Use of Mobile Phones for Monitoring Adverse Drug Reaction in Pharmacy and Drug Stores in Ishaka, Uganda - a Pilot Assessment of Willingness to Report.

Aim: We investigated reporting of Adverse Drug Reaction (ADR) following use of drugs purchased from open system pharmacy (OSP) and drug stores, and the effectiveness of mobile phones for reporting drug reactions and detection of drug interactions. Study Design: The study was descriptive and inceptional. Place and Duration of Study: Selected Pharmacies and drug stores in Ishaka Municipality, Bushenyi, Uganda, between January and April 2012. Methodology: A total of 190 participants purchasing prescription and non prescription drugs in the drug outlets were enrolled and drug purchases documented. Structured interviews were used to assess any existing system of ADR tracking. Possible interactions were assessed using electronic checkers software on drug combinations prescribed or purchased. Mobile phone calls were used to monitor the reporting potential, use of medication and events or reactions following drug use for ADRs. Results: No formalized pre-study system was found for tracking ADR in the OSP and drug stores studied. Participants purchased 420 different medications with 55.8% without prescription. Antibiotics, analgesics and antimalarials ranked most purchased medications. All participants carried at least a functional mobile phone and demonstrated interest to report ADRs. Mean Effective Mobile Phone Contact Ratio (MEMPCR) for ADR monitoring was 0.91+0.2 and follow-up was 96% (n=183) and 89.5% on days 0 and 4 respectively. Interactions predicted were in 24.8% (31). Significant reporting of at least one of 404 reactions occurred within 72hr compared to 96-120hr (P=0.003). Two participants had reaction leading to discontinued use of Cotrimoxazole. Conclusion: Use of mobile phones and drug interaction checker software may avail early detection of ADR and reporting. Facilitated toll free- call service may be an effective means of extending the scope of ADR tracking in addition to Yellow Card scheme, and augment involvement of pharmacists and consumers in safe use of drugs.

Effects of pyrimethamine-sulphadoxine, chloroquine plus chlorpheniramine, and amodiaquine plus pyrimethamine-sulphadoxine on gametocytes during and after treatment of acute, uncomplicated malaria in children

The effects of pyrimethamine-sulphadoxine (PS), chloroquine plus chlorpheniramine, a H1 receptor antagonist that reverses chloroquine resistance in Plasmodium falciparum in vitro and in vivo (CQCP), and amodiaquine plus pyrimethamine-sulphadoxine (AQPS) on gametocyte production were evaluated in 157 children with acute, symptomatic, uncomplicated falciparum malaria who were treated with these drugs. PS was significantly less effective than CQCP or AQPS at clearing asexual parasitaemia or other symptoms of malaria. Gametocyte carriage on days 3, 7, and 14 were significantly higher in those treated with PS. The ratio of the density (per æl blood) of peripheral young gametocyte (PYG), that is, < stage III to peripheral mature gametocyte (PMG), that is, stage IV and V, an index of continuing generation of gametocytes, rose to 1 by day 7 of treatment in those treated with PS, but remained consistently below 1 in the other treatment groups. PYG-PMG density ratio increased significantly from day 0-14 in those treated with PS and CQCP (chi2 = 76, P = 0.000001 and chi2 = 42.2, P = 0.00001, respectively) but decreased significantly in those treated with AQPS (chi2 = 53.2, P = 0.000001). Both PS-sensitive and -resistant infections generated PYG (18 of 29 vs 13 of 20, chi2 = 0.04, P = 0.93) but PYG was present only in those with resistant response to CQCP. Combination of PS with amodiaquine (AQ), that is, (AQPS) resulted in less production of PYG, but in this setting, PYG was not indicative of response to AQPS. These data indicate that PS enhanced production or release of young gametocytes when used alone, but generated less young gametocytes when used in combination with AQ. PYG may be used as an indicator of response to CQCP but not PS or PS-based combination drugs.

Effects of antifolates - co-trimoxazole and pyrimethamine-sulfadoxine - on gametocytes in children with acute, symptomatic, uncomplicated, Plasmodium falciparum malaria

Antimalarial drugs including the antifolate, pyrimethamine-sulfadoxine (PS), can modulate the prevalence and intensities of gametocytaemia following treatment of acute malaria infections. They may also directly influence the transmission and spread of drug insensitivity. Little is known of the effects of co-trimoxazole (Co-T), another antifolate antimalarial, on gametocytes in children with acute malaria infections. We compared the effects of Co-T and PS on the prevalence and intensities of gametocytaemia and gametocyte sex ratios in 102 children aged 0.5-12 years presenting with acute and uncomplicated falciparum malaria. Compared to pre-treatment, both drugs significantly increased gametocyte carriage post-initiation of treatment. However, gametocyte carriage was significantly lower on day 14 in those treated with Co-T than PS. Significant increase in gametocytaemia with time occurred in PS - but not Co-T-treated children. Kaplan-Meier survival curve of the cumulative probability of remaining gametocyte-free in children who were agametocytaemic at enrolment showed that by day 7 of follow up, children treated with PS had a significantly higher propensity to have developed gametocytes than in Co-T-treated children (Log-rank statistic 5.35, df = 1, P = 0.02). Gametocyte sex ratio changes were similar following treatment with both drugs. PS and Co-T treatment of acute malaria infections in children from this endemic area is associated with significant increases in prevalence and intensities of gametocytaemia but these effects are more marked in those treated with PS than Co-T.