FDA Requires Boxed Warnings on Hepatitis C Drugs

On October 4, 2016, the United States Food and Drug Administration (FDA) issued a safety announcement about the actions it plans to take with regards to Direct Acting Antiviral (DAA) medicines used to treat chronic hepatitis C virus (HCV). HCV is an infection that can last a person’s entire life. The virus is spread by blood contact, including transfusions, infected needles, and mother-to-baby transmission during child birth. DAA medicines reduce the amount of HCV in the patient’s body by preventing HCV from multiplying. In most cases, a patient suffering from HCV can be cured by taking the DAA medicines. If left untreated, HCV may lead to serious liver problems, including cirrhosis, liver cancer, and death.

Unfortunately, drugs that may cure HCV can cause flare ups of the hepatitis B virus (HBV). Currently, there is no cure available for HBV. It is transferred by bodily fluids. HBV reactivation may occur in any patient who has currently or previously been infected with HBV and is undergoing DAA treatment for HCV. The FDA has identified twenty-four cases of HBV reactivation in patients who had ingested DAA medicines. According to the FDA, the reported cases included two patients who died and one patient who needed a liver transplant.

As a consequence of its findings, the FDA is requiring that a Boxed Warning, the agency’s most prominent warning, about the risk of HBV reactivation be placed on the labels of DAA medicines. The warning would direct health care professionals to screen and monitor for HBV in all patients being treated with DAA medicines. In addition to being placed on the labels, the new warning will be included in the patient information leaflet or the Medication Guide for DAA medicines that comes with each new prescription.

The new warning would mandate that health care professionals screen all patients for evidence of current or prior HBV infection before starting treatment with DAA medicines, and monitor patients using blood tests for HBV flare-ups or reactivation during treatment and post-treatment follow-up.

 

 

 

A Night of Celebration-St. Vincent Charity Medical Center

Recently, I attended St. Vincent Charity Medical Center’s Caritas Awards celebration. The purpose of the celebration was to honor four individuals whose lives embody the mission of the Sisters of Charity of St. Augustine.

The first recipient of the evening was Dr. Lloyd Cook. Dr. Cook was recognized as the Physician of the Year. The award was given to Dr. Cook because of his passion for healing and his commitment to his patients. For example, Dr. Cook’s practice was recognized with a Gold Star Achievement Award from the Better Health Partnership for the successful treatment and management of his patients with hypertension. The award was presented by Tony and Rachelle Coyne.

The second award winner was Cleveland attorney Margaret Wong. Attorney Wong received the St. Vincent de Paul Award, an award that is given to acknowledge community service. In an attempt to serve others, Attorney Wong has created several endowed scholarships. She also contributed the largest leadership gift to St. Vincent Charity’s “Care Beyond Medicine” campaign. The award was presented by Sister Judith Ann Karam and Dr. David F. Perse.

The third person to be honored was Mary Martin, a nurse at St. Vincent Charity. Nurse Martin was given the Clinical Nursing Excellence Award because of her dedication to her patients and her contributions to the nursing profession. For more than fifteen years, Nurse Martin has cared for patients in St. Vincent Charity’s post-surgery recovery unit. The award was presented by Zydrunas and Jennifer Ilgauskas.

The final award presented was the Radiant Sprit Award. That award was given to Eugene Jordan, a painter at St. Vincent Charity. Mr. Jordan has worked at St. Vincent Charity for over thirty years as a painter in plant operations. Mr. Jordan has spent his life mentoring and encouraging others, especially children. For the last ten years, Mr. Jordan has played Santa Claus at Marion Sterling School. The award was presented by the Honorable Kevin J. Kelley.

St. Vincent Charity has occupied the Central neighborhood in Cleveland for over 150 years. It shares the Campus District with Cleveland State University. The celebration included an announcement describing the manner in which these two institutions will work together to improve the lives of the people living in the community.

 

The leaves are changing colors and slowly falling from the trees. October is the gateway between Fall and Winter.  It is also the official start of influenza (flu) season. In 2015, there were over 40 million cases of the flu and 970,000 people were hospitalized because of the illness.

