ALISSA KOSKI & ELLIE MIRZABAGI JHSPH, BALTIMORE, MARYLAND PATIENCE COFIE PATH, GHANA RESEARCH SUPPORTED BY THE OXYTOCIN INITIATIVE PROJECT MANAGED BY PATH, WITH FUNDING FROM BILL & MELINDA GATES FOUNDATION Perceptions, use and quality of uterotonic substances in Ghana

Presentation Outline Study objectives and methods Key findings Conclusions

Research Objectives To explore knowledge, perceptions, and usage patterns of uterotonic drugs around birth And To assess the chemical potency of a sample of ampoules of oxytocin and ergometrine purchased at private pharmacies, chemical sellers and markets

Methods In-depth interviews Simulated client approach

Study Areas Northern (Savanna belt)  Yendi district Brong Ahafo (Forest belt)  Kintampo North district Western (Coastal belt)  Ahanta West district

Sampling and Content for Qualitative Interviews Sample of Health Care Providers  Snowball sampling began at the district health center and progressed until 10 interviews were conducted (all medical doctors in the district were often included in the sample) Sample of Community members:  A random selection was employed for community respondents Interview Topics  Knowledge of and experience with uterotonic substances  Indications for use and dosage  Perceived benefits of using uterotonic substances  Perceived risk of using uterotonic substances

Key Findings from In-Depth Interviews Place of labor and delivery are influenced by previous and current complication No evidence of pharmaceutical uterotonic use in communities No evidence of traditional (herbal) uterotonic use in health facilities Some midwives give oxytocin to augment prolonged labor at the peripheral/sub-district level Among midwives, knowledge of risk associated with uterotonics and appropriate dosages is inconsistent Traditional substances are used during pregnancy and births at home, but TBAs and new mothers are unaware of risks

Labor Augmentation Some midwives administer oxytocin to augment prolonged labor  Doctors are often unavailable or inaccessible to prescribe a uterotonic  Mid-level providers are forced to make a decision regarding course of treatment independently “It depends on the midwife who is there she can use her own discretion. Like if you are in the village and there is no doctor, you can’t consult anybody. You have to use your own discretion.” (Midwife, Yendi)

Knowledge of Risk Associated with Use of Uterotonic Drugs during Labour Knowledge of risk associated with use of uterotonic drugs during labor is at times incomplete and inconsistent among midwives “I’m yet to see any negative effect it [oxytocin] has on the patient because it makes work smooth, easy, yes very good.” (Midwife, Ahanta West) “...during labor if you give the oxytocin it can rupture the uterus so it going to use force and it can affect the baby too so we don’t give during labor.” (Midwife, Kintampo)

Use of Traditional Substances An enormous variety of traditional substances are used throughout pregnancy and labour  Indications for use vary and are at times unclear:  To make the fetus strong  To ease delivery  To ease stomach pain  To ‘make the baby lie down’ Very little consistency in usage patterns for traditional substances  Substances used  Route of administration  Dosage and frequency of use

Variety in Traditional Substances Kalgutim from Yendi, other substances from Kintampo North and Ahanta West

Simulated Client & Drug Potency Testing Research Assistants visited 78 randomly selected points of sale across all three districts, including:  Private pharmacy shops  Chemical shops  Markets  Mobile peddlers  (Health facility pharmacies) Statistically, we cannot claim this is a random sample, but it is better than a convenience sample Total ampoules collected for chemical testing: 101 Small sample – exploratory study

Key Findings from Drug Potency Testing Active ingredient ranges:  Oxytocin: 22.9% % Ergometrine: 0% % None (0%) of the ergometrine samples met specifications (active ingredient level between % of specified level)  55 of 56 ampoules had active ingredient l evel below specified levels (< 90%)  One ampoule showed 120.7% active ingredient  One ampoule showed 0% active ingredient – suggesting possible counterfeit drug 26% of oxytocin ampoules met specifications (90-110%)  74% of samples did not meet specifications and all showed active ingredient levels below specification levels (<90%) Only 4% of oxytocin ampoules were expired, none of the ergometrine ampoules were expired; The samples of oxytocin and ergometrine that did not meet specifications were purchased from both private pharmacies AND public health facility pharmacies

Interpretation of Drug Testing Results 1. We do not know WHY a majority of drug samples did not meet specifications  We do not know their quality at manufacture OR at departure from manufacturer  We do not know conditions during storage and transport  It is likely that important contributors to low levels of active ingredient are exposure to high temperatures (oxytocin, ergometrine) and/or light (ergometrine)  There was no testing for contamination or Ph

Conclusions and Recommendations Key Finding: Among midwives, knowledge of risk associated with uterotonics and appropriate dosages associated is inconsistent  Recommendation: Training, supervision and monitoring of midwives should be strengthened, re: AMSTL and PPH treatment Key Finding: TBAs and new mothers are unaware of risks associated with use of traditional substances during pregnancy and birth o Recommendation: Behavior change communication program at community level targeting mothers, TBAs and traditional leaders (Queen mothers etc) using both mass media and traditional channels

Conclusions and Recommendations Key Finding: Majority of available pharmaceutical uterotonics (oxytocin and ergometrine) at the peripheral level are of poor quality  Recommendation: Further market surveillance and testing of uterotonic drug quality is warranted  Investigation and improvements to the transportation, distribution and storage of uterotonic drugs  Enforcement of regulations on sale of uterotonic drugs (oxytocin and ergometrine) by the Ghana Pharmacy Council

Catherine Carr –

Thank you for your Attention and Support!