Post on 16-Nov-2014
MEDICATION SAFETY MEDICATION SAFETY UNITUNIT
Pharmacy Practice and Pharmacy Practice and DevelopmentDevelopment Division Division
Ministry of Health MalaysiaMinistry of Health Malaysia
Unit formed in 2007Unit formed in 2007 PersonnelPersonnel
1 pharmacist U48 (2007)1 pharmacist U48 (2007)
1 pharmacist U41 1 pharmacist U41
(April 2008)(April 2008)
OBJECTIVESOBJECTIVES
To establish a medication error To establish a medication error reporting systemreporting system
To create a medication error To create a medication error databasedatabase
To promote medication safety To promote medication safety awareness awareness
To provide training programmes on To provide training programmes on medication safetymedication safety
SECRETARIATSECRETARIAT
Medication Safety Committee, Medication Safety Committee, Pharmaceutical Services DivisionPharmaceutical Services Division
Medication Safety Technical Medication Safety Technical Advisory Committee (MedSTAC)Advisory Committee (MedSTAC)
Pharmacovigilance on Safety of Pharmacovigilance on Safety of Vaccines Vaccines
Medication Medication Error Error
Reporting Reporting SystemSystem
Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in control of the healthcare professional, patient or consumer
NCCMERP, US
MEDICATION ERROR . . .
Maybe related to professional practice, healthcare products, procedures and systems including:
prescribing, order communication, product labeling, packaging, compounding, dispensing, distribution, administration, monitoring and use
Medication errors can be committed (or contributed to) by
Anyone who handles medicine
Physicians/doctors, dentists, pharmacists, other healthcare providers, patients, caregivers etc
Human ErrorHuman Error
Error is inevitable because of human Error is inevitable because of human limitationslimitations
- Limited memory capacityLimited memory capacity- Limited mental processing capacityLimited mental processing capacity- Negative effects of fatigue and other Negative effects of fatigue and other
physiological stressorsphysiological stressors
Traditionally, culture is individual responsibility and blame
Typical response in a punitive environment:
-Attention focused on least manageable ( the person)
-Pressure to cover up mistakes
-Increasing likelihood of error to recur
Look at systems involved in Look at systems involved in medication error medication error
Why? Why?
and not Who?and not Who?
Why report?Why report?Enable the healthcare providers & Enable the healthcare providers &
institutions to learn aboutinstitutions to learn about
• potential risks Risks hidden in the processes used
• actual errors Errors that occur during patient care
• causes of errors Underlying weaknesses in systems & processes that explain why errors happened
• prevention Ways of preventing recurrent events
What to report?What to report?
Risks that can lead to errors or near Risks that can lead to errors or near missesmisses
Sound-alike names or look alike Sound-alike names or look alike packagespackages
Ambigous product labelsAmbigous product labels Use of error prone abbreviationsUse of error prone abbreviations Error-prone functions in cpoe Error-prone functions in cpoe
systemssystems
Pharmacy interventions/ errors detected Pharmacy interventions/ errors detected by prescribers, nurses or patients inby prescribers, nurses or patients in
Prescribing errorsPrescribing errors
Dispensing errorsDispensing errors
Administration errorsAdministration errors
What not to reportWhat not to report
Administrative errorsAdministrative errors Examples:Examples:
• no prescribers stampno prescribers stamp• no countersignature for category no countersignature for category
A medicines A medicines • Medicines not stocked/ nil in stockMedicines not stocked/ nil in stock
• Other units using certain drugs eg. Other units using certain drugs eg. MO A&E using Tramal which is for MO A&E using Tramal which is for specialist clinicspecialist clinic
Types of Medication ErrorsTypes of Medication Errors
Prescribing Prescribing errorerror
Incorrect drug product Incorrect drug product selection (based on selection (based on indications, CI,known indications, CI,known allergies, existing drug allergies, existing drug therapy), dose,dosage therapy), dose,dosage form, quantity, route or form, quantity, route or rate of administration, rate of administration, conc, or instructions for conc, or instructions for use authorised by use authorised by physician; illegible Rx or physician; illegible Rx or med orders that lead to med orders that lead to errorserrors
Omission Omission errorerror
The failure to administer The failure to administer an ordered dose to a an ordered dose to a patient before the next patient before the next ordered dose or failure to ordered dose or failure to prescribe a drug product prescribe a drug product that is indicated.that is indicated.
