Upload
shan-sicat
View
219
Download
0
Embed Size (px)
Citation preview
8/10/2019 3rd MeTA Philippines Forum Maramba Nelia Transparency in Selection of Essential Medicines for PNDF
1/34
. . . now is the time to stop butting heads and
start linking arms. It is not impossible to work
out a united plan that will be acceptable for all,
and in the end will benefit those who need it
most.Esperanza I. Cabral MD
S
ecretary of
H
ealth
Keynote Address at
The rd MeTA Philippines Forum
8/10/2019 3rd MeTA Philippines Forum Maramba Nelia Transparency in Selection of Essential Medicines for PNDF
2/34
TRANSPARENCY IN SELECTION of
ESSENTIAL MEDICINES FOR THEPHILIPPINE NATIONAL DRUG FORMULARY
(PNDF)
Nelia P. Cortes-Maramba, M.D.
Professor EmeritusDepartment of Pharmacology & Toxicology
College of Medicine, UP Manila
Member, National Formulary Committee
8/10/2019 3rd MeTA Philippines Forum Maramba Nelia Transparency in Selection of Essential Medicines for PNDF
3/34
Legal Basis
1. Republic Act No. 6675 GENERICS
ACT of 1988 (13 September)
An Act to Promote, Require and Ensure
the Production of an Adequate Supply,Distribution, Use and Acceptance of Drugs
and Medicines Identified by their Generic
Names.
Prescribed that it is the policy of the Stateto ensure the adequate supply of drugs
with generic names at the lowest possible
cost
8/10/2019 3rd MeTA Philippines Forum Maramba Nelia Transparency in Selection of Essential Medicines for PNDF
4/34
Sec. 4 The Use of Generic Terminology for
Essential Drugs and Promotional
Incentivesa) In the promotion of the generic names for
pharmaceutical products, special
consideration shall be given to drugs andmedicines which are included in the Essential
Drugs List to be prepared within one hundred
eighty days (180) from approval of this Act and
updated quarterly by the Department of Healthon the basis of health conditions obtaining in
the Philippines as well as on internationally
accepted criteria.
8/10/2019 3rd MeTA Philippines Forum Maramba Nelia Transparency in Selection of Essential Medicines for PNDF
5/34
Sec 3 Definition of Terms
(7) Essential Drugs List or National Drug
Formulary it shall consist of core list andcomplementary list
(8) Core list is a list of drugs that meets the
health care needs of the majority of thepopulation.
(9) Complementary List is a list of alternative
drugs used when there is no response to thecore essential drug or when there is
hypersensitivity reaction to the core essential
drug or when for one reason or another, the
core essential drug cannot be given.
8/10/2019 3rd MeTA Philippines Forum Maramba Nelia Transparency in Selection of Essential Medicines for PNDF
6/34
PROCESS of FORMULATING THE PNDF
consultative and participative processthrough
regular meetings among members of NFC
series of deliberation meetings with differentpanels of experts from
o Medical schools
o Philippine Medical Association
o Various specialty and subspecialty societieso Government and private hospitals
inputs from pharmaceutical companies
recommendations of other stockholders
8/10/2019 3rd MeTA Philippines Forum Maramba Nelia Transparency in Selection of Essential Medicines for PNDF
7/34
PNDF Volume 1 Essential Medicines
list 7thEdition (2008)
major step towards rational use of
medicines
medicines selection based on public
health relevance, evidence of efficacy and
safety, quality and comparative cost-
effectiveness
8/10/2019 3rd MeTA Philippines Forum Maramba Nelia Transparency in Selection of Essential Medicines for PNDF
8/34
NationalList of Essential Medicines
Subset of FDA registered medicines divided
according to different levels of care for higher
quality of care, better management of
medicines (improved quality control, morecost-effective use of health resources) and
ensures regular supply of essential
medicines resulting in
real health gain
Increased confidence on the health system
8/10/2019 3rd MeTA Philippines Forum Maramba Nelia Transparency in Selection of Essential Medicines for PNDF
9/34
Primary Care Medicines68 medicines
List of medicines intended for use in the Rural
Health Units To meet the immediate health needs of
majority of the population for commonly
encountered ailments all over the country.
