LEGAL ETHICS Flashcards by Zheian Daryll Taguic

To do something good

Beneficence

How well did you know this?

Not at all

Perfectly

To do no harm

Non-maleficence

How well did you know this?

Not at all

Perfectly

Moral right of patients to make their own meaningful decisions

Autonomy

How well did you know this?

Not at all

Perfectly

People in similar situations should be treated equally

Justice

How well did you know this?

Not at all

Perfectly

The right to be informed and to choose a course of action

Informed Consent

How well did you know this?

Not at all

Perfectly

The right to give or refuse consent relative to the release of privileged information

Confidentiality

How well did you know this?

Not at all

Perfectly

Obligation to tell the truth

Veracity

How well did you know this?

Not at all

Perfectly

It refers to the ethics that a person identifies in respect to people and situations that they deal with in everyday life.

Personal Ethics

How well did you know this?

Not at all

Perfectly

It refers to the ethics that a person must adhere to in respect of their interactions and business dealings in their professional life.

Professional Ethics

How well did you know this?

Not at all

Perfectly

Criminal : Need for conviction

Guilt beyond resonable doubt

How well did you know this?

Not at all

Perfectly

Civil: Need for Conviction

Preponderence of evidence

How well did you know this?

Not at all

Perfectly

Administrative: Need for conviction

Substantial Evidence

How well did you know this?

Not at all

Perfectly

Penalty of Criminal Law

Prison/Fine

How well did you know this?

Not at all

Perfectly

Penalty of Civil Law

Fine

How well did you know this?

Not at all

Perfectly

Penalty of Administrative law

Warning, reprimand,
suspension, revocation

How well did you know this?

Not at all

Perfectly

Venue of Trial of Criminal and Civil

Court

How well did you know this?

Not at all

Perfectly

Venue of trial of adminitrative

PRC

How well did you know this?

Not at all

Perfectly

Terms of Criminal Law

People of the Philippines vs
Toni Fowler (Accused)

How well did you know this?

Not at all

Perfectly

Terms of Civil law

Plaintiff vs Defendant

How well did you know this?

Not at all

Perfectly

Terms of Administrative Law

Complaint vs. Respondent

How well did you know this?

Not at all

Perfectly

RA 5921

Short Title : _____________
Signed on _______________
Signed by ______________

Amendments

__________: Natural born citizen
__________: Max internship 560 hrs
__________: 5 —-> 4 years

Pharmacy Law
June 21, 1969
Ferdinand Marcos Sr.

PD 1363
MC #003
PD 1926

How well did you know this?

Not at all

Perfectly

RA 10918

Short Title _______________
Signed on _______________
Signed by _______________

Philippine Pharmacy Act
July 21, 2016
Benigno Aquino III

How well did you know this?

Not at all

Perfectly

Standardization and regulation of pharmacy education

Administration of licensure examination, registration, and licensing of pharmacists

Supervision, control, and regulation of the practice of pharmacy in the Philippines

Develop and enhance professional competence of pharmacists through continuing professional development, research, and other related activities

Integration of Pharmacy Profession

RA 10918 (Philippine Pharmacy Act)

How well did you know this?

Not at all

Perfectly

Exclusive or Inclusive

Prepare, compound, manufacture, preserve, store, distribute, procure, sell, dispense pharmaceutical products, or its raw materials.

Exclusive

How well did you know this?

Not at all

Perfectly

Inclusive or Exclusive Render services, such as clinical pharmacy services

Exclusive

Inclusive or Exclusive Engage in teaching scientific, technical pharmacy courses

Exclusive

Inclusive or Exclusive Dispense pharmaceutical products

Exclusive

Inclusive or Exclusive Provide telepharmacy services

Exclusive

Inclusive or Exclusive Chemical, biological, or microbiological analysis or assay of pharmaceutical products

Inclusive or Exclusive Physicochemical analysis for medical devices and aids

Inclusive or Exclusive Administration of adult vaccines * Holds a __________________from PPhA under the Immunizing Pharmacist Certification Program * Prescription is valid for _________ * Requires monthly vaccination reports

Inclusive Certificate of Training 7 days

Inclusive or Exclusive Conduct scientific research

Inclusive

* Refers to the Philippine Pharmacists’ Association * President: _________________