The flu is more than an inconvenience. For some people, the flu can be dangerous.  Young children and elderly persons are at the most risk.  However, the Centers for Disease Control (CDC) recommends that every person over the age of six months get the flu vaccine. According to Dr. Tom Frieden, the director of the CDC, a 5% increase in flu vaccination would prevent 800,000 illnesses and 10,000 hospitalizations. The traditional flu vaccine protects against three or four strains of the flu virus.

You should talk to your doctor before getting a flu shot if you have had an allergic reaction to a flu shot or you are suffering from Guillain-Barre syndrome or another serious illness.

The majority of flu is spread by young, healthy, unvaccinated children and adults. It takes about two weeks for the vaccine to take effect.  Fall is known for fairs, football and the flu.  Enjoy the first two and take steps to avoid the third one.

RioWaterMost of the sports included in the Winter Olympics are held on the snow. A significant number of the competition at the Summer Olympics take place in the water. In 2008, when the International Olympic Committee (IOC) selected Rio de Janeiro (Rio) to host the Olympics, the members were concerned about water pollution in that country. Before the 2016 Summer Olympics started, Rio officials took steps to ensure that the water would be safe for the athletes. Athletes like swimmer Michael Phelps probably felt protected because of the bacteria-killing chlorine used to treat the pools. However, there was some cause for concern when a diving pool turned green and emitted a foul odor. Eventually, officials concluded that the green color was a result of a proliferation of algae and posed no threat to the athletes.

Officials may have a difficult time easing the fears of sailors and other athletes who compete in events that take place in the sea. Raw sewage has been washing down from Rio into the Guanabara Bay for decades. As a result, the water is horribly polluted. For example, an independent study conducted by the Associated Press showed that the water contained high levels of viruses and bacteria from human sewage. In addition, experts confirmed that they found the super bacteria carbapenem-resistant Enterobacteriaceae (CRE) in several of Rio’s beaches and in the Rodriogode Freitas lagoon. The lagoon empties into the Guanabara Bay where the Olympic sailing competitions are held. CRE refers to a family of germs that is highly resistance to antibiotics. Exposure to water contaminated with CRE may put sailors with open wounds at risk for urinary tract, blood, and wound infections. In Rio, some of the sailors are washing themselves and their boats with soap as soon as they get out of the Guanabara Bay. Because only one athlete has become ill as a result of being in the water it appears that the precautions are working. Nevertheless, athletes are putting themselves at risk in order to fulfill their dreams of Olympic gold.

The Flint Water Crisis: Same Story, Different Characters

by Browne C. Lewis, Director, Center for Health Law & Policy,
Cleveland-Marshall College of Law

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The public has expressed outraged over the water crisis in Flint, Michigan. In 2011, Governor Rick Snyder took control of the city of Flint and placed it under emergency management. In order to meet cost-cutting objectives, the emergency managers decided to draw the city’s water from the highly corrosive local river. As a result, for 18 months, the citizens of Flint consumed polluted water. When members of the predominately low-income African-American community complained about the appearance and taste of the water, they were ignored.

The government’s failure to acknowledge the validity of those complaints does not surprise me and others who work on environmental justice issues. Environmental justice/environmental racism refers to the disproportionate placement of environmental hazards in neighborhoods with mostly low-income and/or populations of color.

This is not the first time I have seen this story. As a native of Louisiana, I witnessed the growth of “Cancer Alley,” the highly polluted area between Baton Rouge and New Orleans that is the home to mostly African-Americans. During my time in Detroit, I watched as incinerators, medical waste facilities and other environmental hazards were placed in African-American neighborhoods. Even though those areas were already overly saturated with toxic entities, the government kept issuing permits to allow industries to place pollution-creating entities in those neighborhoods. The government failed to act to protect vulnerable people who were drowning in effluence. When the government ignores and/or fails to enforce environmental laws and regulations, it negatively impacts the public’s health. In Flint, as a consequence of the government’s disregard, children were permitted to be poisoned with lead-based water.

I practiced lead-based paint law, so I have in-depth knowledge of how devastating lead poisoning can be. There are no safe levels of lead exposure. In Flint, children who were already disadvantaged because of their race and economic status face the potential of being physically and mentally impaired. Public outrage is good; public action would be better. We need to fight to combat environmental injustice. Without action, the characters who are injured may change, but the story will remain the same.

