PvERS: the Pharmacovigilance Electronic Reporting System: Medications

MINISTRY OF HEALTH

PHARMACY AND POISONS BOARD

P.O. Box 27663-00506 NAIROBI

Tel: +254795743049

Email: pv@pharmacyboardkenya.org

MEDICATION ERROR REPORTING FORM

Tip: Fields marked with * are mandatory

Form ID: new

Date of Event *

Time of Event

24hr:min

NAME OF INSTITUTION/ ORGANZIATION *

Contact/Tel No.

INSTITUTION CODE

COUNTY *

Patient Initials *

DATE OF BIRTH

*--OR--

Age group

GENDER *

MaleFemale clear!

PREGNANCY STATUS

Not ApplicableNot pregnant

1st Trimester2nd Trimester3rd Trimester clear!

Ward

(Specify: medical, paeds, ortho)

Pharmacy

(paeds, main, inpatient, outpatient)

Others

(Please specify)

Clinic

(Specify: outpatient, dental, specialist)

Accident & Emergency/Casualty

Please describe the error. Include description/ sequence of events and work environment (e.g. change of shift, short staffing, during peak hours). *

In which process did the error occur? *

PrescribingDispensing (includes filling)AdministrationTranscribingOthers clear!

Did the error reach the patient? *

YesNo clear!

Describe the direct result on the patient (e.g. death, type of harm, additional patient monitoring e.g. BP, heart rate, glucose level etc)

Please tick the appropriate Error Outcome Category (Tick one appropriate box below):

NO ERROR

Potential error, circumstances/events have potential to cause incident

ERROR, HARM

Treatment /intervention required-caused temporary harmInitial/prolonged hospitalization-caused temporary harmCaused permanent harmNear death event

ERROR, NO HARM

Actual error-did not reach patientActual error-caused no harmAdditional monitoring required-caused no harm

ERROR, DEATH

Death

Indicate the possible error cause(s) and contributing factor(s) below (Tick the appropriate box(es):

Staff factors

Inexperienced personnel Inadequate knowledge Distraction

Medication related

Sound alike medication Look alike medication Look alike packaging

Work and environment

Heavy workload Peak hour Stock arrangements/storage problem

Task and technology

Failure to adhere to work procedure Use of abbreviations Illegible prescriptions Patient information/record unavailable/ inaccurate Wrong labelling/instruction on dispensing envelope or bottle/container Incorrect computer entry Others:

(if others, specify)

Product details: Please complete the following for products involved. Click Add for additional products

	Product Description	No. 1 (intended) *	No. 2 (error)	#
1	Generic name (active ingredient)
	Brand/ Product Name
	Dosage formulation
	Dose, frequency, duration, route *

	Manufacturer
	Strength/concentration
	Type and size of container

Suggest any recommendations, or describe policies or procedures you instituted or plan to institute to prevent future similar errors. If available, kindly attach an investigational report e.g. Root Cause Analysis (RCA)

Did the drug result in an medicine side effects?

YesNo

Do you have pictures or documents that you would like to send to PPB? click on the button to add them:

#	File	Text Description

Name of Initial reporter *

E-MAIL ADDRESS *

Cadre/designation *

PHONE NO. *

Date of report *

Name

E-MAIL ADDRESS

Cadre/designation

PHONE NO.

Date of Submission

MINISTRY OF HEALTH

PHARMACY AND POISONS BOARD

P.O. Box 27663-00506 NAIROBI

Tel: +254795743049

Email: pv@pharmacyboardkenya.org

MEDICATION ERROR REPORTING FORM

Form ID: new

PATIENT INFORMATION

*--OR--

Location of event

Please tick the appropriate Error Outcome Category (Tick one appropriate box below):

NO ERROR

ERROR, HARM

ERROR, NO HARM

ERROR, DEATH

Indicate the possible error cause(s) and contributing factor(s) below (Tick the appropriate box(es):

Staff factors

Medication related

Work and environment

Task and technology

Product details: Please complete the following for products involved. Click Add for additional products

Did the drug result in an medicine side effects?

Do you have pictures or documents that you would like to send to PPB? click on the button to add them:

Is the person submitting different from reporter?

MINISTRY OF HEALTH

PHARMACY AND POISONS BOARD

P.O. Box 27663-00506 NAIROBI

Tel: +254795743049

Email: pv@pharmacyboardkenya.org

MEDICATION ERROR REPORTING FORM

Form ID: new

PATIENT INFORMATION

*--OR--

Location of event

Please tick the appropriate Error Outcome Category (Tick one appropriate box below):

NO ERROR

ERROR, HARM

ERROR, NO HARM

ERROR, DEATH

Indicate the possible error cause(s) and contributing factor(s) below (Tick the appropriate box(es):

Staff factors

Medication related

Work and environment

Task and technology

Product details: Please complete the following for products involved. Click Add for additional products Add

Did the drug result in an medicine side effects?

Do you have pictures or documents that you would like to send to PPB? click on the button to add them:

Is the person submitting different from reporter?

Product details: Please complete the following for products involved. Click Add for additional products