Home intravenous therapy, antibiotic stewardship, medicines reconciliation and biosimilars were just some of the topics addressed by experts describing recent developments at the B Braun Medical Patient Safety Symposium
Christine Clark PhD FRPharmS FCPP(Hon)
Editor, HPE
Home intravenous therapy, antibiotic stewardship, medicines reconciliation and biosimilars were just some of the topics addressed by experts describing recent developments at the B Braun Medical Patient Safety Symposium
Christine Clark PhD FRPharmS FCPP(Hon)
Editor, HPE
There are now more than 30,000 patients receiving nutrition at home through enteral feeding tubes (EFTs), according to Vicky Bradnam (Pharmaceutical Consultant, Bromley, UK). When drugs are given via an enteral feeding tube, this is an off-label use of the drug, and recent research shows that there are more adverse drug events when drugs are administered via this route, she continued. The use of EFTs is increasing and tubes are being made with narrower bores, which make them more comfortable for patients. However, this can make it more difficult to administer medicines, and it is important to know the size and type of tube in use before giving advice. It is useful to remember that even with an EFT in place, some patients can still swallow and could therefore take conventional oral dosage forms. Another important point is that in hospital, nurses do not have the authority to switch medicines’ administration from the usual oral route to the enteral tube route without the prescriber’s approval.
When considering administration of drugs via an EFT, the ‘whole patient’ should be considered, including gastrointestinal function, transit time, the position of the tip of the tube and whether the medication regimen can be rationalised or simplified or given by buccal or transdermal routes. Another consideration is whether the patient has the manual dexterity to draw up doses in oral syringes. It is vital to avoid tube blockage because the tube is the only means of delivering nutrition to the patient, emphasised Ms Bradnam. Crushing tablets for enteral tube administration is not desirable and medicines should never be added to containers of enteral feeds. Effervescent tablets might appear to be useful but some disperse rather than dissolve and some deliver a high sodium load, cautioned Ms Bradnam.
In order to practise safely and in the best interests of the patient, healthcare practitioners should follow the guidance published by the National Institute for Health and Care Excellence, the National Patient Safety Agency and local guidelines, she concluded.
Biosimilars
Biosimilars are generally 20–40% cheaper than the originator products and could provide important savings for the National Health Service (NHS). However, uptake of the biosimilar infliximab (which lost patent protection in 2015) has been slow in the UK compared with Denmark, Poland and Norway (7% versus >70%), said Margaret Dolan (Regional Pharmacy Procurement Specialist, South East Coast, UK). The slow uptake in the UK appears to be related to confusion about clinical trial data and the characterisation of structure and function to judge safety and efficacy, she explained.
It is important to understand that biologic drugs are inherently variable and that changes in the production processes of the originator products mean that they are, in effect, biosimilars of themselves. For example, there have been more than 35 changes in the production process for Remicade® (infliximab) since launch. At each change, a battery of analytical tests has been used to demonstrate that the new version is highly similar to the originator and the same analytical approach is adopted when a biosimilar competitor is made. Analytical high similarity is the most robust scientific basis for comparing independently sourced biologics and the only reason for conducting clinical trials is to assess immunogenicity, said Ms Dolan. Post-marketing surveillance will be of utmost importance, she added.
Pharmacists have a key role in educating prescribers about biosimilars and “stopping them from asking for numerous clinical trials”, she said. They must also insist on prescribing by brand name so that meaningful pharmacovigilance is possible. These issues are so important that a network of UK ‘switch champions’ for the biosimilar infliximab has been established. If the NHS does not embrace the use of biosimilars, then it will become bankrupt, she concluded.
Hospital pharmacy compounding
Any manipulation of injectable doses beyond simple reconstitution leaves the pharmacist responsible for the quality of the product, Paul Le Brun (Hospital Pharmacist and Clinical Pharmacologist, Central Hospital Pharmacy, The Hague, The Netherlands) told the audience. There is a clear need for a number of injections in a ready-to-administer (RTA) form, either because they are high risk products or are not commercially available in the required form, and these are being prepared in large hospitals. Centralised preparation is the logical way forward, he said.
