Recipe
A recipe is the composition of a drug that is manufactured in the pharmacy for a specific patient from the required raw materials, usually on a doctor's prescription. The term recipe can also refer to the composition or preparation of care products or food and luxury goods.
If a recipe is demonstrably prescribed more frequently, the pharmacy may manufacture the drug in advance as a finished drug in accordance with the pharmacy operating rules with restrictions . In this case, one speaks of defecture (with regard to the manufacturing permit) or extended recipe (with regard to the authorization requirement).
In the technical language of pharmacies, a recipe can also mean the preparation of a drug according to a prescription or the work room in which the drugs are prepared. In Austria, the manufacture of pharmaceuticals in pharmacies according to a doctor's prescription is called magistral preparation , in Switzerland the term Formula magistralis is common.
Legal basis (Germany)
If a formulation is a medicinal product as defined by the Medicines Act , its provisions apply. There is no licensing requirement for prescription drugs because a prescription is not a finished drug. In contrast to this, a drug that is manufactured in accordance with the defect is a finished drug, which, however, is exempt from the authorization requirement according to Section 21 (2) No. 1 (extended formulation) or is produced according to a standard authorization (e.g. packaged chamomile flowers, STADA medicines). A manufacturing license according to § 13 AMG is required for the manufacture of pharmaceuticals in general . However, according to Paragraph 2, this does not include the manufacture of drugs in a pharmacy within the framework of normal pharmacy operations (recipes and defects with a maximum of 100 packaging units per day). In addition, the regulated pharmacy regulations in § 7 the production of formulations in the pharmacy.
If a formulation contains prescription substances or narcotics , it should only be prescribed by a doctor , dentist or veterinarian . The issued prescription must meet the requirements of the drug or narcotics prescription ordinance. In contrast to this, an alternative practitioner may, for example , only prescribe pharmacy- only prescriptions.
Manufacturing
Recipes include all types of pharmaceutical forms that can be produced in the pharmacy , such as capsules , suppositories , tinctures and ointments , as well as sterile pharmaceutical forms such as eye drops or parenterals if the pharmacy has a certain qualification. Tablets are seldom made in established pharmacies due to the tablet press required for their production . The pills that used to be associated with the pharmacy profession have also completely disappeared from pharmacy practice since the end of the last century.
Since 2012, the pharmacy regulations stipulate that pharmacists must check and document the plausibility of the medical prescription for each individual recipe. Should an adjustment be necessary, the prescribing doctor must be consulted. The patient himself has no say in such a case.
The production of the recipes and defects takes place in the pharmacy at a specially designed workstation. This recipe, which is also known as a recipe, is usually a workbench that is closed on several sides and, in addition to the necessary equipment such as scales , chemicals and vessels, offers an easy-to-clean surface. This is intended to prevent the pharmaceuticals produced from being contaminated with foreign substances or microorganisms, but also between the pharmaceuticals and auxiliary substances used. The preparation of the formulations is reserved exclusively for pharmaceutical personnel such as PTAs , pharmaceutical interns, pharmaceutical engineers or pharmacists .
The approximately 20,000 (as of February 2016) public pharmacies produce around 8 million patient-specific ointments, capsules or solutions for SHI patients. They also produce around six million special formulas, mainly cytostatics and nutritional solutions. In total, there are around 14 million prescriptions from pharmacies. The number of formulations that are outside of the statutory health insurance regulations (i.e. based on a prescription based on a private prescription and formulations that have been prepared on customer request) is not recorded.
Formulation
In addition to many individual recipes, as prescribed primarily by dermatologists , many generally used recipes are set out in so-called recipe forms. The most well-known of these in Germany is the DAC ( German Medicines Codex ), which has been published as a loose-leaf collection by the ABDA - Federal Association of German Pharmacists' Associations since 1972 . Since 1983, this has been expanded to include the NRF ( New Recipe Form ), which, like the DAC, is supplemented and corrected every year. Within the framework of the NRF, several hundred monographs and several thousand practical handouts have been compiled over the past three decades, which pharmacies can access if questions about recipes arise. The formula collection is attached to the DAC. In addition, the Central Laboratory of German Pharmacists regularly conducts round robin tests in which pharmacists can have the quality of their formulations checked.
