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HOSPITAL DRUG
POLICY
Dr.Sanket R Harimkar.PharmD
 A hospital exists mainly to provide therapeutic services to the patients.
 Drugs are an integral part of patient care. In every hospital, medicines are crucial
to the hospital services.
 Appropriate use of medicines in the hospital is a multidisciplinary responsibility
that includes doctors, nurses, pharmacists, administrators, support personnel and
patients.
 The availability of medicines in the hospitals depends not only on good supplies,
but also on efficient use through good distribution system, rational prescribing,
and dispensing practices.
 "When a drug is required, the appropriate drug must be chosen. It must be
available at the right time, at the right price. It must be dispensed correctly,
be delivered in a right dose, at the right intervals and for the right length of
 In order to ensure that hospitals use drugs judiciously through right
procurement, storage, distribution, inventory control, quality assurance practices
and finally promoting safe use of drugs : a set of Hospital Drug Policies are
required.
 The Hospital Drug Policies a thus, a set of different policies.
 They are :
A) Drugs and Therapeutic Committee (DTC)sometimes also known as Pharmacy and
Therapeutic Committee (P&T Committee)
B) Infection Control Committee and Antibiotic Policy Committee
C) Drug Utilization Review Committee (DUR)
D) Research and Ethics Committee
E) Rational Drug Use Committee
F) Drug Exchange and Drug Donations Committee
Pharmacy and Therapeutic Committee
 Many countries will spend 30 to 40 percent of their health care budgets on drugs
and much of that money is wasted on irrational drug use and inefficiencies in
procurement of drugs.
 Other serious problems that health care organizations face are the over use of
antibiotics, increasing antimicrobial resistance, increasing adverse drug reactions,
and considerably higher costs associated with drug use.
 DTCs can provide the leadership and structure to select appropriate drugs for the
formulary, promote rational drug use, and help reduce drug costs to acceptable
level.
 The pharmacy and therapeutics committee is a policy framing and recommending
body to the medical staff and the administration of hospital on matters related to
therapeutic use of drugs.
OBJECTIVE
The pharmacy and therapeutics have three major roles to play.
These are:
• ADVISORY (Formulary Development, Medication Review, Drug Utilization Evaluation)
• EDUCATIONAL
• DRUG SAFETY AND ADVERSE DRUG REACTIONS MONITIORING.
FUNCTIONS
 Advising medical, administrative, and pharmacy departments on drug related
issues.
 Developing drug policies and procedures.
 Evaluating and selecting drugs for the formulary and providing for its periodic
revision.
 Assessing drug use to identify potential problems.
 Promoting and conducting effective interventions to improve drug use. (including
educational, managerial, and regulatory methods)
 Managing adverse drug reactions.
 Managing medication error.
COMPOSITION
 Composition of pharmacy and therapeutics committee (PTC) might vary from hospital
to hospital.
 The PTC may be composed of:
• At least three physicians from the medical staff
• A pharmacist
• A representative of the nursing staff
• An hospital administrator with his/her designated an ex-officio member of the
committee one of the physicians may be appointed as the chairman of PTC.
• Medical staff
• Hospital pharmacist
• Chairman
• Administrator
• Director
OPERATION OF PHARMACY AND
THERAPEUTICS COMMITTEE
 This committee should meet regularly at least six times in an year and
also when necessary.
 The agenda and the supplementary materials should be prepared by
the secretary and furnished to the committee members well in
advance so that the members can study them properly before
meeting.
ROLE OF PHARMACY AND THERAPEUTICS COMMITTEE
(PTC) IN DRUG SAFETY
 Drug safety is the moral, legal and professional obligation of pharmacist.
 It includes responsibility from dispensing of drugs to drug administration.
 The hospital must employ a qualified, registered pharmacist with at least B.
Pharm degree as 'chief pharmacist’ and the rest are may be at least diploma
holders in pharmacist.
 Should not permit non-pharmacist personnel to dispense drugs and allied
materials.
 Must employ a sufficient members of qualified considering the work load of a
pharmacist and allow for adequate coverage (7days/week).
 Must provide adequate safe, work space, and storage facilities.
 Should have equipment necessary to safely and adequately carry out the
modern practice of pharmacy.
