Medication Safety Unit
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MEDICATION SAFETY UNIT Pharmacy Practice and Development Division Ministry of Health Malaysia
Unit formed in 2007 Personnel 1 pharmacist U48 (2007) 1 pharmacist U41 (April 2008)
OBJECTIVES
To establish a medication error reporting system To create a medication error database To promote medication safety awareness To provide training programmes on medication safety
SECRETARIAT Medication Safety Committee, Pharmaceutical Services Division Medication Safety Technical Advisory Committee (MedSTAC) Pharmacovigilance on Safety of Vaccines
Medication Error Reporting System
MEDICATION ERROR . . . 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
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 Error
-
Error is inevitable because of human limitations Limited memory capacity Limited mental processing capacity Negative effects of fatigue and other physiological 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 medication error Why?
and not Who?
Why report? Enable the healthcare providers & institutions to learn about •
potential risks
•
actual errors
•
causes of errors
•
prevention
Risks hidden in the processes used Errors that occur during patient care Underlying weaknesses in systems & processes that explain why errors happened Ways of preventing recurrent events
What to report? Risks that can lead to errors or near misses Sound-alike names or look alike packages Ambigous product labels Use of error prone abbreviations Error-prone functions in cpoe systems
Pharmacy interventions/ errors detected by prescribers, nurses or patients in
Prescribing errors
Dispensing errors
Administration errors
What not to report
Administrative errors Examples: • no prescribers stamp • no countersignature for category A medicines • Medicines not stocked/ nil in stock • Other units using certain drugs eg. MO A&E using Tramal which is for specialist clinic
Types of Medication Errors Prescribing error
Incorrect drug product selection (based on indications, CI,known allergies, existing drug therapy), dose,dosage form, quantity, route or rate of administration, conc, or instructions for use authorised by physician; illegible Rx or med orders that lead to errors
Omission error The failure to administer an
ordered dose to a patient before the next ordered dose or failure to prescribe a drug product that is indicated. The failure to administer an ordered dose excludes patient’s refusal and clinical decision or other valid reason not to administer.
Wrong time error
Administration of medication outside a predefined time interval from its scheduled administration time
Dispensing or Unauthorised/ administration to the wrong drug patient of medication not error authorised by a legitimate prescriber
Dose error
Dispensing or administration to pt of a dose that is > or< than amount ordered by prescriber or administration of multiple doses to pt
Dosage form error
Dispensing or administration to pt of a drug product in diff dosage form than that ordered by prescriber
Drug preparation error
Drug product incorrectly formulated or manipulated before dispensing or administration
Wrong route of Route of administration administration of the correct drug error Administration Inappropriate procedure or technique error improper technique in the administration of a drug other than wrong route
Deteriorated drug error
Dispensing or administration of a drug that has expired or the physical or chemical dosage form integrity has changed
Monitoring error
Failure to review a prescribed regimen for appropriateness & detection of problems, or failure to use appropriate clinical or lab data for adequate assessment of pt response to prescribed therapy
Compliance error
Inappropriate patient behavior regarding adherence to a prescribed medication regimen
Other medication error
Any medication error that does not fall into one of the above predefined types
NMEC Members
Senior Director of Pharmaceutical Services,MOH – Chairperson Director of Pharmacy Practice and Development,MOH – alternate Chairperson A representative from the Medical Development Division,MOH 14 others appointed by Director General of Health A physician from MOH hospital A hospital pharmacist from MOH
A physician from a university hospital A pharmacist from any local university with expertise in clinical pharmacy practice A physician from the APHM A hospital pharmacist from the Malaysian Armed Forces A Family Medicine Specialist from MOH A rep from the Malaysian Medical Association
A rep from the Federation of Private Medical Practitioners Association A rep from the Community Pharmacy Chapter, MPS A rep from the Private Hospital Pharmacy Chapter, MPS A rep from the Malaysian Dental Association A rep from the Malaysian Nursing Board A rep from the Malaysian Medical Assistants 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 Err
M
Reporters do not necessa practitioners, names of p
Front
ME Report Form
Date and time of event Type of facility Private/ government hospital/clinic/pharmacy Location of event: - ward - pharmacy - A& E - 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 Prescribing/Dispensing/Administration / Others Did error reach patient Y/N Incorrect med, dose or dosage administered or taken by patient Describe direct result on patient eg. death, admission into hospital, drugs prescribed to treat error
19. GUIDE FOR CATEGORIZING MEDICATION ERRORS Circumstances or events that have the capacity to cause error
Classification of Medication Error Severity NO ERROR Category A
Category A
NO
ERROR, NO HARM
Did an actual error occur?
