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
- Establish and integrate a sustainable screening test
w/in Pub.health delivery system.
- All health practitioners are aware of the advantages of
newborn screening
- Parents recognize their responsibility.
Comprehensive Newborn Screening System
ARTICLE 2 – Definition of Terms
Sec. 4 Definition of Terms:
• Follow-up:
• Monitoring of a newborn
• Health Institutions:
• Hospital, health infirmaries, health centers,
lying-in centers, puericulture centers (public
or private)
• Health care practitioners:
• Physicians, nurses, midwives, nursing aides,
and traditional birth attendants.
• Heritable condition:
• Condition that can result in mental
retardation, physical deformity or death.
• NIH: National Institute of Health
• Newborn:
• Means a child from the time of complete
delivery to 30 days old.
• Newborn screening:
• Process of collecting a few drops of blood
from the newborn onto an appropriate
collection card and performing biochemical
testing for determining if the newborn has a
heritable condition
• Newborn Screening Center:
• Facility equipped with a newborn screening
laboratory that complies with the standards.
• Newborn Screening Reference Center:
• Central facility at the NIH that defines testing
and follow up protocols, maintains an
external laboratory proficiencies and national
database.
• Parent Education:
• Various means of providing parents or legal
guardians information
• Recall:
• Procedure of locating a newborn
• Treatment:
• The provision of prompt, appropriate and
adequate medicine, medical and surgical
management or dietary prescription to a
newborn for purposes of treating or
mitigating the adverse health consequences.
ARTICLE 3 – Newborn Screening
Sec. 5 Obligation to Inform:
- Parents or Legal Guardian
- Education & Notification – DOH
Sec. 6 Performance of Newborn Screening:
- Perform after 24 hrs. of life, not later than 3 days
- Newborn in ICU: exempted on 3-day requirement.
Tested 7 days of age
- Joint responsibility of parent and practitioner
Sec. 7 Refusal to be Tested:
- Religious beliefs; shall acknowledge in writing
- Refusal documentation – part of medical record and
refusal shall be indicated in database.
Sec. 8 Continuing Education, Re-education and Training
Health Personnel:
- DOH w/ assistance of NIH
- Disseminate information materials on newborn
screening atleast annually.
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)
- An act authorizing the legacy or donation of all part of
a human body after death for specified purposes.
DATE APPROVED: January 7, 1992
Sec. 1 Title: Organ Donation Act of 1991
Sec. 2 Definition of Terms:
• Organ Bank Storage Facility- a facility
licensed, accredited or approved under the
law for storage of human bodies or parts
thereof.
• Decedent- a deceased individual, and
includes a still born infant or fetus
• Testator- an individual who make a legacy of
all or parts of his body.
• Donor- an Individual authorized under this
act to donate all or part of the body or
decedent.
• Hospital- a hospital licensed, accredited or
approved under the law, and includes a
hospital operated by the government.
• Part- includes transplantable organs, tissues,
eyes, bones, arteries, blood, other fluids and
other portions of human body.
• Person- an individual corporation, estate,
trust, partnership, association, the
government owned or controlled
corporations or any other legal entity.
• Physician or Surgeon- a physician or
surgeon licensed or authorized to practice
medicine under the laws of the republic of
the Philippines
• Immediate family of the decadent- the
person enumerated in sec 4 of this act.
• Death- the irreversible cessation of
circulatory and respiratory functions or the
irreversible cessation of all functions of the
entire brain, including the brain stem. A
person shall be medically and legally dead.
Sec. 3 Person who may execute legacy:
- 18 yrs old
- Sound mind
- Take effect after death
- All or part of body
Sec. 4 Person who may execute donation:
- 1. spouse
- 2. Son or daughter of legal age
- 3. Either Parent
- 4. Brother or sister of legal age
- 5 Guardian over the person of the decedent at the
time of his death
Sec. 5 Examination of Human Body or part:
- Authorize legacy or donation
- Autopsy - conducted on the cadaver of accident,
trauma or other medico-legal cases immediately after
the pronouncement of death to the determine
qualified and healthy human organs for
transplantation and or in furtherance of medical
science
Sec. 6 Beneficiary:
- Any hospital, physician or surgeon
- Any accredited medical or dental school, colleges or
university:
- Any organ bank storage Facility:
- Any specified individual
Sec. 8 Manner of Executing a Legacy:
- Legacy of all or part of the human body made by will.
- Legacy becomes effective upon the death of the
testator w/out waiting for probate of the will
If the will is not probated, it is a declared invalid for
testamentary purposes; to the extent that it was
executed in good health is nevertheless valid and
effective.
- The legatee may also be made in any document:
• The legacy becomes effective upon
the death of the testator and shall be
respected by and binding upon his
executor or administrator,
• The document which maybe a card or
any paper designed to be carried on a
person
 Must be signed by the testator in
the presence of TWO WITNESSES and
should sign also for the presence.
- The testator may designate in his will, card or other
document, the surgeon or physician who will carry out
the appropriate procedures.
Sec. 9 Manner of Executing a Donation
- In the absence of any document of organ donation,
the physician in charge of the patient, the head of the
hospital or a designated officer of the hospital to
undergo transplantation, within 48 hours must locate
the nearest relative.
- In all donations, the death of a person from whose
body of an organ will be removed after his death for
the purpose for the transplantation to a living person
shall be diagnosed separately and certified by 2
QUALIFIED PHYSICIAN
Sec. 13 Rights and Duties after Death
- The legatee or done may accept or reject the legacy
or donation as the case may be.
- Any person who acts in good faith in accordance with
the terms of this act shall not be liable for damages in
any civil action or subject
PHILIPPINE AIDS PREVENTION AND CONTROL
(R.A. 8504)
Human Immunodeficiency Virus
- HIV is classified as RNA virus
- HIV belongs to Retrovirus group
- The virus is considered an obligate intracellular
parasite that infects a specific type of cell called CD4
cell (commonly known as, “T-helper cell”)
- Gp120 and gp41 are present on the surface of HIV
cell wall and are responsible for attachment to the
target cells of humans.
- 3 enzymes that are associated with HIV
• Reverse Transcriptase – used for
the virus transcription of RNA to
DNA inside the cell.
• Integrase – enzyme that the virus
utilizes to penetrate the target cells
in the body.
• Protease – responsible for the
maturation of the virus inside the
target cells.
TRANSMISSION AND SYMPTOMS OF AIDS
- HIV is a fragile organism, which means that it cannot
survive outside the host cell.
- The most common transmission of HIV is through
sexual contact.
- Early stage is when a person with AIDS experiences
the “worst flu ever.”
- During the latency stage, the virus replicates slowly
inside the host cell.
AIDS COUNCIL AND AGENCY
- The Philippine National AIDS Council (PNAC) was
created in December 1992
- The E.O. No. 39 was enacted to establish PNAC
Sec. 2 Declaration of Policies:
- Acquired Immune Deficiency Syndrome (AIDS) is a
disease that recognizes no territorial, social, political
and economic boundaries and for which there is no
known cure
ARTICLE 1 – Provisions on education and information
ARTICLE 2 – Provisions pertaining to safer practices and
procedures
ARTICLE 3 – Provisions on how to carry out screening,
counseling, and testing of HIV
ARTICLE 4 – Health and support services
ARTICLE 5 – The procedures on how to monitor people with
HIV
ARTICLE 6 – Provisions on how to maintain confidentiality of
results
ARTICLE 7 – Discriminatory procedures
ARTICLE 8 – Creation of the National AIDS Council (Power
and Functions)
 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