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RA 10918 - Philippine Pharmacy Act

An act regulating and modernizing the practice of pharmacy in the Philippines, repealing RA 5921

RA 10912 - Continuing Professional Development of 2016

CPD Law of 2016

• Required units: 45 units

• Now: 15 units

Rating required to pass PhLE

75% with no rating below 50% in any subjects

Board of Pharmacy (BoP) Qualifications

• Citizen

• Registered Pharmacist (RPh) with 1 year in practice (preferably 2 years)

• No crime involvement

• Not a faculty of any Pharmacy schools

Internship Requirements in Pharmacy

• RA 5921: 960 hours

• Now: 1200 hours

CATEGORY A

Direct and immediate control of a pharmacist

• Rx medicines

• Manufacturer, importer, exporter, distributor

• Pharmaceutical Labs

• Government units (LGUs: 1st to 3rd class)

CATEGORY B

Supervision or oversight under provision of law

• Retail outlets (OTC and household remedies)

• Satellite pharmacies

• 4th-6th class municipal health units

• Telepharmacy institution

• Non-traditional outlets

Category B pharmacists are allowed to supervise a maximum of ___ establishments

2 hrs/week

Minimum time per establishment (Category B)

25km

Maximum distance of two farthest establishments supervised by a pharmacist:

Pharmacy Aides / Pharmacy Assistants

Assist RPh in different aspects of pharmacy operation based on SOP

Pharmacy Technicians

• Assist in compounding and dispensing of medicines

• w/ RPh supervision, with patient interaction

Pharmacy Aides

• Low degree of independence and decision making

• No direct patient interaction

Pharmacy Assistants

• Moderate degree of independence

• May have supervised interaction with patients

Prescription / Ethical

Only dispensed by pharmacist, with Rx required

OTC

Relief of minor ailments; no Rx required

Pharmacist-only OTC

• Obtained only by licensed pharmacist

• Mandatory pharmacist advice on proper use

Vaccines

• Licensed and trained RPh

• Prescription required (validity: 7 days)

• Monthly vaccination report

Old Penalty: Fine of 1,000-4,000 or imprisonment of 6 months and 1 day to 4 years

Penalty: Fine of or imprisonment of NLT 1 year and 1 day to 6 years

• Displaying COR of RPh (unemployed)

• Dispensing drugs not licensed by FDA

• Adulterating or misbranding of PPs

• Non-compliance with the labelling requirements

Penalty: Fine of or imprisonment of NLT 30 days – 1 year

• Affixing RPh by an unlicensed RPh

• Practicing the profession without COR

• Selling physicians sample

• Removing “physician sample only”

• Using cipher, codes and secret keys in prescribing

RA 3720

Food, Drugs, Devices and Cosmetics Act

ADULTERATED

• Filthy or decomposed substances

• Poisonous

• Unsafe

• Color other than permitted

• Official but substandard

• Mixed or packed then, safety, efficacy, quality reduced

• cGMP non-compliance

MISBRANDED

• False or misleading labeling

• Misleading advertising

• No name of manufacturer

• Information required not in place

• Contains narcotic or hypnotic substance

• With name not recognized in compendium

• Misleading

• Sold under name of another drug

• Dangerous at recommended dose

Personal care products

Skin moisturizers, perfumes, lipstick, nail polishes, makeups, shampoos, toothpaste

Personal care products

Some are regulated: medicated soap, diaper ointment, medicated mouthwashes, anti-dandruff, anti-acne, anti-lice shampoos

RA 11223

Universal Health Care Act

Universal Health Care Act

Essential health benefit package covered by National Health Insurance Program (NHIP)

• Primary care

• Medicines

• Diagnostics and Labs

• Preventive, curative and rehabilitative services

RA 8203

Special Law on Counterfeit drugs

Special Law on Counterfeit drugs

• Correct active ingredient but insufficient (<90%)

• Wrong ingredient

• No API

• Mislabeled identity/source

• Container or labeling with NO identification mark or imprint

• Drug product refilled by unauthorized persons

• An unregistered imported drug product

RA 9165

Comprehensive Dangerous Drugs Act

RA 6425

The Dangerous Drugs Act of 1972

Dangerous Drugs

Prohibited drugs

Regulated drugs

S1 License

Retailer of exempt dangerous drugs preparations

S2 License

Physicians, Dentist, and Veterinarian who is legally authorized to prescribe dangerous drugs exempt preparations.