Generally safe and do not require special
expertise and equipment for proper use.
Two categoriesFor use by All RHUs (N=30 medicines)
For RHUs with Physicians and other health
workers (N=68 medicines)
8/10/2019 3rd MeTA Philippines Forum Maramba Nelia Transparency in Selection of Essential Medicines for PNDF
10/34
Classificacions of Drug as Vital (V), Essential (E)
and less essential (L) based on the following
criteria: 1. frequency of occurrence of target
conditions2. severity of target conditions
3. therapeutic effects of the drug(curative, symptomatic relief, etc)
4. cost of therapy Classification is useful in prioritizing
procurement of medicines especially in resource-
poor areas
Dynamic list of medicines with periodic review
and updating in the light of new developments
and experiences and prevailing health needs of
our population
8/10/2019 3rd MeTA Philippines Forum Maramba Nelia Transparency in Selection of Essential Medicines for PNDF
11/34
GENERAL GUIDELINES FOR ESTABLISHING THE
PHILIPPINE NATIONAL DRUG FORMULARY
Drug selection must be based on the following
1. Relevance to diseaseindicated in the
treatment of prevalent diseases2. Efficacy and safetybased on adequate
pharmacologic studies especially among
Filipinos (Expanded Phase II clinical trials
and/or additional Phase III studies)3. Qualitymust meet adequate quality control
standard including stability and when
necessary bioavailability.
8/10/2019 3rd MeTA Philippines Forum Maramba Nelia Transparency in Selection of Essential Medicines for PNDF
12/34
General guidelines (Contd)
- compliance with WHO Certification Scheme on
the Quality of Pharmaceutical Products Movingin International Commerceproduct
manufactured in accordance with CGMP and
records whether or not the product has been
approved for marketing in the country of origin.
4. Cost of treatment regimen
5. Appropriateness to the capability of health
workers at different levels of health care.
6. Local health problems
7. Benefit/Risk ratio
8/10/2019 3rd MeTA Philippines Forum Maramba Nelia Transparency in Selection of Essential Medicines for PNDF
13/34
General guidelines (Contd)
8. Preferential factors for evaluating therapeuticallyequivalent drugs
8.1 most thoroughly investigatedbeneficial propertiesand limitations
8.2 clinical utility for the treatment of more than onecondition or disease
8.3 most favorable pharmacokinetic properties for
improved compliance and minimize risk in
pathophysiological states
8.4 dosage form that is easy to dispense or easily orsafely administered to patient
8.5 greater acceptability by most patients
8.6 favorable stability under anticipated local conditions
for which storage facilities exist
8/10/2019 3rd MeTA Philippines Forum Maramba Nelia Transparency in Selection of Essential Medicines for PNDF
14/34
General guidelines (Contd)
8.7 existence of local reliable manufacturing facilities
for its production
9. Single Formulations preferred. Fixed ratiocombinations are acceptable when
9.1 value of concomitant use of more than one drug is
clinically documented9.2 therapeutic benefit of the combination is greater
than the sum of the individual components
9.3 the combination is safer than individual drug
9.4 cost of combination product is less
9.5 compliance is improved
9.6 appropriate drug ratio in the combination is
satisfactory for the majority of the population
8/10/2019 3rd MeTA Philippines Forum Maramba Nelia Transparency in Selection of Essential Medicines for PNDF
15/34
General guidelines (Contd)
10. Period of Review of Essential Medicines list
yearly
10.1 New drugs added if with distinct advantage over
drugs previously selected
10.2 Drugs with lower Benefit/Risk ratio should be
replaced by those with higher benefit/risk ratio
11. International NON-PROPRIETARY NAMES(INN) for drugs shall be used
8/10/2019 3rd MeTA Philippines Forum Maramba Nelia Transparency in Selection of Essential Medicines for PNDF
16/34
DRUG SELECTION FOR THE PHILIPPINE
NATIONAL DRUG FORMULARY
Acceptance safety, proven efficacy, quality and purity?
