Ever wonder why some prescription drugs and vaccines are paid for by your insurance company and others are not? What medicines make the cut? Who makes these make-or-break-your-wallet types of decisions, and are they in the best interest of your health and the health of your community? A formulary is the list of primarily prescription items that are covered by your health plan or available in a hospital or other healthcare facility. The selection of products for the formulary is decided by a group of medical professionals, generally known as a Pharmacy & Therapeutics Committee, who evaluate drug quality, safety, and cost-effectiveness.

WHO EML

Now what if someone had to make these decisions for the entire world? That’s what the World Health Organization accomplishes with their WHO Model List of Essential Medicines and Model List of Essential Medicines for Children (2021), known as the EML and EMLc. Updated every 2 years, it’s now in its 22nd version. According to WHO:

  Essential medicines are those that satisfy the priority health care needs of a population. They are selected with due regard to disease prevalence and public health relevance, evidence of efficacy and safety and comparative cost-effectiveness. They are intended to be available in functioning health systems at all times, in appropriate dosage forms, of assured quality and at prices individuals and health systems can afford.

The EML is like a super-formulary; a limited number of essential medicines are chosen based on national disease burden and clinical needs in a country or region. Intended to guide countries or regional health authorities to create their own essential medicines lists according to local needs and treatment guidelines, the core list (there is also a complementary list for medicines that need special facilities or training) presents a list of minimum medicine needs for a basic healthcare system, listing the most efficacious, safe, and cost–effective medicines for priority conditions.

The number of medicines has increased dramatically since the inception of the EML, more than doubling in 40+ years.

WHO Prequalified List

The value of the EML for countries and health authorities cannot be overstated. But what if the quality of medicines in a particular country or region cannot be guaranteed? In the US, the FDA monitors drug manufacturers’ compliance with Current Good Manufacturing Practice (CGMP) regulations to make sure quality of drug and biologic products are ensured during manufacturing, processing, and packaging of these products. The products must be safe, and the ingredients must demonstrate the strength that they are labeled. Many other developed countries have the same regulations as well.

The story is different in parts of the developing world with poor regulatory infrastructures. According to WHO, 1 in 10 medical products throughout the world are substandard or falsified – the most profitable substances in the illicit goods trade. The Prequalification Programme, established by WHO as part of a global surveillance and monitoring system, aims to guarantee that quality medicines, vaccines, in vitro diagnostics, and medical and vector control products are available in low income countries. The program started with vaccines in 1987 and added drugs in 2001. Applying manufacturers and organizations submit a dossier, then are subsequently evaluated and facilities are inspected. Not surprisingly, almost every product that is under review by the Prequalification Program is already on the EML.

US Essential Medicines List

The US Essential Medicines list was established by Executive Order in August 2020. It’s somewhat similar to the EML, although with fewer entries (227) and the addition of “medical countermeasures and critical inputs.” The Order stated in part:

The goal of this work is to ensure the American public is protected against outbreaks of emerging infectious diseases, such as COVID-19, as well as chemical, biological, radiological, and nuclear threats. To accomplish this goal, the executive order seeks to ensure sufficient and reliable, long-term domestic production of these products, and to minimize potential shortages by reducing our dependence on foreign manufacturers of these products.

The categories in this list include:

• Essential medicines: for patients in acute care medical facilities, with severe injuries or illnesses, and urgent medical conditions.
• Medical countermeasures: FDA-regulated drugs, biologics, and devices that may be needed to respond to future pandemics, epidemics, and chemical, biological, and radiological/nuclear threats. They must be available in adequate supply and can be used for the widest populations to have the greatest potential impact on public health.
• Critical inputs: active pharmaceutical ingredients of essential medicines and medical countermeasures.
• Device medical countermeasures: diagnostic testing kits and supplies for rapid test development/processing, personal protective equipment, active vital sign monitoring devices, devices for vaccine delivery, devices for management of acute illnesses such as ventilators, etc.

Pandemic, War, Natural Disasters Create More Need for Essential Medicines

In any given period in history, responding to medical needs of the world is, to say the least, a colossal challenge. Throw in a pandemic, war, and incessant natural disasters, and the challenges magnify and multiply.

COVID-19 has greatly impacted management and treatment of chronic diseases; just 6 months into the pandemic, those with non-communicable diseases (cardiovascular, cancer, diabetes, chronic respiratory diseases) were already more at risk. Even though the WHO Expert Committee for the EML did not add any medications for the prevention or treatment of COVID-19 in their 2021 update (as their goal is to choose medicines with a longer-term scope), they did add a number of medicines for diabetes. As well, programs for the control and elimination of infectious diseases such as malaria, tuberculosis, HIV, measles, and polio, have suffered with the distraction of dealing with COVID-19.

The war in Ukraine is creating a massive medical emergency with the world responding as best as possible, while waiting with bated breath for what’s to come. And with each new natural disaster comes more challenges in getting medications and supplies to ravaged areas.

Getting medicines to patients

For outpatients, mail order delivery of drugs has increased exponentially, especially in the US with massifs like Amazon getting into the game. But how about delivery to rural communities, or to weather or war-torn areas domestically and around the globe? We can drone on about drones, but this terrific blog, Drones in Healthcare, covers a wide range of topics on how drones (besides Amazon’s) are being used to deliver essential medicines and other medical services to challenging areas.