Restricting use of Second Line ANTI-TB Medicines

Pharmacy, Medicines and Poisons Board (PMPB) was established by an Act of Parliament (Cap 35:01 of the laws of Malawi) with the mandate of regulating safety, efficacy and quality of medicines in Malawi. In line with this mandate the Board determines scheduling of medicinal products registered for use in the country. 

PMPB has noted with concern the increased sale and use of drugs restricted for use as second line anti-tuberculosis (TB) medicines without appropriate prescriptions. The malpractice which has largely been reported in private hospitals, clinics and pharmacies involves the inappropriate prescription, sale and use of the following anti-TB drugs: Ofloxacin, Levofloxacin, Gatifloxacin, Moxifloxacin, Amikacin, Streptomycin, Para-aminosalicylic acid, capreomycin, Cycloserine, Terizidone, Ethionamide, Protionamide, Kanamycin, Bedaquiline, Delamanid and clofazimine or combination formulations containing any of these medicines.

As a Board, we are aware that resistance to drugs restricted for use as first line anti-TB medicines is on the rise and therefore as a country, we need to protect the use of second-line anti-TB medicines for patients who show resistance to first line TB medicines. With immediate effect therefore, PMPB is advising all public and private hospitals, clinics, wholesale and retail pharmacies to desist from inappropriately prescribing, stocking and dispensing these medicines as they are restricted for use in Drug Resistant TB. For all other infections, we recommend use of alternative effective antibiotics as guided by the current Malawi Standard Treatment Guidelines (MSTGs).

The general public is also warned against self-medication and demanding prescription or sale of antibiotics, including those reserved for treatment of TB as this malpractice fuels treatment failures due to inappropriate antibiotic use. Emergence of antibiotic resistance renders the product essentially ineffective for anybody else in the future. Antibiotic resistance is a public health crisis and therefore it is imperative that we all take responsibility as a nation.

PMPB inspectors will be carrying out inspection visits to various registered hospitals, clinics, wholesale and retail pharmacies to monitor and enforce compliance to this requirement. Noncompliance is a contravention of the Pharmacy, Medicines and Poisons Act (Cap 35:01) and accompanying Regulations (No 40A) that will lead to closure of the business premises and disciplinary action against personnel in charge of these facilities.

 

Mphatso Kawaye

ACTING REGISTRAR

9th April, 2018