November 2002 Guidelines for Managing Pharmacy Systems for Quality and Safety Background The Australian Council for Safety and Quality in Health Care (ACSQHC) was established by Australian Health Ministers in January 2000 1 in response to a recommendation from the National Expert Advisory Group on Safety and Quality in Australian Health Care. 2 It was recognised that the quality of the Australian health system was ranked as high on an international scale but that studies such as The Quality in Australian Health Care Study 3 showed there was significant opportunity for system-wide change to improve quality and safety. 2 There is also evidence that inappropriate drug use is a significant problem in Australia. The role of the ACSQHC is to lead national efforts to improve the safety and quality of health care. The four priority areas identified for action in 2001 2002 are outlined below. 1,5 All priority areas are relevant to improving safety in relation to medication use. 1. Promote better use of data and information to identify, learn from and prevent system failure and error. 2. Strengthen mechanisms to support health personnel to practice safely. 3. Actively promote opportunities for consumer feedback and participation. 4. Promote a culture of reliability and safety through redesign of systems and processes of care. In setting these priorities the ACSQHC acknowledged it has a role in leading a change in culture to establish a health system that, amongst other things, adopts improvements in health care quality and safety as core goals. 1 Not surprisingly, it has been noted that the community expects those in the health care system to take necessary steps to minimise the risk to consumers. This is seen as fundamental to maintaining and strengthening public trust and confidence in health care. 5 It has been estimated that there are at least 80,000 medication-related hospital admissions in Australia annually at a cost of around $350 million. The scope for improvement is evidenced by the fact that between 32% and 69% of these may be avoidable. 4 Introduction The ACSQHC provides a focus for coordination of national action to improve health system quality and safety. However, responsibility for action to enhance safety and quality in health care rests with all groups in the health system, whether in public, private or community based settings. 2 Pharmacists play a critical role in promoting quality use of medicines (QUM) that is the judicious selection of management options, appropriate choice of medicines where a medicine is considered necessary, and safe and effective use. 6 They provide medicines and medicines advice and have a growing role in a number of aspects of therapeutics and are therefore important participants in the evolving national agenda for improving quality and safety in health care. System failure, medication error and adverse drug events System failure, which is a key source of potentially preventable events such as medication error, is more likely in industries such as health where complex systems and technologies are used. The ACSQHC has proposed that errors are best managed through a change in culture from one of judgement and blame to one of learning for quality improvement where open discussion can occur to identify areas where improvements can be made. 7 Error theory also suggests that when errors occur it is counterproductive to adopt a culture of blame and punish the individuals involved. This is because errors are ubiquitous, are usually caused by faulty systems or system design and involve individuals who are generally performing well in their jobs. 8 Recognition of these facts has been associated with a tendency in health to move from a system of assigning blame to one where efforts are directed to identifying and correcting system errors. 5 Medication error has been recognised as the leading cause of adverse events, 8 and more than three-quarters of all problems associated with medication errors have been attributed to system failure. 5 Medication errors include events such as use of the wrong drug or dose, administration of a dose to the wrong patient or at the wrong time and avoidable drug interactions and adverse reactions. 5 Look-alike packaging, soundalike names and interruptions to process have been cited as factors contributing to medication error. 8 When considering medication safety there are two important issues to note. Although medication errors are common, most have little potential to cause harm.* Not all adverse drug events are preventable. Managing safety and quality a risk management approach The ACSQHC has acknowledged that the complexities of modern health care mean errors or mistakes are almost inevitable. 7 Efforts to improve safety must therefore focus on risk management reducing errors as far as is practicable and effectively managing errors to limit the harm caused. 5 Clinical risk management aims to identify, prevent and manage unexpected events in patient care that can cause harm. It increases our understanding of risks and their impact as well as improving our understanding of why the system failed. It has been recognised that this type of approach will involve major changes in the way health systems operate and health personnel work together. 5 * Of 530 medication errors arising from 10,070 medication orders only 7% were considered to have the potential to cause an adverse drug event. 7 For example, an adverse drug reaction cannot be prevented in a patient properly prescribed and administered a medication for which there is no prior history of reaction. In an analysis of 247 adverse drug events, 28% were considered to be preventable and 43% of 194 potential adverse events were able to be intercepted before they could impact on patients. 7
