IJNHCR Journal

Introduction

A range of ampoule-based preparations are currently used for intravenous administration in critical care situations. Many of the same drugs can be provided in pre-filled syringes (PFS) for emergency situations that are dose or time critical. PFS preparations of a correct dose are used as preventative measures to mitigate the risk of medication errors in perioperative settings [1,2] and reduce drug wastage [3]. There are relatively few studies comparing ampoule-based and PFS preparations in terms of drug preparation time, medication or handling errors and consumables used in the same study using a time and motion methodology. This time and motion market research simulation study aimed to: (1) determine the average time taken by appropriately trained ward nurses to prepare an appropriate single dose of a range of named critical care drugs from an ampoule or prepare a PFS ready for administration; (2) assess the consumable requirements associated with the preparation of each drug; and (3) assess the quality of each preparation, noting any preparation errors.

Materials and Methods

This time and motion study was undertaken by 7i Insights Limited as a market research project. The study was conducted in accordance with the guidelines and codes of practice of a relevant market research professional body, the British Healthcare Business Intelligence Association (BHBIA). A study protocol was developed in advance of the research being conducted.

Five experienced ward nurses from the North West of England were recruited for participation in the study.

*4 ml ampoule used in research as 3 ml ampoule was unavailable; PFS, pre-filled syringe

Table 1: Overview of drug preparations

The nurses were asked to prepare a range of critical care drugs ready for intravenous administration. Seven ampoule-based simulated critical care products were included in the study. Some of these products could be prepared using alternative ampoule sizes and diluent volumes, giving a total of ten ampoule-based variants to be researched (Table 1). The pre-filled syringes used in the study were empty and presented in a twist box.

The order in which the products were prepared for administration was rotated between nurses to avoid any ‘improvement with practice’ bias. Each nurse prepared three single syringes for each reference drug as outlined in Table 1. Two timekeepers simultaneously recorded the total time taken to prepare the final syringe for each single preparation. Both times were recorded for each attempt and used to calculate means and medians of preparation timings. Timings were not stopped except in the event of an actual injury taking place.

The nurses were asked to prepare a single syringe from the allocated ampoule(s) as if for clinical use. They were allowed to obtain and use all the necessary consumables that they would normally use. The gathering of the consumables was done in any order. The nurses were asked not to rush and to do everything they could to ensure that the preparation was performed as they would do in their real-world setting. The nurses took a short pause between the preparation of each syringe of a given product, and a short break between each separate drug preparation.

The drugs were prepared as per their relevant SPCs. Reading time was excluded from the recorded timings.

A tray and sharps bin were provided in the immediate proximity of the workspace where the preparations took place. All consumables used during the preparation of each vial or ampoule were placed directly into the tray during or after the preparation process. All consumables were counted and the confirmed number of each type of consumable was recorded immediately within the study documentation. All sharps were disposed of in the sharps bin.

All preparation errors were accurately captured in the study documentation. Preparation errors included spillage of diluent prior to dilution of drug and spillage of an ampoule. When such events occurred, the nurse continued the preparation, the time was recorded and the error was recorded in the study documentation. Additional ampoules of diluent or drug required due to a spillage were noted in the study documentation.

This was a simulated exercise; the study took place in a mock clinical environment and only non-hazardous liquids were used. No patients were involved in the study and the preparations were disposed of safely. The protocol outlined the procedure for identifying and reporting any safety issues and adverse events (Table 2). As this was a simulation of a real-world clinical environment, some simulated equipment was used in the research (e.g. regular syringe needles to simulate filter needles, a cupboard to simulate a fridge for storage of some preparations etc).

Table 2: Protocol for safety issues and adverse events.

At the end of each day, the participating nurses were asked to complete a short qualitative questionnaire. They were asked their opinions regarding various elements of the study (e.g. preparation of syringes from vials and use of the PFS). They were asked to rate their preference for ampoules vs PFS on a 5-point scale ranging from “I strongly prefer ampoules” to “I strongly prefer PFS”. The criteria were (1) speed of preparation; (2) avoidance of injury; (3) accuracy of dosing; (4) storage considerations and (5) overall preference. The nurses were also asked to rate the simulation compared with their real-world situation in terms of: (1) the process followed; (2) the preparation time take; (3) the consumables used and (4) any storage or packaging issues. The 4-point rating scale options were ‘very similar’, ‘somewhat similar’, ‘not very similar’ and ‘not at all similar’.

Results

Preparation Timings

Overall, the mean preparation time for all 10 ampoule preparations was 137.2 seconds. The mean preparation time by individual product ranged from 105.7 seconds to 191.7 seconds (Table 3). The mean time for the PFS preparations was 33.1 seconds (range from 10 seconds to 44 seconds).

*5 nurses x 3 attempts x 2 timekeepers = 30 recordings per preparation; PFS, pre-filled syringe

Table 3: Preparation timings.

Recorded Events

A total of 73 events were recorded during the study period (Table 4). All five nurses experienced recorded events, although two nurses had substantially fewer events than the other three (11 out of 73 events, or 15.1%).

PFS, pre-filled syringe

Table 4: Recorded events.

The events occurred across all products to a varying degree. There was no obvious correlation between recorded events and use of diluent (e.g. amiodarone, ephedrine ^#1, midazolam), opening more than 1 ampoule of active drug (e.g. amiodarone, atropine ^#1) or using only part of an ampoule of active drug (e.g. atropine ^#2).

The most frequent reported events occurred with ephedrine ^#1 with 14 out of 73 (19.2%) events. It was noted that this product required the largest volume of diluent (9 ml) in its preparation, which may have been one reason for the relatively high number of reported events.

Consumable Use

The preparation of PFSs involved fewer of almost all types of consumables vs ampoules, with only the mean number of needles and mean number of aprons for ampoules being the same as for PFSs.

Preference For Ampoules vs PFS

In almost all criteria in the qualitative questionnaire, four out of five or all the nurses stated they “somewhat prefer” or “strongly prefer” the PFS. The exception was storage considerations, where one nurse indicated a preference for ampoules. Of the remaining four nurses, two nurses reported that they had no preference in terms of storage considerations between ampoules and PFS, one nurse stated they somewhat preferred PFS and one nurse stated they strongly preferred PFS.

The nurses reported potential drawbacks of the PFS. These were: (1) bulky storage; (2) higher cost; (3) potential for complacency during drug preparation (4) occasional lack of local availability.

It was noted that, in terms of ‘overall preference’, all nurses answered “strongly prefer PFS” (Figure 1).

Figure 1: Nurse preference for ampoules vs PFS.

Differences vs Real-world Setting

Across all criteria, most or all of the nurses felt that the simulated environment was “very similar” or “somewhat similar” to their usual real-world setting.

Limitations

The nurses reported that some real-life activities were excluded from the simulation. These included the time taken to access the secure drug preparation room (typically a card key or PIN code), the time taken to wash hands, obtaining a key for the fridge and a key for the controlled drug cupboard from the nurse in charge, computer access, computer printing of syringe labels, seeking counter-signature to approve medication especially for controlled drugs such as midazolam, interruptions from colleagues on a busy ward, familiarity of the nurses’ own drug preparation area.