The Hospital Pharmacist: Your Stakeholder for In-Hospital Medication Safety!

EDITORIAL PATIENT SAFETY The hospital pharmacist: your stakeholder for in-hospital medication safety!

in communication and management prominently in our official journal, the may lead to unsafe practices. European Journal of Hospital Pharmacy, distributed to all our members. Hospital pharmacists are experts in most aspects of safe medication practice. Safe medication practice requires suffi- From drug selection by means of the cient staff. Based on an EAHP survey hospital formulary; support for physi- and OECD data, we have estimated the cians regarding dosing / individual dose average workforce involved in pharma- adjustments, interactions and therapeutic ceutical care (see page 4-6). In the opi- drug monitoring; to acquisition of high nion of the EAHP, medication safety quality drugs, either by purchasing or in- programmes may be under pressure in Jacqueline Surugue Professor AG Vulto house production and quality control, countries with a below-average number logistics; and finally drug distribution to of pharmacists (ie. under 0.9 hospital the patient. Only the pharmacist is equip- pharmacists / 100 beds), unless related ped to overview this whole process and staffing levels are sufficient to compen- atient safety is suddenly high in the EAHP’s opinion the hospital sate. Clearly patients are more at risk in on the political and public pharmacist is the key stakeholder. some countries than in others and the agenda. The safety of European Commission and the national patients in hospital is a small To address safety issues in hospital, health authorities should be concerned part of a developing scenario hospital pharmacists call upon a fourth to provide a sufficient number of fully Pof increased perception and reduced “C”: the need to make the public and trained hospital pharmacists to achieve acceptance of risk, but the part to which policy makers / politicians conscious of what has been promised in European hospital pharmacists are called upon to the ideal position they occupy as policy documents. Or, in the words of respond. The reasons for today’s experts on medicines. The EAHP was the Council of Europe ministers: “the increased vulnerability of patients can surprised to see “Patient Safety – safety of medication and interventions be described by 3 Cs: Making it Happen” organised by the is the essential feature of healthcare European Union Presidency in April provision and its cost should be includ- - Complexity 2005 lacking a single pharmacist ed in the general budget…..”. - Cost-effectiveness among the speakers. In this special - Cooperation and communication issue we report on this meeting, which We hope this special issue will convince resulted in the Luxembourg Declaration you that improvements in medication Treatment in hospital is more complex on Patient Safety (summarised on page safety cannot be taken for granted and than it used to be. Doctors are treating 20). The EAHP is one of the signatories that the EAHP is committed to ensuring more complicated diseases with more of that declaration. the best achievable safe medicines prac- complex interventions. Think of open tice. We welcome your feedback to our heart surgery, solid organ and bone In May 2006 the Council of Europe president, Mrs Jacqueline Surugue marrow transplantation, and intensive issued a document on Patient Safety ([email protected]) or our execu- cancer treatment. In addition, technolo- that says “medication errors are the tive director, Mrs Catherine Hartmann gical advances mean that specialist most common single preventable cause ([email protected]). skills are required to operate a wide of adverse events and European health range of new devices and interpret their authorities should consider them as an Please visit our website (www.eahp.eu) readings. important public health issue.” for more information on our associa- Nonetheless, the word pharmacist tion, our members and the EJHP, our More competition in medical care bet- occurs only once in the 15-page docu- official journal. ween providers, hospitals, and third ment. Again: our message is that where party payers, cost-consciousness and medicines are concerned, hospital phar- On behalf of the Board of the European pressure on efficiency has resulted in macists play a pivotal role. Association of Hospital Pharmacists, reduced staff, shorter hospital stays and Jacqueline Surugue more intensive treatment. The European Association of Hospital EAHP President Pharmacists – representing more than As a result, medical care in hospitals is 20,000 pharmacists in 26 European Professor Arnold G Vulto countries – strongly supports Patient increasingly dependent on seamless EAHP Director of Education, Science cooperation between medical specia- Safety and medication safety: it was the lists and other professionals. Many stu- theme of our 1,700-delegate annual and Research dies have indicated that shortcomings congress this year. Patient safety features Editor-inChief, EJHP Practice

www.ejhp.org 1 PATIENT SAFETY Patient safety: the new challenge The issue of patient safety is now recognised as a serious problem in many countries. Health care is about curing, helping and supporting people and their relatives, and the successes in this area are many. But health care can also have unexpected and unwanted side effects, sometimes causing harm to the patient instead of the planned benefit. Baseline epidemiological research in many countries shows that patient safety is a serious and, until now, mostly hidden problem. Wim Schellekens MD, MPH

atient safety is an umbrella of the main conclusions was that surgery rates are about 1:100; neonatal term under which reside harm to patients in almost all cases is a mortality and general surgery death many categories of (poten- system problem and that naming, rates are about 1:1,000; the death rate in tial) harm to patients: blaming and shaming is counterpro- routine anaesthesia is about 1:10,000; errors, medication prob- ductive for learning and improvement. and the blood bank error rate is lems,P post-surgery wound infections, 1:10,000. To compare: error rates in the falls, bedsores, technical failures, Baseline epidemiological studies in airplane industry, nuclear power plants communication issues, etc. many countries show the same and the petrol chemical industry are results: the rate of adverse events in from 1:1,000,000 to 1:10,000,000—an Research and many successful pro- hospitals is about 10% of all admitted almost error-free environment. grammes show that we can do some- patients (USA, Australia, UK, thing about it. The main barrier to Denmark, New Zealand, Canada). Apart from these data, we now know change is the culture around patient Three per cent of all admitted patients that there is also unacceptable varia- safety: the naming-blaming-shaming experience some kind of moderate or tions among doctors and hospitals: post culture around errors and adverse serious harm, and in about 10% of surgery wound infection rates vary events prevents us from recognising these 3% this harm is so serious that from between 2 and 9%, bedsore rates the problem, from learning from what the patient dies. This means 45,000- between 5 and 25%, etc. This shows goes wrong and to applying what we 95,000 deaths in the US or 3,000- the difference between best practices have learned. This is the reason we 6,000 deaths in The Netherlands; esti- and many other instances. What a great need leadership for change—clinical mates are that with our current know- opportunity to improve! and managerial leadership at all levels ledge about 50% of these deaths of health care. could be preventable. These data are Vision for change only from admitted patients in hospi- There is good news: we can do some- Building the will to change tals. We still have almost no data from thing about it. Breakthrough collabo- Patient safety is a big and, until outpatient clinics, primary care facilities rations in the US, UK, Sweden, recently, hidden problem in our or nursing homes. Australia and The Netherlands show healthcare systems. The report “To that we can reduce medication errors Err is Human” from the Institute of Reliability studies show that in only to almost zero, that unnecessary pain Medicine in the US (1999) was the 60% of cases do patients receive the after surgery can be eradicated, that first that not only revealed the unpop- necessary beta-blockers and aspirin bedsores in hospitals can be reduced ular facts of human error but also after a myocardial infarction (error rate to under 5%. Introduction of blame- treated the issue in a constructive, around 1:10); wound infection after free reporting at the departmental educational and challenging way. One surgery, bedsore and death in high risk level increases the number of reported

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incidents four to 10 times—a wealth priority, the leadership has to take expertise on patient safety, improve- for learning and improvement! action to reformulate the “safety first” ment and implementation. goal (mission), to decide what aims • Introduce measurement, analysis, In many countries, patient safety has have to be reached five years from improvement and control on a nation- become the main strategy for im- now (vision) and what has to be done al level. provement in healthcare systems. The by next year (strategy). • Develop a research agenda for World Health Organization has laun- patient safety. ched the very promising programme Systematic measurement, analysis of “World Alliance for Patient Safety”, data and actions toward improvement On the European level under the leadership of Liam must be introduced, as well as How can the European Union work to Donaldson, England’s Chief Medical sustaining and increasing positive promote patient safety? Officer. The EU started the “Simpatie” results. A real emphasis should be on • Anchor political commitment to project [1], a collaboration of organisa- applying what we already know. create a common sense of urgency tions and knowledge institutes in the and a vision for change. EU to bring together all we know It is also a leadership task to introduce • Collaborate in designing and imple- around patient safety and translate this a “blame-free reporting system” to menting systems. knowledge to patients and providers learn from adverse events. This is the • Take shared action on high priority (coordinated by the Dutch Institute for most important effort to change the topics: i.e. medication safety, post Healthcare Improvement CBO). Under culture from within. surgery wound infections, blame- the presidency of Luxembourg, 2005 free reporting, eHealth. saw the first conference dedicated to On the national level • Organise shared learning: build net- works of experts, support centres. • Build a common research agenda. • Combine efforts to support the new EU countries.

