Delivery category

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In Switzerland, the dispensing category regulates the delimitation of sales for medicinal products , i.e. whether a medicinal product can be dispensed with or without a prescription and in pharmacies or drugstores or outside of them. Swissmedic is responsible for assigning the dispensing category ; the Ordinance on Medicinal Products (VAM) defines the categories. Ultimately, however, what is decisive is the actual listing of the medicinal product or remedy, not the description of the category.

meaning

Medicines in dispensing categories A and B require a prescription , while those in categories D and E can be purchased without a prescription. Drugs of categories A, B can be obtained in pharmacies, those of category D also in drugstores, and e-drugs can be freely sold anywhere. The formerly existing category C (no prescription required, purchase in pharmacies, but not in drugstores) was abolished in 2019.

Veterinary medicines basically follow the same dispensing categories.

In justified exceptional cases (Therapeutic Products Act, Art. 24 Paragraph 1), a pharmacist can dispense a drug without a prescription. This is the case, for example, if there is a risk of damage to health as a result of not dispensing, if acute symptoms can be alleviated, or if the drug has already been prescribed to the patient and the patient is aware of the symptoms to be treated. To prevent misuse of the drugs, doctors can add conditions to the prescriptions; for example through a fractionated dispensing (the patient can obtain certain small amounts of the drug at certain intervals), or he is prescribed to only redeem the prescription in a certain pharmacy.

In 2005, 59% of all pharmaceuticals approved in Switzerland fell into categories A and B, 10% into category C and 31% into categories D and E.

Criteria for categorization

Medicines are generally assigned to the dispensing categories according to their hazard and abuse potential.

The authorization holders can apply for a different classification of their medicinal products at any time - usually a lower rating so that the medicinal product can be freely sold. Conversely, Swissmedic classifies therapeutic products differently based on new medical knowledge - which usually results in an upgrade. The classification is based on an appealable ruling .

The following aspects stand in the way of a downgrading to categories D and E:

  • Drug interactions with prescription drugs are not allowed in Category E; because the therapeutic benefit of the other drug must be ensured when taken at the same time
  • Special documentation obligations on the part of the pharmacist ( e.g. morning-after pill )
  • Narcotics and their precursors
  • The remedy works systemically and is only used in children under two years of age

The relative barriers to classification in categories D and E are considered in an overall view. There are:

  • Serious interactions with prescription remedies
  • Safety: Means that may not be used by pregnant and breastfeeding women, or only to a limited extent
  • The drug works systemically
  • Indication : In the case of remedies in category D, the patient must be able to decide whether the remedy is indicated without medical assistance. The same applies to category E funds, but without assistance from specialist staff ( PTAs , medical assistants, nurses, ...)
  • Diagnosis: The remedy must not mask the symptoms of a serious illness, nor must it make the medical diagnosis of such a disease more difficult or delay it

Further criteria are the comparison with medicinal products that have already been approved with the same active ingredient, as well as the comparison with medicinal products that are approved in the EU.

The fee category does not differentiate between one-time, short-term and long-term use. For example, over-the-counter pain relievers, codeine cough drops (until the end of 2018: Category C, since then Category B) or xylometazoline nasal sprays (Category D) can lead to dependency with withdrawal symptoms if used improperly, but the reverse is true for quite a few short-term, prescription-only sprays Remedies (for example, corticosteroids , category B) are not known to have any health effects.

Delivery categories

The specified dispensing category applies to an approved drug, not to a specific active ingredient. Swissmedic assesses and approves the dispensing category for each new medicinal product applied for.

Category A (single dispensing on medical or veterinary prescription)

The dispensing is possible on a medical prescription ( prescription requirement ). Permanent prescriptions have been permitted since November 2018. If a single dose is noted on the prescription, this must not be deviated from, and the doctor must be consulted again for a new delivery (“tightened prescription drugs”).

Medicinal products are classified in category A if the active ingredient is listed in substance list A, if the duration of therapy is limited and may not be extended for reasons of safety, if use is too serious without medical or veterinary diagnosis and supervision of use Can cause damage to health or if incorrect use could significantly impair subsequent treatment.

Examples: Tramadol , Amoxicillin .

Medicines that require a prescription for narcotics are also sometimes shown as category A + . The doctor may only prescribe an amount sufficient for one month of treatment; In justified exceptions, the medication can be obtained again for three months. Narcotics may only be prescribed by the doctor who examined the patient himself.

Examples: morphine , pethidine , methylphenidate .

