Perspectives on Global Health from Pharmacists Around the World, Part Two

As healthcare continues to morph and adapt based on the requirements of kind, compassionate, evidence-based care, pharmacists are playing a vital role in ensuring patients needs are met in countless regions across the earth. In this four-part IH Blog series, the pharmacy role accompanied by profession-related challenges and pharmacist-led global health initiatives will be explored within a profession that is often underappreciated. The following perspectives, shared by practicing pharmacy professionals from the United Arab Emirates (UAE), Cambodia, and the United States of America (USA) aim at highlighting various aspects of healthcare that should be properly addressed by governmental bodies, NGOs, and all stakeholders by both sustainable political will and empowering solutions. 

This second installment focuses on medication quality in each of these areas and the thoughts that pharmacists from these respective nation states have been willing to share with IH Connect.

The onset of the biomedical and synthetic medication era brought with it a formerly unknown hope for the betterment of humanity’s health. The introduction of antibiotics like the beta-lactam class, vaccinations to completely eradicate diseases like smallpox, medications with unique mechanisms of action to regulate hypertension and diabetes, and more recently, targeted oncology medications to successfully attack cancer cells have all contributed to vastly improving patient care across the globe. However, with this tremendous advancement, novel complications have arisen that have plagued health care professionals in devastating arenas. For the pharmacy profession, specifically, the quality of medications has emerged as an additional concern in the treatment and dispensing process. Although a majority of nation states have regulatory bodies to monitor the quality of medications, low quality medications frequently find themselves in the hands of patients. This often leads to substandard care, furthers health inequalities, creates distrust in healthcare workers, promotes drug resistance, and damages the solemn promise every health care professional strives to follow – to properly care for those afflicted with various ailments. The perspectives and ideas that are shared in the following text explores medication quality throughout various parts of the world and initiatives that aim at addressing this determintental issue. 

Dr. Moeung Sotheara, Ph.D. 

Clinical Research Assistant & Part Time Lecturer – University of Health Sciences

Phnom Penh, Cambodia 

Access to high-quality medicines in many countries is largely hindered by the rampant circulation of counterfeit and substandard medicines. The use of counterfeit and substandard medicines represents a worldwide public health concern, and its prevalence is particularly high in developing countries. In Cambodia, the Ministry of Health reported in 2001 that 13% of medicines were spurious/falsely labeled/falsified/counterfeit, with 21% being substandard and 50% unregistered.

This crisis affects commonly used lifesaving medicines such as antibiotics, analgesics and anti-parasitics. The impact of poor-quality medicines is enormous ranging from increased adverse effects to increased morbidity and mortality. Poor-quality antimicrobials in particular has led to multi-drug-resistant malaria and bacterial infections which result in a huge burden for the country’s health sector. The high prevalence of poor-quality medicines has possibly contributed to the loss of confidence in health systems and health workers due to repeated treatment failure.

Among the reasons for the high rate of fake drugs in Cambodia are corruption, weak law enforcement, poverty and high sales taxes with self-medicating being often the driving force behind counterfeit drug markets. Counterfeit drugs mostly enter Cambodia through illegal drug outlets. The counterfeiting of drugs in Cambodia usually appears in the form of finished pharmaceuticals imported from neighboring countries, rather than the counterfeiting of bulk drug ingredients. This is due to the country’s lack of manufacturing capacity. Substandard drugs on the other hand are the result of limited implementation of good pharmacy practice regarding the distribution and the storage of pharmaceuticals which results in the deterioration in medicine quality.

Efforts have been made by the Cambodian government to tackle this problem. In 2015, the Cambodia Counter Counterfeit Committee (CCCC) was established and has been in charge of tracking counterfeit and substandard medicines circulating in the country. In 2018, the CCCC confiscated 138 types of illegal goods and substandard medication in 10465 packages from a pharmaceutical company in the capital city, Phnom Penh. The government is also working with its neighbors to decrease the number of fake drugs smuggled across the borders of Southeast Asia. Non-licensed drug outlets have been gradually disappearing, especially in the capital, either due to closure or accreditation, resulting from a strengthening of regulatory efforts. These initiatives are supported by pharmacists in communities by creating a front line against the distribution of counterfeits in the Kingdom through educating the public about the dangers of fake pharmaceuticals. 

