Anticipating the three patient safety alerts on injectable medications by the National Patient Safety Agency (NPSA) (see Resources), Hospital Pharmacy Europe hosted a roundtable discussion concerning the use of prefilled computed tomography (CT) contrast media syringes for the improvement of safety in radiology departments across the UK.
Held at the London headquarters of the Royal Pharmaceutical Society of Great Britain, the discussion involved 12 leading UK clinicians – among which 10 were hospital or clinical pharmacists – who examined a number of issues relating to current practices in CT contrast media administration.
Organised into five sessions, the discussion highlighted a number of alarming facts regarding hygiene and safety issues surrounding injectable medications in UK radiology departments, not least of which is the almost ubiquitous “open-bowl” technique for the filling of CT syringes.
Following the day’s events, the roundtable participants concluded that this particular area is in urgent need of review, with a recommendation for national guidance and far higher communicative levels between medication safety professionals and those in the radiology department responsible for contrast administration.
Injectable medication safety
Professor David Cousins (Head of Safe Medication Practice, National Patient Safety Agency) stated that contrast media was one of four high-risk groups of medicines (used in radiology departments in the USA) that caused harm to patients, according to the 2000-2004 report of Medmarx, the US national database for medication errors (see Resources). Of 2,030 reports, 12% were categorised as harmful. This was seven times the rate seen in the general Medmarx dataset. The leading types of errors were wrong drug, wrong dose, drug omission and prescribing, of which the contributing factors included lack of radiologist involvement, radiographers performing procedures under poorly defined standing orders, unqualified “helpers” preparing and administering injections and radiology nurses not being available to take responsibility.
One study has evaluated the safety of the “open-bowl” method of contrast medium delivery in the angiogram theatre, in which contrast medium was decanted into open basins on sterile trolleys.(1) This study showed that the contrast medium (iopromide, Ultravist(R)) was contaminated with airborne bacteria and furthermore the level of bacterial load was heaviest when clinical staff, and the wider department, were at their busiest (comparable with operating room theatres). Since the bacterial load in three of the seven air-exposed galley-basins was below that required to produce septicaemia, the authors of the study concluded that the open system of contrast media delivery was safe. The participants of the roundtable, however, felt that the risk could be easily avoided via the use of a prefilled contrast medium syringe.
Professor Cousins noted the development by the NPSA of risk-assessment tools, which identify, and therefore reduce, the risk of infection associated with injectable products and procedures. The NPSA currently receives approximately 800 reports per month relating to injectable medicines; a number of latent system risks were identified and the NPSA issued guidance earlier this month. The NPSA recommends that from now, an annual risk assessment of injectable medicine products (including contrast media) be done and that procedures be carried out by a pharmacist and senior practitioner from the relevant clinical area. Furthermore, this should be repeated before any new injectable medications or procedures are introduced.
High-risk products – especially those which are prepared in nonaseptic conditions and administered in high volumes – should be provided as ready-to-administer or ready-to-use in order to minimise risk.
Therapeutic risk assessment
Anne Black (Clinical Pharmacist, Newcastle University Hospitals, Newcastle, UK), who has assisted Professor Cousins with his work on injectable medication safety, discussed the factors that should be considered when undertaking a risk assessment of clinical procedures. These included:
- Inadequate technical information.
- Use of unlabelled syringes or bags.
- Use of open systems.
- Preparation of a cytotoxic drug.
- Preparation of or addition to parenteral nutrition.
- Administration using a syringe or bag for longer than 24 hours.
- Admixture of two or more active medicines without information.
- Failure to use an infusion pump or syringe driver when required.
- Use of an injectable medicine in more than a single dose.
- Unauthorised or “off-label” use of unlicensed medicines.
Ms Black continued to describe specific risk assessment of injectable medicines and the factors which should be considered:
- A complex calculation.
- A complex method of preparation.
- Reconstitution of powder in a vial.
- Use of a part-vial or ampoule or use of more than one vial or ampoule.
- Use of a pump.
- Use of nonstandard giving set or device required.
Ms Black concluded that after totalling product risk factors the relative risk could be determined as follows:
- Six or more risk factors = high risk.
- Three to five risk factors = moderate risk.
- Fewer than three risk factors = low risk.
