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IRISH PHARMACY JOURNAL FEBRUARY 2007 68

A Collaborative Study ofMedication Safety inFour Irish hospitals

Abstract

Many Irish hospitals havemedication safety initiatives inoperation. The aims of these

initiatives include collectingincident/near miss reports and usingwhat is learned from incidents/nearmisses to improve systems to promotemedication safety. There has been nonational co-ordination of theseinitiatives. Thus, data collection, analysisand system improvements to avoidrepetition of incidents is carried out invarious ways in various hospitals andlearning from incidents has beenconfined to the individual hospital inwhich they occur. A medication safetysoftware package, Analyze-ERR®, wasobtained from the Institute of SafeMedication Practices, Canada (ISMPCanada). Four Irish hospitals used thissoftware to record and analyse theirmedication safety data for a threemonth period. Aggregate analysis ofthe data was then performed and issummarised in this paper.

IntroductionMany Irish hospitals have medication

safety initiatives in operation. The aims ofthese initiatives include collectingincident/near miss reports and using whatis learned from incidents/near misses toimprove systems to promote medicationsafety. To date, there has been nostandardised approach to data collection

or data analysis. Aggregate data onmedication safety in Ireland has not beenpublished.

Collecting and pooling patient safetyinformation on a national basis is acommon and accepted practice. Examplesinclude the Medication Error ReportingProgram (MERP) in the USA (run by theUnited States Pharmacopoeia inassociation with the Institute for SafeMedication Practices (ISMP)), the NationalReporting and Learning System (NRLS) runby the National Patient Safety Agency(NPSA) in the United Kingdom and theCanadian Medication Incident Reportingand Prevention System (CMIRPS)(developed by ISMP Canada, the CanadianInstitute for Health Information (CIHI) andHealth Canada).

Ireland established enterprise liabilityunder a Clinical Indemnity Scheme (CIS) in2002 to promote safe patient care, reducethe number of claims and to manageclaims in a timely fashion.1 All enterprisescovered by the CIS are required to reportall adverse clinical events and near misseson a mandatory basis via a secure web-based Clinical Incident Reporting System,STARSWeb. Medication errors are onecategory of incidents and near misses thatmay be reported via STARSWeb. Other riskmanagement incidents/near misses mayalso be reported, e.g. surgical incidentsand infection control incidents. STARSWebis not currently configured in a format thatwould have facilitated collectingmedication safety data and pooling it foranalysis in this pilot study.

A medication safety software package,

Analyze-ERR®, was obtained, free ofcharge, from the Institute of SafeMedication Practices, Canada (ISMPCanada) to facilitate a pilot project tocollect and analyse medication safetyinformation in a standardised way in fourhospitals in Ireland.

ISMP Canada is an independentCanadian non-profit agency establishedfor the collection and analysis ofmedication error reports and thedevelopment of recommendations for theenhancement of patient safety. Analyze-ERR® is a software documentation tooldesigned and developed by ISMP Canadafor use in institutions to track and analysemedication errors. In Canada, this isfollowed by a mechanism where userssubmit data to ISMP Canada, where dataare pooled to provide aggregateinformation on medication errors, e.g.event types, contributory causes. ISMPCanada can then use this data to share thelearnings from errors and near misses,including recommendations for preventionof errors, with the healthcare communityin Canada.

AimsThe aims of the study were to:

• use the Analyze-ERR® software tofacilitate standardised medication safetydata collection and analysis, and

• determine whether this softwarefacilitates pooling of information forgreater learning.

Kirke C., M.Sc. (Clin. Pharm.), MPSIi

Tighe, P., MBA, M.Sc. (Clin. Pharm.) MPSIii

Colohan, G., M.Sc. (Clin. Pharm.), MPSIiii

Harnett, B., M.Sc. (Clin. Pharm.), MPSIiv

Creaton, G., B.Sc. (Pharm.), MPSIiii

Delaney, T., B.Sc. (Pharm.), FPSIi

research (peer reviewed)

i Adelaide and Meath Hospital incorporating theNational Children’s Hospital, Tallaght, Dublin 24ii Mater Private Hospital, Eccles Street, Dublin 7iii Portiuncula Hospital, Ballinasloe, Co Galwayiv St. John’s Hospital, St. John’s Square, Limerick

IPJ February 2007 workfile 1/2/07 12/02/2007 13:00 Page 68


MethodsAnalyze-ERR® was installed in each of the

four hospitals and used to enter andmanage medication safety incident/nearmiss reports collected from January toMarch 2006. The hospitals involved in thestudy were:

• Adelaide & Meath Hospital, Dublinincorporating the National Children’sHospital (AMNCH) – a public voluntaryteaching hospital with six hundred beds

• Mater Private Hospital, Dublin – a privatehospital with two hundred and two beds

• Portiuncula Hospital, Galway – a publicgeneral hospital with two hundred and ten beds

• St. John’s Hospital, Limerick – a publicvoluntary general hospital with one hundred andthree beds

Reports included medication errors,adverse drug reactions and hazardousconditions relating to medication. The datawas then sent to the project coordinator forpooling and analysis.