Conclusion Patient safety is a big hidden problem in our health care. We uninten- tionally harm patients. We have dis- covered the problem. We know what we can do about it. It is now time for action. The Dutch Institute for Healthcare Improvement coordinates the SIMPATIE Project, a collaboration of EU institutions formed to share information around patient safety. Author Wim Schellekens, MD, MPH patient safety, which will ensure Change for improvement has to be Healthcare Quality and Safety that this issue is high on the EU- implemented in the working environ- Consultant agenda. ment. How can systems support and Former CEO of the Dutch Institute stimulate the desired actions? What for Healthcare Improvement Strategy for change might governments do? [email protected] Patient safety is a real, but hidden, • Make patient safety a national pri- problem. There is a vision and a ority. Every country needs its own Reference willingness to do something about it, data to create a much-needed sense 1. A collaboration of the Council of Europe, but what should be done? What of urgency. CPME (European Doctors), HOPE (Hospitals should be put on the agenda? • Apply what we already know: dis- of the European Union), ESQH (European cover best practices and develop a Society for Quality in Healthcare), HAS (Haute Autorité de Santé, for accreditation), On the institutional level nationwide strategy for adopting LMCA (Long Term Medical Conditions Patient safety is everybody’s task: them. Alliance, for patient involvement) and CBO doctors, nurses, managers. Anybody • Create incentives that stimulate (Dutch Institute for Healthcare Improvement). can take initiative and make a differ- learning and improvement. This project is funded by the European Union. ence. But to make it an institutional • Build/support a national centre of 213.177.130.12:591/database/Simpatie.pdf.

www.ejhp.org 3 PATIENT SAFETY Workforce of EU hospitals and pharmacy services: a direct patient safety issue

Jacqueline Surugue, EAHP President Professor Arnold G Vulto, EAHP Director of Education, Science and Research

here are many factors that major discrepancies in the ratio of by country—from 0.020 in Germany contribute to a hospital’s hospital pharmacists per 1,000 inhabitants to 0.090 in Finland (see Figure 1). Per ability to provide quality of care, but one of the most basic is the “number Figure 1: Practising hospital pharmacists per 1,000 population (Average: 0.047) Tof hands on the bed.” Patient and med- Finland ication safety cannot be addressed with- United Kingdom out a serious consideration of human France Belgium resources [1]. In a hospital setting, this Latvia Ireland includes an adequate number of doctors Portugal and nurses, of course, but also with Czech Republic Norway regards to medicines, to pharmacists Estonia and pharmacy technicians. Luxembourg Italy Poland Hungary Hospital pharmacists play a key role in Slovakia the “healthcare team” (a term which will Denmark Austria be used throughout this article to refer to Sweden pharmacists, pharmacy technicians, Greece Slovenia nurses and doctors), when it comes to Spain Netherlands medication safety, but any comparison Switzerland of adequate staff must consider the other Germany healthcare team members, as well as the country’s healthcare system.

When looking at populations across the Figure 2: Practising nurses per 1,000 population (Average: 8.31) 26 EAHP member countries, six – Spain, Poland, Germany, Italy, the UK Ireland Netherlands and France – represent 75% of the total Switzerland population but account for 85% of the Luxembourg Norway total number of hospital pharmacists, Denmark while the remaining 15% represent the Sweden Germany 20 countries that make up 25% of the Austria population. So it appears that there is no Czech Republic equal distribution of hospital pharmacy Finland United Kingdom workforce over Europe. This warrants Slovenia some further analysis. Spain France Estonia According to the data published in the Slovakia Belgium 10th Anniversary issue of EJHP 2004;10 Italy (6):106-7 on Development of EAHP [2], Hungary Poland the average number of practising hospital Portugal pharmacists per 1,000 inhabitants across Greece Member States is 0.047, but there are

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hospital bed (see Figure 5), Estonia has tors is made up for by an influx of phar- Republic, for example, an above-average the highest concentration of hospital macists. Similarly, while the number of number of nurses per 1,000 residents pharmacists with nearly two per 100 beds per hospital pharmacist in Germany could be due to pharmacists not practising beds, followed by Norway with 1.75. and Switzerland, as noted above, is very clinical pharmacy; nurses are responsible Switzerland and Germany have the low- high, nursing and physician numbers in for preparing ward stock and for full est ratios at one-third hospital pharmacist both countries are well above the administration of drugs to patients. manpower per 100 beds. This means that European average. This means there Although total number of healthcare in Switzerland, each hospital pharmacist may be adequate overall staff support to workers are adequate in hospitals in the is responsible for 305 beds and in ensure a basic level of safety. country, the lack of pharmacist involve- Germany, 319 beds. The average number ment in the wards is a patient safety con- of hospital pharmacists per 100 beds Although an adequate number of total cern that is not shared by the UK. across Member States is around 1 (exact: staff may exist to ensure some standard of 0.93). This makes it understandable that patient safety, the role and competencies Total numbers of each group of the the role the hospital pharmacy can play in of healthcare team members must also healthcare team lead to certain kinds the healthcare team will vary also consid- be taken into consideration. In Czech of practice, which is why hospital phar- erably across Europe.

Some of these discrepancies are due to Figure 3: Practising doctors per 1,000 population (Average: 3.18) the structure of health systems in various countries, including the respective roles Greece of hospital and community pharmacists Italy Belgium and the roles of other members of the Switzerland Czech Republic hospital healthcare team. The roles Germany played by members of the healthcare France Austria team can depend on healthcare culture or Sweden simply on the total number of each group Portugal Spain available in any given country, which Hungary must be taken into account when assess- Estonia Slovakia ing a country's or hospital’s ability to Norway invest in quality care, including the Netherlands Denmark implementation of successful patient Luxembourg Ireland safety programmes with root cause Finland analyses of adverse events. Poland Slovenia United Kingdom When looking at the three main activities involved in drug treatment – prescribing, distributing and administering – it is easy to ascribe each area to one set of professionals – doctors, pharmacists and Figure 4: Practising total healthcare team members (doctors, nurses, hospital pharmacists) per 1,000 population (Average: 11.54) nurses, respectively. However, in many countries, nurses are largely responsible Ireland Netherlands for both distributing and administering Switzerland drugs. Therefore, in a country with a Norway Sweden high ratio of nurses per bed, a lower ratio Luxembourg of pharmacists might be expected, and Denmark Germany this does not necessarily lead to a lapse Czech Republic in the ability to provide sound patient Austria safety due to lack of staff. Finland United Kingdom France If we look at the UK as an example, we Spain Slovenia see that the number of hospital pharma- Estonia cists per 1,000 residents and per hospital Belgium Slovakia bed is high. However, as Figure 3 shows, Italy the number of practising doctors per Hungary Greece 1,000 residents in the UK is the lowest in Portugal Europe. Therefore, in regards to patient Poland and medication safety, a shortage of doc-

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macy in the UK differs from the rest of Data published in the 10th Anniversary countries with no apparent correlation Europe, with pharmacists not only prac- issue of EJHP 2004;10(6):106-7 showed with population. It is understandable tising clinical pharmacy on the wards Estonia and Norway have the lowest that a hospital pharmacy needs a certain but doing so on a daily basis. This also number of beds to hospital pharmacist. critical mass for proper management helps explain the country’s movement The lower the ratio of beds to total hands, and back-office activities to allow for toward supplementary pharmacist pre- the lower the incidence of accidents and patient-oriented tasks. This can be scribing – a trend directly due to a adverse effects [1, 4, 5]. Thus, even better organised in larger institutions, shortage of available doctors. though Estonia has a below-average total and this is exactly what one sees number of healthcare team members, its happening in the UK and some other Although the total number of healthcare very low ratio of beds to hospital countries where hospitals are merging. workers per 1,000 people in the UK is pharmacists and its average number of average and comparable to several hospital pharmacists per 1,000 popul- When assessing adequate needs for other countries (see Figure 4), the high ation puts hospital pharmacists at an patient safety procedures and outcomes ratio of pharmacists enables them to advantage to contribute to overall safety and the role a hospital pharmacist can apply their specific technical skills to measures in hospitals, particularly in play here, we must take into consideration activities best performed by medication regards to clinical pharmacy. Norway is, the number of pharmacists per hospital, experts. A recent study in The as we can further see in Figures 1 and 4, the number of beds per pharmacist and Netherlands showed that the error rate at an even greater advantage to ensure the role of the pharmacist in the health- at a decentralised pharmacy intra- patient and medication safety. care team (“total number of hands on the venous admixture unit (satellite phar- bed”). With the background data provid- macy) was 2%, while the error rate When comparing statistics across ed in this paper, every hospital can bench- when nurses made preparations on the European countries, all this data must mark its own staff availability to ensure ward was an eye-opening 71% [3]. But be taken into consideration because sta- safe medication practices and to develop because The Netherlands’ ratio of phar- tistics can be misleading. France, for a policy in case it needs improvement. macists to nurses is quite low (0.75 phar- example, at 1.5 pharmacists per hospi- macists per 100 beds compared to 1.28 tal is more than six times less than in nurses), nurses may perform tasks better the UK, despite a similar total number Acknowledgement left to trained pharmacy technicians. of hospital pharmacists. This is because Figures 2, 3 and 4 data are from Health Still, the high overall number of care staff France has a higher total number of at a Glance, OECD Indicators 2005, in The Netherlands, which is 15.9 per hospitals. Also, as data from the ©OECD. 1,000 residents, ensures that nurses are Organisation for Economic Co-opera- Figure 4 data is also based on results not overworked, which is one of the tion and Development (OECD) con- published in EJHP 2004 [2]. leading causes of medication safety firms, there are large differences in the errors. number of hospitals in OECD member Authors Figure 5: Number of hospital pharmacists per 100 beds (Average 0.93) Jacqueline Surugue EAHP President Estonia [email protected] Norway Portugal Ireland Professor Arnold G Vulto United Kingdom EAHP Director of Education, Science Finland and Research Belgium Sweden [email protected] Denmark Italy References Luxembourg 1. Needleman J, Buerhaus P, Soeren Matke RN et al. France Nurse-staffing levels and the quality of care in Latvia Netherlands hospitals. New Engl J Med 2002; 346:1715-22. Spain 2. Development of EAHP, EJHP 2004;10(6): 106-7. Greece 3. Guchelaar HJ, Colen HBB, Kalmeijer MD et al. Slovakia Medication Errors: Hospital pharmacist perspec- Slovenia tive, Drugs 2005;65(13):1735-46. Czech Republic 4. Bond CA, Raehl CL, Franke T. Clinical pharmacy Hungary services, hospital pharmacy staffing, and medi- Austria cation errors in US Hospitals. Pharmacotherapy Switzerland 2002;22:134-47. Germany 5. Bond CA, Raehl C. Clinical pharmacy services, pharmacy staffing and adverse drug reactions in US hospitals. Pharmacotherapy 2006; 26:735-47.

