Drug Legislation

Topics
• Drug Legislation
a. Controlled Substances
b. Generic Drugs
c. Orphan Drugs
d. Over the Counter Drugs
e. Herbal medicines
 Topic Objectives
• Analyze the factors affecting responses to
drugs
• Adhere to ethico-legal considerations when
providing safe, quality, and professional
nursing care.
• Relate the laws, legal, ethical and moral
principles in drug administration to specific
cases
 Definition of Terms
• Drugs
– Drugs are articles that are intended for use in the 
diagnosis, cure, mitigation, treatment, or preventi
on of disease in humans or animals, and any articl
es other than food, water, or oxygen that are inten
ded to affect the mental or body function of huma
ns or animals. 
 Definition of Terms
• Legislation
– a law or set of laws suggested by
a government and made official by a parliament.

Therefore:
Drug legislation are laws or set of laws promulgated
by a certain country of parliament.
 Definition of Terms
• Controlled Drugs
– A drug or other substance that is tightly controlled by
the government because it may be abused or cause
addiction. The control applies to the way the
substance is made, used, handled, stored, and
distributed. 
• Generics Drugs
– A generic drug is a medication created to be the same
as an already marketed brand-name drug in dosage
form, safety, strength, route of administration, quality,
performance characteristics, and intended use. 
 Definition of Terms
• Orphan Drugs
– An orphan drug is a pharmaceutical agent developed
to treat medical conditions which, because they are so
rare, would not be profitable to produce without
government assistance.
• Over the Counter Drugs
– Over-the-counter (OTC) drugs are those available
without a prescription. OTC drugs enable people to
relieve many annoying symptoms and to cure some
diseases simply and without the cost of seeing a
doctor. 
 Definition of Terms
• Herbal Medicines
– Herbal medicines are one type of dietary
supplement. They are sold as tablets, capsules,
powders, teas, extracts, and fresh or dried plants. 
 Offices and Programs for Drug
Regulation
• Food and Drug Administration
– The Food and Drug Administration (FDA) is the
national health product regulatory agency created
by Republic Act (RA3720), as amended by
Executive Order No. 175 and RA 9711.
– FDA regulates the drugs, medical devices, food,
cosmetics and toys, and Household/Urban
Hazardous substances.
– Under DOH
 Offices and Programs for Drug
Regulation
• The Philippine Drug Enforcement Agency
– is the lead anti-drug law enforcement agency,
responsible for preventing, investigating and
combating any dangerous drugs, controlled
precursors and essential chemicals within the
Philippines.
– Under office of the President
 Offices and Programs for Drug
Regulation
• The Department of Health
– is the executive department of the Government of
the Philippines responsible for ensuring access to
basic public health services by all Filipinos through
the provision of quality health care and the
regulation of all health services and products.
– National Family Planning Program
– National Tuberculosis TB Control Program
 Offices and Programs for Drug
Regulation
• RA 8432 Traditional and Alternative Medicine
Act of 1997
– An act creating the Philippine Institute of
Traditional and Alternative Health Care to
accelerate the development of traditional and
alternative health care in the Philippines.
 RA 8432 Traditional and Alternative
Medicine Act of 1997
• Allium sativum (Garlic/Bawang)- wounds, hypertension and toothache
• Blumea balsamifera (Nagal camphor/sambong)-  diuretic treatment for
hypertension
• Cassia alata (Ringworm bush/akapulko)- scabies, fungal infection,
athlete’s foot, tinea flava, ringworm
• Clinopodium douglasii (Mint/yerba Buena)- muscle pain,
arthritis, rheumatism, cough, headache
• Ehretia microphylla (Scorpion bush/Tsaang Gubat)- diarrhea and
stomachache
• Momordica charantia (Bitter Melon/Ampalaya)- diabetes mellitus
• Peperomia pellucida (Silver bush/ulasimang Bato)- gout and rheumatism
•  Psidium guajava (Guava/Bayabas)- wounds and diarrhea
• Quisqualis indica (Rangoon creeper/niyug-niyogan)- anti-helmintic
medicine
• Vitex negundo (Five-leaved Chaste Tree/lagundi)- cough, asthma, and
fever
 Comprehensive Dangerous Drugs Act
of 2002
• Unlawful Acts and Penalties
–  Importation of Dangerous Drugs and/or
Controlled Precursors and Essential Chemicals
– Sale, Trading, Administration, Dispensation,
Delivery, Distribution and Transportation of
Dangerous Drugs and/or Controlled Precursors
and Essential Chemicals
– Maintenance of a Den, Dive or Resort
– Employees and Visitors of a Den, Dive or Resort
 Comprehensive Dangerous Drugs Act
of 2002
• Unlawful Acts and Penalties
– Manufacture of Dangerous Drugs and/or
Controlled Precursors and Essential Chemicals
– Illegal Chemical Diversion of Controlled Precursors
and Essential Chemicals
– Manufacture or Delivery of Equipment,
Instrument, Apparatus, and Other Paraphernalia
for Dangerous Drugs and/or Controlled Precursors
and Essential Chemicals
 Comprehensive Dangerous Drugs Act
of 2002
• Unlawful Acts and Penalties
– Possession of Dangerous Drugs
• 10 grams or more of opium;
• 10 grams or more of morphine;
• 10 grams or more of heroin;
• 10 grams or more of cocaine or cocaine hydrochloride;
• 50 grams or more of methamphetamine hydrochloride
or "shabu";
• 10 grams or more of marijuana resin or marijuana resin
oil;
• 500 grams or more of marijuana; and
• 10 grams or more of other dangerous drugs
 Comprehensive Dangerous Drugs Act
of 2002
• Unlawful Acts and Penalties
– Possession of Equipment, Instrument, Apparatus
and Other Paraphernalia for Dangerous Drugs
– Possession of Dangerous Drugs During Parties,
Social Gatherings or Meetings
– Possession of Equipment, Instrument, Apparatus
and Other Paraphernalia for Dangerous Drugs
During Parties, Social Gatherings or Meetings
– Use of Dangerous Drugs
 Comprehensive Dangerous Drugs Act
of 2002
• Unlawful Acts and Penalties
– Cultivation or Culture of Plants Classified as Dangerous
Drugs or are Sources Thereof
– Maintenance and Keeping of Original Records of
Transactions on Dangerous Drugs and/or Controlled
Precursors and Essential Chemicals
– Unnecessary Prescription of Dangerous Drugs
– Unlawful Prescription of Dangerous Drugs
– Confiscation and Forfeiture of the Proceeds or
Instruments of the Unlawful Act, Including the
Properties or Proceeds Derived from the Illegal
Trafficking of Dangerous Drugs and/or Precursors and
Essential Chemicals
 Comprehensive Dangerous Drugs Act
of 2002
• Unlawful Acts and Penalties
– Custody and Disposition of Confiscated, Seized,
and/or Surrendered Dangerous Drugs, Plant
Sources of Dangerous Drugs, Controlled Precursors
and Essential Chemicals,
Instruments/Paraphernalia and/or Laboratory
Equipment
 RA 6675 Generics Act of 1988
• The Use of Generic Terminology for Essential
Drugs and Promotional Incentives
• Posting and Publication
• Who Shall Use Generic Terminology
• Provision on Quality, Manufacturer’s Identity
and Responsibility
• Required Production
• Education Drive