The Pharmaceutical Journal
Vol 268 No 7184 p193
9 February 2002
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The Pharmaceutical Journal |
Hospital Pharmacists Group
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Aseptic preparation: pharmacy's responsibility in managing riskThe Hospital Pharmacists Group is leading a discussion within the Royal Pharmaceutical Society on ensuring standards of aseptic dispensing, perhaps through some form of registration for unlicensed units offering aseptic dispensing services. There is a long history of hospital pharmacy involvement in aseptic preparation since the Breckenridge report recommended that aseptic preparations should be supplied from pharmacy aseptic units.1 However, there is a need to ensure standards of practice even in pharmacy aseptic units as identified by the Farwell report.2 Although it is appropriate for pharmacy to strive to improve standards within pharmacy aseptic units, we must not lose sight of our responsibilities under the Controls Assurance Framework3 for ward based preparation. The national quality control committee's guidelines for aseptic dispensing, which have recently been updated,4 set stringent criteria for aseptic preparation in hospital pharmacies. The main areas of control include: the environment; the preparation process, worksheet production and documentation; training and competency assessment of staff; and regular quality assurance of this system. Sadly, a great deal of aseptic preparation is still performed at ward level, where none of these standards seem to apply. If the role of improving the standard of aseptic preparation is to minimise risk to patients, surely we must either improve standards of ward level preparation or ensure that aseptic preparation is restricted to pharmacy departments, as recommended by the Audit Commission.5 One study of ward based activity identified a massive error rate among both doctors (96 per cent) and nurses (83 per cent), despite formal training and a double checking system for the latter group.6 An assessment of ward-based activities undertaken in the North West Region showed an alarming lack of awareness of policies governing aseptic preparation.7 Other sources have also identified risks associated with aseptic preparation at ward level. Professor David Cousins and Professor David Upton have highlighted a range of problems associated with intravenous drug preparation on wards, including contamination of parenteral products,8 use of potassium chloride instead of sodium chloride as diluent9 and overdoses of narcotic analgesics.10 Medical and nursing staff may undertake aseptic preparation and assembly activities under Section 9 and 11 exemptions of the Medicines Act, respectively. However, controls assurance puts the onus on chief pharmacists to carry out risk assessment of ward-based activities.3 It is therefore incumbent on chief pharmacists to undertake this assessment on aseptic preparation at ward level. The main principles to establish are that: • Aseptic preparation is an act of assembly
under the Medicines Act 1968 Some of the issues that chief pharmacists should be looking to address in their review are to ensure that policies are in place to describe the circumstances under which ward based assembly can take place and that minimum standards are laid down for the process that protect both staff and patients. Some of the questions that need to be asked are as follows: Training Training should be to an agreed standard and undertaken by individuals who have themselves a documented competency in this field. • Does the training include: personal hygiene? professional and legal aspects? pharmaceutical considerations? microbiological considerations? mathematical aspects? supervised practical demonstration of ability against the written procedure? • Are written records of training and monitoring in preparation of medicines maintained on file for each individual? • Are these subject to annual review by the individual's immediate line manager, with updating training and monitoring undertaken as appropriate? Facilities • Is there a designated area reserved for parenteral preparation that does not contain potential sources of contamination, eg, sinks, sluices, food and drink? • Is the area fitted with smooth, undamaged flush-fitted laminate or stainless steel surfaced benching with good lighting? • Is there regular and adequate cleaning? • Is there any environmental monitoring? Aseptic process • Is adequate information available for ward staff to safely undertake the preparation of each individual product? Are calculations recorded? (Consolidation of this information into a worksheet would facilitate documentation of the process.) • Are drugs, diluents and calculations double-checked by a second trained staff member and the checks recorded? • Is the product prepared using standard aseptic techniques? Other issues to be addressed include a validation process that ensures competence of staff, suitability of the environment and “fitness for purpose” of the products and an audit process that allows identification of product defects and timely remedial action. If hospital pharmacists take action to bring standards of ward based preparation into line with the basic standards required to minimise risk to patients, we believe there will be an increased demand for ready to use products. Until these become available in a licensed form, pharmacy aseptic units will need to fill the gap. To ensure that stringent mechanisms have been introduced to assure the quality of products prepared in a pharmacy aseptic unit are fully adhered to, we feel some form of registration of aseptic dispensing facilities would be desirable. We would welcome comments from the membership about this issue. Comments should be addressed to Hospital Pharrmacists Group Secretariat, Royal Pharmaceutical Society, 1 Lambeth High Street, London SE1 7JN (fax 020 7572 ÐÐÐÐ; e-mail lgriffiths@rpsgb.org.uk). |
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