PvERS: the Pharmacovigilance Electronic Reporting System: Pqmps

(FOM001/HPT/VMS/SOP/001)

MINISTRY OF HEALTH

PHARMACY AND POISONS BOARD

P.O. Box 27663-00506 NAIROBI

Tel: +254795743049

Email: pv@pharmacyboardkenya.org

FORM FOR REPORTING SUSPECTED POOR-QUALITY HEALTH PRODUCTS AND TECHNOLOGIES

Form ID: new

Important Unique Form ID

Product category (Tick appropriate box)

Medicinal product Blood and blood products Herbal product Medical device

Vaccine Cosmeceuticals Others

Name of Facility

Facility Address

Facility Code

Facility Telephone

COUNTY

Sub County

PRODUCT IDENTITY

Brand Name *

Batch/Lot Number *

Date of Manufacture

Date, Month & Year or Year of Manufacture

Name of Manufacturer *

Name of Distributor / Supplier

Generic Name

Date of Expiry *

Date format (dd-mm-yyyy)
If day is missing, use last day of the month.

Date of Receipt

Date format (dd-mm-yyyy)

Country of Origin

start typing for options

Distributor/ Supplier's Address

PRODUCT FORMULATION *

(Tick appropriate box)

COMPLAINT *

(Tick appropriate box/boxes)

FOR MEDICAL DEVICE AND INVITRO DIAGNOSTIC *

Describe the complaint in detail *

Was the cold chain maintained for both transportation and storage?

YesNoNot sure clear!

Does the product require refrigeration?	Yes No	Other Details If Necessary
Was the product available at the facility?	Yes No
Was the product dispensed and returned by client?	Yes No
Was the product stored according to Manufacturer / MOH recommendations?	Yes No

Comments (if any)

Did the drug result in an adverse drug reaction?

YesNo

Add comments

Did the product result in a medication error?

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 Person Reporting *

E-MAIL ADDRESS *

DESIGNATION *

PHONE NO. *

Date *

Is the person submitting different from reporter?

Yes No

Name *

E-MAIL ADDRESS *

Designation *

PHONE NO. *

Date

EXPLANATORY NOTES

EXPLANATION FOR PRODUCT PROBLEMS FOR MEDICAL DEVICES AND DIAGNOSTICS • Packaging – damaged, defective, suspect tampered • Labelling– insufficient instructions for use, illegible • Sampling – device doesn’t collect/transfer specimen • Liquid – leak, splash • Mechanical – misalignment, jam • Electrical - unable to charge, power loss or fluctuation • Data – capture, display, or storage affecting product functionality • Software – network, program, algorithm, or security affecting product functionality • Environmental – noise, temperature, humidity/ moisture, fungal/bacterial growth, or dust affecting product functionality • Failure to calibrate • Results- Increased rate of invalid or unreturnable test results • Reading-Obviously incorrect, inadequate or imprecise result or readings, Unable to obtain reading

HOW TO RESIZE A PHOTO

How to Resize a Photo:

Right click the picture you want to save and open with `Microsoft office picture manager`.

Click on `Edit Pictures` and on the panel that appears on the left, click on `resize`

Select predefined width x height

In the drop down options, select the option `Web Large (640 x 480 px)` and click on ok

Save a copy of the resized photo (using `save as` option) and upload thenew copy