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ADMINISTRATIVE ORDER
JUL 1 2 ?0ll
Republic Act No. 7394, otherwise known as the "Consumer Act of the
Philippines," declares that it is the policy of the State to promote the interest
and general welfare of the consumer by implementing measures for: 1.
protection against hazards to health and safety; 2. protection against deceptive,
unfair and unconscionable sales acts and practices; 3.provision of information
and education to facilitate decision making in choosing the products and
exercise of rights of consumers.
Pharmacovigilance is defined by the World Health Organization in 2006
understanding and prevention of adverse effects or any other possible drugrelated problems,'o wHO 2006. The definition of the World Health Organization
includes the investigational substances used in the clinical trial studies. Thus,
{'
U.
OBJECTIVES
l)
2)
To
(LGUs)
and
III.
SCOPE
;ffiTfi:|;:are
T,
."r"u..h,n,*t"ting
any
2.
3.
6oAdverse
4. ('Contract
nationwide
program which oversees the collection, collation, review and analysis of adverse
events and other problems concerning drug products from professionals,
consumers, the industry and other regulatory bodies for use in setting and
updating policy direction and regulatory action and thus, ensure public safety
from the use of drugs and medicines through timely dissemination of current
and updated information.
10. 66Periodic Safety Update Report (PSIIR)" refers to the report submitted by a
pharmaceutical company intended to provide an update on the worldwide safety
experience of a drug after it has been approved and registered with FDA.
11.
('Peripheral
12. "Pharmaceutical Product" refers to any preparation for human use that is
intended to modifu or explore physiological systems or pathological states for
the benefit of the recipient.
13. "Pharmacovigilance Units (PVu)" refers to the National Center, Regional and
Peripheral Pharmacovigilance units of the National Pharmacovigilance Program.
"trw
health effects.
of
reporting
is the major
source of
will
be used.
23. ,,Unexpected adverse reaction" refers to an adverse reaction, the nature and
severity of which is not consistent with domestic labeling or market
authorization, or expected from the characteristics of the drug.
24. "Uppsala Monitoring Center (UMC)" refers to the WHO reporting center
for adverse drug reactions where reports are submitted and where global
drug signals are generated.
d..{
V. GENERAL GUIDELINES
A. The Food and Drug Administration, in
B.
The National Pharmacovigilance Programme shall promote the culture of blamefree ADR reporting and good pharmacovigilance practices in the country. It shall
include the following components: adverse drug reaction reporting, health
professional education, public advocacy and education, post-market surveillance,
and linkages with local, regional and international partners.
C. FDA shall reorganize, reinstitute and rename the Adverse Drug Reaction Unit to
become the National Pharmacovigilance Center which shall have the primary
responsibility and authority for the effective implementation and coordination of
the National Pharmacovigilance Program.
D. All other bureaus and offices of the DOH, and other stakeholders, including the
academe, shall support FDA by integration of efforts towards an effective
implementation of Pharmacovigilance.
E. The FDA shall develop, adopt and update appropriate regulatory instruments to
ensure safety, efficacy and quality of drug products registered in the country in
agreement with relevant regional, ie, ASEAN and international guidelines, i.e.
CIOMS, IC guidelines. The guiding principle is the complete and timely sharing
of safety information between FDA and marketing authorization holders (MAHs)
and other parties using procedures that ensures confidentiality, qualrty and
reliability of data.
F. FDA
2.
3.
4.
5.
6.
i.
ii.
7.
G. The FDA shall ensure provisions for public education and professional training
and development on Pharmacovigilance.
H. The FDA shall ensure provision for continuous educational development of the
pharmacovigilance staff through upgrading of references, books and materials
and
I.
J.
K. FDA shall provide the adequate human and material resources for the proper
implementation of the National Pharmacovigilance Program'
1.
b. The organizational
illustrated in Annex
(Organogram).
a. The
c. The following
i.
ii.
vii.
with ggglisg
power:
2. FT]NCTIONS
The National Pharmacovigilance Advisory Committee (NPVAC) shall have the
following functions:
a.
*+(
Shall review drug product safety update reports and other related safety
information for this program.
Shall recommend to FDA necessary regulatory measures based on
Pharmacovigilance data received from various units.
d. Shall recommend to the Secretary of Health the involvement of other
parties who may be deputized or accredited to perform specific activities
that would ensure the attainment of the objectives of the National
Pharmacovigilance Program.
Shall recommend to the FDA Director General and the Secretary of
Health appropriate actions based on the results of investigations e.g.,
withdrawal of drugs from the marke.t
b.
c.
