Top Five Global Medication-related Controversies in 2019

The onslaught of biomedical interventions has allowed healthcare professionals globally to provide more effective & efficient treatment. Medications, in particular, have equipped healthcare systems with chemical entities to combat infectious diseases, manage chronic disease states, and provide targeted oncology therapy. However, these synthetic agents are not without controversy or significant glitches. Despite the intention to do no harm, humanity is often burdened with the negative consequences of the biomedical age. As the global health community reflects on this past year, there is substantial insight to be gained by reviewing these controversies that occurred in 2019. The following five issues encompass a few of the biomedical controversies in 2019, so that internationally, our fragile species can learn and grow to further improve the lives around the globe. 

#1: Global Drug Deaths – Opioid Pandemic 

In June of 2019, the United Nations Office on Drugs and Crime (UNODC) released the 2017 World Drug Report that highlighted the reach drug addiction has on humanity. The UNODC found that 35 million individuals were suffering from drug use disorders and required addiction treatment services. This is a 30% rise from near the end of the last decade. Of the deaths that occurred due to drug use disorders, 2/3rds were attributed to opioids alone which include both heroin and legal pain relievers. An increase of opioid use in Africa, Asia, Europe, and North America in concert with the single largest yearly production of cocaine – 2000 tons – are thought to explain this rise in opioid deaths. In addition, this study discovered that parts of West, Central, and North Africa have been flooded with tramadol leading to this opioid’s abuse and the increase in global figures. 

Unfortunately, this study noted that only one in every seven people are receiving effective treatment for their drug-use disorder. Evidence-based interventions are either completely unavailable in their area of inhabitation or inaccessible due to cost, distance, stigma, or saturation of available treatment centers. This report concludes by encouraging nation states and the global community to increase their efforts and funding to providing this vital care to each patient seeking these services. 

#2: Medication Recall – Zantac 

GlaxoSmithKline (GSK), a UK based pharmaceutical industry, issued an October 2019 statement that informed the public on a recall of a common medication to treat peptic ulcer disease (PUD) – Zantac, also known & sold by its generic name ranitidine. The impurity N-nitrosodimethylamine (NDMA) was found in unacceptable limits as this chemical is known to be a potential carcinogen. All prescription dosage forms were recalled which included tables, syrups, and injections, and changes in the manufacturing process are thought to have caused this increased level. This recall follows the 2018 recall of the class of anti-hypertensive agents called angiotensin II receptor blockers (ARB) that were adulterated with the same unacceptable limits of NDMA. 

#3: The Resurrection of Biogen’s Alzheimer’s Medication 

In March of 2019, the pharmaceutical industry Biogen announced that it was terminating its phase three clinical trial of a novel entity in the treatment of Alzheimer’s Disease. The termination of the monoclonal antibody, aducanumab, was due to no significant statistical differences between the treatment and placebo study arms. Aducanumab targets beta-amyloid plaque which has been the substiantal focus in Alzheimer’s treatment throughout the last several years. The preliminary results released by Biogen shocked the Alzheimer’s medical community, as this treatment showed so much promise in early stage trials. It was also the last potential target in this medication class, forcing many to believe a novel treatment modality would need to be pursued. 

However after a retrospective analysis of the complete data, Biogen reversed its decision in October 2019 and restarted their phase three clinical trials. The company stated that the researchers, initially worried about brain swelling and other side effects, increased the dose of aducanumab late in the study. This increased dosage showed increased effectiveness, 25% reduction in the rate of decline compared to placebo, when the researchers conducted the analysis after the initial cancellation. This increased dosage is still marred in controversy as two different trials, EMERGE & ENGAGE, both utilized the high dose regimen with the EMERGE participants seeing the aforementioned positive results while the ENGAGE participants actually seeing an increase in their cognitive decline. Biogen will file approval for the US Food and Drug Administration (FDA) early in 2020, but experts are split on whether it will be approved or will require additional trial data. Regardless of the decision by the FDA, the success of aducanumab will shape the future of Alzheimer’s treatment and research. 

