Preparation in the pharmacy

Extemporaneous preparations, such as creams that are prepared in the pharmacy, have an expiry date of 4 weeks. The creams can be stored at room temperature. 

Large- and small-volume parenteral products are prepared in the pharmacy and delivered at regularly scheduled times to the patient care area 7 days/week. 

The allowance of preparation of medicines in the pharmacy is not self-evident. The main aim of EU legislation is to ensure that medicinal products have a license. This requirement results in a comprehensive external control of the efficacy, effectiveness and safety of the pharmaceutical quality. Medicines prepared in the pharmacy don t have a license and but pharmacy preparation is an allowed exception to this rule. The reason for this exception is the need for some medicines which are not available with a license. The exception is only applicable to the patients of the pharmacist, which should have a prescription from the treating physician. The essence of the exception is limiting the patient s risk of getting an ineffective, inefficient and unsafe medicine by ... 

Informing the patient about the nature of pharmacy preparations is not yet common practice in many countries. In the UK patient leaflets on this topic are available [88]. They explain both the preparation in the pharmacy and off label prescribing of licensed medicinal products. Both situations have in common that physician and pharmacist will of course act according to disease-specific professional guidelines or following a documented risk assessment. 

Preparation in the pharmacy involves more activities than preparation from raw materials only. It comprises (see Fig. 3.2) ... 

Capsules release their contents when at least a part of the capsule shell is dissolved. The Ph. Eur. requires that capsules disintegrate within 30 min [6]. However, the shell of gelatine capsules usually dissolves within 3-15 min in the aqueous, acidic gastric lumen. The powder in capsules prepared in the pharmacy has not been subjected to a compression stage, as is the case of most industrially manufactored capsules. Therefore, the content of pharmacy prepared capsules is usually released more quickly than industrial prepared capsules. 

Dental fluoride gels are normally acidic in order to obtain a better effect. However, when the salivary glands are damaged by radiation or chemotherapy, the acidic licensed preparations are often not tolerated, as they will be too irritant on the mucosa. A neutral dental fluoride gel, prepared in the pharmacy, would be the medicine of choice. Formulations containing ethanol can also irritate a damaged oral mucosa. 

Within this chapter the emphasis is on dosage forms that are prepared in the pharmacy and on forms that are supphed by the pharmacy. 

Active substances formulated as nasal preparations are traditionally used in the treatment of local ailments such as allergy, congestion and infections. Nasal preparations that are prepared in the pharmacy are mainly intended for the inner part of the nose. In addition nasal drops are often applied in diseases of the middle ear, in order to keep the Eustachian tube open (see Sect. 9.1). 

To get an idea of the stability of an extemporaneous preparation the only possibility is to keep a part of the preparation in the pharmacy in order to be able to recall if necessary or to have some information in case of a second prescription. For background information on the instability of disperse systems (suspensions, emulsions) and the ways to overcome those stability problems, see Sect. 18.4. For a useful review about the changes in dissolution rate during shelf life and how to prevent them, reference is made to [4]. 

Starting materials in pharmacy preparation sometimes are semi-finished products, e.g. cream bases for cutaneous preparations, concentrated solutions of preservatives or triturations of active substances. Usually this type of products will be kept in stock in jars. They may be prepared in the pharmacy, or bought from a wholesaler. These products can be considered as raw materials for a preparation. 

In (hospital) pharmacies the responsible pharmacist is in charge of pharmacovigilance of the products prepared in the pharmacy. 

The distance between the rolls can be reduced up to a minimum of 20 pm, thus principally enabling the grinding of crystalline particles to this size. Whether this is appropriate should be determined for each individual product. Commonly preparations in the pharmacy will use raw materials with the required particle size. 

In relation to preparation in the pharmacy, weighing is used in the preparation process and in Quality Control. Firstly measurement uncertainty is dealt with in relatimi to Quality Control. 

Medicines that are prepared by the pharmacy have to meet the specific national law. This depends on the country in Europe. As an example the situation in the Netherlands is described here. Regulations about the quality requirements for medicines prepared in the pharmacy are from 2007. It is stated that medicines prepared in a pharmacy, not being investigational medicines, may only be dispensed when they meet the instructions of the European Pharmacopoeia (Ph. Eur.) or, in the absence of a monograph, meet the monographs of an officially used Pharmacopoeia in a member country, or of an officially used Pharmacopoeia in the United States [3] or Japan [4]. Raw materials of good quality must be used. 

It is also stated that the amount of a drug substance of a medicine prepared in the pharmacy does not deviate more than 10 % of the amount of that substance that is mentioned on the label of the container. For the average content of the active substance the quality requirements from a foreign Pharmacopoeia are not applicable. It is important to note that all quality requirements are valid in principal until the expiry date of the product. 

In the monograph Pharmaceutical Preparations of the Ph. Eur. there are no requirements for the content of the active substances. In some European countries, such as the Netherlands, it is stated in national law that the amount of an active substance of a preparation prepared in the pharmacy should not deviate more than 10 % of the amount of that substance that is stated on the label. 

In practice pharmaceutical quality management systems (PQSs) may follow the structme of quality standards for medicines, mainly GMP, PIC/S-GPP, and QIO to which GMP is referring. These standards are described as well as standards that are more applicable to preparation in the pharmacy i.e. the Ph. Eur. monograph Pharmaceutical Preparations, the Council of Europe (CoE) Resolution and USP Compoimding Standards. If a PQS has to cover the complete life cycle of the product, preparation in pharmacies or even all pharmacy activities then a more universal structure such... 

When a pharmacy is faced with a recall it is usually related to a defective licensed medicine. According to ISO 9001, a recall is considered to be a complaint and should be dealt with according the general complaint procedure. This also applies to complaints due to medicines prepared in the pharmacy. 

The preparing pharmacist must have procedures in place to handle drug recalls from two different perspectives. Firstly as a manufacturer the preparing pharmacist may have to initiate a recall on a product that has been prepared in the pharmacy. Secondly there must be a procedure to handle recalls initiated from outside the pharmacy. This latter procedure is usually the responsibility of the main pharmacy. However the preparing pharmacist must be part of the team which acts on recalls if the recalled product is associated with a prepared medicine because of the legal responsibilities held by the individuals in the preparing section. This may initiate a recall as a manufacturer ... 

Oral suspensions should best be prepared in the pharmacy just before dispensing, but in situations where this is not possible, e.g. on holidays, it will have to be done by the patient. In such cases the pharmacy could supply a bottle with a grade mark, to measure the right amount of water. 

For several years pharmacists in many European countries have felt the need for knowledge, information and guidelines on the practice of preparation in the pharmacy. This was clearly put forward by experts from many European countries at the EDQM symposium on European Cooperation and Synergy and at the BEAM compounding course. During this course it was agreed that the knowledge for the preparative pharmacist were contained in the Dutch book Recepteerkunde and that this book could be used as a base for a European wide textbook on preparation in pharmacies. 

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