Chapter 4 Pharmacy And Therapeutics Committee PDF

CHAPTER 4 PHARMACY AND THERAPEUTICS COMMITTEE  Pharmacy and Therapeutics Committee (PC) is an advisory group of the medical staff which serves as the rational line of communication between the medical staff and pharmacy department. It is a policy recommending body of the medical staff and the a...

CHAPTER 4 PHARMACY AND THERAPEUTICS COMMITTEE  Pharmacy and Therapeutics Committee (PC) is an advisory group of the medical staff which serves as the rational line of communication between the medical staff and pharmacy department. It is a policy recommending body of the medical staff and the administration of the hospital on matters related to drug use. This committee is composed of physicians, pharmacists and other health professionals selected with the guidance of the medical staff. Purpose 1. Advisory – The committee recommends the adoption of or assists in the formulation of broad s professional policies regarding evaluation, selection and therapeutic The primary use of drugs in hospitals. purposes of PTC 2. Educational- The committee are: recommends or assists in the formulation of programs assigned to meet the needs of the professional staff (physicians, nurses, pharmacists and other health care practitioners) for complete current knowledge on matters related to drugs and drug use.  Organization & Operation 1. The PC should be composed of at least 3 5. An agenda and supplementary materials physicians, a pharmacist, a nurse and an (including minutes of the previous meeting) administrator. Committee members are should be prepared by the secretary and appointed by a governing unit or elected submitted to the committee members in official of the organized medial staff. sufficient time before the meeting for them to review) the material properly. 2. A chairman from among the physician representatives should be appointed. A 6. Minutes of the committee meetings should be pharmacist usually is designated as prepared by the secretary and maintained in the secretary. permanent records of the hospital. 3. The committee should meet regularly, at 7. Recommendations of the committee shall be least 6 times per year and more often than when necessary. presented to the medical staff or its appropriate committee for adoption or recommendation. 4. The committee should invite to its meetings persons within and outside the hospital who 8. Liaison with other hospital committees can contribute specialized or unique concerned with drug use (e.g. infection control knowledge, skills and judgments. and medical audit) shall be maintained.  Functions & Scope  To serve in an advisory capacity to the medical staff and hospital administration in all matters pertaining to the use of drugs (including investigational drugs). To develop a formulary of drugs accepted for use in the hospital and provide for its constant revision. The selection of items to be included in the formulary will be based on objective evaluation of their relative therapeutic merits, safety and cost. The committee should minimize duplication of the same basic drug type, drug entity or drug product. To establish programs and procedures that help ensure cost- effective drug therapy. To establish or plan suitable educational programs for the hospitals professional staff on matters related to drug use.  To participate in quality-assurance activities related to distribution, administration and use of medications. To review adverse drug reactions in the hospital. To initiate or direct (or both) drug use review programs and studies and review the results of such activities. To advice the pharmacy in the implementation of effective drug distribution and control procedures. To make recommendations concerning drugs to be stocked in hospital patient-care areas.  Policies of Committee 1. Proposal for a new drug for a new drug for the hospital formulary shall be submitted on a Formulary Request Form. Such request may be submitted by any member of the medical staff. The Committee will evaluate the request and notify the proposer as to acceptance or rejection. The proposer shall have the opportunity to appeal the decision of the Committee. 