LAB Flashcards by Amira Ibrahim Bakhit

refers to the proprietary name given by the manufacturer to distinguish its product from those of competitors.

Brand Name

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means a method of secret writing that substitutes other letters or characters for the letter intended or transposes the letter after arranging them in blocks or squares.

Cipher

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means a system of words or other symbols arbitrarily used to represent words.

Code

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means a characteristic style or symbols kept from the knowledge of others or disclosed confidentially to but one of few.

Secret Keys

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a counterfeit is one which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic drug products.

Counterfeit Drugs

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refer to either prohibited drugs or regulated drugs which require a special prescription form, the use of which is monitored by the dangerous drugs board

Dangerous Drugs

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refers to the sum of processes performed by a pharmacist from reading, validating, and interpreting prescription; preparing; packaging; labeling; record keeping: dose calculations; and counseling or giving information, in relation to the sale or transfer of pharmaceutical products, with or without a prescription or medication order.

Dispensing

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refer to pharmaceutical outlets where registered drugs are dispensed directly to the end users or patients.

Drug Outlets

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a drug that is available only with written instructions from a doctor or dentist to a pharmacist; “he told the doctor that he had been taking his prescription regularly” prescription drug, prescription medicine, prescription.

Ethical Drugs

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means dispensing the patient’s/buyer’s choice from among generic equivalents, in example., finished pharmaceutical products having the same active ingredients(s), same dosage form and same strength as the prescribed drug.

Generic Dispensing

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are not covered by the patent protection and which are labelled solely by their international non-proprietary on generic name.

Generic Drug

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immediate container or wrapping in which any substance is contained for consumption.

Immediate Container

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means a display of written, printed or graphic matter upon immediate container or the wrapper of a drug package.

Label

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is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer.

Medication Error

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written directions provided by a prescribing practitioner for a specific medication to be administered to an individual. The prescribing practitioner may also give a medication order verbally to a licensed person such as a pharmacist or a nurse.

Medication Order

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refer to medicines used for symptomatic relief of minor ailments and which may be dispensed without a prescription

OTC Drugs

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means dispensing less than the total number of units prescribed

Partial Filling of Prescription

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patient counseling means the oral communication by the pharmacist of information to the patient or caregiver, to ensure proper use of drugs and devices.

Patient Counseling

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a prescription is not an order for medication which is dispensed for immediate administration to the ultimate user (e.g., an order to dispense a drug to an inpatient for immediate administration in a hospital is not a prescription)

Prescription Order

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which includes opium and its components and derivatives, such as heroin and morphine; coca leaf and its derivatives, mescaline, lysergic acid diethylamide (LSD) and other substances producing similar effects; Indian hemp and its derivatives; all preparations made from any of the foregoing; and other drugs, whether natural or synthetic, with the physiological effects of a narcotic drug.

Prohibited Drug

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which includes opium and its components and derivatives, such as heroin and morphine; and coca leaf and its derivatives, mescaline, lysergic acid diethylamide (LSD) and other substances producing similar effects; Indian hemp and its derivatives; all preparations made from any of the foregoing; and other drugs, whether natural or synthetic, with the physiological effects of a narcotic drug.

Regulated Drugs

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means a written permission or authorization from DDB to prescribe dangerous drug preparations in any form or drug preparations containing controlled chemicals.

S-2 License

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a label added on to a dispensed medication package by a pharmacist in addition to the usual prescription label.

Auxiliary Labels

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a patient who stays in hospital while under treatment.

In-Patient

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a patient who receives medical treatment without being admitted to a hospital.

Out-Patient

traditional symbol for prescription. Use to line up the other parts of the Rx

sig – write or let it be labeled (Latin terms: signa). Instructions for the patient.

Signa

an informal colloquial term for a prescription

Script

refers to the instruction and special care required in the used of the drug product to avoid undesired effects and to ensure the safe and effective use of the drug.

