FINALS Flashcards
It involves proper preparation and labeling of medicines for patients.
Dispensing Process
It is one of the major cause of medication errors
Dispensing Process
It refers to a display of written, printed, or graphic matter upon the immediate container of the drug product and a requirement set by the FDA.
Label
It refers to the label in the immediate container, and the other printed materials that are made available with the product at the time of purchase and/or what protects the product.
Labeling materials
The DOH has issued requirements for labeling materials through what AO
Administrative Order No.55 s.1988
Generic name shall be the one with the highest point size among the printed elements on the label.
If the product is identified by a brand name, it shall be one-point bigger but in the same typeface, font, and color as the brand name and shall appear immediately above the latter.
It refers to the identification of drugs and medicines by their scientifically and internationally recognized active ingredient.
Generic Name
It refers to the proprietary/trade name assigned to the product by the drug establishment.
Brand Name
It refers to the classification of the product based on its therapeutic action as specified in the product registration.
Pharmacologic Category
It refers to the name(s) of active medicinal ingredient per dosage unit expressed in the metric system.
Formulation
It refers to the approved critical use of the product based on substantial and scientifically supported evidence of the safety and efficacy of the drug in the given dosage form.
Indication
It means the pharmaceutical form of the preparation based on official pharmacopoeia.
Dosage Form
It refers to the site and manner the product is to be introduced into or applied to the body.
Mode of Administration
It refers to the statements regarding the occurrence of potential hazards and side effects as associated with the use of the product and the limitation of its use.
Contraindications
It refers to statements regarding the conditions wherein the use of the product may cause harm to the patient.
Warnings
It refers to instructions and special care required to use the products to avoid undesired effects and ensure the safe and effective use of the drug.
Precautions
For products other than biological products, it means the date (month and year) during which processing of the bulk product, from which the goods are to be filled, is completed.
Date of Manufacture
It refers to any distinctive combination of letters and/or numbers assigned to a particular batch.
It permits the production history of the batch including all stages of manufacture and control, to be traced and reviewed.
Batch number
It refers to any distinctive combination of letters and/or numbers assigned to a particular lot, herein defined as a portion of the batch.
Lot number
It refers to the date after which the product is not expected to retain its claimed safety, efficacy, and quality or potency or after which it is not permissible to sell, distribute, or use said product.
Expiration date
It refers to the total amount/quantity/number of the dosage form in a particular container of a product expressed in the metric system.
Net content
It refers to the prevailing specified range of temperature, humidity, and other environmental factors within which optimal stability of the product is ensured based on laboratory data.
Storage condition
The Revised Rules and Regulations Governing the Generic Labeling Requirements of Drug Products for Human Use
Administrative Order No. 2016-0008
Current guidelines on labeling for dispensed medicine can be found under:
Section 36 of Article II Republic Act 1098 or the Philippine Pharmacy Act