MODULE 1│USA
HOSPITAL PHARMACY INTERNSHIP
HOSPITAL PHARMACY INTERNSHIP
Pharmacy Therapeutics Committee
• The Pharmacy and Therapeutics Committee is an advisory
group that serves as the organizational line of communication
between medical staff and the Pharmacy service.
• It serves as a policy recommending body to the
medicinal staff and administration of the hospital on
matters related to drugs and drug abuse.
• This committee is composed of PHYSICIANS,
PHARMACIST and other health professionals
selected with the inclusion of medicinal staff.
ADDT’L NOTES:
• •
OBJECTIVES
1. Advisory
• The Committee recommends the adoption of policies or
assists in the formulation of broad professional policies
regarding evaluation, selection, and therapeutic use of drugs
in the hospital.
• The Committee serves in an advisory capacity to medical staff
and hospital administration in all matters pertaining to the use
of drugs, including the investigational drugs.
• The Committee advises the pharmacy in implementation of
effective drug administration and control procedures.
ADDT’L NOTES:
• 7. To review reported ADR’s to drug administered to the patients in
2. Educational
• The Committee recommends or assists in the formulation of
functions, designed to meet the needs of professional staff
like the physicians, nurses, pharmacists and other health care
practitioners, for the complete current knowledge of the
matter related to the drugs and their use.
• The Committee develops and complies a formulary of drugs
and prescriptions of formulations accepted for use in the
hospital.
• Evaluates the problem related to Distribution and
administration of medications.
3. Drug Safety and Adverse Drug Monitoring
• The PTC exert vigilance on safety aspect and ADR
monitoring
• The Committee ensures safety in handling and administration
of new class of therapeutic drugs
ADDT’L NOTES:
• meeting the health needs of the great majority of the
Organization of PTC
a. At least (3) Physicians from the medical staff
b. A Pharmacist/ Clinical Pharmacist
c. A representative from the nursing staff
d. A Hospital administrator
ADDT’L NOTES:
•
PTC
• Medical Staff – Chairman
• Hospital Administrator – Director
• Pharmacist – Secretary
ADDT’L NOTES:
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OPERATION OF PTC
1. The Pharmacist (Secretary) organizes meetings, prepares
and distributes agenda of meeting and prepares minutes of
meeting and maintained permanent record of the hospital.
• Review of the Hospital Formulary
• Information of New Drugs/ Adoption of new drugs
• Review of Side effects, ADR, Toxic effects and DI’s
• Review of “Drug Safety” in the Hospital
2. Assists chairman in implementation of committee decisions
3. The meetings of the committee should be organized atleast
six times in a year
ADDT’L NOTES:
FUNCTIONS OF PTC
1. Advice Medical Staff and hospital administrator in all matter
related to use of drug.
2. Recommend for adoption of suitable policies regarding selection,
procurement, storage, prescription, dispensing and use of
medicine.
3. To develop and a prepare hospital drug formulary
4. Develop norms and guidelines for revision of the formulary at
regular intervals or procedures
5. To suggest measures to evaluate clinical data regarding new
drug or agent
6. To establish or plan suitable educational program for hospital
professional matter related to drug use
the hospital
8. To evaluate problem related to procurement, storage distribution
and administration of drug in hospital
9. To develop and establish generic and therapeutic substitution
guideline in hospital
10. To advice pharmacy regarding drug distribution system and
control procedure, develop drug information systems,
maintenance of drug standard and QC, maintenance of records
and disposal of expiry drugs
ADDT’L NOTES:
•
Philippine National Drug Formulary (PNDF)
• is an integral components of the Philippine National Drug
Formulary (PNDF), aimed at making available and
accessible, essential medicines of proven efficacy, safety
and quality at affordable cost.
• The PNDF is a very dynamic list which is regularly
reviewed and updated to make it truly relevant in
population
• The PNDF is an important step to rationalize drug
production, distribution, procurement and consumption
through the Essential Drugs concept
ADDT’L NOTES:
MY.AI
 Criteria for Selection of Formulary Medicines • The Therapeutics Committee/Physician-in -charge of the
Clinic or Infirmary/Procurement officer, whichever is
applicable, shall be responsible for determining which
products and the corresponding quantity to be procured by
the respective government entities.
• Drugs and medicines shall be procured by bidding and on
the basis of their generic name
• Any issue regarding generic terminology shall be resolved
by the Therapeutic Committee-National Drug Committee
(NDC)
• EO.49 DIRECTING THE MANDATORY USE OF THE
PHILIPPINE NATIONAL DRUG FORMULARY (PNDF)
VOLUME I AS THE BASIS FOR PROCUREMENT OF
DRUG PRODUCTS BY THE GOVERNMENT.

