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
Universally Accessible Cheaper and Quality Medicines Act of 2008
Republic Act 9502
These are used in pharmacy and drugstore setting as needed for dispensed individually or loose medicines.
White and Red Labels
Are usually used to label loose capsules and tablets, suspensions, etc. that are taken orally.
White labels
Are used to label compounded medicines that are externally used.
Red Labels
They go together as part of Good Compounding Practice (GCP)
Packaging and Labeling
The new expiration date or beyond-use date of bottles.
6 months from the date the bottle was opened
It must be always observed to avoid contamination/cross-contamination of products to be prepared.
Sanitation
A pharmaceutical preparation of dosage formulation under reconstitution.
Suspension
What is the new expiration if the reconstituted medicine if it is refrigerated?
14 days from the day it was reconstituted
What is the new expiration if the reconstituted medicine if it is non refrigerated?
7 days from the day it was reconstituted
For standard purposes, most regulations required that active ingredients of Compound Sterile Products, with its strength and total volume, be in boldface and larger than the rest of the label information.
It is crucial in the dispensing process to assure rational use of medicine.
Labeling
It is defined as a record of information on a patient’s drug therapy.
It is a current list of all medications prescribed for an individual, any allergies the individual has, and any information relevant to an individual’s ability to take medication safely.
Patient Medication Profile
It is a comprehensive, systemically-derived list of regularly used medications, both prescription and nonprescription agents.
Patient Medication Profile
These are important in preventing prescription errors and consequent risks in patients.
Medication histories
It refers to the medical issue that the patient has for the visit.
Chief Complaint (CC)
It is the story of illness. Its goal is to ascertain a complete, accurate, and chronological account of the illness from the patient.
History of Present Illness
It includes chronic and past acute medical medications, including diabetes, hypertension, hyperlipidemia, hepatitis and asthma, and etc.
Past Medical History
It should include the type of operation undertaken, when it was undertaken, and the indication for the operation.
Surgical history
Among those pointed out are measles, mumps, chickenpox, whooping cough, rheumatic fever, scarlet fever and polio.
Childhood Illnesses
It includes the number of pregnancies, even the deliveries, miscarriages, and terminations.
Obstetric/Gynecologic History
These include information on what immunizations the patient has received.
Health Maintenance/Immunizations
It refers to the health information on the patient’s immediate relatives.
Family history
It is the part of interview where we learn about the patient’s life, including health behaviors and personal choices.
Personal and Social History
It is a systematic, head-to-toe evaluation of the presence or absence of symptoms.
Review of Systems
Information needed in taking medication history
Medication Name
Strength and Dose
Indication
Frequency
Timing
Medication Adherence
Adverse Reactions
Past Medication Use
Allergies