PTC

PHARMACY & THERAPEUTICS COMMITTEE: 

PHARMACY & THERAPEUTICS COMMITTEE

DEFINATION: 

DEFINATION The pharmacy & Therapeutics Committee is a policy framing & recommending body to the medical staff and the administration of hospital on matters related to therapeutic use of drugs.

COMPOSITON OF PHARMACY & THERAPEUTICS COMMITTEE : 

COMPOSITON OF PHARMACY & THERAPEUTICS COMMITTEE At least three physicians from the medical staff A pharmacist A representative of the nursing staff An hospital administrator

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Sub-Committee C.N.S agents Analgesics &antipyretics c) Anticonvulsants d) Psychotherapeutics e) Respiratory &Cerebral f) Sedatives &Hypnotics Sub-committees (Anti- ineffectives ) Pharmacist Secretary Nursing Staff Joint- Secretary Hospital administrators (Director) Sub-Committee Cardio-Vascular drugs Diuretics Cardioacglycocides Hypotensives Vasodilators Spasmolytics Anticoagulant Sub-Committee Gastro-intestinal Drugs Autonomic Sub-Committee a)Endocrinology agents b) Antidiabetic agents c) Anti- inflamatory agents d) Hormones e) Thyroid-Preparations Medical staff Chairman (Physician) Co-chairperson (Physicians) Sub committee (Neo-plastic) PHARMACY & THERAPEUTICS COMMITTEE

Operation of ptc committee should meet the regularly at least six times in an year and also as and when necessary: 

Operation of ptc committee should meet the regularly at least six times in an year and also as and when necessary Minutes of previous meeting Review of the contents of the Hospital Formulary Information regarding new drugs Review &/or adoption of investigational drugs currently under processing in the hospital Review of side effect , adverse drug reactions , toxic effects drug interactions Review of “Drug Safety” in the hospital Reports of various sub-committees Report of medical audit Any other matter with the permission of chair Vote of thanks.

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The Pharmacy and Therapeutics (P & T) Committee is an important medical staff advisory group. As the primary, formal communication link between the pharmacy and medical staff P & T Committee is of particular importance to the department of pharmacy services. All matters pertaining to the use of medications within the institution, including pharmacy programs, must be reviewed and approved through the committee. Important aspects of the committee's operation

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In addition, medication formulary data is reviewed through the committee and recommendations are offered to the medical staff. Such a wide diversification of involvement and activity necessitates the effective communication between all committee members. An active involvement in the committee by the department of pharmacy services is vital in order to develop a contemporary and progressive institutional pharmacy program.

OBJECTIVES: 

OBJECTIVES Advisory Adaptation of policies, evaluation Advise to medical staff of hospital I mplementation of drug distribution and control procedure S election of therapeutics drugs in hospital Recommendatioin to stock and supply of drug Educational Formulation of function Recrutment of qualified staff Evaluate the problem of drug distribution & drug use Evaluate the plan for hospital staff Drug safety and adverse drug monitoring Scope, knowledge and responsibility of hospital pharmacist Drug safety is moral, legal and professional obligation New drug information and use

Mission: 

Mission Promote evidence-based, best practice standards in the formulary decision-making process to assure clinical efficacy, patient safety, and cost-effective prescribing within Health Care, Review policies and procedures related to proper medication administration to assure medications are administered safely and appropriately, Facilitate education of healthcare providers and students regarding medication-related issues, Assure that medications are prescribed appropriately safely , and effectively through medication use evaluation processes,

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Assure compliance with FDA, and other regulatory guidelines related to medication use, Review and support investigational medication studies to ensure patient safety and adherence to Health Care policies Evaluate and assess point-of-care and other technology systems and processes to effectuate safe, prompt, and efficient prescribing in both the inpatient and ambulatory care settings.

Role / Functions of PTC: 

Role / Functions of PTC This Committee formulates and reviews policies regarding the selection, intra-hospital distribution, storage, and safe use and administration of drugs within the Hospital. The P&T Committee has been established to provide the Health Care administration and its clinical leadership with information and advice concerning the proper use of drugs and related products.

