Featured Research

from universities, journals, and other organizations

One-third of antimalarial medicines sampled in three African nations found to be substandard

Date:
February 10, 2010
Source:
US Pharmacopeia
Summary:
The first results from a large-scale study of key antimalarial medicines in ten Sub-Saharan African countries reveal that a high percentage of medicines circulating on national markets are of substandard quality and thus may contribute to the growth of drug-resistant strains of Plasmodium falciparum, the most virulent form of malaria.

The first results from a large-scale study of key antimalarial medicines in ten Sub-Saharan African countries reveal that a high percentage of medicines circulating on national markets are of substandard quality and thus may contribute to the growth of drug-resistant strains of Plasmodium falciparum, the most virulent form of malaria.

The findings, released by the Promoting the Quality of Medicines (PQM) Program, a USAID-funded program implemented by the US Pharmacopeial Convention (USP), are for three countries surveyed in the study -- Madagascar, Senegal and Uganda.

The results are part of the larger Quality of Antimalarials in Sub-Saharan Africa (QAMSA) study, a ten-country collaborative study conducted by the World Health Organization (WHO) and PQM. Within Madagascar, Senegal and Uganda, the study sampled 491 antimalarials, performed basic testing on almost all, and submitted 197 samples to full-scale quality control testing. The focus was on artemisinin-based combination therapy (ACT) products, currently the WHO's recommended form of first-line treatment for uncomplicated malaria, and sulfadoxine-pyrimethamine (SP) products, often used for preventative treatment of malaria during pregnancy. The samples were collected from the public and regulated private sectors in these countries, as well as from informal markets, as many patients obtain their medicines from these sources. Substandard and counterfeit versions of antimalarial medicines are highly problematic throughout Africa, Asia and Latin America because of the direct threat they pose to the lives of individual patients as well as their contribution to the development of drug-resistant strains of these diseases.

In total, the QAMSA study found that approximately 44 percent of sampled medicines from Senegal, 30 percent of samples from Madagascar, and 26 percent of samples from Uganda that underwent full quality control laboratory testing failed such testing and were thus substandard. "Substandard" medicines are those that do not meet the quality specifications set for them, primarily because they do not contain the correct amount of the active ingredient(s), do not dissolve properly in the body or include unacceptable levels of potentially harmful impurities.

"The results of the study paint a very unfortunate picture of the situation in Sub-Saharan Africa," said Anthony Boni, the Agreement Officer's Technical Representative for the PQM Program, USAID Office of Health, Infectious Diseases, and Nutrition. "With almost half of medicines in Senegal and more than one out of four medicines in Madagascar and Uganda failing quality testing, clearly much work needs to be done to provide patients with medicines that meet the level of quality they require--and deserve. These countries are committed to protecting the health of their citizens, but the authorities face many challenges in regulating their markets. We look forward to working together with them to reduce the morbidity and mortality caused by malaria, by improving the quality of the medicines used to treat this disease."

"Although alarming, this study offers extremely valuable information that has already been shared with those countries in the hope that local regulatory bodies will focus their attention on products, brands and geographical locations where substandard medicines were found to pose the biggest threats," said Patrick Lukulay, Ph.D., Director of the PQM Program at USP. "The results show some significant differences in terms of where the problems lie. These findings can be used immediately by officials to target their efforts--an especially useful approach when resources are scarce, as they are in these countries."

The main purpose of the study was to update and expand the knowledge base about the prevalence of substandard antimalarials in Sub-Saharan Africa, which are believed to contribute to antimicrobial resistance of Plasmodium falciparum. Already, Plasmodium falciparum has become resistant to traditional monotherapy drugs such as chloroquine, and more recently to SP products. The sustainability of treatment success depends to a large extent on preventing Plasmodium falciparum's exposure to incomplete doses of these medicines to minimize the possibility of the emergence of drug resistance.

Beyond the overall failure rates, other noteworthy findings across the three countries were that SP products were most likely to fail dissolution tests (35 percent), while ACTs were most likely to fail impurity tests (29 percent). No samples in the full study completely lacked the active ingredient(s). The results also showed that, as a general rule, when a brand passed or failed in one country, it would also pass or fail in other countries. This indicates that the problem of quality is created at the source, rather than during passage through the distribution chain.

Despite some similarities, results by country varied in a number of areas, including at which points of sale the substandard medicines were found. In Madagascar, for instance, poor quality medicines appear to be widespread across regions and not limited to any particular type of distributor. In Uganda, samples fared much better in the public sector than in the country's private sector. Despite overall failure rates, this was one of the bright spots the study revealed; in Uganda's public sector, all ACT and SP samples passed quality tests.

The report is believed to be unique in terms of the large numbers of samples collected as well as the two-step testing approach employed in the study, which included initial screening on site using Global Pharma Health Fund portable Minilabsฎreg; and full-scale quality control confirmatory testing of roughly 40 percent of the total samples at USP's headquarters in the US.


Story Source:

The above story is based on materials provided by US Pharmacopeia. Note: Materials may be edited for content and length.


Cite This Page:

US Pharmacopeia. "One-third of antimalarial medicines sampled in three African nations found to be substandard." ScienceDaily. ScienceDaily, 10 February 2010. <www.sciencedaily.com/releases/2010/02/100209144159.htm>.
US Pharmacopeia. (2010, February 10). One-third of antimalarial medicines sampled in three African nations found to be substandard. ScienceDaily. Retrieved July 23, 2014 from www.sciencedaily.com/releases/2010/02/100209144159.htm
US Pharmacopeia. "One-third of antimalarial medicines sampled in three African nations found to be substandard." ScienceDaily. www.sciencedaily.com/releases/2010/02/100209144159.htm (accessed July 23, 2014).

Share This




More Health & Medicine News

Wednesday, July 23, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Courts Conflicted Over Healthcare Law

Courts Conflicted Over Healthcare Law

AP (July 22, 2014) — Two federal appeals courts issued conflicting rulings Tuesday on the legality of the federally-run healthcare exchange that operates in 36 states. (July 22) Video provided by AP
Powered by NewsLook.com
Why Do People Believe We Only Use 10 Percent Of Our Brains?

Why Do People Believe We Only Use 10 Percent Of Our Brains?

Newsy (July 22, 2014) — The new sci-fi thriller "Lucy" is making people question whether we really use all our brainpower. But, as scientists have insisted for years, we do. Video provided by Newsy
Powered by NewsLook.com
Scientists Find New Way To Make Human Platelets

Scientists Find New Way To Make Human Platelets

Newsy (July 22, 2014) — Boston scientists have discovered a new way to create fully functioning human platelets using a bioreactor and human stem cells. Video provided by Newsy
Powered by NewsLook.com
Gilead's $1000-a-Pill Drug Could Cure Hep C in HIV-Positive People

Gilead's $1000-a-Pill Drug Could Cure Hep C in HIV-Positive People

TheStreet (July 21, 2014) — New research shows Gilead Science's drug Sovaldi helps in curing hepatitis C in those who suffer from HIV. In a medical study, the combination of Gilead's Hep C drug with anti-viral drug Ribavirin cured 76% of HIV-positive patients suffering from the most common hepatitis C strain. Hepatitis C and related complications have been a top cause of death in HIV-positive patients. Typical medication used to treat the disease, including interferon proteins, tended to react badly with HIV drugs. However, Sovaldi's %1,000-a-pill price tag could limit the number of patients able to access the treatment. TheStreet's Keris Lahiff reports from New York. Video provided by TheStreet
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
 
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:  

Breaking News:
from the past week

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:  

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile iPhone Android Web
Follow Facebook Twitter Google+
Subscribe RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins