editorial patient safety the hospital pharmacist

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EDITORIAL PATIENT SAFETY

Patient safety is suddenly highon the political and publicagenda. The safety ofpatients in hospital is a smallpart of a developing scenario

of increased perception and reducedacceptance of risk, but the part to whichhospital pharmacists are called upon torespond. The reasons for today’sincreased vulnerability of patients canbe described by 3 Cs:

- Complexity- Cost-effectiveness- Cooperation and communication

Treatment in hospital is more complexthan it used to be. Doctors are treatingmore complicated diseases with morecomplex interventions. Think of openheart surgery, solid organ and bonemarrow transplantation, and intensivecancer treatment. In addition, technolo-gical advances mean that specialistskills are required to operate a widerange of new devices and interpret theirreadings.

More competition in medical care bet-ween providers, hospitals, and thirdparty payers, cost-consciousness andpressure on efficiency has resulted inreduced staff, shorter hospital stays andmore intensive treatment.

As a result, medical care in hospitals isincreasingly dependent on seamlesscooperation between medical specia-lists and other professionals. Many stu-dies have indicated that shortcomings

in communication and managementmay lead to unsafe practices.

Hospital pharmacists are experts in mostaspects of safe medication practice.From drug selection by means of thehospital formulary; support for physi-cians regarding dosing / individual doseadjustments, interactions and therapeuticdrug monitoring; to acquisition of highquality drugs, either by purchasing or in-house production and quality control,logistics; and finally drug distribution tothe patient. Only the pharmacist is equip-ped to overview this whole process andin the EAHP’s opinion the hospitalpharmacist is the key stakeholder.

To address safety issues in hospital,hospital pharmacists call upon a fourth“C”: the need to make the public andpolicy makers / politicians conscious ofthe ideal position they occupy asexperts on medicines. The EAHP wassurprised to see “Patient Safety –Making it Happen” organised by theEuropean Union Presidency in April2005 lacking a single pharmacistamong the speakers. In this specialissue we report on this meeting, whichresulted in the Luxembourg Declarationon Patient Safety (summarised on page20). The EAHP is one of the signatoriesof that declaration.

In May 2006 the Council of Europeissued a document on Patient Safetythat says “medication errors are themost common single preventable causeof adverse events and European healthauthorities should consider them as animportant public health issue.”Nonetheless, the word pharmacistoccurs only once in the 15-page docu-ment. Again: our message is that wheremedicines are concerned, hospital phar-macists play a pivotal role.

The European Association of HospitalPharmacists – representing more than20,000 pharmacists in 26 Europeancountries – strongly supports PatientSafety and medication safety: it was thetheme of our 1,700-delegate annualcongress this year. Patient safety features

prominently in our official journal, theEuropean Journal of Hospital Pharmacy,distributed to all our members.

Safe medication practice requires suffi-cient staff. Based on an EAHP surveyand OECD data, we have estimated theaverage workforce involved in pharma-ceutical care (see page 4-6). In the opi-nion of the EAHP, medication safetyprogrammes may be under pressure incountries with a below-average numberof pharmacists (ie. under 0.9 hospitalpharmacists / 100 beds), unless relatedstaffing levels are sufficient to compen-sate. Clearly patients are more at risk insome countries than in others and theEuropean Commission and the nationalhealth authorities should be concernedto provide a sufficient number of fullytrained hospital pharmacists to achievewhat has been promised in Europeanpolicy documents. Or, in the words ofthe Council of Europe ministers: “thesafety of medication and interventionsis the essential feature of healthcareprovision and its cost should be includ-ed in the general budget…..”.

We hope this special issue will convinceyou that improvements in medicationsafety cannot be taken for granted andthat the EAHP is committed to ensuringthe best achievable safe medicines prac-tice. We welcome your feedback to ourpresident, Mrs Jacqueline Surugue([email protected]) or our execu-tive director, Mrs Catherine Hartmann([email protected]).

Please visit our website (www.eahp.eu)for more information on our associa-tion, our members and the EJHP, ourofficial journal.

On behalf of the Board of the EuropeanAssociation of Hospital Pharmacists,Jacqueline SurugueEAHP President

Professor Arnold G VultoEAHP Director of Education, Scienceand ResearchEditor-inChief, EJHP Practice

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

Jacqueline Surugue Professor AG Vulto

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PATIENT SAFETY

Patient safety is an umbrellaterm under which residemany categories of (poten-tial) harm to patients:errors, medication prob-

lems, post-surgery wound infections,falls, bedsores, technical failures,communication issues, etc.

Research and many successful pro-grammes show that we can do some-thing about it. The main barrier tochange is the culture around patientsafety: the naming-blaming-shamingculture around errors and adverseevents prevents us from recognisingthe problem, from learning from whatgoes wrong and to applying what wehave learned. This is the reason weneed leadership for change—clinicaland managerial leadership at all levelsof health care.

Building the will to changePatient safety is a big and, untilrecently, hidden problem in ourhealthcare systems. The report “ToErr is Human” from the Institute ofMedicine in the US (1999) was thefirst that not only revealed the unpop-ular facts of human error but alsotreated the issue in a constructive,educational and challenging way. One

of the main conclusions was thatharm to patients in almost all cases is asystem problem and that naming,blaming and shaming is counterpro-ductive for learning and improvement.

Baseline epidemiological studies inmany countries show the sameresults: the rate of adverse events inhospitals is about 10% of all admittedpatients (USA, Australia, UK,Denmark, New Zealand, Canada).Three per cent of all admitted patientsexperience some kind of moderate orserious harm, and in about 10% ofthese 3% this harm is so serious thatthe patient dies. This means 45,000-95,000 deaths in the US or 3,000-6,000 deaths in The Netherlands; esti-mates are that with our current know-ledge about 50% of these deathscould be preventable. These data areonly from admitted patients in hospi-tals. We still have almost no data fromoutpatient clinics, primary care facilitiesor nursing homes.

Reliability studies show that in only60% of cases do patients receive thenecessary beta-blockers and aspirinafter a myocardial infarction (error ratearound 1:10); wound infection aftersurgery, bedsore and death in high risk

surgery rates are about 1:100; neonatalmortality and general surgery deathrates are about 1:1,000; the death rate inroutine anaesthesia is about 1:10,000;and the blood bank error rate is1:10,000. To compare: error rates in theairplane industry, nuclear power plantsand the petrol chemical industry arefrom 1:1,000,000 to 1:10,000,000—analmost error-free environment.

Apart from these data, we now knowthat there is also unacceptable varia-tions among doctors and hospitals: postsurgery wound infection rates varyfrom between 2 and 9%, bedsore ratesbetween 5 and 25%, etc. This showsthe difference between best practicesand many other instances. What a greatopportunity to improve!

Vision for changeThere is good news: we can do some-thing about it. Breakthrough collabo-rations in the US, UK, Sweden,Australia and The Netherlands showthat we can reduce medication errorsto almost zero, that unnecessary painafter surgery can be eradicated, thatbedsores in hospitals can be reducedto under 5%. Introduction of blame-free reporting at the departmentallevel increases the number of reported

Patient safety:the new challenge

Wim SchellekensMD, MPH

The issue of patient safety is now recognised as a serious problem inmany countries. Health care is about curing, helping and supportingpeople 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 thatpatient safety is a serious and, until now, mostly hidden problem.

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Special Supplement • Fall 2006 PATIENT SAFETY

incidents four to 10 times—a wealthfor learning and improvement!

In many countries, patient safety hasbecome the main strategy for im-provement in healthcare systems. TheWorld Health Organization has laun-ched the very promising programme“World Alliance for Patient Safety”,under the leadership of LiamDonaldson, England’s Chief MedicalOfficer. The EU started the “Simpatie”project [1], a collaboration of organisa-tions and knowledge institutes in theEU to bring together all we knowaround patient safety and translate thisknowledge to patients and providers(coordinated by the Dutch Institute forHealthcare Improvement CBO). Underthe presidency of Luxembourg, 2005saw the first conference dedicated to

patient safety, which will ensurethat this issue is high on the EU-agenda.

Strategy for changePatient safety is a real, but hidden,problem. There is a vision and awillingness to do something about it,but what should be done? Whatshould be put on the agenda?

On the institutional levelPatient safety is everybody’s task:doctors, nurses, managers. Anybodycan take initiative and make a differ-ence. But to make it an institutional

priority, the leadership has to takeaction to reformulate the “safety first”goal (mission), to decide what aimshave to be reached five years fromnow (vision) and what has to be doneby next year (strategy).

Systematic measurement, analysis ofdata and actions toward improvementmust be introduced, as well assustaining and increasing positiveresults. A real emphasis should be onapplying what we already know.

It is also a leadership task to introducea “blame-free reporting system” tolearn from adverse events. This is themost important effort to change theculture from within.

On the national level

Change for improvement has to beimplemented in the working environ-ment. How can systems support andstimulate the desired actions? Whatmight governments do?• Make patient safety a national pri-

ority. Every country needs its owndata to create a much-needed senseof urgency.

• Apply what we already know: dis-cover best practices and develop anationwide strategy for adoptingthem.

• Create incentives that stimulatelearning and improvement.

