PHARMACY REGULATION Flashcards
An act regulating in modernizing the practice of pharmacy in the Philippines
R a 10918
Philippine Pharmacy act of 2016
July 21 2016
President benigno Aquino III
An act to promote require an 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
September 13 1988
President corazon C Aquino
An act prohibiting counterfeit drugs
RA 8203
Special law on counterfeit drugs
September 1996
President Fidel v Ramos
An act granting additional benefits and privileges to senior citizens
Ra 9994
Extended senior citizens act
February 15 2010
President Gloria macapagal arroyo
An act strengthening and rationalizing the regulatory capacity of the bureau of food and drugs by establishing adequate testing laboratories in field offices upgrading its equipments and augmenting its human resources complement giving authority to maintain income and renaming it to food and drug administration
Republic act 9711
Food and drug administration act of 2009
August 18 2009
President Gloria macapagal arroyo
Republic act prescribing the intellectual property code and establishing the intellectual property offices
Republic act 8293
Intellectual property act
June 6 1997
President Fidel v Ramos
It is a Republic act providing for cheaper and quality medicines
Republic act 9502
Universally accessible cheaper and quality medicines act of 2008
June 6th 2008
President Gloria macapagal arroyo
It is Republic a campaigning against the trafficking and use of dangerous drugs and other similar substances
Republic act 9165
Comprehensive dangerous drugs act of 2002
June 7th 2002
President Gloria macapagal arroyo
Republic act modernizing the professional regulation commission
Republic act 8981
PRC modernization act
December 5 2000
President Joseph ejercito Estrada
Republic act mandating and strengthening the continuing professional development program for all regulated professions creating CPD council
Republic act 10912
Continuing professional development act of 2016
July 21 2016
President benigno s Aquino III
Republic act 10918 was repealed by Republic act
5921 or the pharmacy law
Enumerate the sections of regulation of the practice of pharmacy under article
Section 25 - vested rights; automatic registration
Section 26 - affixing RPH after a registered pharmacist’s name
Section 27- indication of information
Section 28-registry of pharmacists
Section 29- display of certificate of registration
Section30-dispensing / sale of pharmaceutical products
Section 31 - pharmacist requirement
Section 32-responsibility for quality of pharmaceutical products
Section 33-filling and partial filling of prescription
Section 34 - physicians sample
Section 35-prohibition against the use of Cipher codes or unusual terms in prescriptions and prescription substitutions
Section 36-label of dispense medicines
Section 37 - recording of patient medication profile
Section 38- requirements for the opening and operation of retail Pharmaceutical outlet or establishment
Section39-handling of pharmaceutical products by persons other than a pharmacist
Section 40-administration of adult vaccines
Administrative order for prescribing requirements
Administrative order 62 series of 1989
It shall be used in all prescriptions
Generic names
If the brand name is written on the prescription, it should be in____and be written ____ the generic name
Parenthesis
Under
Administrative order for dispensing requirements
Administrative order 63 series of 1989
It is dispensing the patient’s choice from among generic equivalents
Generic dispensing
Exempted of liability for counterfeit drugs
Certificate - import and export
Present duplicates showing purchase or importer export
Drugs must not appear to be counterfeit
How many percent is the discount for senior citizens
20%
What is the exemption of senior citizens aside from 20% disc
Value added tax or VAT
They should establish guidelines and mechanism of compulsory rebates in the sharing of burden of discounts amongst retailers manufacturers and distributors taking into consideration
Department of health
Indigent Senior citizens shall be entitled to a monthly stipend amounting to
500 pesos
All indigent senior citizens shall be covered by the national health insurance program of
PhilHealth
They should allocate the necessary funds to ensure the enrollment of their indigent senior citizens in accord
Local government units
It is intended to caution the effects of economics shocks disasters and calamities which should be made available for senior citizens
Social safety assistance
These shall include but not limited to food medicines and financial assistance for domicile repair shall be sourced from the disaster calamity funds of LGU
Social safety assistance
Four organizations under food and drug administration
Center for drug regulation and research
Center for food regulation and research
Center for cosmetics regulation and research
Center for device regulation, radiation health and research
It is an organization of FDA that includes veterinary medicine vaccines and biologicals
Center for drug regulation and research
An organization of FDA that includes household hazardous urban substances
Center for cosmetics regulation and research
Divisions per centers for organizations of FDA
Licensing and registration division
Product research and standard development division
Laboratory support division
What is the meaning of USPNF
United States pharmacopoeia national formulary
Any article intended for using the diagnosis cure mitigation treatment or prevention of diseases in humans or animals
Drugs or medicine
Any article other than food intended to affect the structure or any function of the human body or animals
Drugs or medicine
Herbal and/or traditional drugs which are articles of plant or animal origin used in folk medicine
Drugs or medicine
It is a rapid test performed to establish potential / presumptive positive result
Screening test
An analytic test using a device, tool or equipment with a different chemical or physical principle that is more specific which will validate and confirm the results of screening test
Confirmatory test
Any person who sells, trades administers etc to another or transports, broker in any such transaction
Pusher
Illegal cultivation, delivery administration etc of any dangerous drug or controlled precursor and essential chemical
Illegal trafficking
Other term for marijuana
Indian hemp, hashish, bhang
Other name of shabu
Methamphetamine hydrochloride
Other name of ecstasy
Methylene
dioxymethamphetamine
How many years should a dangerous drug prescription be retained by the pharmacist
5 years
The confiscated or cease chemicals should be submitted to PDEA forensic laboratory for a quantitative exam within
24 hours
Drug test certificate issued by accredited drug testing center shelby valid for
1 year
Type of prescription for dangerous drugs
Triplicate
It is the penalty imposed upon any person apprehended or arrested for the first time who is found to be positive for use of any dangerous drug
6 months rehabilitation in a government center
Possession of dangerous drugs could be penalized through the following
Life imprisonment to death and find raging from 5 million to 10 million
It has the power to the classify ad or remove any drug from list of dangerous drugs
Dangerous drugs board
Permanent consultant of dangerous drug board
NBI d
Serves as implementing arm of DDB
PDEA
Head of PDEA
Director general
Monitors the treatment and rehabilitation of drug dependents and operation of drug rehabilitation and testing center
Department of health