Guidel Key strategies for pharmacists It is apparent that strategies intended to improve health care quality and safety should be underpinned by a risk management approach that is they should focus on error prevention and harm minimisation. 5 An example of a specific risk management strategy directed at dispensing accuracy has recently been described. 9 The strategy, which could be implemented in either a community or hospital pharmacy setting, addresses dispensing accuracy through elements directed at both error prevention and analysis of near miss events. Safety may be regarded as a dimension of quality (refer to the Glossary). Therefore, in addressing the quality of health care, systems are created that are also likely to be safer for patients and health professionals. For this reason this document encompasses proactive quality improvement activities as well as reactive responses to system failure. The strategies presented below represent overlapping rather than discrete areas of activity that may be applied in professional practice. 1. Partnership with consumers Consumer involvement (not just as patients) is vital for achieving the change needed to create a safer health care system. The formation of a partnership of care with patients can be an important strategy for reducing the risk of error. Well informed patients are better able to contribute to their own care and can avert problems by speaking up. Also, a partnership of care promotes enhanced communication at all levels, including between health professionals and patients, among health professionals in the treatment team as well as with others involved more peripherally in delivery of care. 5 The ACSQHC has produced # a list of risk reducing tips for consumers and health professionals that presume the existence of a partnership of care. 5 Those that are relevant to pharmacists are summarised below. 1. Actively involve consumers and their carers in their own health care and health care decision-making. 2. Allow time to talk to consumers and their carers about issues or concerns they raise. 3. Provide information to consumers in a language and form that they can understand. 4. Maintain an accurate and up-to-date medication history, including over-the-counter and complementary medicines. 5. Provide oral and written medicines information in language that can be understood. 6. Establish systems that will ensure patients receive the results (and an explanation of their meaning) of their tests, procedures and investigations. 7. Plan the patient s discharge from hospital so that the patient and carer can participate in development of a home care plan and relevant community health providers (e.g. general practitioners) can receive a summary of the hospitalisation and information on the patient s home care needs. 2. Continuous quality improvement (CQI) A further key strategy for making health care safer is the activity of health professionals monitoring and assessing clinical practice to identify opportunities for improvement and change to reduce risk. Practice standards are intended to provide assurance that professional services are performed to an agreed (desired) level. They are important instruments for measuring service quality and are therefore often referred to as quality standards. They demonstrate what the profession expects of itself and their application represents an important part of the commitment health professionals, including pharmacists, make to their patients to ensure services are of a consistent and reliable quality. 10 The professional practice standards 10 applicable to pharmacists are process based and encompass a broad range of professional services. They have been presented in a form that allows pharmacists to assess their own performance, identify areas for improvement and then re-assess their performance after appropriate changes have been implemented. Clinical audit is another important performance review process which health professionals may undertake. It is considered to be an essential element of comprehensive quality improvement programs operating within health facilities. 11 However, from the perspective of individual health practitioners it is also an important means by which they can review and improve the quality of the care they provide to patients. Clinical audit has been described as a quality improvement process that seeks to improve patient care and outcomes through a systematic review of care against explicit criteria and the implementation of change. 11 Clinical audit may deal with aspects of structure, process or the outcomes of care. As with # Adapted from the US Agency for Healthcare Research and Quality patient fact sheets.
