United Nations High-Level Meeting on Tuberculosis: Importance of drug quality

At the end of next month, the inaugural United Nations (UN) High-Level meeting on Tuberculosis (TB) will take place in New York to discuss the future of the bout against the devastating yet elusive disease. As TB remains the largest infectious disease torturer in today’s society taking the lives of 4500 humans each day, the theme of this occurrence is “United to end Tuberculosis: an urgent global response to a global panic”. This unparalleled step undertaken by governments throughout the world along with those allies engaged in ending Tuberculosis will address an assortment of issues at this meeting. Although the exact agenda has yet to be revealed, the resolution to host this single day meeting mentioned the following items could be discussed:

  • Adequate funding for novel diagnostic testing, medications, and vaccinations
  • Multi-Drug Resistant Tuberculosis (MDR-TB)
  • Responsibility for multisectoral collaboration within nation states, regions, and the globe
  • Universal health care coverage and ensuring tuberculosis coverage is included

Each of these items – ranging from the use of prophylactic low dose isoniazid therapy to equal distribution of the recently designed TB diagnostic test Xpert MTB/RIF – are crucial in accomplishing the END TB strategy laid out by the World Health Organization. However, after looking over these action items for the meeting, Tuberculosis drug quality seems to absent.

As health care professionals across the globe continue to treat TB on a patient specific basis, certain untreated cases occur that puzzle even those who have treated the disease for years. The reasoning behind treatment failure? Adherence to medication or drug resistance are often the first assumed thoughts those sharing their patient’s fate may have. Yet, the actual medicine with its various active and inactive ingredients is often not called into question.

Towards the end of last year, the World Health Organization released an alarming figure concerning drug quality in low to middle income countries. In the report released to the public, WHO stated that approximately 10% of medications are counterfeit in these areas of the world – which happen to be the areas where Tuberculosis and other infectious diseases take their largest toll. In addition, WHO added that this percentage is most likely only a small part of the number of humans truly affected by counterfeit medications. To provide clarification, WHO considers counterfeit medications to be unapproved by regulators, unable to meet quality standards, or purposefully misrepresented active or inactive ingredients in the medication. In addition to this report by WHO, the National Institutes of Health (NIH) published a report outlining in 2015 that 9% to 41% of anti-tuberculosis and other infectious disease medications failed to meet the standards sought in specific studies.

It is vital for the global health community to obtain an effective vaccine to prevent pulmonary tuberculosis, to have a rapid yet specific TB diagnostic test, to create a strategy for various sectors of a nation state to work together in ending TB, and novel agents to treat the most severe cases of MDR-TB. Individuals in rural Kampot, Cambodia, inmates in the Russian prison system, or those residing in the slums of Bangalore, India often can be restored to health through the means that have been available for the last half a century. The RIPE (rifampin, isoniazid, pyrazinamide, and ethambutol) regime has proven its success in treating non-resistant tuberculosis – so long as each of the medications are of appropriate quality. However, The Lancet released a report in January 2017 that found that 8.9% of Indian rifampicin products were of inadequate quality in a country that is burdened with the highest prevalence of tuberculosis across the globe. Moreover, WHO revealed that 28.3% of rifampicin containing medications found in the Russian Federation in 2011 failed to meet predetermined specifications for proper quality – a country known to have one of the highest MDR-TB burdens in the world. With the aforementioned statistics released by the WHO, The Lancet, and NIH, a renewed emphasis needs to be placed on ensuring the quality of each and every tuberculosis medication that reaches a human being. The possibility of one in ten (or more) TB medications being counterfeit will continue to lead to failed treatment regimes, inappropriate use of resources, and spread of MDR-TB even if innovative technology is developed.

