National Drug Policy and Authority (Pharmacovigilance) Regulations

SCHEDULE

S T A T U T O R Y I N S T R U M E N T S 2014 No. 37.

The National Drug Policy and Authority (Pharmacovigilance) Regulations, 2014. (Made under Section 64 of the National Drug Policy and Authority Act, Cap. 206)

IN EXERCISE of the powers conferred upon the Minister responsible for health by section 64 of the National Drug Policy and Authority Act and on the advice of the National Drug Authority, these Regulations are made this 24th day of March, 2014.

These Regulations may be cited as the National Drug Policy and Authority (Pharmacovigilance) Regulations, 2014.

In these regulation unless the context otherwise requires- "adverse drug event" means any unwanted medical occurrence in a subject to whom a drug is administered and includes an occurrence which is not caused by or related to the drug; "adverse drug reaction" means a response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease or for the modification of physiological function; "counterfeit drug" means a drug which is deliberately or fraudulently mislabeled with respect to its identity, content or source; "licensed person" means a person licensed under section 14 of the Act; "periodic safety update report" means a report on the safety experience of a drug at defined times, after the drug is registered;

The Authority may conduct an investigation, with regard to a drug where-

A health care professional shall report any serious adverse drug event that arises during the process of providing health care.

The Authority may conduct an investigation, with regard to a drug where-

Any person, who withholds safety information or tries to obstruct the Authority from getting information, commits an offence under the Act SCHEDULE

FORMATS. Regulation 3(4)

Format of Report on Suspected Adverse Drug Reactions for Human Drugs

Please note that identities of the patient, reporting doctor, pharmacist, nurse and health facility are to be kept strictly confidential.

Surname: Other names: Age: Sex: Weight: Date of LMP: OPD No.: Name of health facility: District:

when the patient started and stopped using the drug, the daily dose, diluents details, lot/batch no. and state whether the drug was prescribed or not

when the reaction stopped Mention any treatment that was given to the patient for the reaction. If the patient was admitted, record the duration of admission in days, the outcome of the treatment (whether the treatment is ongoing, or whether the patient recovered or died and if the patient died, indicate the date of death).

vaccines, herbal preparations). Record the name of the drug, the indication, daily dose and the dates the patient started and stopped using the drug.

Record any other information for example the relevant history, allergies, failure of efficacy, counterfeit, test result, follow up data of the drug or patient as the case may be.

Postal address: Designation: Telephone: Telephone/fax number: Signature: Date:

Regulation 3 (4)

Format of Report on Suspected Adverse Drug Reactions for Veterinary Drugs

Please note that identities of the owner of the animal, veterinary surgeon or Para-veterinarian who makes the report and the animal clinic are to be kept strictly confidential

Address: Telephone number: Email address: Village: Sub-county: District:

Breed: Sex: Age: Weight: Productive status: Reproductive status: Name and identification number of animal: Species:

when the animal started and stopped taking the drug, the dosage and batch number

a vet professional, tick both title and owner boxes) Veterinary doctor Owner Para-veterinarian Others (specify)

of the suspected reactions and indicate whether the reaction was immediate or delayed

(including drugs administered by animal owner, vaccines, herbal preparations) Record the name of the drug, the indication, the daily dose and the date the animal started stopped taking the drug.

any other information for example the relevant history, allergies, failure of efficacy, counterfeit, test result and follow up data

Postal address: Designation: Telephone and fax numbers: Signature: Date:

RUHAKANA RUGUNDA (DR.), Minister of Health.