There is a significant unmet need for ready-to-administer injections and a pan-European survey is needed to identify requirements in detail, according to expert pharmacists
Expert panel participants:
Professor David Cousins
Head of medicines safety, National Patient Safety Agency, England
Professor Malcolm Partridge
Head of pharmacy and medicines management, Nottingham University Hospitals NHS Trust, England
Dr Paul Le Brun
Hospital pharmacist and clinical pharmacologist, Central Hospital Pharmacy, The Hague, The Netherlands
Mr Johan Vandenbroucke
Senior pharmacist production, University Hospital Ghent, Belgium and immediate past president, International Society of Oncology Pharmacy Practitioners
Professor Irene Krämer
Director of pharmacy, University Hospital, Mainz, Germany
Moderator – Mr Laurence Goldberg
independent pharmaceutical consultant
In October 2011, a panel of expert pharmacists from Germany, Belgium, The Netherlands and the United Kingdom met to discuss the safety and economic impact of ready-to-use (RTU) and ready-to-administer (RTA) injectable medicines. Three key questions were considered:
- Should injectable medicines be prepared in clinical areas?
- How economic is it for the hospital to produce injectable medicines in the pharmacy?
- Is there a demand for the preparation of injectable medicines by a third party, such as the pharmaceutical industry or a large regional hospital facility?
Describing the current context for safety of injectable medicines, Professor David Cousins (Head of medicines safety, National Patient Safety Agency, England) said that in 2007, 800 incidents were reported each month (in England and Wales) relating to injectable medicines. Moreover, 24% of all reported medicines-related incidents and 58% of serious harm incidents related to injectable medicines. In spite of the publication of guidance on promoting the safety of injectable medicines in 2007, medication safety incidents continued to occur.
Among other things, the NPSA guidance recommended a ‘purchasing for safety’ policy to ensure that injectable medicines with inherent safety features are purchased. It also advises that the range of strengths of high-risk products should be reduced and that RTU or RTA products should be provided to minimise the risks of preparation and administration errors. “Educating doctors to prescribe better should not be the only risk reduction strategy”, said Professor Cousins.
After presentations from each of the panel members and a wide-ranging discussion, the following points were agreed.
- Many errors with injectable medicines can be predicted (high-risk products and practices can be identified readily) and are potentially preventable
- Risk awareness at the operational (ward) level is sometimes poor, and consequently understanding of the importance of risk reduction measures is also poor
- Regulators are often unaware of the types of problems that can arise in the use of injectables
- RTA products are often perceived to be expensive. It is important to emphasise the difference between the acquisition price of a medicine and the actual cost, which includes preparation and administration costs
- Look-alike RTA products from a central manufacturing unit could give rise to selection errors
- The recent Council of Europe resolution (Resolution CM/ResAP(2011)1, PIC/s 010) is likely to be the forerunner of legislation concerning the preparation of injectables on hospital wards
- Barcode scanning to match the product with the original prescription has been introduced in some places. What is now needed is electronic prescribing so that drug, patient and administration time can be matched and checked
- Barcoding has now been accepted as the European standard but it has been agreed that barcodes should appear on only the secondary and tertiary packaging, which is often discarded. Barcoding should appear on the primary packaging in order to support safe systems of working
- Dose-banding for cytotoxic agents could improve patient safety but there is still some reluctance among physicians to use it (often because the summary of product characteristics specifies doses in mg/m2 and physicians do not wish to deviate from this). If dose-banding is used in clinical trials then it will quickly work through into day-to-day practice
- If RTA/RTU products are introduced it will be critical that continuity of supply is guaranteed. Failure to do so will compromise patient safety
- Many injectable products are still accompanied by poor or inadequate technical information
- European tenders will be obligatory from 2012 and this could enable pharmacists to specify aspects such as continuity of supply, label type and technical information
- In Germany it is permitted to manufacture for in-house use without a licence for either the premises or the product
- Pre-loaded 50ml syringes are a convenient and safe presentation for RTA injectable medicines, although the syringes currently available are not designed to be stored when loaded
- 50ml RTU vials are acceptable when pre-filled syringes are not available.
In the discussion, it was noted that nurses often had a marked preference for RTA products and that once one such product was introduced, requests for more generally followed. In one hospital in Germany, for example, pre-loaded syringes containing 1-molar potassium chloride injection were introduced. Shortly afterwards, nurses requested other injections in this presentation; when this could not be done they asked for 50ml vials of RTU injections. In a hospital in Belgium, nurses are now buying pre-loaded syringes of saline for injection (at a cost of €1 each) simply to avoid having to draw up saline from a vial. Initially these were used for flushing, but then the nurses found how convenient they were and started to use them for other things.
Another strong common theme was the use of standardised products and dose-banding. Standardised infusions and standardised concentrations of commonly-used injections have been introduced into the intensive care unit in one hospital. Often, one or two concentrations are sufficient and then the dose can be adjusted by altering the volume administered. In some places this type of change was made possible when computerised physician order entry (CPOE) was introduced. Pharmacists worked out which concentrations would be most appropriate. In the University Hospital in Mainz, a range of products is now presented in 50ml syringes for administration by syringe pump.
Conclusions and recommendations
- Pharmacists have a responsibility for the safe use of injectable medicines and they should take action to raise awareness of the risks of injectable therapy, to discuss risk-reduction measures (including product standardisation) with clinicians and to promulgate the patient safety message
- Hospital pharmacies will not prepare in-house injectable medicines that are commercially available either as licensed products or as ‘specials’
- The decision to use a particular strength of an injectable drug is often based on historical and arbitrary criteria. The possibility of using standardised concentrations should be actively pursued
- The handling of injectable antibiotics is not without risk to health care workers. Pre-mixed products or two-chamber bags for unstable products are highly desirable.
- If 60,000 pre-filled syringes are used each year by one hospital in Germany, a strong commercial case can be made to the pharmaceutical industry for the manufacture and supply of products across the country
- There is a huge demand for both RTU and RTA injections for which the need is not currently being met
- Cost is not necessarily a barrier; if the premium for commercially-made injections is reasonable, many hospitals have expressed a willingness to pay
- A survey should be carried out, under the aegis of a suitable professional or academic body, to identify commonly-used injectable products across Europe. This will give a strong indication of the injections that are needed in RTA form.
In summary, although there are some differences between healthcare systems in the four countries represented on the panel, the problems relating to safe use of injectable medicines were similar and there was strong agreement on the recommended solutions.
The expert panel meeting was held in Birmingham in October 2011. It was supported by B Braun Medical.