The severity of incidents/near misses wascategorised using the NationalCoordinating Council for Medication ErrorReporting and Prevention (NCC MERP)criteria2 as used on the Analyze-ERR®

software (see Fig. 1). In addition to reportsregarding medication error, each of thehospitals received reports about adversedrug reactions (ADRs) which did not involvemedication error. These reports were alsoclassified into the most pertinent NCC MERPcategory, i.e. if the ADR resulted intemporary patient harm requiringintervention, it was classified as NCC MERPcategory E. NCC MERP categories A-B(coloured green in Fig. 1) did not reach thepatient, C and D (coloured amber or yellow)reached the patient but did not result inpatient harm and categories E-I (colouredred) resulted in increasing levels of patientharm. Harm is defined by NCC MERP as‘Impairment of the physical, emotional orpsychological function or structure of thebody and/or pain resulting therefrom’ andcorresponds to NCC MERP categories E-I(see Fig. 1).

ResultsFive-hundred and ten (510) medication

safety incidents/near misses were recorded(mean 128 reports per hospital; range 14-230). Ninety-three percent of theaggregated incident/near miss reports didnot result in patient harm (NCC MERP A-D);7% or 35 incidents resulted in patient harm

(NCC MERP E-I) (Fig. 1).Over 90 drugs were implicated in

incident/near miss reports. Enoxaparin,diclofenac, morphine, aspirin and fentanylresulted in the largest proportion of reportsoverall. The most frequent drug implicatedin reports was enoxaparin, involved in 17reports (3.3% of the total) (Fig. 2).

The drugs involved in the largestproportion of incidents resulting in patientharm (NCC MERP E-I) were enoxaparin(four reports), paclitaxel (three reports) andamiodarone (three reports) (Fig. 3). Thirty-three (33) drugs were implicated in incidentreports resulting in patient harm. Drugsinvolved in incidents resulting in patientharm were classified by British NationalFormulary3 categories. The most frequentlyoccurring categories were cardiovascular,malignancy and immunosuppression andanti-infectives. Together, these threecategories were responsible for over 55%of incidents resulting in patient harm (Fig.4).

The stage(s) in the medication useprocess at which the incident occurred wasrecorded. An incident/near miss couldinvolve more than one stage, e.g. if apatient was prescribed a drug to which

study of medication safety

Severity of aggregate incident/near missreports by NCC-MERP category

FIGURE 1

100

90

80

70

60

50

40

30

20

10

0A B C D E F G H I

NCC-MERP Category

*NCCMERP Categories A Circumstances or events that have the capacity to cause a medication error.B A medication error drug event occurred but did not reach the patient. C A medication error occurred that reached the patient but did not cause patient harm.D A medication error occurred that reached the patient and required monitoring to confirm that it resulted in no harm to

the patient and/or required intervention to preclude harm.E A medication error occurred that may have contributed to or resulted in temporary patient harm and required

intervention.F A medication error occurred that may have contributed to or resulted in temporary patient harm and required initial or

prolonged hospitalization.G A medication error occurred that may have contributed to or resulted in permanent patient harm.H A medication error occurred that required intervention necessary to sustain life.I A medication error occurred that may have contributed to or resulted in the patient’s death.

From: US National Co-ordinating Council for Medication Error Reporting and Prevention (NCCMERP) and United StatesPharmacopoeia (USP), June 2001

Drugs involved in aggregateincident/near miss reports

FIGURE 2

Drug No. of % of(generic) reports reports

Enoxaparin 17 3.3

Diclofenac 14 2.7

Morphine 14 2.7

Aspirin 13 2.5

Fentanyl 12 2.4

Digoxin 9 1.8

Warfarin 9 1.8

Co-amoxiclav 8 1.6

Insulin 8 1.6

Omeprazole 8 1.6

Drugs involved in aggregateincident reports resulting inpatient harm (NCC MERP E-I)

