Pharmacy and Poisons BoardPvERS

(FOM001/HPT/VMS/SOP/001)

in confidenceCOA

MINISTRY OF HEALTH

PHARMACY AND POISONS BOARD
P.O. Box 27663-00506 NAIROBI
Tel: +254795743049
Email: pv@pharmacyboardkenya.org
SUSPECTED ADVERSE DRUG REACTION REPORTING FORM

Tip: Fields marked with * are mandatory

e.g Nevirapine related rash

Form ID: new

Form Type: Initial

The report is on *:

Product category (Tick appropriate box) *



PATIENT INFORMATION

e.g E.O.O

-- clear!

If selected, year is mandatory.

--OR--
clear!

(specify)

(Name/ Number)


Kg
cm

(What was the patient being treated for before getting the reaction)

--

When did the reaction start

Please describe the reaction in terms of symptoms

(Other relevant history including pre-existing medical conditions e.g. allergies, smoking, alcohol use, hepatic/ renal dysfunction etc)

List all medicines being currently used by the patient including OTC, and herbal products (* Tick the suspected medicine)
INN/ Generic Name Brand Name * Batch/ Lot No.* Manufacturer*
Treatment Period (dd-mm-yyyy)
Stop Date
TICK (✓)
SUSPECTED DRUG(S) *
1
Past medication history (List all medicines used in the last 3 months including OTC, herbals, if pregnant indicate medicines used in the 1st trimester)
Treatment Period (dd-mm-yyyy)
Stop Date 		Indication
Dechallenge/Rechallenge

Did the reaction resolve after the drug was stopped or when the dose was reduced?

clear!

Did the reaction reappear after the drug was reintroduced?

clear!

Outcome *

clear!
Grading of the reaction /event

Severity of reaction

Click to view Severity scale below
clear!
clear!

Criteria/reason for seriousness

clear!

Action taken *

clear!
Criteria for Assessment of Severity of an ADR
Mild
  • The ADR requires no change in treatment with the suspected drug.
  • The ADR requires that the suspected drug be withheld, discontinued or otherwise changed. No antidote or other treatement is required
  • No increase in length of stay.
Moderate
  • The ADR requires that the suspected drug be withheld, discontinued or otherwise changed, and/or an antidote or other treatement is required
  • Increases length of stay by at least one day
  • The ADR is the reason for admission.
Severe
  • The ADR requires intensive medical care
  • The ADR causes permanent harm to the patient
Fatal
  • The ADR either directly or indirectly leads to the death of the patient
WHO-UMC Causality Assessment Scale
Causality Term Assessment
Certain
  • Event of laboratory test abnormality, with plausible time relationship to drug intake
  • Cannot be explained by disease or other drugs
  • Response to withdrawal plausible (pharmacologically, pathologically)
  • Event definitive pharmacologically or phenomenologically (i.e an objective and specific medical disorder or a recognized pharmacological phenomenon)
  • Rechallenge satisfactory , if necessary.
Probable / Likely
  • Event or laboratory test abnormality, with reasonble time relationship to drug intake.
  • Unlikely to be attributed to disease or other drugs
  • Response to withdrawal clinically reasonable
  • Rechallenge not required
Possible
  • Event or laboratory test abnormality, with reasonable time relationship to drug intake
  • Could also be explained by disease or other drugs
  • Information on drugs withdrawal lacking or unclear
Unlikely
  • Event or laboratory tests abnormality, with a time to drug intake that makes a relationship improbable (but not impossible)
  • Disease or other drugs provide plausible explanations
Conditional / Unclassified
  • Event or laboratory test abnormality
  • More data for proper, assessment needed or
  • Additional data under examination
Unassessable / unclassifiable
  • Report suggesting an medicine side effects
  • Cannot be judged because of insufficient or contradictory information
  • Data cannot be supplemented or verified
Do you have pictures or documents that you would like to send to PPB? click on the button to add them:
# File Text Description
Is the person submitting different from reporter? 
  
EXPLANATORY NOTES

CONFIDENTIALITY

All information collected in this form, identities of the reporter and patient, will remain confidential.

WHAT TO REPORT

An Adverse Drug Reaction (ADR) is defined as a reaction that is noxious and unintended, and occurs at doses normally used in man for prophylaxis, diagnosis or treatment of a disease, or for modification of physiological function.

Report all suspected adverse experiences with medications,

especially those where the patient outcome is

  • Death
  • Life-threatening (real risk of dying)
  • Hospitalization (initial or prolonged)
  • Disability (significant, persistent or permanent)
  • Congenital anomaly
  • Required intervention to prevent permanent impairement or damage

Report even if:

  • You are not certain if the drug caused the reaction
  • You do not have all the details

WHO CAN REPORT

All healthcare professionals (clinicians, dentists, nurses, pharmacists, physiotherapists, community health workers etc) are encouraged to report. Patients (or their next of kin) may also report.

WHAT HAPPENS TO THE SUBMITTED INFORMATION

All information submitted is handled in strict confidence. The Pharmacy and Poisons Board will assess causality and statistical analysis on each form. Data will periodically be used to review and suggest any interventions that may be required to the Ministry of Health. Data will also be submitted periodically to the Uppsala Monitoring Center - the WHO Collaborating Center for International Drug Monitoring in Sweden

SUBMISSION OF INITIAL OR FOLLOW-UP REPORTS

It is important to tick the appropriate box on the top-right corner of the front page to indicate whether the report is an initial (original) report or is a follow-up (subsequent) report.

It is very important that follow-up reports are identified and linked to the original report.

WHERE TO REPORT

After completing this form, please forward the same to your Pharmacy Department for onward submission, or mail directly, to:

THE PHARMACY AND POISONS BOARD
Lenana Road.
P.O. Box 27663-00506 NAIROBI
Tel: +254795743049 E-mail: pv@pharmacyboardkenya.org
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



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