Development of a paediatric intravenous formulations manual

Abstract

Safe and effective administration of injectable medications is key to patient safety. A Parenteral Drug Therapy Manual (PDTM) is a document or database that includes information related to administration, reconstitution of medicinal products, compatibility with other medicines and adverse reactions. The manual is used as a guidance for the preparation and administration of medications via parenteral routes. The need for a PDTM for paediatrics at the local general acute hospital, Mater Dei Hospital (MDH), led to the development of this research project.

The objectives of the study were to 1) develop and validate drug monographs for the medications administered intravenously in paediatric wards at MDH 2) develop and administer a questionnaire to evaluate the impact of drug monographs on the knowledge, confidence and contributing factors to medication errors from the nurses’ perspective in a pre- and post-test design.

The methodology was divided into three phases. The first phase entailed the identification of medications commonly used in paediatric wards. The data was collected from pharmacy databases, surveying nurses working in paediatric wards and consulting nurses in charge of the respective wards. In the second phase of the study, drug monographs were developed for the selected medications, where each monograph contained therapeutic information and information related to reconstitution, dilution, compatibility and stability, monitoring of safety and efficacy of medications and other data such as interference with lab results and sodium content. Published literature, evidence based local practice, latest updated SmPC (Summary of Product Characteristics) and manufacturers of the medications were consulted to develop monographs. The monographs were sent to hospital pharmacists for review and approval as hospital practice guidelines. For the third phase of the study, a questionnaire entitled Assessment of Administration Practice (AAP-Q) was developed and validated by 11 experts. The AAP-Q was distributed to nurses working in paediatric wards at MDH prior to and after introducing drug monographs in the wards to evaluate the impact of the monographs on the administration practice of nurses.

Twenty active pharmaceutical ingredients were selected and a monograph was developed for all strengths and different brands of the respective medication. Fifty-five paediatric nurses out of 62 participated in the study. Thirty-five nurses acknowledged that they consulted the drug monographs when administering IV medications. Drug monographs were reported to i) assist in overcoming reported difficulties associated with the use of IV medications such as reconstitution and dilution practice (n=27) and choice of compatible fluids (n=20), ii) reduce the impact of factors leading to medication errors associated with insufficient knowledge (pre-test mean rating score (MRS) 4.49 and post-test MRS 1.74, p<0.001) and lack of standard guide for using injectable medications (pre-test MRS 4.05 to MRS 1.56 post-test, p<0.001).

The developed monographs were considered to have a positive impact on the safety of medication administration by contributing to standardisation of practice and providing an easy-to-use reference at the bed side.