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Dissecting Republic Act No. 10354: Medical & Public Health Issues
Dissecting Republic Act No. 10354: Medical & Public Health Issues
10354
AN ACT PPROVIDING FOR A NATIONAL POLICY
ON RESPONSIBLE PARENTHOOD AND
REPRODUCTIVE HEALTH
http://www.digitaljournal.com/article/262211
The real answer to poverty is a two step process :
2nd: Simply teach the odds to
people each year, from 3rd
grade through high school
graduation, as to who are • How Not to Be Poor:
are the poor:
• Stay in School
• High school drop-outs
• Get a Job
• Staying single
• Get Married
• Having children without a
• Don't Have Children
spouse
Out of Wedlock
• Working only part time or - NationalCenter for Policy
not working at all Analysis, Jan, 2003
http://www.ncpa.org/pub/ba428/
- 2001 U.S. Census data
Improve
Maternal Health
Everyday another 10 Filipino women die of
complications due to pregnancy and childbirth
• Birth attendance by
skilled personnel, a proxy Type of Assistance During Delivery
indicator for MMR, has
only slightly increased 70
from 58.8% in 1990 to 60
59.8
62.3
62.3% in 2006 (FPS) 50 52.8
56.4
Percent
• Most women in rural 40 45.3
41.3
37.1
areas prefer hilots (TBAs) 30 34.5
i • 1.1
contraceptives?
• Condic M, 2008, The Westchester Institute For Ethics & the Human Person
When Does Human Life Begin?
At Fertilization
o
n
The Philippine National Drug Formulary System and
V Family Planning Supplies. - the National Drug Formulary
shall include hormonal contraceptives, intrauterine
i devices, injectables and other safe, legal, non-
abortifacient and effective family planning products
o and supplies.
l For the purpose of this act, any product or supply included or to be
included in the essential drug list must have a certification from the
a FDA that said products and supply is made available on the condition
that it is not to be used as an abortifacient.
t
These products and supplies shall also be included in the regular
i purchase of essential medicines and supplies of all national hospitals.
Provided, further, That the foregoing offices shall not purchase or
o acquire by any means emergency contraceptive pills, postcoital pills,
abortifacients that will be used for such purpose and their other
n forms or equivalent.
Criteria for Drug Selection into the Essential Drug
List and the National Drug Formulary
(WHO Technical Report Series No.825, The Use of Essential Drugs)
Relevance to disease Indicated in the treatment of prevalent diseases
Efficacy and safety Based on adequate pharmacologic studies especially
among Filipinos
Quality Must meet adequate quality control standard
including stability &, when necessary,
bioavailability
Compliance with WHO Certification Scheme on the
Quality of Pharmaceutical Products Moving in
International Commerce
Cost of treatment
regimen
Appropriateness to the
capability of health
workers at different
levels of health care
Local health problems
Benefit/Risk ratio
V What is wrong with classifying family
planning supplies as essential medicines?
i
o • Most normal, low-risk pregnancy, per se, is not a
disease, and as such does not need medicines,
l except for iron and folic acid supplementation.
a – Hence, the only “essential” medicines during
t pregnancy would be ferrous sulfate and
multivitamins.
i
o
n
What is wrong with classifying family
V planning supplies as essential medicines?
i • Combined Oral Contraceptives (COC) are not safe, as they are
n http://oncology.thelancet.com
What is wrong with classifying family
V planning supplies as essential medicines?
i• Combined Oral Contraceptives (COC) are not
o safe, as women who were current or recent
l users of birth control pills had a slightly
a elevated risk of developing breast cancer.
– from the analysis of 54 epidemiological studies conducted by
t the Collaborative Group on Hormonal Factors in Breast
Cancer on 53,297 women with breast cancer and 100,239
i women without breast cancer
o • The risk was highest for women who started using OCs as teenagers.
» Lancet 1996; 347:1713–1727.
n
V What is wrong with classifying family
planning supplies as essential medicines?
i
o • Combined Oral Contraceptives (COC) are not
safe, as the risk for breast cancer was highest
l for women who used OCs within 5 years prior
a to diagnosis, particularly in the younger group
• From the National Cancer Institute (NCI)-sponsored study
t among women ages 20 to 34 compared with women ages
35 to 54.
i » Althuis MD, Brogan DD, Coates RJ, et al. Breast cancers among very
young premenopausal women (United States). Cancer Causes and
o Control 2003; 14(2):151–160.
» http://www.cancer.gov/cancertopics/factsheet/Risk/oral-
n contraceptives
V What is wrong with classifying family
planning supplies as essential medicines?
i • Contraceptive hormone use is linked to
o cardiovascular disease.
– Newer generation oral contraceptives (OC) indicate a persistent
l increased risk of venous thromboembolism (VTE or blood clots)
for current users.
a – Current guidelines indicate that, as with all medication,
t contraceptive hormones should be selected and initiated by
weighing risks and benefits for the individual patient.
i – Women 35 years and older should be assessed for cardiovascular
risk factors including hypertension, smoking, diabetes,
o nephropathy, and other vascular diseases, including migraines,
prior to OC use.
n – Shufelt & Bairey Merz, J Am Coll Cardiol. 2009 Jan
V What is wrong with classifying family
planning supplies as essential medicines?
i • FDA Drug Safety Communication: Updated information
about the risk of blood clots in women taking birth
o control pills containing drospirenone.
l • [4-10-2012] Based on its review of recent observational
(epidemiologic) studies, the U.S. FDA has concluded that
a drospirenone-containing birth control pills may be
associated with a higher risk for blood clots than other
t progestin-containing pills.
i • The re drug labels (Beyaz, Safyral, Yasmin and Yaz) report that some
epidemiologic studies reported as high as a three-fold increase in
the risk of blood clots for drospirenone-containing products when
o compared to products containing levonorgestrel or some other
progestins.
n • http://www.fda.gov/Drugs/DrugSafety/ucm299305.htm
Women Sue Bayer Over Yaz Birth
Control Side Effects
• In June 2012, Bayer announced that it had
begun settling some of the approximately
11,000 Yaz lawsuits filed on behalf of women
who allegedly suffered severe side effects
after taking the drug.
