Background
Methods
Results
Identification and categorization of pharmacovigilance and quality assurance activities
PMI, N = 39, N (%) | Global Fund N = 107, N (%) | World Bank N = 13, N (%) | Total, N = 159, N (%) | |
---|---|---|---|---|
WHO Region | ||||
Americas | 0 (0) | 8 (7.5) | 0 (0) | 8 (5.0) |
Africa | 37 (94.9) | 64 | 11 | |
Eastern Mediterranean | 0 (0) | 1 (0.9) | 1 (7.7) | 2 (1.3) |
East Asia and Pacific | 2 (5.1) | 16 (15.0) | 1 (7.7) | 19 (12.0) |
South Asia | 0 (0) | 13 (12.2) | 0 (0) | 13 (8.2) |
Europe | 0 (0) | 5 (4.7) | 0 (0) | 5 (3.1) |
World Bank income group | ||||
Upper-middle income | 4 (10.3) | 8 (7.5) | 0 (0) | 12 (7.6%) |
Lower-middle income | 8 (20.5) | 45 (42.1) | 3 (23.1) | 56 (35.2%) |
Low income | 27 (69.2) | 54 (50.5) | 10 (76.9) | 91 (57.2%) |
Amount of granta
| 12.7 million USD (3–70 million USD) | 30.0 million USD (0.6–284 million USD) | 82.0 million USD (46–500 million USD) | 33.3 million USD (0.6–500 million USD) |
Pharmacovigilance mentions | ||||
Grant mentions pharmacovigilance | 21 (53.9) | 2 (1.9) | 0 (0) | 23 (14.5) |
Grant provides budget line for pharmacovigilance | 21 (53.9) | 16 (15.0) | 0 (0) | 37 (23.3) |
Pharmacovigilance area of interest | ||||||
---|---|---|---|---|---|---|
Activity type | Adverse events | Counterfeit drugs | Drug quality assurance | PV NOS | N/A | Total |
Behaviour change communication | 6 (85.7) | 1 (14.3) | 7 (2.4) | |||
Improve regulatory system | 1 (3.1) | 6 (18.8) | 14 (53.1) | 11 (34.4) | 32 (11.1) | |
Improving supply chain | 1 (6.7) | 7 (46.7) | 7 (46.7) | 15 (5.2) | ||
Laboratory supplies and training | 6 (15.4) | 27 (69.2) | 6 (15.4) | 39 (13.5) | ||
Operations research | 2 (66.7) | 1 (33.3) | 3 (1.0) | |||
Surveillance | 3 (8.3) | 10 (27.8) | 21 (58.3) | 2 (5.6) | 36 (12.5) | |
Training/capacity building | 1 (9.1) | 6 (54.5) | 4 (36.4) | 11 (3.8) | ||
Pharmacovigilance NOS | 2 (6.3) | 1 (3.1) | 23 (71.9) | 6 (18.8) | 32 (11.1) | |
Pharmacovigilance NOS-unfunded | 26 (100) | 26 (9.0) | ||||
Surveillance-not funded | 5 (100) | 5 (1.7) | ||||
Context onlya
| 39 (100) | 39 (13.5) | ||||
Historical activityb
| 12 (17.4) | 37 (53.6) | 17 (24.6) | 3 (4.4) | 69 (24.0) | |
Total | 14 (4.9) | 40 (13.9) | 154 (53.5) | 49 (17.0) | 42 (14.6) |
Pharmacovigilance area of interest | ||||||
---|---|---|---|---|---|---|
Activity type | Adverse events | Counterfeit drugs | Drug quality assurance | PV NOS | NA | Total |
Behaviour change communication | 3 (75.0) | 1 (25.0) | 4 (2.1) | |||
Improve regulatory system | 5 (19.2) | 12 (46.2) | 9 (34.6) | 26 (13.8) | ||
Improving supply chain | 5 (45.4) | 6 (54.5) | 11 (5.9) | |||
Laboratory supplies and training | 4 (18.2) | 17 (77.3) | 1 (4.5) | 22 (11.7) | ||
Operations research | 2 (100) | 2 (1.1) | ||||
Pharmacovigilance NOS | 2 (8.7) | 5 (21.7) | 15 (65.2) | 1 (4.3) | 23 (12.2) | |
Surveillance | 2 (9.5) | 5 (23.8) | 13 (61.9) | 1 (4.8) | 21 (11.2) | |
Training/capacity building | 5 (55.6) | 4 (44.4) | 9 (4.8) | |||
Surveillance-not funded | 1 (100) | 1 (0.5) | ||||
Pharmacovigilance NOS-unfunded | 6 (100) | 6 (3.2) | ||||
Context onlya
| 35 (100) | 35 (18.6) | ||||
Historical activityb
| 6 (13.3) | 26 (57.8) | 12 (26.7) | 1 (3.8) | 45 (23.9) | |
Total | 7 (3.7) | 22 (11.7) | 94 (50.0) | 35 (18.6) | 36 (19.1) | 188 (100.0) |
Pharmacovigilance area of interest | ||||||
---|---|---|---|---|---|---|
Activity type | Adverse events | Counterfeit drugs | Drug quality assurance | PV NOS | NA | Total |
