News
No more short-expiry drugs
View(s):- Health Ministry takes steps to streamline pharmaceutical drugs and devices donated to Sri Lanka
By Namini Wijedasa
The Ministry of Health (MoH) has decided that all pharmaceutical drugs and devices donated to Sri Lanka must have six months of validity at the time of arrival in the country, after unspecified quantities were forced to be discarded over the past year owing to expiry.
It has been ruled that drugs and devices in pre-packed pallets will only be accepted provided the majority of items within were deemed “essential” by the health sector, said Anver Hamdani, Coordinator for Health Care Donor Activities at the MoH. And donors will be informed that they must not dispatch any shipments until Sri Lanka’s medical sector regulator grants approval.
These conditions were introduced to further streamline the process, Dr Hamdani said. They throw light on several serious challenges–both of domestic and international creation–that have dogged donations that became necessary during Sri Lanka’s dire economic crisis.
Short-expiry drugs and devices
Over the past year, doctors routinely observed that some donated drugs were short-expiry. According to published scientific research, low- and middle-income countries struggle with disposing of large stocks of pharmaceuticals that are past their expiry dates, many of which were the result of donations.
“If not adequately monitored or regulated, expired pharmaceuticals may be repackaged and sold as counterfeits or be dumped without any thought of the potential environmental damage,” a recent World Health Organisation bulletin on the Ugandan perspective warns. It said many low- and middle-income countries must, among other things, strengthen the regulation of drug donations.
It is also widely known that pharmaceutical companies, particularly in the US and other Western countries, receive generous tax write-offs for their charitable donations. They use this opportunity to ship off their short-expiry products to developing countries which are then left with the challenge of disposal, as many drugs are often not on the requirement lists of receiving nations.
This practice clearly points to dumping. But countries like Sri Lanka–which “didn’t even have a paracatemol at times, because of the economic crisis”–were helpless enough to absorb it all.
The Sunday Times could not obtain complete information on the quantities or types of donated medication or devices that were short-expiry and had expired without being used. There was no collated data on how much were still in stores or how many had been destroyed and by what methods.
But analysis of publicly available circulars issued by the MoH Medical Supplies Division (MSD) showed that the problem of donated short-expiry drugs cropped up repeatedly throughout 2023.
The MSD issued several notices warning of donated medications being both close to expiry and non-moving, urging hospitals to use them. “The consumption rate of this medicine is considerably low and this may lead to stock accumulation and expiration at MSD warehouses,” the circulars said, referring to both formulary and non-formulary (not commonly used in Sri Lankan hospitals) products.”
Doctors were entreated to use the medication “where it is needed [sic] as far as possible prior to expiry”. Our research showed some circulars even pertained to drugs that would go out of use within days, not weeks or months. The problem was particularly pronounced in the latter half of this year. And where these products ended up is not publicly accessible information, although it strictly should be.
Unnecessary drugs or devices usually came from the West in pallets that were “made for donations”. These are given to organisations that dispatch them to various countries.
But Dr. Hamdani assured that of the drugs that Sri Lanka had accepted and were of use to doctors (as opposed to products in pre-packed pallets that the country did not need but were required to take), 70 percent were consumed and only around 30 percent went to waste.
He also pointed out that certain donations had filled a pressing and urgent gap during a time of great need. “People only see the missed goal in a football match,” he mused.
Health Ministry accepts there’s a problem
In late September 2023, the Health Ministry issued a circular titled “Procedure to be followed when medical supplies received as donations become unserviceable due to passing the date of expiry or any other reasons”.
It admitted that a “smaller portion (in comparison to the value and number of total receipts)” of donations had become unusable for eleven reasons.
For instance, medical supplies had been received with limited residual shelf life while “some of the medical supplies in the same container had expired or were closer to expiry at the time of clearance”.
“Even though received invoices indicated a longer shelf life, the medical supplies had passed dates of expiry or neared the dates of expiry due to donors taking a considerable time to ship/airlift the relevant consignments,” it said.