In order to combat counterfeit medications on a global level, the World Health Organization developed a reporting system for the interconnectedness of the medication market. The Global Surveillance and Reporting System (GSRS), that all WHO members are eligible to contribute to, aims at collecting data on falsified medications, vaccines and other medical equipment to address real-time situations and prevent further harm. With this reporting arrangement in place, the WHO has reacted and thwarted mortality and morbidity associated with counterfeit medications – including the contaminated cough medication supply that led to 60 deaths in Pakistan and a number of individuals treated with an antidote in Paraguay in 2013. On top of the GSRS, WHO has implemented Good Manufacturing Practices (GMP) that each manufacturer should achieve in order to be certified by WHO; thus, providing a reliable source of medications that nation states can purchase from. Although these initiatives have brought about encouraging results along with halting global medication emergencies, there are still barriers that accompany these programs. The technical training, technology, and adequate staffing to properly identify and report through the GSRS is often difficult to obtain in the developing world while GMPs are often misapplied and have inadequate supervision. The root cause is the long-term development of countries’ public health systems – of which continuing problems with counterfeit medications remains deficiently addressed. A county’s public health care system is the vital organ to ensuring quality medications through these mechanisms that WHO has created and employed. An underutilized and under resourced public health care system leads a budding yet unregulated private market – unable to ensure proper treatment for those seeking it.

Since the United Nations declared this a high-level meeting, meaning all heads of member states are encouraged to participate in the highest level possible, this venue provides the ideal opportunity to recommit to guaranteeing TB drug quality. The sustained empowerment of the public health care systems for those countries tirelessly battling tuberculosis will be a step forward into truly ending this devastating disease. Each health care professional spanning the globe has a responsibility to accompany these governments, colleagues, and fellow humans by investing their time, resources, and talents to develop procedures and systems to ensure effective drug quality.

Advertisements

Empowering Women to Take Control of their Sexual Health

Two weeks ago, I attended a powerful and motivating summit hosted by Florida International University (FIU) Robert Stempel College of Public Health and Social Work on empowering women to take control of their sexual health through knowledge of biomedical HIV prevention methods, connecting to community resources, and mobilizing key community stakeholders and providers.

What was most unique about this summit was the rawness of the various conversations. These conversations included voices of state congresswoman Frederica Wilson and Ileana Ros-Lehtinen, community women and activists, a panel of diverse physicians and nurse practitioners, researchers, and LGBT and minority women working across different sectors in the HIV prevention field. When it comes to empowering women surrounding their sexual health, pre-exposure prophylaxis (PrEP) is viewed as the driving vehicle. The problem is that there is a lack of awareness among women particularly LGBT and minority women, and providers about PrEP and post-exposure prophylaxis (PEP). During the engaging providers panel comprised of various physicians working in South Florida, a Haitian physician expressed that before the conference he decided to call several of his provider friends that practice within the local Haitian community and asked them if they have heard of PrEP. How many do you think said, “Of course, I know about PrEP”? The answer is…0. Not one single doctor whom was asked said they have heard of PrEP. We have a lot left to do. The work has not yet been done!

Miami’s HIV Epidemic

So maybe you are wondering…well why host this conference? The county of Miami-Dade continues to lead the nation in new HIV infections. Not too far away is the neighboring county of Broward which continues to compete with Miami when it comes to high prevalence rates as well.

Due to the rising rates of HIV in Miami-Dade County, city officials have responded to the epidemic with the development of a “Getting to Zero” task force comprised of city commissioners and individuals representing various public health agencies throughout Miami-Dade County as well as the state of Florida. The task force devised a multi-pronged action plan with priority goals for the next two years. The plans include to (1) reduce the rates of reported AIDS cases, (2) reduce the percentage of newly diagnosed HIV cases among residents aged 13-19 (3) increase the percentage of newly identified HIV-infected persons who are linked to care within 90 days of diagnosis and are receiving appropriate preventive care and treatment services in Miami-Dade County and (4) reduce the number of newly reported HIV cases in Miami-Dade County (http://www.miamidade.gov/releases/2016-09-29-mayor-getting-to-zero.asp).

