Amostras grátis de medicamentos podem ser uma ameaça às crianças

[Free samples of medicines may be a threat to children]

Em escala global, a industria farmacêutica mantém a prática da oferta de amostras grátis aos médicos, que por sua vez as distribuem aos pacientes. No entanto, conforme estudo de pesquisadores da Harvard Medical School Researchers, na Cambridge Health Alliance, referendado pelo US Centers for Disease Control and Prevention (equivalente norte-americano à Anvisa), os médicos distribuem estas amostras grátis sem avaliar os sérios riscos destas drogas. Os riscos, principalmente de efeitos colaterais não suficientemente testados, podem ser uma ameaça às crianças. Por Henrique Cortez, do EcoDebate.

Os autores do estudo, publicado na revista Pediatrics, destacam que os médicos não estão sendo suficientemente cuidadosos na prescrição de amostras grátis e destacam que, em 2004, mais de 500 mil crianças foram medicados com amostras grátis de quatro medicamentos controlados e com alertas de risco emitidos pela FDA, Food and Drug Administration. Estes quatro medicamentos controlados prescritos para crianças foram Advair, para asma; Adderall e Strattera, ambos para déficit de atenção; e Elidel, para eczema.

Desde março de 2006, a FDA alerta que algumas drogas prescritas para déficit de atenção, incluindo Adderall e Strattera, aumentam os riscos de agressividade, violência e sintomas psicóticos em crianças. Em 20% dos casos exigiram suspensão do tratamento ou hospitalização.

A FDA destaca, ainda, que de 80 a 90% destes casos de severos efeitos adversos não registravam histórico anterior de agressividade, violência e sintomas psicóticos. O Strattera (atomoxetina), de acordo com a FDA, também foi relacionado ao aumento do risco de suicídios.

Para acessar o relatório da FDA clique aqui

O artigo “Free Drug Samples in the United States: Characteristics of Pediatric Recipients and Safety Concerns” [ in PEDIATRICS Vol. 122 No. 4 October 2008, pp. 736-742 (doi:10.1542/peds.2007-2928)] está disponivel para assinantes. Para acessar o abstract clique aqui.

Abaixo transcrevemos o release da Harvard Medical School Researchers, na Cambridge Health Alliance, relativo à pesquisa “Free Drug Samples in the United States: Characteristics of Pediatric Recipients and Safety Concerns”.

* * * * *Most Free Drug Samples go to the Wealthy and Insured * * * *

-First of its Kind Study from Harvard Medical School Researchers at Cambridge Health Alliance Finds Few Samples Distributed to Poor and Uninsured-

Cambridge, MA……Most free drug samples go to wealthy and insured patients and are not used to ease the burden of the poorest nor the uninsured, according to a study by physicians from Cambridge Health Alliance and Harvard Medical School. The study, which is the first to look at free drug samples nationally, will appear in the February 2008 issue of the American Journal of Public Health.

The study found that use of free prescription drug samples is widespread. More than one out of every ten Americans received one or more free drug samples in 2003. Among Americans who take at least one prescription drug, nearly one out of five got free samples.

Few free samples went to the needy. Insured Americans and those with higher incomes were more likely to report receiving at least one free sample. More than four-fifths of sample recipients were insured all year. Conversely, less than one-fifth were uninsured for all or part of 2003, and less than one-third had low family incomes (under $37,000 for a family of four).

Free sample receipt was consistently higher among those with better access to medical care. Non-Hispanics, English-speakers and Whites were all more likely to receive free samples than were members of ethnic, linguistic or racial minorities. Receiving medical care in an office and taking more medications also increased an individual’s chances of receiving free drug samples.

Author Sarah Cutrona, a physician at Cambridge Health Alliance and an Instructor of Medicine at Harvard commented: “The distribution of free samples has become very controversial. Evidence shows that free samples may influence physicians’ prescribing behavior and cause safety problems. For instance, we found that the most widely distributed sample in 2002 was Vioxx, with Celebrex being number 3. These drugs turned out to have lethal side effects. While many doctors still view samples as a safety net for their neediest patients, our study shows that samples are potentially dangerous, and do little for the needy.”

Dr. David Himmelstein, senior author of the study, a physician at Cambridge Health Alliance and an Associate Professor of Medicine at Harvard adds: “We know that many doctors try to get free samples to needy patients when those patients come into the office. We found that such efforts do not counter society-wide factors that determine access to care and selectively direct free samples to the affluent. Our findings strongly suggest that free drug samples serve as a marketing tool, not as a safety net.”

“Free drug samples are not the solution to the disproportionately low amount of health care resources going to the poor and uninsured; they are part of the problem,” said Dr. Steffie Woolhandler, a physician at Cambridge Health Alliance, Associate Professor of Medicine at Harvard, and study co-author.

The study used data on 32,681 US residents from the Medical Expenditure Panel Survey (MEPS), an annual federal survey. Dr. Cutrona’s work on the study was supported under a National Research Service Award.

Recipients of Free Prescription Drug Samples: A Nationally Representative Analysis published in American Journal of Public Health http://www.ajph.org/ February 2008, Vol 98, No. 2. Authors: Sarah L. Cutrona, MD, MPH, Steffie Woolhandler, MD, MPH, Karen E. Lasser, MD, MPH, David H. Bor, MD, Danny McCormick, MD, MPH, and David U. Himmelstein, MD.

Sarah L. Cutrona, MD, MPH, is a hospitalist at Cambridge Health Alliance. She also serves as an instructor of medicine at Harvard Medical School. Dr. Cutrona conducts research on access to health care and pharmacoepidemiology and is particularly interested in issues surrounding access to prescription medications and adherence to medication regimens. She earned her medical degree at Columbia College of Physicians and Surgeons and completed a residency in internal medicine at Rhode Island Hospital. She recently completed a research fellowship in general internal medicine at Harvard Medical School and Cambridge Health Alliance while earning a master’s degree in public health at the Harvard School of Public Health.

[ Free drug samples can be dangerous for children, in EcoDebate, 28/10/2008 ]

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