requesting information on its classification (medicine or food supplement), active substance and indication. Pharmacists should also include check-ups when placing orders to wholesale distributors, receiving deliveries and selling to patients, notably through verification of the active substance.
• Wholesale distributors should confirm the product classification (medicine or food supplement) when preparing orders for pharmacies, notably through verification of the active substance.
• Patients should ask the pharmacist or prescribing physician when in doubt.

A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, August 2017 Issue (Thomson Reuters).

This post was originally co-authored by Patricia Carmona Botana.