#4: A halt to Pediatric HIV Structural Violence: Quadrimune

Cipla, a generic manufacturing company based out of India, announced in late 2019 that they were going to start production of an antiretroviral pediatric formulation for just $1 per day. Quadriume, which contains ritonavir, lopinavir, abacavir and lamivudine, is strawberry flavored to increase the adherence rates for young children afflicted with this infectious disease. Before the availability of this formulation, UNAIDS estimated that globally 50% of the 160,000 children infected with HIV die each year before the age of two largely from access issues and inability to tolerate the older formulations. The older formulations had tolerance problems such as a metallic taste and need for refrigeration while also encountering HIV resistance. The western world’s pharmaceutical industries has continued to turn a blind eye to this population of humanity for the sake of profits, while Cipla has been undertaking pragmatic approaches to HIV care for several years. Cipla hopes to receive FDA approval followed shortly by the World Health Organization (WHO) approval in May 2020 while Doctors Without Borders has already started clinical trials in Uganda to receive support from African health leaders. 

#5: Samoa’s Measles Outbreak: Ill-prepared Vaccines 

The island nation of Samoa announced in December 2019 that 53 individuals, 48 being children under the age of five, have died due to large measles outbreak. In total, approximately 4000 measles cases have been reported in a population of 200,000. Throughout the country, public gatherings have been banned and schools/universities has been closed. Although experts believe the myth of autism being caused by vaccines have led to decreased vaccination rates (31% among young children), there may be a more significant reason for distrust in vaccinations. In July 2018, two nurses in Samoa mistakenly reconstituted the Measles, Mumps, Rubella (MMR) vaccine with a muscle relaxer instead of distilled water. This led to two infant deaths, five years in prison for the nurses, and a plethora of misinformation spread to the island’s inhabitations. This Samoan outbreak reflects a trend across the globe with a quadrupled amount of measles cases in the first three months of 2019 compared to the same time frame in 2018. 

A Promising Outlook: 2020

Despite these biomedical obstructions to a healthier global society in 2019, 2020 promises great advancements in the way humanity’s well-being is cared for. With the perspectives gained from this past year, the following health innovations are due to be initiated to achieve equitable healthcare for all: 

  • A novel class of migraine medications, oral calcitonin gene-related peptide receptor antagonists, is due to have its first agent approved in 2020. Ubrogepant, manufactured by Allergan, will offer an effective therapy for those who cannot tolerate the current gold standard migraine agents – triptans. 
  • The future of the fight against HIV will be equipped with a once-monthly injection of antiretroviral therapy in 2020. The combination therapy of cabotegravir/rilpivirine (Cabenuva) produced by ViiV Healthcare has shown to be as effective as current once daily therapy options. 
  • The eradication of malaria will discover if a vaccine candidate could add to its arsenal of biomedical interventions. Sanaria has developed the PfSPZ vaccine, and will conduct phase three clinical trials in Bioko, Equatorial Guinea in 2020. This new candidate has, thus far, shown to have a more protective effect (48.3%) than the currently approved RTS,S vaccine. 

Part 4: Perspectives on Global Health from Pharmacists Around the World

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 patient needs are met in countless regions across the world. 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), India, 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 fourth and final segment explores targeted populations in each of the aforementioned countries, the health ailments that burden these groups, and each pharmacist’s proposed pathway to overcome these concerns within these nation states. 

In every corner of this vastly diverse planet, healthcare access and delivery affects countless aspects of humanity’s well-being. These aspects can range from the capability of obtaining the correct medications for treating dermatitis or receiving prophylaxis isoniazid therapy to accessing cancer screening with a pap smear and purchasing levemir at an affordable price. In addition to these direct implications on one’s life, healthcare possesses indirect factors such as social relationships influenced by health, hours lost working due to health commitments, and the emotional burden due to certain ailments. The global health community recognizes that health disparities exist throughout various regions of the world which affect these aforementioned facets. However, the inequalities that exist within explicit populations in these regions are often overlooked or overshadowed by more broad global initiatives.

In this final post for the IH Connect blog series, four practicing pharmacists reveal major concerns in their areas of inhabitation for specific populations: older adults, pediatrics, pregnant mothers, women’s health, and men’s health. These healthcare leaders then offer initiatives and solutions to address these complications to improve the lives of each member of their cherished communities. 

Dr. Moeung Sotheara, Ph.D. 
Clinical Research Assistant & Part Time Lecturer – University of Health Sciences
Phnom Penh, Cambodia 

Cambodia has achieved some remarkable health outcomes in recent decades such as improving newborn and child health, ensuring provision of HIV/AIDS treatment to over 80 percent of the infected population, and expanding vaccination coverage. However, there are a number of population-specific concerns that need to be addressed in order to further improve the overall healthcare and wellbeing of the people.