• Build/support a national centre of

expertise on patient safety, improve-ment and implementation.

• Introduce measurement, analysis,improvement and control on a nation-al level.

• Develop a research agenda forpatient safety.

On the European levelHow can the European Union work topromote patient safety?• Anchor political commitment to

create a common sense of urgencyand a vision for change.

• Collaborate in designing and imple-menting systems.

• Take shared action on high prioritytopics: i.e. medication safety, postsurgery wound infections, blame-free reporting, eHealth.

• Organise shared learning: build net-works of experts, support centres.

• Build a common research agenda.• Combine efforts to support the new

EU countries.

ConclusionPatient safety is a big hidden prob-lem in our health care. We uninten-tionally harm patients. We have dis-covered the problem. We know whatwe can do about it. It is now time foraction.

AuthorWim Schellekens, MD, MPHHealthcare Quality and SafetyConsultantFormer CEO of the Dutch Institutefor Healthcare [email protected]

Reference1. A collaboration of the Council of Europe,

CPME (European Doctors), HOPE (Hospitals

of the European Union), ESQH (European

Society for Quality in Healthcare), HAS

(Haute Autorité de Santé, for accreditation),

LMCA (Long Term Medical Conditions

Alliance, for patient involvement) and CBO

(Dutch Institute for Healthcare Improvement).

This project is funded by the European Union.

213.177.130.12:591/database/Simpatie.pdf.

The Dutch Institute for Healthcare Improvement coordinates the SIMPATIE Project, a collaboration

of EU institutions formed to share information around patient safety.

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PATIENT SAFETY

major discrepancies in the ratio ofhospital pharmacists per 1,000 inhabitants

by country—from 0.020 in Germanyto 0.090 in Finland (see Figure 1). PerT

here are many factors thatcontribute to a hospital’sability to provide qualityof care, but one of themost basic is the “number

of hands on the bed.” Patient and med-ication safety cannot be addressed with-out a serious consideration of humanresources [1]. In a hospital setting, thisincludes an adequate number of doctorsand nurses, of course, but also withregards to medicines, to pharmacistsand pharmacy technicians.

Hospital pharmacists play a key role inthe “healthcare team” (a term which willbe used throughout this article to refer topharmacists, pharmacy technicians,nurses and doctors), when it comes tomedication safety, but any comparisonof adequate staff must consider the otherhealthcare team members, as well as thecountry’s healthcare system.

When looking at populations across the26 EAHP member countries, six –Spain, Poland, Germany, Italy, the UKand France – represent 75% of the totalpopulation but account for 85% of thetotal number of hospital pharmacists,while the remaining 15% represent the20 countries that make up 25% of thepopulation. So it appears that there is noequal distribution of hospital pharmacyworkforce over Europe. This warrantssome further analysis.

According to the data published in the10th Anniversary issue of EJHP 2004;10(6):106-7 on Development of EAHP [2],the average number of practising hospitalpharmacists per 1,000 inhabitants acrossMember States is 0.047, but there are

Workforce of EU hospitals and pharmacy services:a direct patient safety issueJacqueline Surugue, EAHP President Professor Arnold G Vulto, EAHP Director of Education, Science and Research

Figure 1: Practising hospital pharmacists per 1,000 population (Average: 0.047)

FinlandUnited Kingdom

FranceBelgium

Latvia Ireland

Portugal Czech Republic

NorwayEstonia

LuxembourgItaly

PolandHungarySlovakiaDenmark

AustriaSwedenGreece

SloveniaSpain

NetherlandsSwitzerland

Germany

Figure 2: Practising nurses per 1,000 population (Average: 8.31)

IrelandNetherlandsSwitzerland

LuxembourgNorway

Denmark Sweden

GermanyAustria

Czech RepublicFinland

United KingdomSlovenia

SpainFrance

EstoniaSlovakia Belgium

Italy Hungary

PolandPortugal

Greece

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hospital bed (see Figure 5), Estonia hasthe highest concentration of hospitalpharmacists with nearly two per 100beds, followed by Norway with 1.75.Switzerland and Germany have the low-est ratios at one-third hospital pharmacistmanpower per 100 beds. This means thatin Switzerland, each hospital pharmacistis responsible for 305 beds and inGermany, 319 beds. The average numberof hospital pharmacists per 100 bedsacross Member States is around 1 (exact:0.93). This makes it understandable thatthe role the hospital pharmacy can play inthe healthcare team will vary also consid-erably across Europe.

Some of these discrepancies are due tothe structure of health systems in variouscountries, including the respective rolesof hospital and community pharmacistsand the roles of other members of thehospital healthcare team. The rolesplayed by members of the healthcareteam can depend on healthcare culture orsimply on the total number of each groupavailable in any given country, whichmust be taken into account when assess-ing a country's or hospital’s ability toinvest in quality care, including theimplementation of successful patientsafety programmes with root causeanalyses of adverse events.

When looking at the three main activitiesinvolved in drug treatment – prescribing,distributing and administering – it iseasy to ascribe each area to one set ofprofessionals – doctors, pharmacists andnurses, respectively. However, in manycountries, nurses are largely responsiblefor both distributing and administeringdrugs. Therefore, in a country with ahigh ratio of nurses per bed, a lower ratioof pharmacists might be expected, andthis does not necessarily lead to a lapsein the ability to provide sound patientsafety due to lack of staff.

If we look at the UK as an example, wesee that the number of hospital pharma-cists per 1,000 residents and per hospitalbed is high. However, as Figure 3 shows,the number of practising doctors per1,000 residents in the UK is the lowest inEurope. Therefore, in regards to patientand medication safety, a shortage of doc-

tors is made up for by an influx of phar-macists. Similarly, while the number ofbeds per hospital pharmacist in Germanyand Switzerland, as noted above, is veryhigh, nursing and physician numbers inboth countries are well above theEuropean average. This means theremay be adequate overall staff support toensure a basic level of safety.

Although an adequate number of totalstaff may exist to ensure some standard ofpatient safety, the role and competenciesof healthcare team members must alsobe taken into consideration. In Czech

Republic, for example, an above-averagenumber of nurses per 1,000 residentscould be due to pharmacists not practisingclinical pharmacy; nurses are responsiblefor preparing ward stock and for fulladministration of drugs to patients.Although total number of healthcareworkers are adequate in hospitals in thecountry, the lack of pharmacist involve-ment in the wards is a patient safety con-cern that is not shared by the UK.

Total numbers of each group of thehealthcare team lead to certain kindsof practice, which is why hospital phar-

Figure 3: Practising doctors per 1,000 population (Average: 3.18)

GreeceItaly

BelgiumSwitzerland

Czech RepublicGermany

FranceAustriaSwedenPortugal

SpainHungaryEstonia

SlovakiaNorway

NetherlandsDenmark

LuxembourgIrelandFinlandPoland

SloveniaUnited Kingdom

Figure 4: Practising total healthcare team members (doctors, nurses, hospital pharmacists) per 1,000 population (Average: 11.54)

Ireland NetherlandsSwitzerland

NorwaySweden

LuxembourgDenmarkGermany

Czech RepublicAustriaFinland

United KingdomFranceSpain

SloveniaEstonia

BelgiumSlovakia

ItalyHungary

GreecePortugal

Poland

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PATIENT SAFETY

macy in the UK differs from the rest ofEurope, with pharmacists not only prac-tising clinical pharmacy on the wardsbut doing so on a daily basis. This alsohelps explain the country’s movementtoward supplementary pharmacist pre-scribing – a trend directly due to ashortage of available doctors.

Although the total number of healthcareworkers per 1,000 people in the UK isaverage and comparable to severalother countries (see Figure 4), the highratio of pharmacists enables them toapply their specific technical skills toactivities best performed by medicationexperts. A recent study in TheNetherlands showed that the error rateat a decentralised pharmacy intra-venous admixture unit (satellite phar-macy) was 2%, while the error ratewhen nurses made preparations on theward was an eye-opening 71% [3]. Butbecause The Netherlands’ ratio of phar-macists to nurses is quite low (0.75 phar-macists per 100 beds compared to 1.28nurses), nurses may perform tasks betterleft to trained pharmacy technicians.Still, the high overall number of care staffin The Netherlands, which is 15.9 per1,000 residents, ensures that nurses arenot overworked, which is one of theleading causes of medication safetyerrors.

Data published in the 10th Anniversaryissue of EJHP 2004;10(6):106-7 showedEstonia and Norway have the lowestnumber of beds to hospital pharmacist.The lower the ratio of beds to total hands,the lower the incidence of accidents andadverse effects [1, 4, 5]. Thus, eventhough Estonia has a below-average totalnumber of healthcare team members, itsvery low ratio of beds to hospitalpharmacists and its average number ofhospital pharmacists per 1,000 popul-ation puts hospital pharmacists at anadvantage to contribute to overall safetymeasures in hospitals, particularly inregards to clinical pharmacy. Norway is,as we can further see in Figures 1 and 4,at an even greater advantage to ensurepatient and medication safety.