The failure to administer The failure to administer an ordered dose excludes an ordered dose excludes patient’s refusal and patient’s refusal and clinical decision or other clinical decision or other valid reason not to valid reason not to administer.administer.
Wrong time Wrong time errorerror
Unauthorised/ Unauthorised/ wrong drug wrong drug errorerror
Administration of Administration of medication outside a medication outside a predefined time interval predefined time interval from its scheduled from its scheduled administration timeadministration time
Dispensing or Dispensing or administration to the administration to the patient of medication not patient of medication not authorised by a legitimate authorised by a legitimate prescriberprescriber
Dose errorDose error Dispensing or Dispensing or administration to pt of a administration to pt of a dose that is > or< than dose that is > or< than amount ordered by amount ordered by prescriber or administration prescriber or administration of multiple doses to ptof multiple doses to pt
Dosage form Dosage form errorerror
Dispensing or Dispensing or administration to pt of a administration to pt of a drug product in diff dosage drug product in diff dosage form than that ordered by form than that ordered by prescriber prescriber
Drug Drug preparation preparation errorerror
Drug product incorrectly Drug product incorrectly formulated or manipulated formulated or manipulated before dispensing or before dispensing or administrationadministration
Route of Route of administration administration error error
Wrong route of Wrong route of administration of the administration of the correct drugcorrect drug
Administration Administration technique technique errorerror
Inappropriate procedure or Inappropriate procedure or improper technique in the improper technique in the administration of a drug administration of a drug other than wrong routeother than wrong route
Deteriorated Deteriorated drug errordrug error
Dispensing or administration Dispensing or administration of a drug that has expired or of a drug that has expired or the physical or chemical the physical or chemical dosage form integrity has dosage form integrity has changedchanged
Monitoring Monitoring errorerror
Failure to review a Failure to review a prescribed regimen for prescribed regimen for appropriateness & detection appropriateness & detection of problems, or failure to use of problems, or failure to use appropriate clinical or lab appropriate clinical or lab data for adequate data for adequate assessment of pt response to assessment of pt response to prescribed therapyprescribed therapy
Compliance Compliance errorerror
Inappropriate patient Inappropriate patient behavior regarding behavior regarding adherence to a prescribed adherence to a prescribed medication regimenmedication regimen
Other Other medication medication errorerror
Any medication error that Any medication error that does not fall into one of the does not fall into one of the above predefined typesabove predefined types
MEDICATION ERROR (ME) REPORTING FLOW CHART
Medication Error encountered
Fill ME form
Send ME report to Medication Safety Centre (MedSC)
Grading of ME report
Register ME report
Record and compile for further action
Check
ME
form
Check ME
form
Contact reporter for details
Incomplete
Complete
Responsibility
Reporter
Reporter
MedSC
NMEC
MedSC
MedSC
Acknowledge report received to reporter
Guideline on Medication Error Reporting 18
NMEC MembersNMEC Members Senior Director of Pharmaceutical Senior Director of Pharmaceutical
Services,MOH – ChairpersonServices,MOH – Chairperson Director of Pharmacy Practice and Director of Pharmacy Practice and
Development,MOH – alternate ChairpersonDevelopment,MOH – alternate Chairperson A representative from the Medical A representative from the Medical
Development Division,MOHDevelopment Division,MOH 14 others appointed by Director General of 14 others appointed by Director General of
HealthHealth A physician from MOH hospitalA physician from MOH hospital A hospital pharmacist from MOHA hospital pharmacist from MOH
