ANNEX E.

PNF FORM NO. 3. LETTER OF REQUEST AND PROPOSAL FORM FOR EXEMPTION

LETTER OF REQUEST

Date

Honorable Francisco Duque III, M.D

Secretary
Department of Health

ATTENTION: Anna Melissa S. Guerrero, M.D

Chief
Pharmaceutical Division
Department of Health

SUBJECT: Proposal to EXEMPT the medicine from E.O. No. 49 s. 1993 that states that only
medicines listed in the PNF shall be procured by government entities.

Dear Secretary Francisco Duque III:

The (Philippine Heart Center) is requesting for the EXEMPTION of the following medicine
(Ceftriaxone+SulbactamZeftrax-S) from E.O. No. 49 s.1993.

Please find attached two (2) hard and soft copies each of the following documents:

1. Accomplished proposal form, including all appropriate tables;

2. Copies of all cited studies and published articles;
3. Other relevant documents (e.g. clinical practice guidelines, excerpts from WHO
documents or other formularies, etc., including photocopies of such).

We understand that incomplete submissions will not be processed.

(Indicate any additional remark)

Respectfully yours,

PROPONENT’S NAME
Chair, Pharmacy and Therapeutics Committee
Name of Health Facility
Indicate email address, telephone and facsimile number
PNF FORM NO. 3:
PROPOSAL FORM FOR EXEMPTION FROM E.O. No. 49 s. 1993
A. GENERAL INFORMATION ON PROPOSED EXEMPTION:
GENERIC NAME
BRAND NAME (if any)
THERAPEUTIC CLASSIFICATION
INDICATION
DOSAGE FORM/ STRENGTH
ROUTE OF ADMINISTRATION
DOSE, FREQUENCY AND
DURATION OF ADMINISTRATION
MANUFACTURER
IMPORTER/ TRADER
DISTRIBUTOR
Ceftriaxone + Sulbactam
ZEFTRAX-S
3rd Generation Cephalosporin Antibiotic
Indicated for the treatment of bacterial infections caused
by susceptible bacterial strains. For lower respiratory
tract infection, Urinary tract infection, Pelvic
inflammatory disease, bone and joint infections, Intra-
abdominal infections, Skin and Skin structure infections,
Acute bacteria otitis media, Bacterial septicemia,
Partially treated meningitis and surgical prophylaxis
1G/500MG
Intravenous/Intramuscular
Can be administered intravenously or intra
musculary after reconstitution. Dosage for adults (in
terms of Ceftriaxone) 1-2G given once a day (or in equally
divided doses twice a day) depending on the type and
severity of the infection. The total daily dose should not
exceed 4G. Should be adjusted in patients with decreased
renal function (creatinine clearance of less than
30ml/min) to compensate for the reduced clearance less
15ml/min should receive maximum of 500 mg of
sulbactam every 12 hours (maximum dosage of 1G of
Sulbactam) Pediatric patients for the treatment of skin
and skin structure infections, the recommended total
daily dose (In terms of Ceftriaxone) is 50 to 75mg/kg
given once a day (or in equally divided dose twice a day)
When treating infections caused by Streptococcus
pyogenes, therapy should be continued for at least 10
days. Nos dosage adjustment is necessary for patients
with renal impairment or hepatic function; however,
blood levels should be monitored in patients with both
renal and hepatic impairment.
Lyka Labs Ltd.
Plot No.4801/B.GIDC, Ankleshwar 393002
Gujarat state, India
Stangen Pharmaceuticals Inc.
Rm 62B-2 GervasiaCntr, 152 amorsolost., Legaspi
Village., Brgy.San Lorenzo., Makati City
Labmate Pharma Inc.
3rd.flr Jafer Bldg. West Avenue., Quezon City
 B. SUMMARY OF JUSTIFICATION FOR EXEMPTION:

The proposed medicine should fulfill ALL of

the following criteria: JUSTIFICATION AND REFERENCES
 It has proven safety Please attach at least a Phase III clinical trial

Based on the clinical trial sponsored and

conducted by Venus Remedies Limited., India
Entitled: Multicentric clinical trial on the
efficacy and safety of ceftriaxone + sulbactam
in lower respiratory tract infection.

Primary outcome: The overall efficacy of

fixed combination dose of
Ceftriaxone+Sulbactam was excellent. The
clinical cure rate was 77.14 and the
bacteriological cure rate was 100%.

Secondary outcome: Ceftriaxone+Sulbactam

in fixed dose combination is an effective and
well tolerated antimicrobial treatment making
it a promising treatment for serious lower
respiratory tract infection.

