« Previous | Contents | Next »
Listen
Good Practice Statement for the Preparation of Injections in Near-Patient Areas, including Clinical and Home Environments
1 INTRODUCTION
1.1 Background
Medicines for injection are not always available from the manufacturer in a ready-to-use form. Therefore, many injections need to be prepared before they can be administered. For example, in NHSScotland, it is estimated that at least 650,000 antibiotic injections are prepared in near-patient areas each year, and 350,000 in pharmacies.
8
The process of preparation may be straightforward, for example a simple dilution, or complicated, for example involving complex calculations, or several manipulations. There are the risks of error in the calculations and during the manipulations involved, and risks of microbial and particulate contamination. The nature of the medicine, and the clinical condition of the patient, affect the degree of the overall risk.
The Expert Group acknowledged at an early stage that the available evidence of error rates associated with the preparation of injections in scientific literature is limited. However, individual cases have resulted in serious outcome or even death to patients,
9,10 and some have been the subject of litigation and media attention.
1.2 Hazards associated with the preparation of medicines for injection
The hazards associated with the preparation of injections may be summarised as follows:
Incorrect dosage calculation Selection of the wrong drug or diluent Incorrect method of preparation Incompatibility of constituents Instability of the final product Microbial contamination Particulate contamination Health and safety risk to the operator or the environment.
|
Since 1990, data on errors in the injection preparation process have been systematically collected.9 Examples of serious medication errors that have been reported include:
Error in the calculation of the dose, e.g. one hundred times the correct dose of morphine administered to a neonate, resulting in patient death.9 Selection of the wrong drug, e.g. gentamicin instead of clindamycin, resulting in serious adverse reaction.9 Selection of the wrong diluent, e.g. strong potassium chloride solution selected instead of 0.9% sodium chloride solution, resulting in patient death.10
|
Physical and chemical incompatibilities may result in loss of potency, or toxicity, e.g. precipitation due to pH changes, breakdown of fat emulsions when electrolytes are added.
Inadequate mixing during preparation of infusions may result in the formation of a concentrated layer of the additive. Strong potassium chloride solution is particularly prone to this effect, and administration of an infusion of this product that has not been thoroughly mixed may result in a serious adverse reaction for the patient.
Degradation of the final product due to instability may result in the formation of toxic substances, or in loss of potency.
The risks of microbiological contamination of the final product increase when injections are prepared in environments without suitable controls. Over the past thirty years, surveys on intravenous medicines prepared in near-patient areas have shown a range of microbiological contamination rates ranging from 2 to 15% (average 8%).
11-20 Although most of the contamination does not lead to sepsis,
21 the nature of the contaminating organism cannot be predicted. Therefore, the risk of serious sepsis cannot be discounted, particularly if the patient is immunocompromised, or if the injection solution supports bacterial growth.
22 There are many possible sources of microbiological contamination,
21,23,
24 for example, dirty preparation areas, omission of handwashing, and failure to swab vial tops. It has been shown that a contamination rate of less than 0.1% is achievable in near-patient areas by an experienced operator using aseptic technique
25.
1.3 Current standards
Injections prepared in pharmacies are subject to a high level of control to comply with national standards.
22,26-35 Integral to the standards is the requirement to undertake external audits of NHS pharmacy aseptic dispensing services. Progress has been made, however, deficiencies remain in premises and their maintenance. Investment is required in the aseptic facilities and in the support available from estates personnel to correct the deficiencies.
There is wide variation in practice in the preparation of injections in near-patient areas, and there are no national standards. This document aims to provide a standard for NHSScotland.
1.4 Improving practice
The standards currently in place for injection preparation
22,26-35 have been developed as a consequence of individual cases that resulted in serious patient harm or death, but the scope of these standards is limited to pharmacy aseptic dispensing services. It is desirable, therefore, to take a pro-active approach, and to review practice to further reduce the risk associated with the preparation of injections.
The good practice statements have been developed to raise awareness that the use of medicines by injection is hazardous, and should be avoided where possible, and to provide guidance on the standards of practice that should be adopted by all personnel involved in the supply and preparation of injections. They provide a framework for the development of policies and procedures to take account of local needs and circumstances. Risk assessments may be applied to patient groups or categories of medicines to decide broad policies, and also to individual patients and situations to decide action in particular circumstances.
The good practice statements are based on the following risk-management principles:
Raise awareness of the existence of the hazard Eliminate the hazard at source, or substitute the hazard with something less hazardous Design and organise practices and processes to minimise risk Provide information, instruction, and training Implement suitable and sufficient control measures.
|
« Previous | Contents | Next »