1. CLICK TO ADD TITLE [DATE][SPEAKERS NAMES] The 6th Global Health Supply Chain Summit November 18 -20, 2013 Addis Ababa, Ethiopia Paper Analytical Devices for Screening Substandard Drugs in Kenya Dr. Mercy Maina

2. Objectives Highlight Substandard/Falsely-labeled/Falsified/ Counterfeit (SFFCs) drugs as a global health challenge Evaluate the impact of SFFCs Discuss the challenges faced with dealing with SFFCs Introduce and demonstrate the use of Paper Analytical Devices (PADs) Briefly describe the use of PADs in western Kenya.

3. Introduction Substandard/Spurious/Falsely-labeled/Falsified/Counterfeit (SFFCs) are a global health challenge

4. Impact of SFFCs

5. Challenges in dealing with SFFCs HPLC machine and accessories Approximate cost : $20 000 Drug Identification kits Approximate cost: $ 2000

6. Innovation

7. Paper Analytical Devices (PADs) PADs: Portable Requires minimal technical expertise Provides results in 5 mins Potential to incorporate computer software analysis Applies the principles of liquid chromatography and combines an array of chemical tests on patterned paper to determine the quality of a medication.

8. Running the test Step 1 Apply the tablet across the lanes on the device Step 2 Dip one edge of the device in to water and let the test run Step 3 Interpret the results using a color based key

9. Examples of run Tests

10. Ampicillin and Amoxicillin Ampicillin B: yellow orange C: dark blue D: transient blue F: Green Amoxicillin B: green C: dark blue F: Green K:orange/brown

11. The Project

12. Sites The Academic Model Providing Access to Health care (AMAPTH), is a health care delivery program located in western Kenya. AMPATH serves a catchment population of approximately 3.5 million people in >250 care sites Its pharmacovigilance unit is implementing the use of Paper Analytical Devices (PADs) in screening the quality of drugs.

13. Use of PADs in western Kenya The objective of the project is to optimize and validate the use of PADs in western Kenya. Two phases, optimization (phase 1) and validation (phase 2). For phase 1, 60 samples of amoxicillin, ampicillin, amoxicillin­- clavulanic acid and acetaminophen tablets were purchased by secret shoppers from registered and unregistered pharmacies in western Kenya. For phase 2, 400 samples of one of the above beta ­lactams will be purchased for validation.

14. Results Physical layout of the device has changes to include More lanes → more drugs can be tested using the same device More stable reagents on the device →

15. Results 180 beta­ lactam antibiotics and 60 acetaminophen tablets samples have been purchased from 90 pharmacies in western Kenya and analyzed using the PAD None of these have shown any unexpected excipients or APIs.

16. Results Of these, 35 samples have been tested using HPLC. None of the HPLC tested samples have contained unexpected APIs or excipients, although four samples, mainly the amoxicillin­ clavulanic acid tablets, had API concentrations more than 15% larger or smaller than the reported contents. In a peer-reviewed lab validation study, the paper tests detected TB drugs and beta lactam antibiotics, as well as 13 substitute pharmaceuticals or inert fillers that might be used in fake formulations. Sensitivity ranged from 100% to 73%, selectivity from 97%-100%.

17. Conclusion From the preliminary results PAD provides a quick and inexpensive device to screen for the presence of APIs and unexpected excipients in drug formulations. PAD can be easily incorporated in monitoring the quality of drugs in supply chains.

18. References Newton PN, Green M, Fernandez M (2010) Impact of Poor Quality Medicines in the “developing world” Trends Pharmacol Sci. 31(3-3): 99–101. Weaver A., Reiser H., Barstis T., et al Paper Analytical Devices for Fast Field Screening of Beta Lactam Antibiotics and Antituberculosis Pharmaceuticals, Anal. Chem., 2013, 85 (13), pp 6453–6460 WHO. Medicine http://www.who.int/medicines/services/counterfeit/impact/Impact F_S/en/index1.html Accessed on the 10 Nov 2013. http://www.who.int/medicines/services/counterfeit/impact/Impact F_S/en/index1.html