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MEDTECH LAWS & BIOETHICS  Life threatening, mental retardation and

Midterms blindness
- Phenylketonuria
 Autosomal recessive dis. Caused by lack of
NEWBORN SCREENING
phenylalanine hydroxylase (converts phenylalanine
- A simple procedure to determine whether a baby has to tyrosine)
congenital metabolic disorder that may lead to mental  Prevalence 1:20,000
retardation and even death if left untreated.  Brain damage and mental retardation may
occur
DISORDERS - Glucose-6-phosphate dehydrogenase def.
- Congenital hypothyroidism  Genetic disorder that most often affect
males. Doesn’t have enough of an enzyme called
 Def. in the production of thyroid hormone
G6PD (= helps red blood cells work). Impairs the
 Prevalence 1:3,350
ability of erythrocyte to form NADPH.
 Early diagnosis and treatment w/ thyroxine
 Without it rbc’s tend to break apart =
- Congenital adrenal hyperplasia
hemolysis. Leads to many rbc’s destroyed =
 Group of inherited disorders caused by
hemolytic anemia.
abnormalities in specific enzymes of the adrenal
 Rbc’s that doesn’t have enough G6PD are
gland.
sensitive to some meds., foods, and infections.
 90% of the cases are caused by the lack of
When these things trigger a quick loss of rbc over a
enzyme steroid 21-hydroxylase
short time, it’s called hemolytic crisis
 Prevalence 1:13,500
 If left untreated, may develop vomiting and - Newborn Screening is done on the 48 hrs. or atleast
severe dehydration. Increased production of 24 hrs. from birth.
androgens that can result in ambiguous genitalia
- Must be screened again after 2 wks.
- Physician, MedTech, nurse, midwife can collect
%
Def. enzyme Substrate Product Andro. Mine.cort.
CAH sample.
Progesteron Deoxycorti
↑ ↓
>90 - Few drops from baby’s heel and blotted on special
e costerone %
21-
17-hydroxy 11- absorbent filter card.
hydroxylase
progesteron deoxycorti
e sol
11β- Deoxycortico Corticoste
hydroxylase sterone rone
↑ ↑ 5%
NEWBORN SCREENING (R.A. 9288)
Nec. For
Steroidogenic chol.
acute Transport
regulatory - into
↓ ↓ Rare - An act promulgating a comprehensive policy and a
protein mitochond national system for ensuring newborn screening.
ria
3β- Pregnenolone, DATE APPROVED:
hydroxysteroid , 17-OH Progestero
dehydrogenas Pregnenolone, ne, 17-OHP
↓ ↓ Rare
e DHEA ARTICLE 1 – General Provisions
17-OH
Progesterone pregnenolo
17α- ne ↓ ↑ Rare
hydroxylase
17-OH (17- Sec. 1 Short title: Newborn Screening Act of 2004
Progesterone
OHP)
Sec. 2 Declaration of Policy:
- Protect and promote the right to health esp. of
- Galactosemia children
 Autosomal recessive dis. Primary form is a - Institutionalized a national newborn screening system
deficiency of GALT (galactose-1-phosphate uridyl - Shall ensure that every baby born in PH is offered the
transferase = enzyme needed to break down the opportunity to undergo screening
milk sugar lactose)
 Prevalence 1:60,000
 Clin. Symptoms 1st week of life.
Sec. 3 Objectives:

- Ensure every newborn has access to screening • Newborn Screening Reference Center:
- Establish and integrate a sustainable screening test
w/in Pub.health delivery system. • Central facility at the NIH that defines testing
- All health practitioners are aware of the advantages of and follow up protocols, maintains an
newborn screening external laboratory proficiencies and national
- Parents recognize their responsibility. database.

• Parent Education:
Comprehensive Newborn Screening System
• Various means of providing parents or legal
guardians information
ARTICLE 2 – Definition of Terms
• Recall:
Sec. 4 Definition of Terms:
• Procedure of locating a newborn
• Follow-up:
• Treatment:
• Monitoring of a newborn
• The provision of prompt, appropriate and
• Health Institutions: adequate medicine, medical and surgical
• Hospital, health infirmaries, health centers, management or dietary prescription to a
lying-in centers, puericulture centers (public newborn for purposes of treating or
or private) mitigating the adverse health consequences.

• Health care practitioners:

