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Pharmaceutical clinical effectiveness


Systems that promote quality and safety in healthcare result in improvements and efficiency, according to experts at a recent conference in Northern Ireland 
Christine Clark PhD FRPharmS FCPP(Hon)
Editor, HPE
It is now five years since the first conference of this type was held in Northern Ireland, and in that time the importance of medicines management has not diminished but the role of technology has increased considerably, said Norman Morrow (Chief Pharmaceutical Officer, DHSSPS (Northern Ireland)). A number of factors are likely to impinge on healthcare in future and pharmacists will need to take account of these when developing medicines management services, he continued.
Automated care of people is likely to be a major development. This could include robot-assisted care and remote monitoring to provide economically viable care for the sick and elderly, enabling people to stay at home for longer. It is estimated that the telehealth market will be worth £50 billion by the end of the present decade, he noted.
The combination of diabetes and obesity – often known as ‘diabesity’ – is likely to become a major healthcare issue. At present, it is estimated that some 255 million people have diabetes and there could be many more in the future. It could cost as much as 5% of total global output to treat this epidemic, said Dr Morrow.
Between two and three major pandemics can be expected in the next ten years. They are likely to start in regions where there is limited public health care and spread rapidly around the globe. There will be a need for careful biosurveillance. The prevalence of Alzheimer’s disease is likely to treble by 2050, and so finding a way to halt the disease will have major significance.
Mass medical tourism could become a commonplace phenomenon – much more than the cosmetic and dental procedures for which people travel today. Routine surgery in India costs about one tenth of what it costs in the West, with similar outcomes, he said.
Dr Morrow also foresaw the development of customised foods as the science of nutrigenomics grows, and the wider acceptance of assisted suicide.
Finally, he suggested that another prominent feature of healthcare in the information age will be global networking between patients to share experiences and aid decision making. Websites such as ‘Patients like me’ ( and ‘Cure together’ ( are leading the way here, he added.
Improving quality
Working on medication errors alone is unlikely to reduce harm, because many errors do not cause harm and much [medication-associated] harm is not caused by errors, according to Frank Federico (Executive Director, Strategic Partners Institute for Healthcare Improvement, Cambridge, Massachusetts, US). He went on to describe how important it is to target the harm caused by both errors and adverse drug events.
Quality problems in the use of medicines include overuse, for example, the use of statins in the over-80s, under-use, for example, the failure to put innovative products into routine use, and misuse. The Institute of Medicine (see Resources) defined the elements of quality healthcare as safety, timeliness, effectiveness, efficiency, equity and a patient-centred approach. Although medication is the most common intervention in healthcare, it is the least successful because of the complexity introduced by multiple prescribers, he noted.
Training and education is one of the essential steps for improvement in the quality of healthcare, but training alone is insufficient – systems must be designed to take human factors into account, explained Dr Federico. Standardisation of products and procedures is a key component of quality improvement. It allows consistent delivery of care at a high level. One example of standardisation is having a hospital-wide insulin protocol. Simplification and the introduction of reliable processes are also important steps. Monitoring of systems is also critical because, over time, systems tend to degrade, he said.
Polypharmacy and medication adherence are two areas where pharmacists could make an impact. One approach to improving medication adherence might be to reproduce the buddy system that is used so successfully in weight-reduction clubs (Weight-Watchers) suggested Dr Federico.
Clinical effectiveness
A pharmaceutical clinical effectiveness programme was introduced in 2005 and has yielded clear, measurable benefits, Professor Michael Scott (Head of Pharmacy and Medicines Management Northern Health and Social Care Trust) told the audience. The programme comprises eight integrated work streams. One of these is the integrated medicines management programme, which involves intensive clinical pharmacy input at admission, during the hospital stay and at discharge. As a result of this programme, length of stay was reduced by two days and time to readmission was increased by 20 days. In addition, medication rounds were faster, the discharge procedure was quicker and errors on discharge prescriptions were sharply reduced. Overall, the integrated medicines management process achieved significant benefits in safety, efficiency and economy in medicines use, giving a return on investment of between £4.8 and £8 for every £1 invested.
Electronic medicines reconciliation
An electronic medicines reconciliation programme has been developed that makes the process rapid and consistent, said Stephanie Tohill (Senior Clinical Pharmacist, Northern Health and Social Care Trust).
Medicines reconciliation has been defined by the Institute for Health Improvement (see Resources) as, ‘…the process of creating the most accurate list possible of all medications a patient is taking – including the drug name, dosage, frequency, and route – and comparing that list against the physician’s admission, transfer, and/or discharge order, with the goal of providing the correct medications to the patient at all transition points within the hospital.’ 
At present, the system in place in the Northern Trust requires 95% of patients to receive a medicines reconciliation interview within 24 hours of admission. The medicines reconciliation process provides the basis for an accurate discharge prescription at the end of the patient’s stay in hospital. Pharmacist-generated discharge prescriptions are associated with many advantages, including accuracy, prompt delivery and improved bed management, noted Ms Tohill. The electronic system has been developed so that it links with the patient administration system, uses the standard descriptors listed in the NHS dictionary of medicines and devices (dm+d) (see Resources) and is linked to the pharmacy activity monitoring system (Electronic Pharmacist Intervention Clinical System). The electronic medicines reconciliation programme allows pharmacists to record promptly, in real time, a list of patients’ medicines in a clear, concise, standardised form. Once recorded in this way, the information can be accessed by all authorised users. Another feature of the system is the ‘medicines reconciliation dashboard’, which provides a profile of the current status of medicines reconciliation activity and is updated every five minutes. This means that pharmacists can be moved to areas of high demand, if necessary, commented Ms Tohill.
