Experts called for more product standardisation and closer working with the pharmaceutical industry at a recent meeting about injectable medicines sponsored by B Braun Medical
BSc MSc PhD FRPharmS
Surveys in the northwest of England identified 319 high-risk injectable medicines and a further 307 medium-risk products that were being prepared on wards and in patient care areas, according to Hazel Meakin (project manager QC Northwest). Additional detailed work concentrated on the top 10% and identified those formulations that were most commonly used. The next step was to categorise the products according to their availability and ease of preparation (see product categories table).
“Trusts need to concentrate on high-usage products with good stability data where some agreement on standard concentrations has already been reached”, said Ms Meakin. Product rationalisation- based on identifying the most appropriate strengths of injectable products-will be essential. This could provide an opportunity to influence prescribing, she explained.
A further study examined the production capacity of the aseptic units in the Northwest of England and compared this with the estimated demand for aseptically-prepared products. The results showed a shortfall equivalent to 0.41 million activity units (equivalent to about 45,000 items) per annum. The production capacity of many units is limited by shortage of staff as a result of recruitment problems, noted Ms Meakin.
Existing NHS manufacturing units and aseptic units should be used to prepare high-risk, short-lived products. This will require a collaborative, region-wide approach, and in some cases,”a change of hearts and minds,” commented Ms Meakin. Low-risk, high-volume products should be passed to the industry, she
One option to improve production capacity would be to employ non-pharmacy science graduates – an approach that can be successful if appropriate training is given, suggested Ms Meakin.
The NPSA Alert was much needed but had faced hospitals with six “mammoth recommendations” said Clare Crowley (lead medicines safety pharmacist, Oxford Radcliffe Hospitals NHS Trust). (See box.) Risk assessment was a key recommendation and this was essential otherwise there is a risk of investing in the wrong things, said Dr Crowley. However, the process was not straightforward as interpretations could vary and trusts were required to identify all sites where injectable doses were prepared. “Some of the greatest risks are with injections for non-intravenous routes” emphasised Dr Crowley.
Finding out the different ways that injectable products are used in practice is a continuing challenge. It is important to investigate areas such as ophthalmic operating theatres, and cardiac catheterisation laboratories. Another challenge is finding information about preparation and administration of products supplied as “special”.
In the South Central region (of England) 1080 risk assessments of injectable products were performed and these identified 143 (13.2%) high-risk products and 138 (12.8%) with medium-high risk scores. Many of these were unlicensed products or off-label uses, noted Dr Crowley.
Turing to solutions, Dr Crowley said that collaboration at regional level is important and that the choice of products needs to be practice-driven rather than being supply-driven. A multi-professional approach is essential to achieving good outcomes for patients and cohesion between prescribers, clinical staff and those involved in aseptic preparation and purchasing is critical, she added. In future a new style of formulary based on a better understanding of how the products are used is planned for Dr Crowley’s hospital.
In the discussion that followed David Upton (clinical director for medicines management at Sheffield Children’s Hospital) commented that clinical pharmacists have an obligation to support the shift of preparation of intravenous doses from wards and that this will involve the introduction of standardised concentrations.
Although this is a more challenging task in paediatrics (than in adults), it can still be done. Dr Crowley added that pharmacists should be curious about how injectable products are used. “If you do not do something about poor practice on the wards then you are condoning it”, she said.
The establishment of a database that lists all the injectable products made in NHS manufacturing units (ProFile) is “one of the really significant successes” in this field, according to Alison Beaney (regional quality assurance specialist, North-East and Yorkshire). This allows pharmacy manufacturing units to communicate with each other and find out which products are being made where. This provides the opportunity to buy a product rather than making it. “Don’t be too territorial”, she advised.
“Risk assessment is only the start of the process” -we need to reduce the risks across the whole spectrum of injectable product preparation.” She suggested five measures to reduce risks:
- Simplify and rationalise the products stocked.
- Provide ready-to-use products.
- Provide guidance on prescribing, preparing and administering injectable doses.
- Infusion monitoring forms.