Older Adults

One of the top concerns regarding older adults in Cambodia is the lack of care centers for older adults and state pension provision. Consequently, the older adults in Cambodia are physically and financially dependent on their children to get access to health services from going to see a doctor to buying medicines. This results in older adults not willing to seek immediate medical care when they have health problems as they feel hesitant to ask for their children to help. Moreover, as they cannot go to the pharmacy on their own, they often miss out on crucial information regarding appropriate drug use. The solution is to provide all Cambodian workers with a social pension scheme and to build care centers for older adults, where they can easily gain access to healthcare.

Pediatrics

The top concern regarding pediatrics is the common and widespread use of fluid infusion. This dangerous practice has become a tradition in Cambodia. When a person is sick, most physicians prescribe intravenous (IV) drips either intentionally or on the patient’s demand even if he/she shows no sign of dehydration or fluid loss and often without careful monitoring. And children are no exception! To solve this problem, there should be campaigns to raise the public’s awareness about the danger of incorrectly used IV drips and to reinforce the doctors’ medical ethics.

Pregnancy

One of the top concerns regarding pregnant women is the use of traditional medicine. Traditional medicine is commonly described at two time points: one month before birth to ease child delivery and postpartum to increase breast milk production and prevent Tos (madness, depression). The most common form of traditional medicine used is herbal medicine which often consists of a mixture of different parts of multiple plants. The toxicity of these plant combinations has poorly been studied. To resolve the problem, a number of well-designed studies should be carried out to investigate the potential toxicity of herbal medicine during pregnancy and post-partum period.

Women’s health

The top concern regarding women’s health in Cambodia is the overuse of skin whitening and skin bleaching products. In a culture where lighter skin is often idealized, whitening is a common practice in Cambodia, especially for women despite the reported danger of those products. Whitening cream or lotion can be dangerous, and many counterfeit products are now on the market, making the practice even more dubious. The problem is of more concern as more and more creams are locally produced without the right standards, by mixing whitening cream with other vitamins and dangerous chemicals. Moreover, they are increasingly available online, or via social media where they are not sufficiently regulated. The immediate solution to this problem is to re-enforce the law regarding online cosmetic products advertisement. Furthermore, all production sites of sub-standard creams or lotions must be closed down. Additionally, any products must be screened for dangerous chemicals before they can be advertised and sold on the market. The public’s education of the danger of sub-standardly-produced skin whitening and skin-bleaching products is also of prime importance. The collective idealization of white skin should be changed and people should be educated to perceive beauty beyond the skin color.

Men’s health

Health impacts related to alcohol overconsumption has become a top concern regarding men’s health in Cambodia. A report by the Asia Foundation in 2015 showed that Cambodian men are drinking 9.7 litres of pure alcohol a year – 3.5 litres above the global average of annual alcohol consumption per capita. Furthermore, the study also found that Cambodian men tend to drink six times as much as their female counterparts. Social, economic and cultural factors together with the influential role of advertising are the predominant drivers of increased alcohol consumption among the Cambodian population, particularly men. Alcohol abuse has resulted in more than 60 major types of diseases including cardiovascular disease, cirrhosis of the liver, cancer and sexually transmitted diseases including HIV/AIDS. Restrictions on alcohol product advertisements, price control strategies and education of the public on the harmful effects of alcohol abuse are among the measures that can be taken to tackle the problem.

Dr. Maneesha Erraboina, PharmD.
International Business Manager – Helics Group Scientific Networks 
Hyderabad, India 

Older Adults

Most older adults use multiple drugs simultaneously for different conditions or for one condition. Polypharmacy causes poor adherence which leads to adverse drug events (ADRs) or medication errors (MEs). To avoid these ADR’s and ME’s, healthcare providers should educate patients about the medication in order to maintain good adherence and try to increase the knowledge of the health condition by performing patient counselling.

Pediatrics

Cost analysis is a ubiquitous problem for all types of diseases in each category of patient populations. In one of my research work entitled “Pharmacoeconomic Analysis and Treatment Pattern in Sepsis Patients: A Cross-sectional Prospective and Retrospective Study”, this publication infers about the cost analysis in sepsis patients particularly in the pediatric population. The major barrier is to overcome situations where health leaders are focused on cost rather than looking at the whole picture in order to provide equitable care. This can be accomplished by having input from these specific populations and reflecting on the role a healthcare provider should have in treatment. 

Pregnancy

For pregnant mothers, perinatal conditions that occur before, during and after the pregnancy can lead to perinatal mortality. In India, the most common conditions resulting in death are haemorrhage, trauma, and severely underweight babies. To avoid perinatal mortality, continuous assessment of pregnant women on medication and diet is needed by encompassing more prenatal and antenatal care health facility visits.