 Must have an automatic stop order regulation for dangerous drugs. eg:
narcotics, anticoagulants etc.
 Should have a drug formulary which periodically revised and kept up to
date.
 The poisonous materials are separated from non-poisonous materials in the
pharmacy.
 The external use preparations should be separated from internal used
medications.
 Must have adequate quality control measures and follow good
manufacturing practices.
 Should provide a teaching program to teach students, nurses the basic
course of pharmaceutical mathematics and pharmacology.
 Should be periodically inspected in order to remove deteriorated and
outdated drugs as well as to check all labels for legibility.
 Should have an adequate reference library which contains texts on
pharmacology, toxicology, posology, and journals containing information
on newer developments in the pharmaceutical world.
ROLE OF PTC IN EMERGENCY DRUG LISTS
 The Time Factor is necessary for the Pharmacy and Therapeutics Committee
of a hospital to get prepared boxes containing emergency drugs which
should be always available readily for use at the bed side.
 List of such drugs and other supplies should compiled by Committee, and it
should find their place in "Emergency Kits“
 After the emergency boxes have been placed in the wards, it is very essential
and compulsory that a system is developed whereby they are checked daily
either by the hospital pharmacists or by nursing supervisor responsible for
the ward.
ROLE OF PHARMACY AND THERAPEUTIC COMMITTEE IN
DRUG PRODUCT DEFECT REPORTING PROGRAMME
 The drugs purchased by hospital may be defective in quality.
 It is for the committee to get information about the defective drug products
and to inform it first to the manufacturer for appropriate action.
 If satisfactory answer is not obtained from the manufacturer, it should be
reported to the Food and Drug Control Administration.
ROLE OF PHARMACY AND THERAPEUTICS COMMITTEE IN
DRUG UTILISATION REVIEW
 Drug utilization includes prescribing, dispensing, administering and ingesting of
prescription of drugs.
 Hospital pharmacist should take medication history that should include following
information:
 Medication being taken at the time of admission, during admission, home
remedies.
 Drug allergies and idiosyncrasy towards food products etc.
 Patent medication profile to be maintained for each patient.
 This will serve the following purposes:
• To help improved drug prescribing practices by promoting the safe and rational use
of drugs.
• To detect and help prevent drug-interactions.
• To detect and prevent adverse drug reactions in sensitive patients.
• To detect and prevents IV additive incompatibilities.
• To detect drug-induced diseases.
• To help detect and potential drug-toxicities.
ETHICAL CONCERNS OF THE DTC
 The committee needs to operate in a manner that ensures transparency and
avoids conflicts of interest with manufacturers and distributors of drugs or
medical supplies.
 In order for the committee to maintain objectivity and credibility, it is necessary
that a strict ethics policy be provided and rigorously enforced.
 There can be no relationships with the pharmaceutical companies other than a
purely professional one that encourages the flow of unbiased information
about their drug products.
Hospital Formulary
Definition
 A Formulary : The official Publication containing list of medicines authorized and
approved by medical staff for use in the hospital of state or country or region of
country for the therapy of patients.
 A Hospital Formulary : It is the continuously revised list of pharmaceutical
Medicines and dosage forms with its important information's which reflects the
current views of medical staff and Pharmacy and therapeutic committee which are
considered to be most useful in the patient care.
Introduction
 No hospital pharmacy can possibly stock every medication which are
prescribed by their affiliated doctors to patients.
 Hence medical and pharmacy staffs of hospitals prepare hospital formulary,
which is a list of the medications that the hospital pharmacy keeps, with
information of medication .
 Doctors use the formulary to find out which medications the hospital has
available to treat a given symptom or disease.
 It is also useful to avoid drug interaction.
 Hospital formulary generally contain generic drugs as compared to costly
other brands.
 Hospital formulary is required as too many pharmacy companies manufacture
so many medicines.
 The newer drugs have various untoward effects.
 Peoples need effective drugs at lowest possible cost.
 For rational use of drugs formulary is needed.
 For Education of medical staff, pharmacy persons ,nurses.
 Hospital formulary is prepared by Pharmacy and therapeutic committee
consisting of Physicians and Pharmacists.