6 www.ejhp.org Special Supplement • Fall 2006 PATIENT SAFETY Risk analysis and assessment: a tool for pharmacy practice

Extrinsic risks of treatment in a hospital include failures of the medical system and practitioners. The Bow Tie method can be used to identify where control over a process is lost and whether it is proactive (maintaining control) or mitigating (attempting to minimise consequences). Analysis of the medication process has identified at least 120 different threats and a number of systematic weaknesses.

Professor Dr PTW Hudson

he medical profession We can label this second class of risks developing incident reporting sys- has always paid atten- “extrinsic.” The famous 1999 study tems – for example, the UK NHS tion to the risks of proce- by the US Institute of Medicine [1] report An organisation with a dures and drugs when estimated that in the US between memory [2]. These are pitched as a treating patients. We can 44,000 and 98,000 people may die way of flushing out problems that Tdistinguish between intrinsic risks, yearly as a result of medical errors. can then be solved, and incident which are inherent in treatments, and a There are no indications that the EU reports currently form the main different class of risks that cover fail- is significantly different in this resource of information available on ures or inappropriate procedures and spect, which implies an EU mortality such failures. A major problem with medicines. For instance, there are a rate from medical error between this is that members of the medical number of dangers intrinsic to nephrec- 68,000 and 152,000. All of these inci- professions find it difficult, and tomy; the risks are well known and dences are the result of failures of the often threatening, to report adverse involve the individual characteristics of medical system to provide what is events and near misses, whether they the patient, the anatomy and physio- agreed to be the best care. This is involve themselves or their col- logy of the systems under consideration quite different from mortality or mor- leagues. An alternative approach, and the necessary elements of the pro- bidity resulting from problems where one used in highly hazardous opera- cedure, such as anaesthesia. What is the risks were well known and those tions such as the nuclear power and not included are a number of risks of risks were taken, even if the conse- oil and gas industries, involves the medical failures, such as removing the quences were unfortunate. systematic analysis of hazards and wrong kidney, performing the operation poorly or connecting the wrong lines for the anaesthesia. “As the medication system relies primarily on people rather than Similarly, significant risks are recognised with respect to medications hardware, opportunities for failure that are intrinsic to the pharmacological processes and individual character- are much less clear.” istics of patients. These recognised risks do not, however, include incor- Medical systems are not well prepar- risks associated with the organisation’s rect dosage, administration of the ed to manage extrinsic risks, as activities and environment [3]. wrong medication or the fact that a shown by these high failure rates. patient may have been given an incor- Most approaches to managing medi- Risk assessment forms the core of any rect diagnosis. cal errors have concentrated on safety management system. Without a

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which barriers have holes and how Figure 1: The Swiss Cheese Model (Courtesy J Reason) large they are. When a failure reflects badly on the individual, especially if Some holes due to there has been no clinically signifi- active failures cant consequence that must be report- Hazards ed, it is hard to persuade people to own up. When reporting does take place, it is often used simply to achieve other ends rather than to learn about system failures by having an Other holes due to unbiased sample of reported failures. latent conditions For example, people may selectively (resident 'pathogens') report incidents to highlight a specific problem they experience, such as Losses understaffing. Successive layers of defences, barriers and safeguards Industrial risk assessment So how is risk analysis and assess- systematic identification and evalua- from reports of adverse events and ment performed elsewhere? There are tion of the hazards, any approach to near misses. It is essentially reactive: two basic approaches. One uses inci- the management of extrinsic risks will 1) waiting for something to go wrong, dents and uncovers root causes by be essentially ad hoc. The system and then 2) relying upon the issue working backward from consequence needs to know how hazards can being recognised as an incident/error, to cause. The other, Failure Mode and occur, how they can be controlled and as many failures may produce no Effect Analysis, moves from possible consequences mitigated and how clinical effects, and finally 3) the causes towards potential incidents by these controls themselves might fail. practitioner(s) involved considering it systematically varying every element So, how can we analyse the extrinsic to be worth reporting. or component in a system and seeing risks of medication and assess whe- what failures result. The latter ther they are significant for patients? In terms of J Reason’s Swiss Cheese approach, while proactive, is labour The current approach is heavily model (Figure 1) [4], this system pro- intensive and is usually only applied biased towards collecting information vides us with information about to engineering problems with a concentration on “hard” component failures. As the medication system Figure 2: Bow Tie Risk Analysis Model relies primarily on people rather than hardware, opportunities for failure and assessing how failures propagate are much less clear [5].

A risk analysis method called the Bow Tie model provides a way of combining these two approaches while significantly reducing the complexity (see Figure 2). Bow ties are based around a “top event,” the event or situation at which no adverse consequences have yet occurred, but where control over the process has been lost. There are a number of “threats,” ways in which the “hazards” can be released leading to a “top event” and on to the undesirable “consequences.” To prevent hazards

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being released and the consequences the right-hand side of the “top event,” quences, in this case the risks associat- happening, we can place barriers on we have the pathways to different ed with medication. The technique for the “threat pathway.” These barriers consequences, which may range from developing bow ties is non-threaten- may depend on hard controls, such as no clinically observable effect to ing, in fact often energising, as all infusion pumps that can only deliver a death of the patient, as well as reputa- involved in the process can use their fixed rate, on protocols, such as tion damage to the healthcare profes- knowledge of what might go wrong requiring the presence of two people sional(s) and the hospital. On this and what can prevent it [6]. For a to administer medicines, a mixture, side, the barriers represent mitigation patient, the risk picture actually such as requiring the use of bar codes measures, ranging from an antidote, if includes both intrinsic and extrinsic for drugs and patients, and training one is available, to procedures for talk- risks; they do not distinguish the and competence, such as when ing to patients or relatives to reduce the causes if something goes wrong. vigilance is required to check the chance of legal action. Antidotes, or difference between NaCl and KCl. palliative measures, require timely Fortunately, the approach described detection of problems after the event; here need not be restricted to extrinsic A full bow tie represents a risk analy- sincere apologies go a long way to risks, where the medical system and sis with all the threat pathways and reducing legal consequences. When individuals may have failed. We can barriers identified. If the frequencies dealing with a “top event,” the meas- and must ask the same questions and of threats and the effectiveness of the ures required on the right-hand side are collect similar data when we attempt to barriers are quantified, then we have a usually independent of what threat understand the intrinsic risks. If a spe- risk assessment. In the case of medi- created the problem in the first place. cific substance is both potentially cation, we can simplify our task by For instance, an incorrect dosage has to effective and hazardous (as all medi- assuming that medicines are always be remedied, if this is possible, regard- cines are at some level), then we ought hazardous, as may be their absence. less of how it came to be incorrect. to be able to identify the threat pathways and the controls that can be Medication risk analysis So far we have identified about 120 applied to minimise the risks to Generally, in the case of medication different threat pathways. For in- patients while maximising therapeutic error, there are five undesirable situa- stance, the mere presence of twins efficacy. tions that can be represented by dis- raises the possibility of a wrong tinct “top events” [6]. These are: 1) patient event, so the next question is, the Wrong Patient, 2) the Wrong what can we do to raise the chance of Author Diagnosis, 3) the Wrong Drug, 4) The getting the right patient above 50% in Professor Dr PTW Hudson Wrong Dose and 5) the Wrong the case of twins? Neonate twins may Department of Social Sciences Delivery Route. The left side of the not even have names, so we can use Leiden University bow tie takes the hazards of medi- bar-coding, which can be highly Room 2A49, Pieter de la Court cines and shows how they can be effective – provided that the docu- 52 Wassenaarseweg unleashed. The right side shows how mentation is itself correct and the 2333 AK Leiden, The Netherlands the undesired consequences can barcode printer and readers are func- [email protected] occur, including harm to patients, tional. We have also learned that the reputation and other losses for a hos- diagnosis step, often excluded from References pital or for health professionals. There definitions of medical error, is both 1. Kohn L, Corrigan J, Donaldson M, eds. To Err are a number of routes to and from the critical and poorly defended from is Human: Building a Safer Health System. Institute of Medicine. National Academy Pr “top event.” Along each pathway, we error/failure. An incorrect diagnosis, 1999. can identify possible barriers (the slices once made, is hard to overturn. Many 2. Department of Health. An Organisation with a of Swiss cheese) that can prevent the of the barriers require vigilance by Memory. The Stationery Office 2000. threat from becoming actualised. members of the nursing staff, a com- 3. Hudson, PTW. Applying the lessons of high- risk industries to medicine. Quality and Safety modity easily pressured by other in Health Care 2003;12:7-12. On the left-hand side of the bow tie, demands. 4. Reason, JT. Human Error. Cambridge the barriers represent preventative University Press 1990. controls. Each of these barriers is Conclusion 5. Reason JT, Hobbs A. Managing Maintenance Error: A Practical Guide. Ashgate 2003. unlikely to be perfect, and we can fur- The bow tie approach allows us to 6. Hudson, PTW, Guchelaar HJ. Risk assessment ther identify what factors can reduce provide a systematic analysis of in clinical pharmacy. Pharmacy World & the effectiveness of any barrier. On the ways hazards can lead to conse- Science 2003;25:98-103.

