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Methods for providing safer IV medication for adults and children were described by specialists from the UK and USA at a meeting in Birmingham, UK, in October 2007, organised by B Braun Medical
Christine Clark
PhD
Contributing Editor
HPE
Incomplete or ambiguous prescribing for intravenous (IV) medicines that omits details of the diluent required or the final dose volume is one of the main risk factors in intravenous treatment, according to David Cousins (Head of Safe Medication Practice, National Patient Safety Agency, London, UK). This type of essential technical information has often not been available to staff involved in the prescription or administration of medicines, but a recent NPSA alert requires NHS trusts to provide it, he explained (see Resources).
NPSA reports show that between January 2005 and June 2006, 58% of deaths and “severe harm” medication incidents were attributable to injectable medicines. More than 70% were associated with preparation and administration of the medicine, and about a quarter were classified as “wrong drug, dose or frequency”.
Other factors contributing to errors with injectable products are lack of multidisciplinary procedures, calculation errors, and variable levels of knowledge, training and competence among staff. Incidents with amphotericin injections typified the type of incident that can occur when staff are unfamiliar with products. Nonlipid and lipid formulations with 1–5 mg/kg amphotericin dosages had been confused on several occasions, leading to two deaths.
Measures that could improve safety of injectable medicines include implementation of the provisions in the NPSA alert and redesign of labelling and packaging for intravenous products. Professor Cousins identified several critical features of packaging and labelling. Technical information needs to be in a legible font size and the generic name and total quantity in the vial or ampoule should be prominent on the label. Many errors have occurred when a concentration such as “5 mg/ml” has been misinterpreted as the total contents, he reminded attendees. Soft intravenous bags could be made with an extra portion that remained legible when the bag collapsed during administration and barcoding could be introduced for identification. The barcode must be on the unit of use and a two-dimensional barcode might be easier to incorporate because it was smaller.
Outsourcing of IVs
Outsourcing of preparation of intravenous doses represents another approach to improved safety. Eric Steen (president, Central Admixture Pharmacy Services [CAPS], USA) explained how preparation of intravenous doses had been outsourced at the MD Anderson Cancer Hospital in Houston, Texas, in order to allow pharmacists more time for patient contact. In order to meet the hospital’s needs seven deliveries a day were made.
CAPS pharmacies work to high standards with purpose-built facilities and carefully specified procedures for all tasks. For example, the hand hygiene procedure is defined, including washing up to the elbows for 30 seconds, and the procedure for donning sterile gloves without contaminating them is set out. “Our staff look very different from IV personnel in US hospitals – because there is no uncovered hair or beards”, Mr Steen pointed out. No makeup is permitted either; this was easy to enforce because CAPS started this way, he added.
Safer labelling
Miriam Klein (medication safety fellow, Kingsbrook Jewish Medical Center, New York, USA), is herself profoundly deaf after receiving an antibiotic overdose in infancy. She described how labelling can be improved for high-alert, injectable medicines. One of the goals for 2008 of the Joint Commission, against which hospitals will be accredited, is the improvement of medication safety, and this includes labelling of “all medications, medication containers (for example, syringes, medicine cups, basins), or other solutions on and off the sterile field” (the Joint Commission is the US healthcare accreditation body). However, it is difficult for many organisations to comply with this requirement and pharmaceutical firms must be prepared to take a collaborative role in providing safer labelling options, Dr Klein said.
She said medication errors in the operating theatre occur significantly more frequently than in other perioperative settings, according to the 2007 MedMarx data report. Moreover, 7.3% of errors in the operating theatre resulted in harm to patients. The administration of injections from unlabelled syringes was believed to be a major contributory factor.
A 2006 US Institute of Medicine report concerned with 32,000 errors arising from “look-alike, sound-alike” drug names showed that labelling and packaging issues accounted for 33% of all the errors and 30% of the fatalities, she said.
Premixed, ready-to-use injections are unlikely to be the complete solution to this problem because there simply will not be sufficient storage space.
In Germany, Dr Klein had found most injectable medicines now had transferable (peelable) labels that can be transferred to the syringe. This ensures that clinicians have essential information in their hands at the time of administration.
Dr Klein is currently working in collaboration with the NPSA and several UK pharmacists. She described how a label for atracurium injection has been redesigned so that it can be transferred from the vial to the syringe when the product is drawn up. The label also contains dosing information, the total dose and volume, a high-alert symbol and space for the expiry time and operator identity. The dosing information enables the person administering the medication to make a second check at the moment of use.
