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Drug donation costly

 

Globally, high and low-income countries experience shortages of essential medicines due to several factors, including poor financing.

The magnitude of these shortages is prominent in poor countries and humanitarian assistance in form of drug donations may be necessary in time of need.

However, benefit-risk assessments have to be done before accepting drug donations as low quality medicines have far-reaching public health consequences.

To ensure that patients get maximum benefit from donated medicines, the Ministry of Health and the Pharmacy, Medicines and Poisons Board (PMPB) developed strict guidelines.

The standards on drug donations aim at improving the quality of donated medicines and not necessarily to hinder the donations. 

The guidelines provide valuable, step-by-step information to both the prospective donor and the beneficiaries on what constitutes an acceptable donation.

Prior consent should be obtained from the beneficiary before an application for drug donation is submitted to PMPB for approval. This must be done way before the medicines are dispatched from the donor country.

In principle, drug supply should not be donor-driven but based on sound needs analysis of the country.

The donation should be relevant to Malawi situation, disease pattern, drug policies, treatment guidelines and the intended health facility’s expertise and infrastructure to support the use of the ‘free’ medicine.

The major considerations  include the quality of medicines.

While a comprehensive assessment of the quality of donated medicines cannot always be done as quality certification goes beyond laboratory testing, risk-based approaches are employed to ascertain the quality of donated medicines.

The medicines should be sourced from well-established outlets, preferably certified manufacturers.

The drugs should have a remaining shelf-life of at least one year to prevent them from expiring while in the country.

Similarly, there should be an assurance, ideally in form of the beneficiary’s drug consumption data, that the requested quantities of the medicines will be used before indicated expiry dates.

Medicines returned by patients to pharmacies or clinics are not acceptable. So, medicines not acceptable in the donor country due to quality problems, must be rejected in Malawi.

Donated medicines must be labelled at least in English language for ease of use of the medicine and management of any possible adverse drug reactions by both the healthcare provider and the patient.

The presentations, formulations and the strength of the medicines should be the same as those commonly used or accepted in the country.

It is important to note that not all drug donations are made in good faith.

Some unscrupulous individuals take unfair advantage of economic hardships experienced by low-income countries.

In donor countries, the pharmaceutical industry may enjoy tax deductions whenever a drug donation is made and some companies may prefer getting rid of excess medicines on the verge of expiry by donating to poor countries.

It is unethical for companies to turn poor countries into dumping grounds instead of disposing the medicines in their countries which is very expensive.

Without strict regulatory measures, developing countries may become dumpsites for unwanted medicines.

Such medicines may not be efficacious. This may exacerbate underlying diseases.

The cost of treating the intended illnesses becomes high, preventing a healthcare facility from getting enough funding for procuring medicines or receiving any more supplies of medicines.

The donations, often publicised in the press, creates the assumption that the facility is well stocked when the drugs donated cannot meet the patients’ needs. n

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