Accredited Professional Organization (APO) Aleth Therese Dacanay

Established national framework for quality standards and guidelines of the practice of pharmacy

Philippine Practice Standards for Pharmacists

Processed food products intended to supplement the diet

Food Supplements

Any product that is used to maintain, enhance, and improve the healthy function of the human body

Health Supplements

Any preparation used to relieve common physical ailments

Household Remedies

Method of writing that substitutes other letters or characters for the letter intended

Cipher

System of words or other systems arbitrarily used to present words

Code

Characteristic styles or symbols kept from the knowledge of others or disclosed confidentiality to one or few

Secret Keys

Act of dispensing or providing medicines in accordance with a prescription or medication order

Filling

Act of dispensing the remaining balance of medicines ordered in the prescription

Refilling

Act of dispensing less than what was ordered in the prescription

Partial Filling

Assist RPh in different aspects of pharmacy operation based on SOP VERY MINIMAL degree of independence NO direct patient interaction

Aides

Assist RPh in different aspects of pharmacy operation based on SOP MINIMAL degree of independence May have SUPERVISED INTERACTION with the patient

Assistants

Assist compounding and dispensing of medications Highly INDEPENDENT w/ supervision of RPh w/ Patient interaction; May dispense drugs as long as it is reported to RPh in < 24 hrs.

Technician

Composition of Board of Pharmacy

1 chairperson + 2 members

Appointment Process of The Board Of Pharmacy _______ ---> _______ ----> ______ * PPhA submits __ for each position. * PRC submits __ for each position.

PPhA → PRC → President of the Philippines 5 names 3 names

Qualification for Board Of Pharmacy * Citizen and resident for ______ * Registered RPh preferably with MSPharm/PhD * Active in the practice for ______ * Not convicted of any crime involving __________ * Good standing of APO ___________ * NOT a faculty or lecturer of review center

> 5 years > 10 years moral turpitude > 5 years

Power and Functions of Board of Pharmacy

* Administer and implement RA 10918 * Promulgate rules and regulations and AOs to carry out RA 10918 * Prepare the Board Exam * Recommend issuance and suspension of CoR and PIC * Administer oaths * Regulate and monitor practice of pharmacy * Represent the profession * Investigate cases * Delegate hearing or investigations * Issue or promote guidelines on CPD * Accredit specialty boards of pharmacy * Regulates medical representatives

Terms of Office: Each term: ________ Max. # of terms: _________

3 years 2 terms

Grounds for Suspension/Removal:

Gross neglect, incompetence, or dishonesty Manipulation of the exam Conviction of a crime of moral turpitude Unprofessional or unethical conduct

To pass the board exam: GWA: ____ * NO rating _____ in any area * Refresher program if you fail the _______.

≥ 75 % < 50 % 3rd time

To qualify to take the Board Exam: 1. Filipino Citizen → 2. Good Moral Character → 3. Degree Holder → 4. Completed 1200 hours of internship →

birth certificate Certificate from School, Church, or Barangay Transcript of Records Certificate of Completion

Bears the registration number, date of issuance, signatures of the PRC and BOP, and the official seals of the PRC and the BOP. Must be displayed in establishments and a duplicate is allowed in ___________ establishments Remains in full force and effect unless revoked or suspended A revoked COR may be reissued after _____

Certificate of Registration (COR) Category B 2 years

Bears the registration number, date of issuance and expiry, and signature of the PRC Chairperson Renewed every _______ * ___________________ from PPhA * ___________________

Professional Identification Card 3 years Certificate of Good Standing fron PPhA CPD Requirements

Qualifications for Special Temporary Permit * ______________ pharmacist or expert in a field or specialty of pharmacy * Engaged in the provision of a professional service which is determined to be necessary due to a lack of Filipino specialist or expert * Required to work with a ____________

Internationally Renowned Filipino counterpart

* Convicted of an offense involving moral turpitude * Misrepresentation or Falsification of documents * Immoral or Dishonorable conduct * Medically proven to be addicted to any drug or alcohol * Declared of unsound mind

