Академический Документы
Профессиональный Документы
Культура Документы
• Licensing of Establishments
• Registration of health
products
• Post-Marketing Surveillance
• Enforcement of FDA
Mandates
BRIEF BACKGROUND HISTORY
Philippine
National Drug
Policy
Republic Act No. 6675:
1986 Generics Act of
Medium Term
1988
Philippine
Development Republic Act No. 9502:
Program Universally
Accessible and
Affordable Quality
Medicines Act
Pharma 50 2005
Botika ng
2008
Baranggay National Center for
Pharmaceutical
2010 Access and
Management
2015
Pharmaceutical
Division
National Drug Policy Programs
• Phil. National Formulary
(PNF)
• Antimicrobial Stewardship Program • Pharmaceutical Supply Chain
(AMS) Management (PSCM)
• Drug Pricing Programs
GOVERNMENT MEDIATED ACCESS • Medicines Access Programs (MAPs)
PRICE (GMAP)
MAXIMUM RETAIL PRICE (MRP) Insulin
Drug Price Reference Index (DPRI) Mental Health
Drug Price Watch (DPW) DOH Maintenance Medicines
Electronic Drug Price Monitoring System
DRUG PRICING
PROGRAMS
GOVERNMENT MEDIATED ACCESS PRICE (GMAP)
MAXIMUM DRUG RETAIL PRICE (MRP)
www.pharmadiv.doh.gov.ph
www.pharmadiv.doh.gov.ph
www.pharmadiv.doh.gov.ph
www.pharmadiv.doh.gov.ph
“Universally Accessible Cheaper and Quality
Medicines Act of 2008”
Cost
DPR 2013: Php 49.60 Savings
www.edpms.doh.gov.ph
Uploading schedule
Type of Establishment (Facility) Acquisition Price Selling Price Month of Uploading
Distributor
Importer Quarterly
Exporter Quarterly
Wholesaler Quarterly
Hospitals (government and private) x Quarterly
www.pharmadiv.doh.gov.ph
For LGUs (RHUs) For HOSPITALS
AMR
Antimicrobial Resistance
• Antimicrobial Stewardship Program for Hospitals
• Advocacy
• Philippine Antibiotic Awareness Week (PAAW)
Administrative Order no. 42 s. 2014
Members:
Department of Trade and Industry
Department of Interior and Local Government
Department of Science and Technology
www.icamr.doh.gov.ph
Antimicrobial Stewardship Program (AMS)
Restricted antimicrobials may only be procured by
health facilities that satisfy any of the following
conditions:
Breast
Childhood
Cancer
Cancer
Insulin Stroke
RHU as Botika ng
Bayan
BRONCHODILATORS
• Salbutamol 100mcg/dose x 200 actuations
• Salbutamol 1 mg/mL, 2.5 mL (unit dose) Nebule
• Salbutamol 2mg/5ml, 60ml syrup
• Fluticasone + Salmeterol 125 mcg + 25 mcg x 120 doses Metered Dose Inhaler
• Fluticasone + Salmeterol 250 mcg + 25 mcg x 120 doses Metered Dose Inhaler
PROPOSED LIST OF ADDITIONAL MEDICINES FOR
UNDERSERVED POPULATION (GIDA & URBAN POOR)
ANTI-THROMBOTIC ANTACID
Clopidogrel 75 mg Tablet Omeprazole 40 mg Capsule
ANTI-INFLAMMATORY ANTI-DYSLIPIDEMIA
Celecoxib 200 mg Capsule Atorvastatin 40mg tablet
Mefenamic Acid 250mg tablet/capsule
Mefenamic acid 500mg tablet/capsule
VITAMINS
Vitamin B1 B6 B12 100 mg + 5 mg + 50 mcg Tablet
Multivitamins for pediatric patients
PHARMACEUTICAL SUPPLY CHAIN MANAGEMENT
Organizational structure
SELECTION
Financing management Quantification
Information management
Motivated staff
Management
USE PROCUREMENT
Support
Reception
DISTRIBUTION
Storage
PHARMACEUTICAL SUPPLY CHAIN MANAGEMENT
1. 13
Is there a dedicated (8%)
person assigned to
handle medicines
and other health
154
commodities in the
(92%)
health facility?