Disease/Condition/Indicationfound in the Philippines?
High prevalence of disease/condition in the Philippines?
Two or more therapeutically equivalent drugs?
Favorable benefit / risk ratio?
Thoroughly investigate / extensive clinical experience?
Favorable pharmacokientic properties?
Stable under anticipated local conditions?
(Accelerated and long term stability)
Cost-effective and/or reliable local
manufacturing facilities?
CoreList
Delist/Deny
Registration
Delist/DenyRegistration
Life saving
drug
Further
Review
Core
List
Comp.
List
Comp.List
Comp.
List
Comp.
List
Comp
list
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
No
No
No
No
No
8/10/2019 3rd MeTA Philippines Forum Maramba Nelia Transparency in Selection of Essential Medicines for PNDF
17/34
CRITERIA FOR INCLUSION ANDDELETION OF DRUGS FROM THE
PHILIPPINE NATIONAL DRUG FORMULARY
In addition to the guidelines as stated previouslythe National Formulary Committee consideredthe following criteria for including additional
drugs:1. The drug is needed for the prevention and treatmentof conditions not already covered in the existinglist;
2. The drug is more effective and/or less toxic than a
drug listed for the same indication;3. The drug is at least as effective and safe and of
lower cost than the drug listed for the sameindication; and
4. The drug is deemed essential for a specific DOH
health program/project.
C it i f I l i /D l ti (C td)
8/10/2019 3rd MeTA Philippines Forum Maramba Nelia Transparency in Selection of Essential Medicines for PNDF
18/34
Criteria for Inclusion/Deletion (Contd)
On the other hand, the following criteria wereapplied for deleting a drug from the list:
1. A more effective or equally effective but less toxic drugbecomes available;
2. In the light of further knowledge, the therapeutic efficacyof the drug is found to be unsatisfactory orquestionable;
3. Toxicity/Suspected toxicity or potential for abuse ordangerous interactions prove to outweigh its therapeuticvalue;
4. The drug has fallen into disuse and is no longeravailable;
5. The drug is no longer deemed cost-effective to othertherapies; and
6. The drug is fixed dose combination which does notsatisfy the requirements of A.O. 96 s, 1990.
8/10/2019 3rd MeTA Philippines Forum Maramba Nelia Transparency in Selection of Essential Medicines for PNDF
19/34
ANNEX A
PROCESS ALGORITHM FOR INCLUSION / DELETION OF PNDF DRUGS
Part 1 RVIEW OF CURRENT PNDF DRUGS
Check BFAD registry
Conduct systematic literaturereviewB
Consider for deletion if there are better drugs interms of efficacy, safety and cost
Consider for deliberation w/
resource persons
Has the drug been
withdrawn from the
market due to safety reason?A
Is there a new strong evidence of
Unfavorable risk: benefit?C
Is additional good evidence of
acceptable safety, proven efficacy,
quality and purity presentedduring deliberations?D
Delete
Mark for deletion
Retain the drug
Yes
Yes
Yes
No
No
No
ANNEX B
8/10/2019 3rd MeTA Philippines Forum Maramba Nelia Transparency in Selection of Essential Medicines for PNDF
20/34
REVIEW OF NEW DRUGS FOR POTENTIAL INCLUSION
Check BFAD registry
Is it officially registered
w/ BFAD & marketed in
the Philippines
Is the drug under
monitored release?
Conduct systematic literaturereviewB
Is there a goodevidence of favorable risk:
benefit? C
Is there any additionalstrong evidence that confirmsunfavorable risk: benefit from
interested parties? D2
Mark for possible inclusion
Is there a safer and more cost-effective, therapeutically
equivalent drug available?
Include the drug
Do not include
Is the drug needed for theprevention & treatment of conditions
not covered in theformulary?
