Risk assessment pharmacy preparation

Prior to initiating the design phase, feasibility of a preparation or product has to be assessed. For pharmacy preparation this assessment is discussed in Sect. 2.2. At the end of the life cycle, a production is discontinued due to an unfavourable risk/benefit ratio or economic reasons. For pharmacy preparations, loss of feasibility may also be the reason for discontinuation. 

Upon receipt of a request from a prescriber for a pharmacy preparation, the pharmacist must decide whether the request is appropriate and reasonable, and judge the level of risk associated with proceeding with the request. The pharmacist must also consider the risks of not supplying a medicine which may lead to the patient not receiving treatment. Further discussion with the medical team may be needed. This chapter approaches the risk assessment of the prescription in a structured way, referring to procedures and forms from different countries. The assessment also includes the feasibility of producing a preparation of appropriate pharmaceutical quality and with all necessary clinical information. 

Has a risk assessment been carried out that has established pharmacy preparation as the most appropriate choice for this patient ... 

Bouwman Y (2013) Risk assessment forms for pharmacy preparation. Eur J Hosp Pharm 20 A58. doi 10.1136/ejhpharm-2013-000276.161... 

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. 

Storage in a refrigerator Deep-freeze storage These measures reduce microbial contamination or prevent an increase in contamination during preparation and storage. For extemporaneous preparation of eye drops in pharmacies the responsible pharmacist must select the most adequate sterilisation technique after performing a risk assessment. 

Pharmaceutical companies, hospital and community pharmacies prepare medicines. Although batch sizes vary greatly, the underlying principles of product development are comparable and driven by physical chemistry, physiology and pharmacokinetics. When the medication is meant for only a small group of patients or even for individual use, these principles cannot be fully elaborated and formulation becomes more and more based on risk assessment. 

This section discusses some applications of risk assessment in preparation and pharmacy practice. In this book more examples can be found see Sect. 34.14.2 on parametric release at autoclaving Sect. 2.2. on prescription assessment Sect. 26.7.3 on occupational safety and health risk matrix. 

For prioritising actions both hazards (microbial contamination and faulty composition) were related to the frequency of administration. The top 10 of both frequency lists are taken into the risk assessment. The risk matrix puts the frequency of administration against the risk of contamination or the risk of faulty composition respectively (= Tables 21.4 and 21.5). These matrixes visualise which products have to be improved first. Risk reduction can be achieved by decreasing the number of steps, for example by pharmacy preparation of premixed preparations or prefilled syringes. 

In pharmacy preparation, management of risk, whether structured or not, is used on many occasions within the lifecycle of the medicine (see Sect. 35.4). QRM starts with the assessment of the physician s request for pharmacy preparation (see Sect. 2.2). The scientific and professional knowledge of a pharmacist has to be used to decide whether the... 

Before preparation, a risk assessment should always be carried out in order to define the level of the quality assurance system which should be applied to the preparation of the medicinal product. And The Product dossier should therefore state the considerations about the risk of pharmacy preparation versus unavailability of the product and should contain more information for products with a higher risk. The Risk Assessment should refer to ... 

Wearing gloves for protection of the skin is increasingly common practice with pharmacy preparation. In the risk assessment model of Sect. 26.7.3 it even replaces any effort of estimation of skin exposure. Gloves are minimally indicated when the substance bears specific H statements, see Table 26.4, rows Irritation (skin, respiratory tract and/or eyes) and Sensibilisation (skin and or respiratory tract). 

The European Resolution on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients [2] describes the following list of topics to be covered in a product file, depth and interpretation depending on a risk assessment (see Sect. 21.6.3) ... 

Before a prescription with a request for a pharmacy preparation can be approved, it has to be decided whether there is a specific clinical need for it. When defining the place in therapy, part of the assessment is the risk that is presented to the patient or a patient group both from receiving the preparation and from not receiving the preparation because it would not be available [3]. The risk should be estimated on the basis of a documented risk assessment (see Sect. 2.2.3) and the outcome of the assessment is recorded in the product file. 

Section 35.6 describes a large series of PQS elements, each of them with examples from pharmaceutical preparations. The extent of their use in the manufacturing situation or in pharmacies depends on the outcome of risk assessments. As elements they should principally be adhered to in both situations. 

If the pharmacist however has to assess which products are less critical he may as well use the GMP principles as starting point. These principles are valid for any sort of preparation they just have to be detailed and specified (by a risk assessment, see Sect. 21.6.3) for any pharmacy preparation situation. 

For the quality management of therapeutic assessment of the physician s request and formulation design (two other processes of pharmacy preparation s life cycle), no reference is made other than to professional respruisibility and education. In this way, the Resolution (and thus its example model for a risk assessment) is rather unbalanced, because too much is focussed on the preparation process itself. 

The ICH QIO guideline is developed as a PQS model for the whole life cycle of an industrially made product. It therefore starts with the design phase of the product and ends with product discontinuation. It does not include however the very first step the therapeutic issues (prescription assessment, benefit/risk balance) which are relevant for pharmacy preparations. 

In pharmacy preparation the very first step of Product realisation is the prescription assessment for an individual patient or the benefit/risk assessment (and definition of indications) for a stock preparation. See Sect. 2.2 for the performance of this step and for the assignment of responsibilities. 

The frequency of internal audits should be the highest for the most critical processes. A risk assessment, focussed on the risk for the patient, can be used to put processes in an order of criticality. In hospital pharmacies the preparation of parenterals is generally seen as having the highest risk. For a large medicines preparation department in a hospital pharmacy, frequencies may be set at ... 

Make a risk assessment and decide if a pharmacy preparation must be destroyed or recalled (see Sect. 36.11.2). 

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