Rockville, U.S.A. — Two articles recently published in Malaria Journal shed new light on the quality of antimalarial medicines circulating in countries in the Amazon Basin in South America.

Researchers from the Promoting the Quality of Medicines (PQM) program, a cooperative agreement between the U.S. Agency for International Development (USAID) and the U.S. Pharmacopeial Convention (USP), in conjunction with country partners, coordinated these studies in the context of the Amazon Malaria Initiative (AMI).

“Though several studies in recent years have assessed the quality of antimalarial medicines circulating in Africa and Asia, there have been no comprehensive studies looking at the situation in the Americas,” said Patrick Lukulay, Ph.D., vice president of Global Health Impact Programs at USP and director of the PQM program.

“This region has been largely overlooked, perhaps because of a perception that substandard and counterfeit medicines pose less of a threat in these countries. However, the findings in one of the studies in which medicines were assessed in the private and informal sectors in two countries indicate that poor-quality medicines are indeed a serious concern for antimalarials. The data from the other study suggests that the systematic implementation of basic, rapid and low-cost quality testing helps in reducing the prevalence of poor-quality medicines on the market.”

The first study, Quality of Antimalarials Collected in the Private and Informal Sectors in Guyana and Suriname, assessed the quality of circulating antimalarial medicines in the private (licensed pharmacies, wholesalers and distributors) and informal (unlicensed shops and convenience stores) sectors.

No information was previously available about the quality of these medicines. Though antimalarials are usually distributed through public health facilities at no cost in these countries, the private and informal sectors thrive in Guyana and Suriname—particularly in the remote interior regions where the presence of public facilities is limited or nonexistent, and large populations of workers in the gold mining and logging industries live.

Buying from these facilities poses increased risk of access to and use of non-recommended treatments and/or poor-quality products, which can have serious repercussions on patients’ health.

In Guyana, 45 of 77 (58 percent) of antimalarial medicines were found to be of poor quality. Visual and physical inspection unveiled 30 failures and analytical tests revealed 18; a medicine failing more than one test was considered a single failed medicine. Visual and physical inspections provide valuable information about the physical appearance and labeling of medicines, and in many cases these inspections can detect counterfeit medicines.

Quality control tests assess critical quality attributes of a medicine, such as identity, content, impurities and dissolution, among others. Of particular concern was the proportion of monotherapy (single drug) treatments failing quality control tests in Guyana (43 percent).

This included a high failure rate for artesunate monotherapy, a treatment not recommended by the World Health Organization (WHO) for Plasmodium Falciparum malaria, the most common type of malaria in the interior of Guyana. WHO recommends artesunate combination therapy for Plasmodium Falciparum.

In Suriname, 86 percent of the samples collected were Artecom, and only this antimalarial was analyzed. All Artecom samples lacked a label claim for the content of one of the components—primaquine—which resulted in an automatic failure of visual and physical inspection. Inadequate labeling is problematic because it renders it impossible for patients to know the dosage of the medicine they are taking, which could lead to ineffective treatment.

Additionally, undeclared strength of primaquine poses a safety concern to individuals who are glucose-6-phosphate dehydrogenase deficient. This antimalarial medicine was also found in Guyana; it is not registered in the countries nor is part of their national treatment guidelines. All samples in Guyana and Suriname were collected between June and August 2009.

“These findings point to significant problems in the quality of antimalarials available in private and informal sector facilities in Guyana and Suriname,” said Lawrence Evans, Ph.D., the study’s lead author. “Besides the presence of medicines not included in the World Health Organization malaria treatment guidelines, the ease with which medications were procured without accurate diagnosis poses another major risk to patients’ safety.

In addition, this could have serious implications for the development of drug-resistant strains of Plasmodium parasites, particularly Falciparum, as novel treatments are not foreseeable in the near future.”

The second study, Implementation of Basic Quality Control Tests for Malaria Medicines in Amazon Basin Countries: Results for the 2005-2010 Period, looks at the quality of malaria medicines in seven South American countries over a five-year period. In this study, basic analytical tests were utilized as a rapid and low-cost screening mechanism to identify substandard or counterfeit medicines. Performing basic tests is the first stage in a quality control framework developed by PQM for use in developing countries.