Some substances or preparations regulated by narcotics law (lists b and c of the Narcotics Directory Ordinance) are exempt from the obligation to prescribe narcotics prescriptions and are subject to category B (e.g. benzodiazepines , barbiturates ).

Category B (dispensed on medical or veterinary prescription)

Requires a prescription. Long-term prescriptions for repeated use are permitted, although federal laws do not limit the period of validity of long-term prescriptions. However, various cantons set an upper limit of either 12 or 24 months based on laws or collective agreements with the health insurance companies .

Category B drugs can be harmful to health even if used as intended. Medicines in this category are used for diseases for which medical diagnosis and / or monitoring is recommended. There are also active ingredients whose effects have not yet been sufficiently researched and active ingredients for parenteral use in this category. Novel active ingredients are therefore initially considered to require a prescription before they can be released into Category D.

Examples: Methylprednisolone , Ibuprofen (in higher doses), Novalgin , Ringer's lactate (because it is administered parenterally), Tamiflu , Midazolam , Temesta , Atorvastatin , Gardasil (parenteral), Desogestrel ( birth control pill ) and isotonic saline solution (parenteral).

The competence of pharmacists to dispense category B drugs without a prescription has been expanded with the revision of the Therapeutic Products Act (in force since January 1, 2019):

  • Medicines that were previously classified in Category C can still be obtained without a prescription.
  • The active ingredient is known and has been approved for several years, and the disease to be treated occurs frequently: The Federal Council determines the indications for which the remedy can be dispensed without a prescription.
  • The drug is used to continue a long-term medication. The drugs can be obtained for one year after the initial prescription.

The dispensing of category B remedies without a prescription must be documented by the pharmacist in all cases.

Category C (historical, submitted after specialist advice from medical personnel)

Category C drugs, which existed until 2018, were only allowed to be sold in pharmacies . They were primarily defined by the fact that they did not appear in categories A or B. These remedies required specialist advice from medical professionals. The specialist advice had to be given in particular if there were significant restrictions on use ( contraindications ) or significant undesirable side effects were to be expected. Depending on the canton, drugstores could also sell these drugs if they had received a (limited) authorization to do so.

Examples of drugs that could be dispensed according to the former category C were - in limited doses or quantities - ibuprofen , hydrocortisone (dermal), codeine drops, and levonorgestrel as a pill for emergency contraception .

With the revision of the Therapeutic Products Act, which came into force on January 1, 2019, Category C was dissolved. Most of the remedies (85%) were moved to Category D, the rest (around 15%) to Category B. One reason for this is the professionalism of the specialists working in Swiss pharmacies and drugstores.

The classification in category B particularly affected drugs with codeine or dextromethorphan (opiate derivatives), which can show a considerable potential for abuse. These drugs, which are usually cough preparations, may only be dispensed by people with a narcotics license. Drugs that can seriously interact with prescription drugs and / or that require special advice were also assigned to category B.

Category D (submitted after specialist advice)

Dispensing without prescription after specialist advice, which does not have to be offered by a medical professional. Sale in pharmacies and drug stores. Medicines in this category are primarily defined by the fact that they have not been included in categories A or B.

Examples: paracetamol in limited doses , xylometazoline in lower doses.

As part of the revision of the Therapeutic Products Act, many medicinal products were moved from Category D to Category E.

Category E (submission without specialist advice)

The submission is possible in all shops without specialist advice.

Examples: remedies such as lemon balm or chamomile tea .

Web links

Individual evidence

  1. ↑ HMG, Art. 24
  2. ^ Fridolin Marty: Medicines In: Gerhard Kocher, Willy Oggier (Ed.): Health Care Switzerland 2007–2009. Huber, Bern 2007, ISBN 978-3-456-84422-0 .
  3. ↑ Ordinance on Medicines (Medicines Ordinance, VAM) of September 21, 2018 (as of January 1, 2019). Chapter 3: Tax categories and tax.
  4. ↑ Swissmedic, Swissmedic criteria for dispensing categories D and E - List of criteria for the allocation of medicinal products to other dispensing categories (as of July 2017) , accessed on March 25, 2019.
  5. ↑ Lists and directories , swissmedic, accessed on March 25, 2019.
  6. ↑ BAG: Easier dispensing of prescription drugs. September 15, 2018, accessed November 12, 2018 .
  7. ↑ Reallocation of medicinal products to dispensing category C: Evaluation completed , swissmedic, November 16, 2018.
  8. ↑ Advance information on the procedure for reallocating human medicinal products from dispensing category D to category E , swissmedic, November 21, 2018.