Women’s Health

Breast cancer is one of the top concerns in women’s health throughout the world, and this includes in India. In India, the etiological factors are difficult to identify for this type of cancer; however it mostly occurs in older women. It may occur due to older age and genetics. To decrease the risk of breast cancer, one should focus on non-pharmacological therapy that includes dietary and social changes.

Men’s Health

Commonly, pancreatitis occurs mostly in men with social history of alcohol consumption in India. In a study examining the main causes of pancreatitis, it was found that approximately 1/3rd of all pancreatitis cases was caused by alcohol. Counseling on decreases in alcohol consumption should be undertaken by all healthcare professionals in order to prevent this ailment.

Nazgul Bashir, B. Pharm
Registered Pharmacist – Super Care Pharmacy
Dubai, United Arab Emirates

As a pharmacist, we encounter a number of various types of populations seeking our care, both gender-specific and age-specific. Dubai, being a cosmopolitan city, sees many different ethnic groups and nationalities. With so much of diversity in the community, we see a number of different issues and it is our sole responsibility to identify them, recommend the most appropriate over the counter treatment to fulfill the need of the concerned person, or refer to a prescriber for more serious issues. One of the best aspects about being a pharmacist is that we have the opportunity to encounter new types of people and novel ailments every day. On the other end, some of the ailments encountered are difficult to manage due to a variety of reasons. Different groups of people who visits the pharmacy can be divided into men, women, older adults, pediatrics, and soon to be parents. In each population there are multiple issues which I will describe in detail in the following sections.

Pediatrics 

I would like to start talking about my most favorite population, pediatrics. Multiple concerns are present when it comes to children in the UAE including obesity, vitamin D deficiency, genetic problems, diabetes, and, most commonly, allergies and asthma. Out of these concerns, asthma and vitamin D deficiency are frequent ailments patients seek the care of a pharmacist for. One in every five children is suffering from asthma which initially, parents don’t realize. They self-diagnose it as night time coughing, chest congestion or persistent nagging. The cause is not simple. it could be anything airborne like construction dust (In the UAE, there is constantly large buildings being constructed), sand (UAE being the desert) and pollen from palm trees. Another major cause can be going in and out of air conditioner due to hot & humid weather. Cough suppressants and expectorants are first requests by parents and desperate patients even ask for montelukast or steroid based inhalers which is not an appropriate avenue to address the issue. First and foremost, the triggering allergen should be identified as airborne, smoke, or a viral cold. Educating parents about the importance of flu shots, the use of a peak flow meter to find out a child’s lung function and supplementing them with Echinacea, zinc, Elderberry or even Vitamin C to keep their immune boosted are also viable methods to address this ailment. Vitamin D deficiency is another common concern in children. Because hot and sunny summers last for a long time, children stay indoors rather than going out for any physical activities. Most of the body parts are covered with clothes which is common in UAE. 90% of the population is suffering from vitamin D deficiency including men, women and children. Pharmacists should recommend Vitamin D supplementation during these months in order to prevent this deficiency. 

Men’s Health 

Men’s health is often the most difficult to discuss because males make limited health visits. This could be because men ignore the illness affecting them or they could be uncomfortable discussing their health problems. Mainly, I want to talk about erectile dysfunction (ED) in men. One in every 3 men from age 40-70 suffer from ED, but due to cultural issues, the topic is often avoided. They avoid asking for professional help on this sensitive issue because they feel challenged, embarrassed and/or guilty. High diabetes and obesity rates and smoking/alcohol use are the main factors causing ED. Pharmacist counseling can provide significant help with lifestyle advice, proper supplementation, and education for reasons to follow up with a prescriber.

Older Adults

No matter which part of the world we belong to, a majority of older adults we see are on poly-pharmacy. This creates unique challenges in this population by having multiple health issues and taking a number of medications. In the UAE, proper guidance on use of these medications is often missing which leads to non-adherence to medications. From a patient’s perspective, taking 5 or more medications, either prescription or non-prescription, can be time-consuming and frustrating. For older adults with cognitive issues, issues surrounding medication adherence is exacerbated. As a community pharmacist, I would like to raise awareness about poly-pharmacy, adherence, and its effect on older adults. Many steps can be taken to increase the adherence. Color-coded pill boxes, properly labelled vials and easily read fonts should be used. Technology reminders should also be utilized to improve adherence. Another commonly noticed concern in older adults is drug induced nutritional deficiency which is defined as being on multiple medications that lead to a number of important nutrients being depleted. As pharmacists,  we should inform the patients the importance of this issue and help patients to identify the nutrition depletion by the medications they are taking.