www.ejhp.org 9 PATIENT SAFETY Drug-related problems: definitions and classification When reviewing literature on drug-related problems, most studies are difficult to compare because of variations in definitions and classification. A uniform definition and classification system for drug-related problems would solve this. A proposal for such a system is described in this article.

PMLA van den Bemt Professor ACG Egberts PhD

rugs are a dualistic ther- extrinsic toxicity. Intrinsic toxicity is phenomenon that a medicine is well tol- apeutic tool. They are caused by the interaction of the pharma- erated by the (vast) majority of users but intended to cure, prevent ceutical, chemical and/or pharmacologi- elicits an idiosyncratic reaction in predis- or diagnose diseases, cal characteristics of the drug itself and posed patients. Type B effects are often signs or symptoms, but the human biosystem. Intrinsic toxicity unexpected (ie from pharmacology), Dthe shadow side is that improper use can is therefore synonymous with adverse rare and severe. Type B reactions have be the cause of patient morbidity and even drug reactions (ADRs). An ADR is historically been the major reason for the mortality. While in the 1960s the interest defined by the World Health withdrawal of medicines from the in adverse drug reactions increased great- Organization (WHO) as “any response market. Characteristically there is no ly after the thalidomide disaster (which to a drug which is noxious and uninten- dose-response relationship. Type B can be considered as the final trigger for ded and which occurs at doses normally effects are either immunological or non- the establishment of formal programmes used in man for prophylaxis, diagnosis immunological forms of hypersensitivity of drug approval and subsequent surveil- or therapy of disease, or for the and occur in patients with a predisposing lance), only in recent years has attention modification of physiological function” condition, which is often unknown shifted toward the problem of medication [5]. Previously unknown drug-drug or unrecognised. Stevens-Johnson errors [1]. Literature is now expanding interactions and lack of therapeutic effect Syndrome and anaphylactic shock are rapidly for both adverse drug reactions [6] are included in this definition. two examples of Type B reactions. and medication errors. Mechanistically there are two types of ADRs: Type A and Type B [2]. Extrinsic toxicity refers to the problems In general, problems related to the use of caused by the handling of the drug either approved drugs can be summarised with Type A reactions are pharmacological by the healthcare professional or by the the term “drug-related problems” [2]. effects as much as therapeutic actions patient. The drug is not used in the When reviewing the literature on drug- are, the essential difference being that proper way: a medication error has been related problems (DRPs), one quickly they are unintended. Examples are made. A medication error is defined as discovers that most studies are difficult constipation during the use of morphine any preventable event that may cause or to compare because of variations in defi- and peptic ulcer induced by NSAIDs. lead to inappropriate medication use or nitions and classification of DRPs [3, 4]. Type A effects are by far the most prev- patient harm while the medication is in A uniform definition and classification alent. As a rule, there is a dose-response the control of the healthcare profession- system for drug-related problems would relationship: Type A ADRs are more al, patient or consumer [7]. Therefore, solve these difficulties. frequent and more severe when higher medication errors do not necessarily doses are taken. need to result in harm to the patient. Definitions In contrast, ADRs always involve DRPs can be divided into intrinsic and Type B reactions, in contrast, refer to the some form of harm. Known drug-drug

10 www.ejhp.org Special Supplement • Fall 2006 PATIENT SAFETY

Figure 1: Relations between definitions both ADRs and medication errors [8-10]. The relationship adverse drug reactions between the various definitions is depicted in Figure 1.

Classification of intrinsic toxicity ADRs can be classified using the WHO adverse reaction drug terminology [11]. According to this, ADRs are divided therapy into 32 system-organ classes (e.g. skin). The class forms symptoms the first part of the code (e.g. 0100 for skin). The second related to part is formed by the so-called “preferred term,” a code disease or that describes the ADR more specifically (e.g. 0001 for therapy acne). Together both codes form the exact classification of the ADR, so 0100-0001 would refer to the skin reaction acne. A classification of seriousness is also often necessary. This can be achieved by applying the WHO Critical human or medication Terms List [12], which are ADR-codes related to possibly systematic medication errors error serious conditions. In practice, this classification is more no morbidity errors with morbidity useful than the more legal definition of serious: death, invalidity or (a longer duration of) hospitalisation. Finally, it is important to do a causality assessment of ADRs, for which various systems exist [13]. Table 1: Classification of prescribing errors Another ADR terminology coding system, the Coding Administrative and procedural errors • general (e.g. readability) Symbols for a Thesaurus of Adverse Reaction Terms • patient data (e.g. patient mix-up) (COSTART), was used together with the WHO coding • ward data and prescriber data system and the International Classification of Diseases • drug name (ICD) to create the Medical Dictionary for Drug • dosage form and route of administration Regulatory Affairs (MedDRA). This terminology is increasingly being used in the pre- and post-marketing Dosage errors phases of the medicines regulatory process [14]. • strength • frequency Classification of extrinsic toxicity • dosage too high/low Medication errors can be divided into five main classes: • no maximum dosage in “at need” prescription prescribing, transcription, dispensing, administration • length of therapy (including non-compliance) and “across settings” (errors • directions for use occurring on the interface between different healthcare settings – for example, between hospital and ambulatory Therapeutic errors care) [3, 7, 15]. • indication • contra-indication Prescribing errors are those occurring in the process of • monitoring selecting and prescribing a drug and on monitoring of • drug-drug interaction therapy. Table 1 shows a subclassification of types of • incorrect monotherapy prescribing errors [16]. • (pseudo) duplicate therapy (duplicate therapy would be e.g. inderal [contains propranolol] and propranolol; pseudo Transcription errors occur when transcribing or interpret- duplicate therapy would be e.g. omeprazol and pantoprazol ing a medication order of the physician. In literature, no [two drugs from same therapeutic category]) subclassification of transcription errors can be found: an order is either transcribed correctly or not. interactions can be seen as medication errors because the drugs were prescribed not taking into account the interaction. When the pharmacy makes an error, it is called a dispensing error. For example, the wrong drug or strength can be Finally, the term “adverse drug events” is frequently encountered in dispensed or a preparation error may occur [17]. A sub- literature. These are defined as injuries occurring during drug therapy, classification of dispensing errors can be found in Table 2. but this association may not necessarily be causal. They comprise Errors made in the last stage of the drug distribution