2. Drugs evaluated by the Committee will be assigned to one of the Four categories: a. Formulary Drugs - An FDA approved drug which is recommended as being essential for good patient care with a well-established usage. Once accepted as a formulary drug, it may be prescribed by all members of the attending and house staffs. b. Drugs approved on a Conditional, Trial Period – A drug approved by the FDA for the general use but which the Committee will evaluate for a 6 to 12 month period before final consideration. During that period, the drug may be prescribed by all members of the attending and house staffs. C. Specialized Formulary Drug – an FDA approved drug which is recommended for use in specialized patient care. The drug may be placed in this category by the proposer or the Committee and either may designate those persons authorized to prescribe the Specialized Formulary Drug. D. Investigational Drug – A drug which has been approved by the FDA for a specific use by its principal investigator and designated associates. Such drugs are not commercially available. A protocol of the study must be submitted to the pharmacy if it is to be used in the hospital. The drug is not necessarily a new chemical substance but may be: 1. An old or approved drug proposed for a new use. 2.A new combination of 2 or more old drugs 3.A combination of old rugs n new proportions and 4.A new dosage form or method of administration E. Non-Formulary drugs – drugs which do not qualify for the four categories listed and will not be stocked in the pharmacy. If prescribed, the pharmacy will obtain and dispense a limited quantity of the drug. Formulary system dictates that all drugs will be dispensed on the basis of generic names. Authority for the routine selection of drug brands is delegated to the Pharmacy Department utilizing a fair and equitable bid process when necessary. Drug recall may emanate from manufacturers, regulatory agencies or the Pharmacy Department and may be of a general nature or a specific recall for one or more lot numbers. Once the recall notice is received, the drugs will be removed and replaced and this information will be sent to staff and pertinent hospital departments. Inpatient Prescribing a. Routine Drug Orders A physician’s medication order written on a patient order form is seemed a legal prescription. A legible copy of the medication order must be forwarded to the Pharmacy. Orders written by medical students must be countersigned by a member of the medical staff. Quantitates of drugs to be dispensed need not be specified since the pharmacist will determine optimum amounts keeping with greatest economy to the patient and efficiency in handling and storage by the nurse and pharmacy staff. b. I. V Orders Orders for intravenous medications must be written in the same manner as routine drugs and must include the following information: i. The exact quantity of the drug (s) which must be added; ii. The exact volume and name of the infusate solution; iii. Specific directions for administration such as IV drip, IV bolus, IV push, etc. iv. Specific times to hang infusate solution and drip rate and v. Specific directions for continuing or discontinuing any IV medications c. Total Parenteral Nutrition (TPN) TPN has been designated to serve as nutritional infusion providing essential amino acids, carbohydrates, and electrolytes for patients incapable of ingesting, digesting or absorbing food substances given by mouth. Since a standard hyperalimentation solution must always be prepared extemporaneously, the pharmacy department shall be responsible for the preparation of these solutions. d. Self-Medication Only Nitroglycerin and Antacids may be left to the patient’s bedside for self- administration if so ordered by the physician. The quantity of nitroglycerin is limited to 10 tablets which must be counted by the nurse at the conclusion of each shift and charted in the patient’s medical record. Antacids must be recorded and replenished in the same manner. e. Automatic Stop Orders Applies to instances when the physician did not specify the exact number of doses or duration of therapy (open ended drug order). The automatic stop order policy serves as a protection against indiscriminate and indefinite open ended drug orders that can be harmful to the patient and at the same time ensures continuous therapy if so desired by the physician. Automatic stop order requirements for medications are: 1. 24 hours for controlled drugs 2. 7 days for all other drugs f. A new medication order must be written by the physician if a change is wanted in route of administration or in dosage. g. Discharge Prescription A separate prescription is required for each medication which the patient is to take home. Discharge prescriptions must be received in the pharmacy prior to discharge, so that they may be processed and returned to the nursing station. Delays may result in the patient having to wait which is not consistent with food patient care. h. Emergency (STAT orders) Bonafide emergency orders should be rare and in most cases obtained from the nursing station emergency drug supplies. When necessary, these orders should be transmitted in writing on the pharmacy copy of the patient order form. This procedure