When the patient leaves hospital, the discharge prescription is pre-populated from the list generated at the original reconciliation. This can then be adjusted, if necessary, to reflect changes during the hospital stay and then exported into the Immediate Discharge Summary document. This feature has proved to be particularly useful in practice, said Ms Tohill.
The scheme is currently being piloted on five wards in the Northern Trust. One early problem was that pharmacists had difficulty gaining access to computers, so portable hand-held devices have now been provided. Future developments will include integration of the medicines reconciliation data into the patient’s electronic care record.
Clinical rules 
The quality of a medication review varies considerably depending on the information available and who undertakes the review. Medication review can be performed more effectively by pharmacists if all the relevant information is available and the pharmacist has a good knowledge of the conditions in question, explained Hugo van der Kuy (Pharmacist and Clinical Pharmacologist, Orbis Medical Centre, Sittard, The Netherlands). A recent study had shown that when given a medication list alone, pharmacists identified a limited number issues but this progressively increased as they were given laboratory data and a medical history.
In the locality of the Orbis Medical Centre, there are 800 patients in nursing homes each of whom requires two annual medication reviews. Given that reviews take approximately one hour each, this would require 1600 hours of a pharmacist’s time. In addition to the shortage of time available there were concerns that the reviews could be of poor quality because of lack of familiarity with the patients. The pharmacy staff at Orbis Medical Centre set out to find a solution that combined efficiency with the capability for ongoing surveillance and availability for all hospitals. Efficiency is critical to avoid unnecessary alerts, noted Dr van der Kuy. They developed the Clinical Rule Reporter. This is based on a ‘clinical rule engine’ that receives information extracted from the medication record, patient characteristics and laboratory data files. The engine then analyses the data according to ‘rules’ compiled from guidelines and clinical experts. Examples of the types of issues reported include prescriptions for opioids without laxatives, NSAIDs prescribed for patients with renal failure, high blood glucose levels with no anti-diabetic treatment, and heart failure treated with standard-release metoprolol instead of the modified-release product. It produces three categories of alert – new alert, recurrent alert and ‘high risk patient with everything in order’. The system can produce a daily report, known as the ‘weather forecast’, that shows the total number of reports and a breakdown by category. Ideally, the number of category 2 reports (recurrences) should be zero, commented Dr van der Kuy.
At present, the system is analysing 2000 patients each day and is still under development. The developers plan to seek input from a community of expert clinical pharmacists to refine the rules engine further.
Microbiology surveillance
In the past, management of antibiotics and infection control had been largely on the basis of reacting to problems and then withdrawing a single agent or a class of antibiotics but a comprehensive infection surveillance programme now enables the infection control team to manage hospital-acquired infections in a more informed way. Fidelma Magee (Antimicrobial Pharmacist, Northern Health and Social Care Trust) and Patricia Kearney (Consultant Microbiologist, Northern Health and Social Care Trust) described how a secure, web-based microbiology surveillance system had been developed in partnership with Yarra Software Ltd.
An estimated 25,000 European patients die each year as a result of healthcare-acquired infections (HCAI) and the associated costs are believed to be up to one billion pounds per year. In the Northern Trust, an outbreak of Clostridium difficile (C. difficile) several years ago prompted the development of antibiotic stewardship policies and a robust infection surveillance system. “We wanted to be able to monitor emerging new strains of organisms, resistance trends and potential outbreaks”, explained Mrs Magee.
The program had to include laboratories, pharmacy, infection control and the information technology department. It was also critical that it used existing processes wherever possible, avoided double entry of data and operated in real time. Thus, a central database was developed based on live data feeds from the microbiology, pharmacy and patient administration databases. This was essential because “live data tells you what is really happening”, said Dr Kearney.
The completed program displays an HCAI dashboard menu in six ’tiles’; each section can be searched rapidly with only a few mouse clicks. For example, questions such as how many Pseudomonas aeruginosa isolates have there been in NICU in the past two years and what have been their sensitivities? Or how many C. difficile isolates have there been in hospitals and clinics in the region in a given period and which health centres have they come from? One benefit of this system (in contrast to other microbiology surveillance systems) is that it includes every nursing home and clinic, as well as hospitals; it is, therefore, possible to get a complete picture of patterns of infection across the region and manage infection control and antibiotic usage in a more rational way, explained Dr Kearney.
Transitional pharmaceutical care
At Sint Lucas Andreas Hospital in Amsterdam, ‘pharmaceutical consultants’ – pharmacy technicians with a three-year bachelor training – have been appointed to operate the transitional care programme, because pharmacists would be too expensive, explained Fatma Karapinar (Pharmacist, Sint Lucas Andreas Hospital, Amsterdam). The transitional care programme involves medication reconciliation and patient education at admission and discharge and, in addition, the provision of discharge information to both the community pharmacist and the general practitioner. For each patient the process takes approximately one hour of the pharmaceutical consultant’s time at a cost of €41 but saves €97 as a result of medicines discontinued or changed – a net saving of €56 per patient.
A comparison of usual care with the transitional care programme failed to show any significant difference between all-cause rehospitalisations in the two groups but many readmissions were not drug-related, noted Dr Karapinar.
Institute of Medicine
The Institute of Medicine provides information and advice concerning health and science policy
Institute for Health Improvement  
The Institute for Healthcare Improvement (IHI), an independent not-for-profit organisation based in Cambridge, Massachusetts, is a leading innovator in health and health care improvement worldwide.
NHS dictionary of medicines and devices (dm+d)
The dm+d is a dictionary containing unique identifiers (codes) and associated textual descriptions for representing medicines and medical devices in information systems and electronic communications.
Quality + Safety = Improvement + Efficiency was held at the Dunadry Hotel, County Antrim, Northern Ireland on 17–18 January 2013.

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