Pharmacy preparation

Radiopharmaceuticals. Radioactive isotopes for human use in the diagnosis and treatment of disease states are called radiopharmaceuticals. Whereas the dosage form types used, e.g., solutions or injections, are traditional, special handling of these products during compounding, transport, and use is vital. Most are administered intravenously and shortly after preparation. Specialized pharmacies prepare these products overnight and transport them to hospitals for early administration by members of nuclear medicine departments. 

An important element of financial cost analysis in the pharmacy department is the development of productivity assessment reports. Most directors of pharmacy prepare a productivity report for each pay period... 

This budget shows expected cash receipts as a result of selling goods or services and planned cash disbursements to pay the bills incurred by the pharmacy. Pharmacies prepare cash budgets to allow them to anticipate changes in cash flows over a period of time. 

American society of hospital pharmacists, technical assist- 35. ance bulletin on quality assurance for pharmacy-prepared... 

ASHP technical assistance bulletin, quality assurance for pharmacy-prepared sterile products. AJHP 1993, 50,... 

To evaluate impact of i.v. to oral switch program for ranitidine OA Pre/post None DCA, pharmacy preparation costs Cost avoidance 4214 Input costs not considered... 

American Society of Hospital Pharmacists. ASHP technical assistance bulletin on quality assurance for pharmacy prepared sterile products. American Journal of Hospital Pharmacy 50 2386-2390, 1993. Anderson, R. Security Engineering. New York Wiley, 2001. 

Crawford, S.Y., Narducci, W.A., and Augustine, S.C. National survey of quahty assuranee activities for pharmacy-prepared sterile products in hospitals. American Journal of Hospital Pharmacy 48 2398— 2413, 1991. 

Santell, J.P. and Kamalich, R.F. National survey of quality assurance activities for pharmacy-prepared sterile products in hospitals and home infusion facilities 1995. American Journal of Health-System Pharmacy 53 2591-603,1996. 

The pharmacist needs to assess the doctor s prescription, for therapy reasons, but within the focus of this book also for availability and, in case of a pharmacy preparation, for safety and quality as weU. 

The textbook started its life in the field of pharmacy preparation and although the focus of this edition is on mainstream manufactured products as well, much attention goes to provisions that the hospital or community pharmacist has to offer because not every patient fits the mainstream. It became obvious that official terminology for these peripheral activities is insufficiently discriminating. Therefore a terminology was developed as pictured in Fig. 1.2. 

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. 

This case is typical of requests for pharmacy preparations in order to give tailor-made care, the doctor has prescribed an individual preparation instead of a licensed pharmaceutical preparation. When the oral route would have been an option, licensed oral solid medicines had to be adapted anyway because of the low dose required. 

However, pharmacy prepared products are not subject to the same levels of scrutiny with respect to quality assurance and efficacy as licensed medicines therefore prescribers and pharmacists cannot make the same assumptions of quality, safety and efficacy about these products as they do for licensed medicines. 

This is due to the wide range of elevated risks associated with pharmacy preparation, including calculation and manipulation errors, formulation failures leading to overdose or underdose, possible toxicity from raw materials and microbiological contamination. The relative lack of... 

Despite the relative lack of information about side effects related to pharmacy prepared products, there have been reports of catastrophic errors associated with them, including an error in the US that led to a 1,000-fold overdose of clonidine in a 5 year old child [1]. A high profile error also occurred in 1998 in the UK, when a baby died following a calculation error in preparing peppermint water in a community pharmacy [2]. 

The same principles apply for reviewing prescriptions for pharmacy preparations as for licensed medicinal products. 

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

At Leeds Teaching Hospitals NHS Trust in England, the Pharmacy department has a catalogue of authorised pharmacy preparations, which is periodically reviewed to ensure that other more suitable options are not available. Each of the approved preparations on the catalogue have been reviewed by a group of senior technicians and pharmacists to ensure that they have a sound evidence base and are backed by an authorised preparation instruction and agreed label. 

A risk-benefit form has been elaborated for extemporaneous and for stock preparation (Figs. 2.4 and 2.5). They enable the pharmacist to list and balance the benefits and risks of the clinical and pharmaceutical qualities of the required pharmacy preparations. The form follows the process for handling of requests for preparation, and defines decisive steps, levels of evidence of decisions, individuals concerned and responsibilities. 