FIGURE 3

No. of % ofDrug reports reports

Enoxaparin 4 8.5

Paclitaxel 3 6.4

Amiodarone 3 6.4

Insulin 2 4.3

Moxifloxacin 2 4.3

Zoledronic acid 2 4.3

Aspirin 2 4.3

Clopidogrel 2 4.3

Tetracaine 2 4.3


they had a documented allergy and thedrug was subsequently administered, theincident/near miss would be entered asboth a prescribing and an administrationerror. Prescribing was responsible for nearly50% of overall incident/near miss reports(Fig. 5), with administration responsible fornearly 30% and dispensing for

approximately 10%. The stage(s) involvedin incidents resulting in patient harm (NCCMERP E-I) were mainly administration(49%) and prescribing (22%), with 3% dueto dispensing (Fig. 6). Sixteen percent ofincidents resulting in patient harm were inthe ‘not applicable’ category. These weremainly adverse drug reactions where astage in the medication use process couldnot be identified as being involved in thegenesis of the incident.

The type of incident/near miss wasrecorded. The ‘other’ category was themost frequent type of incident/near missreported, accounting for 29% of reportsoverall (Fig. 7) and 44% of incidentsresulting in patient harm (NCC MERP E-I)(Fig. 8). A large proportion of this was dueto adverse drug reactions and infusion-related reactions, which could not becaptured appropriately using the Analyze-ERR® categories. Wrong dose, wrongfrequency/rate and dose/drug omissionwere the next most frequent types (Fig. 7).The monitoring category includes patientsbeing prescribed or administered drugsthey had a documented allergy to, drug-drug interactions, contra-indications andclinical monitoring issues.

Of those incidents resulting in patientharm (NCC MERP E-I), the ‘other’ categoryaccounted for 44% of reports, monitoringfor over 22%, and dose/drug omission for14% (Fig. 8).

DiscussionStandardising data collection and

classification by using the Analyze-ERR®

database in each of the four hospitalsfacilitated the first pooled analysis ofmedication safety incident/near miss datain Ireland.

The data collected show a number ofinteresting factors worthy of further studyor attention. The severity of incidents/nearmisses reported were categorised as 93%not reaching the patient, or reaching thepatient but resulting in no harm, with 7%resulting in patient harm. There were twocases of possible permanent patient harmdue to an adverse drug reaction and theother harmful incidents involved temporaryharm, from which the patients recovered.

Of the 7% of reports involving patientharm, a large proportion were reports ofadverse drug reactions and infusion-relatedincidents, i.e. they did not involvemedication error. Although the Analyze-ERR® database has been developed for theanalysis of medication errors and uses theNCC MERP system for classifyingmedication errors, each of our pilot sitesreceived reports regarding medicationerrors and adverse drug reactions. This ledto difficulty in classifying certain incidents(type of incident, stage(s) involved),resulting in use of the ‘other’ category fortype of incident and the ‘not applicable’category for stage(s) involved.

There was a wide distribution of drugsand type of drugs involved in reports. Whilesome drugs such as enoxaparin, diclofenacand aspirin emerged more frequently, theyare also used widely in the participatinghospitals. The data was not analysed in anygreater detail to identify trends in incidentreports.

The stage(s) involved in the medicationsafety incident or near miss provided someinteresting information. Althoughprescribing accounted for nearly 50% ofoverall reports, it accounted for just over20% of incidents resulting in patient harm.Conversely, administration was responsiblefor less than 30% of overall reports butnearly 50% of incidents resulting in patient



British National Formulary2

categories of drugs involved inaggregate incident reports resulting

in patient harm (NCC MERP E-I)

FIGURE 4

BNF No. of % ofCategory Reports of Reports

Cardiovascular 10 21.3

Malignancy, immuno-suppression 9 19.1

Anti-infectives 7 14.9

Endocrine 5 10.6

Anticoagulants 5 10.6

CNS 3 6.4

Anaesthesia 3 6.4

Nutrition and blood 2 4.3

Musculoskeletal and joint 2 4.3

Diagnostics 1 2.1

Aggregate incident/near missreports by stage(s) involved

(n=510)

FIGURE 5

Prescribing

Percentage of Reports

0 10 20 30 40 50 60

Ordering

Dispensing/Delivery

Administration

Monitoring

N/A

Aggregate incident reports resultingin patient harm (NCC MERP E-I) by

stage(s) involved (n=35)

FIGURE 6

Prescribing

Percentage of Reports

0 10 20 30 40 50 60

Ordering

Dispensing

Administration

Monitoring

N/A

Type of incident/near miss in aggregate reports (n=510)

FIGURE 7

0

5

10

15

20

25

Type of Incident/Near Miss

Monitoring

Other

Omission DrugFrequency/Rate

Strength Form

Dose

Route

30

35

Perc

enta

geof

Repo

rts

Expired Drug Patient

Technique Time Duration


harm. Dispensing accounted for 10% ofthe overall figure but just 3% of incidentsresulting in patient harm. The way thatmedication safety incident/near miss data iscollected in a hospital can influence thesefigures significantly. Pharmacy staff arelikely to report primarily dispensing andprescribing errors, whereas nursing staff aremore likely to report administration errors.In our pilot group, approximately 65% ofreports overall were submitted bypharmacy staff and 35% by nursing staff.