nes other quality improvement activities confirmation that the changes implemented have resulted in improvements in care should be sought through system monitoring. 11 Pharmacists can now participate in clinical audits offered on a selfassessment basis through the National Prescribing Service. A recent example was the clinical audit on the management of allergic rhinitis in community pharmacy that included criteria relating to practice standards as well as therapeutic decision-making. 12 Quality improvement activities such as those discussed above provide pharmacists with the opportunity to assess their own clinical practice. However, many of the other quality improvement activities pharmacists may wish to conduct will involve other pharmacy personnel and consumers. It is important to remember that the trust and confidence of both health professionals and patients is required for effective monitoring and redesign of health systems. 5 Pharmacists may wish to adopt a broad approach to achieving superior performance and enhanced quality and safety. Total quality management (TQM) offers one such pathway. TQM has been described as a management philosophy that seeks to achieve continuous improvement in the quality of performance of all organisational products and processes. It relies on measurement and an understanding of variation, and emphasises the need to involve customers and employees at all levels of the organisation. 13 It focuses on correction of system design to minimise the probability of error and adverse events. 8 TQM seeks to achieve improvement through an accelerated incremental small step approach. Each step is achieved through a feedback loop that consists of the elements of Plan-Do-Check-Act (PDCA). The quality management system used to consolidate performance gains into a sustainable base for future improvements is known as quality assurance. It too is the responsibility of everyone in the organisation. 13 TQM depends on the application of both quality assurance and process improvement activities to be effective in improving quality and performance. A TQM approach to quality improvement can give organisations a competitive advantage in the marketplace through enhanced productivity and capacity for satisfying customer needs. 13 Adoption of a TQM approach will inevitably lead to a change in organisational culture and the need for individuals to change their behaviour. In this context it is important to recognise that change is a process rather than an event. It has been suggested that for change to occur there must be: dissatisfaction with current arrangements; a vision for the future; a plan for achieving that vision; and the sum of the above three elements must outweigh the costs of change (emotional and financial). 13 The challenge for organisations adopting TQM is that each individual will experience change in a different way and will therefore also relate to the elements of the change equation in a unique way. Therefore, change must take place in individuals first. Organisational change will only occur when the motivation to change exceeds its perceived costs in a critical mass of individuals within the organisation. 13 Benchmarking is a CQI process. It may be used to systematically and continuously measure products, services and practices against those of competitors or industry leaders or to compare processes within the same organisation. 14,15 It has been described as the search for those best practices that will lead to the superior performance of a company. 14 Whatever the particular model adopted benchmarking is, like other quality improvement activities, underpinned by a feedback loop of the form Plan-Do- Check-Act. 15 However, it will not solve all performance problems and should therefore be integrated with other performance improvement initiatives. Together, benchmarking, TQM and quality assurance form the management tools for achieving best practice. 14 3. System review and redesign Health systems can be designed to be safer for patients and health personnel through redesign processes that rely on human factor principles that is principles that are informed by determinants of human capacity such as memory, skills, energy and knowledge. These have become known as change concepts and include practices such as simplification, standardisation and reduced reliance on memory. 16 The Institute for Healthcare Improvement (IHI) in Boston has established a collaborative model in which a number of health institutions may share lessons learned to achieve accelerated improvements in health care. As with TQM the model involves the continuous and repeated use of quality improvement cycles (of Plan, Do, Study, Act) to test and measure the effect of change. It is a model that relies on learning as the basis for achieving incremental improvements. 16 A number of change concepts have proven to be successful in the collaborative model in reducing adverse drug events. They fall into the two general categories of process design and organisational change. 16 The change concepts for process design are presented in summary form in Table 1. Those relating to organisational change may be summarised as follows:
Optimise the work environment e.g. reduce noise and change shifts to reduce worker fatigue. Environmental factors cited as contributing to dispensing errors include high dispensing workload, worker fatigue from long working hours and interruptions to the dispensing process; 17 Increase feedback e.g. feedback on the causes for adverse events can assist health professionals to selfcorrect to prevent recurrence; Train for teamwork teamwork encourages communication and coordination of effort and can provide valuable support to team members; Drive out fear enhance awareness of the potential for errors and encourage error reporting by creating a supportive environment; Obtain leadership commitment management action and support at all levels is a prerequisite for achieving organisational change; and Improve direct communication. System errors that result in adverse drug events are considered more likely to arise from failures in communication than deficiencies in knowledge. 