Despite the effort being made by the Government to provide improved health care services such as access to medicine in the country, there have been some impediments with the latest being the recall of white rose cotton wool by the Zambia Medicines Regulatory Authority and the unavailability of an Antiretrovirals (ARV) drug known as Zidovudine.
The Zambia Medicines Regulatory Authority issued a nationwide withdrawal of all batches of White Rose Absorbent Cotton Wool Hospital Grade to the consumer level.
The Zambia Medicines Regulatory Authority Acting Director General Makomani Siyanga noted in a press statement issued that the product which is manufactured by Ermine Enterprises Limited, Zambia, was found non-compliant with respect to microbiological contamination and labelling requirements.
He added that the product, which claims to be hospital grade, is used in sterile surgical procedures in various health facilities.
Mr Makomani explained that the product poses a risk to public health as it has potential to introduce infections on wounds or surgical sites where it is used.
He disclosed that the product is packaged in a primary package made of a white and blue plastic, with one big white rose flower at the top of the package and other smaller ones spread across the entire blue portion of the package.
“It is further labelled for medical and sanitary use’ at the back of the package,” Mr Makomani explained
He said that the product was distributed nationwide in both wholesale and retail outlets, including various health facilities.
“If you are in possession of the above-mentioned product, please return it to your supplier who should in turn notify ZAMRA,” he said
Mr Makomani has since advised anyone who may suffer any adverse drug reaction, event or suspect any other quality problem with the use of this product, to seek immediate medical attention.
“Report the incident to the National Pharmacovigilance Unit at Zambia Medicines Regulatory Authority by phone: +260 211 432 356 or +260 1/956 521 094 or email the Regulatory at [email protected] or [email protected]” Mr Makomani said
“Should you need further clarification, please do not hesitate to contact our Secretariat,” Mr Makomani added
Meanwhile, the Ministry of Health Permanent Secretary for Technical Services Lackson Kasonka disclosed in statement that, the Ministry has faced a delay in the shipment of Zidovudine/ Lamivudine (ZDV/3TC) 300mg/150mg an ARV combination agent used as part of a three-drug regimen used for managing individuals on second line Antiretroviral Treatment (ART).
Consequently, the National HIV Programme has recommended the following as an interim mitigation measure for individuals receiving this commodity combined with either a boosted protease inhibitor (bPI) Atazanavir-ritonanvir (ATV-r) or Lopinavir-Ritonavir (LPV-r) or Dolutegravir (DTG).
The Permanent Secretary has since instructed that Individuals who are virally suppressed on AZT/3TC/bPI and receiving care from health facilities which do not have AZT/3TC in stock should be switched to Tenofovir Disoproxil Fumarate/ Lamivudine/ Dolutegravir (TLD) or Tenofovir Alafenamide/ Emtricitabine/ Dolutegravir (TAFED) while maintaining the bPI component.
“The Combination regimen must be TLD or TAFED plus LPV-r or ATV-r,” he said
Mr Kasonka noted that individuals supplied with this interim regimen could have their antiretroviral therapy reversed to the standard AZT+3TC+Bpi once the AZT+3TC stock status normalizes.
He added that for individuals on AZT+3TC+DTG in all facilities, guidance is given that they be permanently switched to TLD or TAFED.
Mr Kasonka disclosed that for individuals on AZT+3TC+bPI with a high viral load, enhanced adherence counselling (EAC) plus genotype testing while being moved to the interim therapy of TLD or TAFED plus LPV-r or ATV-r.
Mr Kasonka cited that these recommendations are based on the current evidence of the use of DTG with a recycled nucleoside reverse transcriptase inhibitor (NRTI) backbone deduced from the VISEND, NADIA and 2SD trials.
“For any clarification, please contact the Director Infectious Diseases Prof. Lloyd Mulenga on +260977344604 or the National HIV Technical Advisor Dr Suilanji Sivileon +260977430210,” Mr Kasonka has advised