1 Department of Pharmacology, University of Colombo, Sri Lanka. 2 Ministry of Health, Sri Lanka.

1. 1 Tsunami Drug Donations in Sri Lanka: Have the WHO Guidelines on Drug Donations been Effective in Meeting Public Health Pharmaceutical Needs in Times of Disaster? Rohini Fernandopulle1,Hemantha Beneragama2,Priyadarshini Gallappatthy1,Nilesh Fernandopulle2. 1Department of Pharmacology, University of Colombo, Sri Lanka. 2Ministry of Health, Sri Lanka.

2. What is known on medicines donation? 1980’s: main complaints: → • Arrived after or near expiration. • Inappropriate or unsuitable to the recipient country • Sent without first asking the recipient about their needs, without prior notification or shipping documents. • Were inadequately packaged or labelled with no prescriber or patient information. Development of guidelines for donors and recipients. • Christian Medical Commission of the World Council of Churches; 1990. ↓ • World Health Organization. Guidelines for Drug Donations. Geneva: WHO; 1996. • WHO. Interagency Guidelines for Drug Donations; 1999.

3. Guideline Selection Donations should be based on expressed needs, appear in the national EML/WHO – EML. Donations of vaccines, be directed through a responsible agency. Presentation, packaging and labelling Labelled in a language that is understood. Contain the INN , batch No. dosage form, strength, name of manufacturer, quantity in container, storage conditions and expiry date. The drugs should not be mixed with other supplies in the same carton Information and management. Costs of international and local transport, warehousing, port clearing, storage and handling should be paid by the donor. Quality assurance and shelf life • Drugs issued to patients, or free samples to health professionals should not be donated. • Donated drugs /INN should be approved for use in recipient country. • Should have a remaining shelf-life of at least one year after arrival.

4. Objectives and Methodology • To categorise the medicines into the ATC drug classification system, to quantify and cost. • To assess the level of adherence to the 1999 edition of the WHO Guidelines for drug donation. • To generate evidence on effectiveness of the WHO guideline and make recommendations for a national policy on pharmaceutical donations. • Study period: March to July 2005. • Tools: questionnaires for MSD, hospital pharmacist, refugees. • Database to inventory medicines. • Adherence to guideline determined on:selection, quality assurance and shelf life, presentation packing and labelling, information and management. • Destroying costs calculated using available documents.

5. Results: General Information • 278 donors. • 98 local individuals and organisations. • 150 Foreign organisations, companies and individuals. • From over 30 countries. • 86% were under names of individuals. • ≈50% were adhoccollections of medicines from individuals, transported via international relief organizations including the International Red Cross Federation. Quantity donated • Total weight = 55 tons. (150 tons had expired and removed to be destroyed). • Total number of single units = 248 × 106. • Number of INNs 769. • Oral 71%, parenteral 15%. • For580,000 injured and displaced. Medicines per person = 434.65 units.

6. Results: Selection The top 5 categories J, N ,C , A, R Vaccines:hepatitis A, B, influenza and tetanus toxoid were not sent from a responsible agency, UNICEF. Inappropriate medicines: etoposide, doxorubicin, flutamide, exemestane. Withdrawn drugs: dipyrone, cisapridedihydroergocristine. Radiolabelled Progesterone-Iodine 125.

7. Results: Quality Assurance and Shelf Life • 2% of medicines, labelled as free professional samples. • 38% INNs not registered in Sri Lanka. • Of the 55 metric tons, 28 metric tons (50.5%) did not have the expiry dates. • 57% unusable from the start. Presentation, Packaging and Labelling

8. Information and management Storage Donated medicines were stored in hospital corridors, refugee camps, temples, churches, schools and hired warehouses. • ≈150 metric tons of useless medicines destroyed at a cost of LKR 2.6 million. • Cost of local transport, port clearing, storage and handling not by the donor. • The monetary value claimed by one donor in USA had the purchasing power to buy 50% of the medicines for the state sector. But tsunami donations reduced the total drug budget (4.24 billion) in 2005 by only 4%.

9. Compliance with the guidelines resulted in 100% usable medicines. Key messages The WHO guideline has been available for 5 years, but it has not been effective in preventing useless donations in resource limited settings in times of disaster – Banda Aceh reported similar findings. • Not having a national policy and guideline on medicines donation before the disaster was a major contributory factor. • Soon after disaster it was known that most medicines were useless but country was help less; came unannounced to the MSD, airport or port. • The WHO guideline is clear, comprehensive, practical and implementable if donors follow it and recipients enforce it. The other tsunami affected countries; India and Thailand immediately communicated via press release that they will not accept medicines as donations.

10. Policies and programs to improve donations Immediately Long term Request National Drug Regulatory Authorities of donating countries to give a clearance certificate prior to shipping / airlifting, baggage carrying of medicines for donation based on the WHO guideline. Education of the public, customs officials and relevant organisations on Good Donation Practices. • Dissemination of the findings to all international organisations to prevent repetition. • WHO to select medicines donation as a theme to raise awareness on the extent of the problem, as natural disasters are quite frequent. • For WHO to send out short messages when severe disasters occur through the mass media on availability and adherence to the guideline.

11. Future research? Long term continued WHO/ HAI to initiate a website for reporting bad donation practices. Local WHO offices to identify activities on raising awareness on good donation practices. • Research on awareness of “Good Donation Practices” guideline at the level of the • Government • International Organisations • Public • Public: maybe incorporated into the guideline on “How to investigate the use of medicines by consumers” • Impact of useless donations on the environment.