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Table 2: Classification of dispensing errors process are administration errors. These References errors are made by nurses or doctors in • for wrong patient or for wrong ward 1. Kohn L, Corrigan J, Donaldson M, Ed. To Err Is Human: Building a Safer Health System. hospital or by the patient in the ambula- • wrong drug Committee on Quality of Health Care in America. tory setting (non-compliance). Table 3 • wrong dosage form Institute of Medicine. Washington, DC, National shows the subclassification [18]. • wrong strength Academy Press, 1999. 2. Meyboom RHB, Lindquist M, Egberts ACG. An • wrong time ABC of drug-related problems. Drug Safety A bit of an exotic class of medication 2000;22:415-23. Erratum in: Drug Safety errors are the “across settings” errors, 2000;23:99. Table 3: Classification of administration 3. Bemt van den PMLA, Egberts ACG, De Jong-van which are not mentioned as such in inter- den Berg LTW, Brouwers JRBJ. Drug-related pro- errors national literature. Yet studies have been blems in hospitalized patients – a review. Drug • omission (drug not administered) Safety 2000;22:321-33. performed on this class of errors, which 4. Mil van JW, Westerlund LOT, Hersberger KE, occur, for example, when patients are • unordered Schaefer MA. Drug-related problem classification admitted to or discharged from hospital. • wrong preparation systems. Ann Pharmacother 2004;38:859-67. • wrong dosage form 5. Edwards IR, Aronson JK. Adverse drug reactions: As in transcription errors, no subclassifi- definitions, diagnosis, and management. Lancet cation is made. • wrong route of administration 2000;356:1255-9. • wrong administration technique 6. Meyboom RHB, Lindquist M, Flygare AK, Biriell • wrong dosage C, Edwards IR. The value of reporting therapeutic As is the case with ADRs, medication ineffectiveness as an adverse drug reaction. Drug errors can be classified in classes of • wrong time (at least 60 minutes Safety 2000;23:95-9. 7. National Coordinating Council for Medication seriousness. This can be done by using a early/late) • compliance/adherence Error Reporting and Prevention (NCCMERP), modified version of the classification of www.nccmerp.org (approached May 2006). the National Coordinating Council for 8. Leape LL. Preventing adverse drug events. Am J Health-Syst Pharm 1995;52:-379-82. Medication Error Reporting and Table 4: Classification of medication 9. Nebeker JR, Barach P, Samore MH. Clarifying Prevention (NCCMERP) [7, 19]. This errors in classes of seriousness adverse drug events: a clinician's guide to termino- classification is illustrated in Table 4. logy, documentation and reporting. Ann Intern A Med 2004;140:795-801. An error has been made, but the 10. Morimoto T, Gandhi TK, Seger AC, Hsieh TC, Conclusion medication did not reach the patient Bates DW. Adverse drug events and medication errors: detection and classification methods. Qual By choosing uniform definitions and B Saf Health Care 2004;13:306-14. classification of DRPs, results of studies An error has been made, and the 11. International monitoring of adverse reactions to can be communicated unambiguously. medication reaches the patient, but no drugs. Adverse reaction terminology. Uppsala: harm is done WHO Collaborating Centre for International The same goes for reports in medication B1 Drug Monitoring, 2002. error reporting systems. The classifica- medication not administered 12. WHO adverse reaction terminology – critical tion system presented in this article is not term list. Uppsala: The Uppsala WHO B2 Monitoring Centre, 2002. definite. Although it has proven value in medication administered but no harm 13. Meyboom RHB, Hekster YA, Egberts AC, et al. Dutch studies on drug safety [20], it is C Causal or casual? The role of causality assessment in pharmacovigilance. Drug Saf 1997;17:374-89. subject to further improvement. An error has been made which results in 14. Brown EG, Wood L, Wood S. The medical dictio- Nevertheless, it may certainly constitute an increased frequency of monitoring, nary for regulatory activities (MedDRA). Drug a firm basis for a uniform classification but no harm is done Saf 1999;20:109-17. 15. Shojania KG. Safe medication prescribing and system. The authors welcome reactions D monitoring in the outpatient setting. CMAJ to this proposal. An error has been made, and harm is 2006;174:1257-8. done 16. Fijn R, Van den Bemt PMLA, Chow M, et al. D1 Hospital prescribing errors: epidemiological Authors temporary damage necessitating assessment of predictors. Br J Clin Pharmacol PMLA van den Bemt, PhD treatment 2002;53:326-31. Professor ACG Egberts 17. Kelly WN. Pharmacy contributions to adverse D2 medication events. Am J Health-Syst Pharm Division of Pharmacoepidemiology and temporary damage resulting in an 1995;52:385-90. Pharmacotherapy increased length of hospital stay 18. Allan EL, Barker KN. Fundamentals of medica- D3 tion error research. Am J Hosp Pharm Utrecht Institute for Pharmaceutical permanent damage 1990;47:555-71. Sciences D4 19. Bemt van den PMLA, Fijn R, Voort van der PHJ, Utrecht University patient nearly dies Gossen AA, Egberts ACG, Brouwers JRBJ. Frequency and determinants of drug administra- PO Box 80082 E tion errors in the intensive care unit. Crit Care 3508 TB, Utrecht, The Netherlands An error has been made which results in Med 2002;30:846-50. p.m.l.a.vandenbemt@ pharm.uu.nl the death of the patient 20. Van den Bemt PMLA. Drug Safety in Hospitalised Patients [thesis]. Groningen [email protected] University, 2002.

12 www.ejhp.org Special Supplement • Fall 2006 PATIENT SAFETY Patient safety across the EU: minimizing the variations

Commissioner Markos Kyprianou

he topic of patient safety share common goals of providing high- variations and to raise standards across the across Europe is of vital quality care on the basis of medical need EU to those of the most successful, we will importance. Healthcare inter- and financed through collective solidarity. be making a very significant contribution ventions are, of course, Together with the enormous potential for to health and health care. intended to benefit patients, greater collaboration to help improve the Tbut they may in some cases cause harm. effectiveness and efficiency of all health I would like to see European collaboration systems, this provides a solid foundation on patient safety as being a driver for Modern health care puts into daily practice for the need to develop European coopera- change. As a benchmark for success. As a some of the most advanced technology tion in the area of patient safety. source of ideas, knowledge and inspira- and techniques of any field of human tion. Working collaboratively, we can turn endeavour. We all benefit from this con- To do this, we have established a frame- the variations between our systems into a stant striving to do more. But, as with any work for policy exchanges through the shared resource from which we all can complex set of processes and choices, mis- open method of cooperation, as well as a learn. takes will happen. High Level Group on health services and medical care to take forward practical Of course, however good the ideas are, Research from around the globe suggests coordination. In addition to issues such as they need to be backed with resources. We that a considerable percentage—perhaps health technology assessment and a are already financing some projects under 10% of hospital admissions may involve European system of centres of reference, the existing public health programme. some kind of patient safety incident. Some this High Level Group is also addressing However, I hope to be able to announce studies estimate that up to half of these today’s topic of patient safety. significant new funds to support work in errors may be avoidable. this area. You can expect to see a new pro- As set out in the 2004 report of the High posal for an integrated and expanded Even if clear figures on patient safety inci- Level Group, several member states have health and consumer protection pro- dents are difficult to come by, the large established their own patient safety programme, which will include support of variations in techniques and outcomes grammes and systems for reporting and cooperation on health systems, including across Europe themselves tell the story. learning from incidents, including patient safety, and providing essential new For example, five-year survival rates for Sweden, Denmark, The Netherlands, resources to support work on these issues breast cancer range from 81% in Sweden Ireland, Czech Republic and the United into the future. I hope that these new to 58% in Slovakia and Poland. Or take Kingdom. The World Health Organization resources will help to turn at least some of skin cancer—for malignant melanoma, has also established a World Alliance for your ideas into action in the coming five-year survival rates vary from 89% in Patient Safety, providing a global frame- years—and action into results. Sweden and 86% in The Netherlands, to work for activities. Work is also taking 62% in Estonia, 64% in Poland and 68% place within the Council of Europe to This will not be easy, but it will be worth it. in Italy. develop recommendations. Improving patient safety will bring benefits in driving up standards and quality These variations have both a negative and With this wide range of increasing activity, throughout Europe. It will also help to a positive side. On the one hand, they show it is important to bring different groups improve the confidence of patients in how far we have to go before we have a together to ensure that we share a common health care wherever they are across the consistent high standard of care for every- vision and that we focus energy and EU. one in the European Union. On the other resources so as to achieve the best possible hand, they underline the potential of bene- results. Creating an organisation such as an Note: This article is the narrative form of a fiting from best practices to raise standards EU patient safety network could help to speech presented at the Luxembourg throughout Europe. As these statistics share information on different activities Conference on Patient Safety held on 4-5 show, this is not just a matter of resources. and to ensure a coherent approach among April 2005. these many different initiatives. Of course, more money is important, and we are working to improve the resources However we organise our work, it is vital available at the European level, but what that we make progress on patient safety. Author resources are available still need to be used Not only because of the importance for Markos Kyprianou in the most effective way. Sharing exper- patients themselves but also because when Commissioner for Health and tise at the European level can help to we put the systems in place to ensure Consumer Protection achieve this. patient safety, we will also be making a European Commission major contribution to ensuring overall DG Health and Consumer Protection Health systems across Europe face quality in health systems. If we can take B-1049 Brussels, Belgium increasingly common challenges. We also concrete steps to reduce the statistical www.europa.eu.int/comm/dgs/health_consumer

www.ejhp.org 13 PATIENT SAFETY European strategy for health and patient safety Citizens across the EU, whether they seek care in other Member States or remain in their own, expect the care they receive to be of high quality. Systemic approaches to improving patient safety are key toward improving overall quality in health care, and collaboration across Member States is crucial.