Women’s Health 

Last but not the least, about 60% of the female population has issues regarding women’s health and are visiting pharmacists more often. Women’s health concerns are almost all interlinked including irregular menstruation, infertility, post menopausal symptoms, and urogenital complications. There are many more complications which could contribute to the larger discussion about this population. However, the one problem I would like to discuss is polycystic ovary syndrome (PCOS) which is infrequent or irregular menstruation or increase in androgen levels. It can be difficult to diagnose,  but many symptoms are excessive hair loss, acne/oily skin, weight gain and infertility. UAE has the highest rate of PCOS than any other part of the world. PCOS is a more recent disease which could be linked to modern lifestyles, more indoor activities and a decrease in outdoor activities, stress, and junk food intake. It can be caught initially if any adolescents discover a missed period or heavy periods. Most of the time, they don’t take it seriously and realize it when it is too late which could result in difficulties with conception or infertility. PCOS can not only lead to infertility but also anxiety and depression. Rates of infertility are increasing. When I investigate patients on their cycle most of the time, I find out they were having irregular periods in their early 20s, missed 3-4 months, and no action was taken because of it being such an intimate topic. I believe if we have any female patients coming to the pharmacy with issues like hair loss, excessive oily skin, facial hair, they should be advised for early screening of PCOS. Folic acid supplementation should be advised to people who are trying to conceive with PCOS or anyone with an irregular menstrual cycle. Lifestyle modification and weight loss should be emphasized as well.

Dr. Bryce Adams, Pharm D., RPh.
Oncology Medical Science Liaison
Washington D.C., United States of America 

Older Adults

I believe the biggest health concern for older adults in the USA is Alzheimer’s disease. This has been a growing concern as the human race’s lifespan has been exponentially increasing. While billions of dollars have been spent in research looking for a treatment, there hasn’t been much success. The current treatment options, cholinesterase inhibitors or N-Methyl-D-aspartate (NMDA) antagonists, only slow the progression of the disease, albeit, with limited success. Therefore, these agents are most effective when initiated before the severity of the disease reaches a certain point. To address this concern, I believe we need to work on detecting the disease earlier and continue to research new options. Alzheimer’s screening needs to be incorporated into routine check ups in older adults, and implemented at a younger age with those with a family history of this ailment. Additionally, there needs to be continued research regarding the disease. This includes research to gain a better understanding of the pathophysiology as well as new agents to treat the disease. Most of our current research has been in regards to amyloid beta. While this could lead to better treatments, most of the efforts focusing on this have failed, therefore, I think we should start to focus more efforts elsewhere.

Pediatrics

The biggest health concern for American pediatric patients is the lack of novel treatments. While there have been great strides and new medicines for adult patients, there is typically a delay for access to these medicines for pediatrics. One way to combat this is to ensure there are a proportionate amount of clinical trials that include pediatric patients. This work is currently underway and hopefully will result in greater access to medicines for pediatric patients.

Pregnancy

I believe preeclampsia is the greatest concern during pregnancy as it is fairly common and can result in the death of the mother and/or child. While there are some treatments for this condition, there is still much room for improvement in terms of early diagnosing, prevention, and more effective therapy options. I believe we can improve outcomes by focusing our efforts on the aforementioned methods of improvement: identifying risks for preeclampsia more efficiently and preventative measures. 

Men and Women’s Health

I’ve combined men’s and women’s health into one as I believe the greatest concern is the same: heart disease. While there are several treatments currently for heart disease with decent success, there hasn’t been much advancement in recent years. Our current agents can manage the disease and reduce symptoms, but for the most part, they are unable to cure the disease. In order to combat this issue, American researchers and practitioners need to improve screening to identify the disease earlier on as well as focusing on new treatment options that have the potential to cure the disease.

Realizing the full potential of pharmaceutical industry partnerships

Successful partnerships between pharmaceutical companies and global health organizations have been increasing access to medicines and vaccines since the 1970s. From early partnerships in the Expanded Program on Immunization, to GAVI, the Vaccine Alliance and Access Accelerated the research-based pharmaceutical industry, which spends over $149 billion on research and development (R&D) every year, has an important role to play in global health.