A physician from a university hospitalA physician from a university hospital A pharmacist from any local university with A pharmacist from any local university with
expertise in clinical pharmacy practice expertise in clinical pharmacy practice A physician from the APHMA physician from the APHM A hospital pharmacist from the Malaysian A hospital pharmacist from the Malaysian
Armed Forces Armed Forces A Family Medicine Specialist from MOH A Family Medicine Specialist from MOH A rep from the Malaysian Medical A rep from the Malaysian Medical
AssociationAssociation
A rep from the Federation of Private A rep from the Federation of Private Medical Practitioners AssociationMedical Practitioners Association
A rep from the Community Pharmacy A rep from the Community Pharmacy Chapter, MPSChapter, MPS
A rep from the Private Hospital A rep from the Private Hospital Pharmacy Chapter, MPSPharmacy Chapter, MPS
A rep from the Malaysian Dental A rep from the Malaysian Dental AssociationAssociation
A rep from the Malaysian Nursing BoardA rep from the Malaysian Nursing Board A rep from the Malaysian Medical A rep from the Malaysian Medical
Assistants BoardAssistants Board
TOR National Medication Error Committee (NMEC) Members
1.To study and grade the ME reports received
2.To propose remedial actions in relation to medication errors
3.To actively promote medication error reporting in Malaysia
18. Medication Error (ME) Reporting Form
MEDICATION ERROR (ME) REPORTING FORM Reporters do not necessarily have to provide any individual identifiable health information, including names of practitioners, names of patients, names of healthcare facilities, or dates of birth (age is acceptable)
1. Date of event Time of event Place /Location of event 2. Please describe the error. Include description/sequence of events, type of staff involved, and work environment (e.g. change of shift, short staffing, during peak hours). If more space is needed, please attach a separate page. 3. Did the error reach the patient? (Tick appropriate box) Yes No
4. Was the incorrect medication, dose or dosage form administered to or taken by the patient? (Tick appropriate box) Yes No
4 .1 Circle the appropriate Error Outcome Category (select one – see Guide for details) A B C D E F G H I
4 .2 Describe the direct result on the patient (e.g., death, type of harm, additional patient monitoring).
5. Indicate the possible error cause(s) and contributing factor(s) (e.g., abbreviation, similar names, distractions, etc). 6. What category of staff or healthcare provider made the initial error? 7. Indicate if other provider (s) were also involved in the error (category of staff perpetuating error)
Front
ME Report FormME Report Form
Date and time of eventDate and time of event Type of facilityType of facility Private/ government Private/ government
hospital/clinic/pharmacyhospital/clinic/pharmacy Location of event:Location of event: - ward- ward - pharmacy- pharmacy - A& E- A& E - OT/ ICU etc- OT/ ICU etc
Description of event - sequence of events - work environment (peak hour,
change of shift) - details (what? how? of the
incident) Attach separate page if more space is
needed
In which process error occur In which process error occur Prescribing/Dispensing/Administration Prescribing/Dispensing/Administration / Others/ Others
Did error reach patient Y/NDid error reach patient Y/N Incorrect med, dose or dosage Incorrect med, dose or dosage
administered or taken by patientadministered or taken by patient
Describe direct result on patient eg. death, admission into hospital,
drugs prescribed to treat error
Did an actual error occur?
Category C
Circumstances or events that have the capacity to cause
error
Did the error reach the patient? *
Did the error contribute to or result in patient death?
Was the patient harmed?
Did the error require an intervention necessary
to sustain life ?
Did the error require initial or prolonged hospitalization
Was the harm temporary ?
Was the harm permanent ?
Category H
Category G
Category E Category FWas intervention to
preclude harm or extra monitoring required ?