18 The ACSQHC has adopted a strategy of promoting the uptake of methods such as those developed by IHI that are proven to be effective in reducing serious adverse events. 1 This is an equally valid strategy for pharmacists to pursue to reduce medication error and preventable adverse drug events. For example, each of the process design change concepts could serve as the focus for a quality improvement activity just as any one or several may become part of the solution for reducing errors and near miss events. Medication incident reporting is one important means by which we can learn about system flaws. However, our ability to correct system flaws and prevent errors depends on our capacity to gather information that characterises the problem in a meaningful way. 18 A minimum data set for incident reporting has been described as consisting of the following: a full description of the incident (what, when and where); contextual and causative factors (how and why); the outcome or impact on the patient and the organisation; any factors that might have minimised the impact; and actions taken or proposed to be taken. 19 Though most incident reporting systems tend to focus on active errors it is important that they also encompass near miss incidents as these represent valuable opportunities for system change and error prevention. The first step to redesigning systems to reduce medication error is to create an environment where errors are reported so that their causes can be better understood. It has been estimated that 95% of medication errors are not reported and an unreported error cannot be investigated nor can its recurrence be prevented. 16 Under-reporting of dispensing errors has been acknowledged as a problem as has the focus of most error reporting systems on documenting the error rather than improving the system. 17 A supportive, non-blaming environment is required to encourage error reporting and also facilitates the open disclosure of circumstances surrounding any particular event that is subject to review. Importantly, error and near miss reports must be analysed to assist our understanding of why the system failed and how it can be improved. Since there are usually a series of problems or errors encountered before harm results to patients, it is rarely possible to find a single solution that will prevent recurrence of system failure. For this reason responses may need to be multi-tiered. 5 As for all quality improvement activities, when information from a medication error reporting system is applied to improve system design a checking or monitoring mechanism should be included to determine whether the changes made have achieved the desired improvements. It should also confirm that the changes have not created undesirable effects or further system design flaws. Audit can be a useful tool in this context. It allows an objective and systematic assessment of performance or actions against a specified set of criteria so that a judgement can be made about the degree of correlation between the two. It can therefore be useful for measuring compliance with policies and procedures introduced in a quality improvement activity and can provide information on areas in which further change or improvement should occur. Pharmacist intervention reporting is also a valuable source of information for improving the quality of care and addressing system failure. Pharmacists have an important role to pro-actively contribute to drug therapy to improve its quality and to optimise the outcomes of therapy. However, pharmacist interventions in drug therapy may also be instrumental in preventing or correcting medication errors and harm. Intervention reporting will therefore pick up many medication incidents that encompass both active and latent errors. Medication safety improvement activities may be prompted by a single incident or through analysis of composite data to identify trends that may be worthy of attention. A number of different intervention classification systems have been identified that may assist this type of analysis. 20
Guidel Glossary Adverse event: An unintended injury or complication that results in disability, death or prolongation of hospital stay and is caused by health care management rather than the patient s disease. 2 An incident in which harm resulted to a person receiving health care. 5 Best practice: In the health sector this means the highest standards of performance in delivering safe, high quality care, as determined on the basis of available evidence and by comparison among other health care providers. 2 Clinical practice guidelines: Systematically developed statements to assist providers and users of health services to make decisions about appropriate health care for specific circumstances. 2 Error: The failure to complete an action as intended, or the wrong use of a wrong plan to achieve an aim. 5 Active error: An error which is the result of an act of omission (failing to do the right thing) or commission (doing the wrong thing). 5 Latent error: An error that implies a predisposing condition or circumstance. 5 Health care outcome: Something that follows as a result or consequence of health care. 5 Incident: An event or circumstance which could have, or did lead to unintended and/or unnecessary harm to a person, and/or a complaint, loss or damage. 5 Intervention: An activity or set of activities aimed at modifying a process, course of action or sequence of events, in order to change one or several of their characteristics such as performance or expected outcome. 5 Monitor: To check, supervise, observe critically, measure or record the progress of an activity, action or system on a regular basis in order to identify change. 5 Near miss: An incident that did not cause harm. 5 Potential adverse drug event: A serious medication error that had the potential to cause harm to the patient but, either by luck or interception, did not. 16 Quality of health care: The extent to which a health care service or product produces a desired outcome. 5 Risk: The chance of something happening. It is measured in terms of consequences and likelihood. 