Clare Crowley (Medicines Safety Pharmacist, John Radcliffe Hospital, Oxford, UK) explained that most of the hazards associated with the use of IV medicines arise during preparation and administration. Where an IV route is used, more complex medicines use processes (MUPs) should be in place. Errors are more severe than with other routes of administration, and the onset of action is immediate. Frequently, patients are on multiple IV medicines, and prescriptions for such medicines are sometimes incomplete. The rate of errors during the preparation and administration stage is 25-49% for IV drugs, vs 3-5% for oral medications. Unique contributory factors include handling uncommon medicines, unusual presentation or procedure, multiple-step preparation, use of infusion pumps and calculation. Risks of microbial contamination are also associated with IV preparation in the near-patient area due to uncontrolled environments, poor aseptic techniques and the preparation of syringes in advance of needs. Sharp injuries can also occur.
Practices that increase or carry a high risk of errors include:
- Open-bowl technique.
- Multidosing (using the same bottle for different patients).
- Unlabelled syringes/infusions.
- Unfamiliar medicine/technique.
- Inadequate checks.
Safe preparation and administration requires:
- Dedicated preparation areas.
- Adequate resources (in terms of staff, equipment and time).
- Standard operating procedures.
- Training and competence assessment.
- Readily accessible information on the IV medicine in the clinical area.
Ms Crowley concluded that most risks of microbial contamination and opportunities for error could be eliminated or reduced by the use of prefilled syringes. Only certain potential errors would remain, notably administration-rate errors and use of expired products. The use of prefilled syringes aids the process of infusion standardisation and, if the products can be barcoded, the audit trail can also be improved substantially.
Safety and sterility
Safety and sterility issues linked with the use of prefilled syringes were presented by Amanda Mclean (Chair, UK Clinical Pharmacy Association Quality Assurance and Risk Management Group). Ms Mclean explained that risk management is the containment and minimisation or elimination of a hazard. The principles of risk management are to: raise awareness; eliminate the risk at source; design and organise processes; inform; instruct and train; and implement control measures. Limiting factors, however, include position bias, familiarity and complacency and a lack of training and awareness in risk assessment. In general, risk assessments are being carried out after an incident has occurred.
To reduce the risk associated with injections, several measures can be introduced. Closed systems and the use of aseptic techniques improve the chances of retaining sterility, while potential for contamination can be controlled by reducing packaging (without losing product protection). It is also important that syringes are properly labelled to improve identification and traceability. Given that the procedures put into place and that competence assessment and training do not tend to last, all such measures need to be revised and updated regularly.
Ms Mclean continued by saying that an important point to consider is the minimisation of microbiological contamination. Surveys on IV medications prepared in near-patient areas show that contamination rates are between 2% and 15%. In addition, a large percentage of the patient population are vulnerable, with some 25% of patients presenting for scans being classified as “high-risk”. Various barriers can and should be implemented to reduce contamination. The environment (cleaning, access) should be controlled; staff should be made aware of personal hygiene (handwashing), competence required to carry out a procedure and the hazards of the task; and the products to be injected should be controlled (presentation, formulation). Clearly, prefilled formats eliminate these problems almost entirely.
Of all clinical cases, emergency scenarios are perhaps the most likely to lead to medication administration errors. According to Elaine Wright (Chair, Royal College of Nursing Imaging Nurses Forum), emergency situations are by nature unpredictable and healthcare staff have to work quickly and efficiently. Manual handling in these situations can lead to needlestick injuries and problems associated with radiation safety.
Emergencies mean that healthcare workers are dealing with acutely ill patients, and request forms and medical histories are not always available. Hygiene issues remain important in emergency situations where contrast media are injected, and safe and proper administration becomes crucial. Dangerously, in some UK hospitals and trusts, some single-use administration sets are still used several times, which is in direct breach of good-practice guidelines. Additionally, clinical staff on duty at night are often relatively inexperienced; again, this increases the chance of a potentially fatal administration error, as per the previously reported case of an elderly female patient accidentally injected with an antiseptic solution of chlorhexidine in the USA. This tragic situation would, arguably, never have happened if not for latent system failures such as the use of open basins for intravenous solution preparation. Whilst labelling of basins may ameliorate the situation, a prefilled solution of contrast media might have prevented loss of life altogether in this situation.
Injecting contrast media in an emergency requires the availability of appropriate equipment, oxygen and resuscitation drugs. Patients are at risk of developing anaphylaxis. Although department protocols and standards have been set by the Royal College of Radiology, documentation is often poor. For example, staff involved in injecting contrast media note which contrast medium is being used but they should also note any adverse reaction that occurs. In the future, robust protocols should be established and measures for infection control implemented. Cannulation techniques and competencies must be assessed regularly and guidelines should be immediately available in case of extravasation. With these points in mind, and when time is at a premium in clinical practice, it would seem use of single-dose prefilled syringes may be the way forward.