Category B
Category A
Category I
Category D
NO
NO
NO
NO
NO
NO
NO
YES
YES
YES
YES
YES
NO
YES
YES
NO
YES
YES
Classification of Medication Error SeverityClassification of Medication Error Severity
NO ERRORNO ERROR
Category ACategory A Potential error, Circumstances/events have potential to Potential error, Circumstances/events have potential to cause incidentcause incident
ERROR, NO HARMERROR, NO HARM
Category BCategory B Actual Error – did not reach patientActual Error – did not reach patient
Category CCategory C Actual Error – caused no harmActual Error – caused no harm
Category DCategory D Additional monitoring required – caused no harmAdditional monitoring required – caused no harm
ERROR HARMERROR HARM
Category ECategory E Treatment/Intervention required –caused temporary Treatment/Intervention required –caused temporary harmharm
Category FCategory F Initial/prolonged hospitalization –caused temporary harmInitial/prolonged hospitalization –caused temporary harm
Category GCategory G Caused permanent harmCaused permanent harm
Category HCategory H Near death eventNear death event
ERROR, DEATHERROR, DEATH
Category ICategory I DeathDeath
An error of omission does reach the An error of omission does reach the patientpatient
All ME reports should be sent to :
Medication Safety Centre
Pharmaceutical Services Division , Ministry of Health P.O. Box 924, Jalan Sultan, 46790 Petaling Jaya, Selangor.
Fax: 03-79682268
© 2001 NCCMERP. All rights reserved
19. GUIDE FOR CATEGORIZING MEDICATION ERRORS
Possible contributing factor (s)
Example: - Sound alike or look alike drug - Look alike packaging - Different strength of same drug - Unclear instruction on Rx - Illegible handwriting
Category of staff made initial error?
Other category involved Category of staff,provider or
individual who discovered the error/potential error
Example: Doctor, pharmacist, staff nurse, pharmacist assistant, asst medical officer, PRP, trainee MA or SN
Patient’s particulars Do not provide patient’s name Info needed = age, M or F, diagnosis
Product 1 intended (prescribed)/ error
brand name, generic name, dose, freq,duration, route
similar packaging- manufacturer, dosage form, strength, container type
Relevant materials can be providedRelevant materials can be provided
- copy of Rx, label of product, - copy of Rx, label of product, picture of product involvedpicture of product involved
Recommendations/ preventive Recommendations/ preventive actions takenactions taken
Reporter’s detailsReporter’s details
P.O Box 924,
Jln Sultan
46790 Petaling Jaya
Tel : 03-
7841 3200
Fax: 03-
79682268 Online
Sistem pengurusan farmasi
ME
MedSC
StateState FacilityFacility
JohorJohor Hosp Sultanah AminahHosp Sultanah Aminah
Hosp Sultan IsmailHosp Sultan Ismail
Hosp Batu PahatHosp Batu Pahat
Klinik Pesakit Luar Johor BaruKlinik Pesakit Luar Johor Baru
KK PontianKK Pontian
MelakaMelaka Hospital MelakaHospital Melaka
KK JasinKK Jasin
Negeri Negeri SembilanSembilan
Hosp Tunku Jaafar,SerembanHosp Tunku Jaafar,Seremban
Hosp TA Najihah,K PilahHosp TA Najihah,K Pilah
KK SerembanKK Seremban
KK TampinKK Tampin
SelangorSelangor Hosp SelayangHosp Selayang
HTAR,KlangHTAR,Klang
KK Kelana JayaKK Kelana Jaya
WPKL/ WPKL/ PutrajayaPutrajaya
Hosp PutrajayaHosp Putrajaya
KK PantaiKK Pantai
PerakPerak Hospital Raja Permaisuri Hospital Raja Permaisuri Bainun, IpohBainun, Ipoh
Hosp Teluk IntanHosp Teluk Intan
KK GreentownKK Greentown
KK SetiawanKK Setiawan
Hospital Kuala LumpurHospital Kuala Lumpur
Two months duration ( July- August)Two months duration ( July- August) Number of reports received Number of reports received
= 779= 779 Category A = 42 ( 5.4 %)Category A = 42 ( 5.4 %)
Category B = 714 (91.7 %)Category B = 714 (91.7 %)
Category C = 6 (0.8 %)Category C = 6 (0.8 %)