5 Risk management: The culture processes and structures that are directed towards effective management of risk. 5 Safety: The extent to which the probability of preventable unintended injury or complications that may result in disability, death or prolongation of hospital stay, caused by health care management rather than the patient s disease, is minimised. 2 A state in which risk has been reduced to an acceptable level. 5 System failure: A fault, breakdown or dysfunction within operational methods, processes or structure. 5 References 1. Australian Council for Safety and Quality in Health Care. National Action Plan 2001. Canberra: ACSQHC; 2000 Dec. 2. National Expert Advisory Group on Safety and Quality in Australian Health Care. Implementing safety and quality enhancement in health care: Final report to Health Ministers. Canberra: NEAGSQAHC; 1999 Jul. 3. Wilson RM, Runciman WB, Gibberd RW, Harrison BT, Newby L, Hamilton JD. The Quality in Australian Health Care Study. Med J Aust 1995; 163:458 471. 4. Roughead EE. The nature and extent of drugrelated hospitalisations in Australia. J Qual Clin Practice 1999; 19:19 22. 5. Australian Council for Safety and Quality in Health Care. First national report on patient safety. Canberra: ACSQHC; 2001 Aug. 6. Commonwealth Department of Health and Ageing. The National Strategy for Quality Use of Medicines. Canberra: CDHA; 2002. 7. Australian Council for Safety and Quality in Health Care. Safety First. Report to the Australian Health Ministers Conference, 27 July 2000. Canberra: ACSQHC; 2000 May. 8. Bates DW. Frequency, consequences and prevention of adverse drug events. J Qual Clin Practice 1999; 19:13 17. 9. Dooley MJ, Streater J, Wilks JJ. Strategy for identification of near miss events and improving dispensing accuracy. Aust J Hosp Pharm 2001; 31:125 128. 10. Pharmaceutical Society of Australia. Professional practice standards. Canberra: PSA, 2002. 11. National Institute for Clinical Excellence. Principles for Best Practice in Clinical Audit. Radcliffe Medical Press, 2002. 12. National Prescribing Service Limited. Management of allergic rhinitis. Pharmacy Letter 4; 2001 September. 13. Crosling R, Munzberg B. AusIndustry. TQM How To Approach: guide to concepts, principles and imperatives. Canberra: Commonwealth Department of Industry, Science and Technology; 1995. 14. Camp RC. Benchmarking: the search for industry best practices that lead to superior performance. Wisconsin: ASQC Quality Press; 1989. 15. Evans A. Benchmarking: taking your organisation towards best practice. Australian Print Group; 1994. 16. Leape LL, Kabcenell A, Berwick DM, Roessner J. Reducing adverse drug events. Boston: Institute of Healthcare Improvement; 1998. 17. Low J. Saving lives by accurate dispensing. Aust J Pharm 2001; 82:713. 18. Clark RB, Graham JD, Williamson JA. Toward system-wide strategies for reducing adverse drug events. J Qual Clin Practice 1999; 19:37 40. 19. Building a safer NHS for patients: implementing an organisation with a memory. Report of an expert group on learning from adverse events in the NHS. Department of Health, 2001. 20. The Society of Hospital Pharmacists of Australia. SHPA Standards of Practice for Clinical Pharmacy. In: Johnstone JM, Viénet MD, eds. Practice Standards and Definitions. Melbourne: SHPA 1996. Definitions sourced from reference 5 are still the subject of wider community consultation. Endorsed by National Council November 2002
nes Table1: Change concepts for process design (Note that some examples fit more than one change concept) Change concepts Examples 1. Reduce reliance on memory through use of Use computerised drug alert systems. memory joggers, protocols and checklists. Use electronic patient medication profile. Use dosing algorithms e.g. for patients with renal failure. Use drug administration protocols. 2. Reduce complexity by simplifying processes. Use protocols for hazardous drugs or those with complex dosing regimens. Reduce the number of different concentrations of a single drug. Reduce the range and variation in equipment and supplies. Select equipment which is simple to use. 3. Reduce variation by standardising equipment Standardise drug dosing times and drug storage locations. and procedures. Use a single type/brand of equipment. Standardise product packaging and labelling. Use a pharmacy based IV admixture service. 4. Introduce constraints and forcing functions. Enforce standard prescribing abbreviations, measures and drug names e.g. 0.1mg not.1mg and unit not u. Allow particularly hazardous drugs to be used only according to a protocol. Program computers not to process orders that lack specified key information. 5. Use protocols and checklists wisely. Use a checklist for monitoring dosing and response in drugs with narrow therapeutic index. Establish a double checking protocol for hazardous drugs. Produce IV drug administration guidelines and compatibility charts. Produce simple instructions on how to use equipment. 6. Improve access to information. Use an electronic medication record or patient profile. Prominently display information on drug allergies on medication chart. Include a pharmacist on the ward round team and have them available on clinical units. Use computerised drug information. 7. Decrease reliance on vigilance. Eliminate look-alike drugs or store them separately. Establish a system to assist differentiation of sound-alike drugs. Develop a system to differentiate sound-alike drugs. 8. Reduce the number of handoffs. (a) Use computerised order entry by prescribers. Use automated dispensing system. 9. Decrease multiple entry. (b) Use computerised order entry by prescribers. 10. Improve differentiation. Eliminate look-alike and sound-alike products. Develop a system to differentiate sound-alike drugs. 11. Introduce automation to increase Use bar codes for drug identification. worker support. Use computerised medication administration record and patient medication profile. (a) Defined as a transfer of information, materials, people or supplies from one person to another. 16 (b) Defined as entry of the same data by more than one person in several locations. 16 JN0559