Author: Jacqueline Castellanos
Pharmaceutical Chemistry – Life Sciences
According to FDA report on the appropriate use of medicines, over-the-counter drugs are defined “Over-the-counter or over-the-counter (OTC) drugs are those that can be purchased without a prescription or prescription.”
That is, we are referring to those whose delivery and administration do not require the authorization of a doctor to be dispensed in a pharmacy, usually their use, their conditions and the authorized doses are safe for the consumer. But, what conditions does it depend on that do not require a prescription for its dispensing and administration?
Manufacturers and competent official bodies try to balance the safety and effectiveness of medicines, evaluating their risks-benefits over time.
Next, let's see some requirements to be classified as over-the-counter drugs:
1. Efficacy and safety:
The drug must show its efficacy and safety from the beginning of its studies and over time, in which the possible harmful effects that it may cause for different age groups, from lactating groups to geriatric groups, are known. Taking into account the correct and incorrect use that may occur of the drug.
Such is the case of the inappropriate use of injectable and oral antibiotics, which create resistance to some bacteria in the population and in turn puts the health of people who consume these drugs at risk. This leads the authorities to regulate their use through the requirement of prescriptions so that the population can acquire them and thus contribute to the safety and efficacy of antibiotic treatments. In El Salvador, the DNM has started regulating the consumption of antibiotics, changing the modality of sale of some antibiotics to prescription.
2. Wide therapeutic margin:
The medicine must guarantee that, under its inadequate administration at high doses and wrong use of the medicine, it does not represent a serious damage to the health of the person who consumes the medicine, whether its impact is direct or indirect.
3. Risks-benefits:
That their benefits are greater than their risks, although over-the-counter drugs have a well-characterized risk-benefit profile, all drugs can cause side effects, likewise they can affect the impact of other drugs that are being taken concomitantly. However, in any circumstance the risks must be minor, that is, the benefits outweigh the risks.
4. Route of administration:
The way of use must be easy, identifiable for the consumer, it must have sufficient product information in its prospectuses, said information must be understandable to the person who is going to consume the medicine.
5. Identification:
The consumer must be able to correctly identify their symptoms and the medications that can help treat them without the intervention of a health professional.
6. Costs and accessibility:
Over-the-counter medicines should make it possible to alleviate many symptoms and cure some illnesses in a simple way and without the cost of a medical consultation.
From the efficacy and safety of the drug to its consumption cost, these are requirements that may vary over time and are transcendental in classifying the way a drug is sold, with the intervention of both the manufacturer and the Official bodies may at some point reclassify the modality of sale, whether it be from sale with a medical prescription to sale without a prescription or vice versa.
Consult the list of Over-the-Counter Medications in El Salvador here
For more information, contact us at la@latinalliance.co