Implementing a “purchasing for safety” policy was one of the original recommendations, however, many licensed, ready-to-use (RTU) products are not high-risk items, Ms Beaney emphasised. Industry is now more aware of what is needed and there have been improvements in the provision of technical information with products, she noted. The NHS now needs to work with the industry to identify new, safer, RTU products, she added.
The NHS also needs to scrutinise requests for products critically. Before making a new injectable product she suggested that some key questions should be asked, including:
- Is there a clinical need?
- Are there suitable alternatives?
- Is it technically feasible to prepare?
- Can the industry help?
- Is it viable (stability/demand/cost)?
Quality and productivity
Improving quality and productivity whilst reducing waste would be key measures in the ongoing response to this alert, Martin Stephens (national clinical director for Hospital Pharmacy) told the audience. Sustaining quality is a guiding principle and this will be achieved through innovation. “Safer, more effective care can be less costly than low quality care”, he said. High quality intravenous treatment eliminates waste and using innovations to solve problems with poor use of injectables will take out costs. The Department of Health will support the development of new ways of working, he added.
In conclusion Mr Stephens said that we must convey the vision for better intravenous therapy and ensure that clinical teams are engaged in the process.
A label for compounded intravenous doses that has been described as ‘revolutionary’ has been developed by Miriam Klein High quality labels for IV bags and syringes are important because errors have been associated with mislabelling and unlabelled bags. A good label should also help to prevent wrong-route errors, such as confusion between epidural and intravenous routes. Dr Klein explained that it was important to develop a one-size-fits-all label that conformed to the Institute for Safe Medication Practices (ISMP) recommendations for safe IV labels. The prototype label is peelable and printed on robust material. It folds to form a label that is attached via the hanging loop or hole of the IV bag; the label is then suspended from the hook on which the bag itself would normally hang. The label incorporates a “stop sign” to alert users to the fact that an addition has been made and a “line marker” that is attached to the administration tubing to prevent confusion. This style of label is to be evaluated in Dr Klein’s hospital for fentanyl and bupivacaine epidural injections. (assistant director of pharmacy, Kings County Hospital Centre & medication safety fellow, Kingsbrook Medical Centre).
Aseptic compounding services
“Be clear and specific about your requirements when it comes to outsourcing of aseptically prepared products”, advised Roger Brookes (manager, B Braun Compounding). A number of factors contribute to a successful outsourcing operation and a balanced approach is best. Ideally this would involve outsourcing of certain items for cost-effectiveness whilst maintaining some local expertise and facilities. “It is much easier to have a technical discussion where there is local expertise”, noted Mr Brookes. Considering the question of which products should be outsourced Mr Brookes emphasised the importance of standardised products. It is also very important to have a predictable workload. The products themselves need to be physically robust, transportable and stable. Monoclonal antibodies are difficult to transport and therefore not suitable candidates for outsourcing. Penicillins and cephalosporins, in general, are not stable and are therefore also unsuitable. The presentation of a product can also influence its suitability for outsourcing, for example, Mr Brookes has declined to provide TPN solutions with a giving set attached because the final product would be physically unstable.
Areas of opportunity for outsourcing include batch chemotherapy for dose-banding, standardised TPN, fixed-dose antibiotics and prefilled syringes. In conclusion, Mr Brookes reminded the audience that genuine commitment is likely to secure lower prices.
The results of a training programme for junior doctors concerned with the preparation of injectable medicines showed that although 100% were able to perform the manipulations correctly, 20% failed to complete the calculations correctly. Anne Black (quality assurance pharmacist, Newcastle upon Tyne Hospitals NHS Foundation Trust) described how, in the past, the available training had been targeted at new members of nursing staff. For other disciplines there was little formalised training – although there were pockets of good practice, for example in the medical physics department. Doctors remained a problem in this regard, largely because of their separate staffing and training structures. They developed an interest after the injectable medicines policy (that reflected the NPSA requirements) was posted on the hospital intranet.
In closing the meeting the chairman, Laurence Goldberg said that English studies during the 1980s had shown that the cost of each IV dose prepared by a doctor was £11.70, and that a recent French study had costed pharmacy compounding at Euro 31 + the cost of the drugs. “There is money in the system- let us find it”, he said.