Over the last 50 years the pharmaceutical industry has learned that global health is about more than just medicines and vaccines, and with the integrated nature of the Sustainable Development Goals, public-private partnerships are increasingly important. According to the International Federation of Pharmaceutical Manufacturers and Associations, the industry understands that global health requires building and supporting strong health systems, developing public health education and strengthening standards and regulations. This is why in 2018, 17 out of the 20 largest pharmaceutical companies (accounting for 70 percent of global pharmaceutical revenues) developed a business strategy, supported by goals and targets, to address access to medicines in low-and middle-income countries (LMICs), according to an Access to Medicine Foundation report

Good, but not good enough

However, much of the increased access to medicines has been made by a small percentage of pharmaceutical companies, and has overwhelmingly been focused on a handful of diseases. Of the 20 companies assessed by the Access to Medicine Foundation report, five companies (GlaxoSmithKline, Johnson & Johnson, Merck KGaA, Novartis and Sanofi) were found to be conducting 63 percent of R&D on products urgently needed by people in LMICS; and nearly all of the R&D from these companies was focused on five diseases: malaria, HIV/AIDS, tuberculosis, Chagas disease and leishmaniasis. 

While overall, pharmaceutical companies are entering LMIC markets, the industry still puts profits first.  Between 2008 and 2018 more medicines for profitable non-communicable diseases were developed for people in high-income countries, than medicines for diseases of poverty. Additionally, only four out of 20 pharmaceutical companies supported international trade agreements designed to ensure the world’s poor benefit from innovative medicines and vaccines. 

Closing the gaps

Public perception does matter to the pharmaceutical industry. According to the Reputation Institute, between 2017 and 2018 the pharmaceutical industry saw a 3.7 percent decline in its reputation score, and overall the industry had a significant decline in the public’s perception of industry transparency, openness and authenticity. The decline of public trust and confidence in the industry has also led to a decline in the public’s willingness to buy by eight percent between 2017 and 2018. One way to improve company reputation is through global health partnerships, and with recent negative media attention on the industry, between the opioid epidemic and price-fixing drugs, it is no secret that the industry could use a reputation boost.

So how can the global health community capitalize on this? The Access to Medicines Foundation has an effective recipe for engaging pharmaceutical companies in global health: one, setting clear priorities endorsed by global health experts; two, advocating for publicly funded mechanisms to reduce investment risk and shape less profitable markets; and three, finding sustainable funding support from multiple donors, including the government. One example of a mutually beneficial partnership is GAVI, which used pooled procurement mechanisms to encourage pharmaceutical companies to enter fragile markets in LMICs to strengthen the global vaccine market. 

In 2018 the reputation scores for the top 22 pharmaceutical companies were made public, creating an opportunity for global health organizations to engage poorly ranked companies. Global pharmaceutical sales are expected to reach over $1 trillion by 2022, so resources for global health partnerships are abundant, and organizations should consider targeting partnerships with companies impacted by negative public perception; turning a bad reputation into increased affordable access to life-saving medications. 

 

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.

Perspectives on Global Health from Pharmacists Around the World

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, these roles 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), India, 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 initial segment focuses on medication access in each of these areas and the thoughts that pharmacists from these respective nation states have been willing to share with IH Connect.

Throughout both developed and developing healthcare systems, access to medications is consistently a top priority for pharmacists and health care systems. As this health care profession attempts to provide services that meet the needs of their communities, access deficiencies habitually impede the ability to follow through with individualized and compassionate care. The lack of access to life altering chemical entities can affect anyone anywhere, from an affluent metropolitan city like Washington D.C. to a small rural Cambodian village in the province of Kampot. Despite the differences in these locations, each of these instances cause significant harm, breed mistrust in healthcare professionals, and create despair among those that seek healing. These frustrating situations are due to intensify because of the increased strain on medical resources who take a “do-what-has-always-been-done” approach. These following four pharmacists, all from various corners of this vast planet, will describe the barriers they consistently face regarding medication access and initiatives that are being undergone to ensure that a novel approach is commenced to address this looming medical tragedy.

Nazgul Bashir, B. Pharm

Registered Pharmacist – Super Care Pharmacy

Dubai, United Arab Emirates

Before discussing medication access in the United Arab Emirates, I would like to give a brief introduction about the United Arab Emirates (UAE). It is a middle eastern country with a population of 9.68 million. The country is comprised of seven emirates and healthcare in UAE is regulated both federally & at the Emirate level. 

Now, starting with the topic on hand about medication access in UAE, there are several factors that have an impact on it and I will touch on them individually and in detail. 