From 2005 to 2010, the quality of a total of 1,663 malaria medicines sampled in Bolivia, Brazil, Colombia, Ecuador, Guyana, Suriname and Venezuela was evaluated. The medicines sampled comprised all the therapies included in countries’ therapeutic guidelines, and were mostly collected from the public sector (1,445, or 86.9 percent).

In all, 193 (11.6 percent) were found not to meet quality specifications, of which only 51 (three percent) failed analytical tests; these values compare favorably with results reported for other regions of the world. None of the artemisinin derivatives failed basic analytical tests. Most failures were found during visual and physical inspections, and most of those were due to expired medicines.

Under the storage conditions prevailing in many of these areas (e.g., high temperatures and high humidity), medicines of good quality could degrade faster, and the risk of consuming degraded substandard medicines increases if utilized beyond their expiration date. The highest rates of expired products were found in Bolivia and Colombia, both of which addressed this problem by better controlling their inventory, and in subsequent years no expired medicines were reported in these countries. During 2009 and 2010 a dramatic decrease in poor-quality medicines was observed.

The authors also identified areas that need to be strengthened. This includes performing confirmatory testing, a critical component of the quality control framework proposed by PQM, which was not implemented thoroughly. These tests are performed at a qualified laboratory and utilize validated methodologies to assess compliance with quality specifications.

Basic analytical tests should be used for screening purposes, and need to be followed by confirmatory testing on subsets of the sampled medicines. In addition, sampling should include the private and informal sectors when these are prevalent. By not performing confirmatory testing methodically and/or assessing only the public sector, some poor-quality medicines may still go undetected.

Finally, the official medicine control laboratory and the medicines regulatory authority, both of which are crucial to ensuring proper execution of quality monitoring activities and prompt implementation of corrective actions, should always be included.

“This comprehensive study provides the first documented regional information on the quality of malaria medicines in the Americas. Of relevance is that all participating countries adopted the same methodology to assess the sampled medicines—something that has never been done before in this region,” said Victor Pribluda, Ph.D., lead author of the study.

“This is significant because use of consistent methodology promotes collaboration and exchange of information between countries, a hallmark of the holistic approach implemented by AMI to prevent and control malaria in the region.”

Image Courtesy of  Official U.S. Navy Imagery

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Hollywood, U.S.A. — Medbox company CEO, Dr. Bruce Bedrick commented on the recent admission by some Los Angeles City Councilmen that they are in favor of legalized medical marijuana. “We applaud the courage and conviction of belief shown by these city leaders,” Bedrick stated. “The weight of science validates that marijuana has significant medical efficacy. To ignore the evidence is to succumb to political tradewinds.”

Councilman Bill Rosendahl told The Los Angeles Times that he is in favor of legalizing marijuana and that he has had his own medical marijuana prescription for a decade, and relies on the drug to cope with neuropathy – a painful nerve disorder.

Paul Koretz, Councilman for the city’s Fifth District, told The Times that he is, “an unabashed supporter of medical marijuana.”

Both Koretz and Rosendahl said they share constituent concerns about the proliferation of marijuana, but disagree with the council’s latest strategy, which prohibits businesses from providing medical marijuana to even the most seriously ill patients.

Shortly after the Los Angeles City Council voted to ban medical marijuana, the United States Court of Appeals for the D.C. Circuit agreed to hear arguments challenging the federal government’s classification of marijuana as a dangerous drug with no medical value.

The appeal asserts that the federal government has acted arbitrarily and capriciously in its efforts to deny marijuana to millions of patients, and that the government cannot apply “different criteria to marijuana than to other drugs, ignore critical scientific data, misrepresent social science research, or rely upon unsubstantiated assumptions.”

Numerous studies have been published that show the medical benefits of marijuana for illnesses such as neuropathic pain, multiple sclerosis, and Alzheimer’s. Last year, the National Cancer Institute added cannabis to its list of Complementary and Alternative Medicines, pointing out that it’s been therapeutically used for millennia.

A new, comprehensive study on the evidence that cannabis may be useful as medicine was published in May of this year in The Open Neurology Journal, a leading peer reviewed publication. The study concluded that marijuana’s federal classification as a Schedule I substance “is not tenable; (and) it is not accurate that cannabis has no medical value, or that information on safety is lacking.”