When formulating a recipe, the doctor uses a code that enables him to describe a recipe clearly and with little writing effort. The text begins with Rp. , The Latin abbreviation for recipe ("take"). Then the desired medicinal substances and the amount to be used are given in grams. In the past, the names of the fabrics were only given with their Latin names. Nowadays, however, due to the possible confusion ( Kalium chloratum denotes, for example, potassium chloride and not, as can be assumed, potassium chlorate ), the German names are largely used. If the abbreviation āā for ana partes aequales (Latin for “equal parts”) is placed in front of a quantity , this means that the specified substances should be used in the same quantity. The last substance named was the base or filler to be used, which with the addition of ad (Latin for "on") indicated the mass of the entire preparation to which this base was to be filled. Instead of the amount of an auxiliary or filler, the abbreviation qs can stand for quantum satis , which indicates that “as much as needed” should be taken from this substance.
At the end of the formulation there is an instruction under the substance list, what is to be made from it and how it should be dispensed. On the one hand, this can be MDS as an abbreviation for the Latin “misce, da, signa” , which means something like “mix, give and denote”, followed by a note on how to use the remedy. "Mix" is not necessarily to be understood literally, but should mean something like "make"; the production is often much more complex than a mundane mixing of the components. If, based on the recipe, it is not clear which dosage form is to be produced, the doctor can also state the desired type of preparation with the number of individual doses. For example, instruction “M. f. caps. No. XX “ to produce 20 capsules. Written out, this Latin instruction means "Misce [, ut] fiat capsulae" and translates as "Mix so that they become capsules".
The specified amount of medicinal substances in the formulation refers to the total weight of the preparation as standard, which is based on e.g. B. 20 pieces is to be divided. The doctor can do this by adding “div. in part. aequ. No. XX ” , “ divide in partes aequales numero XX ” by stating“ divide into 20 equal parts ”. In contrast to this, the instruction “dentur tales doses numero XX” , or “d. valley. dos. no. XX " , that the above formulation quantity refers to a single dose and, as mentioned in the example, 20 of these are to be dispensed.
The instruction “da” (“give”) should actually be followed by the information on the packaging, but such information is extremely rare.
The last part of the prescription instruction, which is abbreviated as signa ("denote") from MDS , or independently as S. , states the number and duration of the use of the drug and, if necessary, instructions for use, which are intended for the patient and therefore not in Latin, but are written in the national language. This can be formulated, for example, “three times a day” or “in case of pain up to four times a day” with the note “shake vigorously before use”. As modern dosage information , especially for finished medicinal products , the doctor uses a spelling such as “1–0–2” (ie one in the morning, none at noon, two tablets in the evening), alternatively also in four steps, e.g. B. "0-0-0-1", read as "morning-noon-evening-at night". Although instructions for use are mandatory for prescription drugs in accordance with the drug prescription ordinance, they are mostly forgotten by the doctor.
A complete closing formula could read something like: “M. f. Ungt. D. ad Ollam albam S. 2 × daily thinly on the affected areas of the skin "(" Misce, ut fiat Unguentum, da ad Ollam albam, signa twice daily ... "); in German: Mix so that it becomes an ointment, put (this) in a white jar , label (it with the inscription) "2 × daily ..."
Examples
The following examples are intended to clarify the use of the recipe language and are given without application reference. Omitting the units of measure for the components is common practice, since what is usually meant is grams . The pharmacist is also responsible for checking the pharmaceutically appropriate quantities of the ingredients (over- or under-dosing), which may need to be clarified with the doctor.
Rp.
Urea pur. 10,0 Cremor bas. ad 100,0
S: 1xtägl./Füße
In this case, the doctor prescribes that 10.0 grams of urea (lat. Urea pura ) should be mixed in 90.0 grams of base cream DAC (lat. Cremor basalis ), i.e. a total of 100.0 grams of cream. The Signa 1x daily / feet means to apply the cream to the feet once a day. The instructions for use ( Misce, [ut] fiat unguentum ) are often omitted for creams and ointments.
Rp.
Ol. Oliv. 20,0 Zinc. ox. Talcum āā 15,0 Ungt. molle ad 100,0
In addition to 20.0 grams of olive oil , the doctor prescribes 15.0 grams of zinc oxide ( lat.Zincum oxydatum ) and 15.0 grams of talc . The instruction āā ( ana partes aequales ) saves him from repeating the same weight specification . In order to achieve the required 100.0 g total mass, 50.0 grams of soft ointment (Latin: Unguentum molle ) must be added.
Rp.
Ol. Oliv. 20,0 Zinc. ox. Talcum āā ad 15,0 Ungt. molle ad 100,0
In contrast to the previous example, the amount of 15.0 grams is divided into equal parts of zinc oxide and talc, i.e. 7.5 grams each. This does the instruction āā ad .
Rp.
Fluconazol. 0,1 Mannitol. q. s.
M.f.Caps. d. tal. dos. Nr. XX
Here the doctor prescribes 20 capsules each containing 0.1 grams (100 mg) of fluconazole . Since dentur tales doses number XX is indicated, the indicated amount per capsule is interpreted as “20 capsules dosed in this way” should be given. Mannitol quantum satis should be used as an excipient, i.e. as much as needed to properly fill the capsules. However, the explicit mention of the filler is unusual on prescriptions and is not absolutely necessary according to the drug prescription ordinance (only the indication of the active ingredients is required ). According to the general recipe specification of the New Recipe Form, 0.5% highly dispersed silicon dioxide ( Aerosil 200 ) is added to the mannitol as a flow control agent. In addition, white- opaque hard gelatine capsules of size “0” should be used, unless otherwise stated.
Rp.
Fluconazol. 4,0 Mannitol. q. s.
M.f.Caps. div. in part. aequ. Nr. XX
In contrast to the previous example, the 4.0 grams of fluconazole are divided equally between 20 capsules ( divide in partes aequales numero XX ). Each capsule should therefore contain 0.2 grams (200 mg) of active ingredient.
Labeling of prescription drugs
In accordance with the labeling obligation for finished medicinal products according to Section 10 of the Medicines Act, the Pharmacy Works Regulations require - albeit less extensive - labeling of prescription medicinal products. As mandatory information according to § 14 , at least the following must be stated on the label :
- Name or company of the owner of the pharmacy and their address
- Contents according to weight, volume or number of pieces
- Type of application and, if applicable, the instructions for use given in the prescription ("Signa")
- The active ingredients according to type and amount and other ingredients according to Art
- The date of manufacture
- The expiration date
- Name of the patient
In practice, in addition to the active ingredients, the additives added and any preservatives used are usually mentioned . These pharmaceutically necessary substances are increasingly the cause of allergic reactions, which is why they are mentioned on the label in the interests of consumer protection. Recipes with dangerous physical properties, such as flammable ethanolic or diethyl ether-containing solutions, must be marked with a hazard pictogram , the signal word, the information about the special risks and the safety advice in accordance with the Hazardous Substances Ordinance . In contrast to this, the hazard warnings for the active ingredients used do not have to be given, as these are no longer hazardous substances in the legal sense when they are processed into a medicinal product.
If the formulation refers to a standard formulation, for example from the New Formulation Form , this identifier (e.g. NRF 11.23 ) must also be specified on the formulation label . If necessary, the regulations of standard formulations require additional information on the label.
Documentation obligation
According to the pharmacy operating regulations, there has been an obligation to document formulations since 2012, as well as the obligation to carry out a written plausibility check of prescribed formulations.
See also
literature
Individual evidence
- ↑ Duden online: recipe. see meaning 2
- ↑ Duden online: recipe. see meanings 1a and 1b
- ↑ Verdict: The recipe is not a request concert. on: apotheke-adhoc.de , September 14, 2016, accessed on September 14, 2016.
- ↑ »www.abda.de« , Figures, Data, Facts 2015 (accessed on March 9, 2016).
- ↑ History of the DAC and NRFs .
- ↑ Factsheet: Prescription drugs from the pharmacy .