Dispensing Categories of Medicinal Products

Definition

The dispensing of licensed medicines is strictly regulated by law in many countries. Drugs may be available by prescription (prescription-only), nonprescription, and over-the-counter. Typical dispensing points are pharmacies, drugstores and doctors’ offices, provided that self-dispensing is permitted by the canton. Category E drugs may also be sold in the retail trade, for example in supermarkets or kiosks. The drugs approved in many countries are divided into four categories. The list shows the new dispensing categories, which are valid from January 1, 2019: Dispensing Category A:

  • Dispensing category A includes prescription medications that may be obtained in a physician’s office or with a physician’s prescription on a one-time basis from a pharmacy. Documentation is required for health care professionals. Examples are antibiotics, narcotics and cytostatics.

Dispensing category B:

  • Dispensing category B contains prescription drugs that may be obtained in a doctor’s office or with a doctor’s prescription once or several times in a pharmacy. Some drugs from category B can be dispensed by the pharmacist without a prescription after a consultation. These are in particular the so-called List B+ and the Ex-List-C. The dispensing is subject to documentation (depending on the product, e.g. entry in the patient dossier, algorithm, checklist). Furthermore, in a justified exceptional case, a so-called emergency dispensing is possible. And after an initial prescription, a drug may be dispensed without a prescription for a period of one year in the case of continuous therapy. Examples: Antihypertensives, cholesterol-lowering drugs, codeine, “morning-after pill”.

Dispensing category D:

  • Category D drugs are not subject to prescription and may be dispensed in doctors’ offices, pharmacies and drugstores after a specialist consultation. There is no documentation requirement. Examples are painkillers such as ibuprofen or remedies against diarrhea such as loperamide.

Dispensing category E:

  • Category E medicines do not require a prescription and may be dispensed in doctors’ offices, pharmacies, drugstores and retail stores (sale in all stores). No specialist advice is required and there is no documentation requirement. Examples are cough drops and some teas.

The dispensing category C, which is obviously missing from this list, was repealed at the end of 2018. It contained in the years before the pharmacy-required drugs. These 640 drugs were reclassified in 2019 and 2020 either to dispensing category B (prescription, ex-list C) or dispensing category D (specialist advice). At the same time, list D drugs were reclassified to list E (over-the-counter). All non-prescription drugs may now be sold in drugstores.

Criteria for dispensing categories

Why are drugs divided into different categories? The primary concern is patient safety. Patients should be protected from dependence and addiction, adverse effects and drug-drug interactions. Before initiating therapy, the correct diagnosis must be made and clarifications such as laboratory tests may be required, which are only carried out under medical supervision. Good therapy monitoring is also often crucial. Finally, the use of medication is often complicated and requires good instruction and explanation. However, in addition to technical reasons, political and commercial aspects also play an important role. Therefore, the allocation of a drug is not infrequently controversial among patients and specialists.

Revision of the Therapeutic Products Act

In 2019, as part of the revision of the Therapeutic Products Act, various medications that were previously required to be dispensed by pharmacies (previously dispensing category C) were made subject to prescription (now dispensing category B) in many countries. The remainder have been placed in category D. The new prescription-only medicines are available on prescription from a doctor or in doctors’ surgeries. They may be sold by pharmacists after a consultation with dispensing documentation (entry in the patient dossier). Pharmaceutical assistants, who were previously allowed to dispense many of these medications, were exempted from dispensing.

Drugs that have been reclassified from category C to category B (ex-list-C).

Newly prescription-only medicinal products for human use according to Swissmedic’s preliminary information of November 16, 2018. The final classification(s) will take place in 2019 and 2020. (B) means that the reclassification has already taken place:

Active ingredients Examples (selection) Application area
Beclometasone Otri hay fever Hay Fever
Cinnarizine (B) Stugeron Motion sickness, dizziness
Codeine (B) Macatussin, Resyl plus Cough
Dextromethorphan Bexin, Pulmofor Cough
Dihydrocodeine (B) Paracodin Cough
Diphenhydramine Benocten Sleep disorders
Domperidone (B) Motilium, generic Nausea and vomiting
Doxylamine (B) Sanalepsi Sleep disorders
Etilefrin (B) Effortil Deep blood pressure
Hexamidine (B) Desomedin Eye infections
Potassium (B) Potassium Hausmann, KCL-retard Potassium substitution
Levonorgestrel (B) NorLevo “morning-after pill”
Mometasone furoate (B) Mometasone pollen Hay fever
Naloxone (B) Nyxoid Opioid overdose
Oxomemazine (B) Toplexil Cough
Pholcodine (B) Phol-tussil Cough
Pseudoephedrine (B) Rinoral Common cold
Triamcinolone acetonide (B) Nasacort Allergo Hay Fever
Ulipristal acetate ellaOne “morning-after pill”

The following medications were reclassified to dispensing category D rather than dispensing category B as originally planned: Vicks MediNait juice, Otalgan ear drops.

List B+ (B plus) – examples.

Listed below are some examples of List B+ agents. The corresponding restrictions and specifications of the Federal Office of Public Health (FOPH) must be observed, for example, with regard to dose, dosage form, and duration of therapy:

  • Amorolfine (Loceryl, generics).
  • Adapalene (Differin)
  • Azelastine (Allergodil, generic).
  • Aciclovir (Zovirax cream)
  • Bilastine (Bilaxten)
  • Cetirizine (Zyrtec, generics)
  • Ciclopirox (eg, Ciclopoli).
  • Crotamiton (Eurax, out of trade).
  • Desloratadine (Aerius, generic).
  • Domperidone (Motilium, generics)
  • Epinastine (Relestat, generics)
  • Esomeprazole (Nexium, generic).
  • Fexofenadine (Telfast, generic).
  • Finasteride (Propecia, generic).
  • Fluticasone (Flutinase a.H., generics).
  • Isotretinoin (Roaccutane Gel)
  • Ivermectin (Soolantra)
  • Ketotifen (Zaditen, generics).
  • Lansoprazole (Agopton, generics).
  • Levocetirizine (Xyzal, generic).
  • Loperamide (Imodium, generics)
  • Loratadine (Claritine, generic)
  • Macrogol 3350 (Movicol, generic)
  • Mebeverine (Duspatalin, generic)
  • Mometasone (Nasonex, generic)
  • Sodium picosulfate (Laxoberon, generic).
  • Olopatadine (Opatanol, generics)
  • Omeprazole (Antramups, generic).
  • Orlistat (Xenical, generics)
  • Pantoprazole (Pantozol, generic)
  • Permethrin (Scabi-med)
  • Rabeprazole (Pariet, generics)
  • Salbutamol (Salbu Orion 100, does not apply to Ventolin).
  • Sildenafil (Viagra, generic).
  • Tretinoin (Airol)