A follow-up to the 2011 Council of Europe Resolution on Quality and Safety Assurance Requirements for Medicinal Products Prepared in Pharmacies for the Special Needs of Patients is likely to recommend a risk-based approach for reconstitution and the designation of a suitably experienced person in each hospital with responsibility for assessing the risks of reconstitution. “These measures will improve patient safety”, said Dr Le Brun. In addition, there will be a strong focus on the availability of ready-to-use (RTU) and RTA injections, he added.
Automated preparation will become increasingly important and pharmacists will need to consider aspects such as speed, accuracy, software, cleaning and disinfection when selecting robots. Use of a robot will increase safety, reduce occupational health problems for staff and reduce wastage. Automated preparation will be a routine part of daily practice within five years, he predicted.
Home IV therapy
Community-based intravenous (IV) therapy can save money by avoiding the need for long hospital stays and reducing the rate of hospital-acquired infections, Susan O’Hanlon (Lead Nurse for IV Therapy, Bridgewater Community Healthcare NHS Trust, UK) told the audience. The community IV service that she leads is responsible for saving more than 6000 (inpatient) bed-days annually. Although the British Society for Antimicrobial Chemotherapy has recommended a standardised approach, in real life a number of different models are in operation. These include administration at infusion centres, community clinics and self-administration at home.
Once-daily treatment is ideal particularly for community outpatient antimicrobial therapy (C-OPAT) services, but patients always prefer home treatment. Theoretically there is a higher risk to the patient if anaphylaxis were to occur in the home, in the absence of a healthcare professional. However, the incidence of anaphylaxis is low – Ms O’Hanlon has only seen one case in ten years of practice. Self-administered OPAT was originally developed for patients with cystic fibrosis but has now been extended to other conditions. It requires a lot of training and so it is only worthwhile for long-term treatment. Moreover, some patients find the process of preparing and drawing up injections technically difficult, she explained. Clear referral criteria are essential and Ms O’Hanlon’s service has developed a detailed referral form to ensure that, in addition to clinical information and treatment plan, all drugs, diluents and flush solutions are prescribed before the patient leaves hospital. There is also a space on the form for the community IV team to add important administration details.
During the discussion Ms O’Hanlon said that RTA injections were not available for her service and that she would welcome a pharmacist on her team.
Antimicrobial stewardship
Antimicrobial resistance (AMR) is increasing worldwide and by 2050 deaths from so-called superbugs are expected to exceed deaths from cancer, according to Philip Howard (Consultant Antimicrobial Pharmacist, Leeds Teaching Hospitals NHS Trust, UK). AMR is now recognised to be a national risk, together with terrorism and natural disasters. Without effective antibiotics, surgery and chemotherapy will be greatly limited. The UK government has devised a five-year AMR strategy with seven key areas for action, including optimising prescribing, improving infection control and prevention and improving professional education, he explained.
All healthcare professionals should be vaccinated against influenza to avoid passing the disease on to vulnerable patients, such as immunocompromised patients, whose risk of death from influenza is higher than normal.
There is no room for complacency – antibiotic consumption in the UK is relatively high, he said. The Advisory Committee on Antimicrobial Resistance and Healthcare Associated Infection (ARHAI) has recommended rolling back antibiotic prescribing to 2009–10 levels by reducing at a rate of 1% per year. As part of this, broad-spectrum antibiotics should account for less than 10% of primary care antibiotic prescribing. New diagnostic techniques could help to prevent starting treatment or enable early discontinuation.