prevents unnecessary delay and confusion which results from hurried verbal transmission orders. If it is necessary to phone the pharmacy of emergency drugs, calls should be placed either by the physician or the nurse in order to avoid delays and error. DRUG UTILIZATION REVIEW Drug utilization has been defined as the prescribing, dispensing, administering and ingesting of prescription drugs. Within the hospital, the Pharmacy and Therapeutic Committee provides the institutional authority for the formulary system of drug use control as well as the mechanism for the continuing education of physicians, nurses and pharmacists. Thus, some constitutions have initiated patient drug utilization profiles and medication history taking as part of their clinical pharmacy programs thereby enabling the pharmacists to monitor drug utilization within the hospital. Medication histories are taken by pharmacists of every patient administered to the hospital or seen in the ambulatory care section. These may be accomplished by personal interview or via computerized questionnaire specifically designed for the purpose. In addition to personal identification and general diagnosis, the following information is elicited: 1. Medications being taken at the time of admission 2. Medications taken during the recent past ( Including antibiotics) 3. Home remedies (OTC drugs) used 4. Drug allergies 5. Laboratory tests performed out of the hospital during which diagnostic agents were ingested 6. Idiosyncrasy towards food products The Patient drug profile is developed by the pharmacists for the following purposes: 1. To help improve the prescribing practices by promoting the safe and rational use of drugs 2. To detect and help prevent potential drug interactions 3. To help detect and prevent adverse drug reactions in sensitive patients 4. To detect and prevent IV additive incompatibilities 5. To detect drug induced laboratory test abnormalities 6. To detect possible drug induced diseases 7. To help detect and prevent potential drug toxicities When the Patient Medication Profile, Patient history, and Laboratory Procedure Profile are compared, the pharmacist is in excellent position to monitor proper drug utilization.  Adverse Drug Reactions Adverse drug reactions (ADR) have been defined by the World Health Organization as “are response to a drug which is noxious and unintended which occurs at dosed used in man for prophylaxis, diagnosis or therapy”. In the past century great advances have been made to discover, test and market medications that cure diseases and alleviate suffering. Although every effort is made by the pharmaceutical industry and governmental regulatory agencies to market safe and effective medications, all drugs have the potential to cause harm in susceptible individuals. All who manufacture, dispense, prescribe, regulate and use drugs have a responsibility to assure their proper use and reduce the possibility of drug-induce disease.  Role of the Pharmacist in ADR monitoring Pharmacists stand at the crossroads of drug therapy, where they have the responsibility of providing professional services to patients receiving drugs prescribed by physicians and also to patients self-medicating with nonprescription drugs. No other person is trained similarly to know the actions, interactions, side effects and ingredients for such a wide range of medications. The role of the pharmacist continues to change and in many settings, the pharmacist has a profound influence on both drug selection and administration. Through development and implementation of improved drug-delivery systems and pharmacokinetic services, the pharmacist has made great strides in reducing medication errors and preventing ADRs. IN organized health care settings, many pharmacists participate directly in the evaluation of new drugs to assure that the most effective and least costly agents are included in institutional formularies Pharmacists practicing in hospitals already are responsible for developing written procedures for recording and reporting ADRs. Pharmacists also will be called upon increasingly to take an active role in educating the public concerning the safe and rational use of medications. These new responsibilities probably will be carried out through written material, which will be no doubt be aided by the computer. In addition, it is expected that new software computer will become available to screen patients’ medication regimens for potential drug-drug, drug-diet and drug-disease interactions. It also can be expected that pharmacists are knowledgeable in the area of ADRs will have expanded opportunities to participate in post marketing surveillance programs and to monitor for and  