4.1. ANALISIS E INTERPRETACIÓN DE LOS RESULTADOS
4.1.2. DESCRIPCIÓN LOS RESULTADOS DE LOS INDICADORES DE LAS VARIABLES
National Drug Authority (NDA) was established by the National Drug Policy and Authority (NDP/A) Act, Cap. 206 (Laws of Uganda 2000 Revised edition). The NDA mandate is to ensure availability, at all times drugs which are of good quality, safe, efficacious and cost-effective to the entire population of Uganda, as a means of providing satisfactory healthcare and safeguarding the appropriate use of drugs.
[Annual Health Sector Performance Report 2012/13 FY]
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Key output Indicators 2012/13 Dossiers evaluated.
Proportion of the premises (pharmacies and drug shops) inspected by December of every year.
GMP inspection of local and foreign pharmaceutical manufacturing sites conducted. 95% of the Verification Certificates processed within 5 working days of application. All consignments presented to the Inspector inspected within 24hours.
Post marketing surveillance conducted.
Health personnel sensitised on adverse event reporting. Public sensitised
Main achievements 2012/13
A total of 976 pharmacies were licensed; 604 retail and 372 wholesale pharmacies; 6,140 drug shops were licensed.
Inspection of 12 local manufacturing facilities was carried out, and 9 facilities complied with cGMP; 118 foreign facilities were inspected for cGMP compliance; 103 passed and 15 failed; and 29 GMP assessments of foreign pharmaceutical manufacturing sites through document review were evaluated and all were approved.
3,761 consignments were handled at the various ports of entry; released – 3,691, rejected – 04, queried – 66.
NDA was able to train 100 health workers in Kampala and 60 health workers from upcountry stations on pharmacovigilance.
Developed 2,000 sensitization materials which were disseminated in various fora including a workshop held in July 2012 with media and other stakeholders about advertising of medicines. This workshop also addressed issues of advertising herbal medicines.
663 health workers were sensitized on ADR monitoring.
Support supervision was carried out in 10 established regional Pharmacovigilance Centres and 93 health facilities were visited. Support to 3 regional centers was given by provision of new computers and 10 pharmacovigilance centers were given office imprest to facilitate them in carrying out pharmacovigilance activities.
Held 5 talk shows on Top Radio, Namirembe FM and Top TV on drug promotion and advertising of herbal medicines and food supplements.
Held sensitization workshops on herbal medicine regulation in the districts of Adjumani, Moyo, Yumbe, Nebbi, Arua and Koboko.
NDA continued to run information spots on radios, newspapers and televisions to alert the public against drug hawkers, unlicensed outlets and use of SMS drug information facility. The messages are monitored by Synovate and also aimed to re-emphasize the public’s need to be more vigilant against unscrupulous or illegal operators.
NDA organized a meeting with the Media and Stakeholders to sensitize them about the current unethical advertising of herbal medicines in Uganda.
Held 18 FREE on air interactive one to two hours talk-shows on 14 FM radios and 3 televisions. Namely; Radio Sapientia, Prime FM, Namirembe FM, Kingdom FM, Voice of
[Annual Health Sector Performance Report 2012/13] Page 142
Most of the above achievements have been realized with support from development partners who are winding down in the following year which will impact on the sustainability of the achievements and organizational structures of the pharmaceutical sector management.
Recommendations
Conduct an assessment on equity in budget allocation for EMHS and revisit resources allocation criteria to achieve equity in financing and management of EMHS.
Government to increase financing in the pharmaceutical sector for sustainability of SPAS with the pending exit of the IP’s.
All IP’s supporting districts in medicines management should embrace SPAS. 3.2.4 National Medical Stores
The mandate of NMS is to procure, store and distribute essential medicines and other medical supplies primarily to public health facilities
Core Indicators
The percentage of health units without monthly stock outs of any indicator medicines (49% of health facilities did not have stock out of any of the six tracer medicines in the FY 2011/12– first line antimalarials, Depoprovera, SP, measles vaccine, ORS, Cotrimoxazole).
Main achievements 2012/13
Supplied essential medicines and medical supplies to all Health facilities, including UPDF, Police Force and Prison services.
