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Introduction
In January 2015, the US Food and Drug Administration (FDA) reported that at least 40 patients had received non-sterile intravenous fluids, resulting in associated adverse events and one death. The offending products were produced for educational purposes by a company supplying the growing healthcare simulation market, and were not intended for patients. The plastic bags, labelled to mimic sterile 0.9% saline solution, contaminated the medication supply chain in 22 locations.1 Although the sequence of events is not yet clear, the supply shortage of 0.9% saline in the USA2 may have been a contributory factor. The presence of fake products was a latent condition or ‘resident pathogen’3 which in certain circumstances led to error and patient harm.
Harbingers of the tragic events above have been reported, such as the discovery of demonstration adrenaline syringes on an emergency trolley for clinical use and the treatment of anaphylaxis with an Epipen subsequently found to be an inactive training device.4 An editorial on unintended consequences of simulation5 highlighted administration of fake medications as a potential hazard to patients, and simulating medications has been an active topic in the simulation community, for example on the Society For Simulation in Healthcare Listserve.
Simulation-based activities are common in healthcare education and an expanding evidence base suggests they are also useful for improving patient safety6 ,7 and for detecting latent safety threats in new products.8 Debate continues on how accurately the clinical environment should be recreated to achieve educational objectives and to enable transfer of learning to the workplace.9 One approach is to use clinical areas for simulation activities (in situ) as opposed to using separate, dedicated simulation spaces.10
Medication errors are a persistent and important problem in healthcare.11 Simulation-based education in any location often incorporates medication, either real or recreated with variable accuracy depending on perceived needs of learners, safety and regulatory compliance requirements and financial considerations.
In this paper, we consider risks associated with the use of medications in simulation and discuss strategies to reduce risk.
Medications in simulation
In simulation, the options are to use real, in-date medications; real but time-expired medications; substitute (fake) medications or a combination of these.
For reasons of cost, when real medications are used, expired stock is frequently substituted for in-date medications and participants are asked to ignore the expiry date during simulation.
Fake medications range from hand-labelled syringes of water to saline-containing ampoules with fake labels (figure 1), to a variety of commercially produced products with inactive contents (figure 2), and even to relabelling of active medications to represent more expensive or restricted medications (figure 3). Fake oral medications include plastic capsules or candy presented in labelled containers. Convincing fake labels may be easily made by educators or conveniently created with open-source software specifically for this purpose.12 As is often the intention, both ‘home-made’ and commercially produced facsimiles of medication may look and feel very similar to the real medication.
Saline ampoules relabelled as fentanyl.
Commercially produced fake insulin, salbutamol inhaler and nitroglycerin sublingual spray. Note the ‘Practi-’ prefix and ‘for instructional purposes only’ warning.
Adrenaline ampoules relabelled as morphine.
Risk
Fake or expired medications may be inadvertently administered to a patient in the belief that the medications are fit for purpose. Vulnerability to this error rests on the presence of fake or expired medications in the clinical environment, which here we will call contamination.
Contamination can occur via clinical procurement and distribution routes,1 by inadvertent carriage by personnel returning from a simulation area, or when fake or expired medications are unintentionally left in a clinical area after in situ simulation.
The first of the two incidents reported by Cohen4 occurred in a clinical area colocated with a simulation area. Use of fake or expired medication in areas remote from clinical areas is likely to present a lower (but not zero) risk. Nonetheless, the frequency of contamination is probably under-reported. Few data are available to quantify this risk, but the potential consequences are considerable. Patients may be seriously harmed or killed, and the reputational and professional impact on the simulation programme, staff and associated institution may be substantial.
Strategies to reduce contamination
Use only real, ‘in-date’ medications
This would eliminate contamination, and learners would practice using products they meet clinically. However, the cost of using real medicines needs to be considered.
Real medications are usually subject to regulations to reduce misappropriation and abuse. Compliance measures carry important costs such as an approved safe in which to store restricted medications, lockable carts and cupboards and staff time for audit and recordkeeping. For example, our free-standing simulation centre in New Zealand uses some real medications and must purchase a licence biannually subject to government inspection to ensure appropriate medication handling and documentation. We manage all medications, fake or real, as required for real medications, engaging pharmacy staff to ensure that our procedures align with clinical practice. We consider that this improves safety.
In fact, purchase costs of most real medications are trivial compared with other costs such as faculty and learner time, other consumables, manikins, rent and the opportunity cost of replacing patient throughput with simulation activities.13 However, the costs of medications are readily quantified and, as in operating room budgets,14 are frequently a target for cost reduction. In comparing the costs of real with fake medications, it should be remembered that fake medications made ‘in-house’ require employee time. Any savings should also be weighed against the risk of inadvertent administration of fake medications to patients.
