Laurence A Goldberg
HPE Editorial Consultant
Evidence-based formularies, quality of pharmaceutical services, barcoding and safety initiatives were the main topics developed at the EAHP Congress.
Formularies should be based on explicit, robust, evidence-based criteria, and the process for including a medicine should be defined, transparent and open to the public, according to Roger Walker (Professor of Clinical Pharmacy and Consultant in Pharmaceutical Public Health, Cardiff, UK).
The reasons for having formularies are that they are believed to improve quality of prescribing, enhance the quality of patient care, promote cost-effective prescribing and prevent unnecessary use of newer or more expensive medicines of inferior benefit. However, there are few studies that demonstrate the effectiveness of formularies – a recent Medline search yielded fewer than 50 papers. Formularies should manage the way that medicines are used and combat other influences. For example, a government committee in the UK had concluded that the pharmaceutical industry “positively nurtured anxieties about ill-health” as a way of increasing public demand for medicines. In addition, patients do not respond to medicines in a uniform way, and there is wide variation in the uptake of new drugs. Furthermore, formularies provide opportunities for bulk purchasing and economies of scale. The main criticisms of formularies are that they restrict or delay access to innovative therapeutic developments, reduce clinical freedom and exclude stakeholders, such as patients, from the decision-making process. A further concern is the lack of consistency between formularies. A recent study compared four well-known sources of drug information regarding adjustment of dose for renal function.(1) The findings showed that the recommendations were worded in qualitative and undefined terms, that drugs were contraindicated in one but not all sources, that there were no references to primary sources, and that there were variations in recommended doses and dosing intervals. Other criticisms include concerns that decisions can be influenced by the articulate few, conflicts of interest often not being publicly declared, lack of appeals and review procedures, and implementation and adherence rarely being monitored.
The SOJA (system of objectified judgement analysis) is a model for rational decision-making about drug selection, explained Rob Janknegt (Maaslandziekenhius Sittard, The Netherlands). According to this method, the selection criteria (eg, clinical efficacy, incidence and severity of side-effects) for a given group of drugs are defined in advance, and the extent to which each drug fulfils the requirements of each criterion is determined by a group of experts after careful evaluation of the literature. The weight given to each criterion must be determined by the user. For this reason, interactive software has been developed to enable users to adjust the weights and try “what if” scenarios. Experience has shown that when this process is used by formulary committees it improves the quality of discussion. All nonrational criteria are eliminated, and the drug selection process becomes fully transparent.
Implementation of a modified form of SOJA in Northern Ireland could lead to a saving of up to £3 million on one group of products alone, according to Michael Scott (Chief Pharmacist, United Hospitals Trust, Antrim, UK). Dr Scott described how the drivers for this initiative were not only costs but also inefficiencies in the current medicines management system caused by the availability in primary care of a mixture of generic products and parallel-imported products. This is a common cause of confusion for elderly patients. STEPS (Safe, Therapeutic, Economical Pharmaceutical Selection) had been developed from the SOJA process, he explained. STEPS involves three sequential stages – clinical evaluation, risk assessment and budgetary impact analysis. This ensures that only products that meet the quality, safety and efficacy criteria are evaluated for budgetary impact. The risk assessment involves two elements – information that is considered critical, such as clear labelling and packaging, and information that adds value, such as presentation in a calendar pack or EAN barcode on each pack. The process has been applied to angiotensin-converting enzyme inhibitors (ACEIs). Of 26 products, 22 reached the final stage of the process. Three products – enalapril, lisinopril and ramipril – were eventually selected. The target is now to achieve 70% usage of these three agents. The target is not 100%, to allow a small measure of clinical freedom and to accommodate patients who have already been stabilised on other products, explained Dr Scott. Savings of £700,000 per annum for the local Health Board are anticipated.
The benefits of STEPS include full involvement of all stakeholders and a robust, transparent objective system of product selection, concluded Dr Scott.
Quality of pharmaceutical services
Pharmaceutical services that are embedded in the hospital’s quality improvement process can help to reduce drug overuse, underuse and misuse. However, management of quality and quality improvement require a combination of approaches, Johnny Beney (Institut Central des Hôpitaux Valaisans [ICHV)] Sion, Switzerland) told the audience.
Interest in the quality of healthcare services can be traced back to Florence Nightingale, who was an avid user of statistics. In recent years the focus has progressively shifted from the structure of healthcare services to processes and outcomes. The Institute of Medicine in the USA has defined quality of care as “the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge”.