Caution

entering through the dermis, or skin, as in administration of a drug applied to the skin in ointment or patch form.

Transdermal

is a document included in the package of a medication that provides information about that drug and its use.

Package Insert

the measured quantity of a therapeutic agent to be taken at one time. An amount of something likened to a prescribed or measured quantity

Dose

is defined as the physical form of a dose of a chemical compound used as a drug or medication intended for administration or consumption. Are the means by which drug molecules are delivered to sites of action within the body.

Dosage Form

Is the path by which the a drug, fluid, poison or other substances is taken into the body. They are generally classified by the location at which the substance is applied.

Route Of Administration

Is the sealing mechanism of the container, or the pharmaceutical product. Also known as stoppers or bungs

Drug Closure

An act regulating and modernizing the practice of pharmacy in the Philippines, repealing for the purpose republic act numbered five thousand nine hundred twenty-one (RA No. 5921),

RA 10918 - Pharmacy law

Objectives: ▪ The standardization and regulation of pharmaceutical education

RA 10918 - Pharmacy law

The examination for registration of graduates of school of pharmacy; and The supervision, control and regulation of the practice of pharmacy in the Philippines

RA 10918 - Pharmacy law

Development and enhancement of professional competence of pharmacists through continuing professional development, research, and other related activities; and ▪ Integration of the pharmacy profession

RA 10918 - Pharmacy law

An act to ensure the safety and purity of foods, drugs and cosmetics being made available to the public by creating the food and drug administration which shall administer and enforce the laws pertaining thereto.

RA 3720 - Food, Drug and Cosmetic act

An act instituting the comprehensive dangerous drugs act of 2002, repealing republic act no. 6425, otherwise known as the dangerous drugs act of 1972, as amended, providing funds therefor, and for other purposes.

RA 9165 – Comprehensive Dangerous Drug act of 2002

An act of prohibiting counterfeit drugs, providing penalties for violations and appropriating funds.

RA 8203 – Special Law on Counterfeit Drugs

An act to promote, require and ensure the production of an adequate supply, distribution, use and acceptance of drugs and medicines identified by their generic names.

RA 6675 – Generics Act of 1988

The policy of the states to protect the interest of the consumer, promote his general welfare and to establish standards of conduct for business and industry.

RA 7394 – Consumer Act of the Philippines

Protection against hazards to health and safety; Protection against deceptive, unfair and unconscionable sales acts and practices; Provision of information and education to facilitate sound choice and the proper exercise of rights by the consumer;

Objectives: RA 7394

Provision of adequate rights and means of redress; and Involvement of consumer representatives in the formulation of social and economic policies.

Objectives: RA 7394

An act granting additional benefits and privileges to senior citizens, further amending RA 7432 as amended, otherwise known as “an act to maximize the contribution of senior citizens to nation building, grant benefits and special privileges and for other purposes.

RA 9994 – Expanded Senior Citizen act

An act providing for cheaper and quality medicines, amending for the purpose republic act no. 8293 or the intellectual property code, republic act no. 6675 or the generics act of 1988, and republic act no. 5921 or the pharmacy law, and for other purposes

RA 9502 - "Universally Accessible Cheaper and Quality Medicines Act of 2008".

Guidelines on the implementation of new rules and regulations on the licensing of drugstore/pharmacy/botica and similar outlets following administrative order no. 2014-003, dated October 2014

FDA Circular No. 2014-025

Guidelines on the implementation of new rules and regulations on the licensing of retail outlets for non-prescriptions drugs (RONPDS) following administrative order no. 2014-0034, dated 13 October 2014

FDA Circular no. 2014-028

Adoption and implementation of the world health organization annex 5 guide to good distribution practices (GDP) for pharmaceutical products, and annex 9 guide to good storage practices for pharmaceuticals

A.O. No. 2013-0027

Guidelines on the unified licensing requirements and procedures of the food and drug administration (FDA)

A.O. No. 2016 - 0003

Drugs: current good manufacturing practice in manufacture, processing, packing or holding of products.