Behaviour change communication | 3 (100) | 3 (3.2) | ||||
Improve regulatory system | 1 (16.7) | 1 (16.7) | 2 (33.3) | 2 (33.3) | 6 (6.3) | |
Improving supply chain | 1 (25.0) | 3 (75.0) | 4 (4.2) | |||
Laboratory supplies and training | 2 (14.3) | 7 (50.0) | 5 (35.7) | 14 (14.7) | ||
Operations research | 1 (100) | 1 (1.1) | ||||
Pharmacovigilance NOS | 1 (11.1) | 8 (88.9) | 9 (9.5) | |||
Surveillance | 1 (6.3) | 4 (25.0) | 10 (62.5) | 1 (6.3) | 16 (16.8) | |
Training/capacity building | 1 (50.0) | 1 (50.0) | 2 (2.1) | |||
Surveillance-not funded | 3 (100) | 3 (3.2) | ||||
Pharmacovigilance NOS-unfunded | 17 (100) | 17 (17.9) | ||||
Context onlya
| 3 (100) | 3 (3.2) | ||||
Historical activityb
| 6 (25.0) | 11 (45.8) | 5 (20.8) | 2 (8.3) | 24 (25.3) | |
Total | 5 (5.3) | 18 (18.9) | 57 (60.0) | 13 (13.7) | 5 (5.3) | 95 (100) |
Qualitative findings
(Angola, PMI 2016 Grant).“PMI will continue to strengthen Ministry of Health in pharmaceutical management. PMI will provide technical assistance to the DNME, the Inspectorate General, and the NMCP in all steps of the procurement and distribution process: quantifying and forecasting demand of malaria commodities; procurement of quality malaria commodities; testing and quality assurance/quality control QA/QC of malaria commodities; planning distributions in accordance with needs; and distributing in an efficient and timely manner”
(Guinea PMI 2015 Grant).“Improve drug regulatory capacity: Continue to support improvement of the regulatory and oversight capacities of the DNPL, revision of national list of essential drugs, and enhanced control of compliance to the pharmaceutical policy and regulations by PCG and the private pharmacies network. Capacity building of the pharmaceutical system will include improving capacity to combat counterfeit drugs and the illicit sale of drugs. ($250,000)”
(Mali, PMI 2016 Grant).“Strengthen the national laboratory: Provide additional training and supervision to improve the functioning and quality of the national laboratory while maintaining the current MQM programme. Develop a five-year strategic plan outlining specific areas to strengthen, how to improve quality, and the sustainability of the laboratory in regards to maintaining staff, steps to take to achieve ISO 17025 accreditation, and improving the working relationship with the national regulatory authorities around counterfeit and sub-standard medicines. (Laboratoire National de Santé) ($100,000)”
“Evaluation of single-dose primaquine roll out ($500,000): This study will systematically monitor the effects of primaquine roll out on malaria transmission and reported drug toxicity and health costs through careful review of routinely collected malaria incidence data and cross sectional surveys to assess parasite burden and multiplicity of infection.”
These activities included ensuring drug quality throughout the supply chain within a country. In addition, the standardized language of the Global Fund grants also required countries to “monitor adverse drug reactions according to existing international guidelines,” as illustrated in a Global Fund grant to Tanzania.“…the Principal Recipient shall ensure that random samples of Finished Pharmaceutical Products financed under the Agreement are obtained at different points in the supply chain, from initial receipt of the products in the Host Country to the delivery of those products to patients. Such samples shall be sent to one of the following laboratories for Quality Control testing…”.