When comparing statistics acrossEuropean countries, all this data mustbe taken into consideration because sta-tistics can be misleading. France, forexample, at 1.5 pharmacists per hospi-tal is more than six times less than inthe UK, despite a similar total numberof hospital pharmacists. This is becauseFrance has a higher total number ofhospitals. Also, as data from theOrganisation for Economic Co-opera-tion and Development (OECD) con-firms, there are large differences in thenumber of hospitals in OECD member

countries with no apparent correlationwith population. It is understandablethat a hospital pharmacy needs a certaincritical mass for proper managementand back-office activities to allow forpatient-oriented tasks. This can bebetter organised in larger institutions,and this is exactly what one seeshappening in the UK and some othercountries where hospitals are merging.

When assessing adequate needs forpatient safety procedures and outcomesand the role a hospital pharmacist canplay here, we must take into considerationthe number of pharmacists per hospital,the number of beds per pharmacist andthe role of the pharmacist in the health-care team (“total number of hands on thebed”). With the background data provid-ed in this paper, every hospital can bench-mark its own staff availability to ensuresafe medication practices and to developa policy in case it needs improvement.

AcknowledgementFigures 2, 3 and 4 data are from Healthat a Glance, OECD Indicators 2005,©OECD.Figure 4 data is also based on resultspublished in EJHP 2004 [2].

AuthorsJacqueline SurugueEAHP [email protected]

Professor Arnold G VultoEAHP Director of Education, Scienceand [email protected]

References1. Needleman J, Buerhaus P, Soeren Matke RN et al.

Nurse-staffing levels and the quality of care inhospitals. New Engl J Med 2002; 346:1715-22.

2. Development of EAHP, EJHP 2004;10(6): 106-7.3. Guchelaar HJ, Colen HBB, Kalmeijer MD et al.

Medication Errors: Hospital pharmacist perspec-tive, Drugs 2005;65(13):1735-46.

4. Bond CA, Raehl CL, Franke T. Clinical pharmacyservices, hospital pharmacy staffing, and medi-cation errors in US Hospitals. Pharmacotherapy2002;22:134-47.

5. Bond CA, Raehl C. Clinical pharmacy services,pharmacy staffing and adverse drug reactions inUS hospitals. Pharmacotherapy 2006; 26:735-47.

Figure 5: Number of hospital pharmacists per 100 beds (Average 0.93)

Estonia

Norway

Portugal

Ireland

United Kingdom

Finland

Belgium

Sweden

Denmark

Italy

Luxembourg

France

Latvia

Netherlands

Spain

Greece

Slovakia

Slovenia

Czech Republic

Hungary

Austria

Switzerland

Germany

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The medical professionhas always paid atten-tion to the risks of proce-dures and drugs whentreating patients. We can

distinguish between intrinsic risks,which are inherent in treatments, and adifferent class of risks that cover fail-ures or inappropriate procedures andmedicines. For instance, there are anumber of dangers intrinsic to nephrec-tomy; the risks are well known andinvolve the individual characteristics ofthe patient, the anatomy and physio-logy of the systems under considerationand the necessary elements of the pro-cedure, such as anaesthesia. What isnot included are a number of risks ofmedical failures, such as removing thewrong kidney, performing the opera-tion poorly or connecting the wronglines for the anaesthesia.

Similarly, significant risks are re-cognised with respect to medicationsthat are intrinsic to the pharmacologi-cal processes and individual character-istics of patients. These recognisedrisks do not, however, include incor-rect dosage, administration of thewrong medication or the fact that apatient may have been given an incor-rect diagnosis.

We can label this second class of risks“extrinsic.” The famous 1999 studyby the US Institute of Medicine [1]estimated that in the US between44,000 and 98,000 people may dieyearly as a result of medical errors.There are no indications that the EUis significantly different in this re-spect, which implies an EU mortalityrate from medical error between68,000 and 152,000. All of these inci-dences are the result of failures of themedical system to provide what isagreed to be the best care. This isquite different from mortality or mor-bidity resulting from problems wherethe risks were well known and thoserisks were taken, even if the conse-quences were unfortunate.

Medical systems are not well prepar-ed to manage extrinsic risks, asshown by these high failure rates.Most approaches to managing medi-cal errors have concentrated on

developing incident reporting sys-tems – for example, the UK NHSreport An organisation with amemory [2]. These are pitched as away of flushing out problems thatcan then be solved, and incidentreports currently form the mainsource of information available onsuch failures. A major problem withthis is that members of the medicalprofessions find it difficult, andoften threatening, to report adverseevents and near misses, whether theyinvolve themselves or their col-leagues. An alternative approach,one used in highly hazardous opera-tions such as the nuclear power andoil and gas industries, involves thesystematic analysis of hazards and

risks associated with the organisation’sactivities and environment [3].

Risk assessment forms the core of anysafety management system. Without a

Risk analysis and assessment:a tool for pharmacy practice

Professor Dr PTW Hudson

Extrinsic risks of treatment in a hospital include failures of themedical system and practitioners. The Bow Tie method can be used toidentify where control over a process is lost and whether it isproactive (maintaining control) or mitigating (attempting to minimiseconsequences). Analysis of the medication process has identified atleast 120 different threats and a number of systematic weaknesses.

“As the medication system relies primarily on people rather than hardware, opportunities for failure are much less clear.”

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PATIENT SAFETY

systematic identification and evalua-tion of the hazards, any approach tothe management of extrinsic risks willbe essentially ad hoc. The systemneeds to know how hazards canoccur, how they can be controlled andconsequences mitigated and howthese controls themselves might fail.So, how can we analyse the extrinsicrisks of medication and assess whe-ther they are significant for patients?The current approach is heavilybiased towards collecting information

from reports of adverse events andnear misses. It is essentially reactive:1) waiting for something to go wrong,and then 2) relying upon the issuebeing recognised as an incident/error,as many failures may produce noclinical effects, and finally 3) thepractitioner(s) involved considering itto be worth reporting.

In terms of J Reason’s Swiss Cheesemodel (Figure 1) [4], this system pro-vides us with information about

which barriers have holes and howlarge they are. When a failure reflectsbadly on the individual, especially ifthere has been no clinically signifi-cant consequence that must be report-ed, it is hard to persuade people toown up. When reporting does takeplace, it is often used simply toachieve other ends rather than to learnabout system failures by having anunbiased sample of reported failures.For example, people may selectivelyreport incidents to highlight a specificproblem they experience, such asunderstaffing.

Industrial risk assessmentSo how is risk analysis and assess-ment performed elsewhere? There aretwo basic approaches. One uses inci-dents and uncovers root causes byworking backward from consequenceto cause. The other, Failure Mode andEffect Analysis, moves from possiblecauses towards potential incidents bysystematically varying every elementor component in a system and seeingwhat failures result. The latterapproach, while proactive, is labourintensive and is usually only appliedto engineering problems with aconcentration on “hard” componentfailures. As the medication systemrelies primarily on people rather thanhardware, opportunities for failureand assessing how failures propagateare much less clear [5].

A risk analysis method called theBow Tie model provides a way ofcombining these two approacheswhile significantly reducing the com-plexity (see Figure 2). Bow ties arebased around a “top event,” the eventor situation at which no adverseconsequences have yet occurred, butwhere control over the process hasbeen 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

Figure 1: The Swiss Cheese Model (Courtesy J Reason)

Figure 2: Bow Tie Risk Analysis Model

Some holes due to active failures

Losses

Hazards

Successive layers of defences, barriers and safeguards

Other holes due to latent conditions

(resident 'pathogens')

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being released and the consequenceshappening, we can place barriers onthe “threat pathway.” These barriersmay depend on hard controls, such asinfusion pumps that can only deliver afixed rate, on protocols, such asrequiring the presence of two peopleto administer medicines, a mixture,such as requiring the use of bar codesfor drugs and patients, and trainingand competence, such as whenvigilance is required to check thedifference between NaCl and KCl.

A full bow tie represents a risk analy-sis with all the threat pathways andbarriers identified. If the frequenciesof threats and the effectiveness of thebarriers are quantified, then we have arisk assessment. In the case of medi-cation, we can simplify our task byassuming that medicines are alwayshazardous, as may be their absence.

Medication risk analysisGenerally, in the case of medicationerror, there are five undesirable situa-tions that can be represented by dis-tinct “top events” [6]. These are: 1)the Wrong Patient, 2) the WrongDiagnosis, 3) the Wrong Drug, 4) TheWrong Dose and 5) the WrongDelivery Route. The left side of thebow tie takes the hazards of medi-cines and shows how they can beunleashed. The right side shows howthe undesired consequences canoccur, including harm to patients,reputation and other losses for a hos-pital or for health professionals. Thereare a number of routes to and from the“top event.” Along each pathway, wecan identify possible barriers (the slicesof Swiss cheese) that can prevent thethreat from becoming actualised.