1. COMPOSITION/CAPABILITIES
a. The Head of the Pharmacovigilance Center shall have the appropriate
training on risk management, pharmacovigilance and adverse drug
reporting, preferably a medical doctor or one with an M.S. degree in
b.
i. 3 clinical pharmacists
ii. I administrative assistant
iii. 1 pharmaco-epidemiologist/biostatistician
2. FUNCTIONS
The FDA, through its National Pharmacovigilance Center shall be the
authority responsible for the effective implementation and coordination of the
National Pharmacovigilance Program. The National Pharmacovigilance Center
shall have the following functions, among others:
a. Shall receive, encode and consolidate all reports from patients, reporters,
industry, consumers, healthcare providers and Pharmacovigilance Units
under the scope of the National Pharmacovigilance Program. The reports
shall be forwarded to the ADR Unit of the FDA either by fax or post with
the four important elements of the report included- the patient, the
suspected drug, the adverse reaction and the reporter.
i. Collection, assessment
ii.
iii.
iv.
v.
vi.
c.
of
analysis,
by
i.
f. Shall ensure complete and timely sharing of safety information between FDA
and marketing authorization holders and other parties using procedures that
ensures confidentiality, quality and reliability of data.
h. Shall amend or update other functions of the regional and service provider
level Pharmacovigilance units, as appropriate.
i.
j.
Shall provide resources for the units in terms of staff and equipment.
Shall recommend sanctions for violators of this Order.
COMPOSITION/CAPABILITIES
a.
i.
ii.
b.
The staff ofthe RPVu shall be provided with adequate haining and resources
by the FDA to implement the National Pharmacovigilance Program.
c.
2.
FT'NCTIONS
1.
COMPOSITION
a. The Peripheral Pharmacovigilance Unit coordinator shall preferably be a
medical doctor, a pharmacist or a nurse with adequate training on
Pharmacovigilance.
b.
2.
FUNCTIONS
The functions of the Peripheral Pharmacovigilance unit are enumerated also in Annex 2.
10
A. FDA
l.
Supervision of the use of drugs, and other pharmaceutical products that have been
registered in the Philippines.
2. Formulate the measures necessary to ensure the safe and effective use of such
products, through the implementation of pharmacovigilance obligations and its
monitoring.
3. Ensure the compliance of MAHs and clinical trial investigators and sponsors with
Pharmacovigilance obligations.
b. The Regulation Division I shall be the implementing arrn and as such shall
inspect drug retail outlets and distribution, as well as conduct random product
sampling and collection.
c.
The Regulation Division II shall be the implementing arrn and as such shall
inspect and audit manufacturers.
assistance
by
conducting
e. The Product Services Division shall verifu if products involved in local and
international reports, alerts, updates has a counterpart in the Philippines,
implement the recommended labeling changes and re-classifu drugs
accordingly based on evaluated data.
f.
*'v
{
ll
g. The Pharmacovigilance (PV) Task Force shall spearhead and ensure the
conduct of trainings on pharmacovigilance, and conduct PV inspections of
institutions to assess functionality of their respective PV systems.
9.
B, DoH oFFIcES
w
' l.
The Health Service Delivery Cluster, through the National Center for Health
Facilities Development (NCHFD), shall take appropriate measures and
information campaign to encourage reporting of suspected adverse events to
the FDA by hospitals and health facilities by virtue of the AO 003 s 2008
(National Patient Safety Program).
2. The Bureau of
6.
The National Epidemiology Center (NEC) shall provide the NPVC copies of
the submitted reports on adverse events arising from vaccines and biologicals
from the Expanded Program on Immunization (EPI) of the DOH. The NEC
shall also assist in the investigation of reported ADRs to establish causality or
possible link of the drug to the reported reaction. NEC designated sentinel
products.
7.
proper implementation
Program
on
Pharmacovigilance.
4, u,tmnr
" l.
1F'a
t
S"t up a surveillance system for their marketed drugs. MAHs must have on file
written procedures for the receipt, evaluation and reporting of adverse events
to be submitted to FDA.
Z.
Conduct spontaneous reporting and submit the Periodic Safety Update Reports
(pSURs) based on the timeframe of the FDA in line with the type of product
iegistraiion granted to them (i.e. monitored release, initial, renewal, etc.)
3. Submit local reports adopting the format of the FDA report form (CIOMS form
for foreign reports) set by this Administrative Order, as appropriate and other
additional information required by the National Pharmacovigilance Center.