Separate fake medications from the clinical supply chain
Another strategy to reduce contamination is separating the simulation supply chain from the clinical supply chain. The FDA is evaluating wholesaler and distributor systems for fake medications with this in mind.1 Further steps would be to require clinical institutions to have separate systems for the purchasing, handling and storage of fake medicines, with tracking of supplies and disposal (somewhat like systems for managing hazardous substances). Unfortunately, fake medications may be introduced to clinical areas in various ways, as described above, and these systems may not prevent all of these.
Use labelling to alert users to the nature of fake medications
Commercially produced fake medications are often similar in presentation to the real product, but with alterations to the labels to alert clinical users to their nature. However, differences in appearance between real and fake medications are often subtle and unfortunately an alert becomes obvious only if one perceives it. Fake medications created by simulation staff can be near-identical to real medication. Misidentification errors are more likely in stressful circumstances with multiple distractors15 ,16 as may occur in the clinical environment, and when labels are unclear.17 Our team has demonstrated such phenomena in the context of medication errors18 and errors with medical devices.19
At present, there are no national or international guidelines to promote uniform labelling of fake medication, so there is no easy way to train clinicians to be alert to specific indicators. A difference in presentation from real medication may be perceived by the clinician, yet no significance ascribed to it. Double checking all medications with a second person has been recommended as a final safeguard against giving fake medication to patients, but evidence suggests that double checking reduces rather than eliminates error.20 The presentation of real medications may change with little or no notice depending on availability of supplies, purchasing decisions and manufacturer-led changes, and this may add to the potential for confusion. In New Zealand, this occurs at a national level when the government agency in charge of pharmaceutical procurement (PHARMAC) changes its supplier,21 but in many countries the differences tend to occur more locally, at an institutional level.
Develop systems for prereconciliation and postreconciliation of fake or expired medications
Simulation centres may limit inadvertent carriage of fake or expired medication by requiring learners and staff to empty their pockets on departure. This deliberate check is most likely to be critical if the learners do not change clothes before returning to clinical areas.
Simulation staff undertaking in situ activities may intentionally take fake or expired medications into clinical areas. A formal presimulation and postsimulation count comparing residual medications with those used or wasted in the activity may avoid leaving such ‘pathogens’. This requires staff motivation and time, and to our knowledge there is no such regulatory requirement for fake or expired medications in any jurisdiction.
Clinical areas hosting simulation will already have established pharmaceutical licensure and procedures surrounding medications. Given the risk of contamination, we recommend that real medications are always used for in situ simulation. This opinion has been strongly supported by pharmacy staff in our institution.
Conclusions
The issue of managing fake and expired medications in simulation is complicated, but important. We believe more discussion is needed and that consensus on robust safety practices to protect patients would be helpful.
We consider there is a strong case for using only real, ‘in-date’ medications for in situ simulation. If compelling reasons arise for using fake or expired products in situ, accounting for them post activity by a named person could be seen as an essential part of risk management.
When simulation takes place in a free-standing simulation centre distant from clinical areas, fake or expired medications may be considered acceptable as the risk of contaminating a clinical environment with them is probably low.
Management of fake or expired medications in simulation centres within hospitals or in spaces adjacent to clinical areas presents a particular challenge. In these, we suggest the ideal approach is to use only real in-date medications along with standard medication handling procedures. If fake or expired medications must be used, security measures seem appropriate for supply, storage, dispensing and audit. Examples include ‘simulation’ crash carts that are prominently labelled and locked when not supervised, reconciliation and a requirement for all users to change clothes or empty pockets prior to leaving the simulation area.
A standardised method of labelling fake medications, whether produced commercially or by simulation staff, would be a valuable safety initiative. Wherever simulation takes place, engaging with local pharmacy staff is of value as they are familiar with regulatory requirements and alert to potential medication errors. They are also expert at developing standard operating procedures for handling all medicines.
We propose the considerations for management of fake and expired medication also pertain to medical devices adapted or recreated for educational purposes. For example, a recent post on a simulation discussion forum described purchasing real defibrillators which the vendor had modified on request to make them ‘not live’.22 This reduces the risk of accidental shocks to participants, but would be a problem if such a device found its way into a clinical environment.
In conclusion, the risk management of medications used in simulation, especially the risk to patients through contamination of the workplace, warrants increased attention. There is an opportunity for simulation bodies such as the Society for Simulation in Healthcare to engage with pharmacists and national and local regulators to ensure such legislation is both comprehensive and feasible to implement.