• Physicians, nurses, midwives, nursing aides, ARTICLE 3 – Newborn Screening


and traditional birth attendants. Sec. 5 Obligation to Inform:
• Heritable condition: - Parents or Legal Guardian
• Condition that can result in mental - Education & Notification – DOH
retardation, physical deformity or death.
Sec. 6 Performance of Newborn Screening:
• NIH: National Institute of Health - Perform after 24 hrs. of life, not later than 3 days
• Newborn: - Newborn in ICU: exempted on 3-day requirement.
Tested 7 days of age
• Means a child from the time of complete - Joint responsibility of parent and practitioner
delivery to 30 days old.
Sec. 7 Refusal to be Tested:
• Newborn screening:
- Religious beliefs; shall acknowledge in writing
• Process of collecting a few drops of blood - Refusal documentation – part of medical record and
from the newborn onto an appropriate refusal shall be indicated in database.
collection card and performing biochemical
testing for determining if the newborn has a Sec. 8 Continuing Education, Re-education and Training
heritable condition Health Personnel:
- DOH w/ assistance of NIH
• Newborn Screening Center: - Disseminate information materials on newborn
• Facility equipped with a newborn screening screening atleast annually.
laboratory that complies with the standards.
Sec. 9 Licensing and Accreditation: Sec. 13 Establishment of a Newborn Screening Reference
- DOH & Phil Health Insurance Company (PHIC) shall Center:
require newborn screening services to institutions for
accreditation/licensure. - NIH – establish NBS Reference Center
 National testing database
 Case registries, training, technical
ARTICLE 4 – Implementation assistance
 Continuing education for laboratory staff
Sec. 10 Lead Agency:
- DOH
- Establish the advisory committee Sec. 14 Quality Assurance:
- Develop implementing rules and regulations for
immediate implementation nationwide within 108 days - NIH
from the enactment of this Act. - Drafting and ensuring good lab. practice standards
- Coordinate with DILG for the NBS programs. - Establish an external laboratory proficiency testing
- Coordinate with the NIH NBS Reference Center for and certification program
the accreditation of Newborn screening centers - Principal repository of technical information
relating to newborn screening standards and
Sec. 10 Advisory Committee on Newborn Screening: practices
- Inter-agency collaboration - Technical assistance to newborn screening
- Integral part of the office of the secretary of the DOH centers needing such assistance.
- Review annually and recommend conditions
Sec. 15 Database:
- Review and recommend the newborn screening fee
- NBS Reference Center - maintain National
Sec. 11 Committee: Database of Patients and registry
- 8 members - Submit reports annually to
- Chairman: Secretary of DOH the committee and DOH
- Vice Chairman: Executive Director of NIH
- Undersecretary of the DILG Sec. 16 Newborn Screening Fees:
- Executive Director of the Council for the - Testing costs
Welfare of Children - Education
- Director of the Newborn Screening - Sample transport
Reference Centers - Follow-up cost
- 3 representatives appointed by the Secretary - Reasonable overhead expenses
of Health (pediatrician, obstetrician,
endrocrinologist, family physician, nurse or
midwife) – term: 3 years subject for reappointment ARTICLE 5 – Final Provisions
for another 3 years.
Sec. 17 Repealing Clause
- Secretariat of the committee: NIH
Sec. 18 Separability Clause
Sec. 12 Establishment and Accreditation of Newborn
Screening Centers: Sec. 19 Effectivity
- Accessible
- Certified lab. Performing all test
- Recall/follow-up programs for infants positive of
conditions
- Supervised and staffed by trained personnels ( NIH
qualified)
- Submit to inspections by Reference Center
ORGAN DONATION (R.A. 7170)

Sec. 3 Person who may execute legacy:


- An act authorizing the legacy or donation of all part of
a human body after death for specified purposes. - 18 yrs old
DATE APPROVED: January 7, 1992 - Sound mind
- Take effect after death
Sec. 1 Title: Organ Donation Act of 1991 - All or part of body
Sec. 2 Definition of Terms: Sec. 4 Person who may execute donation:
• Organ Bank Storage Facility- a facility - 1. spouse
licensed, accredited or approved under the - 2. Son or daughter of legal age
law for storage of human bodies or parts - 3. Either Parent
thereof. - 4. Brother or sister of legal age
- 5 Guardian over the person of the decedent at the
• Decedent- a deceased individual, and
time of his death
includes a still born infant or fetus
Sec. 5 Examination of Human Body or part:
• Testator- an individual who make a legacy of
all or parts of his body. - Authorize legacy or donation
- Autopsy - conducted on the cadaver of accident,
• Donor- an Individual authorized under this
trauma or other medico-legal cases immediately after
act to donate all or part of the body or
the pronouncement of death to the determine
decedent.
qualified and healthy human organs for
• Hospital- a hospital licensed, accredited or transplantation and or in furtherance of medical
approved under the law, and includes a science
hospital operated by the government.
Sec. 6 Beneficiary:
• Part- includes transplantable organs, tissues,
- Any hospital, physician or surgeon
eyes, bones, arteries, blood, other fluids and
- Any accredited medical or dental school, colleges or
other portions of human body.
university:
• Person- an individual corporation, estate, - Any organ bank storage Facility:
trust, partnership, association, the - Any specified individual
government owned or controlled
corporations or any other legal entity. Sec. 8 Manner of Executing a Legacy:
- Legacy of all or part of the human body made by will.
• Physician or Surgeon- a physician or - Legacy becomes effective upon the death of the
surgeon licensed or authorized to practice testator w/out waiting for probate of the will
medicine under the laws of the republic of If the will is not probated, it is a declared invalid for
the Philippines testamentary purposes; to the extent that it was
executed in good health is nevertheless valid and
• Immediate family of the decadent- the effective.
person enumerated in sec 4 of this act. - The legatee may also be made in any document:
• The legacy becomes effective upon
• Death- the irreversible cessation of the death of the testator and shall be
circulatory and respiratory functions or the respected by and binding upon his
irreversible cessation of all functions of the executor or administrator,
entire brain, including the brain stem. A • The document which maybe a card or
person shall be medically and legally dead. any paper designed to be carried on a
person
Must be signed by the testator in • Integrase – enzyme that the virus
the presence of TWO WITNESSES and utilizes to penetrate the target cells
should sign also for the presence. in the body.
- The testator may designate in his will, card or other • Protease – responsible for the
document, the surgeon or physician who will carry out maturation of the virus inside the
the appropriate procedures. target cells.