Medbox supports sensible regulations on the medical marijuana industry, including assuring that dispensaries maintain a proper distance from schools, parks and playgrounds; and that operators submit fingerprint samples to the City to insure that they are not convicted felons.

Medbox is also in favor of increasing legitimacy and transparency in the medical marijuana industry. The company has developed a patented system that tightly controls access of marijuana to only those patients that possesses a current doctor’s recommendation, and verifies the identity of the patient through both an identification card and a fingerprint scan. The Medbox system also maintains a permanent and unalterable record of each transaction to assure compliance with all regulations and for taxation purposes.

Bedrick summarized, “We believe that the Los Angeles City Council will construct sensible regulations regarding medical marijuana through the upcoming referendum or court challenges, if needed. This along with the upcoming federal hearing in October regarding reclassification of the drug, may allow access to this medicine without further legal ramifications for patients that rely on its

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Philadelphia, U.S.A. – Premature babies are more likely to survive when they are born in high-level neonatal intensive care units (NICUs) than in hospitals without such facilities, and this benefit is considerably larger than previously reported.

The likelihood that an extremely premature baby will survive if born in a high-technology, high-volume hospital unit was already known, but the current study, the largest to date, revealed a stronger effect. Pediatric researchers who analyzed more than 1.3 million premature births over a 10-year span found that the survival benefits applied not only to extremely preterm babies, but also to moderately preterm newborns.

The research team performed a retrospective study of all hospital-based deliveries of infants with a gestational age between 23 and 37 weeks in Pennsylvania, California and Missouri—a total of over 1,328,000 births. The study focused on preterm deliveries in high-level NICUs, compared to preterm deliveries at all other hospitals.

“Prior studies from the early 1990s found increased survival rates of 30 to 50 percent among preterm infants delivered at high-level NICUs, compared to preterm infants delivered elsewhere,” said study leaderScott A. Lorch, M.D., a neonatologist at The Children’s Hospital of Philadelphia. “However, our research found rates as high as 300 percent improvement, when our study design controlled for the effect of sicker patients who typically deliver at high-level NICUs.” Complication rates were similar for both types of hospitals.

The retrospective study, which appeared online July 9 in the journal Pediatrics, analyzed records for all births occurring between 1995 and 2005 in Pennsylvania and California, and all births between 1995 and 2003 in Missouri. Lorch added that the results varied slightly among the states, possibly reflecting state-level differences in health policies, such as whether or not the state government designated hospitals within a regional perinatal system.

Premature babies are those born before 37 weeks gestational age (full term is 40 weeks). In this study, the researchers defined extremely preterm infants as those born before 32 weeks and moderately preterm infants as those born between 32 and 37 weeks. They defined a high-level NICU as a level III facility that delivered at least 50 very low birth weight infants annually. “We found survival benefits in high-level NICUs for both extremely premature and moderately premature infants,” said Lorch. “This suggests that the choice of a delivery hospital may influence the outcomes for the full range of preterm infants.”

Unlike many previous analyses of birth outcomes, said Lorch, the current study covered more than a single state system. Using hospital data from states in three regions of the country suggests that the results may be more generalizable throughout the United States than in more limited studies, he added.

However, concluded Lorch, “this research does not imply that every hospital should aspire to build a high-tech NICU—there just aren’t enough babies born prematurely for every birth hospital in the U.S. to have a high-level, high-volume NICU. Instead, the results may assist health care policy makers in organizing regional and statewide care systems to more efficiently provide the best care for premature infants within a geographical area.”

Financial support for this study came from the Agency for Healthcare Research and Quality, part of the U.S. Department of Health and Human Services. Lorch’s co-authors were Michael Baiocchi, Ph.D., andDylan S. Small, Ph.D., of the University of Pennsylvania, and Corinne E. Ahlberg, M.S., of The Children’s Hospital of Philadelphia. In addition to his position as an attending neonatologist at Children’s Hospital, Lorch is also on the staff of the Hospital’s Center for Outcomes Research and is a senior fellow at the Leonard Davis Institute of Health Economics at the University of Pennsylvania.

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