Prep around the globe

PrEP has served as a vehicle for prevention and is being used worldwide. Countries such as the United States has large scale PrEP programs while others are still in the stages of development and some have not implemented as of yet. There has been many PrEP initiatives enacted. The US Agency for International Development (USAID) is currently supporting 5 Microbicide Product Introduction Initiative (MPii) projects in Kenya, South Africa, Zimbabwe, Malawi, and Uganda from 2015-2020 focused on gender-based violence, drug resistance, creating demand, introducing new products, and models for delivering services. Another program is the DREAMS (Determined, Resilient, Empowered, AIDS-free, Mentored and Safe) initiative, a collaborative effort between US President’s Emergency Plan for AIDS Relief (PEPFAR), Bill & Melinda Gates Foundation, Girl Effect, Johnson & Johnson, Gilead Sciences and ViiV Healthcare. DREAMS aims to reduce the incidence of HIV by 40% among adolescent girls and young women by 2020 in the highest HIV burden countries including Kenya, Lesotho, Malawi, Mozambique, South Africa, Swaziland, Tanzania, Uganda, Zambia and Zimbabwe. Of the 10 countries, 5 have included PrEP for adolescent girls and young women in their strategic plans to address HIV. Recent data from PEPFAR shows significant declines in new HIV diagnoses among adolescent girls and young women. In the 10 African countries implementing PEPFAR’s DREAMS partnership, the majority of the highest HIV-burden communities or districts achieved greater than a 25 percent–40 percent decline in new HIV diagnoses among young women (https://www.usaid.gov/what-we-do/global-health/hiv-and-aids/technical-areas/dreams). In other areas of the globe such as Latin America and the Caribbean, a combination of biomedical, structural, and behavioral interventions is greatly needed in order to reach target objectives and goals and ultimately increase HIV prevention efforts. I am excited to see the future of PrEP.

Women’s Perspectives

During the women’s perspectives breakout sessions, workshops were broken down into specific focus groups including African American, Latina and Haitian. Amongst the African American women breakout session, some key topics that were addressed included stigma, specifically communication between the medical provider and client such as clear language on how to ask questions during the appointment while also considering time constraints, policy, and the need for funding toward effective behavioral interventions for HIV negative black women in the community.

Sistas Organizing to Survive (SOS) is a grassroots mobilization of black women in the fight against HIV and AIDS. In Florida, one in 68 non-Hispanic black women are known to be living with HIV/AIDS and has been the leading cause of death among black women aged 25-44 years within the state. (http://www.floridahealth.gov/diseases-and-conditions/aids/administration/minority-initiatives.html)

Call to Action

Miami is the #1 city in the United States with new HIV infections. This is a huge public health issue. We have a call to action to advocate for ourselves and others when it comes to ending the epidemic. We have made significant strides, but the work has not yet been done. Sexual health including HIV prevention should be something that we freely discuss with our family, colleagues, peers, physicians, and anyone that we come in contact with that is willing to listen. It is these conversations that we can decrease stigma surrounding HIV. Women across the counties of Broward, Miami-Dade, and Palm Beach have answered the call to action by organizing and advocating for all women. We have accepted the call to action together that we can get Miami to Zero!

“A future where new HIV infections are rare, and when they do occur, every person, regardless of age, gender, race/ethnicity, sexual orientation, gender identity, or socio-economic circumstance will have unfettered access to high quality, life-extending care, free from stigma and discrimination.”

–Quote from the National HIV/AIDS Strategy Updated to 2020: Strategy Vision

For additional information, please visit http://www.who.int/hiv/topics/prep/en/ http://amp4health.org/ and http://getting2zeromiami.com/

Conference Reflections: Emergency Preparedness & International Health – Different Fields, Same Goals

Last week I was given the opportunity to attend the Preparedness Summit in Atlanta. This conference is the first and longest running national conference that discusses and revolves around the world of public health preparedness (think: natural disasters, medical countermeasures, flu, Zika and Ebola responses, biological threats and much more). There were many different opportunities to learn about preparedness activities including plenaries, small discussions, learning sessions and networking with local, state and federal partners. It was overwhelming, but in a good way!