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Each Plan is to have a Pharmacy and Therapeutics Committee. It is to provide expertise on clinical issues, not financial or benefit issues. P&T committees are to meet regularly, and at least quarterly. All P&T members must sign a conflict of interest statement.

guidelines for Drug safety: 

guidelines for Drug safety The hospital must employ a qualified , at least a registered pharmacist with atleast B.Pharm Degree as the chief pharmacist and the rest are may be atleast Diploma holder in pharmacy The hospital should not permit non-pharmacist personnel to dispense drugs and allied materials The hospital must employ a sufficient number of qualified personnel considering the work load of pharmacist and allow for adequate coverage of the pharmacy seven days a week The hospital must provide adequate safe, work space, & storage facility for the pharmacy

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The pharmacy should have necessary equipments to safely and adequately carry out the modern practice of pharmacy The hospital must have an ‘automatic stop order’ regulation drugs e.g Narcotics, Hypnotics, Anticoagulants etc. The hospital should have the firm policy regarding the use of research drugs in the hospital & its clinics The hospital should have a drug formulary which periodically revised & kept upto date The hospital should not permit any person other than a registered pharmacist into the pharmacy “outside its working hours” 14

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The poisons & poisonous materials should be adequately separated from non- poisonous materials in the pharmacy and in the wards etc The external use preparations should be separated from internal use medication in the pharmacy & in the wards etc The pharmacy manufactured products for patients use if any must have adequate quality control measures and follow good manufacturing practices during the processing and also in the final products The hospital should provides or to the chief pharmacist sufficient help to permit him to engage in a teaching programme to familiarize the nursing and resident staff with new drugs and teach the students, nurses, the basic course of pharmaceutical mathematics and pharmacology

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All nursing drug statistics should be periodically inspected for the purpose of removing deteriorated and outdated drugs as well as to check all labels for legibility The pharmacy should have an adequate reference library which contains texts on pharmacology, toxicology, posology and journals containing adequate information on newer developments in the pharmaceutical world 16

Role of PTC in Adverse Drug Reaction Monitoring Programme: 

Role of PTC in Adverse Drug Reaction Monitoring Programme Adverse drug reaction –as any unusual or unexpected harmful reaction including acute poisoning by narcotics, barbiturates and amphetemines To prepare confidential report on adverse drug reaction Forward that report to central cpmmittee of state Governement drug control authorities of the state or drug controller of India

The P&T Committee must review a research protocol if it involves: 

The P&T Committee must review a research protocol if it involves ⇛ T he administration of investigational new drugs or drugs that are given "off-label"; ⇛ FDA approved drugs that are given as a component of a research protocol; ⇛A ny other substance that is ingested (with the exception of enteral feedings such as baby formulas, unless they contain a non-Generally Regarded As Safe [GRAS] ingredient); or ⇛ A ny other substance that is injected or applied to the body.

PROFORMA FOR MONITERING OF ADVERSE DRUG REACTIONS (ADR) IN INDIA: 

19 1. Do not leave any item blank 2. Mark tick in the appropriate box 3. Type or write in BLOCK LETTERS PROFORMA FOR MONITERING OF ADVERSE DRUG REACTIONS (ADR) IN INDIA Centre name : ------------------------------- ----------------- Type of patient:----------------------------------------------- Inpatient (1) Outpatient (2) Serial No:------------------------------ Name of patient:----------------------------------------------- Address (complete):------------------------------------------ --------------------------------------------Pin code:------------- Age :---------- Years Sex : Male (1) Female (2) Occupation :---------------------------------------------------- Hospital Record No:-------------------------- Registration Date:----------------------------- Dietary Habit: veg (1) Non-veg. (2) Smoking habit: No (1) Yes(2) If yes , duration (----yrs.) Alcoholic habit: No (1) Yes(2) If yes , duration (-----yrs.)

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20 Drug name Indication Total daily dose Route Duration Trade & (Diagnosis) Generic 14. Relevant Medical History : If yes, details i ) Allergy No(1) Yes(2)------------------ ii) Environmental exposure No(1) Yes(2)------------------ iii) Occupational exposure No(1) Yes(2)----------------- iv) Previous drug reaction No(1) Yes(2)------------------ v) Pregnancy 0/1/2/3 TRIMESTER ------------------------------ vi) Family history of ADR No(1) Yes(2)-------------------- 15. Background signs / symptoms:---------------------------------- 16. Provisional diagnosis:---------------------------------------------- 17. Treatment Schedule (including traditional medicines) 18. Date of end of treatment:---------------------------------------- 19. Outcome of management:--------------------------------------- Recovered (1); Still under Rx (2); Died (3); Lost to follow up (4); ADR suspected (5) 20. If ADR is suspected fill in the PROFORMA –II No (1) Yes (2)