Nazgul Bashir, B. Pharm

Registered Pharmacist – Super Care Pharmacy

Dubai, United Arab Emirates

Maintaining a healthy environment, reducing the healthcare cost, and using effective treatment options are all linked to medication quality. In any community, city, or region there are countless investments undertaken to improve the quality of healthcare overall. The Institute of Medicine defines health care quality as “ The degree to which healthcare services for individuals and populations increases the likelihood of desired health outcomes and are consistent with current professional knowledge.”

More specifically, medicine quality has two major roles: patient safety and effectiveness of treatment. Consuming a poor quality medicine will not only increase the risk to patient safety, but will hinder the proper treatment of patient. This can cause a patient to suffer more and increase the cost of treatment. Being a pharmacist and dispensing a low quality medication will also result in losing a patient’s trust. Since pharmacists have the role of dispensing medications, it is vital to ensure the medicine is in highest quality.

Quality of pharmaceutical products, mainly medicines, poses a serious challenge to the entire healthcare sector including drug manufacturers, distributors and dispensing pharmacists. According to the World Health Organization (WHO), the influx of fake or counterfeit medicine is a major concern in the market over all the globe.

Medicine in the United Arab Emirates (UAE) is manufactured so that medications go through systematic quality checks which are checked and re-checked several times while maintaining records in order to avoid any health hazard, Quality assurance teams then conduct self inspection or hire a third party to undertake inspections. The health regulations make sure that medicine distributed meet the standards of the listed quality and accepted internationally. On the other hand, imported medicines have similar criteria for safety and quality management. 

In order to further address low quality medications, the UAE Ministry of Health unveiled a new machine to detect imported drugs and inspect fake or counterfeit drugs. This machine is known as the TruScan RM Analyzer. It’s high tech detector is used to identify low quality drugs that pose health threats to the community. The device is helpful for chronic disease medicines such as diabetes, heart problems or even cancer drugs. The TruScan RM Analyzer also helps inspection regulators in the country to make informed and timely decisions for the release of drug shipments which are entering the country. In addition, UAE has been fighting the spread of low quality medicines in the country by taking many measures like high quality control labs and research on medicines and healthcare products.

Dr. Bryce Adams, Pharm D., RPh.

Oncology Medical Science Liaison

Washington D.C., United States of America

In the United States, the quality of medications isn’t commonly considered in the process of treating a patient. This is because of laws and regulations that are in place to ensure the quality of the medication. However, this wasn’t always the case. Up until 1906, there was no law requiring medications to be pure. That changed in 1906 with the passage of the Pure Food and Drug Act. This required medications to be labeled correctly and to meet purity standards put forth by the United States Pharmacopeia. 

This act greatly improved the quality of medications produced in the United States as manufacturers were required to list the ingredients that are used in the creation of medicine, and the ingredients and manufacturing process must meet certain standards. However, there is still a market for counterfeit medications as patients search for ways to reduce the cost of medications. It is estimated that 19 million US citizens purchase medicine outside of the current regulated system (e.g. from unlicensed sources such as foreign online pharmacies).  One recent example is with counterfeit Avastin, an anticancer drug, that was found to have no active ingredient. Another example is the recent opioid epidemic. Street drugs are being laced with fentanyl leading to increased overdoses and mortality. 

Recently, there have been discussions to allow for greater importation of medications into the United States. While this could potentially reduce the cost of medications, it could also increase the risk of counterfeit medications. Medications originating from outside of the United States makes it harder for the Food and Drug Administration (FDA) to regulate the quality and purity of medications. 

Patients in the United States can reduce the risk of receiving counterfeit medications by picking up their medications from their local pharmacy and can feel comfortable knowing those medications are of high quality. If cost is an issue, a patient can discuss their options with the pharmacist. There may be a cheaper alternative or an assistance program that can help offset the cost of the medication.