Fernand Sauer Honorary Director General, European Commission

fficacy, quality and safety of Detailed figures for adverse events are and the Luxembourg presidency. The health care must be still difficult to obtain for Europe as a conference produced an official state- addressed in professional whole, but every national survey ment, the “Luxembourg Declaration on practices in consultation confirms the trend shown in the US – a Patient Safety” (see page 20), which all with patients and patient 10% incidence of serious mistakes. The delegates signed, including the European Egroups. Improving patient safety is Commission has introduced provisions Association of Hospital Pharmacists. important for all health systems across to encourage pan-European projects on the world, and the World Health quality assurance of health systems, The Luxembourg Declaration calls for Organization has addressed the issue in covering in particular patient safety: patient safety to be taken into greater recent years, including the launch of the account when designing regulations on World Alliance for Patient safety in 2004. • SIMPATIE: Safety Improvement for medical devices and pharmaceuticals. The European Commission, which Patients in Europe, led by the Dutch Europe already has an extensive struc- founded the European Centre for Disease Institute for Healthcare Improvement ture of regulation regarding the Prevention and Control (ECDC) also in (www.cbo.nl) quality, safety and efficacy of medicinal 2004, is keen to co-operate with this proj- • EUHORIC: EU Public Health Out- products. Further improvements to ect, which raises awareness and increas- come Research and Indicators pharmacovigilance were introduced as es political commitment in the area of Collection, led by Instituto Superiore di a consequence of the recent revision of patient safety. On the basis of experi- Sanità (www.iss.it) pharmaceutical legislation, with an ence gained with initiatives on tobacco • EARSS: European Antimicrobial increasing role for the European control and on the quality of blood, Resistance Surveillance System Medicines Agency (EMEA). tissues and cells, the Commission is (www.rivm.nl/earss) proposing a new health programme for • ABS: appropriate use of antibiotics in The EU has recently adopted rules on the coming years. EU hospitals the quality and safety of blood and (www.antibiotika-strategien.at) blood products, as well as cells and tis- Patient mobility • IPSE: Improving Patient Safety in sues of human origin. This includes In 2003, the Commission invited all EU Europe (helics.univ-lyon1.fr) provisions to minimise errors at the Health Ministers, a representative of bedside, such as providing the wrong the European Parliament and six Euro- Under the 2006 work plan of the public blood to the wrong patient, and notifi- pean Non-Governmental Organisations health programme, it states that in order to cation of serious adverse events and (NGOs), including doctors and patients, improve and maintain a high level of reactions. to discuss patient mobility and healthcare patient safety, we must support networking European agencies for the developments in the European Union. and the work of stakeholders – namely set protection of health and safety This led to the establishment of the High up a “forum” or task force for stakeholders Europe must act to protect its people Level Group on health services and medi- and fund research on patient safety. against major health threats such as cal care, which has the commitment of all HIV/AIDS, SARS or pandemics, which Member States and the support of Safety of health products do not stop at national borders. The European NGOs and successive EU The Standing Committee for European ECDC began operations in Stockholm in Presidencies, for comparing, benchmark- Doctors (CPME) organised in April 2005 May 2005 and works in close partnership ing and sharing data, experience and a major conference on patient safety, co- with the World Health Organization and guidelines. sponsored by the European Commission

14 www.ejhp.org Special Supplement • Fall 2006 PATIENT SAFETY

with the Center for Disease Control in on these issues through the High Level European citizens need reliable and user- Atlanta. Group on Health Services and Medical friendly information about what to do to Care. The High Level Group has agreed stay in good health. And when they fall While the ECDC is finding its feet, the to involve civil society participants in ill, people want clear information about progress made since 1995 by the EMEA relevant working groups, and there is their condition and treatment options. In in London is spectacular and of major clearly a valuable contribution that April 2005, the Commission proposed a importance for public health. These health organisations can make. new health strategy for Europe together organisations are two examples of with funding plans under the new finan- effective mechanisms available for The World Alliance for Patient Safety, cial perspectives (2007-2013) and the transforming policy objectives into chaired by Sir Liam Donaldson, Chief further development of the ECDC. That concrete activities, which benefit more Medical Officer for Britain’s Depart- development would include a new directly the health and safety of ment of Health, is also looking at how to department dedicated to cooperation on European citizens and may have a signi- develop collaboration on these issues. In healthcare systems, including patient ficant impact on health professionals and November 2005 in London, the UK safety, and on essential new resources, economic operators. Presidency organised, in partnership such as:

• Surveillance and early warning system “The ECDC provides a structured against infectious diseases • Centres of excellence and recognised approach for co-operation between expertise shared between Member States on key healthcare system issues experts in the EU, the US and Canada.” • Information campaigns to address some of the main health problems The ECDC strengthens Europe’s disease with the European Commission, a major faced by the EU, such as the resur- and early warning systems by providing “Patient Safety Summit.” The EU Health gence of HIV/AIDS a structured approach for scientific co- Forum, which groups some 50 European • Informational activities for citizens to operation between experts in the public representative NGOs in the health sector, learn about healthcare entitlements health institutes of the EU, the US, has also created a special working group when visiting another Member State Canada and other parts of the world. An on patient safety. area of high sensitivity is influenza and, Patient safety was an important topic in particular, the threat of the emergence The Commission has launched a net- on the agenda of the annual meeting of of a lethal strain. The ECDC is helping work for health technology assessment the European Association of Hospital Member States build up their defences across Europe, following the recommen- Pharmacists in Paris in June 2005 and against influenza and update their pre- dations of the High Level Group. The was the theme of its 11th Congress this paredness plans. In the fall of 2005, an Commission is also working on health- year in Geneva. It is an area where exercise was conducted to test and eval- care-associated infection control in the European collaboration between health uate coordination between the national context of the Council Recommendation professions and patient organisations plans. Moreover, the Commission is on the prudent use of antimicrobials. can help to achieve important national pushing for partnerships between the aims. The Commission looks forward to pharmaceutical industry and Member A new public health strategy for working together with all interested States with a view to accelerating Europe partners and European organisations, pandemic flu vaccine development and Currently, health systems still focus on including European pharmacists and the availability of antiviral drugs. combating health threats and providing hospital pharmacists. treatments. Europe needs to do more to But while influenza might appear to be a encourage precautionary measures – for For more information, please visit likely source of a future global health example, tackling tobacco use now so as europa.eu.int/comm/health/index.html. crisis, threats might arise from unknown to reduce the need for lung cancer treat- or unexpected sources. The ECDC ment in the future. The Commission has This is a revision of a paper originally enables us to be ever more vigilant launched a massive “Help” anti-smoking published in EJHP Practice 2005; against new or deliberate disease out- campaign with TV spots across Europe. 11(4)65-6. breaks by pooling expertise and knowledge to rapidly assess whatever heath The health gap across the EU is widen- threats are in store. ing. Far too much depends on where you live, what work you do and how much EU co-operation you earn. There is also a new tendency Author The Commission welcomed the call in for health professionals and patients to Fernand Sauer, Honorary Director the Luxembourg Declaration for greater travel across Europe in order to find a General EU collaboration on these issues and better situation, better service or a European Commission to work in alliance with the World shorter waiting list in another Member 12 Avenue de la Marne Health Organization. The Commission is State. The recent enlargement of the EU F-13260 Cassis, France developing structures for collaborating has exacerbated such variations. [email protected]

www.ejhp.org 15 PATIENT SAFETY

Patient safety - Making it Happen In response to the growing concern over patient and medication safety, Luxembourg played host to “Patient Safety - Making it Happen!” EAHP President, Jacqueline Surugue gives her overall impression of the conference and its key speakers.