Contents of hospital formulary
1) Title Page
2) Name and title of PTC members
3) Table of contents
4) List of drugs approved by PTC
5) Introductory information
6) Information on hospital policies and procedures for uses of drugs
a) Objective of formulary
b) Hospital rules and regulations for distribution of drugs
c) Hospital pharmacy services rule and procedures
d) Directions for how to use formulary
 7) Information on drugs
 8) Special information of drugs
a) Drug related hospital policies
b) Drug Product listing
c) Particular information
Introductory Information
 Acknowledgement
 List of Abbreviations
 Usage manual for usage of formulary
Hospital Policies and Procedures
 How to use the drug.
 Details of the PTC.
 Pharmacy operating procedures (SOP).
 Information on how to use formulary.
 Rules decided by hospital for prescription, dispensing and administration of
drug.
 Rules for use emergency and controlled drugs.
 Patients Counseling information.
Drug Product Listing
Formulary List of Drugs
o Alphabetically with the generic name
o Alphabetically with the Pharmacotherapeutic
Class
Index of Dosage forms of drug
o Brand name or Generic name of drug
o Therapeutic index
Information of drug
o Dosage form
o Dose of drug: Paediatric and Geriatric
o Strength of drug
o ADR, Side Effects
o Mode of action
o Active Pharmaceutical ingredient
o Packaging
o Cost of Drug
Special Information
 Abbreviations approved by hospital
 Calculation of Dose of drugs
 Poison control information
 Strength of drug as per accepted metric system
 List of Sugar free drugs
 List of drug Interaction
 List of Dialyzable Poisons (ethylene glycol and methanol)
 Diagnostic aids Storage
 Table of Common values
 Labelling Information
 Formulas for diagnostic stains
Differentiation of hospital formulary and Drug list
Hospital Formulary
a) List of drug as per Generic names also has
strength, form, toxicology, use, Posology and
quantity to be dispensed
b) Prepared locally by own medical staff
c) Details given is for local needs and desire.
Drug List
a) Generic names of drugs with its
strength and form
b) Prepared by Pharmacists, clinical and
Pharmacological staff
c) Information is written as per their
Pharmacological Property.
Preparation of Formulary
 Pharmacist play leading role in Preparation of Formulary.
 Pharmacist collects details of drug from Pharmacopoeias
 Also he Checks the drugs as per PTC guidelines
 He Prepares formulary under policies of PTC
 Further he is responsible for revision
Typical formulary will be prepared as :
 Title page
 Details of PTC
 Table of contents
 Policy of hospital
 Basic Information of Drug
• All Pharmacological Details
 Prescribing and Dispensing Guidelines
• Avoid ADR and Interactions
• Proper Strength
 Size of Formulary
• Size should be small to be carried easily by medical staff.
• Hospital decides the size.
 Format
• Loose leaf or Bound & Printed or Mimeographed
• Formats of different hospitals are checked before preparing
• Formulary sent to Govt. of India, PCI, General health services
 Index: General and Pharmacological
 The formulary should be visually pleasing, readable and professional in look
Revision of Formulary
 PTC will decide the revision of formulary
 Meeting is held by PTC for the revision
 Annual revision is done and is must because of alterations in drug products,
removal of some drugs from market, new drugs and changes in hospital policies
 Drug details are added at the end of formulary by attaching the sheets at the back
or last of formulary
 The addition or deletion of drug is only done after reporting to medical staff.
Addition of drug
 The drug should be present in NFI (National Formulary of India) or Pharmacopoeia
 The dosage form of drug should be manufactured by Licensed company with good
record
 The dosage form with all contents written can only be added in formulary
 The specified dosage form should get approval from local physician for its therapeutic
activity
 The drug only with reported therapeutic efficacy be added to the formulary
 Before adding new drug following parameters checked,
• Efficacy
• Potency
• Safety
• Quality
 After checking above parameters a request for addition is done by submitting formulary
addition request along with supporting literature along with signed disclosure of interest
of PTC
Deletion of drug
 Suggestion for deletion is given by medical staff to PTC
 Suggestion should provide superiority or inferiority of drug depending on MOA or
with specific indication.
 To control growth of formulary, some addiction are balanced by deletions of drugs.
 PTC periodically review the deletion of drugs on the basis of duplication and less
use of drugs.