Category D = 10 (1.3 %)Category D = 10 (1.3 %)
Category E = 2 (0.2%)Category E = 2 (0.2%)
Category F = 5 (0.6 %) Category F = 5 (0.6 %)
Sound-alike drugsSound-alike drugs
Zantac - ZentelZantac - Zentel Sertraline - StellazineSertraline - Stellazine lansoprazole - pantoprazolelansoprazole - pantoprazole bisoprolol - metoprololbisoprolol - metoprolol bisoprolol - carvedilolbisoprolol - carvedilol Lovastatin - simvastatinLovastatin - simvastatin
T. Pyridostigmine 60mg 5x/day was T. Pyridostigmine 60mg 5x/day was prescribed to myasthenia gravis patientprescribed to myasthenia gravis patientStaff Nurse served once daily doseStaff Nurse served once daily dose Patient condition worsened - muscle Patient condition worsened - muscle weakness and shortness of breath weakness and shortness of breath worsenedworsenedError detected by doctor and the staff Error detected by doctor and the staff nurse was told to follow dosing time 8am, nurse was told to follow dosing time 8am, 1pm, 6pm, 11pm and 4am1pm, 6pm, 11pm and 4am
Possible error causes: Staff Nurse Possible error causes: Staff Nurse misunderstood the prescription because misunderstood the prescription because very seldom the encounter 5x daily very seldom the encounter 5x daily dosagedosage
ERROR CATEGORY - F
ERROR CATEGORY - EERROR CATEGORY - E Patient was prescribed T. Lithium 300mg Patient was prescribed T. Lithium 300mg
BD x 3/12 but was supplied with T. Lithium BD x 3/12 but was supplied with T. Lithium 600mg BD x 3/12600mg BD x 3/12
Patient had giddiness, diarrhoea, loss of Patient had giddiness, diarrhoea, loss of weight, tremor. Went to A&E twice.weight, tremor. Went to A&E twice.
Staff who made the initial error: Pharm Staff who made the initial error: Pharm Asst.Asst.
Contributing factors: Poor compliance to Contributing factors: Poor compliance to work procedure – no counterchecking of work procedure – no counterchecking of dispensed medicine with prescriptiondispensed medicine with prescription
Remedial action: Remedial action: • Medication & labelling of instruction Medication & labelling of instruction
must be countercheckedmust be counterchecked• Staff involved counseledStaff involved counseled• Staff deployment during peak hourStaff deployment during peak hour
A 44 year old male with Dengue haemorrhagic A 44 year old male with Dengue haemorrhagic fever in ICUfever in ICU
Prescribed IV Piperacillin-tazobactam 2.25g qid by Prescribed IV Piperacillin-tazobactam 2.25g qid by specialist using abbreviation pip-tazo specialist using abbreviation pip-tazo
Medication supplied by pharmacy assistant : IV Medication supplied by pharmacy assistant : IV Piperacillin 4 mg Piperacillin 4 mg
3 doses were administered to patient by staff nurse3 doses were administered to patient by staff nurseError discovered by pharmacist Error discovered by pharmacist Fortunately no harm to patient Fortunately no harm to patient
ERROR CATEGORY - D
Error Reduction StrategiesError Reduction Strategies
Alerts eg a new drug with confusing Alerts eg a new drug with confusing labellabel
Share ‘lessons learned’ to avoid Share ‘lessons learned’ to avoid similar mistakes similar mistakes
Disseminate new methods adopted Disseminate new methods adopted by facilities to prevent errorsby facilities to prevent errors
Provide information to healthcare Provide information to healthcare stakeholdersstakeholders
Drug Safety AlertDrug Safety Alert
Pharmacy websitePharmacy website
Medication Safety NewsletterMedication Safety Newsletter
Call for medication safety relatedCall for medication safety related
ArticlesArticles
Activities eg 5SActivities eg 5S
WorkshopsWorkshops
CPE /CPD sessionsCPE /CPD sessions
CartoonsCartoons
PicturesPictures
TERIMA KASIHTERIMA KASIH