Sepsis accounts for 37,000 deaths annually in England, of which about 12,000 could be prevented. Prompt antibiotic treatment (within one hour) is a critical measure and guides such as the emergency department sepsis screening tool, the ‘Sepsis Six’ (Sepsis Trust – see Resources) and the Leeds ‘BUFALO’ (Blood culture, Urine output, Fluid resuscitation, Antibiotics IV, Lactate measurement, Oxygen) can prompt staff to implement effective measures. The Sepsis Six is associated with a number-needed-to-treat (NNT) of five for survival and so is well worth following, Mr Howard emphasised.
Penicillin allergy
Some 10–20% of patients claim to be allergic to penicillin but the true figure is probably nearer to 1% and this gives rise to a number of problems. Penicillin allergy is a risk factor for serious infections including Clostridium difficile, methicillin-resistant Staphylococcus aureus and vancomycin-resistant enterococcus. Furthermore, alternative antibiotics are associated with more adverse reactions and Streptococcus pneumoniae resistance to macrolides and doxycycline is now increasing. Thus, higher mortality and higher costs are possible. “The allergy label is not good for you”, he said. “Who is routinely reversing inappropriate allergy labels?” he asked.
In summary, he said antibiotic stewardship was everybody’s responsibility and that we have to improve hygiene and educate members of the public to look after themselves better and only use antibiotics when essential.
Medication safety officers
A 2010 European Directive says that the term ‘adverse reaction’ should be applied not only unintended effects of the drug but also to medication errors and off-label use, David Gerrett (Senior Pharmacist, Patient Safety, NHS England, UK) explained. All types of incident are reported to the National Reporting and Learning System (NRLS), which is now the world’s largest dataset.
A total of 378 Medication Safety Officers (MSOs) have been appointed (in England) and 90% of these are pharmacists. A two-way flow of information (between NHS England Patient Safety and MSOs) is now becoming possible and a functioning network of MSOs is being established.
An example of the benefits of this network was a report from one MSO of an incident involving desmopressin. Another member of the network, who had reported incidents of desmospressin omission in the past, contributed a local newsletter that warned of serious harm due to polyuria and hypernatraemia if patients did not receive desmopressin when prescribed. Further investigation showed that other, similar, incidents had occurred. Contributory factors included lack of understanding among doctors and nurses of the management of diabetes insipidus and the importance of desmopressin treatment and lack of timely pharmaceutical input. NHS England is now considering issuing a Stage 1 patient safety alert on this topic. It is unlikely that this serious risk would have been identified from the NRLS alone, said Dr Gerrett.
Medicines reconciliation
Over a four-year period the pharmacy team at North Bristol NHS Trust worked towards its target of medicines reconciliation within 24–48 hours of admission for 95% of patients. Jane Smith (Principal Pharmacist, Development and Governance and Medication Safety Officer, North Bristol NHS Trust, UK) explained how quality improvement methodology was used to develop the service in a robust and sustainable way. The result is a service that each year saves an estimated £350,000 from medicines reconciliation and a further £650,000 from the re-use of patients’ own drugs.
Some of the savings arise from shorter hospital stays and reduced harm. A good example of this was a patient who was admitted via the emergency department (ED) over a weekend. On the following Monday, the pharmacist noted that the patient was prescribed insulin but did not have his own supply. Further investigation revealed that the doctor had copied the medication details from a slip of paper found on the floor of the ED cubicle but this was left over from the previous patient. The key to effective medicines reconciliation is always talking to the patients to determine exactly how they use their medicines, emphasised Ms Smith. Another important aspect of the medicines reconciliation system at North Bristol is continual monitoring of performance. This provides a much better reflection of the service than isolated ‘snapshot’ audits, she said. Medicines reconciliation could save £40 million per year and re-use of patients’ own drugs could save £80 million if the services were fully implemented in England, concluded Ms Smith.
Resources
The Sepsis Trust
The Sepsis Trust seeks to save lives and improve outcomes for survivors of sepsis. http://sepsistrust.org
The ninth B Braun Medical Patient Safety Symposium was held at the International Conference Centre in Birmingham on 4 November 2015