A number of approaches are used to ensure the quality of healthcare. These include licensure of individuals or establishments and external quality assessment (EQA). EQAs comprise a range of organisational reviews, all of which assess performance against established standards. They include generic models such as ISO 9000 and the European Foundation for Quality Management (EFQM) Excellence Model, as well as healthcare-oriented approaches such as peer review and accreditation.
Both ISO 9000 and EFQM are generic models but have the advantage of being well-recognised benchmarks. Peer review is concerned with the performance of individuals or teams and is therefore isolated from other quality activities. It has the advantage that it is concerned with the quality of care and is endorsed by the clinical professions. Accreditation is healthcare-oriented, places a strong emphasis on safety and is usually concerned with ideal achievable standards rather than with minimum acceptable standards (that are used for licensure). Accreditation can be an onerous process for small organisations, but it has the advantage of promoting public accountability.
There is little published evidence to demonstrate the effectiveness of quality improvement programmes, said Dr Beney. This does not mean that they are not effective, but could be due to the methodological challenges of measuring outcomes and attributing causality to complex interventions in organisations or healthcare systems, he continued. Moreover, randomised controlled trials are not necessarily the gold standard for quality improvement studies. The goal of quality improvement studies is to improve performance, and tools such as statistical process control, interrupted time series and before/after studies can be more appropriate, explained Dr Beney.
One study showed that the introduction of a medication safety programme reduced the frequency of adverse drug events (ADEs).(2) A statistical process control chart was used to display the results each month, and this clearly showed that the average frequency of ADEs fell from 1.7 per 100 doses to 0.7 per 100 doses after the introduction of the programme.
Another study has shown that overuse of medicines is reduced when a pharmacist takes part in postadmission ward rounds.(3) Expenditure on medicines during hospital admission is reduced, and the number of medicines discontinued is increased.
A third study focused on improving the use of ACEIs in patients with both coronary artery disease (CAD) and diabetes.(4) Underdosing was a common problem for this group of patients. The numbers of patients receiving the optimal dosage of lisinopril were compared at baseline and at the end of the study in both control and intervention groups. The results showed a large increase in the numbers of patients in the intervention group receiving 20mg doses of lisininopril instead of 5mg or 10mg doses.
Barcode and RFID
The mission of the GS1 Healthcare User Group is to lead the healthcare industry in the effective utilisation and development of global standards, with the primary focus on automatic identification to improve patient safety, explained Christian Hay (Medinorma, Switzerland). GS1 is the most widely used supply chain standards system in the world, formed by the merger of EAN (European Article Number) and UCC (Uniform Code Council) in 1995. A pilot study of the hospital warehouse at St Marien Hospital in Bonn, Germany in association with B Braun Melsungen AG compared the time taken for manual processing and scan-based processing of incoming goods, inventory control and outgoing goods. The central warehouse serves 1,000 beds, with 120 cost centres and a yearly turnover of over €400 million. Seven fulltime-equivalent staff run the operation; 318 working hours, costed at €5,700, were saved annually. In addition to these savings, the study showed that there was greater accuracy during the picking process, a reduction of errors in the inventory recording process and a reduction of inaccuracies in the delivery process.
Safety initiatives in The Netherlands
The hospital pharmacist is the medication safety specialist who maps risk and executes improvement processes, Martin Schuitenmaker (President, Netherlands Association of Hospital Pharmacists [NVZA]) told the audience.
The NVZA is involved in four major medication safety projects. They are:
- The implementation of a uniform medication-error classification system in hospitals.
- Propagation of best practices in medication safety.
- The creation of a national medication error data bank (Central Registration of Medication Errors [CRME]).
- National postgraduate education on medication safety for hospital pharmacists.
The CRME has been set up not only to provide a central register but also to give feedback to participating hospitals and to alert participants to sentinel errors. So far, 22 hospitals are participating and about 500 reports have been received.
More than 30% of the errors reported to date are concerned with drug administration errors in which patients were given drugs that had not been prescribed for them.
- Vidal L, Shavit M, Fraser A, et al. Systematic comparison of four sources of drug information regarding adjustment of dose for renal function. BMJ 2005;331:263.
- Cohen MM, Kimmel NL, Benage MK, et al. Medication safety program reduces adverse drug events in a community hospital. Qual Saf Health Care 200;14:169-74.
- Fertleman M, Barnett N, Patel T. Improving medication management for patients: the effect of a pharmacist on post-admission ward rounds. Qual Saf Health Care 2005;14:207-11.
- McConnell KJ, Humphries TL, Raebel MA, Merenich JA. Clinical pharmacy specialist implementation of lisinopril therapy in patients with coronary artery disease and diabetes mellitus. Pharmacotherapy 2003;23:1564-72.