“Receipts of non-formulary items, unregistered items, or items with dosage forms not used in Sri Lanka in the same container with usable medical supplies,” it continued.
“Information is not printed or provided in English. (There is no possibility for pre-sample checking or prior review of the content of labelling,” it said. “Donated surgical consumables may not be compatible with the existing equipment in institutions.”
“Medical supplies received in quantities that cannot be consumed within their shelf lives,” was another listed reason.
Then there were “donated non-formulary medicines” which “cannot be used as short-term alternatives for patients on long-term therapy for chronic diseases as it is not clinically recommended”; “receipts of items without invoices with invoiced medical supplies on certain occasions”; and “disturbance of cold chain maintenance for heat-sensitive medical supplies”.
The circular also said this: “Medical supplies have passed expiry dates or neared the expiry dates when clearance had been delayed due to technical reasons”.
What “technical reasons”?
Dr Hamdani was placed in charge of donations in April 2022. He introduced a transparent and structured methodology which, he said, had functioned smoothly for several months. The donating party had to provide an invoice with the consignee name, expiry and manufacturing dates, manufacturer details and generic name of the products.
Working with just three officers, his bureau would then send a covering note to the National Medicines Regulatory Authority (NMRA) requesting WoRs. Once that is issued, the consignee is given the signal to dispatch the shipment.
“There have been instances where donors are so eager to send the consignment that they start sea-freighting it as soon as they send the invoice,” he said. This practice will be stopped.
When the seaway (or airway, as the case may be) bill is obtained and necessary checks are carried out, Dr. Hamdani prepares a note to the Health Secretary to speed up import control registration and customs duty waiver. After this is granted, it is the MSD that must clear the stocks from the port and distribute them.
Over the past year, delays from the NMRA to issue WoRs and MSD to get consignments out of the port and dispense them to hospitals also led to wastage, authoritative sources said. Are these the “technical reasons” the MoH circular obtusely refers to?
“All these messes came up, to tell you very honestly, when they started going to these small boutiques to buy drugs,” a senior MoH official said, requesting anonymity. “When the problem is in the procurement arm, the focus is not on donations but on who can benefit from drug purchases.”
As at October 31, 2023, there were 29 consignments awaiting NMRA, official data shows. These include donations from the World Health Organisation (WHO) and United Nations Children’s Fund (UNICEF).
During the year, certain consignments were delayed longer than others, whilst others were cleared much faster by the NMRA and MSD. In view of the recent controversies related to drug procurement, officials suspected that some donations were blocked because high-priced tenders were in the pipeline or were being “negotiated”.
Such purchases, typically from Indian drug companies via favoured local suppliers, were expedited by the Secretary and an Additional Secretary to the Ministry of Health, the MSD and NMRA and often attracted priority over donations, authoritative sources said. And hundreds of WoRs were granted for lucrative purchases.
Six months expiry
Sri Lanka faces many issues related to drug donations. This includes storage limitations, usability problems and challenges in transportation. When the process started, there was no fuel. It wasn’t business as usual. With dire shortages, the country wasn’t in a position to refuse donations, even when they contained items it didn’t need and would have to store and destroy. So a decision was made to accept short-expiry drugs.
“There came a time when we ran out of everything,” Dr Hamdani said. “Initially, we observed a six-month expiry timeframe but we cut it short to three months.” But in cases (not all) where processing was delayed in institutions like the NMRA and MSD, several weeks would lapse, shaving off even more time from the drugs and devices.
The policy has now changed. And international donors also have a responsibility to ensure they aren’t causing more dilemmas for local health officials than they wish to solve.
At the last count, the MSD still lacked 217 essential medicines and hospitals lacked 67. As at October 30 this year, Sri Lanka had received 32 donations from states or governments and 382 from organisations. Another 22 are pending from the latter category. The total value is estimated at Rs. 353.5mn.is
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