This article is based on a lecture given by Dr Henri Manasse, Executive Vice President and Chief Executive Officer, American Society of Health-System Pharmacists, at the 4th ESCP Spring Conference on Clinical Pharmacy in Lisbon, Portugal, May 2003
Laurence A Goldberg
People can create or compromise safety, and in systems that are designed to affect complex processes, errors sometimes get through. Two recent examples illustrate this point. In February 2003, a child suffered a fatal blood type mismatch during a heart–lung transplant operation, in spite of multiple checking procedures. In 1995, another child died after xylocaine and epinephrine, both in unmarked containers, were accidentally switched in the operating theatre. These were attributed to system errors, but it is important to consider whether, in blaming the systems, the issue of personal accountability is now underemphasised.
Discontinuities in care at interfaces are now recognised areas of risk. One study has shown that 13% of patients suffered adverse drug events after discharge from hospital. Another study showed that 25% of the patients surveyed experienced adverse drug events in the outpatient setting. Of these, 28% were attributed to poor communication, in both directions, between doctors and patients. There is, therefore, a need to ensure safe and accountable pharmaceutical care. The original definition of pharmaceutical care did not include accountability, but this is essential. Safe and accountable pharmaceutical care is built on a set of principles of practice (see Panel 1).
Measures to ensure safe and accountable pharmaceutical care
Turning to the measures that are in place to ensure a safe and accountable system of pharmaceutical care, Dr Manasse said that the US healthcare system is undoubtedly the most expensive system in the world and is sometimes of questionable quality. Three recent publications from the Institute of Medicine, entitled To Err is Human, Crossing the Quality Chasm and Priority Areas for National Action, provide valuable insights into the medication use process and the ways in which it can be improved. The National Quality Forum in the USA has identified 27 “Never events” – serious reportable events that should never happen in healthcare. These include: wrong site or wrong patient injury, retention of a foreign object in a surgical patient, and death or serious injury from medication errors or contaminated medicines. The same body has published a list of 30 approved safe practices, one of which is that pharmacists should actively participate in the medication use process, which should include, at a minimum, consultation with prescribers, preparation, dispensing, administration and monitoring of medications.
The Food and Drug Administration (FDA) has made major efforts to identify, learn from and prevent medication errors. These include: automatic data collection, enhanced partnerships between health organisations, regulatory entities and payers, and a communications infrastructure to ensure rapid dissemination of new learning among providers nationwide. This latter facility means that, for example, news of serious, fatal errors can be disseminated quickly to alert others to a particular risk. Recently, barcode regulation has been proposed, which requires machine-readable codes (barcodes or reduced space symbology) on all medication packaging. The encoded data would comprise drug name, dosage form and strength. The American Society of Health-System Pharmacists (ASHP) is keen to see in addition a batch number and expiry date.
The accreditation standards of the Joint Commission on Accreditation of Healthcare Organisations (JCAHO), the body that accredits hospitals in the USA, mandate continual assessment and refinement (and, where necessary, redesign) of medication use systems. They also call for sentinel events to be recorded and disseminated, for pharmacists to participate in accreditation teams, and, among the patient safety goals, for improvements in the safety of high-alert medication use. Examples of these might be the removal of concentrated electrolytes from patient care areas or standardising the number of different drug concentrations on a site.
ASHP continues to be committed to failsafe medication use, according to Dr Manasse. The organisation holds consensus conferences on medication misadventures and has entered into collaborative relationships with other organisations. A joint pharmacy and nursing executive session on the theme of “Shared vision for safe medication use in hospitals” identified the need for strong partnerships with nursing colleagues. ASHP is also working with the National Alliance for Health Information Technology and is concerned with advocacy for legislation and regulation. “If you are involved at all, you will know that the systems cannot always communicate with each other,” he said.