S3 License

Retail dealer of dangerous drugs exempt drugs preparation

S4 License

Wholesaler dealers of dangerous drugs, exempt drug prep.

S-5I License

Importer of dangerous drugs

S-5C License

Compounders, manufacturers and/or producers of DD

S-5E License

Exporter of exempt dangerous preparations

S6 License

Legally authorized to obtain and use dangerous drugs and exempt drugs for research

Fine: 500K-10M and lifetime imprisonment

10 grams or more	50 grams or more	500 grams or more
Opium	Methamphetamine hydrochloride ("shabu")	Marijuana
Morphine
Heroin
Cocaine or Cocaine hydrochloride
Marijuana resin or marijuana resin oil
Methylenedioxymethamphetamine (MDA) or "ecstasy"
Paramethoxyamphetamine (PMA)
Trimethoxyamphetamine (TMA)
Lysergic acid diethylamine (LSD)
Gamma hydroxyamphetamine (GHB)
Newly introduced dangerous drugs and derivatives without therapeutic value or far beyond therapeutic requirements

10 grams

• Opium

• Morphine

• Heroin

• Cocaine or Cocaine hydrochloride

• Marijuana resin or marijuana resin oil

• Other dangerous drugs such as:

  • Methylenedioxymethamphetamine (MDA) or "ecstasy"

  • Paramethoxyamphetamine (PMA)

  • Trimethoxyamphetamine (TMA)

  • Lysergic acid diethylamine (LSD)

  • Gamma hydroxyamphetamine (GHB)

50 grams

Methamphetamine HCl or shabu

500 grams

Marijuana

RA 7432

Senior Citizen’s Act

Senior citizen

• 60 years old and above

• Annual income: NMT 60K

RA 7432 - Senior Citizen’s Act

Discount 20%

• Transportation

• Hotel

• Medicines

• Restaurants

RA 9994

Expanded Senior Citizens Act of 2010

RA 9994 - Expanded Senior Citizens Act of 2010

20% Discount

• Medicine

• Professional fees

• Medical, dental, and lab services in all private hospitals

• Transportation

• Airport

• Theaters, concerts, cinemas

• Hotels and restaurants

• Funeral and burial services for the death of senior citizens

RA 9994 - Expanded Senior Citizens Act of 2010

Discount Exemption from

• Individual income tax

• Training fee for socioeconomic program

RA 9994 - Expanded Senior Citizens Act of 2010

5% water and electricity bill

RA 9994 - Expanded Senior Citizens Act of 2010

Free

• Medical and dental services, diagnostic and laboratory fees (government)

• Anti-flu vaccination (indigent senior citizens)

• Educational assistance to senior citizens

RA 9994 - Expanded Senior Citizens Act of 2010

Others

• Express lanes for senior citizens

• Death benefit assistance (minimum of 2,000)

RA 9994 - Expanded Senior Citizens Act of 2010

How to avail

• OSCA ID

• Passport

• Proof of citizenship

RA 6675

Generics Act of 1988

RA 9502

Universally Accessible, Quality, Safe, and Effective Medicines Act

Essential Drug List (National Drug Formulary)

List of drugs prepared and periodically updated by DOH

• Core list

• Complementary list

Core list

Drugs that meet the health care needs of the majority of the population

Complementary list

Alternative drugs used when core essential drug is unresponsive or causes hypersensitivity reactions

Core list

Drugs that meet the health care needs of the majority of the population

Complementary list

Alternative drugs used when core essential drug is unresponsive or causes hypersensitivity reactions