On the left-hand side of the bow tie,the barriers represent preventativecontrols. Each of these barriers isunlikely to be perfect, and we can fur-ther identify what factors can reducethe effectiveness of any barrier. On

the right-hand side of the “top event,”we have the pathways to differentconsequences, which may range fromno clinically observable effect todeath of the patient, as well as reputa-tion damage to the healthcare profes-sional(s) and the hospital. On thisside, the barriers represent mitigationmeasures, ranging from an antidote, ifone is available, to procedures for talk-ing to patients or relatives to reduce thechance of legal action. Antidotes, orpalliative measures, require timelydetection of problems after the event;sincere apologies go a long way toreducing legal consequences. Whendealing with a “top event,” the meas-ures required on the right-hand side areusually independent of what threatcreated the problem in the first place.For instance, an incorrect dosage has tobe remedied, if this is possible, regard-less of how it came to be incorrect.

So far we have identified about 120different threat pathways. For in-stance, the mere presence of twinsraises the possibility of a wrongpatient event, so the next question is,what can we do to raise the chance ofgetting the right patient above 50% inthe case of twins? Neonate twins maynot even have names, so we can usebar-coding, which can be highlyeffective – provided that the docu-mentation is itself correct and thebarcode printer and readers are func-tional. We have also learned that thediagnosis step, often excluded fromdefinitions of medical error, is bothcritical and poorly defended fromerror/failure. An incorrect diagnosis,once made, is hard to overturn. Manyof the barriers require vigilance bymembers of the nursing staff, a com-modity easily pressured by otherdemands.

ConclusionThe bow tie approach allows us toprovide a systematic analysis ofthe ways hazards can lead to conse-

quences, in this case the risks associat-ed with medication. The technique fordeveloping bow ties is non-threaten-ing, in fact often energising, as allinvolved in the process can use theirknowledge of what might go wrongand what can prevent it [6]. For apatient, the risk picture actuallyincludes both intrinsic and extrinsicrisks; they do not distinguish thecauses if something goes wrong.

Fortunately, the approach describedhere need not be restricted to extrinsicrisks, where the medical system andindividuals may have failed. We canand must ask the same questions andcollect similar data when we attempt tounderstand the intrinsic risks. If a spe-cific substance is both potentiallyeffective and hazardous (as all medi-cines are at some level), then we oughtto be able to identify the threat path-ways and the controls that can beapplied to minimise the risks topatients while maximising therapeuticefficacy.

AuthorProfessor Dr PTW HudsonDepartment of Social SciencesLeiden UniversityRoom 2A49, Pieter de la Court 52 Wassenaarseweg 2333 AK Leiden, The [email protected]

References1. Kohn L, Corrigan J, Donaldson M, eds. To Err

is Human: Building a Safer Health System.Institute of Medicine. National Academy Pr1999.

2. Department of Health. An Organisation with aMemory. The Stationery Office 2000.

3. Hudson, PTW. Applying the lessons of high-risk industries to medicine. Quality and Safetyin Health Care 2003;12:7-12.

4. Reason, JT. Human Error. CambridgeUniversity Press 1990.

5. Reason JT, Hobbs A. Managing MaintenanceError: A Practical Guide. Ashgate 2003.

6. Hudson, PTW, Guchelaar HJ. Risk assessmentin clinical pharmacy. Pharmacy World &Science 2003;25:98-103.

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PATIENT SAFETY

Drugs are a dualistic ther-apeutic tool. They areintended to cure, preventor diagnose diseases,signs or symptoms, but

the shadow side is that improper use canbe the cause of patient morbidity and evenmortality. While in the 1960s the interestin adverse drug reactions increased great-ly after the thalidomide disaster (whichcan be considered as the final trigger forthe establishment of formal programmesof drug approval and subsequent surveil-lance), only in recent years has attentionshifted toward the problem of medicationerrors [1]. Literature is now expandingrapidly for both adverse drug reactionsand medication errors.

In general, problems related to the use ofapproved drugs can be summarised withthe term “drug-related problems” [2].When reviewing the literature on drug-related problems (DRPs), one quicklydiscovers that most studies are difficultto compare because of variations in defi-nitions and classification of DRPs [3, 4].A uniform definition and classificationsystem for drug-related problems wouldsolve these difficulties.

DefinitionsDRPs can be divided into intrinsic and

extrinsic toxicity. Intrinsic toxicity iscaused by the interaction of the pharma-ceutical, chemical and/or pharmacologi-cal characteristics of the drug itself andthe human biosystem. Intrinsic toxicityis therefore synonymous with adversedrug reactions (ADRs). An ADR isdefined by the World HealthOrganization (WHO) as “any responseto a drug which is noxious and uninten-ded and which occurs at doses normallyused in man for prophylaxis, diagnosisor therapy of disease, or for themodification of physiological function”[5]. Previously unknown drug-druginteractions and lack of therapeutic effect[6] are included in this definition.Mechanistically there are two types ofADRs: Type A and Type B [2].

Type A reactions are pharmacologicaleffects as much as therapeutic actionsare, the essential difference being thatthey are unintended. Examples areconstipation during the use of morphineand peptic ulcer induced by NSAIDs.Type A effects are by far the most prev-alent. As a rule, there is a dose-responserelationship: Type A ADRs are morefrequent and more severe when higherdoses are taken.

Type B reactions, in contrast, refer to the

phenomenon that a medicine is well tol-erated by the (vast) majority of users butelicits an idiosyncratic reaction in predis-posed patients. Type B effects are oftenunexpected (ie from pharmacology),rare and severe. Type B reactions havehistorically been the major reason for thewithdrawal of medicines from themarket. Characteristically there is nodose-response relationship. Type Beffects are either immunological or non-immunological forms of hypersensitivityand occur in patients with a predisposingcondition, which is often unknownor unrecognised. Stevens-JohnsonSyndrome and anaphylactic shock aretwo examples of Type B reactions.

Extrinsic toxicity refers to the problemscaused by the handling of the drug eitherby the healthcare professional or by thepatient. The drug is not used in theproper way: a medication error has beenmade. A medication error is defined asany preventable event that may cause orlead to inappropriate medication use orpatient harm while the medication is inthe control of the healthcare profession-al, patient or consumer [7]. Therefore,medication errors do not necessarilyneed to result in harm to the patient.In contrast, ADRs always involvesome form of harm. Known drug-drug

Drug-related problems:definitions and classification

When reviewing literature on drug-related problems,most studies are difficult to compare because ofvariations in definitions and classification. A uniformdefinition and classification system for drug-relatedproblems would solve this. A proposal for such asystem is described in this article.

PMLA van den Bemt PhD

Professor ACG Egberts

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both ADRs and medication errors [8-10]. The relationshipbetween the various definitions is depicted in Figure 1.

Classification of intrinsic toxicityADRs can be classified using the WHO adverse reactionterminology [11]. According to this, ADRs are dividedinto 32 system-organ classes (e.g. skin). The class formsthe first part of the code (e.g. 0100 for skin). The secondpart is formed by the so-called “preferred term,” a codethat describes the ADR more specifically (e.g. 0001 foracne). Together both codes form the exact classification ofthe ADR, so 0100-0001 would refer to the skin reactionacne. A classification of seriousness is also often neces-sary. This can be achieved by applying the WHO CriticalTerms List [12], which are ADR-codes related to possiblyserious conditions. In practice, this classification is moreuseful 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, forwhich various systems exist [13].

Another ADR terminology coding system, the CodingSymbols for a Thesaurus of Adverse Reaction Terms(COSTART), was used together with the WHO codingsystem and the International Classification of Diseases(ICD) to create the Medical Dictionary for DrugRegulatory Affairs (MedDRA). This terminology isincreasingly being used in the pre- and post-marketingphases of the medicines regulatory process [14].

Classification of extrinsic toxicityMedication errors can be divided into five main classes:prescribing, transcription, dispensing, administration(including non-compliance) and “across settings” (errorsoccurring on the interface between different healthcaresettings – for example, between hospital and ambulatorycare) [3, 7, 15].

Prescribing errors are those occurring in the process ofselecting and prescribing a drug and on monitoring oftherapy. Table 1 shows a subclassification of types ofprescribing errors [16].

Transcription errors occur when transcribing or interpret-ing a medication order of the physician. In literature, nosubclassification of transcription errors can be found: anorder is either transcribed correctly or not.

When the pharmacy makes an error, it is called a dispens-ing error. For example, the wrong drug or strength can bedispensed or a preparation error may occur [17]. A sub-classification of dispensing errors can be found in Table 2.Errors made in the last stage of the drug distribution

interactions can be seen as medication errors because the drugs wereprescribed not taking into account the interaction.

Finally, the term “adverse drug events” is frequently encountered inliterature. These are defined as injuries occurring during drug therapy,but this association may not necessarily be causal. They comprise

adverse drug reactions

medicationerrors withmorbidity

medicationerrors

no morbidity

symptomsrelated todisease ortherapy

drugtherapy

human orsystematic

error

Administrative and procedural errors• general (e.g. readability)• patient data (e.g. patient mix-up)• ward data and prescriber data • drug name• dosage form and route of administration

Dosage errors• strength• frequency• dosage too high/low• no maximum dosage in “at need” prescription• length of therapy• directions for use

Therapeutic errors• indication• contra-indication• monitoring• drug-drug interaction• incorrect monotherapy• (pseudo) duplicate therapy (duplicate therapy would be e.g.

inderal [contains propranolol] and propranolol; pseudo duplicate therapy would be e.g. omeprazol and pantoprazol[two drugs from same therapeutic category])

Figure 1: Relations between definitions

Table 1: Classification of prescribing errors

12 www.ejhp.org

PATIENT SAFETY

process are administration errors. Theseerrors are made by nurses or doctors inhospital or by the patient in the ambula-tory setting (non-compliance). Table 3shows the subclassification [18].