 Further deletion of drug also done in case of availability of cheaper and equally
efficacious and potent drug as compared to costlier ones.
HOSPITAL DRUG POLICY.pptx

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HOSPITAL DRUG POLICY.pptx

  • 2.  A hospital exists mainly to provide therapeutic services to the patients.  Drugs are an integral part of patient care. In every hospital, medicines are crucial to the hospital services.  Appropriate use of medicines in the hospital is a multidisciplinary responsibility that includes doctors, nurses, pharmacists, administrators, support personnel and patients.  The availability of medicines in the hospitals depends not only on good supplies, but also on efficient use through good distribution system, rational prescribing, and dispensing practices.  "When a drug is required, the appropriate drug must be chosen. It must be available at the right time, at the right price. It must be dispensed correctly, be delivered in a right dose, at the right intervals and for the right length of
  • 3.  In order to ensure that hospitals use drugs judiciously through right procurement, storage, distribution, inventory control, quality assurance practices and finally promoting safe use of drugs : a set of Hospital Drug Policies are required.  The Hospital Drug Policies a thus, a set of different policies.  They are : A) Drugs and Therapeutic Committee (DTC)sometimes also known as Pharmacy and Therapeutic Committee (P&T Committee) B) Infection Control Committee and Antibiotic Policy Committee C) Drug Utilization Review Committee (DUR) D) Research and Ethics Committee E) Rational Drug Use Committee F) Drug Exchange and Drug Donations Committee
  • 4. Pharmacy and Therapeutic Committee  Many countries will spend 30 to 40 percent of their health care budgets on drugs and much of that money is wasted on irrational drug use and inefficiencies in procurement of drugs.  Other serious problems that health care organizations face are the over use of antibiotics, increasing antimicrobial resistance, increasing adverse drug reactions, and considerably higher costs associated with drug use.  DTCs can provide the leadership and structure to select appropriate drugs for the formulary, promote rational drug use, and help reduce drug costs to acceptable level.  The pharmacy and therapeutics committee is a policy framing and recommending body to the medical staff and the administration of hospital on matters related to therapeutic use of drugs.
  • 5. OBJECTIVE The pharmacy and therapeutics have three major roles to play. These are: • ADVISORY (Formulary Development, Medication Review, Drug Utilization Evaluation) • EDUCATIONAL • DRUG SAFETY AND ADVERSE DRUG REACTIONS MONITIORING.
  • 6. FUNCTIONS  Advising medical, administrative, and pharmacy departments on drug related issues.  Developing drug policies and procedures.  Evaluating and selecting drugs for the formulary and providing for its periodic revision.  Assessing drug use to identify potential problems.  Promoting and conducting effective interventions to improve drug use. (including educational, managerial, and regulatory methods)  Managing adverse drug reactions.  Managing medication error.
  • 7. COMPOSITION  Composition of pharmacy and therapeutics committee (PTC) might vary from hospital to hospital.  The PTC may be composed of: • At least three physicians from the medical staff • A pharmacist • A representative of the nursing staff • An hospital administrator with his/her designated an ex-officio member of the committee one of the physicians may be appointed as the chairman of PTC. • Medical staff • Hospital pharmacist • Chairman • Administrator • Director
  • 8. OPERATION OF PHARMACY AND THERAPEUTICS COMMITTEE  This committee should meet regularly at least six times in an year and also when necessary.  The agenda and the supplementary materials should be prepared by the secretary and furnished to the committee members well in advance so that the members can study them properly before meeting.
  • 9. ROLE OF PHARMACY AND THERAPEUTICS COMMITTEE (PTC) IN DRUG SAFETY  Drug safety is the moral, legal and professional obligation of pharmacist.  It includes responsibility from dispensing of drugs to drug administration.  The hospital must employ a qualified, registered pharmacist with at least B. Pharm degree as 'chief pharmacist’ and the rest are may be at least diploma holders in pharmacist.  Should not permit non-pharmacist personnel to dispense drugs and allied materials.  Must employ a sufficient members of qualified considering the work load of a pharmacist and allow for adequate coverage (7days/week).  Must provide adequate safe, work space, and storage facilities.