Do not include
Do not include
Do not include
Do not includeYes
Yes
Yes
No
No
No
Yes
Yes
No
No
ANNEX B
ANNEX C
8/10/2019 3rd MeTA Philippines Forum Maramba Nelia Transparency in Selection of Essential Medicines for PNDF
21/34
ANNEX C
EVIDENCE TABLE
NoTITLE/AUTHOR
YEAR/JOURNALSTUDY
DESIGN
PARTICIPANT
DESCRIPTION
INTERVENTIONRESULTS/OUTCOME
GRADE OF
EVIDENCE
REMARKSEVENTS TREATMENT
DRUG GROUP
CONTROL
DRUG GROUP
(including
adverse
events)
No. of
events
Total #
of
patients
No. of
events
Total #
of
patients
Drug
*group means with standard deviationsmay be reported if the data are continuous
:
8/10/2019 3rd MeTA Philippines Forum Maramba Nelia Transparency in Selection of Essential Medicines for PNDF
22/34
Systematic Literature Review Process
Clinical Question: Is Drug x a safe and
efficacious drug for condition Y? Comprehensive Search: MEDLINE, HERDIN,
COCHRANE, EMBASEthrough the NATIONAL
DRUG INFORMATION CENTER based in UP
Manila
Critical Appraisal of abstracts/full text to verify
claims (RCT quality, level of evidence)
Examine similarities and differences of findings
across studies may perform META-ANALYSIS.
Independent search submitted by National Drug
Information Center (NDIC)
8/10/2019 3rd MeTA Philippines Forum Maramba Nelia Transparency in Selection of Essential Medicines for PNDF
23/34
LEVELS OF EVIDENCE (Evidence Based
Medicine or EBM)
Level A- STRONG
Several relevant high quality scientific studiesand results are convergent
Level BMODERATEAt least one high quality study and severaladequate studies
Level CLIMITED
At least one adequate study Level DWEAK OR NO Adequate Study
Expert Panel evaluationdoes not fulfill criteriaof scientific evidence
8/10/2019 3rd MeTA Philippines Forum Maramba Nelia Transparency in Selection of Essential Medicines for PNDF
24/34
Drugs listed by WHO requiring in vivo
bioequivalence studies based on the WHO Model
List of Essential Medicines which are immediate-
release, solid, oral dosage forms
Antimicrobials (9)
cefixime 400 mg
Clofazimine 100 mg
dapsone 100 mg
erythromycin stearate and ethyl succinate 250 mg
rifampicin300 mg and rifampicin FDC with otheranti-TB
medicinesulfamethoxazole 400 mg + trimethoprim 80 mg
sulfazalazine 500 mg
Trimethoprim 200 mg
8/10/2019 3rd MeTA Philippines Forum Maramba Nelia Transparency in Selection of Essential Medicines for PNDF
25/34
Antiparasitics (9)
albendazole 400 mg
artemether 20 mg + lumefantrine 120 mg
diloxanide furoate 500 mg
griseofulvin 250 mg
ivermectin 6 mg
mefloquine hydrochloride 250 mg
praziquantel 600 mg
pyrimethamine 25 mg
Sulfadoxine 500 mg + pyrimethamine 25 mg
8/10/2019 3rd MeTA Philippines Forum Maramba Nelia Transparency in Selection of Essential Medicines for PNDF
26/34
Contd Bioequivalence Studies
Anticancer/Immuneresponse modifyers (5)
azathioprine 500mgcyclosporine 25 mg
etoposide 100 mg
mercaptopurine 50 mg
tamoxifen citrate 200 mg
HIV/AIDS Medicines (5)
Endenavir sulfate 400 mg
Nelfinavir mesilate 250 mg
Neviraprine 200 mg
Itonavir 100 mg
Saquinavir 200 mg
OTHERS
8/10/2019 3rd MeTA Philippines Forum Maramba Nelia Transparency in Selection of Essential Medicines for PNDF
27/34
OTHERS
Acetazolamide 250 mg
Carbamazepine 200 mg
Furosemide 40 mg
Glibenclamide 5 mg
Haloperidol 2 mg
Iopanoic acid 500 mgMifepristone 200 mg
Nifedipine 10 mg
Retinolpalmitate 10 mg (200,000 IU)
Spironolactone 25 mg
Verapamil 80 mg
Added by NFC Phenytoin sodium
Theophylline anhydrous