GROUNDS FOR NONREGISTRATION

Requires the direct and immediate control and supervision of an RPh

Category A

Requires the supervision and oversight of an RPh

category B

Category A or B Wholesale and retail sale of drugs

Category A or B Retail of OTC and Household Remedies

Category A or B manufacture, Importation, Exportation, and Distribution

Category A or B Pharmaceutical Laboratories

Category A or b Government units 1st to 3rd Class Municipalities

Category A or B Satellite pharmacies

Category A or B Government units in 4th to 6th class

Category A or B Telepharmcy Services Nontraditional Outlets

Category A or B RPh must be present for ____/week in a maximum of ___ establishments with none farther than ___ km

2 hrs 15 establishments 25 km

Penalty for Major Violations

* 250,000 to 500,000 PESOS AND * Imprisonment of NLT 1 year and 1 day & NMT 6 years

Grounds for Major Violations

* Violation of Sec. 30 (sale of drugs) & Sec. 31 (Pharmacist Requirements) * Ghost Pharmacist * Dispensing & Compounding drugs in an unlicensed place or with no pharmacist * Forcing an RPh to dispense drugs in violation of the law * Fraudulent Manufacture, and Manufacture of Adulterated and Misbranded Products * Operating drug establishments with no pharmacist * Practicing without a license

Penalty of Minor Violations

* 100,000 to 200,000 PESOS AND/OR * Imprisonment of NLT 30 days & NMT 1 year

Grounds for mInor violations

* Affixing “RPh” with no license * Practicing with no COR, PIC, or STP * Non-indication of COR or Professional Tax Receipt (PTR) in official documents * Noncompliance with requirements on filling or partial filling * Sale or alteration of labels of physician samples * Use of cipher, code, or secret keys * Noncompliance with labelling requirements or not keeping record books * Refusal to undergo training and certification of personnel, when necessary

RA 8981 Short Title ___________ Signed on ____________ Signed by ____________ Amendments ____________ --> Office of Board of Examiners __________ ---> Created the PRC

PRC Modernization Act December 5, 2000 Joseph Estrada RA 546 PD 223

RA 10912 Short Title ___________ Signed on ____________ Signed by ____________

CPD Law of 2016 July 21, 2016 Benigno Aquino III

CPD

Continuing Professional Development

Ground for Exception for CPD uNITS

* Professional working overseas * Newly licensed professionals for the first renewal cycle (3 years)

REQUIRED CPD UNITS

45 UNITS

RA 3720 Short Title ___________ Signed on ____________ Signed by ____________ Amendments ____________ --> FDA ->BFAD ____________--> Food , drug, Devices and Cosmetics Act

Food, Drugs & Cosmetics Act June 22, 1963 Diosdado Macapagal EO 851 s. 1982 EO 175 s. 1985

EO 175 s. 1987 Signed on: Signed by:

May 22, 1987 Cory Aquino

* Filthy, putrid, or decomposed substances * Unsanitary conditions * Poisonous or deleterious substances * Color other than permitted * Substandard * Mixed with any substance that reduces its quality * Non-cGMP compliant

Adulterated

* False or Misleading label or container * Missing label * Missing information * Contains narcotic or hypnotic substances * Not using the official compendium name * Liable to deterioration * Imitation * Sold under another name * Antibiotic without batch certification

Misbranded

RA 9711 Short Title ___________ Signed on ____________ Signed by ____________

Food and Drug Administration Act August 18, 2009 Gloria Macapagal Arroyo

Director-General * Director ______________ * Appointed by the ___________ * May be a _______ or _________

Samuel Zacate President doctor or MS pHARMA gRAD

Directly under the Director-General

Policy and Planning Office (PPO) Legal Services Support Center

Headed by Deputy Director General

Administration and Finance Office (AFO) Field Regulatory Operations Office (FROO)

* Includes veterinary medicines, vaccines, and biologicals * HEAD: _________________

Center for Drug Regulation and Research (CDRR) Maria Cecilia Matienzo

Includes chewing gum, food supplements * HEAD: ___________________

Center for Food Regulation and Research (CFRR) Pilar Marilyn Pagayunan

* Includes toys * HEAD: _________________

Center for Cosmetics and Household Urban Hazardous Substances Regulation and Research (CCHUHSRR) Engr. Ana Trinidad River

Center for Device Regulation, Radiation Health, and Research (CDRRHR) HEAD: ________________

Valeriano Timbang Jr.