A bit of an exotic class of medicationerrors are the “across settings” errors,which are not mentioned as such in inter-national literature. Yet studies have beenperformed on this class of errors, whichoccur, for example, when patients areadmitted to or discharged from hospital.As in transcription errors, no subclassifi-cation is made.

As is the case with ADRs, medicationerrors can be classified in classes ofseriousness. This can be done by using amodified version of the classification ofthe National Coordinating Council forMedication Error Reporting andPrevention (NCCMERP) [7, 19]. Thisclassification is illustrated in Table 4.

ConclusionBy choosing uniform definitions andclassification of DRPs, results of studiescan be communicated unambiguously.The same goes for reports in medicationerror reporting systems. The classifica-tion system presented in this article is notdefinite. Although it has proven value inDutch studies on drug safety [20], it issubject to further improvement.Nevertheless, it may certainly constitutea firm basis for a uniform classificationsystem. The authors welcome reactionsto this proposal.

AuthorsPMLA van den Bemt, PhDProfessor ACG EgbertsDivision of Pharmacoepidemiology andPharmacotherapyUtrecht Institute for PharmaceuticalSciencesUtrecht UniversityPO Box 800823508 TB, Utrecht, The Netherlandsp.m.l.a.vandenbemt@ [email protected]

References1. Kohn L, Corrigan J, Donaldson M, Ed. To Err Is

Human: Building a Safer Health System.Committee on Quality of Health Care in America.Institute of Medicine. Washington, DC, NationalAcademy Press, 1999.

2. Meyboom RHB, Lindquist M, Egberts ACG. AnABC of drug-related problems. Drug Safety2000;22:415-23. Erratum in: Drug Safety2000;23:99.

3. Bemt van den PMLA, Egberts ACG, De Jong-vanden Berg LTW, Brouwers JRBJ. Drug-related pro-blems in hospitalized patients – a review. DrugSafety 2000;22:321-33.

4. Mil van JW, Westerlund LOT, Hersberger KE,Schaefer MA. Drug-related problem classificationsystems. Ann Pharmacother 2004;38:859-67.

5. Edwards IR, Aronson JK. Adverse drug reactions:definitions, diagnosis, and management. Lancet2000;356:1255-9.

6. Meyboom RHB, Lindquist M, Flygare AK, BiriellC, Edwards IR. The value of reporting therapeuticineffectiveness as an adverse drug reaction. DrugSafety 2000;23:95-9.

7. National Coordinating Council for MedicationError Reporting and Prevention (NCCMERP),www.nccmerp.org (approached May 2006).

8. Leape LL. Preventing adverse drug events. Am JHealth-Syst Pharm 1995;52:-379-82.

9. Nebeker JR, Barach P, Samore MH. Clarifyingadverse drug events: a clinician's guide to termino-logy, documentation and reporting. Ann InternMed 2004;140:795-801.

10. Morimoto T, Gandhi TK, Seger AC, Hsieh TC,Bates DW. Adverse drug events and medicationerrors: detection and classification methods. QualSaf Health Care 2004;13:306-14.

11. International monitoring of adverse reactions todrugs. Adverse reaction terminology. Uppsala:WHO Collaborating Centre for InternationalDrug Monitoring, 2002.

12. WHO adverse reaction terminology – criticalterm list. Uppsala: The Uppsala WHOMonitoring Centre, 2002.

13. Meyboom RHB, Hekster YA, Egberts AC, et al.Causal or casual? The role of causality assessmentin pharmacovigilance. Drug Saf 1997;17:374-89.

14. Brown EG, Wood L, Wood S. The medical dictio-nary for regulatory activities (MedDRA). DrugSaf 1999;20:109-17.

15. Shojania KG. Safe medication prescribing andmonitoring in the outpatient setting. CMAJ2006;174:1257-8.

16. Fijn R, Van den Bemt PMLA, Chow M, et al.Hospital prescribing errors: epidemiologicalassessment of predictors. Br J Clin Pharmacol2002;53:326-31.

17. Kelly WN. Pharmacy contributions to adversemedication events. Am J Health-Syst Pharm1995;52:385-90.

18. Allan EL, Barker KN. Fundamentals of medica-tion error research. Am J Hosp Pharm1990;47:555-71.

19. Bemt van den PMLA, Fijn R, Voort van der PHJ,Gossen AA, Egberts ACG, Brouwers JRBJ.Frequency and determinants of drug administra-tion errors in the intensive care unit. Crit CareMed 2002;30:846-50.

20. Van den Bemt PMLA. Drug Safety inHospitalised Patients [thesis]. GroningenUniversity, 2002.

• for wrong patient or for wrong ward• wrong drug• wrong dosage form • wrong strength• wrong time

• omission (drug not administered)• unordered • wrong preparation• wrong dosage form• wrong route of administration• wrong administration technique• wrong dosage• wrong time (at least 60 minutes

early/late)• compliance/adherence

AAn error has been made, but the medication did not reach the patient

BAn error has been made, and the medication reaches the patient, but noharm is doneB1medication not administeredB2medication administered but no harm

CAn error has been made which results inan increased frequency of monitoring,but no harm is done

DAn error has been made, and harm isdoneD1temporary damage necessitating treatment D2temporary damage resulting in anincreased length of hospital stay D3permanent damageD4patient nearly dies

EAn error has been made which results inthe death of the patient

Table 2: Classification of dispensing errors

Table 3: Classification of administrationerrors

Table 4: Classification of medicationerrors in classes of seriousness

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The topic of patient safetyacross Europe is of vitalimportance. Healthcare inter-ventions are, of course,intended to benefit patients,

but they may in some cases cause harm.

Modern health care puts into daily practicesome of the most advanced technologyand techniques of any field of humanendeavour. We all benefit from this con-stant striving to do more. But, as with anycomplex set of processes and choices, mis-takes will happen.

Research from around the globe suggeststhat a considerable percentage—perhaps10% of hospital admissions may involvesome kind of patient safety incident. Somestudies estimate that up to half of theseerrors may be avoidable.

Even if clear figures on patient safety inci-dents are difficult to come by, the largevariations in techniques and outcomesacross Europe themselves tell the story.For example, five-year survival rates forbreast cancer range from 81% in Swedento 58% in Slovakia and Poland. Or takeskin cancer—for malignant melanoma,five-year survival rates vary from 89% inSweden and 86% in The Netherlands, to62% in Estonia, 64% in Poland and 68%in Italy.

These variations have both a negative anda positive side. On the one hand, they showhow far we have to go before we have aconsistent high standard of care for every-one in the European Union. On the otherhand, they underline the potential of bene-fiting from best practices to raise standardsthroughout Europe. As these statisticsshow, this is not just a matter of resources.

Of course, more money is important, andwe are working to improve the resourcesavailable at the European level, but whatresources are available still need to be usedin the most effective way. Sharing exper-tise at the European level can help toachieve this.

Health systems across Europe faceincreasingly common challenges. We also

share common goals of providing high-quality care on the basis of medical needand financed through collective solidarity.Together with the enormous potential forgreater collaboration to help improve theeffectiveness and efficiency of all healthsystems, this provides a solid foundationfor the need to develop European coopera-tion in the area of patient safety.

To do this, we have established a frame-work for policy exchanges through theopen method of cooperation, as well as aHigh Level Group on health services andmedical care to take forward practicalcoordination. In addition to issues such ashealth technology assessment and aEuropean system of centres of reference,this High Level Group is also addressingtoday’s topic of patient safety.

As set out in the 2004 report of the HighLevel Group, several member states haveestablished their own patient safety pro-grammes and systems for reporting andlearning from incidents, includingSweden, Denmark, The Netherlands,Ireland, Czech Republic and the UnitedKingdom. The World Health Organizationhas also established a World Alliance forPatient Safety, providing a global frame-work for activities. Work is also takingplace within the Council of Europe todevelop recommendations.

With this wide range of increasing activity,it is important to bring different groupstogether to ensure that we share a commonvision and that we focus energy andresources so as to achieve the best possibleresults. Creating an organisation such as anEU patient safety network could help toshare information on different activitiesand to ensure a coherent approach amongthese many different initiatives.

However we organise our work, it is vitalthat we make progress on patient safety.Not only because of the importance forpatients themselves but also because whenwe put the systems in place to ensurepatient safety, we will also be making amajor contribution to ensuring overallquality in health systems. If we can takeconcrete steps to reduce the statistical

variations and to raise standards across theEU to those of the most successful, we willbe making a very significant contributionto health and health care.

I would like to see European collaborationon patient safety as being a driver forchange. As a benchmark for success. As asource of ideas, knowledge and inspira-tion. Working collaboratively, we can turnthe variations between our systems into ashared resource from which we all canlearn.