ADDT’L NOTES:
•

Drugs and medicines not listed in the PNDF Volume I, current edition
may be procured by Government agencies through a written request
with corresponding justification addressed to the Head of the National
Drug Policy Staff who may approve or disapprove the request.
However, in determining whether the drug(s) requested is/are justified
ADDT’L NOTES: or not, the said Head shall refer the request to the National Formulary
• Committee (NFC)

A letter shall be submitted justifying that:

Criteria for Inclusion and Deletion of Drugs from the • The drug is needed for the prevention and treatment of
Philippine National Drug Formulary conditions not already covered in the existing list.
• The drug is more effective and/or less toxic than a drug
ADDITION listed for the same indication.
• The drug is needed for the prevention and treatment of • The drug is at least as effective and safe and of lower cost
condition not already covered in the existing list than the drug listed for the same indication.
• The drug is more effective and/or less toxic than a drug listed
• The drug is deemed essential for a specific DOH-Health
for the same indication
program/project.
• The drug is deemed essential for a specific DOH health
program/projects
ADDT’L NOTES:
•
•
ADDT’L NOTES:
•
PHARMACOVIGILANCE
DELETION
• A more effective or equally but less toxic drug becomes
• The science and activities relating to the detection,
available
assessment, understanding, and prevention of adverse
• In the light of further knowledge, the therapeutic efficacy of the
effects or any other medicine/vaccine related problem.
drug is found to be unsatisfactory or questionable
• Toxicity/suspected toxicity or potential for abuse or dangerous
Adverse reactions are considered serious if they result in any of the
interactions prove to outweigh its therapeutic value
following:
• The drug has fallen into disuse and is no longer available
• Death
• The drug is a fixed dose combination which does not satisfy the
requirements of A.O. 96 S. 1990 • Are life-threatening
• Hospitalization or prolonged hospital stay
ADDT’L NOTES: • Involve a persistent disability or incapacity or congenital
• anomaly
Procurement Policy and Guidelines • Other medically important event (require medical
intervention to prevent any of the above outcomes)
Government procurement of pharmaceutical products in the
Philippines are governed by several policies: ADDT’L NOTES:
•
1. Government Procurement Reform Act (Republic Act [RA]
9184)
2. The Generics Act (RA 6675)
3. The Cheaper Medicine Act (RA 952)

Beyond these, there are other important policies the regulate the
production and trade of pharmaceutical products

a) Food Drug and Cosmetics Act or RA 3720

b) Food and Drug Administration Act of 2009 or RA 9711
c) Comprehensive Dangerous Drugs Act or RA 9165
d) The practice of pharmacy professionals (Philippine
Pharmacy Act or RA 10918
e) Promote consumer protection (e.g., Consumer Act of the
Philippines or RA 7394; Price Act or RA 7581
f) Set public spending priorities and limits (e.g., annual
General Appropriate Act)

ADDT’L NOTES:
•

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 WHY DO WE NEED TO REPORT?

Yor report may contribute to:

• The identification of previously unrecorded and unorganized
rare of serios side effect;
• Changes in products safety information or labelling, or other
regulatory actions such as product recall or removal from the
market;
• International data regarding benefit, risk or effectiveness
assessment of medicines and vaccines

ADDT’L NOTES:
•

Reference/ Source:
• Review notes in NEOLMS USA
• Discussion Video

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