First and foremost, I think the most important factor is the number of medications available in UAE. The majority of medications available in UAE are imported drugs. UAE imports pharmaceutical products from 72 different countries. Of those, 10 countries constitute approximately 80% of the entire country’s supply. The domestic sector is rather small; however the UAE Ministry of Health (MOH) plans to increase the number of pharmaceutical manufacturing facilities to 30 by 2020 up from 16 in 2017. Availability of different medication combinations or different strengths are difficult to find due to the limited number of industries in UAE. One such example is oral prednisolone, which in UAE is available in strengths of 1mg, 5mg, 10mg & 20mg. In the USA, there are more strengths available including 1mg, 2.5mg, 5mg, 10mg, 20mg and 50mg. Tourists or expats coming from overseas that need a particular medicine or medicine combination or a particular strength may not find it available.

The second hindrance to medication access is the cost of medications. There are many reasons for the high cost medication. The aforementioned fact that about 80% of medications in UAE are being imported rather than locally manufactured is one reason. Another reason is an insignificant availability of generic medicines as the majority of medicines available are brand name. The final reason is the national health insurance model. Because all national citizens do not have to pay for their own medications, there is no incentive to keep the medicine prices low. As a result, individuals who are not insured under the public national insurance system, for example expats and tourists, face a huge barrier to obtaining medicines. 

With these barriers in mind, initiatives have started to take place in UAE to find a solution. The government reduced 24% of the prices for 8732 medicines over the course of 6 years. Another initiative which took place is increasing the number of generic medicines while also advising physicians and pharmacists to dispense the generic rather than the branded medicines. Through this initiative, generic medicines now account for 30% of the overall pharmaceutical market which has increased from 12% of the market two years ago. If the UAE can bump these numbers up to 70-80% of the overall market in UAE, the UAE will be seen in better position in terms of generic medicines. 

I am glad to be a part of a region where these issues are actively tackled, not just by the government but by private sectors as well. We are also seeing that pharmacists are playing a larger role, providing information on availability of cheaper alternatives on medicines. Pharmacists are the most accessible healthcare professional and it should be part of their responsibility to help make medicines as accessible as possible to their clients.

 Dr. Bryce Adams, Pharm D., RPh.

Oncology Medical Science Liaison

Washington D.C., United States of America

Although there are a host of issues surrounding access to medications, I will be focusing on oncology medications as oncology is my current specialty as a medical science liaison in the USA. 

To begin, I would like to highlight encouraging statistics that show the accessibility of oncology medications in the USA. A recent 2019 study found that 96% of new cancer medications were available within the United States, the next highest nation was at 71%. Furthermore, the average delay in the availability of cancer medications within the United States was 3 months, with the next closest nation being at 9 months.

In terms of novel and innovative treatment options, oncology drugs have been increasingly approved by the Food and Drug Administration (FDA) throughout the last few years. The FDA has enacted policy changes to attempt to increase the efficiency of drug reviews. The results have been significant – in 2017 alone, 46 new oncology drugs were approved. Moreover, from 1991 to 2016 there was a 27% decrease in cancer related deaths in large part to the expanded and more targeted-based therapy. The chance that a patient will live for 5 or more years has increased by 41% since 1975.

Outside of regular treatment options of those living with cancer, patients have the ability to participate in a clinical trial. Currently, there are 24,351 clinical trials listed as active (defined as not yet recruiting, recruiting, enrolling by invitation, or active) – 11,813 of those trials are active in the United States. However, even with the surplus of ongoing clinical trials, it still seems there is a lack of patient enrollment. It is estimated that roughly 70% of patients are interested in clinical trials, and yet <5% of patients actually enroll in clinical trials. Some of these barriers to enrollment include: lack of availability at a specific clinic, lack of a specific trial available, patient ineligibility, physician is unaware of trials/not offering them to patients, and a patient deciding not to enroll in a clinical trial (perhaps due to a fear of receiving the placebo).

An aforementioned barrier to cancer treatment that needs to be emphasized is the locations of specialized cancer clinics. Studies have shown that patients who are diagnosed with advanced staged cancer are likely required to drive an hour or more to the nearest cancer clinic for the appropriate care they need. Additionally, travel distance may affect treatment decisions. A patient may select a slightly less efficacious therapy if that means they have to travel less often. 

Two initiatives have recently been instituted to further increase the accessibility of medications. First, in an effort to go towards value-based contracting, some companies are beginning to only charge patients if their medications are effective. While this is a rarity, it will be interesting to follow the impacts of this on other more costly treatments and to determine the impact on patients. Secondly, in 2018, the right to try act was passed. This essentially gives terminally ill patients who are unable to enroll in a clinical trial and have no other remaining FDA approved options, access to other treatments. While this is a relatively new policy and there are some restrictions, hopefully it will give patients hope and additional treatment options. 

