Strengthening pharmacovigilance in South Africa.

This report outlines findings and recommendations of a national pharmacovigilance workshop held in August 2012 in South Africa (SA). A survey of current pharmacovigilance activities, conducted in preparation for the meeting, identified multiple programmes collecting drug safety data in SA, with limited co-ordination at national level. The meeting resolved that existing pharmacovigilance programmes need to be strengthened and consolidated to ensure that important local safety issues are addressed, data can be pooled and compared and outputs shared more widely. Pharmacovigilance activities should inform treatment guidelines with the goal of improving patient care. A variety of pharmaco-epidemiological approaches should be employed, including nesting drug safety studies within existing sentinel cohorts and the creation of a pregnancy exposure registry. The attendees agreed on key principles that will inform a national pharmacovigilance plan and compiled a list of priority pharmacovigilance issues facing public health programmes in SA.

[Expanded Programme on Immunization: status and perspectives]. / Le Programme Elargi de Vaccination: situation et perspectives.

PIP: Several attempts were made without great success to improve vaccination programs in Rwanda before the Expanded Program of Immunization (EPI) was initiated in 1978. The program of immunization against polio, diphtheria, whooping cough, tetanus, tuberculosis, and measles has reached 80% of children in Rwanda at least once, but it has not yet had a demonstrable effect on mortality. Among the factors hindering achievement of program objectives were the insufficient information provided to parents and inaccessibility of program posts, but failure to mobilize the population was perhaps the greatest shortcoming. The EPI has had a particularly significant effect in reducing morbidity due to measles (from 155.0/10,000 in 1980 to 18.6 in 1987, after an epidemic in 1986) and whooping cough (16,187 cases in 1980 and 996 in 1987). The number of cases of polio, tetanus, and tuberculosis has however not declined significantly since 1978, and the number of cases of tuberculosis has actually increased. Many of the cases of tuberculosis and tetanus were in adults while the EPI stresses immunization of children, suggesting that greater efforts are needed to prevent these diseases in adults. The government of Rwanda with the aid of several international organizations plans to intensify the immunization program over the course of 5 years from 1988-92. The program has specific coverage goals culminating in 100% coverage of infants under 1 year for the 6 diseases and 100% coverage of pregnant women for tetanus by 1992. Program strategies will include decentralization of vaccination activities to health regions, integration of vaccination into the routine of health centers, and improved logistics and maintenance of the cold chain. An intensive communication program will seek collaboration of the political, religious, and educational authorities and use of available media to inform the population of the benefits and availability of the vaccination program.^ieng

Parasitologic and clinical efficacy of 25 and 50 mg/kg of chloroquine for treatment of Plasmodium falciparum malaria in Rwandan children.

The standard chloroquine treatment for Plasmodium falciparum malaria is 25 mg (base)/kg (C25) given over 3 days. In Rwanda, 50 mg/kg (C50) administered over 6 days has been recommended by the Faculty of Medicine, Ministry of Health. The present study compared clinical and parasitological efficacy and side effects of C25 and C50 in children less than or equal to 5 years of age. In vitro studies with chloroquine, mefloquine, pyrimethamine, and quinine were also performed. Ninety children were given a 3-day treatment of C25 and 48 a 5-day treatment of C50. Cases were followed for a total of 15 days (D0 to D14). At day 14, 73% of the C25 and 67% of the C50 children were still parasitemic, but the mean geometric parasite density had decreased by at least 96% in both groups. Clinically, 44 C25 and 12 C50 children had fever on day 0; by day 14 only 4 (9%) C25 and 4 (33%) C50 children still had fever. Side effects were found to be minimal. The chloroquine in vitro tests corroborated the in vivo findings. P. falciparum was found to be quite sensitive to mefloquine and quinine, but showed a high (59%) resistance to pyrimethamine.

AIDS definition for Africa.

PIP: The positive predictive values for HIV seropositivity are compared using WHO and US Centers for Disease Control (CDC) clinical case definitions of acquired immunodeficiency syndrome (AIDS), for cases in Rwanda, Africa. It is postulated that the article by Colebunders and co-workers should encourage clinicians and epidemiologists working in Africa to adopt the World Health Organization's provisional clinical case definition for AIDS. Although the predictive value for HIV seropositivity calculated in urban-based adults, as measured by the 2 different criteria, is comparable, (both criteria yield a 93% positive predictive value), this high % is not reached for cases of AIDS diagnosed for rural adults or urban-based children, using the WHO criteria. These data confirm the opinion of Colebunders and co-workers that regional variations in the prevalence of HIV infection can interfere with the positive predictive value for HIV seropositivity of this definition. Workers in other countries should test the validity of the WHO criteria in their own settings and evaluate the WHO case definition adapted to pediatric AIDS in Africa.^ieng

[Program to combat communicable diseases in children]. / Programme de lutte contre les maladies transmissibles de l'enfance

PIP: The project for the struggle against childhood diseases began in Rwanda in 1984. Lack of birth spacing, malnutrition, unhealthy environments and infectious diseases sicken and kill children in all of Africa, and many may be alleviated by simple measures. The project focuses on diarrhea and malaria, attempting to reduce mortality by 25%, administering chloroquine to children with fever and pregnant mothers for malaria, and oral rehydration therapy (ORT) for diarrhea. Goals are breastfeeding and gradual weaning being as universal as possible, and proper alimentation for sufferers of infant diarrhea. ORT is expected to be administered by the mother herself, and should reduce the 60% to 70% of diarrhea deaths caused by dehydration. Measles, whooping cough, neonatal tetanus, polio, diphtheria, and tuberculosis among children will be the targets of innoculation campaigns. All of the diseases are major child killers in Africa; measles are responsible for an estimated 31.3% of child deaths from 1 to 4, 10.3% in the 1st year of life. Community oriented primary care of the type necessary to execute these programs is not presently a priority among medical personnel; it should become an important component of medical education. Education to counter ignorance and the designation of the family as the primary instrument of good health will assure child survival and eliminate the need for multiple births to maintain the family.^ieng