Over the counter vs prescription drugs
| Requires a written order or prescription from a Physician |
• May be purchased without the use of a prescription. |
| • Requires a medical diagnosis and decision by a licensed physician as to which drug is to be used. |
• Relies on self-diagnosis. The product chosen is usually based on the patient’s preference. |
| • Can only be dispensed from a pharmacy by a licensed Pharmacist |
• May be available for purchase from store shelves in Pharmacies, supermarkets and other convenience stores. |
| • Prescribed for and intended to be used by only one person. |
• May be used by more than one individual, however, to limit contamination, sharing is not recommended for medications such as eye drops and nasal sprays. |
| • Generally more potent than OTC, and has a relatively narrower margin of safety and its usage requires stricter monitoring. |
• Has a wider margin of safety than prescription drugs |
| • Can be used to treat both minor illnesses and more serious or chronic diseases |
• Used to treat minor illnesses which are occasional and require a short duration of treatment, for example, the common cold and seasonal allergies. |
| • May be harmful if misused | • May be harmful if misused. It’s always best to consult your Physician or Pharmacist before using OTC’s if other medical conditions exist, or if taking prescription medication |
What are generic Drugs?
A generic drug is identical or bioequivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Bioequivalence means the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study
(FDA). Although generic drugs are chemically identical to their branded counterparts, they are typically sold at considerable discounts from the branded price.
New drugs, like other new products, are developed under patent protection. The patent protects the investment in the drug’s development by giving the company the sole right to sell the drug while the patent is in effect. When patents or other periods of exclusivity expire, manufacturers can apply to the appropriate regulatory authority to sell generic versions. The Standards and Regulation Division of the Ministry of Health, Jamaica is responsible for the approval of drug registration in Jamaica. To gain approval, a generic drug must:
• contain the same active ingredients as the innovator
drug (inactive ingredients may vary)
• be identical in strength, dosage form, and route of
administration
• have the same use indications
• be bioequivalent
• meet the same batch requirements for identity, strength,
purity, and quality
• be manufactured under good manufacturing practice
regulations as required for innovator products
Source: www.fda.gov
Contributed by Jamie-lee Clarke (Pharmacist)