AO 62 = Prescribing Requirements

• Generic name

• Always written in capital letters

• Salt

• Clearly written after Rx symbol

• Brand name optional

Erroneous Rx

• Brand name, generic name

• Generic name has parenthesis

• Brand name has no parenthesis

• Two or more drugs in one prescription

Violative Rx

• Generic name not written

• Generic name and brand name written, but generic name is not legible

• Brand name with no substitution

Impossible Rx

• Generic name written, not legible

• Generic name and brand name written, not legible

• Generic name and brand name do not match

• Drug not FDA registered

AO 63 = Dispensing Requirements

Generic dispensing

Generic dispensing

Dispensing the patient’s choice from among generic equivalents (same API, dosage form, and strength)

Generic dispensing

• Inform the patient of all available drug products generically equivalent to the prescribed drug

• All drug outlets shall post in a conspicuous place a list of drug products using generic names with their brand names

EO 55 = Labeling Requirements

Principal Display Panel: Front of the container

• Name

• Dosage form and strength

• Category

• Rx (if prescription drug)

• Size: Large enough to read easily

• Name and address of manufacturer

• Net content

• Formulation

• Indications

• Contraindications, precautions, warnings

• Mode of administration/directions for use

• Batch and lot number: Written per FDA guidelines

• Expiry date: MM/YYYY

• Registration number

• Storage conditions

• For Rx Drugs: Foods, Drugs, Devices, and Cosmetics Act prohibits dispensing without prescription

EO 56 = Establishment of Outlet

• Premise Requirements

  • A signboard

  • A well-ventilated area with at least 20 sqm floor space

  • Compounding area (hospitals only)

  • Storage area

  • Cabinet for keeping dangerous drugs and poisons

  • Adequate water supply

• References

  • PNDF (when available)

  • USP/NF (latest edition)

  • RA 3720, RA 6675, RA 5921

  • Remington’s Pharmaceutical Sciences (latest edition)

  • Goodman and Gilman – Pharmacological Basis of Therapeutics (latest edition)

• Record Books

  • Rx Book

  • Dangerous Drug Book

  • Exempt Preparation Book

  • Poisons Book

  • Record Book for Selected Non-Prescription Drugs

Premise Requirements

• A signboard

• A well-ventilated area with at least 20 sqm floor space

• Compounding area (hospitals only)

• Storage area

• Cabinet for keeping dangerous drugs and poisons

• Adequate water supply

References

• PNDF (when available)

• USP/NF (latest edition)

• RA 3720, RA 6675, RA 5921

• Remington’s Pharmaceutical Sciences (latest edition)

• Goodman and Gilman – Pharmacological Basis of Therapeutics (latest edition)

Record Books

• Rx Book

• Dangerous Drug Book

• Exempt Preparation Book

• Poisons Book

• Record Book for Selected Non-Prescription Drugs

License to Operate (LTO)

• Initial Registration: 1 year

• Renewal: 1 year

• If LTO is revoked: Can’t operate within 2 years

Rx / Poison / Dangerous Drug Validity

• Prescription: 2 years

• Poison: 5 years

• Dangerous Drugs: 1 year

Identify RA 3720

A. Newborn Screening Act

B. Food, Drug and Cosmetic Act

C. Pharmacy Act

D. Expanded Senior Citizens Act

Identify the Core List

A. List of drugs that are for special medical patients such as cancer patients

B. List of drugs that meet the health care needs of majority of the population.

C. List of medical devices needed by majority of the population

D. List of drugs for geriatric patients

Choose which explains why generic drugs are as effective and safe as brand-name medicines.

A. Both are of the same dosage form

B. Both contain the same active ingredients, both have the same risks and benefits, both are of the same strength, stability, and quality, both are the same in terms of safety and effectiveness.

C. Both have the same benefits

D. Both are of the same strength, dosage form, and quality.

Select the components of an erroneous prescription.