The most frequent types of incidentreported were wrong dose, wrongfrequency/rate and dose omission. Wrongdose could involve error at the prescribing,ordering, dispensing or administrationstages. Wrong frequency/rate and doseomission could involve prescribing oradministration. However, it is interesting tonote that of those incidents resulting inpatient harm, the ‘monitoring’ categoryaccounted for over 20% of incidents. Manyof these incidents involved allergicreactions, i.e. a medication that the patientwas allergic to was prescribed andadministered, resulting in an allergicreaction to the patient. In addition, thiscategory included situations where patientfactors were not taken into considerationwhen prescribing and/or administeringdrugs, e.g. there was a contra-indication orcaution to the use of the drug in thatpatient or a drug-drug interaction.

The pilot was conducted over a very shorttime period and with limited resources.Comparison of the pilot data withpublished data from other countries wasnot carried out at this stage. It is clear thatfurther collection and analysis of Irishmedication safety information would beuseful to identify trends and issuesrequiring attention.

Following the pilot project, feedback hasbeen given to ISMP Canada. Overall, the

pilot group found Analyze-ERR® veryhelpful for collecting and analysing theirmedication safety data and will continue touse it for this purpose. The pilot group werepleased to be able to share medicationsafety information with their colleagues. Anumber of issues were raised which ISMPCanada feel could be addressed should thepilot lead to a more permanent solution forIreland. These include the need to adaptthe database to the Irish medication usesystem and to incorporate information onadverse drug reactions.

For Analyze-ERR® to function optimally inthe Irish setting, a central Irish Analyze-ERR® database is needed. This means thateach institution would send theiranonymised data to the central database,thus compiling Irish data. The individualhospitals could then compare their data tothe overall Irish data. The value of suchcomparisons would include reassurancelocally that the data collected is ‘normal’ orvalid data. In addition, it could be used toidentify when local data is out of line withgeneral trends, e.g. if data is being enteredunder different categories by differentparticipants, whether the professionsreporting lead to more of particular types ofreports, whether the participatingorganisation is identifying a high or lowproportion of incidents resulting in harm(and that if the number is very low, whethersome important information is beingmissed by the reporting system). In additionto the advantages to individual hospitals,having reliable, internationally comparablestatistics on medication safety events wouldbe of great value to the Irish health system.

The pilot group has presented to theState Claims Agency, which operates theClinical Indemnity Scheme (CIS). Currently,medication safety incidents/near missesneed to be entered by organisationsindemnified by the CIS to STARSWeb in

addition to Analyze-ERR®. The CIS isinvestigating ways of improving the qualityof medication safety information availableto them and is liaising with the pilot groupto facilitate this.

ConclusionUsing a standardised, medication safety-

specific database to record medicationsafety incident/near miss data facilitatedaggregate analysis. Standardising themedication safety data collected byhospitals and having an appropriatelyresourced facility to house a centraldatabase would facilitate analysis ofmedication safety data for Ireland andcomparison with international information.

AcknowledgementsThe pilot group would like to

acknowledge David U, Robert Lam andcolleagues in ISMP Canada for providing uswith the Analzye-ERR® software and usersupport.

References ~1 Clinical Indemnity Scheme Newsletter, Nov 2006.

Available from http://www.stateclaims.ie (lastaccessed on 18/12/06)

2 National Coordinating Council for MedicationError Reporting and Prevention (NCC MERP)criteria. Available from http://www.nccmerp.org(last accessed 18/12/2006)

3 British National Formulary, 51st Edition, March2006, British Medical Association, RoyalPharmaceutical Society of Great Britain

Type of incident in aggregate reports resulting inpatient harm (NCC MERP E-I) (n=35)

FIGURE 8

0

10

20

Type of Incident

Omission Frequency/Rate Dose

Strength/Concentration

Monitoring

30

40

Perc

enta

geof

Repo

rts

Drug

Other

50




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