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.