Jacqueline Surugue, EAHP President

uropean patients have the and insisted on collaboration of all which provides an appropriate platform to right to expect a high stan- involved partners (see page 2). address hospital pharmacists’ concerns dard of safety in their health- regarding patient safety. care environment. Solid doc- Professor Angela Coulter, CEO of Picker umentation on reported acci- Institute Europe, stressed crucial aspects Parallel sessions held on the conference’s Edents and adverse events in the healthcare of communication between patients and second day offered practical examples of setting make it impossible to ignore the health professionals, while Dr Jesper possible risks: from an increase of error facts: it is time for Europe to take action to Poulsen, Vice President of the Standing due to fatigue and stress to misrepresenta- prevent accidents and to enhance patient Committee of European Doctors and tive communication with immigrants to safety. President of the board of the Danish the lack of EU regulations for expressing Medical Association, presented the the concentration of injectable drugs to too This was the focus of the conference “Danish Patient Safety Act” for improve- similar drug packaging. All participants “Patient Safety - Making it Happen!”, ment of patient safety in the healthcare agreed that error reporting should be which was organised in Luxembourg on sector. This intriguing presentation high- made with a “non-naming non-blaming 4-5 April 2005 under the auspices of the lighted the obligation for health profession- non-shaming” attitude and under confi- Luxembourg EU Presidency and the als to report adverse events. According to dentiality. European Commission by the Standing Dr Poulsen, reports under the act are made Committee of European Doctors and under confidentiality, do not lead to disci- At the end of the conference, participants health partners committed to making plinary measures (“no blame policy”) and supported the “Luxembourg Declaration patient safety a priority. result in prophylactic action. It is worth on Patient Safety”, which is reproduced mentioning that in its first year, 50% of here on page 20. The venerable and still completely relevant reports were related to medication errors. Hippocratic oath “First do no harm” was Despite no system ever being able to com- immediately stressed in the first speech of As we heard from Dr Michel, representa- pletely remove all risk of possible harm to the conference by Luxembourg Minister of tive of the World Health Organization’s patients, it is of prime importance to esta- Health and Social Security, Mars Di World Alliance for Patient Safety and blish a culture of openness and trust in the Bartolomeo, who said that risk manage- Medical Director of the French European healthcare sector in which it is ment should be a routine part of hospital CCECQA, a coordination unit for clinical expected—indeed an obligation—for management and that hospitals should evaluation, risk management and quality healthcare providers to participate in avoid general acceptance of routine inci- improvement, France has already learning from adverse events. This is the dents. In his well-documented presenta- developed an integrated risk management right way for all health professionals to tion, Dr James Bagian, Director of the system for healthcare products and some take the first steps toward a new road to US Veterans Affairs National Centre for at-risk activities. We also heard from him improved patient safety. Patient Safety, called this the “normali- the six action areas targeted by the World sation of deviance”. He concluded that Alliance programme. We as hospital pharmacists have to take cultural change is needed to ensure the up the challenge that is expected from us: analysis of errors, action and feedback Dr Adamos Adamou, a Medical Oncologist to create a medical environment in the that are key in leading to safety. from Cyprus and member of the European hospital that minimises risk and maximi- Parliament, gave his view on patient safety, ses the benefit for the patient. The EAHP Meanwhile, Markos Kyprianou, Euro- stressing that illness should be an accident wishes to play an active role in promoting pean Commissioner for Health and not an expected part of our lives, while Sir this goal. We will keep you posted! Consumer Protection, insisted on the Liam Donaldson, Chairman of the WHO need for European cooperation and dis- World Alliance for Patient Safety and Note: Please visit www.cpme.be for more cussed the programme of the High Chief Medical Officer for England, led a information regarding this challenging Level Group on health services and vivid presentation on “Tackling the patient conference. patient care (see page 13). Dr Wim safety agenda in Europe” with poignant Schellekens, CEO of the Dutch Institute examples of what errors in the field Author for Healthcare Improvement, identified of health care can lead to. Professor Jacqueline Surugue, President of the steps to be taken at the EU level and at Donaldson has also been appointed to lead European Association of Hospital the national level—as he said, it is all the special project on patient safety of the Pharmacists about mission, vision and strategy— High Level Group of EU Health Directors, [email protected]

16 www.ejhp.org Special Supplement • Fall 2006 PATIENT SAFETY Recommendation of the Council of Europe to Member States on patient safety Acknowledging that access to safe health care is a basic right, the Committee of Ministers of the Council of Europe [1] adopted recommendation R(2006)7 in May 2006. Welcoming this, the EJHP presents the recommendation and the main opinions held by the Council.

lthough error is inherent A system-based approach presupposes wrong with the system in which the in all human activity, the systematic design of safe structures, individuals were working. The system it is possible to learn procedures and processes, together with should be consistent with already esta- from mistakes and to corrective reactions in response to safety blished quality-management systems. prevent their reoccur- incidents. It should be accepted that Quality and risk management should be Arence. Healthcare providers and organi- errors are a consequence of normal led by the highest level of the organisa- sations that have achieved a high level human fallibility and/or deficiencies of tion and translated into shared values, of safety have the capacity to acknowl- the system; these could be prevented by norms and behaviour at all levels. The edge errors and learn from them. The improving the conditions in which Council makes several recommendations methodology for the development and humans work. The aim is a system about aspects of good communication. implementation of patient-safety policies designed with built-in defences. crosses national boundaries; as their There is a need to assess patient safety evaluation requires substantial resources The best way of supporting patient on an ongoing basis. Prior to embarking and expertise it should be shared. safety within a healthcare system is to on actual patient-safety assessment acti- develop a safety culture. A safety cul- vities, a systematic strategy should be Patient safety is the philosophy under- ture is one in which everyone is actively established at an institutional or regional pinning quality improvement and all aware of her/his role and contribution to level to measure and report, using infor- possible measures should therefore be the organisation, and of the potential for mation about the most common services taken to organise and promote patient- things to go wrong. It is an open and fair associated with a high probability of safety education and quality of health- culture, where people are able to learn error. A qualitative approach to patient- care education. There is also a need to about what is going wrong and then put safety indicators maps the activities that promote open co-ordination of national things right. Developing a safety culture exist in the routine delivery of services. and international regulations concerning in an organisation needs strong leader- A quantitative approach uses indicators research on patient safety. ship and careful planning and monitor- and epidemiological methods to system- ing. It also requires changes and com- atically quantify distinct aspects of Appendix to Recommendation mitment to safety at all levels of the processes. R(2006)7 system, from government to clinical The appendix to the recommendation teams and supporting staff. Commit- The Organisation for Economic Co- sets out a number of factors, attention to ment to safety should be backed up by operation and Development report on which will assist in the smooth running policies and the allocation of resources. patient-safety indicators is recommend- of healthcare systems. As a prerequisite ed (OECD health technical paper to developing patient-safety strategies, Effective risk management requires DELSA/ELSA/WD/HTP (2004) 18, governments should take a proactive, understanding of human behaviour, www.oecd.org/els/health/ technical- preventive and systematic attitude: human error, and the conditions likely to papers). It selects a total of 21 patient- admit that errors happen, identify and cause such error. It must be accepted safety indicators which address hospital manage risk points in processes. The that under specific circumstances and patient-safety incidents and include only multi-factorial requirements if we are to for various reasons individuals can measures that focus on specific clinical achieve safety (sufficient levels of make errors and that processes and outcomes. resources, financing, staff, connections equipment will sometimes fail. A sys- between processes, information systems-based approach moves the investi- The primary objective of an incident tems, documentation, communication, gator away from focusing blame on reporting system is the enhancement of etc.) are clearly set out. individuals and looks at what was patient safety, by learning from adverse

www.ejhp.org 17 PATIENT SAFETY

Recommendation R(2006)7 on management of patient safety and prevention of adverse events in health care [2]

The Council of Europe recommends that governments of Member States, according to their competencies: 1. ensure that patient safety is the cornerstone of all relevant health policies, in particular policies to improve quality; 2. develop a coherent and comprehensive patient-safety policy framework which: a. promotes a culture of safety at all levels of health care; b. takes a proactive and preventive approach in designing health systems for patient safety; c. makes patient safety a leadership and management priority; d. emphasises the importance of learning from patient-safety incidents; 3. promote the development of a reporting system for patient-safety incidents in order to enhance patient safety by learning from such incidents; this system should: a. be non-punitive and fair in purpose; b. be independent of other regulatory processes; c. be designed in such a way as to encourage healthcare providers and healthcare personnel to report safety incidents (for instance, wherever possible, reporting should be voluntary, anonymous and confidential); d. set out a system for collecting and analysing reports of adverse events locally and, when the need arises, aggregated at a regional or national level, with the aim of improving patient safety; for this purpose, resources must be specifically allocated; e. involve both private and public sectors; f. facilitate the involvement of patients, their relatives and all other informal caregivers in all aspects of activities relating to patient safety, including reporting of patient-safety incidents; 4. review the role of other existing data sources, such as patient complaints and compensation systems, clinical databases and monitoring systems as a complementary source of information on patient safety; 5. promote the development of educational programmes for all relevant healthcare personnel, including managers, to improve the understanding of clinical decision making, safety, risk management and appropriate approaches in the case of a patient- safety incident; 6. develop reliable and valid indicators of patient safety for various healthcare settings that can be used to identify safety problems, evaluate the effectiveness of interventions aimed at improving safety, and facilitate international comparisons; 7. co-operate internationally to build a platform for the mutual exchange of experience and knowledge of all aspects of healthcare safety, including: a. the proactive design of safe healthcare systems; b. the reporting of patient-safety incidents, and learning from the incidents and from the reporting; c. methods to standardise healthcare processes; d. methods of risk identification and management; e. the development of standardised patient-safety indicators; f. the development of a standard nomenclature/taxonomy for patient safety and safety of care processes; g. methods of involving patients and caregivers in order to improve safety; h. the content of training programmes and methods to implement a safety culture to influence people’s attitudes (both patients and personnel); 8. promote research on patient safety; 9. produce regular reports on actions taken nationally to improve patient safety; 10. to this end, whenever feasible, carry out the measures presented in the appendix to this recommendation; 11. translate this document and develop adequate local implementation strategies; healthcare organisations, professional bodies and educational institutions should be made aware of the existence of this recommendation and be encouraged to follow the methods suggested so that the key elements can be put into everyday practice. events and mistakes made. Reporting An incident reporting system should be The reports should also be objective and and collection of incident data is mean- voluntary; confidential (however, if the incentives should possibly be given to ingful only if the data is analysed and event is to be analysed in order to learn encourage reporting (for example, evaluated and if feedback is given to the from it, the names of the personnel express recognition). The reporting professionals involved in the incident, involved may need to be known inside system should be independent of and to all others who could learn from the actual institution); anonymous, at regulatory or accrediting processes. A the incident. least at regional and national levels; common format should be used to be non-punitive with regard to those report all incidents. Incidents may be reported by health pro- who report, but provide no immunity fessionals, patients and relatives, or by because of the consequences to the Use of data: reporting and collection of other informal caregivers and suppliers. patient. patient-safety data is meaningful only if

