Background. Methods. Study Objectives. Methods - 2. Pilot Study

Transcription

1 Current Administration Practices and Preferred Formulations of s Medicines in Tanzania Background 8.1 million child deaths / year Lack of pediatric formulations for many medicines to treat common illnesses Dispensing adult dosage forms Inaccurate dosing Formulations can affect adherence Lisa V. Adams, MD, Dartmouth Medical School, USA Inadequate information exists about current practices and preferences, esp from resource-poor countries Study Objectives Assess current admin. practices by HCWs and parents/caregivers in Tanzania Determine formulation preferences by HCWs, parents/caregivers, and children Assess social significance of medicines in this context Methods National cross-sectional survey 200 Licensed HCWs 200 parents/caregivers (> age 18) 200 children (between ages 6-12) 10 regions of Tanzania, including Zanzibar Random sampling 1 rural and 1 urban district in each region Ethical review by WHO, Dartmouth, Muhimbili and National Institute of Med. Research, Tanzania Methods - 2 Pilot Study Survey Tools 3 surveys developed Peer reviewed Translation and back translation Supplemental free text questions (10%) 12 Interviewers Research methods and ethics training Worked in pairs Balanced gender, regional and disciplinary background Conducted March interviews Urban and peri-urban Dar es Salaam Results of pilot informed revision of survey tools and contributed to interviewer training Established Data QA procedures Concurrent permissions for full data collection obtained during this time

2 Results Interviews 206 children 202 parents/caregivers 202 HCWs Dates: 17 May 6 July 2010 Stratified by setting (urban vs. rural) and by education level (<primary school, primary school, >primary school) Parent/Caregivers Most in every subgroup preferred sweet tasting medicines Greater preference for sweet medicines among respondents with more than a primary school education (P=0.0001). A higher prevalence of no preference among those with less than a primary school education (P=0.0001) & HCWs Syrups preferred for newborns toddlers; pills to swallow preferred for primary school aged; preschool aged children in cross-over No differences when compared by setting or education level Overall, age group rather than setting or education level seemed to be the main driver for stated preferences.

3 Most recent illness reported by child Malaria/Fever: 50.6% Diarrhea/Stomach: 17.6% Cough/pneumonia/chest: 13.7% Most recent illness reported by parents/caregivers Malaria/Fever: 71.8% Diarrhea/Stomach: 20.8% Cough/flu/pneumonia/chest: 41.6% *Responses were not mutually exclusive. Stratified by setting (urban vs. rural) and age (6-8 vs. 9-12) Healthcare Workers Clear preference for sweet tasting medicines No differences in taste preferences by setting Though all groups preferred sweet tasting medicines, this preference statistically significant for children aged 6 to 8 When asked about formulation preferences: 62% (128/168) syrup; 14.6% (30/168) capsule/tablet/pill Healthcare Workers Discussion Study Participant Overview Even gender balance among HCWs and children; more female parents/caregivers Lower level HCWs see majority of children in Tanzania Illnesses reported consistent with known disease epidemiology Dosing medicines by HCWs Nearly all HCWs report using scales to determine weights of pediatric patients All urban and rural HCWs report basing medication dose on both weight and age for all (100%) infants

4 Discussion - 2 Discussion - 3 Administration Practices Crushed pills mixed with water most common method of admin. reported for recent illness Pills swallowed whole by older children Problems with palatability and vomiting Prescriptions for impossible fractions Current admin. practices of parent/caregivers did not differ by setting or level of education Potable water obtained when giving children medicines Bottled water in some cases similar usage rate across urban and rural areas and by education level Overall, age group is the main driver for medication formulation preferences expressed by parent/caregivers; did not vary by setting or education level. Strong preference for syrups for youngest age groups (newborns, infants and toddlers), pills to swallow for older children Benefits to packaging of medicines by age group, e.g., age group color-coded labels or packaging and/or age group color-coded administration instructions Discussion - 4 Overwhelming preference among all cohorts for sweet tasting medicines Lack of preference for chewable tablets by parent/caregivers may indicate unfamiliarity rather than a lack of desirability The reality Most children being given pills, crushed or whole Problems with dosing, palatability, and adherence Non-adherence linked to side-effects, bad taste and vomiting Exacerbated by breaking pills, leading to bitter taste Discussion - 5 HCWs prefer syrups for children regardless of setting GPs prefer syrups and chewable tabs compared to RNs Infrequent preference expressed for dispersible and chewable tabs Possible lack of familiarity of with these formulations Factors Influencing Prescribing Availability of meds main determinant of choice for HCWs (practical considerations vs. ideal preferences) Ease of administration and tolerability next most important determinants for HCWs (formulation issues) Conclusions There are many impediments to acceptable and accurate administration of medicines to children Current administration practices clearly suboptimal Associated with poor tolerability & the potential for under or over-dosing Parents/caretakers, children and HCWs in Tanzania have clear preferences for pediatric medication taste and formulations More similarities than differences between stratified subpopulations All expressed a strong preference for sweet tasting medicines, syrups for younger age groups Their responses should be used to inform the development, manufacturing, and marketing of pediatric medications for resource-limited setting Ensuring availability of medicines (and possibly reasonable cost) should remain an important goal of child medicines initiatives, along with child-friendly formulations for ease of administration Next Steps and Recommendations Future plans Preparing manuscripts for publication Qualitative data analysis social science literature Study being conducted in Ghana Lessons learned from Tanzania study informed survey revisions, study implementation, and data management Recommendations for Drug Manufacturers Results should be used to inform new formulation development Both biopharmaceutical issues and social acceptability crucial

5 Acknowledgements