As an epidemiologist, I have some experience and background in public health preparedness activities, but my main interests and time have always been spent with infectious diseases and global health initiatives. When I worked for the state health department, I actually was on a team that was half epidemiologists and half preparedness staff and we continually supported each other’s activities. Those experiences helped me with preparedness lingo and acronyms used during the conference so that things didn’t go completely over my head. However, I would not consider myself a preparedness expert by any means and soaked up as much as I could from the various sessions I attended.

One of the most exciting activities from the week was visiting the Emergency Operations Center (EOC) at the Centers for Disease Control and Prevention (CDC). This EOC is the center that gets activated in a public health emergency and where experts gather and get ready to respond. The main room of the EOC is spacious, with many computers, television screens and telephones set up and ready to be filled with points of contacts from different divisions and organizations. When there’s not an emergency response going on (like on our tour), it’s actually pretty quiet. However, staff are still on call working to monitor information and sift through potential threats. During a response, I’m sure the place is bustling with people, calls, information sharing and meetings. It was a neat experience to be in the center communication hub where past emergency responses like Hurricane Katrina in 2005 or the 2014 Ebola outbreaks took place.

I did some research after attending the summit and found that the EOC has become an integral part of meeting the goals of the “Global Health Security Agenda (GHSA)”. This agenda is focused on “accelerating progress toward a world safe and secure from infectious disease threats and to promote global health security as an international security priority.” Over 50 countries have joined in partnership with the U.S. to meet this objective and the CDC aims to activate the EOC and respond within 2 hours of any mandated public health emergency. There’s even a fellowship offered by the CDC called the “Public Health Emergency Management Fellowship” that provides an opportunity for public health workers to learn and train over a four-month course then go back to their respective countries and create their own local EOCs. Emergency management experts can also be sent to these countries and help guide and train responders in their own environment if needed.

This post-tour research made me start thinking about the importance of the EOC and preparedness in relation to international health. Public health threats (like pandemic flu, Zika, Ebola) of any degree can happen at any time at the local, state, national, or international level. Bill Gates recently spoke out about the necessity of being prepared for public health threats such as these at the Massachusetts Medical Society 2018. He stressed how unprepared we are for the next epidemic and the world’s need for a “global approach” with “better tools, an early detection system, and a global response system”. Gates’ is most likely alluding to the poor handling of the Ebola outbreaks in the recent past. These are a perfect example of why the field of preparedness is so important to global health. During Ebola, public health response was “too late” and there were too many “deaths that could have been prevented”. There were many disagreements among global health leaders over things like travel bans, how to handle public panic and how to best respond. The aftereffects of the outbreak point to the integral link between a strong preparedness field and international health that was lacking. Gates’ argues that we weren’t prepared to handle prior outbreaks, but we are capable and should spend time and money on planning and preparing for similar epidemics in the future.

Overall, these events – the conference, EOC tour and recent news and outbreaks – have helped hit home that these different public health fields, although working in slightly different capacities, are really aligned and influential on each other. Ultimately, preparedness and global health are working to reach the same goals of keeping our planet safe and healthy and we must first be prepared for any global threat in order to achieve these goals. Today, I feel refreshed in my perspective of the field and inspired and hopeful of future preparedness efforts. I no longer feel that preparedness and international health belong in the different boxes or divisions I’ve created in my mind, but as two parts to the same path.

I challenge other public health workers to also think about the important link between preparedness and global health and advocate for changes that strengthen this partnership. The Preparedness Summit conference is a great starting place and I encourage all fields of public health workers to look into it! I truly believe the more you learn, the more you see how everything is connected and the better you are able to achieve your public health goals … and maybe find some new teammates from other fields to help you along your journey, too.

 

Is Zika still a thing? My experiences as a Zika Case Manager in the field (South Florida)

Zika was a hot topic, but now it seems like it is a thing of the past. People always ask me…”Is Zika still is a thing?” And my response is, “Of course! Just because it has declined, certainly does not mean that it isn’t still a public health threat.”