Repurposing Medications: Reimagining Treatment Options

Last month around the Chinese New Year holiday, a prominent Chinese scientist from Guangzhou Medical University made an announcement that stirred controversy both domestically and internationally while also highlighting a route to combat ailments that global academia and pharmaceutical industries have been attracted to for years. The scientist revealed that his team had been injecting patients with a malaria-causing parasite in order to cure a range of cancers – with two patients seeming to have no cancer cells remaining at the site of tumor and five additional patients having no disease progression out of ten total patients receiving this malarial therapy for at least a year. Although this type of treatment has been attempted in the past in an attempt to combat HIV in the 1990s, the Centers for Disease Control (CDC) and other health governing bodies determined that there was insufficient pre-clinical data to justify human trials during this time period. The controversy revolving around this announcement encompasses the aforementioned determination by CDC, the release of trial results before being published in a peer-reviewed journal, and, most importantly, the possibility of creating a malaria public health emergency for a country due to eradicate the communicable disease by 2020. Although the scientist who underwent this study clearly abdicated internationally conferred health principles, this avenue of repurposing – repositioning, re-profiling, re-tasking, etc – medications and therapy is becoming more appealing to those invested in novel treatment options for both established and emerging diseases.

Throughout the development lifecycle of new chemical entity (NCE), the process for regulatory approval could span over ten to fifteen years with an associated cost of over 2 billion dollars. This has led to an average of only 20 to 30 NCEs being approved by the Food & Drug Administration (FDA) each year. However, through repurposing medications, the development span can be cut to five to eight years at approximately 60% of the total NCE cost – in addition to higher approval rates from regulatory agencies. This repurposing process, as shown by the statistics, is enormously appealing for pharmaceutical companies/investors, but also provides targeted therapy for patient’s disease states at a theoretically lower price than an NCE. Even for rare genetic diseases, repurposing has become common due to only 400 medications being on the market to treat over 7000 genetic conditions. Repurposing is accomplished through the theory of translational research which takes a look at basic scientific discoveries and determining how a medication can be made to match this discovery – for example, examining the molecular pathway of diabetes and then matching it with a chemical entity that has an effect within the pathway like glucagon-like peptide 1 (GLP-1). The known chemical entities are commonly stored in giant databases within academia and the industry. Through big-data analytics, advanced modeling, and high throughput screening techniques, these chemical entities can then be extracted from the databases and determined if it has a possible role in a certain molecular pathway.

This method of establishing novel treatment options ought to be utilized more frequently and effectively, though there are medications over the years that have undergone this type of approval. The following are examples of already approved medications and others undergoing clinical trials:

Approved Repurposed Medications:

  1. Thalidomide, which was originally developed as a racemic mixture of enantiomers for the treatment of morning sickness but found to be teratogenic due to the effect of the (S)-isomer, was later successfully developed by Celgene as a single (R)-isomer product for the treatment of leprosy and multiple myeloma.
  2. Viagra (Pfizer’s sildenafil) was a drug that initially failed as an angina treatment in clinical studies; however, during these trials, its effect on erectile dysfunction was noted and then later approved for this indication.
  3. Celebrex, commonly used in osteoarthritis, works by inhibiting COX-2 receptors. Recently it has been shown that for patients that previously had colon cancer, taking this agent can reduce the risk of additional polyp formation without negative gastrointestinal effects associated with existing treatments.
  4. All-trans retinoic acid (ATRA), which is an acne medication, when combined with traditional chemotherapy, results in complete remission of acute promyelocytic leukemia in 90% of treated patients.
  5. Tamoxifen, a hormone therapy medication, treats metastatic breast cancers, or those that have spread to other parts of the body, in both women and men, and it was originally approved in 1977. Thirty years later, researchers discovered that it also helps people with bipolar disorder by blocking the enzyme PKC, which goes into overdrive during the manic phase of the disorder.
  6. Raloxifene was initially developed to treat osteoporosis, but has since been shown to reduce the risk of invasive breast cancer in postmenopausal women in 2007.
  7. Zidovudine (AZT) was initially developed to treat various types of cancer, but was determined to be ineffective. However, it was repurposed into the first approved HIV/AIDs medications in 1987 and has had a tremendous impact on the progression of the autoimmune disorder.