Reducing the risks
“Risk assessment is fundamental – you need to see what practices are current in your hospital” said Tom Gray (chief pharmacist, Derby Hospitals NHS Foundation Trust, UK), describing how safe practices for IV medicines could be introduced.
A recent study comparing ward preparation of injections in three European countries (UK, Denmark and France) had revealed very different practices. For example, nurses in the UK did not wash their hands before preparing IVs and neither did they swab the vials with alcohol. They were also more likely to administer the drug at the wrong rate than their counterparts in Denmark and France.
“We cannot assume that people are washing their hands,” Mr Gray concluded.
The ward environment might not be a “safe, effective and appropriate” place to prepare intravenous doses, Mr Gray suggested. Ward refrigerators were often “chaotic”, with medicines stored alongside sandwiches and expired products. The risks were compounded by the fact that labels were often not applied. Administration was the highest-risk activity and the one where there were fewest opportunities for intervention. If the “second check” was not effective (because of poor procedure), the patient might be harmed.
Intravenous injections should be made in the pharmacy, provided that the required standards could be met – if not, managers should consider outsourcing preparation. However, in many situations preparation of IV doses on wards was the reality, and this was more responsive to patient need, he said.
Mr Gray had recently moved into a new hospital building that incorporated satellite pharmacies, including special facilities for dispensing of injectable medicines, on each floor. Pneumatic tubes link the pharmacy to the wards, and in the future electronic links to the pharmacy dispensing robot are anticipated. The plan is to integrate multiskilled pharmacy teams to undertake both clinical and aseptic work. “Everything will be done at satellite level – near to the patient,” Mr Gray said.
Another measure that had helped reduce risks with intravenous medicines was standardisation of intravenous administration devices. The number of different types of device in use had been reduced from 40 to five. Smart pumps with drug libraries, keypad lockouts and activity logs had been introduced. A centralised equipment library had also been established, and as a result complaints relating to equipment availability fell from 250 to fewer than 10 in one year. There were no more devices than previously, but now they were utilised more efficiently, Mr Gray explained. They could also be serviced and cleaned regularly. Many other items in the hospital should be managed in this way, he suggested.
Safe use of IV medicines in children
Apparently small differences can have a big impact in paediatric patients; for example, if a 0.5 kg neonate is weighed while wearing a wet nappy its weight could be greatly increased, explained Steve Tomlin (consultant pharmacist, children’s services, Evelina Children’s Hospital, London).
It is estimated that 1,675 medication errors occur in paediatric inpatients in England each year and that 85 of these are likely to be moderate or severe. The true numbers are probably higher but there is likely to be underreporting.
A study conducted in Glasgow had shown that the error rate was higher in intensive care areas, and that errors were more common in younger children – 20% occurred in patients under one month of age. Intravenous doses accounted for 56% of errors and 8% of errors were due to 10-fold errors. Problems commonly arise when decimal points have to be inserted. In a recent survey of the injection stocks held in the neonatal intensive care unit (NICU) at Mr Tomlin’s hospital, the quantities in the vials were compared with the doses that are usually required. The results showed that 31% of NICU prescriptions call for a dose that amounts to less than one-tenth of the contents of one vial. Nearly 5% require less than one-hundredth of the vial contents. When a doctor or nurse has to open multiple vials to give a dose, mental alarm bells often start to ring, but if one ampoule or vial contains 100-fold overdose there is no such alarm, and the potential for error is huge, said Mr Tomlin.
There are special safety considerations when purchasing injectable medicines for children. Problems can arise because of excipients or additional ingredients in medicines which are primarily designed for adult use. For example, benzyl alcohol – found in some amiodarone and lorazepam injections – must be avoided in neonates because it causes gasping syndrome. Phenobarbital injection is formulated in 90% propylene glycol, which can cause hyperosmolality in infants. Until recently, licensed preparations of ibuprofen injection, used for closure of patent ductus arteriosus in neonates but designed for adults, were imported into the UK. Some of these contained lignocaine, which made them completely unsuitable for infusion into premature neonates. ■
Resources
UK National Patient Safety Agency (NPSA)
NPSA Alert: Promoting safer use of injectable medicines. March 2007.
Available from: www.npsa.nhs.uk/patientsafety/alerts-and-directives/alerts/injectable-medicines
NPSA Rapid Response Report 2: Risk of confusion between non-lipid and lipid formulations of injectable amphotericin. October 2007.
Available from:
www.npsa.nhs.uk/patientsafety/alerts-and-directives/rapidrr/injectableamphotericin
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“Dear Dr. Christine Clark,
A great article. I hope that ALL hospitals’ pharmacists will read it! Thanks!” – Zvi Levinhar, Israel
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