A. When only the brand name is written in the prescription

B. When the generic name is NOT legible, and the brand name is legible

C. When the brand name and generic name are NOT legible

D. When the generic name is enclosed within a parenthesis, and the brand name is NOT

Select which explains why generic drugs cost less than brand-name medicines.

A. Generic drugs DO NOT need to repeat animal and clinical studies required of brand-name medicines; multiple applications for a single generic drug are often approved, creating competition in the market, resulting in lower prices; and waivers are granted for the non-biologic strengths.

B. Ingredients used are of lower quality

C. Less amounts of active ingredients are used.

D. Manufactured under lower standards as the brand-name medicine.

Select the components of a violative prescription

A. When the generic and brand names are both legible

B. When the brand name is NOT enclosed within a parenthesis

C. When the generic name is enclosed within a parenthesis

D. Only the brand name is written on the prescription, with the phrase, “No substitution”

Identify the law violated when Sampaguita Pharmacy was found selling counterfeit medicines.

A. RA 9502

B. RA 6675

C. RA 8203

D. RA 9944

Identify the law violated when impure Gold Supermarket, a Category B establishment, was found selling prescription and non-prescription drugs.

A. RA 10840

B. RA 9502

C. RA 10918

D. RA 9165

Select the description of “Refilling of a Prescription”.

A. Filling a prescription order for a second time

B. Dispensing a repeat prescription order dated 2 years ago.

C. Dispensing the remaining balance of medicines ordered in the prescription.

D. Compounding a prescription order for the fourth time

Select the statement that BEST describes Category B pharmaceutical establishments.

A. Retail outlets selling prescription medicines.

B. Supermarket selling prescription drugs placed in shelves together with OTC medicines.

C. Where the supervising pharmacist must be physically present for a minimum of two (2) hours per week; includes satellite institutional pharmacies, fourth, fifth, and sixth class municipal units involved in the procurement, distribution, dispensing, and storage of pharmaceutical products; Retail outlets selling household remedies; institutions providing telepharmacy services; and nontraditional outlets of pharmaceutical products.

D. Drug establishments where the supervising pharmacist must be physically present during the entire operational hours of the establishments.

Identified the law violated by Pharmacy Watson that has an LTO on display dated March 19, 2004.

A. Special Law on Counterfeit Drugs

B. Philippine Pharmacy Act

C. Universally Accessible, Cheaper and Quality Medicines Act

D. Generics Act of 1988

Identify the components of the “Essential Health Benefit Package” in the Universal Health Care Law

A. Primary care, medicines, laboratory tests, food allowance

B. Preventive, curative, rehabilitative services.

C. Diagnostic and laboratory tests.

D. Primary care, medicines, diagnostic and laboratory tests, preventive, curative, rehabilitative services.

Where do senior citizens get their senior citizen card?

A. Office of the Provincial Governor

B. Office of the Mayor

C. Office of the Provincial/Municipal/ City Treasurer

D. Office of Senior Citizen Affairs

The Expanded Senior Citizens Act of 2010 is______

A. RA 11223

B. RA 6675

C. RA 9502

D. RA 9994

Identify the S-license issued to retailers of drug preparations containing Controlled Chemicals

A. S-3

B. S-1

C. S-5

D. S-4

Select the Act that as promulgated, repealing Dangerous Drug Act.

A. Comprehensive Dangerous Drug Act

B. Dangerous Medicines Act

C. Universal Health Care Act

D. Pharmacy Act

A physician, dentist, veterinarian, or practitioner authorized to prescribe any Dangerous Drug shall issue a prescription in ______.

A. One (1) original copy only

B. One (1) original and three (3) triplicate copies.

C. One (1) original and two (2) duplicate copies.

D. One (1) original and one (1) duplicate copy.

Identify cosmetics which are regulated as drugs.

A. Lip balms, Mouthwashes, Antiperspirants, Diaper ointments

B. Skin moisturizers, perfumes, nail polishes

C. Hair colors, toothpastes

D. Shampoos, Lipsticks