  • 10.  Should have equipment necessary to safely and adequately carry out the modern practice of pharmacy.  Must have an automatic stop order regulation for dangerous drugs. eg: narcotics, anticoagulants etc.  Should have a drug formulary which periodically revised and kept up to date.  The poisonous materials are separated from non-poisonous materials in the pharmacy.  The external use preparations should be separated from internal used medications.  Must have adequate quality control measures and follow good manufacturing practices.  Should provide a teaching program to teach students, nurses the basic course of pharmaceutical mathematics and pharmacology.
  • 11.  Should be periodically inspected in order to remove deteriorated and outdated drugs as well as to check all labels for legibility.  Should have an adequate reference library which contains texts on pharmacology, toxicology, posology, and journals containing information on newer developments in the pharmaceutical world.
  • 12. ROLE OF PTC IN EMERGENCY DRUG LISTS  The Time Factor is necessary for the Pharmacy and Therapeutics Committee of a hospital to get prepared boxes containing emergency drugs which should be always available readily for use at the bed side.  List of such drugs and other supplies should compiled by Committee, and it should find their place in "Emergency Kits“  After the emergency boxes have been placed in the wards, it is very essential and compulsory that a system is developed whereby they are checked daily either by the hospital pharmacists or by nursing supervisor responsible for the ward.
  • 13. ROLE OF PHARMACY AND THERAPEUTIC COMMITTEE IN DRUG PRODUCT DEFECT REPORTING PROGRAMME  The drugs purchased by hospital may be defective in quality.  It is for the committee to get information about the defective drug products and to inform it first to the manufacturer for appropriate action.  If satisfactory answer is not obtained from the manufacturer, it should be reported to the Food and Drug Control Administration.
  • 14. ROLE OF PHARMACY AND THERAPEUTICS COMMITTEE IN DRUG UTILISATION REVIEW  Drug utilization includes prescribing, dispensing, administering and ingesting of prescription of drugs.  Hospital pharmacist should take medication history that should include following information:  Medication being taken at the time of admission, during admission, home remedies.  Drug allergies and idiosyncrasy towards food products etc.  Patent medication profile to be maintained for each patient.
  • 15.  This will serve the following purposes: • To help improved drug prescribing practices by promoting the safe and rational use of drugs. • To detect and help prevent drug-interactions. • To detect and prevent adverse drug reactions in sensitive patients. • To detect and prevents IV additive incompatibilities. • To detect drug-induced diseases. • To help detect and potential drug-toxicities.
  • 16. ETHICAL CONCERNS OF THE DTC  The committee needs to operate in a manner that ensures transparency and avoids conflicts of interest with manufacturers and distributors of drugs or medical supplies.  In order for the committee to maintain objectivity and credibility, it is necessary that a strict ethics policy be provided and rigorously enforced.  There can be no relationships with the pharmaceutical companies other than a purely professional one that encourages the flow of unbiased information about their drug products.
  • 17. Hospital Formulary Definition  A Formulary : The official Publication containing list of medicines authorized and approved by medical staff for use in the hospital of state or country or region of country for the therapy of patients.  A Hospital Formulary : It is the continuously revised list of pharmaceutical Medicines and dosage forms with its important information's which reflects the current views of medical staff and Pharmacy and therapeutic committee which are considered to be most useful in the patient care.
  • 18. Introduction  No hospital pharmacy can possibly stock every medication which are prescribed by their affiliated doctors to patients.  Hence medical and pharmacy staffs of hospitals prepare hospital formulary, which is a list of the medications that the hospital pharmacy keeps, with information of medication .  Doctors use the formulary to find out which medications the hospital has available to treat a given symptom or disease.  It is also useful to avoid drug interaction.  Hospital formulary generally contain generic drugs as compared to costly other brands.
  • 19.  Hospital formulary is required as too many pharmacy companies manufacture so many medicines.  The newer drugs have various untoward effects.  Peoples need effective drugs at lowest possible cost.  For rational use of drugs formulary is needed.  For Education of medical staff, pharmacy persons ,nurses.  Hospital formulary is prepared by Pharmacy and therapeutic committee consisting of Physicians and Pharmacists.
