ROCKVILLE, Md. — Through USAID’s Promoting the Quality of Medicines (PQM) program, the U.S. Pharmaceutical Convention (USP) announced on June 10 that prequalification status has been given to the first Active Pharmaceutical Ingredient (API) used to help treat multi-drug resistant tuberculosis (TB).
After much assessment by the World Health Organization the API Capreomycin may be a critical achievement in the fight against TB.
According to the WHO, an API is a substance contained in a Finished Pharmaceutical Product (FPP) to effectively prevent, diagnose, mitigate or cure a disease. When this type of ingredient receives a prequalification status, it simply means that its quality is satisfactory and its manufacturing process meets the WHO’s Good Manufacturing Practices requirements.
Capreomycin is actually only the first second-line TB antibiotic API to be given this status, meaning it will be used if the first line therapy is not successful in treating a specific patient with this disease.
TB usually affects a person’s lungs. It is spread when someone breathes in the air infected by TB bacteria. When someone with TB in his or her lungs or throat does something as simple as cough, sneeze or even speak, the bacteria can stay in the air for several hours and can infect those who breathe in that air.
Even though the mortality rate declined by 43 percent from 1991 to 2011, TB is still a major health issue that caused approximately 1.4 million deaths in 2011 alone according to the U.N. — evidence that not enough people have access to the necessary treatment.
TB is usually treated by isoniazid or rifampin, but multi-drug resistant TB has further complicated the treatment of this disease. According to the Centers for Disease Control and Prevention (CDC) multi-drug resistant TB is usually caused by the misuse of antibiotics in the chemotherapy stage of TB patients. For example, if they are prescribed the wrong drug or if the quality of the drug is poor, a patient’s TB can become drug resistant.
Since millions suffer from TB, the quality of the drug is imperative to promote recovery in TB patients. The U.N.’s Prequalification Program — managed by the WHO — works to make high-quality medicines available to those who need them the most. This program is mainly concerned with medicines used to treat not only TB, but also HIV/AIDS, malaria and the list of pre-qualified drugs. Their work helps agencies like UNAIDS and UNICEF obtain the best possible medications.
Since 2009, the Prequalification Program has already given this status to three drugs: Capremycin for multi-drug resistant TB, Cycloserine for TB and ZinCfant for treating diarrhea in children.
Even though it is both preventable and curable, TB alone is a difficult disease to combat, and multi-drug resistant TB only makes it more difficult. Although all the targets of the U.N.’s sixth Millennium Development Goal to combat HIV/AIDS, malaria and other diseases may not be reached by the 2015 deadline, this goal still might be achieved over some time with the help of organizations like the USP.
– Meghan Orner