Repurposed Medications Undergoing Clinical Trials:

  1. The lipid soluble simvastatin is currently undergoing a trial in the UK to assess the efficacy of reducing the progression of Parkinson’s disease. The statin drug class is thought to prevent this ailment through its pleiotropic effects including reducing inflammation, reducing oxidative stress, reducing the formation of sticky bundles of alpha-synuclein, and increasing the production of neurotrophic factors. The results are expected to be released in 2020.
  2. Purdue University received a grant from the National Institutes of Health (NIH) to discover the effectiveness of Ebselen, a chemical entity, against methicillin-resistant Staphylococcus aureus (MRSA), and auranofin, which is FDA-approved for the treatment of unresponsive rheumatoid arthritis, against Clostridium difficile.
  3. Metformin, a first line agent for many diabetics, has been shown to reduce the risk of breast cancer in diabetes patients and is being investigated as a treatment for cancer in many different clinical trials

Although this is certainly not an exhaustible list of the impacts repurposing has had on healthcare, the majority of this repurposing stems from serendipitous observations rather than targeted interventions. Through these unanticipated occurrences, a range of disease states can now be more effectively treated ranging from communicable diseases like HIV/AIDS to mental health ailments including bipolar disorder and Parkinson’s disease to non-communicable diseases. As the rising cost of healthcare continues to devastate humanity and lead to health inequalities, heads of governments, pharmaceutical industries, academia, and nonprofits need to commit themselves into investing their time and resources into this repurposing method. The targeted repurposing interventions are more vital and should be devoted to in order to expand options for health disorders rather than the unexpected observed effects. The financial and health outcomes will lead to novel treatment options accessible to a majority of the world which will allow health care professionals to properly accompany their patients through their disease state.

It’s National Public Health Week!

From the National Public Health Week Website: http://www.nphw.org/

We hope you’ll take advantage of all National Public Health Week 2019 has to offer as we celebrate public health and highlight key issues. During these seven days of inspiring events, conversations and celebrations nationwide, don’t miss:

  • Our annual Twitter chat, a conversation with public health leaders from around the country. Mark your calendar for April 3, and don’t forget to RSVP.
  • The NPHW Forum on April 1 featuring grassroots organizers sharing how they’ve activated their communities to improve health right where they live. You can register to attend in person or watch the event via webcast.
  • NPHW’s Student Day discussion on April 4, when public health professionals will share tips on how to break into the field. You can join us in D.C. or watch the webcast to ask questions about getting that first job out of school.
  • Our Shareables page featuring images you can post on social media and NPHW logos to help you spread the word about NPHW 2019.
  • NPHW events in your community, from fundraising fitness walks to health fairs to educational workshops. You can search by state on our Events page.

Our fact sheets are available year-round on the NPHW website so we can keep the momentum and learning going. Learn more about this year’s daily themes and how you can be part of the movement for science, action and health.

Why do we celebrate National Public Health Week? APHA Executive Director Georges Benjamin explains that perfectly in his NPHW 2019 Welcome Letter.

Kaiser Family Foundation releases budget summary analyzing global health-related funding in FY20 budget request

KFF released a budget summary analyzing global health-related funding contained in the FY20 budget request. The analysis includes a table that compares U.S. global health funding in the FY20 request to the FY19 request and enacted levels. It will be updated as more information becomes available.

https://http://www.kff.org/news-summary/white-house-releases-fy20-budget-request/

Looking Ahead: Global Health Threats in 2019

The past year felt turbulent across many facets of life- global health included. Between threats to health from climate change, infectious disease outbreaks, the opioid crisis, threats to healthcare in war zones, and the ever-present health risks of noncommunicable diseases, global health resources are stretched thin. The coming year promises to be just as challenging.