Your Doctor is Just a Click Away

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On July 7, 2015, Delaware became the 29th state to enact a new Telemedicine Act (HB69). Telemedicine is very futuristic and allows patients to communicate with their doctor without actually having to be with the doctor. This Act has unanimous support from both Delaware’s House and Senate. The text of the Act provides this will go into effect immediately, however it may take licensing boards sometime to actually implement regulations called for by the Act.

Telemedicine is described as “a form of telehealth which is the delivery of clinical health care services by means of real time two-way audio, visual, or other telecommunications or electronic communications, including the application of secure video conferencing or store and forward transfer technology to provide or support health care delivery, which facilitate the assessment, diagnosis, consultation, treatment, education, care management and self-management of a patient’s health care by a health care provider practicing within his or her scope of practice as would be practiced in-person with a patient, and legally allowed to practice in the state, while such patient is at an originating site and the health care provider is at a distant site.” Telehealth is “the use of information and communications technologies consisting of telephones, remote patient monitoring devices or other electronic means which support clinical health care, provider consultation, patient and professional health-related education, public health, health administration, and other services as described in regulation.”

Establishing a doctor-patient relationship with telemedicine can be established by, but is not limited to: fully verifying and authenticating the location and, to the extent possible, identifying the requesting patient; disclosing and validating the provider’s identity and applicable credential(s); obtaining appropriate consents from requesting patients after disclosures regarding the delivery models and treatment methods or limitations, including informed consents regarding the use of telemedicine technologies; establishing a diagnosis through the use of acceptable medical practices, including patient history, mental status examination, physical examination (unless not warranted by the patient’s mental condition), and appropriate diagnostic and laboratory testing to establish diagnoses, as well as identify underlying conditions or contra-indications, or both, to treatment recommended or provided; discussing with the patient the diagnosis and the evidence for it, the risks and benefits of various treatment options; ensuring the availability of the distant site provider or coverage of the patient for appropriate follow-up care;and providing a written visit summary to the patient.

There are some exceptions, and some services may be provided without a doctor-patient relationship. Those include: informal consultation performed by a physician outside the context of a contractual relationship and on an irregular or infrequent basis without the expectation or exchange of direct or indirect compensation; furnishing of medical assistance by a physician in case of an emergency or disaster if no charge is made for the medical assistance; or episodic consultation by a medical specialist located in another jurisdiction who provides such consultation services on request to a person licensed in this state.

In the instances where the doctors can not diagnose or treat the person with out a face-to-face appointment, they must do at least one of the following: an appropriate examination in-person; have another Delaware-licensed practitioner at the originating site with the patient at the time of the diagnosis; the diagnosis must be based using both audio and visual communication; or, the service meets standards of establishing a patient-physician relationship included as part of evidenced-based clinical practice guidelines in telemedicine developed by major medical specialty societies, such as those of radiology or pathology. Any prescriptions made online are subject to the same standards as traditional prescriptions. Only a doctor who has formed a relationship with a patient may prescribe him or her medicine. A physician is not allowed to prescribe medicine to a person solely an the basis of an internet questioner or phone or internet consult. All medicines may be prescribed to a proper patient via telecommunications, including controlled substances in some cases.

The practice of telemedicine is not just limited to primary care doctors either. Other health care professionals can utilize this service too, including: psychologists, physician assistants, nurses, pharmacists, genetic counselors, chiropractors, respiratory care practitioners, podiatrists, dentists, occupational therapists, optometrists, mental health counselors and chemical dependency professionals, dietitians and nutritionists, and clinical social workers.

Many hospitals around Delaware are already using telemedicine to some extent. The new laws that Delaware are enacting will help guide the practitioners who already use this service and open the doors for many more. Surveys reveal that healthcare executives are optimistic about about the benefits offered by these teleservices.

There are many pros to having teleservices. These include: convenience, cost efficiency, less waiting time, quick transmission of x-rays, etc. to another doctors for a second opinion, and everything is privet because telepractice is subject to the same HIPAA standards as traditional practice. On the down side telemedicine is subject to technological glitches, inadequate assessments, resistance from physicians, and intrusion by hackers. Telemedicine is a great thing, but it should never and could never replace traditional medical services.