Automatic Stop Orders for Dangerous Drug: 

Automatic Stop Orders for Dangerous Drug All the drugs orders for narcotics, sedative, hypnotics, anticoagulants and antibiotics (administered orally or parenterally ) shall be automatically discontinued after 48 hours. All orders for narcotics, sedative, hypnotics must be re-written every 24 hours. All standing order for all medicines except narcotics, sedative, hypnotics shall expires at 10 am or an hours which may be determine by PTC Automatic stop orders for dangerous drug practice 21

Role of PTC in Developing Emergency Drug List: 

Role of PTC in Developing Emergency Drug List To prepare list of drugs required in emergency situation and place in “Emergency Kit” Kit should be stored in every where in hospital 22 Supplies to be maintained in Emergency Box Syringes of various range Two each of 1ml i.e Tuberculin or Insulin syringe , 2ml. Syringe and 5ml and one each of 10ml and 20ml syringe Needles, preferably two each of 16’,18’, 20’, 21’, 23’and 26’ Files for breaking the ampoule Torniquets Airways equipment Ryles tube (A)

(B) Drugs for Emergency Box:: 

(B) Drugs for Emergency Box: These may selected in consultation with the physician but the following list is illustrated only Amihophylline Amylnitrite glass capsules for inhalation Atropine sulphate 0.4 mg/ml Caffeine sodium benzoate 0.5g/2ml Calcium Gluconate 1g/10ml Digoxin 0.25mg/ml Diphenylhydantoin sodium 50mg/ml Epinephrine Hcl /1mg/ml Heparin 10.000 units/ml

(C) Supplies for cabinet Utility Room: 

(C) Supplies for cabinet Utility Room Venous cannulation set Each set 12&17 venous catheters Pieces 6” shock blocks Oxygen catheters Razor with blades Package sterile gelatin sponge Resuscitation tube

(D) Other emergency supplies: 

(D) Other emergency supplies Resuscitation carts Phlebotomy sets Oxygen equipments Tracheotomy sets Dextran & tubing Burn sheets Note:- Each hospital may modify this list by adding or deleting items as found necessary

Role of PTC in Drug Product Defect Reporting Programme : 

Role of PTC in Drug Product Defect Reporting Programme Address----------------------- Date received--------------- HOSPITAL PHARMACIST DRUG DEFECT REPORT Reference No…………………… Trade name ------------------------ Dosage form---------------------------------- Strength------------------------ Lot No.------------------ Expiry Date------------------------------------ Date Purchased------------------------------------ Name of supplier---------------------------------- Name & address of the manufacturer----------------------------------- Reporting pharmacist’s name----------------------------------------------- Defects Noted or suspected---------------------------------------------- Signature of the chairman Date --------------------- Pharmacy and Therapeutics Committee XYZ HOSPITAL Hospital Pharmacist’s Drug Defect Report Form

Role of PTC in drug Utilization Review: 

Role of PTC in drug Utilization Review Medication being taken at the time of admission, during admission , home remedies(OTC) drugs) Drug –allergies and idiosyncrosy towards food products etc. (PATIENT MEDICATION PROFILE)

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28 XYZ HOSPITALS PATIENT MEDICATION PROFILE Record No…………. Name of the patient ------------------------------------------------------------------------ Age ------------- Sex -------------------- Address --------------------------------------------- ------------------------------------------- Date of admission-------------------------------- Admission Diagnosis ------------------------------------------------------------------------- Other Pathology ------------------------------------------------------------------------------ Pre Operative Medications Used--------------------------------------------------------- Date Drugs Dose Route Started Discontinued Remarks PATIENT MEDICATION PROFILE

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To help improved drug prescribing practices by promoting the safe and rational use of the drugs To detect and help prevent drug-interactions. The help detect and prevent adverse drug reactions in sensitive patients To detect and prevents IV additive incompatibilities To detect drug-induced disease To detect possible drug induced disease To help detect and potential drug-toxicities 29 Purpose of PATIENT MEDICATION PROFILE

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