HEALTH

MinuteClinic prepares to educate patients about swine flu

BY Michael Johnsen

MINNEAPOLIS MinuteClinic is prepared to answer consumers’ questions about the swine flu (H1N1) and provide rapid testing services, treatment and prevention for all types of influenza when medically appropriate, the retail clinic operator announced Wednesday morning.

“Patients with positive influenza A test results can be treated by MinuteClinic nurse practitioners with the anti-viral medication oseltamivir (Tamiflu) or zanamivir (Relenza) to help them recover more quickly if they are seen within 48 hours of being symptomatic,” stated Troyen Brennan, CVS Caremark EVP and chief medical officer. “These are the same anti-viral medications the CDC recommends for the treatment of the swine strain.

MinuteClinic is coordinating with local health departments to establish working relationships for surveillance of swine flu cases.

Located inside select CVS/pharmacy stores in 25 states, MinuteClinic healthcare centers are staffed by masters-prepared nurse practitioners, the clinic operator noted, adding that seasonal influenza A is still active in most states.

In addition, MinuteClinic practitioners are updated daily on the latest World Health Organizations and Centers for Disease Control guidelines and protocols for diagnosing and treating swine flu.

A rapid flu test to check for influenza A can be administered at MinuteClinic, but it can’t diagnose the swine flu strain specifically. The test — administered as a simple nasal swab — takes five minutes and results are available immediately.

Any patient testing positive for influenza A who is suspected of having swine flu, such as those who have traveled to Mexico recently or live in a community with confirmed swine flu cases, will be treated. Any cases categorized as probable swine flu would also be reported to the local health department to coordinate confirmatory testing.

Anti-viral medication may also be prescribed for family members or other close contacts of anyone infected by the flu to help prevent the spread of the virus, Brennan said.

CVS/pharmacy and MinuteClinic are following the CDC recommendations for infection control at stores and clinics to prevent the spread of any influenza virus, including swine flu. This may include the use of masks, gowns and gloves when appropriate.

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FDA to require NSAID manufacturers to revise labeling

BY Michael Johnsen

ROCKVILLE, Md. The Food and Drug Administration issued a final rule Tuesday that requires manufacturers of over-the-counter pain relievers and fever reducers to revise their labeling to include warnings about potential safety risks, such as internal bleeding and liver damage, associated with the use of these drugs.

Products covered by the FDA action include acetaminophen, and a class of drugs known as the nonsteroidal anti-inflammatory drugs. NSAIDs include aspirin, ibuprofen, naproxen and ketoprofen.

The revised labeling applies to all OTC pain relievers and fever reducers, including those that contain one of these ingredients in combination with such other ingredients, as cold medicines containing pain relievers or fever reducers.

“Acetaminophen and NSAIDs are commonly used drugs for both children and adults because they are effective in reducing fevers and relieving minor aches and pain, such as headaches and muscle aches, “ stated Charles Ganley, director of FDA’s Office of Nonprescription Drugs in the Center for Drug Evaluation and Research. “However, the risks associated with their use need to be clearly identified on the label so that consumers taking these drugs are fully aware of the potential harm they can cause. It is important that they know how to take these medications safely to reduce their risk.”

Under the final rule, manufacturers must ensure that the active ingredients of these drugs are prominently displayed on the drug labels on both the packages and bottles. The labeling also must warn of the risks of stomach bleeding for NSAIDs and severe liver damage for acetaminophen.

The new rule requires all manufacturers to relabel their products by April 28, 2010.

However, many analgesic manufacturers are already in compliance with the new labeling rules, Barbara Kochanowski, VP regulatory affairs for the Consumer Healthcare Products Association, stated Tuesday.

“CHPA member companies voluntarily have begun implementing many of the label changes included in the final rule that will publish April 29, 2009, well ahead of the April 28, 2010, implementation deadline,” she said. “These label changes are designed to provide consumers with a greater understanding of some of the risks that could be associated with the misuse of these medications.”

An FDA Advisory Committee meeting will convene on June 29 and 30 to discuss further steps the FDA could take to reduce the risk of liver damage associated with acetaminophen overdoses.

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World Health Organization announces flu pandemic alert change

BY Michael Johnsen

GENEVA The current situation regarding the outbreak of swine influenza A(H1N1) is evolving rapidly, the World Health Organization stated in a press release Monday.

“As of 27 April, the United States government has reported 40 laboratory confirmed human cases of swine influenza A(H1N1), with no deaths. Mexico has reported 26 confirmed human cases of infection with the same virus, including seven deaths. Canada has reported six cases, with no deaths, while Spain has reported one case, with no deaths,” WHO stated.

In responose, WHO Director-General Margaret Chan has raised the level of influenza pandemic alert from the current phase 3 to phase 4. The change to a higher phase of pandemic alert indicates that the likelihood of a pandemic has increased, but not that a pandemic is inevitable.

In Phase 3, an animal or human-animal influenza reassortant virus has caused sporadic cases or small clusters of disease in people, but has not resulted in human-to-human transmission sufficient to sustain community-level outbreaks. Limited human-to-human transmission may occur under some circumstances, for example, when there is close contact between an infected person and an unprotected caregiver. However, limited transmission under such restricted circumstances does not indicate that the virus has gained the level of transmissibility among humans necessary to cause a pandemic.

Phase 4 is characterized by verified human-to-human transmission of an animal or human-animal influenza reassortant virus able to cause “community-level outbreaks.” The ability to cause sustained disease outbreaks in a community marks a significant upwards shift in the risk for a pandemic. Phase 4 indicates a significant increase in risk of a pandemic but does not necessarily mean that a pandemic is a forgone conclusion.

Phase 5 indicates an imminent pandemic and phase 6 signifies an actual pandemic.

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