 It has proven efficacy Based on the clinical trial conducted by the

Department of laboratory Medicine and
Research Institute of Bacterial Resistance,
Yonsei University College of Medicine, Seoul,
Korea and Published by Lab Med Online on
October 2011 entitled.,

In vitro activities of Ceftriaxone+Sulbactam

against major Aerobic and Anaerobic bacteria
from clinical samples.

Conclusions: Ceftraxone+Sulbactam showed

good antimicrobial activity and thus useful for
the treatment of infections by MSSA,
S.Pneumoniae, S.Pyogenes, viridans group
streptococci, M.catarrhalis, N.gonorrhoeae,
H.influenzae, H.parainfluenzae, E.coli,
K.pneumoniae, B.fragilis group, other
bacteriodes sp. Prevotella sp., and
Porphyromonas sp.

Based on the Clinical trial carried out at the

Department of Microbiology, Khyber Medical
College Peshawar, Pakistan, published on the
journal of post graduate medical institute year
2008, entitled.,

Comparative susceptibilities of B-lactamase

producing isolates of proteus mirabilis to
Ceftriaxone alone and in combination with
Sulbactam

Conclusions: The disk containing


 There is no other medicine listed in the
formulary which is indicated for the
same condition.
 Itwill be used for an urgent health
situation defined as immediately
requiring treatment to prevent death,
permanent disability or major or
permanent organ dysfunction (specify
situation);
Ceftriaxone+Sulbactam showed larger zones
of inhibition, compared to ceftriaxone alone,
therefore the sensitivities to proteus mirabilis
to Ceftriaxone can be restored by adding
sulbactam.
Currently, the combination of
Ceftriaxone+Sulbactam 1G/500G (Zeftrax-S)
was first introduced and marketed by
Labmate Pharma here in the Philippines.
1. Why is the situation urgent?
Base on the 2016 Antimicrobial resistance
surveillance program-Philippines, showed
high rates of bacterial resistance of the
most common antibiotics comparing to
isolates like klebsiella pneumoniae, one of
the most common causative agent of
respiratory tract infection and E.coli the
common causative agent of genitourinary
tract infection, and according
Dr.Margaret Chan General director of the
WHO, “Antimicrobial resistance poses a
fundamental threat to human health” the
challenge now is to address therapeutic
failure, that contributes to high cases of
mortality and morbidity by providing a
novel combination drug on the same
generation so to we can still optimize the
other antibiotics to when we need it the
most.
ARSP, 2016
2. What is the ranking of the disease relative
to other disease conditions in the health
facility?
Base on the 2016 data Pneumonia (3rd),
Chronic lower respiratory tract infection
(9th) and Genitourinary tract infection
(10th) is among of the Top 10 leading cause
of mortality in the Philippines.
www.psa.gov.ph
3. What is the potential for spread of the
disease?
C. DETAILS REQUIRED FOR COST-EFFECTIVENESS ANALYSIS

Instruction: Please gather data on the price of the proposed medicine from the pharmaceutical
company. For the comparator drug, please refer to the Drug Price Reference Index (DPRI).

PARAMETER NEW MEDICINE CURRENTLY

(Indicate information for OR PROPOSED LISTED MEDICINE REFERENCES
intended recipient) NEW INDICATION/ FOR SAME
FORMULATION/ INDICATION IN
INTENDED RECIPIENT: ROUTE OF THE PNF OR
ADMINISTRATION STANDARD OF
CARE
UNIT COST OF MEDICINE (A) 1560
NUMBER OF DOSAGE UNITS 1-2 vials x 7 days
PER TREATMENT COURSE (B) 14 vials per treatment
course
DURATION OF TREATMENT 7 days
(C)

TREATMENT COST PER PHP21,840

PATIENT (D)
Formula: A x B x C

OTHER MEDICAL COSTS

ASSOCIATED WITH THE USE
OF THE DRUG:(E)
a. Implementation costs: -
cost of drug administration
(e.g., syringe, diluent)
monitoring (.e.g, PT, PTT),
additional diagnostic
services (e.g., Xray, CT
scan), additional equipment

b. Intervention costs:
(management of adverse
drug reaction treatment)

TOTAL TREATMENT COST

PER PATIENT(F)

Formula: D + E

EXPECTED NUMBER OF
PATIENTS WHO WILL USE
THE DRUG (G)
Possible references:
 Burden of Disease
 If no local epidemiological
study, current volume of use
in the Philippines based on
market data
ESTIMATED BUDGET
IMPACT

Formula: F x G