  • 20. Contents of hospital formulary 1) Title Page 2) Name and title of PTC members 3) Table of contents 4) List of drugs approved by PTC 5) Introductory information 6) Information on hospital policies and procedures for uses of drugs a) Objective of formulary b) Hospital rules and regulations for distribution of drugs c) Hospital pharmacy services rule and procedures d) Directions for how to use formulary
  • 21.  7) Information on drugs  8) Special information of drugs a) Drug related hospital policies b) Drug Product listing c) Particular information
  • 22. Introductory Information  Acknowledgement  List of Abbreviations  Usage manual for usage of formulary
  • 23. Hospital Policies and Procedures  How to use the drug.  Details of the PTC.  Pharmacy operating procedures (SOP).  Information on how to use formulary.  Rules decided by hospital for prescription, dispensing and administration of drug.  Rules for use emergency and controlled drugs.  Patients Counseling information.
  • 24. Drug Product Listing Formulary List of Drugs o Alphabetically with the generic name o Alphabetically with the Pharmacotherapeutic Class Index of Dosage forms of drug o Brand name or Generic name of drug o Therapeutic index Information of drug o Dosage form o Dose of drug: Paediatric and Geriatric o Strength of drug o ADR, Side Effects o Mode of action o Active Pharmaceutical ingredient o Packaging o Cost of Drug
  • 25. Special Information  Abbreviations approved by hospital  Calculation of Dose of drugs  Poison control information  Strength of drug as per accepted metric system  List of Sugar free drugs  List of drug Interaction  List of Dialyzable Poisons (ethylene glycol and methanol)  Diagnostic aids Storage  Table of Common values  Labelling Information  Formulas for diagnostic stains
  • 26. Differentiation of hospital formulary and Drug list Hospital Formulary a) List of drug as per Generic names also has strength, form, toxicology, use, Posology and quantity to be dispensed b) Prepared locally by own medical staff c) Details given is for local needs and desire. Drug List a) Generic names of drugs with its strength and form b) Prepared by Pharmacists, clinical and Pharmacological staff c) Information is written as per their Pharmacological Property.
  • 27. Preparation of Formulary  Pharmacist play leading role in Preparation of Formulary.  Pharmacist collects details of drug from Pharmacopoeias  Also he Checks the drugs as per PTC guidelines  He Prepares formulary under policies of PTC  Further he is responsible for revision
  • 28. Typical formulary will be prepared as :  Title page  Details of PTC  Table of contents  Policy of hospital  Basic Information of Drug • All Pharmacological Details  Prescribing and Dispensing Guidelines • Avoid ADR and Interactions • Proper Strength  Size of Formulary • Size should be small to be carried easily by medical staff. • Hospital decides the size.
  • 29.  Format • Loose leaf or Bound & Printed or Mimeographed • Formats of different hospitals are checked before preparing • Formulary sent to Govt. of India, PCI, General health services  Index: General and Pharmacological  The formulary should be visually pleasing, readable and professional in look
  • 30. Revision of Formulary  PTC will decide the revision of formulary  Meeting is held by PTC for the revision  Annual revision is done and is must because of alterations in drug products, removal of some drugs from market, new drugs and changes in hospital policies  Drug details are added at the end of formulary by attaching the sheets at the back or last of formulary  The addition or deletion of drug is only done after reporting to medical staff.
  • 31. Addition of drug  The drug should be present in NFI (National Formulary of India) or Pharmacopoeia  The dosage form of drug should be manufactured by Licensed company with good record  The dosage form with all contents written can only be added in formulary  The specified dosage form should get approval from local physician for its therapeutic activity  The drug only with reported therapeutic efficacy be added to the formulary  Before adding new drug following parameters checked, • Efficacy • Potency • Safety • Quality  After checking above parameters a request for addition is done by submitting formulary addition request along with supporting literature along with signed disclosure of interest of PTC
  • 32. Deletion of drug  Suggestion for deletion is given by medical staff to PTC  Suggestion should provide superiority or inferiority of drug depending on MOA or with specific indication.  To control growth of formulary, some addiction are balanced by deletions of drugs.  PTC periodically review the deletion of drugs on the basis of duplication and less use of drugs.  Further deletion of drug also done in case of availability of cheaper and equally efficacious and potent drug as compared to costlier ones.