YES Category B
NO
YES Category C NO Was intervention to preclude harm or extra monitoring required ?
YES
Category D
NO NO
Was the patient harmed?
Category B
Actual Error – did not reach patient
Category C
Actual Error – caused no harm
Category D
Additional monitoring required – caused no harm
ERROR HARM
Did the error reach the patient? *
Did the error contribute to or result in patient death?
YES
Category E
Treatment/Intervention required –caused temporary harm
Category F
Initial/prolonged hospitalization –caused temporary harm
Category G
Caused permanent harm
Category Category I H Category I
Category E
NO
Death
NO
Anthe Did errorerror of omission does reach the YES patient require initial or Category F prolonged hospitalization
YES NO
YES Was the harm permanent ?
Near death event
ERROR, DEATH
YES Did the error require an intervention necessary to sustain life ?
Potential error, Circumstances/events have potential to cause incident
Was the harm temporary ?
NO YES
Category G
All ME reports should be sent to : Medication Safety Centre
Category H
Pharmaceutical Services Division , Ministry of Health P.O. Box 924, Jalan Sultan, 46790 Petaling Jaya, Selangor.
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 provided - copy of Rx, label of product, picture of product involved Recommendations/ preventive actions taken Reporter’s details
ME
MedSC
Tel : 037841 3200 Fax: 03-
P.O Box 924, Jln Sultan 46790 Petaling Jaya
79682268
Online Sistem pengurusan farmasi
State
Facility
Johor
Hosp Sultanah Aminah Hosp Sultan Ismail Hosp Batu Pahat Klinik Pesakit Luar Johor Baru KK Pontian Hospital Melaka KK Jasin
Melaka Negeri Sembilan
Hosp Tunku Jaafar,Seremban Hosp TA Najihah,K Pilah KK Seremban KK Tampin
Selangor
WPKL/ Putrajaya Perak
Hosp Selayang HTAR,Klang KK Kelana Jaya Hosp Putrajaya KK Pantai Hospital Raja Permaisuri Bainun, Ipoh Hosp Teluk Intan KK Greentown KK Setiawan Hospital Kuala Lumpur
Two months duration ( July- August) Number of reports received = 779 Category A = 42 ( 5.4 %) Category B = 714 (91.7 %) Category C = 6 (0.8 %) Category D = 10 (1.3 %) Category E = 2 (0.2%) Category F = 5 (0.6 %)
Sound-alike drugs Zantac Sertraline lansoprazole bisoprolol bisoprolol Lovastatin
-
Zentel Stellazine pantoprazole metoprolol carvedilol simvastatin
ERROR CATEGORY - F T. Pyridostigmine 60mg 5x/day was prescribed to myasthenia gravis patient Staff Nurse served once daily dose Patient condition worsened - muscle weakness and shortness of breath worsened Error detected by doctor and the staff nurse was told to follow dosing time 8am, 1pm, 6pm, 11pm and 4am Possible error causes: Staff Nurse misunderstood the prescription because very seldom the encounter 5x daily dosage
ERROR CATEGORY - E
Patient was prescribed T. Lithium 300mg BD x 3/12 but was supplied with T. Lithium 600mg BD x 3/12 Patient had giddiness, diarrhoea, loss of weight, tremor. Went to A&E twice. Staff who made the initial error: Pharm Asst. Contributing factors: Poor compliance to work procedure – no counterchecking of dispensed medicine with prescription Remedial action: • Medication & labelling of instruction must be counterchecked • Staff involved counseled • Staff deployment during peak hour
ERROR CATEGORY - D A 44 year old male with Dengue haemorrhagic fever in ICU Prescribed IV Piperacillin-tazobactam 2.25g qid by specialist using abbreviation pip-tazo Medication supplied by pharmacy assistant : IV Piperacillin 4 mg 3 doses were administered to patient by staff nurse Error discovered by pharmacist Fortunately no harm to patient
Error Reduction Strategies
Alerts eg a new drug with confusing label Share ‘lessons learned’ to avoid similar mistakes Disseminate new methods adopted by facilities to prevent errors Provide information to healthcare stakeholders
Drug Safety Alert
Pharmacy website
Medication Safety Newsletter Call for medication safety related Articles Activities eg 5S Workshops CPE /CPD sessions Cartoons Pictures
TERIMA KASIH
Unit formed in 2007 Personnel 1 pharmacist U48 (2007) 1 pharmacist U41 (April 2008)
OBJECTIVES
To establish a medication error reporting system To create a medication error database To promote medication safety awareness To provide training programmes on medication safety
SECRETARIAT Medication Safety Committee, Pharmaceutical Services Division Medication Safety Technical Advisory Committee (MedSTAC) Pharmacovigilance on Safety of Vaccines
Medication Error Reporting System
MEDICATION ERROR . . . 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
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 Error
-
Error is inevitable because of human limitations Limited memory capacity Limited mental processing capacity Negative effects of fatigue and other physiological 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 medication error Why?
