National Drug Authority explains access to medicines and drug classification

By Abiaz Rwamiri

Equitable access to drugs is a global priority to achieving sustainable healthcare in any county. The availability, accessibility and affordability of health products of assured quality is critical in realizing health outcomes for patients.  Access to drugs is a global concern and a huge challenge for developing countries with limited ability to provide full and affordable access to quality health care. It is estimated that approximately 2 billion people around the world are not able to access the medicines they need due to several obstacles.

Primary health care services rely on access to health products, including medicines, vaccines and medical devices. These products must be of assured safety, efficacy, performance and quality, as well as being appropriate, available and affordable. Failure to access medicines causes suffering from no relief for the agonizing pain and deaths from diseases that are can be easily and inexpensively prevented or cured.

The World Health Organization (WHO) designated access to safe and effective medicines as a basic human right. Access to drugs is also enlisted among the United Nations’ Sustainable Development Goals (SDGs) target which demands that everyone should have access to essential medicines, which must continuously be available and affordable at a health facility or medicines outlet, within a one-hour walking distance from the patient’s home.

Before I dig deep into access, it is important to appreciate that there is a thin line between a drug and poison; every drug when used inappropriately is a potential poison. What differentiates a drug from a poison is the extent to which the potential harm matches the potential benefits. Before a substance can be designated as a drug, the potential benefits must significantly outweigh the risks. When the regulatory agency like National Drug Authority (NDA) approves a drug, it is convinced through the process of rigorous scientific examination that the drug’s benefits outweigh its risks for the conditions it is intended.

Given the risks associated, drugs are classified into prescription, pharmacist initiated and over the counter drugs. In Uganda, drugs are specifically classified in one of six classes including; Class A, Class B -Group 1, Class B Group 2, Class C – Group 1 and Class C – Group 2. Class A & Class B Group 1 are prescription-only medicines which should be accessed with a prescription of a medical practitioner, dentist or veterinary surgeon. Class B (Group 2) are pharmacist-initiated drugs which can be issued by a pharmacist without a need for prescription while Class C are off-counter drugs and these can be dispensed by a pharmacist or licensed seller without a prescription. These classifications are available on NDA website.

The class to which a drug is assigned is determined on the basis on several factors including the route of administration, the extent to which expertise of a healthcare provider is required, the potential for abuse and the safety profile of the drug. the This categorization therefore determines how the drug will be accessed including the level of healthcare where it will be available. The place where a particular class of drug is accessed is further determined by the availability of the qualified personal who is able to diagnose, interpret the diagnosis and dispense the medicine appropriately after risk-benefit assessment.

The risk-benefit ratio is determined by the safety profile of the drug and benefit is determined by the condition it seeks to treat, prevent or manage. The risk-benefit balance is determined at the individual patient level by the qualified health professional through diagnosis and prescription or at community level by policy on advice of a drug regulator like NDA.

Whereas drugs are classified and scheduled, regulatory and health authorities can reclassify a particular medicine in the interest of public health. The National Drug Authority and Policy Act gives the Minister of Health a policy mandate (on advice of NDA) to reclassify and reschedule a drug. For example, when there is prevalence of a condition/disease, a particular drug can be reclassified to ease access based on the risk-benefit ratio.

To effectively ensure that drug classifications are followed and implemented, there should be a clear separation of prescription and dispensing. On one side, there should be a clinician who is supposed to diagnose and prescribe and on the other side, a pharmacist who is supposed to review the prescription and dispense the drug. In developing countries, this is however not the case, in most cases, you find a clinician doing diagnosis, prescription and dispensing. The idea of separation of these critical roles is to ensure that there is independent review of prescription before dispensing to avoid any medication errors.

The model of separation of prescription and dispensing assumes that the patient first sees a clinician before they access medicines. Unfortunately, access to medicine is heavily dependent on model of payment. It is estimated that close to 70% of people in developing countries pay for their health by out of pocket. This means that for the majority of people, their treatment decision is driven by the ability to pay for their medical needs. In some unfortunate cases, some people negotiate to take only the drug they can pay for instead of a full dose!

Access to medication is not a luxury. People should pay according to their ability and consume medical services based on health needs. This is possible with pre-payments method like health insurance where there is cross-subsidization so that even those who are less fortunate can assess the same quality healthcare that addresses their health needs.

The drug classification system and decision on whether a drug stays as prescription or non-prescription drug category is utilized as a regulatory strategy to ensure patient safety. NDA, like other regulators around the world imposes different restrictions on drug availability, such as prescription status to protect public health. Different drug categories, such as prescription and over-the-counter drugs, lead to different drug access and channel of drug distribution.

Improving access to drugs still remains a global multidimensional challenge that requires comprehensive national policies and strategies. These should align public health needs with economic and social development objectives and promote collaboration with other sectors, partners and stakeholders. Like a friend told me recently, most of us are one big medical bill away from being bankrupt!

The writer, Abiaz Rwamiri, is the Public Relations Manager at the National Drug Authority