YES NO
REGION VIII
RURAL HEALTH UNITS
A. MANAGEMENT, ADMINISTRATION & HUMAN
RESOURCE
1.
Is there a dedicated
person assigned to 2
handle medicines (33%)
4
and other health (67%)
commodities in the
health facility?
YES NO
REGION VIII
PROVINCIAL HEALTH OFFICE
A. MANAGEMENT, ADMINISTRATION & HUMAN
RESOURCE
PSCM ORIENTATION/
2. TRAINING
Is the dedicated
person assigned
given an 81 86
orientation or
training on
handling 49% 51%
medicines/
commodities and
inventory YES NO
management?
REGION VIII
RURAL HEALTH UNITS
A. MANAGEMENT, ADMINISTRATION & HUMAN
RESOURCE
PSCM ORIENTATION/
2. TRAINING
Is the dedicated
person assigned 2
given an
orientation or 4 33%
training on
handling
67%
medicines/
commodities and
inventory YES NO
140
computer that can 111
120
be used for 100
encoding? 80
60
56
4. 40
16
Does the health 20
facility have 0
YES NO
encoding? 3
2
2
4. 1
1
Does the health
facility have 0
YES NO
80
6. 60
2
6. 1.5
Is the health facility 1
2 2
cooperative and 0.5
consistent in providing 0
the documentation YES NO
93 24
YES
74
143 NO
127
40
YES
6 NO
1
4
2
YES NO
13.
Does the health 31,
facility update
19%
every movement of
stock through stock
cards, log books or 136,
electronic copy? 81%
REGION VIII
RURAL HEALTH UNITS
D. INVENTORY MANAGEMENT
UPDATED STOCKCARDS
YES NO
13.
Does the health
facility update
every movement of
3, 3,
stock through stock
cards, log books or
50% 50%
electronic copy?
REGION VIII
PROVINCIAL HEALTH OFFICE
D. INVENTORY MANAGEMENT
FEFO
14. YES NO
REGION VIII
RURAL HEALTH UNITS
D. INVENTORY MANAGEMENT
FEFO
14. YES NO
REGION VIII
PROVINCIAL HEALTH OFFICE
D. INVENTORY MANAGEMENT
15. 170
Has the health facility
experienced stock outs
this quarter? Which
118 91
commodity and what
month/s?
W/ STOCKOUTS
16.
Has the facility W/ OVERSUPPLY
experienced oversupply
of DOH commodities?
1
REGION VIII RURAL
HEALTH UNITS
D. INVENTORY MANAGEMENT
15.
Has the health facility
6
experienced stock outs
this quarter? Which
commodity and what
month/s?
W/ STOCKOUTS
16. 3 3
Has the facility W/ OVERSUPPLY
experienced oversupply
of DOH commodities?
1
REGION VIII PROVINCIAL
HEALTH OFFICE
D. INVENTORY MANAGEMENT
170
17.
Does the health 141
facility PHYSICALLY
separate the
SORTS OUT
damaged, expired
43 UNWANTED
and recalled PHARMACEUTICALS
medicines from the
lot of inventory?
WITH EXPIRED
STOCKS
18.
Are there expired
medicines in stock now?
1
REGION VIII RURAL
HEALTH UNITS
D. INVENTORY MANAGEMENT
6
17.
Does the health
facility PHYSICALLY
separate the
damaged, expired 4 SORTS OUT
UNWANTED
and recalled
medicines from the 3 PHARMACEUTICALS
lot of inventory?
WITH EXPIRED
STOCKS
18.