Efficiency savings and economics
During the roundtable Frank Ellwood (CT Super‑intendent Radiographer, Derriford Hospital, Plymouth, UK) provided an insight into the current use of prefilled CT contrast media syringes. Having introduced them to his department several years ago, he found them easier to use, faster, safer, cleaner and, perhaps, surprisingly, very cost-effective. Mr Ellwood’s experience with this type of product has shown that prefilled syringes are technically less demanding to prepare and can make inventory control much easier. Moreover, prefilled syringes may be set up in 15 seconds, compared with two minutes to fill and set up an empty, non-prefilled syringe. This creates a saving of 87.5 minutes each day, based on a list of 50 patients and three scanners. For the same fixed costs, the use of prefilled syringes thereby allows for the treatment of an additional three patients per day, plus additional time for more direct patient contact. By increasing departmental throughput and reducing preparation time on a payment-per-patient scheme in a profit-centre organisation, profits will rise, thus alleviating the increased cost compared with a multi-dose bottle. Based on three scanners operating 50 weeks per year, Mr Ellwood’s department has saved approximately £68,750 per year through the use of prefilled CT contrast media syringes.
Continuing on the topic of efficiency savings of prefilled syringes, Mr Ellwood remarked that, because prefilled syringes are labelled with the product name, concentration, batch number and expiry date, the likelihood of using the wrong preparation is drastically reduced. This allows generalist radiographers rotating through the CT scanning department to handle the prefilled preparation of the contrast media with minimal training, thus allowing more qualified staff to carry out other procedures. In addition, the risk of loading an empty syringe into an automated injector is eliminated, as it is impossible to do so with existing prefilled set-ups. Subsequently, the risk of air embolism is virtually eliminated.
Further information on Mr Ellwood’s experiences with prefilled CT contrast media is available in this issue of the journal for the interested reader.
Following Mr Ellwood’s presentation of his experience with prefilled CT contrast syringes, Allan Karr (Pharmacy Services Business Manager, University College London Hospital, UK) introduced the topic of UK National Health Service financial processes. He commented upon the differences between relevant and irrelevant costs, fixed and variable costs and opportunity costs. In looking for efficiency savings, he sought products that were easier and faster to use,while reducing wastage and breakage and the need for consumables.
Mr Karr, although conscious that prefilled syringes were key to patient safety in terms of contrast media administration, was quick to point out pitfalls when procuring this type of product versus high-volume CT bottles. Mr Karr observed that the contracting for, and procurement of, disposables is moving towards collaborative procurement hubs.
With “cost-saving” remits and performance indicators of £8-9m for a region such as North Central London, collaborative procurement hubs are unlikely to look at efficiency savings as a viable means of reducing hospital costs. Thus, added-value products such as prefilled contrast media and their importance in terms of patient safety may be overlooked when compared with cheaper, high-volume alternatives.
It is of paramount importance that pharmacists and other members of the clinical team “should be involved in the setting up of the specification and the adjudication” of tendering plans with procurement hubs. Management accountancy continues to remain highly interpretable; issues of cost relevance and indeed irrelevance are highly variable between hospital trusts. Therefore, it is the duty of the chief pharmacist to increase visibility and understanding of products and procedures which have patient safety features that may not be quantifiable during cost analysis.
Many issues need to be considered when switching from multi-dose bottles and open-bowl preparation of CT contrast to prefilled syringes, and the roundtable proceedings presented an unequivocal argument, advocating the safety advantages conferred by the prefilled format.
The main conclusions of the day were that ready-to-use injections of contrast media would increase patient safety through:
- Reduction of administration error (injection of incorrect medication and/or dosage).
- Reduction of embolisms.
- Reduction of microbial contamination during preparation and administration.
- Reduction of mislabelling errors.
- Reduction of sharp injuries.
Further advantages offered by prefilled products include:
- Reduction of time required for procedures.
- Reduced packaging wastage.
- Ease of inventory management.
Concepts to emerge from the discussion included that radiologists should work more closely with pharmacist colleagues and, where appropriate, pharmacists should recommend the use and purchase of products able to alleviate the need for medication preparation outside of dedicated, aseptic areas.
Carole Mongin-Bulewski PhD
Managing Editor, HPE
- Tress BM, Hellyar AG, Pennington J, Martinkus J, Lavan JJ. Bacteriological studies of open versus closed contrast medium delivery systems in angiography. Australas Radiol 1994;38(2):112-4.