Professor Malcolm Partridge
Dr Paul Le Brun
Mr Johan Vandenbroucke
Professor Irene Krämer
Moderator – Mr Laurence Goldberg
- 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?
- 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.
- 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.