* Any instrument with purposes similar to a drug

Medical Device

Electrical or electronic apparatus emitting any form of radiation

radiation device

Any device not used in healthcare but may adversely affect the health of the people

Health-related device

Class A Device

Low risk Bandage, Dressing, Lubricating Jelly

Class B Device

Low-moderate risk Catheter (short-term), Lancet, Mask

Class C Device

Moderate-high risk Anesthesia set, blood bag

RA 8203 Short Title ___________ Signed on ____________ Signed by ____________

Special Law on Counterfeit Drugs September 4, 1996 Fidel V. Ramos

* Correct ingredients but insufficient (<80% drug) * Wrong ingredient * NO API * Mislabeled identity/source * Container/label with no identification mark or imprint * Drug product refilled by unauthorized person * Unregistered imported drug product

Counterfeit Drugs

RA 6425 Short Title ___________ Signed on ____________ Signed by ____________

Dangerous Drugs Act March 30, 1972 Ferdinand Marcos Sr.

* Opium and active components and derivatives (e.g. elixir paregoric, heroin, morphine) * Coca and derivatives (e.g. cocaine, alpha & beta eucaine * Hallucinogenic substances (e.g. mescaline, LSD) * Indian hemp and its derivatives

Prohibited

* Hypnotic drugs, such as nitrazepam, methaqualone * Amphetamine * Barbiturates

Regulated

RA 9165 Short Title ___________ Signed on ____________ Signed by ____________

Comprehensive Dangerous Drugs Act January 23, 2002 Gloria Macapagal Arroyo

Facility used for illegal manufacturing of dangerous drugs

Clandestine Laboratory

Place where any dangerous drug is administered, delivered, stored, distributed, sold, or used

Den, Dive, Resort

Organized group of 2 or more people violating this act

Syndicate

Person who knowingly consents to unlawful acts and uses his/her influence in shielding violators

Protector/Coddler

Sells dangerous drugs

Pusher

Person who pays for, raises, or supplies money for illegal activities

Financier

* Exempt DD preparation * Retail of drug preparations containing controlled chemicals

S-1

Prescribers

S-2

Retailers of DD preparation in any form and DD prep containing controlled chemicals

S-3

Wholesaler

S-4

* S-5-I: _____________ * S-5-C: ____________ * S-5-E: __________________ * S-5-D: __________________

Importer Compounder Exporter Bulk Depot/Storage

Research

S-6

S-7

Importer and Compounder

Special Prescription * Retained by pharmacist for ______ * MAXIMUM OF: _______ * Issued by: ____ * Produced by: ______ * Confiscated or seized chemicals shall be submitted to ___ within _______

1 year 10 booklets DOH DDB PDEA within 24 hours

Triplicate Copies

Pharmacist - yellow Patient - green Doctor - white

maximum limit (10 grams)

* Opium * Morphine * Heroin * Cocaine * Marijuana Resin or Resin Oil * MDMA * PMA * TMA * LSD * GHB

maximum limit (50 grams)

shabu

maximum limit (500 grams)

marijuana

Policymaking and strategy formulating body of RA 9165

DDB

Composition of DDB

Permanent Consultants -> NBI Director --> PNP Chief

Implementing arm of the RA 9165

PDEA (Philippine Drug Enforcement Agency)

Composition of PDEA

1 Director-General 2 Deputy Director-Generals * Operations * Administration

RA 7394 Short Title ___________ Signed on ____________ Signed by ____________

Consumer Act April 13, 1992 Cory Aquino

Objectives of RA 7394

* Protection against hazards * Protection against deceptive, unfair, and unconscionable sales acts & practices

Applicability of RA 7394

* When there is a complainant * When the subject of violation is a consumer product or service * When the nature of the complaint is any of the aforementioned concerns

RA 7394 is implemented by

Department of Trade and Industry Department of Agriculture Department of Health

RA 7581 Short Title ___________ Signed on ____________ Signed by ____________

Price Act May 27, 1992 Cory Aquino

Goods vital to the needs of consumers for sustenance and existence * Examples: Potable water, PNDF-EDL, sugar, kerosene

Basic Necessities

* Goods not considered basic necessities but essential to consumers * Examples: Paper, Onions

Prime Commodities

Fund in the budget not to be used in normal or regular operations

Buffer/Emergency Funds

MAXIMUM PRICE of any basic necessities or prime commodities

Price Ceiling

Consumers buy basic necessities and prime commodities in excess of their normal requirements