18 www.ejhp.org Special Supplement • Fall 2006 PATIENT SAFETY

the data is intelligently analysed and adverse drug reactions (pharmacovigi- safety incident. Education and training information is, where appropriate, fed lance) to product safety, whereas curricula for all health professions back to healthcare professionals, mana- medication errors are linked to the should include basic knowledge of the gers and patients. There needs to be a safety of healthcare services. principles of clinical decision making; clear understanding and agreement with risk awareness; risk communication; healthcare institutions and professionals A medication error is defined as follows: risk prevention; individual and collec- on how the data collected will be put to “Any preventable event that may cause tive attitudes and behaviour in the case use. or lead to inappropriate medication use or of adverse events (medical, legal, finan- patient harm while the medication is in cial and ethical aspects). Effective data collection depends on the the control of the health care profession- willingness of frontline clinical staff. al, patient, or consumer. Such events Patients using health services must have Several barriers to reporting exist, which may be related to professional practice, adequate information available, allow- should be removed through appropriate healthcare products, procedures, and ing them to include safety considera- policies: fear of blame, resulting from a systems, including prescribing; order tions when making decisions. This lack of open and fair culture; fear of the communication; product labelling, pack- information should allow patients to reports being used out of context by the aging, and nomenclature; compound- understand and balance the risks and media and others; lack of feedback as to ing; dispensing; distribution; administra- benefits of different treatment options, what has changed as a result of the tion; education; monitoring; and use.” in which they are considered a partner. report; lack of time to report; lack of Patients must feel able to speak up when support from the management. The following key dimensions in the they feel that something could go, or has provision of care should be taken into gone, wrong during the course of their Patient-safety incident reporting sys- account in order to prevent medication treatment. tems can be established as “stand- errors: alone” systems or can be integrated • the organisation and structures used The report concludes that the successful with other systems for recording com- within health care that govern the pre- implementation of a patient-safety plaints and compensation claims or scription, dispensing, administration, policy requires concerted action by all applications for benefits (the sources of and monitoring of medication use; stakeholders and makes further useful information will differ for each coun- • a patient-safety culture in health care suggestions, including patient safety try). Each organisation should develop that promotes the understanding of education programmes, research and systems to analyse this information and activities that may have a high risk of country-specific legislation. The safety to learn from it. Complaints, criticism undesirable outcomes with the use of of medication and interventions is the and suggestions may contribute to medication, in the overall care process; essential feature of healthcare provision patient safety and should be taken • the use of indicators that can establish and its cost should be included in the seriously and handled appropriately. a baseline for the actual incidence of general budget. Clear procedures should be implement- undesirable events; ed for recording and analysing com- • a level of understanding among staff of plaints, which should be handled in a the necessary and ongoing observa- Author fair, transparent, flexible and concilia- tions that need to be made to prevent Judith Martin, MRPharmS tory manner, whether they come from or minimise the likelihood of errors in EJHP Editor patients or their representatives. medication use. References Medication safety is a specific Improvements in the system of medica- 1. The Council of Europe is an organisation compris- strategy to promote patient safety. tion use require continuing, specific ing 46 democratic European countries. It was set up to promote democracy and protect human rights Medication errors are the most strategies to promote patient safety at and the rule of law in Europe The Committee of common single preventable cause of every stage of the medication process. Ministers, the Council's decision-making body, adverse events and European health comprises the Foreign Affairs Ministers of all the authorities should consider them as an Human factors in error and patient Member States, or their permanent diplomatic important public health issue. empowerment are discussed. For representatives in Strasbourg. It is a forum where Medication safety comprises both example, health professionals should be national approaches to problems facing European society can be discussed on an equal footing, and adverse drug reactions and medication given the opportunity to learn how to where Europe-wide responses to such challenges errors. A clear distinction has to be handle guilt and be supported to avoid are formulated. www.coe.int made between them. The WHO links becoming “the second victim” of the 2. wcd.coe.int/ViewDoc.jsp?id=1005439&

www.ejhp.org 19 2005 Luxembourg Declaration on Patient Safety (Summary) Access to high quality health care is a key human right recognised and valued by the European Union, its institutions and the citizens of Europe. Accordingly, patients have a right to expect that every effort is made to ensure their safety as users of all health services. EAHP is one of the signatories of this Declaration.

Background: costs associated with complaints and risk management routines—for exam- The health sector is a high-risk area applications for compensation. Most ple, by developing guidelines and indi- because adverse events, arising from importantly, patient safety contributes to cators as a part of a quality assessment treatment rather than disease, can lead to an increase in quality of life. In order to system in the healthcare sector. death, serious damage, complications achieve this, the culture of safety can be • To optimise the use of new techno- and patient suffering. Although many improved significantly in various ways. logies—for example, by introducing hospitals and healthcare settings have In light of the above, the conference electronic patient records. Such records procedures in place to ensure patient recommends that “Patient Safety” has a would include the personal medical safety, the healthcare sector still lags significant place high on the political profile and decision-making support behind other industries and services that agenda of the EU, nationally in the EU programmes for health professionals have introduced systematic safety pro- Member States and locally in the health- with a view to reducing medication cesses. care sector. errors and increasing compliance rates. • To establish national fora, with partici- A number of investigations from all over The conference recommends to the pation by relevant stakeholders, to the world have underlined the need for EU Institutions: discuss patient safety and national and the possibility of reducing the • To establish an EU forum with partici- activities. number of adverse events in the health pation by relevant stakeholders to dis- • To safeguard working conditions for all sector. Current data show that almost half cuss European and national activities healthcare professions and to ensure of all preventable adverse events are a regarding patient safety. that policies on recruitment and reten- consequence of medication errors. • To work in alliance with WHO Alliance tion are linked to patient safety. towards a common understanding on • To recognise and support the user train- Accordingly, tools must be introduced patient safety issues and to establish ing provided by medical devices, tools aimed at reducing the number and conse- an “EU solution bank” with “best and appliance manufacturers, thereby quences of adverse events. The health practice” examples and standards. ensuring the safe use of new medical sector should be designed in a way that • To create the possibility of support technology and surgical techniques. errors and adverse events are prevented, mechanisms for national initiatives • To include patient safety in the standard detected or contained so that serious regarding patient safety projects, ack- training of health professionals combin- errors are avoided and compliance with nowledging that patient safety is in the ed with integrated methods and proce- safety procedures is enhanced. programme of DG Health and dures that are embedded in a culture of Consumer Protection continuous learning and improvement. As a result of the work done in this field • To ensure that EU regulations with • To ensure that national regulatory by many players and institutions and the regard to medical goods and related framework protects the privacy and evidence gathered, it is now clear that the services are designed with patient confidentiality of patient records in the first step that needs to be taken should be safety in mind. best interests of the patient, while at the to establish a culture of patient safety • To encourage the development of inter- same time ensuring that relevant patient throughout the entire health system. Risk national standards for the safety and information is readily available to management must be introduced as a performance of medical technology. healthcare professionals. routine instrument within the running of • To ensure that the European regulatory • To create a culture that focuses on the entire health sector. A precondition framework protects the privacy and learning from near misses and adverse for risk management is an open and trust- confidentiality of patient records in the events as opposed to concentrating on ing working environment with a culture best interests of the patient, while at the “blame and shame” and subsequent that focuses on learning from near misses same time ensuring that relevant patient punishment. and adverse events as opposed to concen- information is readily available to trating on “blame and shame” and subse- healthcare professionals. The conference recommends to quent punishment. healthcare providers: The conference recommends to the • To facilitate a collaborative care Health sector induced harm to patients National Authorities: approach between health professionals imposes a heavy burden on society. • To provide patients with full and free and healthcare providers aimed at Investment in patient safety therefore has access to their personal health informa- enhancing patient safety. the potential to generate savings in tion whilst ensuring data accuracy and • To implement workplace projects expenditure coupled with an obvious that patients fully understand their treat- focusing on patient safety and to benefit to patients. ments. It is acknowledged that “inform- establish an open culture to deal with ed patients” are well positioned to safe- errors and omissions more effectively. Focus on patient safety leads to savings guard their own health. • To initiate a co-operation between in treating patients exposed to adverse • To consider the benefits of a national patients/relatives and healthcare pro- events and the consequential improved voluntary confidential reporting sys- fessionals in order to inform patients/ use of financial resources. In addition, tems of adverse events and near misses. relatives of near misses and adverse savings are achieved in administration • To work towards the introduction of events.

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