Interesting enough, comments like “Is Zika still a thing” come from physicians and various public health professionals as well as individuals living in regions with active Zika transmission. Those that express more of a concern include individuals that have planned future travel to the state of Florida and are planning to conceive, or a close family member of someone who is currently pregnant.

What is Zika?

Perhaps you never heard of Zika, or still quite aren’t sure what Zika is exactly. Zika can be described as a virus that spreads to people primarily through the bite of an infected Aedes species mosquito. It is closely related to other flaviviruses such as Zika can also be transmitted sexually from a person that has Zika to their partner as well as from a pregnant woman to her developing fetus, which can result in serious birth defects. Want to learn more about Zika? Check out some other IH section blog posts about Zika here.

My role, criteria for testing, testing/funding limitations

I was hired as one of two Zika Case Managers within my local county health department through funding allocated to the state of Florida by the CDC. One of my duties is to coordinate the testing of suspected local, or travel cases, pregnant women, and any infant born to a potentially exposed pregnant woman. The testing criteria for pregnant women include those who traveled to a Zika-active transmission area, had sexual exposure during pregnancy, or 8 weeks prior regardless of the mother’s testing status, as well as those with any abnormal ultrasound results. Testing is also recommended if the mother was not previously tested. Just like other reportable infectious diseases, it takes effective communication between health professionals at all levels to get quality information across regarding Zika. In order to get the job done, we collaborate with infection control practitioners of local hospitals, nurses, physicians, and other public health clinicians to get samples of babies collected at birth for Zika testing while also making sure that a head ultrasound and hearing test are performed on the baby. This is very important because once the baby leaves the hospital it is almost impossible to get samples collected. A majority of the pediatric clinics don’t have the means to ship the specimens to the state laboratories. Some of the general responses we have received from these clinics include not knowing how to properly prepare the specimens for shipping, having the money to do so, and lack of knowledge about billing the patient’s insurance for the procedure. Although the county health department has the access and ability to ship specimens, it would be a liability for us to ship the specimens if another facility collected the samples.

As of March 2017, the department of health has conducted Zika virus testing for more than 13,020 people statewide. At Governor Scott’s direction, all county health departments were mandated to offer a free Zika risk assessment and testing to pregnant women. Unfortunately, due to a decline in cases, and federal funding allocated to state programs winding down, free testing is no longer accessible to the community, and is only provided on a case by case basis. Zika tests can be pretty expensive ranging anywhere from $200 – $400 when conducted at a commercial laboratory and even more in some cases.

State laboratories have just about depleted federal funds received for testing initiatives. If a patient does not meet testing criteria at our department of health, we recommend testing through affiliated commercial laboratories. In addition to the many changes in testing criteria including requiring patients to show proof of insurance, there has been issues with the insurance companies and patients’ have been incorrectly billed over $1000 for their Zika tests when in fact the test was free. This has been a big issue with tests conducted as far back as November and December which we have recently been made aware of. Mosquito control services specifically for Zika efforts provided by our county health department’s Environmental Health program has ended.

Management of Infants with confirmed, or possible Zika Infection

Currently, we have reached the stage where the pregnant women that are case managed have already given birth. We are now tasked with conducting 24 month active follow-ups of all infants exposed to a positive mother via in utero. We conduct follow-up of the infants exposed regardless of whether the infant tested negative, or positive. These infant follow-ups occur at 2, 6, 12, 18, and 24 months. This is because abnormalities can still occur during child development. A majority of our babies being followed are currently between the 12 and 18 month mark.

Out of all the babies we have tested, and are currently following, only one is confirmed to be microcephalic. Looking into the future, at the 18 month follow-up mark, the infants being followed will have to be re-tested in order to confirm if the antibodies are indeed negative or positive. Another complication with testing these babies will be whether the baby has traveled since it has been born. There is a possibility that the baby could have been infected during travel and not in utero. As of July 31st 2018, Zika contracts for our county health department will end and it is unsure who will take on the responsibility for maintaining the case management of these families.