A continuing problem
In spite of the plethora of guidance and regulation, a study in 2002 showed that one in five US families were affected by adverse medical events. The same study revealed marked differences in the degree of concern about patient safety. Asked if the quality of care was a problem, 29% of doctors responded affirmatively, compared with 68% of patients. Similarly, patients preferred to have even minor errors disclosed and explained, whereas doctors preferred to give little or no information about errors that were minor or caused no harm.
Dr Manasse believes there are moral and professional imperatives in safe therapeutics: “We should consider ourselves as a profession of healers, and this elevates our status and confers privileges.” Traditionally, healers have codes of ethics. These are an expression of the covenant or obligation of the healer to their patients and profession, and they acknowledge the sacred trust intrinsic to that covenant. However, what is often missing is the patient’s obligation to follow the healer’s advice and avoid the counsel of quacks and incompetents.
There may be a business case for cost-effective healthcare. Such a case would exist if the payers realise a financial return on their investments – in money or costs avoided – in a reasonable timeframe, and using a reasonable rate of discount. Impediments to cost-effective care include:
- Failure to pay for quality; willingness to pay for defects.
- Difficulty in determining degrees of quality for comparison shopping.
- Returns on investments in quality are often delayed – sometimes until after the patient has changed payers.
- Lack of flexibility, innovation and customisation in care options offered to payers and patients (“monolithic systems”).
- Uneven access to clinical information among clinicians, giving rise to discontinuity of care.
It is the view of ASHP and many others that pharmacists must be compensated for direct patient care. This has led to the “provider status” movement in the USA, which argues that provider status would harness accountability and incentivise care management and continuity. An important question is whether payment could be based on outcomes and demonstrated quality rather than on volume of visits or transactions.
A new vision for pharmacy
Considering all of these factors, Dr Manasse analysed the implications for pharmacy. The profession would be based on a philosophical grounding that emphasises continual earning of patient trust and is committed to demonstrating the value of pharmacists. It would become a standards-driven profession that has practice parameters determined internally rather than by external forces, would promulgate evidence-based practice, and would utilise a consensus of experts and common sense.
A key factor in this new vision for pharmacy is the readiness for accountability and the willingness to demonstrate competence. For example, some pharmacists are already authorised to run clinics in hypertension or diabetes for which they are held accountable. Continuing professional development could become the basis for gaining accreditation, suggested Dr Manasse. Another key factor is the commitment to safe medication use system design. At present, 10% of US hospital pharmacists devote some time to patient medication safety. In addition, pharmacists must continue to focus their efforts on therapeutic rationalisation.
Finally, academics must incorporate safe care and systems thinking into the curriculum and set the scene for team-based care through multidisciplinary education. The finishing touch would be to follow the recommendation made by the IoM in its April 2003 report, Health Professions Education: A Bridge to Quality – to hold biennial, interdisciplinary summits to assess and plan progress in achieving common core competencies. These would cover the provision of patient-centred care, interdisciplinary teamworking, evidence-based practice, quality improvement and informatics.
Asked to expand on the new vision for pharmacy, Dr Manasse said that the key factor is accountability. He envisages a healthcare professional who would be accountable for therapeutic outcomes. At present there is often no individual who is accountable for the care of a patient. Pharmacists have a foundation from which to do this by virtue of the constant one-to-one relationship that they have with patients. A pharmacist could come forward and be accountable for a patient’s treatment, regardless of where the medicines are dispensed. Such accountability would need to be documented, verified and validated, he added.
When asked if near-misses as well as sentinel events should be reported and whether reports should be anonymous, Dr Manasse replied that in high-reliability organisations (HROs), such as aviation and chemical manufacturing, near-miss reporting is critical. In aviation, near-miss reporting is mandatory because managers need to know about potential risks to safety. In HROs, near-misses are often more significant than sentinel events in improving systems, although they might not improve individual behaviour. Concerning reporting, he said that research showed that voluntary reporting grossly underrepresents the true picture, but identification of the reporter is often a deterrent to reporting. “In the USA, we need to move the patient safety sphere into a nonpunitive dialogue. We in healthcare hold ourselves to a standard that is unrealistic – we are not infallible.”