and not Who?
Why report? Enable the healthcare providers & institutions to learn about •
potential risks
•
actual errors
•
causes of errors
•
prevention
Risks hidden in the processes used Errors that occur during patient care Underlying weaknesses in systems & processes that explain why errors happened Ways of preventing recurrent events
What to report? Risks that can lead to errors or near misses Sound-alike names or look alike packages Ambigous product labels Use of error prone abbreviations Error-prone functions in cpoe systems
Pharmacy interventions/ errors detected by prescribers, nurses or patients in
Prescribing errors
Dispensing errors
Administration errors
What not to report
Administrative errors Examples: • no prescribers stamp • no countersignature for category A medicines • Medicines not stocked/ nil in stock • Other units using certain drugs eg. MO A&E using Tramal which is for specialist clinic
Types of Medication Errors Prescribing error
Incorrect drug product selection (based on indications, CI,known allergies, existing drug therapy), dose,dosage form, quantity, route or rate of administration, conc, or instructions for use authorised by physician; illegible Rx or med orders that lead to errors
Omission error The failure to administer an
ordered dose to a patient before the next ordered dose or failure to prescribe a drug product that is indicated. The failure to administer an ordered dose excludes patient’s refusal and clinical decision or other valid reason not to administer.
Wrong time error
Administration of medication outside a predefined time interval from its scheduled administration time
Dispensing or Unauthorised/ administration to the wrong drug patient of medication not error authorised by a legitimate prescriber
Dose error
Dispensing or administration to pt of a dose that is > or< than amount ordered by prescriber or administration of multiple doses to pt
Dosage form error
Dispensing or administration to pt of a drug product in diff dosage form than that ordered by prescriber
Drug preparation error
Drug product incorrectly formulated or manipulated before dispensing or administration
Wrong route of Route of administration administration of the correct drug error Administration Inappropriate procedure or technique error improper technique in the administration of a drug other than wrong route
Deteriorated drug error
Dispensing or administration of a drug that has expired or the physical or chemical dosage form integrity has changed
Monitoring error
Failure to review a prescribed regimen for appropriateness & detection of problems, or failure to use appropriate clinical or lab data for adequate assessment of pt response to prescribed therapy
Compliance error
Inappropriate patient behavior regarding adherence to a prescribed medication regimen
Other medication error
Any medication error that does not fall into one of the above predefined types
NMEC Members
Senior Director of Pharmaceutical Services,MOH – Chairperson Director of Pharmacy Practice and Development,MOH – alternate Chairperson A representative from the Medical Development Division,MOH 14 others appointed by Director General of Health A physician from MOH hospital A hospital pharmacist from MOH
A physician from a university hospital A pharmacist from any local university with expertise in clinical pharmacy practice A physician from the APHM A hospital pharmacist from the Malaysian Armed Forces A Family Medicine Specialist from MOH A rep from the Malaysian Medical Association
A rep from the Federation of Private Medical Practitioners Association A rep from the Community Pharmacy Chapter, MPS A rep from the Private Hospital Pharmacy Chapter, MPS A rep from the Malaysian Dental Association A rep from the Malaysian Nursing Board A rep from the Malaysian Medical Assistants 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 Err
M
Reporters do not necessa practitioners, names of p
Front
ME Report Form
Date and time of event Type of facility Private/ government hospital/clinic/pharmacy Location of event: - ward - pharmacy - A& E - 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 Prescribing/Dispensing/Administration / Others Did error reach patient Y/N Incorrect med, dose or dosage administered or taken by patient Describe direct result on patient eg. death, admission into hospital, drugs prescribed to treat error
19. GUIDE FOR CATEGORIZING MEDICATION ERRORS Circumstances or events that have the capacity to cause error
Classification of Medication Error Severity NO ERROR Category A
Category A
NO
ERROR, NO HARM
Did an actual error occur?
