Study Set Content:
refers to any drug or pharmaceutical establishment that imports or experts raw materials, active ingredients and/or pharmaceutical establishments or outlets. If the distributor/ importer/ exporter/ wholesaler sells to the general public, it shall be considered retailer
Drug Distributor/Importer/Exporter/Wholesaler
¨ refer to any activity in response to a drug information request or query from healthcare professionals, organizations, committee, patients and other individuals with the goal of providing carefully evaluated, evidence-based drug information and recommendation to support medication use practice, enhance quality of patient care, improve patient outcomes and ensure prudent use of resources
Drug Information Services
refer to pharmaceutical outlets where registered drugs are dispensed directly to the end users or patients
Drugstore/Pharmacy/Botica and Hospital Pharmacy
refer to life-threatening situations where a patient needs immediate medical attention and treatment, including the occurrence of epidemic or natural calamities
Emergency cases
refers to the end date when the manufacturer can guarantee that a product possesses its claimed potency, efficacy, quality, and safety; after which its sale or distribution is prohibited
Expiration date
refers to the act of dispensing or providing medicines in accordance with a prescription or medication order
Filling
refer to processed food products intended to supplement the diet that bears or contains one (1) or more of the following dietary ingredients: vitamins, minerals, herbs, or other botanicals, amino acids, and dietary substances to increase the total daily intake in amounts conforming to the latest Philippine-recommended energy and nutrient intakes or internationally agreed minimum daily requirements. It usually is in the form of capsules, tablets, liquids, gels, powders, or pills and not represented for use as a conventional food or as the sole item of a meal or diet or replacement of drugs and medicines, as defined under R.A. 9711
Food/Dietary Supplements
refers to the scientifically and internationally recognized name of the active ingredients, as approved by the FDA pursuant to Republic Act No. 6675, otherwise known as the "Generics Act of 1988"
Generic name
refers to an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects
Good Clinical Pharmacy Practice (GCPP)
refers to that part of quality assurance which ensures that the quality of a pharmaceutical product is maintained through adequate control throughout the numerous activities which occur during the distribution process
Good Distribution Practice (GDP)
refers to the quality system concerned with the organizational process and the conditions under which non-clinical health and environment safety studies are planned, performed, monitored, recorded, archived, and reported.
Good Laboratory Practice (GLP)
refers to a system of quality assurance aimed at ensuring that product are consistently manufactured to a quality appropriate for their intended use. It is thus concerned with both manufacturing and quality control processes and procedures.
Good Manufacturing Practice
refers to the practice of pharmacy that responds to the needs of the people who use the pharmacists’ services to provide optimal evidence-based care
Good Pharmacy Practice
refers to the practice of regulation that should be clear, simple and practical for users through identified policy objectives, consistent with international standards in a sound legal and empirical basis which produces benefits that justify and minimize costs and market distortions, in consideration of its market society and taking into account the economic, environment and social factors
Good Regulatory Practice (GRP)
refers to that part of quality assurance which ensures that the quality of a pharmaceutical product is maintained through adequate control throughout its storage
Good Storage Practice
refers to that part of quality assurance which ensures that the quality of a pharmaceutical product I maintained through adequate control throughout the warehousing
Good Warehouse Practice (GWP)
refers to the activities or range of pharmacy operations from selecting, ordering, delivery, transport, receipt, inventory of stocks, to arranging and display, compounding, storage, dispensing, provision of medication and health information to patients and healthcare providers, selling of pharmaceutical products including waste disposals
Handling of Pharmaceutical Products
refers to the process of enabling communities, patients and clients to increase control over their health and its determinants by engaging in healthy behaviors to reduce the risk of developing diseases and other comorbidities.
Health Promotion
refers to any product that is used to maintain, enhance and improve the healthy function of the human body and contains one (1) or more or a combination of the following: (1) herbal fatty adds, enzymes, probiotics, and other bioactive substances (2) substances derived from natural sources, induding animal, plant, mineral, and botanical materials in the form of extracts, isolates, concentrates, metabolites, synthetic sources of substances mentioned in (1) and (2). It is presented in dosage forms or in small unit doses such as capsules, tablets, powder, liquids and it shall not include any sterile preparations (i.e. injectables, eyedrops)
Health Supplement
refers to the drugs that bear a heightened risk of causing significant patient harm when sued in error
Health-alert Medications