Of course, however good the ideas are,they need to be backed with resources. Weare already financing some projects underthe existing public health programme.However, I hope to be able to announcesignificant new funds to support work inthis area. You can expect to see a new pro-posal for an integrated and expandedhealth and consumer protection pro-gramme, which will include support ofcooperation on health systems, includingpatient safety, and providing essential newresources to support work on these issuesinto the future. I hope that these newresources will help to turn at least some ofyour ideas into action in the comingyears—and action into results.

This will not be easy, but it will be worth it.Improving patient safety will bring bene-fits in driving up standards and qualitythroughout Europe. It will also help toimprove the confidence of patients inhealth care wherever they are across theEU.

Note: This article is the narrative form of aspeech presented at the LuxembourgConference on Patient Safety held on 4-5April 2005.

AuthorMarkos KyprianouCommissioner for Health andConsumer ProtectionEuropean CommissionDG Health and Consumer ProtectionB-1049 Brussels, Belgiumwww.europa.eu.int/comm/dgs/health_consumer

Patient safety across the EU:minimizing the variationsCommissioner Markos Kyprianou

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PATIENT SAFETY

Efficacy, quality and safety ofhealth care must beaddressed in professionalpractices in consultationwith patients and patient

groups. Improving patient safety isimportant for all health systems acrossthe world, and the World HealthOrganization has addressed the issue inrecent years, including the launch of theWorld Alliance for Patient safety in 2004.The European Commission, whichfounded the European Centre for DiseasePrevention and Control (ECDC) also in2004, is keen to co-operate with this proj-ect, which raises awareness and increas-es political commitment in the area ofpatient safety. On the basis of experi-ence gained with initiatives on tobaccocontrol and on the quality of blood,tissues and cells, the Commission isproposing a new health programme forthe coming years.

Patient mobilityIn 2003, the Commission invited all EUHealth Ministers, a representative ofthe European Parliament and six Euro-pean Non-Governmental Organisations(NGOs), including doctors and patients,to discuss patient mobility and healthcaredevelopments in the European Union.This led to the establishment of the HighLevel Group on health services and medi-cal care, which has the commitment of allMember States and the support ofEuropean NGOs and successive EUPresidencies, for comparing, benchmark-ing and sharing data, experience andguidelines.

Detailed figures for adverse events arestill difficult to obtain for Europe as awhole, but every national surveyconfirms the trend shown in the US – a10% incidence of serious mistakes. TheCommission has introduced provisionsto encourage pan-European projects onquality assurance of health systems,covering in particular patient safety:

• SIMPATIE: Safety Improvement forPatients in Europe, led by the DutchInstitute for Healthcare Improvement(www.cbo.nl)

• EUHORIC: EU Public Health Out-come Research and IndicatorsCollection, led by Instituto Superiore diSanità (www.iss.it)

• EARSS: European AntimicrobialResistance Surveillance System(www.rivm.nl/earss)

• ABS: appropriate use of antibiotics inEU hospitals (www.antibiotika-strategien.at)

• IPSE: Improving Patient Safety inEurope (helics.univ-lyon1.fr)

Under the 2006 work plan of the publichealth programme, it states that in order toimprove and maintain a high level ofpatient safety, we must support networkingand the work of stakeholders – namely setup a “forum” or task force for stakeholdersand fund research on patient safety.

Safety of health productsThe Standing Committee for EuropeanDoctors (CPME) organised in April 2005a major conference on patient safety, co-sponsored by the European Commission

and the Luxembourg presidency. Theconference produced an official state-ment, the “Luxembourg Declaration onPatient Safety” (see page 20), which alldelegates signed, including the EuropeanAssociation of Hospital Pharmacists.

The Luxembourg Declaration calls forpatient safety to be taken into greateraccount when designing regulations onmedical devices and pharmaceuticals.Europe already has an extensive struc-ture of regulation regarding thequality, safety and efficacy of medicinalproducts. Further improvements topharmacovigilance were introduced asa consequence of the recent revision ofpharmaceutical legislation, with anincreasing role for the EuropeanMedicines Agency (EMEA).

The EU has recently adopted rules onthe quality and safety of blood andblood products, as well as cells and tis-sues of human origin. This includesprovisions to minimise errors at thebedside, such as providing the wrongblood to the wrong patient, and notifi-cation of serious adverse events andreactions.

European agencies for the protection of health and safetyEurope must act to protect its peopleagainst major health threats such asHIV/AIDS, SARS or pandemics, whichdo not stop at national borders. TheECDC began operations in Stockholm inMay 2005 and works in close partnershipwith the World Health Organization and

European strategy for healthand patient safety

Fernand SauerHonorary Director General, European Commission

Citizens across the EU, whether they seek care in other Member Statesor remain in their own, expect the care they receive to be of highquality. Systemic approaches to improving patient safety are keytoward improving overall quality in health care, and collaborationacross Member States is crucial.


www.ejhp.org 15

with the Center for Disease Control inAtlanta.

While the ECDC is finding its feet, theprogress made since 1995 by the EMEAin London is spectacular and of majorimportance for public health. Theseorganisations are two examples ofeffective mechanisms available fortransforming policy objectives intoconcrete activities, which benefit moredirectly the health and safety ofEuropean citizens and may have a signi-ficant impact on health professionals andeconomic operators.

The ECDC strengthens Europe’s diseaseand early warning systems by providinga structured approach for scientific co-operation between experts in the publichealth institutes of the EU, the US,Canada and other parts of the world. Anarea of high sensitivity is influenza and,in particular, the threat of the emergenceof a lethal strain. The ECDC is helpingMember States build up their defencesagainst influenza and update their pre-paredness plans. In the fall of 2005, anexercise was conducted to test and eval-uate coordination between the nationalplans. Moreover, the Commission ispushing for partnerships between thepharmaceutical industry and MemberStates with a view to acceleratingpandemic flu vaccine development andthe availability of antiviral drugs.

But while influenza might appear to be alikely source of a future global healthcrisis, threats might arise from unknownor unexpected sources. The ECDCenables us to be ever more vigilantagainst new or deliberate disease out-breaks by pooling expertise and know-ledge to rapidly assess whatever heaththreats are in store.

EU co-operationThe Commission welcomed the call inthe Luxembourg Declaration for greaterEU collaboration on these issues andto work in alliance with the WorldHealth Organization. The Commission isdeveloping structures for collaborating

on these issues through the High LevelGroup on Health Services and MedicalCare. The High Level Group has agreedto involve civil society participants inrelevant working groups, and there isclearly a valuable contribution thathealth organisations can make.

The World Alliance for Patient Safety,chaired by Sir Liam Donaldson, ChiefMedical Officer for Britain’s Depart-ment of Health, is also looking at how todevelop collaboration on these issues. InNovember 2005 in London, the UKPresidency organised, in partnership

with the European Commission, a major“Patient Safety Summit.” The EU HealthForum, which groups some 50 Europeanrepresentative NGOs in the health sector,has also created a special working groupon patient safety.

The Commission has launched a net-work for health technology assessmentacross Europe, following the recommen-dations of the High Level Group. TheCommission is also working on health-care-associated infection control in thecontext of the Council Recommendationon the prudent use of antimicrobials.

A new public health strategy forEuropeCurrently, health systems still focus oncombating health threats and providingtreatments. Europe needs to do more toencourage precautionary measures – forexample, tackling tobacco use now so asto reduce the need for lung cancer treat-ment in the future. The Commission haslaunched a massive “Help” anti-smokingcampaign with TV spots across Europe.

The health gap across the EU is widen-ing. Far too much depends on where youlive, what work you do and how muchyou earn. There is also a new tendencyfor health professionals and patients totravel across Europe in order to find abetter situation, better service or ashorter waiting list in another MemberState. The recent enlargement of the EUhas exacerbated such variations.

European citizens need reliable and user-friendly information about what to do tostay in good health. And when they fallill, people want clear information abouttheir condition and treatment options. InApril 2005, the Commission proposed anew health strategy for Europe togetherwith funding plans under the new finan-cial perspectives (2007-2013) and thefurther development of the ECDC. Thatdevelopment would include a newdepartment dedicated to cooperation onhealthcare systems, including patientsafety, and on essential new resources,such as:

• Surveillance and early warning systemagainst infectious diseases

• Centres of excellence and recognisedexpertise shared between MemberStates on key healthcare system issues

• Information campaigns to addresssome of the main health problemsfaced by the EU, such as the resur-gence of HIV/AIDS

• Informational activities for citizens tolearn about healthcare entitlementswhen visiting another Member State

Patient safety was an important topicon the agenda of the annual meeting ofthe European Association of HospitalPharmacists in Paris in June 2005 andwas the theme of its 11th Congress thisyear in Geneva. It is an area whereEuropean collaboration between healthprofessions and patient organisationscan help to achieve important nationalaims. The Commission looks forward toworking together with all interestedpartners and European organisations,including European pharmacists andhospital pharmacists.

For more information, please visiteuropa.eu.int/comm/health/index.html.

This is a revision of a paper originallypublished in EJHP Practice 2005;11(4)65-6.

AuthorFernand Sauer, Honorary DirectorGeneralEuropean Commission12 Avenue de la MarneF-13260 Cassis, [email protected]

“The ECDC provides a structuredapproach for co-operation betweenexperts in the EU, the US and Canada.”