Fig. 2.6 Balancing benefits and risks of specific pharmacy preparations...

The pharmacist should consult the prescriber if it is possible or more appropriate to use a different medicine. A licensed medicinal product should be used in preference to a pharmacy preparation, if an appropriate product is available. 

The parents express concern to the paediatrician that Pirn is unlikely to comply with his treatment. Therefore, the paediatrician requests a pharmacy preparation in which all vitamins are combined. 

Pirn now only has to use daily 4 mL of the oral solution that the pharmacy prepares for him every month. 

Various national formularies exist and may be useful to consult during discussions with the relevant doctor e.g the Dutch national child formulary (wwwJdnderformulariumjil) [6] contains various pharmacy preparations, which are included in the Dutch pharmacists Formulary (FNA, see Sect. 39.4.5). 

The pharmacokinetic and pharmacodynamic changes usually become clinically more relevant over the 75th year of life. There are however large intra- and interindividual differences in aging of organ functions. Therefore, it is difficult to predict the exact pharmacological response of a given elderly patient. As with licensed medicines, it may be necessary to adjust doses of pharmacy prepared medicines carefully and cautiously in elderly patients. 

The amount of a pharmacy preparation requested can vary widely, depending on the indication and area for use. The pharmacist should assess whether the amount is right for the use (see Fig. 2.7), the length of the treatment and the shelf life. In some countries, there are systems for standardising amounts used in order to improve consistency of products and maximise efficiency in the pharmacy setting, hi addition in some countries the amounts are limited by the health insurance. 

Not every request for a pharmacy preparation is by definition a medicine. Examples include biocides, medical devices, starting materials and chemicals. It is important to make this distinction, because with that it becomes clear under which regulation the pharmacy preparation falls. The legal... 

The pharmacist should only fulfill a request for a pharmacy preparation when the prescription comes from a homeopathic or anthroposophic doctor and relates to a single medicine of a non-animal or non-microbiological source and with dilution >1 10,000, for oral or external use. 

A pharmacy preparation is allowed if necessary but uses an allowed disinfectant and excipients. 

Pharmacy preparation allows the doctor and pharmacist to provide individualised and tailor-made pharmaceutical care. The preparation of a medicine in the pharmacy fills a need when the licensed pharmaceutical preparation is not available or when a licensed pharmaceutical preparation does not satisfy a specific situation. 

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

Medicines are made available as authorised medicines, pharmacy preparations, or investigational medicinal products. For many diseases active substances are available, and yet groups of neglected patients or special patient groups will not receive the medicines they need. If a patient needs a medicine, which is not on the national market, it may be imported from abroad or prepared in a pharmacy. The complicated rules, which are nationally determined, for reimbursement (in some Countries) and Iraig procedures render importation a laborious way to make medicines available for the patient To be reimbursed some Countries require that medicines are to be shown to be efficacious, appropriate and economic. 

Globalisation of pharmaceuticals supply Medicines shortages medicines Pharmacy preparations medicines Medicines... 

Medicines are available for patients as authorised medicines or as pharmacy preparations (unlicensed medicines). Market logic ensures that only medicines with sufficient return on investment will be marketed. However, health care logic requires pharmacists to provide their patients with necessary medicines. There are regulations that cover medicines for clinical research, marketing authorisation and import, as well as traffic between European countries (parallel imports). If medicines are not available as authorised medicines, various options such as compassionate use or parallel trial programme can be considered. The authorisation of medicines for orphan diseases is promoted by the orphan dmg regulations. The system of reimbursement will be discussed briefly due to its special situation at the interface of both public health and social insurances. 

Preparations prepared in pharmacies may serve as the last choice to provide patients with their necessary medicines. The European Ministers have formally confirmed that the preparation of medicinal products in pharmacies, which may be required as a consequence of the individual or medical condition of the patient in the absence or unavailability of appropriate medicinal products on the market, is indispensable for accommodating the special needs of individual patients in Europe [1]. Mainly special patient groups need pharmacy preparations. Another need for pharmacy preparation arises from drug shortages. 

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