4. Establish a PV
b.
c.
Shall act as a single contact point for NPVC during inspection and
monitoring and respond promptly for any request/inquiry from FDA
qualified PV
e.
f.
6. Submit to the NPVC a copy (full protocol) of the post marketing or post
registration studies for proper monitoring of serious adverse events.
D, INVESTIGATORS OF
w l.
CLINICAL TRIALS
The investigators and research organizations that are conducting clinical trials
in the Philippines, shall submit reports of serious adverse event or adverse
drug reaction occurring after use of unregistered products (i.e pre-marketing
clin'ical trials) directly to the National Pharmacovigilance Center not later
than24-48 hours from the detection of the adverse drug event by the clinical
investigator and/ or sub-investigators, even if the report has not been
just alert
assessed/evaluated by the sponsoi. The purpose of such report is to
an
submit
then
can
sponsor
The
the FDA on the occunence-of such incident.
assessed report 7 days after the occurrence ofthe event.
l3
*rY
2. The investigators and research organizations shall meet and cooperate with
the pharmacovigilance inspectors during the conduct of inspection, as
appropriate.
E. HEALTHCARI, PROFESSIONALS
l.
2. Healthcare professionals
of
2. The local
of
G. HOSPITALS
4.
5.
of
any
l.
The patients and the consuming public shall be enjoined to report any
adverse event or questionable efficacy observed in the use of pharmaceutical
products to the National Pharmacovigilance Center or in any of the
Pharmacovigilance units.
of
t4
VIII. REPORTING
All
IX.
SANCTIONS
X.
HONORARIUI\{/ADDITIONAL COMPENSATION
Honorarium or additional compensation shall be given to the members of the
Pharmacovigilance Center and other Pharmacovigilance units, as may be
determined by the Secretary of Health, upon recommendation of the FDA.
XII.
F'T]I\DING
The FDA and the DOH, through the NCPAM, shall assure that line items in
the General Appropriations Act shall be for the National Pharmacovigilance
Program development, implementation, monitoring and evaluation.
XIII. AMENDMENTS
Iv.
v?-
*r'r
,,
0'
XV.
of
XVII. EFFECTIVITY
This Order shall take effect thirty (30) days after its complete publication in two national
newspapers of general circulation. A copy of this Administrative Order shall be submitted to
the University of the Philippines Law Center. Subsequent amendments to this Administrative
Order shall take effect 15 days after promulgation.
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ANNEX
No.
1
2
3
4
5
I
10
11
12
13
14
15
16
17
18
(2;r
I-r
d'
2. THE RESPONSIBILITIES
Responsibilities
NPVAC
To collect AE reports
To receive blank AE forms and
acknowledge receipt
To fill or get filled AE forms (fill all
mandatory data)
To fonryard duly-filled AE forms to
next higher level unit
To maintain a log of allAE notification
forms (blank or filled) received and
RPVU
./
{
{
./
,V
^/
fonrvarded
To identify, induce SPLPU/RPU (with
concurrence of NPU), provide them
with general technical support,
coordinate and monitor their
functioning
To identify and deploy a
Pharmacovigilance Inspection Team
PhPVU
NPVu
-t
Optional
* Only
archiving
*Every 15
days
*Weekly
Monthly
Monthly
Every 15
days
for management of
Pharmacovigilance tasks
To carry out ( or review) causality
analysis of all AE forms or review
such analysis by RPU
To fonruard all duly-filled AE
forms(those generated at the same
unit and those received from
immediate lover level unit) as per predetermined time line
To report all serious adverse events
to NPU within two days, subsequent
to receipt of its notification at the unit
To review AE consolidated reports
./
^/
,V
19
20
,V
./
22
To
23
./
,V
conduct
pharmacovigilance projects on
various products which may be of
special concern or interest to the
./
Department of Health.
25
26
National
To
conduct annual
operations
assessment
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98.
a='
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(n
tr
only
Date received:
*Sex: tr Male
*Patient's Initials
*Age_
First Name
Date of Birth
tr Female
Weight_Kg
(mm/dd/yr)_
Date/ of onset:
am
pm
to be serious
tr
why:
B No
tr
tr
tr
tr
tr
E Unrecovered Other
tr
E Unknown
trNo
tr
tr
Yes
No
trNo
Unknown
*Contact no:
Email address:
Signature of reporter:
*Profession:
Date reported (mm/dd/yr):
*Facility:
nwj
to:
The ADR Unit, FDA, Civic Drive, Filinvest Estate, Alabang, Muntinlupa
Allergy