8/10/2019 3rd MeTA Philippines Forum Maramba Nelia Transparency in Selection of Essential Medicines for PNDF
28/34
Primary Medical Care Drugs
A.For all Rural Health Units (RHUs)
B.For RHU & Staffed by Physicians and otherHealth Workers
C.Characteristics of Drugs Included
1. Occurrence of Target
conditions
Vital Essential Less Essential
Persons affected (% of
population)
> 5% 1-5% < 1%
Persons diagnosed(cases/100,000 population/year)
200 50-100 < 50
Persons treated (frequency of
target condition seen by health
workers)
Moderate Low Very low
8/10/2019 3rd MeTA Philippines Forum Maramba Nelia Transparency in Selection of Essential Medicines for PNDF
29/34
2. Severity of Target Conditions Vital Essential Less
Essential
LIFE THREATENING
(likely to cause death if untreated)
Possibly Infrequently Rarely
CHRONIC
(likely to cause recurrence,
relapse, continued disease)
Possibly Infrequently Rarely
DISABLING
(likely to cause permanent
disability if untreated)
Possibly Infrequently Rarely
RESTRICTING
(likely to cause loss of workingand housekeeping time)
Frequently Occasionally Infrequently
8/10/2019 3rd MeTA Philippines Forum Maramba Nelia Transparency in Selection of Essential Medicines for PNDF
30/34
Therapeutic
Effects
Prevention ofDisease,Cure of
DiseasePrevention ofComplication
Cure ofDisease,Prevention or
Treatment ofComplication
Relief and/ormitigation ofself-limited
diseasePALLIATIVEtreatment ofminorsymptoms/
complication4. COST
Average costof a singlecourse of
therapy (acutetherapy)
Averageyearly cost, oftherapy
(chronictherapy
Low
Low
Moderate
Moderate
High
High
3. DRUG ACTION Vital Essential Less Essential
8/10/2019 3rd MeTA Philippines Forum Maramba Nelia Transparency in Selection of Essential Medicines for PNDF
31/34
PHILIPPINE NATIONAL DRUG
FORMULARY Vol 1, 7thEDITION 2008
No. of Sections of Therapeutic Categories = 22
No. of Active Ingredients = 627
Core list = 350
Complementary List = 277No. of pharmaceutical products added = 45
No. of pharmaceutical products deleted = 32
No. of pharmaceutical products not available
in the market but considered essential (*) = 64No. of new drugs under Monitored Release = 38
No. of Dangerous Drugs (A1) = 19
(Internationally controlled)
8/10/2019 3rd MeTA Philippines Forum Maramba Nelia Transparency in Selection of Essential Medicines for PNDF
32/34
PHILIPPINE NATIONAL DRUG FORMULARY Vol 1, 7th
EDITION 2008 (Cont)
No. of Controlled Precursors and EssentialChemicals (A2) = 3
No. of medicines requiring specific expertise,
diagnostic precision, or special equipment
for proper use (1) = 155
No. of medicines with limited indications or
narrow spectrum of activity (2) = 136
No. of antibiotics in the PNDF to be used only
in hospitals with DOH accredited Antimicrobial
Resistance Surveillance Program (ARSP) (3) = 6
No. of list B medicines = 40
No. of medicinal plant products registered with
BFAD (*) = 5
8/10/2019 3rd MeTA Philippines Forum Maramba Nelia Transparency in Selection of Essential Medicines for PNDF
33/34
Thank you!
8/10/2019 3rd MeTA Philippines Forum Maramba Nelia Transparency in Selection of Essential Medicines for PNDF
34/34
. . . now is the time to stop butting heads and
start linking arms. It is not impossible to work
out a united plan that will be acceptable for all,
and in the end will benefit those who need it
most.Esperanza I. Cabral MD
S
ecretary of
H
ealth
Keynote Address at
The rd MeTA Philippines Forum