• http://www.jdsupra.com/legalnews/women-sue-bayer-
over-yaz-birth-control-s-57418/
What is wrong with classifying family
V planning supplies as essential medicines?
i Safety Labeling Changes Approved By FDA Center for
Drug Evaluation and Research (CDER) , May 2008
o Mirena (Levonorgestrel-releasing Intrauterine Device)
l WARNINGS: Ectopic Pregnancy
a • ...Up to half of pregnancies that occur with Mirena in
place are ectopic (incidence: about 1 ectopic
t pregnancy per 1000 users per year.)
– Tell women who choose Mirena about the risks of ectopic
i pregnancy, including the loss of fertility. Teach them to
recognize and report to their physician promptly any
o symptoms of ectopic pregnancy...
• http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety-
n RelatedDrugLabelingChanges/ucm119274.htm
V What is wrong with classifying family
planning supplies as essential medicines?
i
Mirena (levonorgestrel-releasing IUD) - WARNINGS
o Sepsis
l • ...In some cases, severe pain occurred within
hours of insertion followed by sepsis within days...
a Perforation
t • Perforation or penetration of the uterine wall or
cervix may occur during insertion although the
i perforation may not be detected until some time
later...
o
n – http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety-
RelatedDrugLabelingChanges/ucm119274.htm
V What is wrong with classifying family
planning supplies as essential medicines?
i
o Mirena (levonorgestrel-releasing IUD) - WARNINGS
l Ovarian Cysts
• ...Surgical intervention is not usually required.
a
Breast Cancer
t • ...Two observational studies have not provided
evidence of an increased risk of breast cancer
i during the use of Mirena.
o
– http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety-
n RelatedDrugLabelingChanges/ucm119274.htm
V What is wrong with classifying family
planning supplies as essential medicines?
i• IUDs are not safe
o – During the use of a copper IUD, menstruation tends to be
longer with a greater loss of blood; in 70% of women who
l use a hormonal IUD oligomenorrhea or even amenorrhoea
develops. In the first weeks after IUD insertion, there is an
a increased risk of pelvic inflammatory disease (PID).
• Summary of the practice guideline 'The intrauterine
t device' from the Dutch College of General Practitioners,
2009
i – A World Health Organization multi-centre study established
that pelvic inflammatory disease (PID) risk is temporally
o related to IUD insertion procedures.
n – Shapiro, Reprod Health Matters. 2004 May
What is wrong with classifying family
V planning supplies as essential medicines?
i • IUDs are not safe
o • Innulliparous
15 studies comparing IUD performance in parous vs.
women, nulliparous women had higher rates of
l expulsion and removals due to bleeding and pain.
– Hubacher, Contraception. 2007 Jun
a • Uterine perforation is a rare yet serious complication and is
usually seen during insertion of the IUD.
t – Koltan et al, J Chin Med Assoc. 2010 Jun
• There are about 70 cases in the literature of IUDs that have
i migrated into the bladder. The resulting bladder perforation can
be complete or partial.
o – Istanbulluoglu et al, J Chin Med Assoc. 2008 Apr
• There is a reported case of a colon penetration by a copper IUD.
n – Arslan et al, Arch Gynecol Obstet. 2009
Mirena: Lawsuits & FDA warning
• Mirena, manufactured by Bayer Pharmaceuticals, has
come under scrutiny for its dangerous side effects
and has led to many lawsuits claiming the product is
“defective and unreasonably dangerous.” Among
the many claims of negligence, Bayer is accused of
intentionally selling a dangerous product, deceptive
advertising and concealing the risk of complications.
• In reviewing the manufacturer’s script for advertising
for the product, the FDA warned Bayer in a Dec. 30,
2009, letter that the company was in violation of the
Federal Food, Drug, and Cosmetic Act. The agency
further stated that the advertising included false or
misleading presentations and misbranded the drug.
• http://www.drugwatch.com/mirena/lawsuit/
Unjust
V Distribution of Benefits & Burdens
i REPUBLIC ACT NO. 10354
o AN ACT PPROVIDING FOR A NATIONAL
POLICY ON RESPONSIBLE PARENTHOOD AND
l REPRODUCTIVE HEALTH
a about promoting a program to “achieve
equitable allocation of resources” when
t problems pertaining to lack of “reproductive
i health” is not as prevalent nor as life-
threatening as our other health problems.
o
n
Top Ten Leading Causes of Morbidity and
Mortality in Low-Income Countries
(WHO, 2004)
Deaths in millions
% of deaths
The end does not justify the proposed means which are:
Not reliable
Not harmless
Not immediately reversible
Not inexpensive
Not respectful of every Filipino’s beliefs and moral values
The youth is the hope of
the fatherland.
-Jose Rizal