Definition
Most drugs today are pre-produced in large quantities and enter the market ready for use. However, drugs also exist that are produced in the laboratory by pharmacies on a doctor’s prescription for individual customers. These are referred to as extemporaneous preparations. The following is the definition according to the Federal Law on Medicinal Products and Medical Devices (HMG, 2019): “Medicinal products prepared in a public pharmacy or in a hospital pharmacy in execution of a medical prescription for a specific person or a specific group of persons or for a specific animal or a specific animal population (magistral formula); based on such a prescription, the medicinal product may be prepared in the public pharmacy or hospital pharmacy on an ad hoc or defect basis, but may only be dispensed in response to a medical prescription.” The manufacture of extemporaneous preparations may also be entrusted to a company with a corresponding manufacturing license, for example, a specialized laboratory (contract manufacturing). The reason for the production is usually that there is no corresponding drug available on the market or the desired dosage or form is not available. This is, for example, because the drug is not available, is no longer distributed, it is an off-label use or the sale is not commercially interesting. Incompatible excipients can also play a role in this context. Now and then, extemporaneous preparations are no longer needed because a new finished drug has been registered. Extemporaneous preparations are traditionally particularly important in dermatology, hospital pharmacy and pediatrics. Medicines for children, such as deep-dose drops, suppositories and syrups, are often lacking. In Germany, the term “individual prescriptions” is also used, especially when there is no officially tested manufacturing specification. Magisterial prescriptions increase the flexibility of drug therapy by prescribing patients individual preparations for which no official approval exists. Disadvantages include laborious and sometimes costly manufacturing and limited availability.
Examples
The following list shows a small selection of known extemporaneous preparations:
- N-acetylcysteine eye drops
- 4-Aminopyridine capsules
- Azathioprine suspension
- Calcitriol drops
- Capsaicin cream
- Castellani solution
- Cortisone mixed ointments
- Diltiazem ointment
- DMSO cream
- Intravesical oxybutynin solution
- Methadone solution
- Midazolam nasal spray
- Nifedipine cream
- Riboflavin capsules
- Salicylvaseline
- Spironolactone cream
- Timolol gel
- White shake mixture
Manufacturing instructions
An up-to-date manufacturing prescription is required for the preparation. For galenic, pharmacological and toxicological reasons, tested and established prescriptions should be used if they are accessible. Appropriate instructions can be found in the technical literature (e.g. DMS), in pharmacopoeias, in databases (e.g. New Formulation Formulary, NRF) and in internal company documents. The basis for the procedure is presented in the Swiss Pharmacopoeia (Pharmacopoea Helvetica) in the chapter “Rules of Good Manufacturing Practice for Medicinal Products in Small Quantities”. Controversial, outdated and questionable formulations should be avoided.
Price Calculation
In many countries, the price of extemporaneous prescriptions is usually calculated using the Federal Office of Public Health‘s List of Medicines with Tariff (ALT). This is because it contains the prices that may be charged to health insurers for the substances, the work performed, and the vessels. However, this list is not complete.
Labeling
Magistral formulations must be labeled “Formula magistralis” on the container and packaging material, according to the Ordinance on Medicinal Products.
Sources of supply
Magistral prescriptions are generally available at any pharmacy on prescription from a physician. Pharmacies either make them themselves or order them from specialized suppliers. Specialized suppliers of extemporaneous preparations to the specialty trade are (contract manufacturing, examples):
- Apolab
- Bichsel laboratory
- Elvetix Pharma
- Formula Laboratory Schaffhausen
- Hänseler AG
- Hospital pharmacies and cantonal hospital pharmacies
- Pharmacie Golaz
Former suppliers that are no longer operational:
- Laboswiss in Davos, discontinued since 1.8.2013.
- Galderma / Spirig, discontinued since 22.6.2018, successor: Elvetix Pharma.
- Streuli, discontinued since the end of 2010
Suppliers of active ingredients, excipients and packaging materials.
Specialty retailers can order the required active ingredients, excipients and vessels from the following suppliers, among others (selection):
- Anwander (vessels, laboratory material).
- Dixa (medicinal drugs)
- Dynapharm
- Hanseler
- Inresa (via Hanseler)
- Müller and Krempel (vessels, laboratory material)
- Sigma-Aldrich
- Fagron
- Pharmaserv