Sec. 9 Manner of Executing a Donation


- In the absence of any document of organ donation, TRANSMISSION AND SYMPTOMS OF AIDS
the physician in charge of the patient, the head of the - HIV is a fragile organism, which means that it cannot
hospital or a designated officer of the hospital to survive outside the host cell.
undergo transplantation, within 48 hours must locate - The most common transmission of HIV is through
the nearest relative. sexual contact.
- In all donations, the death of a person from whose - Early stage is when a person with AIDS experiences
body of an organ will be removed after his death for the “worst flu ever.”
the purpose for the transplantation to a living person - During the latency stage, the virus replicates slowly
shall be diagnosed separately and certified by 2
inside the host cell.
QUALIFIED PHYSICIAN

Sec. 13 Rights and Duties after Death AIDS COUNCIL AND AGENCY
- The legatee or done may accept or reject the legacy
or donation as the case may be. - The Philippine National AIDS Council (PNAC) was
- Any person who acts in good faith in accordance with created in December 1992
the terms of this act shall not be liable for damages in - The E.O. No. 39 was enacted to establish PNAC
any civil action or subject

Sec. 2 Declaration of Policies:

- Acquired Immune Deficiency Syndrome (AIDS) is a


PHILIPPINE AIDS PREVENTION AND CONTROL disease that recognizes no territorial, social, political
(R.A. 8504) and economic boundaries and for which there is no
known cure
Human Immunodeficiency Virus
- HIV is classified as RNA virus ARTICLE 1 – Provisions on education and information
- HIV belongs to Retrovirus group ARTICLE 2 – Provisions pertaining to safer practices and
- The virus is considered an obligate intracellular procedures
parasite that infects a specific type of cell called CD4 ARTICLE 3 – Provisions on how to carry out screening,
cell (commonly known as, “T-helper cell”) counseling, and testing of HIV
- Gp120 and gp41 are present on the surface of HIV ARTICLE 4 – Health and support services
cell wall and are responsible for attachment to the ARTICLE 5 – The procedures on how to monitor people with
target cells of humans. HIV
ARTICLE 6 – Provisions on how to maintain confidentiality of
- 3 enzymes that are associated with HIV results
ARTICLE 7 – Discriminatory procedures
• Reverse Transcriptase – used for ARTICLE 8 – Creation of the National AIDS Council (Power
the virus transcription of RNA to and Functions)
DNA inside the cell.
COMPREHENSIVE DANGEROUS DRUG (R.A. 9165) A. IMPORTATION
- Life Imprisonment to Death + 500K-10M
- A consolidation of Senate Bill no. 1858 & House Bill = Dangerous Drugs
no.4433
- President GMA - 12 to 20 yrs. + 100K-500K
- Signed on January 23, 2002 = Controlled precursor and essential
- Repealed R.A. 6425 (DDA ’72) chemical
CLASSIFICATIONS
- Max. Penalty + Death + 10M
A. Legal = Acts both or one thru the use of a
1. Prohibited Drugs – Opium, Marijuana, etc. diplomatic passport
2. Regulated Drugs – Contains salt or any drug
which produces a physiological action similar - Max. Penalty + Death + 10M
to amphetamines or hypnotic drugs. = Financier of both or one

DRUG DEPENDENCY & ABUSE - 12 to 20 yrs. + 100k-500k


= Protector/coddler of both or one
Stages

A. Use – taking drugs as prescribed by a


med. Practitioner for beneficial B. SALE, TRADING, ADMINISTRATION,
purposes. DISPENSATION, DELIVERY, DISTRIBUTION AND
B. Drug Abuse – act of taking or TRANSPORTATION
administering a drug in a ways than that
-
prescribed. Drug misuse
C. Drug Dependence – physiological or
physical dependence due to continuous
use of drugs.
D. Drug Addiction – tolerance of an
individual to high dosage resulting from
prolonged excessive use.
E. Drug Habituation – desire to repeat the
use of drugs occasionally or
continuously because of emotional
reasons.

SHABU – white odorless crystal powder w/ bitter numbing


taste.

Methods of Use

A. Injection
B. Sniffing/Snorting
C. Sipping

POSSESSION OF DANGEROUS DRUGS AND THEIR


PENALTIES
- Life Imprisonment & 500K-10M
= 10 g < Opium, Shabu, Cocaine, etc.
= 500 g < Marijuana