YES Category B
NO
YES Category C NO Was intervention to preclude harm or extra monitoring required ?
YES
Category D
NO NO
Was the patient harmed?
Category B
Actual Error – did not reach patient
Category C
Actual Error – caused no harm
Category D
Additional monitoring required – caused no harm
ERROR HARM
Did the error reach the patient? *
Did the error contribute to or result in patient death?
YES
Category E
Treatment/Intervention required –caused temporary harm
Category F
Initial/prolonged hospitalization –caused temporary harm
Category G
Caused permanent harm
Category Category I H Category I
Category E
NO
Death
NO
Anthe Did errorerror of omission does reach the YES patient require initial or Category F prolonged hospitalization
YES NO
YES Was the harm permanent ?
Near death event
ERROR, DEATH
YES Did the error require an intervention necessary to sustain life ?
Potential error, Circumstances/events have potential to cause incident
Was the harm temporary ?
NO YES
Category G
All ME reports should be sent to : Medication Safety Centre
Category H
Pharmaceutical Services Division , Ministry of Health P.O. Box 924, Jalan Sultan, 46790 Petaling Jaya, Selangor.
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 provided - copy of Rx, label of product, picture of product involved Recommendations/ preventive actions taken Reporter’s details
ME
MedSC
Tel : 037841 3200 Fax: 03-
P.O Box 924, Jln Sultan 46790 Petaling Jaya
79682268
Online Sistem pengurusan farmasi
State
Facility
Johor
Hosp Sultanah Aminah Hosp Sultan Ismail Hosp Batu Pahat Klinik Pesakit Luar Johor Baru KK Pontian Hospital Melaka KK Jasin
Melaka Negeri Sembilan
Hosp Tunku Jaafar,Seremban Hosp TA Najihah,K Pilah KK Seremban KK Tampin
Selangor
WPKL/ Putrajaya Perak
Hosp Selayang HTAR,Klang KK Kelana Jaya Hosp Putrajaya KK Pantai Hospital Raja Permaisuri Bainun, Ipoh Hosp Teluk Intan KK Greentown KK Setiawan Hospital Kuala Lumpur
Two months duration ( July- August) Number of reports received = 779 Category A = 42 ( 5.4 %) Category B = 714 (91.7 %) Category C = 6 (0.8 %) Category D = 10 (1.3 %) Category E = 2 (0.2%) Category F = 5 (0.6 %)
Sound-alike drugs Zantac Sertraline lansoprazole bisoprolol bisoprolol Lovastatin
-
Zentel Stellazine pantoprazole metoprolol carvedilol simvastatin
ERROR CATEGORY - F T. Pyridostigmine 60mg 5x/day was prescribed to myasthenia gravis patient Staff Nurse served once daily dose Patient condition worsened - muscle weakness and shortness of breath worsened Error detected by doctor and the staff nurse was told to follow dosing time 8am, 1pm, 6pm, 11pm and 4am Possible error causes: Staff Nurse misunderstood the prescription because very seldom the encounter 5x daily dosage
ERROR CATEGORY - E
Patient was prescribed T. Lithium 300mg BD x 3/12 but was supplied with T. Lithium 600mg BD x 3/12 Patient had giddiness, diarrhoea, loss of weight, tremor. Went to A&E twice. Staff who made the initial error: Pharm Asst. Contributing factors: Poor compliance to work procedure – no counterchecking of dispensed medicine with prescription Remedial action: • Medication & labelling of instruction must be counterchecked • Staff involved counseled • Staff deployment during peak hour
ERROR CATEGORY - D A 44 year old male with Dengue haemorrhagic fever in ICU Prescribed IV Piperacillin-tazobactam 2.25g qid by specialist using abbreviation pip-tazo Medication supplied by pharmacy assistant : IV Piperacillin 4 mg 3 doses were administered to patient by staff nurse Error discovered by pharmacist Fortunately no harm to patient
Error Reduction Strategies
Alerts eg a new drug with confusing label Share ‘lessons learned’ to avoid similar mistakes Disseminate new methods adopted by facilities to prevent errors Provide information to healthcare stakeholders
Drug Safety Alert
Pharmacy website
Medication Safety Newsletter Call for medication safety related Articles Activities eg 5S Workshops CPE /CPD sessions Cartoons Pictures
TERIMA KASIH
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