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PATIENT SAFETY

European patients have theright to expect a high stan-dard of safety in their health-care environment. Solid doc-umentation on reported acci-

dents and adverse events in the healthcaresetting make it impossible to ignore thefacts: it is time for Europe to take action toprevent accidents and to enhance patientsafety.

This was the focus of the conference“Patient Safety - Making it Happen!”,which was organised in Luxembourg on4-5 April 2005 under the auspices of theLuxembourg EU Presidency and theEuropean Commission by the StandingCommittee of European Doctors andhealth partners committed to makingpatient safety a priority.

The venerable and still completely relevantHippocratic oath “First do no harm” wasimmediately stressed in the first speech ofthe conference by Luxembourg Minister ofHealth and Social Security, Mars DiBartolomeo, who said that risk manage-ment should be a routine part of hospitalmanagement and that hospitals shouldavoid general acceptance of routine inci-dents. In his well-documented presenta-tion, Dr James Bagian, Director of theUS Veterans Affairs National Centre forPatient Safety, called this the “normali-sation of deviance”. He concluded thatcultural change is needed to ensure theanalysis of errors, action and feedbackthat are key in leading to safety.

Meanwhile, Markos Kyprianou, Euro-pean Commissioner for Health andConsumer Protection, insisted on theneed for European cooperation and dis-cussed the programme of the HighLevel Group on health services andpatient care (see page 13). Dr WimSchellekens, CEO of the Dutch Institutefor Healthcare Improvement, identifiedsteps to be taken at the EU level and atthe national level—as he said, it is allabout mission, vision and strategy—

and insisted on collaboration of allinvolved partners (see page 2).

Professor Angela Coulter, CEO of PickerInstitute Europe, stressed crucial aspectsof communication between patients andhealth professionals, while Dr JesperPoulsen, Vice President of the StandingCommittee of European Doctors andPresident of the board of the DanishMedical Association, presented the“Danish Patient Safety Act” for improve-ment of patient safety in the healthcaresector. This intriguing presentation high-lighted the obligation for health profession-als to report adverse events. According toDr Poulsen, reports under the act are madeunder confidentiality, do not lead to disci-plinary measures (“no blame policy”) andresult in prophylactic action. It is worthmentioning that in its first year, 50% ofreports were related to medication errors.

As we heard from Dr Michel, representa-tive of the World Health Organization’sWorld Alliance for Patient Safety andMedical Director of the FrenchCCECQA, a coordination unit for clinicalevaluation, risk management and qualityimprovement, France has alreadydeveloped an integrated risk managementsystem for healthcare products and someat-risk activities. We also heard from himthe six action areas targeted by the WorldAlliance programme.

Dr Adamos Adamou, a Medical Oncologistfrom Cyprus and member of the EuropeanParliament, gave his view on patient safety,stressing that illness should be an accidentnot an expected part of our lives, while SirLiam Donaldson, Chairman of the WHOWorld Alliance for Patient Safety andChief Medical Officer for England, led avivid presentation on “Tackling the patientsafety agenda in Europe” with poignantexamples of what errors in the fieldof health care can lead to. ProfessorDonaldson has also been appointed to leadthe special project on patient safety of theHigh Level Group of EU Health Directors,

which provides an appropriate platform toaddress hospital pharmacists’ concernsregarding patient safety.

Parallel sessions held on the conference’ssecond day offered practical examples ofpossible risks: from an increase of errordue to fatigue and stress to misrepresenta-tive communication with immigrants tothe lack of EU regulations for expressingthe concentration of injectable drugs to toosimilar drug packaging. All participantsagreed that error reporting should bemade with a “non-naming non-blamingnon-shaming” attitude and under confi-dentiality.

At the end of the conference, participantssupported the “Luxembourg Declarationon Patient Safety”, which is reproducedhere on page 20.

Despite no system ever being able to com-pletely remove all risk of possible harm topatients, it is of prime importance to esta-blish a culture of openness and trust in theEuropean healthcare sector in which it isexpected—indeed an obligation—forhealthcare providers to participate inlearning from adverse events. This is theright way for all health professionals totake the first steps toward a new road toimproved patient safety.

We as hospital pharmacists have to takeup the challenge that is expected from us:to create a medical environment in thehospital that minimises risk and maximi-ses the benefit for the patient. The EAHPwishes to play an active role in promotingthis goal. We will keep you posted!

Note: Please visit www.cpme.be for moreinformation regarding this challengingconference.

AuthorJacqueline Surugue, President of theEuropean Association of [email protected]

Patient safety - Making it Happen

Jacqueline Surugue, EAHP President

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

www.ejhp.org 17


Although error is inherentin all human activity,it is possible to learnfrom mistakes and toprevent their reoccur-

rence. Healthcare providers and organi-sations that have achieved a high levelof safety have the capacity to acknowl-edge errors and learn from them. Themethodology for the development andimplementation of patient-safety policiescrosses national boundaries; as theirevaluation requires substantial resourcesand expertise it should be shared.

Patient safety is the philosophy under-pinning quality improvement and allpossible measures should therefore betaken to organise and promote patient-safety education and quality of health-care education. There is also a need topromote open co-ordination of nationaland international regulations concerningresearch on patient safety.

Appendix to RecommendationR(2006)7The appendix to the recommendationsets out a number of factors, attention towhich will assist in the smooth runningof healthcare systems. As a prerequisiteto developing patient-safety strategies,governments should take a proactive,preventive and systematic attitude:admit that errors happen, identify andmanage risk points in processes. Themulti-factorial requirements if we are toachieve safety (sufficient levels ofresources, financing, staff, connectionsbetween processes, information sys-tems, documentation, communication,etc.) are clearly set out.

A system-based approach presupposesthe systematic design of safe structures,procedures and processes, together withcorrective reactions in response to safetyincidents. It should be accepted thaterrors are a consequence of normalhuman fallibility and/or deficiencies ofthe system; these could be prevented byimproving the conditions in whichhumans work. The aim is a systemdesigned with built-in defences.

The best way of supporting patientsafety within a healthcare system is todevelop a safety culture. A safety cul-ture is one in which everyone is activelyaware of her/his role and contribution tothe organisation, and of the potential forthings to go wrong. It is an open and fairculture, where people are able to learnabout what is going wrong and then putthings right. Developing a safety culturein an organisation needs strong leader-ship and careful planning and monitor-ing. It also requires changes and com-mitment to safety at all levels of thesystem, from government to clinicalteams and supporting staff. Commit-ment to safety should be backed up bypolicies and the allocation of resources.

Effective risk management requiresunderstanding of human behaviour,human error, and the conditions likely tocause such error. It must be acceptedthat under specific circumstances andfor various reasons individuals canmake errors and that processes andequipment will sometimes fail. A sys-tems-based approach moves the investi-gator away from focusing blame onindividuals and looks at what was

wrong with the system in which theindividuals were working. The systemshould be consistent with already esta-blished quality-management systems.Quality and risk management should beled by the highest level of the organisa-tion and translated into shared values,norms and behaviour at all levels. TheCouncil makes several recommendationsabout aspects of good communication.

There is a need to assess patient safetyon an ongoing basis. Prior to embarkingon actual patient-safety assessment acti-vities, a systematic strategy should beestablished at an institutional or regionallevel to measure and report, using infor-mation about the most common servicesassociated with a high probability oferror. A qualitative approach to patient-safety indicators maps the activities thatexist in the routine delivery of services.A quantitative approach uses indicatorsand epidemiological methods to system-atically quantify distinct aspects ofprocesses.

The Organisation for Economic Co-operation and Development report onpatient-safety indicators is recommend-ed (OECD health technical paperDELSA/ELSA/WD/HTP (2004) 18,www.oecd.org/els/health/ technical-papers). It selects a total of 21 patient-safety indicators which address hospitalpatient-safety incidents and include onlymeasures that focus on specific clinicaloutcomes.

The primary objective of an incidentreporting system is the enhancement ofpatient safety, by learning from adverse

Recommendation of the Council of Europeto Member States on patient safety Acknowledging that access to safe health care is a basic right, the Committee of Ministersof the Council of Europe [1] adopted recommendation R(2006)7 in May 2006. Welcomingthis, the EJHP presents the recommendation and the main opinions held by the Council.

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events and mistakes made. Reportingand collection of incident data is mean-ingful only if the data is analysed andevaluated and if feedback is given to theprofessionals involved in the incident,and to all others who could learn fromthe incident.

Incidents may be reported by health pro-fessionals, patients and relatives, or byother informal caregivers and suppliers.

An incident reporting system should bevoluntary; confidential (however, if theevent is to be analysed in order to learnfrom it, the names of the personnelinvolved may need to be known insidethe actual institution); anonymous, atleast at regional and national levels;be non-punitive with regard to thosewho report, but provide no immunitybecause of the consequences to thepatient.

The reports should also be objective andincentives should possibly be given toencourage reporting (for example,express recognition). The reportingsystem should be independent ofregulatory or accrediting processes. Acommon format should be used toreport all incidents.

