Drug Information and Promotion
The Drug Information, Clinical trials and Pharmacovigilance Department has achieved quite a number of targets in the past year under review including:
- Dissemination of Drug Information and regulation and control of drug promotion
- Revised/reviewed the guidelines on drug promotion, developed regulations from the guidelines.
- Developed guidelines on promotion of local herbal medicines, a chapter contained in the main Guidelines on the Minimum Requirements for the Regulation of Traditional Herbal Drugs
- Sensitized 193 herbalists and traditional Healers in Arua
- Developed guidelines and other regulatory materials on the control of promotion and advertising of animal acaricides and public health products
- Drafted and developed Statutory Instruments for the Regulation of drug promotions.
Regulation of Drug Related Clinical Trials
15 applications to use drugs in clinical trials were processed and approved during the period under review.
Guidelines for the conduct of clinical trials:
Guidelines for the conduct of clinical trials were developed. These are to guide Sponsors, local investigators and others that may apply for a clinical trial import license/certificate to import investigational products; and/or manufacturers of products intended for the purpose of clinical trials in Uganda. The guidelines apply to all medicinal products. Open document for Clinical trial guidelines
Products that require the license/certificate
Prior to importation/local manufacture of medicinal product meant for clinical trials, the Principal Investigator will be required to apply for a license/certificate from NDA. This applies to:
- Unregistered products intended to be imported for purpose of clinical trial
- Registered products when used or assembled (formulated or packaged) in a way different from the approved form
- Registered products when used for an unapproved indication
- Registered products when used to gain further information about an approved use
- A local product manufactured for a purpose of a clinical trial
Documents to be submitted with the application for a license/certificate include:
- Filled Clinical Trial Application form
- Declaration form signed by all Investigators.
- Study protocol and its amendments
- GMP certificate/statement for investigational product
- For local product, the manufacturing license is required
- Participant Information Leaflet and Informed Consent
- Pharmaceutical data on the dosage form
- A sample of the label for the imported products
- Approval letters from Uganda National Council for Science and Technology and Institutional Review Ethics Committees
- Letter of authorization from the manufacturer/product owner, if applicant is not the manufacturer
- Copies of peer reviewed literature
Pharmacovigilance and Adverse Drug Reactions Monitoring
The National Drug Authority hosts the National Pharmacovigilance Centre (NPC).The center was established in 2005. The goal of the centre is to promote patient safety by monitoring adverse drug reactions. In 2007, the NPC of Uganda, which had been an associate member of the WHO Adverse Drug Reaction (ADR) monitoring centre based in Uppsala, Sweden, became a full member.
The roles of the NPC are to:
Train and sensitize Health workers.
Distribute adverse drug reaction (ADR) reporting forms and collect ADR reports.
Maintain an adverse drug reactions database
Only Medical personnel may report an adverse event relating to administration of medicinal products.
To contact the NPC, one may use the hotline which is 0141344052
Human Pharmacovigilance bulletin,issue No.1
Human Pharmacovigilance bulletin,issue No.2
The information on adverse drug reactions is used to improve upon the quality, safety and efficacy of human and veterinary drugs.
In the period under review the following were accomplished:
Drafted and developed the Statutory Instruments for the Regulation of Pharmacovigilance.
Trained of the coordinators of Regional Pharmacovigilance centers and NDA Regional Inspectors in using Vigiflow software to report adverse drug reactions.
Conducted Training of Trainers (TOT) in February 2009.
Continuous follow up trainings in various regions
Kabale Regional Pharmacovigilance Centre where 6 districts participated and 43 people were trained from 21st– 24th September, 2009,
Mbarara Regional Pharmacovigilance centre where 30 people were trained from 29th June – 2nd July, 2009 and
Jinja Regional Pharmacovigilance centre was conducted from 7th -9th September 2009. Other centres established in the same period were Mbale, Arua and Mulago.
- Printed Pharmacovigilance guidelines, posters for the public, health professionals to report adverse drug reactions and the Pharmacovigilance Bulletin
- Printed brochures in which information about monitoring adverse drug reactions in veterinary drugs is mentioned;
- Distributed and disseminated of such information in animal corridor districts of South West, Western, greater Eastern and part of Northern Region
- Conducted sensitization seminars in the above districts about Adverse Drug Reactions monitoring in veterinary animals,
- Distributed Veterinary sensitization material in the districts of Mbarara, Ntungamo, Rukungiri, Bushenyi, Ibanda and Kiruhura from 15th – 24th December 2009
- Sensitized 30 nurses in Mulago on Pharmacovigilance on 6th July 2009
- Sensitized 28 Pharmacy students and 4 lecturers in Pharmacovigilance in Mbarara University of Science and Technology on 11th November 2009.
Support supervision for Pharmacovigilance was conducted in the following regions Nakasongola,Nakaseke, Kayunga, Mukono, Mityana, Mubende, Luweero, Jinja, Kamuli, Kaliro, Bugiri, Iganga, Mayuge Namutumba, Kabale, Kisoro, Kanungu, Rukungiri, Kabale, Kisoro, Kanungu, Rukungiri, Ntungamo., Mulago Regional Pharmacovigilance centre Soroti sub region Masaka , Mbarara ,Gulu, Lira, West Nile Karamoja Sub region and Hoima.
Guide for reporting Adverse Drug Reaction (Veterinary)
Form for Veterinary ADR reporting |
