Some pharmaceutical donations for tsunami victims ‘useless, dangerous’

COLOMBO: Several pharmaceutical donations for tsunami victims belonged to the non-list category while some were never registered for use in the country, the Healthcare and Nutrition Ministry said in a release yesterday.

A research by the Health Ministry Medical Supplies Division revealed that 43 per cent unique drug products for tsunami victims belonged to the “non list” category and 38 per cent of the drug substances were never registered for use in the country.

“Hence these drugs could be considered totally useless and sometimes dangerous,” the Ministry said. Twenty eight metric tonnes (50.5 per cent of the total donations) did not have expiry dates, the Ministry release said.

The Health Ministry carried out the research to determine the drugs appropriateness and the extent of compliance with WHO guideline.

The survey was carried out from March 2005 to July 2005 and included mainly donations received and handled by the Ministry’s Medical Supply Division.

The data was collected using investigator administered questionnaires from the Medical Supply Division and of administrators, pharmacists, stores managers and hospitals and internally displaced persons in camps from tsunami affected areas.

A product that had the same drug substance, in the same dosage form and in the same strength irrespective of their brand name and package size was classified as a ‘Unique Drug Product’ (UDP) to determine compliance with the World Health Organisation (WHO) Good Donation practices guideline the 2003 version of the WHO Essential Medicines List, (WHO-EML) the Ministry of Health expressed list of needed drugs (MHO List) and the Sri Lanka Hospital Formulary List of Medicines (HFL).

Useless drugs included medicine irrelevant to the epidemiological contest or unregistered drug substances.

Unusable drugs comprised medicine already expired on arrival or expired within a month of arrival and unidentifiable drugs (labelled in foreign languages, seven without labels).

Appropriateness was checked for by comparing with the WHO list of essential medicines in emergency situation.

The majority of the UDPs over 80 per cent were unsolicited, came unannounced and in unsorted boxes. Around 50 per cent of the donations were non-discriminatory collections of unused of private individuals collected at various centers and transported via international relief organisations.

These donations were a mixture of many different brands mixed with other relief items.

Forty three per cent of UDPs belonged to the “non-list” category (not listed in the MOH list, WHO-ML-HFL, WHO Emergency Medicines list) and 38 per cent of the drug substances were never registered for use in the country and could be considered totally irrelevant, useless and sometimes dangerous.

Twenty eight metric tonnes (50.5 per cent of the total donations) did not have expiry dates. Within those with the expiry date 6.5 per cent had expired on arrival and only 67 per cent complied with the WHO guideline requirement that after arrival in the recipient country all donated drugs should have a remaining shelf-life of at least one year.

A large proportion of non-essential drugs were irrelevant to the emergency situation. Sixty two per cent of the pharmaceutical products were labelled in languages not understood locally, 81 per cent were without package inserts and 15 per cent were without generic names.

Stockpiling of unnecessary or expired drugs cluttered up storage depots, resulting in shortages of space for proper storage of essential medicines, the Ministry said. Medicines purchased by local residents and organisations after consulting the Director MSD and over 90 per cent of the donation sent directly by Government on the MOH expressed list, had the required shelf life of over one year and were 100 per cent utilised.

The monetary value of one donation as claimed by the donor was equivalent to approximately 50 per cent of the public health drug budget of Sri Lanka.

All tsunami donations reduced the total drug budget for 2005 by only four per cent. The cost of destruction of some of the unwanted medicines was approximately Rs. 2.5 million.

The Ministry study showed that the donations were more a burden than of benefit to the country.

The study also highlighted that although guidelines on ‘Good Donation Practices’ had been in place and regularly updated on the available evidence since 1988 they have had very little impact to date on the quality of pharmaceuticals.