Many global health organizations, such as the World Health Organization and IntraHealth, release reports on health risks to look out for at the start of each year. Between these lists, there is significant overlap, suggesting that the problems in global health are not a matter of lack of data or direction, but poor prioritization and lack of resources. Pollution and climate change rank high on almost all such lists; the WHO reports that 90% of people breathe polluted air on a daily basis. As a result, the WHO considers air pollution the greatest environmental threat to health for 2019- a significant step considering the threats of water pollution and other environmental contaminants. As with most global health issues, the world’s poorest people are hit the hardest. Nearly nine in ten of global deaths due to inhaled pollutants are in low- and middle-income countries (LMIC), due to entirely preventable causes like poor regulation of transport emissions and using gas-powered cookstoves in homes.

Another problem heavily featured in the forecasting reports for 2019 include health risks due to conflict. More than 1 in 5 people across the globe (22%) live in a conflict-affected environment. These are the populations least likely to meet health and development targets, like the Sustainable Development Goals. Specific conflicts are high on the radar of global health officials, especially Yemen and Syria. Both countries have experienced heavy destruction of their existing health infrastructure, brain drain of medical personnel, and tangential struggles that bode poorly for health, such as food insecurity and poor sanitation. Dogged efforts by both local and international humanitarian workers have been able to stave off many public health disasters in such environments, but as wars proliferate and donor attention drifts, only the most pressing issues can be addressed. For example, in Yemen, an unprecedented multi-wave cholera outbreakled to more than 1 million cases of cholera. Of these cases, 30% were children. An effort by many international and local NGOs to distribute vaccines to these cases likely decreased the death toll, but the existing malnutrition of the population coupled with factors like destroyed water supplies exacerbated the outbreak and accelerated the need for resources and personnel.

Risks from infectious disease are typically present throughout global health forecasts, and this coming year was no different. In fact, for the first time, the WHO considers vaccine hesitancy, which they define as the reluctance or refusal to vaccinate despite the availability of vaccines, to be a public health risk that threatens to undo decades of work eradicating diseases that, until quite recently, affected people around the world. Vaccine hesitancy is thought to be one of the factors that has led to a 30% increase in global measles cases. Outbreaks of Ebola have shown how dangerous and fast-moving an infectious disease can be, even with the health workers tasked with treating ill patients. Resurgence of polio in war-torn Syria was only dissipated through a massive vaccination effort. The growing threats from influenza, Dengue, Zika, MERS, SARS, and many other diseases have raised the alarm as to how well global public health processes are able to deal with a potentially catastrophic pandemic. Unfortunately, another global health risk identified by the WHO is antimicrobial resistance for the types of antibiotics that, for decades, have saved the lives of millions. This could cause currently treatable infections like pneumonia, gonorrhea, and salmonellosis to be as dangerous as in times before antibiotics were available. One such infection, tuberculosis, affects 10 million people per year and kills almost 20% of those afflicted. In 2017, almost 500,000 cases of tuberculosis were classified as “multi-drug resistant.”

It’s not all bad news. Overall, global health trends are moving in a generally positive direction. Global life expectancy has increased by 5 years since 2000. Every day, more people will be able to access clean water, electricity, and the internet. Global child mortality has fallen by almost 15% since 1960, while global extreme poverty has fallen to less than 10%, an almost 30% decrease from just three decades ago. Almost 90% of children receive the DTP vaccine before their first birthday. However, progress is uneven, and for many is too slow. Many experts believe that some of the long-simmering global health concerns of the past few decades may be coming to a head as 2019 begins.

For anyone concerned with global health, these risk forecasts can seem dire. Even under the best of conditions, most initiatives set to tackle these risks can at best hope to minimize, and not completely eradicate, the threats from these challenges. The MDGs and SDGs are an important first step in setting a global agenda that puts the social welfare of populations at the front and center, and such efforts must continue. Yet, policymakers cannot ignore the many countries around the world that continuously fail to meet minimum standards of health and well-being. We cannot decouple the political and economic circumstances that lead to failures in global health progress. Short-term aid packages are a necessary salve, but not a sustainable solution. Many global health advocates contend that putting health and well-being at the center of state strategic planning would cascade into positive indicators in all aspects of life, such as food security, education outcomes, economic development, and inter-state diplomacy and coordination. To ensure that we are poised to meet the known and still unknown risks that may come in the coming years, global health must be a primary consideration.