Reclassification of therapeutic products in dispensing category C: Evaluation concluded
As part of the revision of the Therapeutic Products Act, the government has decided to eliminate the current dispensing category C (pharmacy-only) and to liberalise the dispensing of medicinal products without endangering patient safety. This requirement necessitates the evaluation and reclassification of all medicinal products currently assigned to dispensing category C and some medicinal products in dispensing category D.
The scientific criteria were defined and the dispensing categories were reviewed with the participation of external experts.
The evaluation focused on aspects relating to medication abuse and on possible interactions between non-prescription and prescription medicinal products.
The government has stipulated that medicinal products that are upgraded from dispensing category C to dispensing category B can continue to be dispensed, without a medical prescription, by the pharmacist in person. This requires a consultation between pharmacist and patient, and dispensing must be documented in the same way as for any medical prescription.
The re-evaluation of all the medicinal products in dispensing category C involved some 650 products, 22 of them veterinary medicinal products. Roughly 10% of the human medicinal products are so-called "co-marketing medicinal products". All the medicinal products were reviewed in groups using pre-defined and published criteria. The reclassification proposed by Swissmedic following the analysis was discussed at six meetings with a commission of external experts. The meetings were attended by recognised experts representing the Swiss Medical Association FMH, Swiss Pharmacists’ Association Pharmasuisse, Swiss Druggists’ Association SDV, the complementary medicine umbrella organisation Dakomed, the Swiss association for complementary medicinal products SVKH, the Association of the Swiss Self-Medication Industry ASSGP, Gesellschaft Schweizer Tierärztinnen und Tierärzte (GST), patient organisations and cantonal pharmacists. The proposed classification was reviewed and revised as necessary on the basis of the discussions and the opinions submitted by the external experts after the meetings.
The vast majority (85%) of the evaluated medicinal products in dispensing category C qualified for reallocation to dispensing category D. These include plant-based medicines containing active substances obtained from St. John’s wort, which can cause serious interactions with prescription medicinal products. Reallocation of these medicinal products to dispensing category D is considered to be acceptable since some medicines containing St. John’s wort can already be dispensed in drug stores, and druggists have already received specific training in this issue. Patients should additionally be made aware of the need for professional advice by means of a warning on the folding carton.
Allocation to dispensing category B is considered to be necessary for around 15% of the medicinal products (1/3 of them co-marketing medicinal products). 2/3 of these contain so-called opiate derivatives, codeine or dextromethorphan – i.e. substances with a considerable potential for abuse. Medicines containing codeine can only be dispensed by persons with a narcotics permit; the terms of the narcotics legislation preclude druggists from obtaining this permit. In addition to the potential for abuse, many of these medicinal products are associated with a substantial risk of serious interactions. The other medicinal products for which allocation to dispensing category B has been proposed are primarily associated with serious interactions with other prescription medicines or else their dispensing must be documented, which in both cases requires consultation with a healthcare professional (pharmacist or doctor).
The actual reclassification of the medicinal products will take place in early 2019, once the revised Therapeutic Products Act has entered into force and in the course of normal administrative procedures. Information about the process was provided to the industry at information events and in published Q&A documents.
The evaluation of medicinal products in dispensing category D for suitability for sale without professional advice (reallocation to dispensing category E) is currently being concluded and the results will be published during the coming weeks.
Revision of the TPA – reclassification of medicinal products in other dispensing categories