The economic and clinical burden of preventable drug-related morbidity (PDRM) was a fundamental problem facing health services today, Professor Hepler told the meeting. A secondary problem was that, despite long-standing awareness of PDRM, the underlying causes had not changed. The burden seemed to persist, and was perhaps intensifying. A key tactic in his proposed solution was to broaden the recognition of the problem, especially by managers on the ground, and to develop standards for co-operative medicines use systems.
Professor Hepler cited studies from the United States and Europe to show that PDRM was a significant factor in about 3.2 per cent of hospital admissions and that about half of all drug-related admissions could have been avoided. Morbidity was broadly comparable with cancer, myocardial infarction, diabetes mellitus and asthma, making PDRM a major public health - and financial - problem. He argued that improvements in the quality of drug therapy would prevent expensive events such as emergency visits and hospital admissions and so lower the total cost per head.
Despite the statistics, there was little evidence of attempts to solve the problem. Possible reasons were that the problem was of such a scale that it might not be believed, that the problem might seem too complex to resolve efficiently, and that the obvious solutions, such as formularies and drug restrictions, appeared to have been ineffective, or even counter-productive.
Major causes of PDRM were the health care environment and the structure of health care delivery systems. Other problems included inappropriate prescribing, over- and underdosing, unexpected adverse reactions, non-compliance, failure to recognise symptoms, lack of necessary drug therapy, medication errors and delays in response or inadequate follow-up of clinical signs and symptoms. The approach so far had been to try to resolve individual problems although it was unrealistic to expect such an approach to be helpful. However, the causes were known and controllable. The key was in good processes that could detect problems that came from the environment or structure of health care.
This could be illustrated by the "Swiss cheese" error prevention model, developed by Professor James Reason of the University of Manchester. Each stage in a process could be viewed as a slice of cheese with holes representing process failures that might allow potentially injurious events through to the next stage. If the chance of passing through a hole was one in 100 at each successive stage, the potential for harm would be one in 10,000 after two stages and one in 1,000,000 after three stages (with the patient, the prescriber and the pharmacist each representing a stage). The risk of "system failure" at each stage depended on how much information flowed through that stage. Hence, if relevant information was not supplied through the system to the pharmacist then the risk at that stage in the process and overall would not decrease and might even increase.
To improve patient outcomes it was necessary to construct medicines use systems both for medical care in general and for individual patients.
Although the problem of PDRM had been recognised by pharmacy and medicine for more than 10 years, the concept was not well defined, researchers were not familiar with it, and it did not attract research attention. It was also "invisible". For instance, badly treated asthma was not generally coded as a drug problem on a hospital admission form; it was coded as "asthma". If they could not see a problem for what it was, health care managers would allocate resources to more visible problems. With initiatives such as clinical governance and evidence-based medicine, the NHS in Scotland was in a position to respond to the problem.
Suggesting that there was bias against change, Professor Hepler said that compelling evidence was demanded to "prove" the worth of medicines use systems, despite numerous encouraging, albeit imperfect, studies. In contrast, formularies were people's favourite tool. But evidence from managed care organisations in the US showed that the more restrictive a formulary was, the higher became the subsequent use of other, possibly more expensive, health care services. Thus, in the US there was little evidence that prescribing restrictions achieved cost-effectiveness. In contrast, system changes improved outcomes and reduced costs per patient. Examples were given of an anticoagulation clinic, an asthma programme in Danish pharmacies, and the impact of changes to drug distribution systems and addition of clinical pharmacists.
"The irony," said Professor Hepler, "is that we worry more about drug costs than drug consequences, even if the consequences cost more than the drugs themselves." In addition, money was spent on programmes that did not work and might be counter-productive through unintended consequences. Despite encouraging research evidence, there was a failure to redesign systems. "The worst error," he said, "is that we do not routinely assess the consequences of our programmes - and their outcomes."
Professor Hepler proposed a four-point solution to encourage safer systems. The first point was to increase awareness. Professional bodies should take the lead to increase awareness among their members and other stakeholders, adapting their communications to fit the target audience.
The second action was to identify and assess the problem locally. Managers should evaluate the quality of drug therapy outcomes in their own populations. This required: standardised definitions and methods for PDRM research; PDRM outcome indicators for screening population databases; and process indicators for measuring the impact of corrective actions.
The third component was clinical governance (quality improvement), for which the methodology was well known and did not have to be reinvented. Through the use of those tools, pharmaceutical care might be discovered, or even rediscovered, as a way to solve problems in medicines use systems.
Lastly, there was a need to improve standards for medicines use. The first three points used market forces to allocate health care resources. They would promote the assessment and resolution of problems of medicines use that providers could recognise as reducing efficiency. However, this might not be enough. From an economic perspective, standards were meant to fill the gap between public interest and market forces. There was a need to change the regulatory approach rather than to add new regulations. In the Scottish context of the NHSiS this would require NHS trusts to have clinical governance programmes involving the outcomes of medicines use.
Professor Hepler also set out a four-element practical approach to changing medicines use systems: target a major drug therapy issue, eg, candidates for model schemes or health improvement programmes; develop and implement process and outcome indicators relevant to the issue; demonstrate, if possible, process improvements; and publish a realistic standard or benchmark based on this work.