Technology Revolutionizing Health Safety Code Enforcement in Kenya

1. Use of Technology in the Fight against Illegal Pharmacies in Kenya: A case of the Health Safety CodeLucia Keter, Joyce Ondicho, Lilian Koech, PhidelisWakoli, Beatrice IrunguKenya Medical Research Institute, Centre for Traditional Medicine and Drug Research, P.O. Box 54840-00200, Nairobi, Kenya 7th EAHSC Conference 27th – 29th March 2019

2. INTRODUCTION • Community pharmacies and pharmacists are the main providers of primary healthcare worldwide through dispensing of prescriptions medicines to the patients with care, accuracy, and legality (WHO, 1993) • It is also the main provider of primary health care to low income groups for communicable and non-communicable diseases in many low and middle income countries since they act as the first point of health care contact for many patients (Mackey and Liang, 2011) • However, the modern pharmaceutical supply chain from the manufacturer to patient is complex giving opportunity for falsified or substandard products to infiltrate the market (Amin and Snow, 2005). • Studies have shown that unlicensed pharmacies are a main source of falsified and substandard medicines for patients around the world and especially in in resource-poor countries. • This is due to lack of sufficient infrastructure and technical expertise to regulate and detect criminal activity; In addition to a growing consumer base for prescription drugs and the need to access drugs at lower prices (Mackey and Liang, 2011) • Surveys and studies have shown that an estimated 30% of drugs sold in Kenya are counterfeit (IMPACT, 2006) • The consequence of counterfeits include therapeutic failure, rise of drug-resistant pathogens, adverse effects, inaccurate reports of drug resistance, increased morbidity and mortality. Main Theme: Technology for health systems transformation and attainment of the UN-Sustainable Development Goals.

3. INTRODUCTION • However, technology has revolutionized communication, trade and health services globally. • The Pharmacy and Poisons Board (PPB), who is the regulatory body in charge of the practice and the pharmaceutical products in Kenya, have taken advantage of the extensive mobile phones presence in the Country and introduced the Health Safety Code (HSC) aimed at weeding out quacks who run illegal pharmacies. • The innovative technology involved using of a mobile product authentication solutions and mobile enabling consumers to verify and report if an outlet is illegal using mobile technology. • The HSC enables any customer to ascertain legitimate pharmacists and premises through a free mobile phone short message service (SMS). • Hence, the aim of the study was to assess the impact of technology in the fight against illegal pharmacies, falsified and substandard medicines in Nairobi, Kenya. Main Theme: Technology for health systems transformation and attainment of the UN-Sustainable Development Goals.

4. MATERIALS AND METHODS • Market surveillance was first undertaken to determine the legitimacy of the pharmacy premises within Nairobi County in 2018 • Through adoption of the Krejie and Morgan sample table (Morgan and Krejcie, 2012), a total of 315 private hospitals and community pharmacies in purposively selected wards in all the seventeen Sub-Counties in Nairobi were sampled. • The selection of the wards was based on the socio-economic status; upper, mid and lower. • The Health Safety Code (HSC) was used to determine the registration status of each premise through identifying and recording of the HSC and the physical location of each premise using a data capture sheet. • The HSC status were later confirmed through SMS sent to the Pharmacy and Poisons Board (PPB) provided toll free number and the response outcome recorded in the data capture form. • Analysis were done by comparing the SMS response and the precise recorded physical location of each premise Main Theme: Technology for health systems transformation and attainment of the UN-Sustainable Development Goals.

5. RESULTS AND DISCUSSION TABLE: PREMISES AND PHARMACISTS REGISTRATION STATUS AS PER THE HEALTH SAFETY CODE (HSC) Main Theme: Technology for health systems transformation and attainment of the UN-Sustainable Development Goals.

6. RESULTS AND DISCUSSION • Seventy nine (25.08%) Pharmacies visited had their HSC clearly displayed of which 63 were registered. • These registered pharmacies are those that complied with the regulator’s requirement for legitimate premise location, qualified pharmacists or pharmaceutical Technologist, up to date annual registration licenses and appropriate premises conditions. • Four (4) were registered but the premise location were not valid while registration had been revoked for 10 premises. • According to the PPB, premise registration may be revoked due to failure to renew annual premise registration or absence of legitimate superintendent personnel. • The 4 pharmacies with invalid premises are Pharmacies that were within the Nairobi County yet official the are registered to be in other Counties Such as Mombasa, Kisii, Kakamega and Kiambu Counties. These were all located within the informal settlement of our study sites. Shifted premises are illegal premises according to PPB regulations • Two premises displayed invalid registration while the majority (75.24%) of the premises were either not registered or the HSC was not visibly displayed. Main Theme: Technology for health systems transformation and attainment of the UN-Sustainable Development Goals.

7. CONCLUSION AND RECOMMENDATION • The widespread of illegal Pharmacy outlets threatens patient safety and public health. • They carry with them numerous disadvantages such as lack of meaningful interaction with physician and pharmacists, misdiagnosis and inappropriate use of medicines among others • In this study, only 20 % of the outlets visited were legitimate according to the PPB requirements. • Hence, there is need for increase public awareness on the importance of the HSC in the effort to weed out illegally operated pharmacies in Kenya. • There is need to encourage legally registered premises to display their HSC in a more visible place within their premises in order to enhance customer confidence. • This information on the registration status of the premises will be correlated to the quality analysis outcome of co-trimoxazole (trimethoprim-sulfamethoxazole), a broad spectrum antibiotic that provides benefits for adults and children, reducing morbidity and mortality especially to HIV infected individuals, in Nairobi County. Main Theme: Technology for health systems transformation and attainment of the UN-Sustainable Development Goals.

8. REFERENCES • Amin, A., and Snow R., 2005. Brands, costs and registration status of antimalarial drugs in the Kenyan retail sector. Malaria Journal 4(36). DOI: 10.1186/1475-2875-4-36. • International Medical Products Anticounterfeiting Taskforce (IMPACT), 2006. Counterfeit Medicines: an update on estimates 15 November 2006 Global pharmaceutical market shares are 83% for developed markets, and 17% for developing world. Based on audited IMS sales data, 2005 publicly available at http://www.imshealth.com/ims/portal/front/articleC/0,2777,6599_77478579_77479643,00.html • Mackey T.K. and Liang B.A., 2011. The Global Counterfeit Drug Trade: Patient Safety and Public Health Risks. Journal of Pharmaceutical Sciences, 100 (11): 4571 – 4579 • Morgan, D., and Krejcie, R. (2012). Sample Size Determination Using Krejcie And Morgan Table. Kenya Projects Organization (KENPRO). • WHO, 1993. The role of the Pharmacist in the Health Care System. Report of the WHO meeting in Tokyo, Japan Main Theme: Technology for health systems transformation and attainment of the UN-Sustainable Development Goals.

9. ACKNOWLEDGEMENT • The Director KEMRI • Wellcome Trust for funding • Organizers and Sponsors of the 7th EAHSC Conference • CTMDR Technical staff • Study participants • Conference participants Main Theme: Technology for health systems transformation and attainment of the UN-Sustainable Development Goals.

10. THANK YOU Main Theme: Technology for health systems transformation and attainment of the UN-Sustainable Development Goals.