Supplied Vaccines, gas and other immunization materials to all 111 districts and KCCA, including the new PCV to pilot district of Iganga
Regionalized the Basic kit for HC II and HC III
Made improvements in aligning the Orders from Health facilities with their procurement plans
Responded to all the medical emergencies and epidemics in the country with required additional supplies
Continued with the embossment of medicines and medical supplies- now at 97% Continued with the last mile delivery of medicines to health facilities
3.2.5 National Drug Authority
National Drug Authority (NDA) was established by the National Drug Policy and Authority (NDP/A) Act, Cap. 206 (Laws of Uganda 2000 Revised edition). The NDA mandate is to ensure availability, at all times drugs which are of good quality, safe, efficacious and cost-effective to the entire population of Uganda, as a means of providing satisfactory healthcare and safeguarding the appropriate use of drugs.
[Annual Health Sector Performance Report 2012/13 FY] Page 135
[Annual Health Sector Performance Report 2012/13] Page 143
Key output Indicators 2012/13 Dossiers evaluated.
Proportion of the premises (pharmacies and drug shops) inspected by December of every year.
GMP inspection of local and foreign pharmaceutical manufacturing sites conducted. 95% of the Verification Certificates processed within 5 working days of application. All consignments presented to the Inspector inspected within 24hours.
Post marketing surveillance conducted.
Health personnel sensitised on adverse event reporting. Public sensitised
Main achievements 2012/13
A total of 976 pharmacies were licensed; 604 retail and 372 wholesale pharmacies; 6,140 drug shops were licensed.
Inspection of 12 local manufacturing facilities was carried out, and 9 facilities complied with cGMP; 118 foreign facilities were inspected for cGMP compliance; 103 passed and 15 failed; and 29 GMP assessments of foreign pharmaceutical manufacturing sites through document review were evaluated and all were approved.
3,761 consignments were handled at the various ports of entry; released – 3,691, rejected – 04, queried – 66.
NDA was able to train 100 health workers in Kampala and 60 health workers from upcountry stations on pharmacovigilance.
Developed 2,000 sensitization materials which were disseminated in various fora including a workshop held in July 2012 with media and other stakeholders about advertising of medicines. This workshop also addressed issues of advertising herbal medicines.
663 health workers were sensitized on ADR monitoring.
Support supervision was carried out in 10 established regional Pharmacovigilance Centres and 93 health facilities were visited. Support to 3 regional centers was given by provision of new computers and 10 pharmacovigilance centers were given office imprest to facilitate them in carrying out pharmacovigilance activities.
Held 5 talk shows on Top Radio, Namirembe FM and Top TV on drug promotion and advertising of herbal medicines and food supplements.
Held sensitization workshops on herbal medicine regulation in the districts of Adjumani, Moyo, Yumbe, Nebbi, Arua and Koboko.
NDA continued to run information spots on radios, newspapers and televisions to alert the public against drug hawkers, unlicensed outlets and use of SMS drug information facility. The messages are monitored by Synovate and also aimed to re-emphasize the public’s need to be more vigilant against unscrupulous or illegal operators.
NDA organized a meeting with the Media and Stakeholders to sensitize them about the current unethical advertising of herbal medicines in Uganda.
Held 18 FREE on air interactive one to two hours talk-shows on 14 FM radios and 3 televisions. Namely; Radio Sapientia, Prime FM, Namirembe FM, Kingdom FM, Voice of
[Annual Health Sector Performance Report 2012/13] Page 144
Africa, and, Bilali FM, Radio Simba, Pearl of Africa FM, Mboona FM, Etop Radio, Radio 5 fm, Top radio, Metro FM, Community FM, FM J, UBC TV, Top TV and Record TV.
Procured equipment for the laboratory to facilitate the testing of medicine samples:
A total of 348 batches of medicine samples were tested, 321 passed and 27 failed the tests. A total of 226 batches of male Latex condoms were tested; 221 passed and 05 failed. Out of 454 samples of medical gloves tested, 439 passed and 15 failed the test done at the NDQCL. 148 LLINs were tested and all passed.
NDA developed a customer identification system that gives unique identifiers (Facility Identification Numbers) to each drug outlet (pharmacy, drug shop and manufacturing facility) in order track each drug outlet in the country and also facilitate bank reconciliations.
Cabinet approved the NDA/NFDA transformation on 25th July 2012.
The Draft NFMA Bill was finalised and discussed by NDA Senior Management in February, April and May 2013. Further consultations with the MoH, MAAIF and stakeholders are ongoing.