A.O. No. 220 S. 1974

these are prescriptions for prepared drugs.

Pre compounded prescriptions

the pharmacist prepares the medication directed by the physician

Extemporaneous prescription

a prescription for a single component

Simple prescription

written for more than a single component

Compounded/complex prescription

prescriptions in an institution like hospital. (inpatient RX)

Medication order

also known as electronic prescription, is the use of electronic means for the generation and transmission of prescription.

E – prescription

yellow prescription or narcotic prescription contains narcotic substance or other habit forming drugs.

Dangerous drug prescription

Derived from the Latin word “praescriptio” (prae, ‘before’ and scribo “i write”)

Prescription

An order of medication issued by a physician, dentist, veterinarian or other properly licensed medical practitioner

Prescription

Most prescription blanks are imprinted with the ....

name, address, telephone number and other pertinent information of physician or his/her practice site

with only one ingredient

Simple prescription

with more than one ingredient

Compound prescription

with ten or more than two ingredients of the same therapeutic uses. Also called the shotgun preparation

Polypharmacy

is a prescription which is prescribed very often by the same doctor, of the same ingredients and compounded by the same pharmacist

Magistral prescription

also called the blind prescription and consists of word, symbols, to represent the names of the drugs. This is unethical practice.

Coded prescription

routine orders, commonly prescribed medical treatments

Standing order

written while the patient is in the emergency room

Admission order

written while the patient is in the emergency room

Admission order

new orders or changes to existing medication order.

Daily orders

Policy-making body and the strategy- formulating body in the planning and formulations of policies and programs on drug prevention and control.

Dangerous drug board (DDB)

Implementing arm of the DDB ▪ Responsible for the efficient and effective law enforcement of all the provisions on any dangerous and/or controlled precursors and, essential chemicals as provided by this act.

Philippine drug enforcement agency (PDEA)

includes opium and its active components and derivatives, such as heroin and morphine; coca leaf and its derivatives.

Prohibited drug

includes sleep-inducing sedatives

Regulated drug

No currently accepted medical use High potential for abuse.

Schedule I

Most dangerous drugs of all the drug schedules with potentially severe psychological or physical dependence.

Schedule I

High potential for abuse, less abuse potential than schedule I drugs With use potentially leading to severe psychological or physical dependence

Schedule II

Moderate to low potential for physical and psychological dependence. Drug abuse potential is less than schedule I and II drugs but more than schedule IV.

Schedule III

Low potential for abuse and low risk of dependence.

Schedule IV

Consist of preparations containing limited quantities of certain narcotics. ▪ Antidiarrheal, antitussive, and analgesic purposes.

Schedule V

chief, active ingredient

Basis

used as assist to the basis

Adjuvant

qualifies the action of basis and the adjuvant

Corrective

added to dilute the active ingredients processing the prescription order

Vehicle

Generic name is not written Generic name is illegible but brand name is legible Both are written but with word "no substitution"

Violative prescriptions

Brand name precedes generic name Generic is in parenthesis Brand is not in parenthesis Also if RX contains more than one drug

Erroneous prescriptions

Only generic is written but not legible Generic name does not match with brand name Both written - both illegible Drug is not registered with DOH

Impossible prescriptions

An act to promote, require and ensure the production of an adequate supply, distribution, use and acceptance of drugs and medicines identified by their generic name.

R.A. 6675: Generics act of 1988

Section 12: Penalty: First conviction:

reprimand

Section 12: Penalty: Second conviction:

fine (N.L.T. 2,000 N.M.T. 5,000)

Section 12: Penalty: Third conviction:

fine (N.L.T. 5,000 N.M.T. 10,000) and suspension of license for 30 days

Section 12: Penalty: Fourth conviction:

fine (10, 000) and suspension of license for 1 year or longer