Are there expired
medicines in stock now?
1
REGION VIII
PROVINCIAL HEALTH
OFFICE
E. USE OF MEDICINES, DISPOSAL AND
DONATIONS
19.
Does the health
facility have a
system, for
recording
dispensed
medicines to the
166 (99%)
patients such as
logbooks, index YES NO
cards, etc.?
REGION VIII
RURAL HEALTH UNITS
E. USE OF MEDICINES, DISPOSAL AND
DONATIONS
19.
Does the health
facility have a
system, for
recording
dispensed 5,
83%
medicines to the
patients such as
logbooks, index YES NO
cards, etc.?
REGION VIII
PROVINCIAL HEALTH OFFICE
E. USE OF MEDICINES, DISPOSAL AND
DONATIONS
20. 21.
Is there a functional system for Has the facility received any
reporting Adverse Drug Reaction complaints from patients and
(ADR)? Is there a reported ADR clients on the use of any
during the quarter? commodities from DOH?
170 YES,
14
98
69 YES
NO
NO,
0 153
REGION VIII RHU
REGION VIII RHU
E. USE OF MEDICINES, DISPOSAL AND
DONATIONS
20. 21.
Is there a functional system for Has the facility received any
reporting Adverse Drug Reaction complaints from patients and
(ADR)? Is there a reported ADR clients on the use of any
during the quarter? commodities from DOH?
YES, 0
YES
NO NO,
1 6
0
0
REGION VIII PHO
REGION VIII PHO
D. INVENTORY MANAGEMENT
DONATION
22. W/ DONATED MEDICINES
Are there donated NO DONATED MEDICINES
medicines in the health
facility? Does the health
130
facility have a functional
system for processing
medicine donations like 37
documentations and
operational
measures/systems are
followed on the
acceptance?
24. YES NO
24. YES NO
NO NO
59 10 YES
YES
35% 6%
108 157
65% 94%
1
YES 17%
3
NO 50% YES
3 5
50% 83%
YES,
YES,
69
NO, 75 NO,
92 98
YES,
YES, 0
1
NO,
5 NO,
6
NO,
25
NO,
68
YES, YES,
99 142
NO,
YES,
1
2
NO,
YES,
4
5
31. YES NO
Generally, is there
enough space to
store all medicines? 47,
28%
120,
72%
31. YES NO
Generally, is there
enough space to
store all medicines?
3, 3,
50% 50%
32.
Is there a system of
arranging products 50,
in the storeroom? 30%
117,
70%
32.
Is there a system of
arranging products 2,
in the storeroom? 33%
4,
67%
0
REGION VIII RHU
F. STORAGE CONDITION
33.
6
Is there a functioning and well-
maintained biological refrigerator or
refrigerator for medicines? 6 6
W/ BIO REF
34.
Is the health facility prepared to
maintain cold chain during
emergency situations? W/
CONTINGENCY
PLAN
0
REGION VIII PHO
DOCUMENTARY REQUIREMENTS FOR THE PROCUREMENT OF
HEALTH-RELATED GOODS BASED ON EXISTING LAWS AND
REGULATIONS
• CERTICATE OF PRODUCT REGISTRATION – is the certificate being
issued to a licensed manufacturer, trader, importer, or distributor for
the purpose of marketing or free distribution of a product after
evaluation for safety, efficacy and quality from FDA.
• CERTICATE OF PRODUCT LISTING – is the certificate being issued to a
licensed manufacturer, trader, importer, or distributor for the purpose
of distribution and/or sale of cosmetic specialty qualified listing
(without pre-market approval) with FDA after evaluation for safety,
efficacy and quality from FDA.
• CERTIFICATE OF GOOD MANUFACTURING PRACTICE – current system of quality
assurance aimed at ensuring that products are consistently manufactured to a
quality appropriate for intended use. It is concerned with both manufacturing
and control process and procedures.