Controversy over expired drug

A batch of expired Nevirapine suspension is being dispensed at anti-retroviral therapy (ART) initiating sites across the country, The Sunday Mail has established.

There are fears that the drug, which expired on December 31, 2017,  could expose infants to the risk of contracting the virus from their mothers through breastfeeding.

Nevirapine suspension is currently being used as prophylaxis to reduce mother to child transmission of HIV.

Officials at Chitungwiza Hospital reiterated that the distribution of the expired drug is a nationwide “problem”.

Ms Sheila Mabhachi (not her real name), who receives ART from Chitungwiza Hospital, fears for her child’s health.

“I’ve been on ART for the past 10 years and one thing I’m particular about is the expiry date,” she said.

“I fear that my child will eventually contract HIV through breastmilk.

“I asked the nurse manning the Opportunistic Infections (OI) Clinic why she had given me expired Nevirapine suspension and she assured me that I had nothing to worry about.

“However, I’m still sceptical because it’s my child’s health we are talking about here.”

The latest developments threaten the fight against new HIV infections among children under five years of age.

The global target aims to reduce new HIV infections among children to less than five percent by end of this year.

A recent survey indicated that as of 2016, the country stood at 5,2 percent.

Health and Child Care Ministry director of the Aids and TB Unit, Dr Owen Mugurungi, reassured the nation: “An expiry date on a drug or medicine packaging doesn’t necessarily mean that soon after the expiry date, the drug stops working immediately. Hence parents of HIV-exposed infants have nothing to worry about,” said Dr Mugurungi.

He said when they have expiring drugs in stock, medical institutions seek authority from the Medicines Control Authority of Zimbabwe (MCAZ) to check the efficacy of the drug after its shelf-life.

“lf they approve continuous usage, that’s what we do,” he said.

MCAZ spokesperson Mr Richard Rukwata concurred.

“The usage of the batches in question should not be a cause of concern for Zimbabweans. This is a short-term solution for a very specific subset of the population and the authority has carried out the necessary risk assessment and reached the conclusion that the medicine is safe to use in the short term. It would be riskier for the affected patients not to receive the medicine at this time,” explained Mr Rukwata.

“With respect to how long the stocks will be used, the authority’s extension is for not more than 90 days from the date of expiry. Also note that the authority has laboratories to carry out the necessary analysis to support the shelf-life.

“Please note that as long as the potency and other specifications of the product are still within the accepted range, as confirmed by laboratory analysis, then the side-effect profile of the particular batches of medicines will not change.

“In fixing the date, the authority considers stability data submitted by the applicant, the nature of the formulation, as well as limitations on shelf life as guided by international recommendations as well as best practice,” added Mr Rukwata.

“The authority is also confident that this shelf-life extension is a stop-gap measure whilst logistical arrangements are being made to supply fresh stocks to the affected facilities.”

According to Section 2 of S.I. 150 of 1991, “shelf life” in relation to any batch of a medicine, means the period up to which a medicine in that batch will retain the potency and properties stated on the label as fixed by the authority.

The National Aids Council (NAC) estimates that one out of every eight children die before the age of five from HIV and Aids-related causes.

About 21 percent of children’s deaths are caused by HIV/Aids, followed by pneumonia, diarrhoea, measles and malaria.

Approximately two thirds of childhood deaths occur during infancy, with more than one third taking place during the first month of life.

HIV can be passed on from a mother to her baby during pregnancy, delivery or whilst breastfeeding.

Without any intervention, the chances that a baby born to an HIV positive mother will be infected are 15 to 30 percent without breastfeeding and 25 to 45 percent with breastfeeding.

With interventions for prevention of mother-to-child transmission (PMTCT), the chances of mother to child transmission are reduced to less than five percent in developing countries and less than two percent in developed countries.

When PMTCT was first introduced in the country in 2009, it took time be accepted by communities due to the high levels of stigma and discrimination.

World Health Organisation (WHO) guidelines of single dose Nevirapine or Option A were adopted.

The Health Ministry estimates that more than 13 percent of the country’s pregnant women are HIV positive and many have no access to PMTCT services.

Government estimates that 1,4 million people are living with HIV, of whom 86 percent are on the ART programme.

With nearly 14 percent of the adult population infected by HIV, Zimbabwe is still one of the countries most affected by HIV/Aids in the world.

The Government of Zimbabwe remains committed to achieving zero new HIV infections, zero HIV-related deaths and zero HIV-related stigma and discrimination in HIV treatment.

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