Use of data: reporting and collection ofpatient-safety data is meaningful only if

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 learningfrom 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 specificallyallocated;

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 safetyproblems, 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 ofhealthcare 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 followthe methods suggested so that the key elements can be put into everyday practice.

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the data is intelligently analysed andinformation is, where appropriate, fedback to healthcare professionals, mana-gers and patients. There needs to be aclear understanding and agreement withhealthcare institutions and professionalson how the data collected will be put touse.

Effective data collection depends on thewillingness of frontline clinical staff.Several barriers to reporting exist, whichshould be removed through appropriatepolicies: fear of blame, resulting from alack of open and fair culture; fear of thereports being used out of context by themedia and others; lack of feedback as towhat has changed as a result of thereport; lack of time to report; lack ofsupport from the management.

Patient-safety incident reporting sys-tems can be established as “stand-alone” systems or can be integratedwith other systems for recording com-plaints and compensation claims orapplications for benefits (the sources ofinformation will differ for each coun-try). Each organisation should developsystems to analyse this information andto learn from it. Complaints, criticismand suggestions may contribute topatient safety and should be takenseriously and handled appropriately.Clear procedures should be implement-ed for recording and analysing com-plaints, which should be handled in afair, transparent, flexible and concilia-tory manner, whether they come frompatients or their representatives.

Medication safety is a specificstrategy to promote patient safety.Medication errors are the mostcommon single preventable cause ofadverse events and European healthauthorities should consider them as animportant public health issue.Medication safety comprises bothadverse drug reactions and medicationerrors. A clear distinction has to bemade between them. The WHO links

adverse drug reactions (pharmacovigi-lance) to product safety, whereasmedication errors are linked to thesafety of healthcare services.

A medication error is defined as follows:“Any preventable event that may causeor lead to inappropriate medication use orpatient harm while the medication is inthe control of the health care profession-al, patient, or consumer. Such eventsmay be related to professional practice,healthcare products, procedures, andsystems, including prescribing; ordercommunication; product labelling, pack-aging, and nomenclature; compound-ing; dispensing; distribution; administra-tion; education; monitoring; and use.”

The following key dimensions in theprovision of care should be taken intoaccount in order to prevent medicationerrors:• the organisation and structures used

within health care that govern the pre-scription, dispensing, administration,and monitoring of medication use;

• a patient-safety culture in health carethat promotes the understanding ofactivities that may have a high risk ofundesirable outcomes with the use ofmedication, in the overall care process;

• the use of indicators that can establisha baseline for the actual incidence ofundesirable events;

• a level of understanding among staff ofthe necessary and ongoing observa-tions that need to be made to preventor minimise the likelihood of errors inmedication use.

Improvements in the system of medica-tion use require continuing, specificstrategies to promote patient safety atevery stage of the medication process.

Human factors in error and patientempowerment are discussed. Forexample, health professionals should begiven the opportunity to learn how tohandle guilt and be supported to avoidbecoming “the second victim” of the

safety incident. Education and trainingcurricula for all health professionsshould include basic knowledge of theprinciples of clinical decision making;risk awareness; risk communication;risk prevention; individual and collec-tive attitudes and behaviour in the caseof adverse events (medical, legal, finan-cial and ethical aspects).

Patients using health services must haveadequate information available, allow-ing them to include safety considera-tions when making decisions. Thisinformation should allow patients tounderstand and balance the risks andbenefits of different treatment options,in which they are considered a partner.Patients must feel able to speak up whenthey feel that something could go, or hasgone, wrong during the course of theirtreatment.

The report concludes that the successfulimplementation of a patient-safetypolicy requires concerted action by allstakeholders and makes further usefulsuggestions, including patient safetyeducation programmes, research andcountry-specific legislation. The safetyof medication and interventions is theessential feature of healthcare provisionand its cost should be included in thegeneral budget.

AuthorJudith Martin, MRPharmSEJHP Editor

References1. The Council of Europe is an organisation compris-

ing 46 democratic European countries. It was set upto promote democracy and protect human rightsand the rule of law in Europe The Committee ofMinisters, the Council's decision-making body,comprises the Foreign Affairs Ministers of all theMember States, or their permanent diplomaticrepresentatives in Strasbourg. It is a forum wherenational approaches to problems facing Europeansociety can be discussed on an equal footing, andwhere Europe-wide responses to such challengesare formulated. www.coe.int

2. wcd.coe.int/ViewDoc.jsp?id=1005439&

Background:The health sector is a high-risk areabecause adverse events, arising fromtreatment rather than disease, can lead todeath, serious damage, complicationsand patient suffering. Although manyhospitals and healthcare settings haveprocedures in place to ensure patientsafety, the healthcare sector still lagsbehind other industries and services thathave introduced systematic safety pro-cesses.

A number of investigations from all overthe world have underlined the need forand the possibility of reducing thenumber of adverse events in the healthsector. Current data show that almost halfof all preventable adverse events are aconsequence of medication errors.

Accordingly, tools must be introducedaimed at reducing the number and conse-quences of adverse events. The healthsector should be designed in a way thaterrors and adverse events are prevented,detected or contained so that seriouserrors are avoided and compliance withsafety procedures is enhanced.

As a result of the work done in this fieldby many players and institutions and theevidence gathered, it is now clear that thefirst step that needs to be taken should beto establish a culture of patient safetythroughout the entire health system. Riskmanagement must be introduced as aroutine instrument within the running ofthe entire health sector. A preconditionfor risk management is an open and trust-ing working environment with a culturethat focuses on learning from near missesand adverse events as opposed to concen-trating on “blame and shame” and subse-quent punishment.

Health sector induced harm to patientsimposes a heavy burden on society.Investment in patient safety therefore hasthe potential to generate savings inexpenditure coupled with an obviousbenefit to patients.

Focus on patient safety leads to savingsin treating patients exposed to adverseevents and the consequential improveduse of financial resources. In addition,savings are achieved in administration

costs associated with complaints andapplications for compensation. Mostimportantly, patient safety contributes toan increase in quality of life. In order toachieve this, the culture of safety can beimproved significantly in various ways.In light of the above, the conferencerecommends that “Patient Safety” has asignificant place high on the politicalagenda of the EU, nationally in the EUMember States and locally in the health-care sector.

The conference recommends to theEU Institutions:• To establish an EU forum with partici-

pation by relevant stakeholders to dis-cuss European and national activitiesregarding patient safety.

• To work in alliance with WHO Alliancetowards a common understanding onpatient safety issues and to establishan “EU solution bank” with “bestpractice” examples and standards.

• To create the possibility of supportmechanisms for national initiativesregarding patient safety projects, ack-nowledging that patient safety is in theprogramme of DG Health andConsumer Protection

• To ensure that EU regulations withregard to medical goods and relatedservices are designed with patientsafety in mind.

• To encourage the development of inter-national standards for the safety andperformance of medical technology.

• To ensure that the European regulatoryframework protects the privacy andconfidentiality of patient records in thebest interests of the patient, while at thesame time ensuring that relevant patientinformation is readily available tohealthcare professionals.

The conference recommends to theNational Authorities:• To provide patients with full and free

access to their personal health informa-tion whilst ensuring data accuracy andthat patients fully understand their treat-ments. It is acknowledged that “inform-ed patients” are well positioned to safe-guard their own health.

• To consider the benefits of a nationalvoluntary confidential reporting sys-tems of adverse events and near misses.

• To work towards the introduction of

risk management routines—for exam-ple, by developing guidelines and indi-cators as a part of a quality assessmentsystem in the healthcare sector.

• To optimise the use of new techno-logies—for example, by introducingelectronic patient records. Such recordswould include the personal medicalprofile and decision-making supportprogrammes for health professionalswith a view to reducing medicationerrors and increasing compliance rates.

• To establish national fora, with partici-pation by relevant stakeholders, todiscuss patient safety and nationalactivities.

• To safeguard working conditions for allhealthcare professions and to ensurethat policies on recruitment and reten-tion are linked to patient safety.

• To recognise and support the user train-ing provided by medical devices, toolsand appliance manufacturers, therebyensuring the safe use of new medicaltechnology and surgical techniques.

• To include patient safety in the standardtraining of health professionals combin-ed with integrated methods and proce-dures that are embedded in a culture ofcontinuous learning and improvement.

• To ensure that national regulatoryframework protects the privacy andconfidentiality of patient records in thebest interests of the patient, while at thesame time ensuring that relevant patientinformation is readily available tohealthcare professionals.

• To create a culture that focuses onlearning from near misses and adverseevents as opposed to concentrating on“blame and shame” and subsequentpunishment.

The conference recommends tohealthcare providers:• To facilitate a collaborative care

approach between health professionalsand healthcare providers aimed atenhancing patient safety.

• To implement workplace projectsfocusing on patient safety and toestablish an open culture to deal witherrors and omissions more effectively.

• To initiate a co-operation betweenpatients/relatives and healthcare pro-fessionals in order to inform patients/relatives of near misses and adverseevents.

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 andthe citizens of Europe. Accordingly, patients have a right to expect that every effort is made to ensure their safety as usersof all health services. EAHP is one of the signatories of this Declaration.

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editorial patient safety the hospital pharmacist

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