Failure to adhere to guidelines for drug donations in Malawi is adversely affecting stock uptake at Central Medical Stores Trust, leading to expiries and write-offs, resulting in losses.
This is according to the 2024 Ministry of Finance and Economic Affairs’ Annual Economic Report. The situation has since compelled policy experts in the health sector to appeal to relevant authorities to ensure the guidelines are strictly enforced and adhered to.
Ministry of Health and the Pharmacy and Medicines Regulatory (PMRA) developed guidelines for drug donations for Malawi in 2008 to improve the quality of drugs from donations in both public and private health facilities.
Read part of the guidelines: “Medicines will be donated in presentations, strength and formulations commonly used or accepted in Malawi. Quantities may be vetted as necessary to ensure that there is no overstocking which may create problems of disposal.
“Donations must always be based on sound analysis of needs; hence, there should always be communication between the donor and recipient in the initial stages of planning for a donation. Prior consent by the recipient in Malawi is necessary before the donation is initiated.”
Failure to adhere to the guidelines, Ministry of Finance and Economic Affairs’ Annual Economic report states that: “The Trust [CMST] has been engaging with key stakeholders, especially the Pharmacy and Medicines Regulatory Authority [PMRA] and the Ministry of Health to ensure enforcement of the national guidelines’ donations.”
In separate interviews during the week, policy experts in the health sector have appealed to the Ministry of Health to ensure the guidelines are enforced, failing which it will be disadvantageous to CMST; hence, the trust will keep incurring losses due to the stock write-offs and expiries, leading to poor fiscal performance.
According to the annual economic report, the expiries and stock write-offs have in the past four years contributed to CMSTs deteriorating financial performance.
Health and Rights Education Programme executive director Maziko Matemba in an interview on Tuesday said the situation is a wake-up call for policymakers to think about enforcement of the drug donations guidelines, among other things.
“We are aware that the government has a policy on donated medicines and equipment which needs adherence to avoid the Central Medical Stores Trust making losses. After all, these medicines are meant to save lives,” he said.
“Additionally, we want to urge the Ministry of Health to ensure that all donors, well-wishers and health managers are aware of this policy before they make donations to minimise the loss of these resources.”
However, Matemba said since the Drug Donations Guidelines were developed more than a decade ago, there is need for a thorough review to ensure they serve the intended purpose.
The guidelines stipulate that a committee of officials from the Ministry of Health and PMRA has to approve medicine as a donation within 10 days upon receiving a particular application.
“Decisions by the committee will be final and the registrar of PMRA will endorse the approval by signing at the appropriate section of the application form,” further read the guidelines.
In a separate interview on Tuesday, Malawi Health Equity Network executive director George Jobe said it would be interesting to learn if there has been improvement in the coordination part of the guidelines.
He said: “We have been recommending that there should be fully stocking of the commodities at CMST which requires the Trustee to do accurate quantifications based on consumption of the hospitals; hence, it made sense that when hospitals receive donations, the already stocked commodities would face a risk of expiries.
“Our expectation is that CSMT now knows in advance any anticipated donations to some hospitals so that their stocking considers the same. If that is not happening, Malawi shall continue to suffer those expiries, which is a loss to the health sector.”
Pharmaceutical Society of Malawi (Phasom) president William Mpute in an email response on Thursday said: “While acknowledging the country’s pressing need for essential medicines, Phasom stresses that the acceptance of donated medicines must be stringely managed.
“Reverse logistics for expired or unusable donated medicines are prohibitively expensive and divert critical resources from patient care.”
But as of press time 6pm yesterday, we were yet to get a response from the Ministry of Health.