Community Outreach

Best practices we have utilized as a county has been community outreach which we collaborate across the division of communicable diseases. I have been able to work closely with a CDC field assigned Zika Community outreach nurse to assemble and distribute Zika prevention and testing kits with a specific focus on obstetrician-gynecologist and pediatricians. We have been able to identify the gaps in testing and communication among our health department and local hospitals, clinics, and private physician offices. Additional community outreach activities of focus include visiting women, infant, and children (WIC) clinics throughout the county in order to conduct health education on Zika as well as community health fairs primarily within the Haitian population due to Haiti being one of the top countries which we get the most amount of travel related cases. Unfortunately, these outreach efforts will also end at the end of this summer due to the depletion of funds, and our CDC field assigned nurse’s contract ending.

Where we are now

As of right now, Florida still does not have any identified areas with ongoing, active Zika transmission. Florida is a hotspot for vacationers, especially the counties of Miami-Dade and Broward. Since the local transmission of Zika in 2016 in both counties, it seems that very few individuals consider Zika as being a major concern. Very few physicians’ are screening for Zika. Some still aren’t sure what it is exactly, and how it can affect an unborn fetus. Congenital Zika infection is still a global health threat to pregnant women and their infants. Zika is still a fairly new infectious disease, and we are learning as we go, especially the risks after pregnancy. The reality is that Zika is here to stay. Funding for zika prevention and treatment should be a top priority in order to aid in the health and wellbeing of children and families across the United States.

World TB Day 2018

5149398656_ebd66669fa_z

Tuberculosis is caused by Mycobacterium (seen in the image), a genus postulated  to have originated some 150 million years ago! The first written records about TB from India and China, date back to 3300 and 2300 years ago respectively.

Hippocrates accurately defined symptoms of “Pthisis” (Greek for TB) and described it as a fatal disease. There is also plenty of historical evidence about tuberculosis and its impact on human culture. From being identified as a “romantic disease” to being associated with poetic and artistic qualities, TB has had its fair share of time in the limelight.

All this history aside, the fact is, if untreated, TB can be fatal.  Effective treatment became available about 50 years after Robert Koch showed that TB was caused by an infectious agent in 1882Soldier TB 2. Isolation in sanitariums and surgical interventions were all part of treatment until the advent of streptomycin in 1944. BCG vaccine has also been in use since 1921. Several public health campaigns (such as the one seen here) were also conducted to raise awareness once TB was established as a contagious disease.

Unfortunately even to this day, TB is still a major public health concern in many parts of the world and is among the top 10 leading causes of death worldwide.  Seven countries account for two-thirds of total TB cases with India leading the count.

The disease typically affects the lungs and is spread in the air when a person infected with TB coughs or sneezes. Sadly the cost of having TB goes beyond the damage it does to one’s health. Recent studies show that economic impact TB can have people; TB can lead to a downward spiral into poverty and for the poor a TB diagnosis can prolong the cycle of poverty they already live in.

TB3March 24th is World TB Day. The theme for World TB Day 2018 is “Wanted: Leaders for a TB-free World”.

TB rate spike due to the humanitarian crisis in Venezuela, poor TB infection control in South African clinics and jail time for doctors who fail to report TB cases in India, have all been in the news leading up to World TB day. Clearly these news reports show the need for stepping up global action, if we hope to end TB by 2030.

The message about greater commitment and better leadership comes ahead of the UN General Assembly High Level Meeting on TB in September 2018. Given the surge in multiple drug-resistant TB, it is imperative that leaders at all levels work together to end TB. End TB strategy adopted in 2014 outlines interventions that fall under three key pillars that include integrated, patient-centered care and prevention, policies and supportive systems and research and innovation.

But as public health professionals, community leaders and residents, we all can take small steps to make sure we put an end to TB. The path to ending TB will hopefully improve the lives of most vulnerable people world-wide.

TB4.png