Dr. Moeung Sotheara, Ph.D. 

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

Phnom Penh, Cambodia 

In rural Cambodia, access to medication is especially limited when compared to urban areas. Access is limited by two main factors in these communities. Firstly, many people living in rural areas have low incomes which means it is difficult for poor rural individuals to buy medicines for serious illnesses. Secondly, community drug outlets and public health facilities are generally concentrated in the provincial capitals/cities, making it difficult for people from rural, remote areas to get access to those places. 

Usually, medicines imported from other Asian countries such as India, China, Vietnam, Thailand, or Malaysia are cheaper and therefore, more accessible. These cheaper medications, however, tend to be held toward a lower quality standard which can lead to disease state progression, antibiotic resistance, and other situations that can inflict harm onto patients. However, western brand medicines, which are usually held to a higher standard of quality, are less accessible because their prices are higher. Locally, they are generally considered “medicines for the rich.”

The lack of access due to  these aforementioned barriers makes diseases difficult or impossible to treat in cases where medication is necessary to cure it. Patients may see their disease aggravated and could die of it.

In order to address these medication access complications, a specialized team should be created that assists patients or their relatives to get medication which is far from their home and provide a specific loan with very low or no interest rate for villagers who cannot afford to buy medicines. This approach has been initiated in Cambodia through the increased access of health equity funds (HEF). These funds, allocated to individuals unable to afford the out-of-pocket expenses for public services, are pooled from a variety of sources like the national health budget and various donors. These patients are then given a specialized card to receive these funds when public services are used. The HEF focuses on addressing low medication access through the initial financing as aforementioned, community support, quality assurance, and finally policy dialogue. The results of this project have been promising – there was a 28% increase of patients utilizing public services with HEF than before without the HEF. In addition, the patients were not perceived to be more stigmatized within their communities.  

Veda Peddisetti, B. Pharm.

Clinical Pharmacist – Satya Sree Clinic & Diagnostics 

Hyderabad, India 

India is the largest country in South Asia and the second most populous country (1.35 billion) in the world. In addition, India is said to be in the third stage of demographic transition with birth rates declining and death rates decreasing. In the past few decades, India has experienced monumental population growth. This has led to many problems in healthcare management throughout the country, in particular, medication access. The direct cause seems to be the over-demand of medications. However, various indirect causes include poverty, varying per-capita incomes, unemployment, and out of pocket expenditures (India doesn’t have an established federal healthcare insurance system like Medicare in the USA, National Health Service in the United Kingdom, etc.).

In addition to the aforementioned causes, the literacy level in villages and rural areas are quite low. Many of the farmers and laborers from rural India are uneducated. As a result, many don’t know how medication can help them get better and how important it is to take medication every day to keep chronic conditions like hypertension and diabetes in control. In urban areas, all income classes are more educated and are given awareness more frequently about healthcare when compared to individuals in rural areas. So, they tend to use medication and other healthcare facilities more frequently. Accessibility is not a huge issue in cities but this creates competition among providers and results in high costs which turns into a problem for low and average income communities of the urban population.

Usually, regular medications like anti-diabetics, anti-hypertensives, common antibiotics, analgesics, vitamins are available throughout the country except in some deeply located tribal areas. Medications which are used for some cancer chemotherapies, auto-immune diseases, and some orphan drugs are not widely available. People have to go to highly rated hospitals in developed metropolitan cities to get these medications, and I believe this scenario is the same anywhere in the world. This kind of accessibility shouldn’t affect any patient or healthcare provider unless there is any medical emergency. And thanks to the continuous efforts of the Government of India, India is improving the accessibility of medication. Recently, various health benefit schemes were implemented like free supply of in-patient medications in civil hospitals and sale of reasonably priced generic medications in rural and urban communities.

It is a well-established fact that India is a potential supplier of medications to many countries in the world. India is a manufacturing and research hub for many reputed pharmaceutical companies. However, this often leads to pharmaceutical companies who are exporting their products in large quantities rather than supplying them domestically. These medications range from certain medications for chronic diseases like diabetes drugs to life saving medical devices like the Epi-Pen. These pharmaceutical companies more interested in profit are preventing the Indian population from getting the best medications.

With the lack of proper medications, healthcare professionals cannot take the proper steps in patient care that they could actually do if they had adequate access to medications. So, it is vital to educate people of India, especially the rural population, while simultaneously framing and implementing some regulations and limits on the export of medications by pharmaceutical companies in order to improve healthcare in India.