Panic Buying

Undue accumulation of any basic necessity or prime commodity beyond inventory levels

Hoarding

Sale of any basic necessity grossly in excess of its true worth

Profiteering

Agreement between 2 or more people to unreasonably increase or manipulate the price

Cartel

RA 6675 Short Title ___________ Signed on ____________ Signed by ____________

Generics Act September 12, 1988 Cory Aquino

A list of drugs prepared periodically updated by the Department of Health on the basis of health conditions obtaining in the Philippines as well as on internationally accepted criteria

Essential Drug List

is a list of drugs that meets the health care needs of the majority of the population

Core List

a list of alternative drugs used when there is no response to the core essential drug or when there is hypersensitivity reaction to the core essential drug or when for one reason or another, the core essential drug cannot be given.

Complementary List

RA 9502 Short Title ___________ Signed on ____________ Signed by ____________

Universally Accessible and Cheaper Quality Medicines Act June 6, 2008 Gloria Macapagal Arroyo

RA 11223 Short Title ___________ Signed on ____________ Signed by ____________ RA 8293: ___________________ RA 6675: ____________________ RA 5921: ___________________

Universal Healthcare Act February 20, 2019 Rodrigo Roa Duterte Intellectual Property Code Generics Act Pharmacy law

% of beds to be classified as basic or ward accommodation: Government

90%

% of beds to be classified as basic or ward accommodation: Specialty

70%

% of beds to be classified as basic or ward accommodation: Private

10%

RA 7876

Senior Citizens Center Act

place established with recreational, educational, health, and social programs and facilities designed for the full enjoyment and benefit of the senior citizens in the city or municipality and accredited by the DSWD

Senior Citizen Center

Defined Seniors as > 60 years old, with an annual income of NMT 60K

RA 7432 (Senior Citizens Act of 1992)

* Removed the income threshold * Added free medical and dental services

RA 9257 (Expanded Senior Citizen Act of 2003)

* Exemption from VAT and Income Tax

RA 9994 (Expanded Senior Citizens Act of 2010)

How to avail Senior Citizen discount?

* OSCA ID; Passport * Proof of citizenship * Booklet (not applicable now) * Prescription, if it is an Rx drug

AO 55 (Label)

* Name of the Product * Dosage form and Strength * Pharmacologic Category * Rx symbol, if Rx drug (NLT 1/5 of the height of the display panel) * Name and address of manufacturer * Net content * Formulation * Indication/s * Contraindication, Warning, Precaution * Mode of Administration/Directions for Use * Batch and Lot number * Expiry date and Date of manufacture * Registration number * Storage Conditions * “Foods, Drugs, Devices, and Cosmetics Act prohibits dispensing without prescription”

AO 56 (Licence) Premise Requirements

* Signboard * Well-ventilated area * Compounding area * Storage area * Cabinet for Dangerous Drugs and Poisons * Adequate Water Supply

AO 56 (Licence) Reference Books and Documents

* PNDF * USP/NF * RA 3720, RA 6675, RA 5921 * Remington * Goodman and Gillman

Record Books

Conventional Rx: 2 years Dangerous Drugs Rx: 1 year Poison drugs: 5 years

Validity of Licence to Operate (Initial registration)

1 year (old) 3 years (new)

Validity of Licence to Operate (Renewal)

2 years (old) 6 years (new)

If LTO is revoked, it may be reissued again after?

5 years

Major Variations (Licence to operate)

* Change of Ownership * Transfer of Location * Additional Activity

Minor Variations (Licence to operate)

* Prior approval: Expansion, Change of Business Name, Zonal Change in Address * Notification: Change of RPh or PA, Deletion of Activity

Absence of RPh on 3 inspections

Temporary Closure

* Failure to provide invoices and receipts * Failure to properly record and keep a file of prescriptions in the past 3 years * Refusal to allow entry of inspector

Suspension of LTO

* Selling of drugs with “Not for sale” mark * Failure to properly record dangerous drugs * Absence of RPh

Revocation of LTO

AO 67

Registration

Approved for sale to the generic public without restriction other than the usual

Drugs for General Use

Approved for sale to the general public under certain conditions

Drugs for Restricted Use

Used for at least 5 years and involving at least 5,000 patients

Tried and Tested Drugs

Needs phase IV

New Drug

Needs phase I, II, III

Investigational Drug