INVESTIGATIONAL DRUGS The hospital pharmacist is in a strategic position to participate in an evaluation program on investigational drugs cause such drugs must be tried in a hospital setting where the necessary laboratory and other medical facilities are available. It is thus a prime responsibility of the pharmacy and Therapeutic Committee to establish policies and procedures relative to the handling and control of investigational drugs in the hospital. There are many problems associated with the use of investigational drugs in the hospital, some of which are: 1. Legal problems may result if a hospital does not exercise due care in the proper handling of investigational drugs in the overall care of the patient. 2. Nurses, as agents of the hospital, usually are responsible for administering investigational drugs to patients. In performing this act, it is essential that sufficient information on the proper dosage, route of administration, possible toxic reactions and side effects, precautions and proper labeling is available to them. 3. Investigational drugs, as they are made available from the manufacturer to the principal investigator, are not labeled sufficiently in many instances to prevent the possibility of error in their administration to patients. 4. Because investigational drugs fall in the area of research in contrast to accepted methods of treatment, there are legal implications revolving around the need for written consent by patients. 5. In case of double-blind studies, it is essential that the person holding the code be readily available 24 hours a day, 7dyas a week, in case the patient’s condition warrants a breaking of the code. 6. The legal requirements for proper records on the use of investigational drugs have been delineated by the FDA. In case a recall because of severe permanent toxicity resulting from investigational drug, it is essential that records of its use for specific patients in a hospital should be readily available. 7. In cases where, investigational drugs are used on patients it is essential that such drugs be labeled to conform to legal requirements. It should be obvious that information must readily be available to assist physicians in other hospitals who may be required to treat patients suffering from accidental overdose of toxic symptoms. 8. It is essential that the supply of an investigational drug is available during the night and weekends as well as when the principal investigator is at the hospital if nurses are to maintain uninterrupted dosage schedule in the best interest of the patient. 9. It is common practice for physicians to obtain written consent from the patients prior to the use of an investigational drug. When the hospital pharmacist is called upon to handle an investigational drug he needs to maintain adequate dispensing records. DRUG DEFECT REPORTING Defect reported includes inadequate packaging; confusing or inadequate labels or labeling; deteriorated, contaminated, or defective dosage forms; inaccurate fill or count of a drug product; faulty drug delivering apparatus, etc. EMERGENCY DRUG LISTING The Pharmacy and Therapeutic Committee should develop a list of supplies and drugs which ought to be in an emergency box. Once the content of the box has been established and the responsibility for its stocking assigned, the units should be prepared and placed on each pavilion, in the clinic, in the emergency ward and in the special procedures room of the department of radiology.  Supplies to be maintained in the Emergency Box Syringes Needles: 2 # 16 4 – 2 ml 2 # 18 4 – 5 ml 2 # 20 1 – 20 ml 2 # 23 1 insulin 2 cardiac, #20, 4” Airway Files, ampuls Tourniquets Drugs for Emergency Box Aminophylline 0.25 Gm/10 ml Mannitol Injection 25% Amphetamine Sulfate 20 mg/ml Nalorphine HCl 10 mg/2 ml Neostigmine Methylsulfate 0.25 mg/ml Amyl Nitrate Inhalation Norepinephrine Injetion 0.2% Atropine Sulfate 0.4 mg/ml Pentobarbital 50 mg/ml Caffeine Sodium Benzoate 0.5 Gm/2ml Pentylenetetrazol Injection 0.1 Gm/ml Calcium Gluconate 1 Gm/10 ml Phenobarbital 120 mg/ml Chloroprophenpyrimadine Maleate 50 mg/ml Phenylephrine HCl 10 mg/ml Phytonadione Injection 50 mg/ml Digoxin 0.25 mg/ml Picrotoxin Injection 3 mg/ml Diphenylhydantoin Sodium 50 mg/ml Procaine Amide 100 mg/ml Epinephrine HCl 1:1000 Protamine Sulfate 10 mg/ml Heparin 10,000 Units/ml Saline for Injection 30 ml Hydrocortisone 100 mg Sodium Molar lactate solution Water for Injection 50 ml Isoproterenol 1:100 Metaraminol Bitartrate 10 mg/ml Magnesium Sulfate Injection 10% and 50% Assignment: Explain the process of reporting ADRs as Pharmacist in the Philippines. In a plain short bond paper. Format: Name of the Hospital Thru: Chief Pharmacist Body of Letter Sincerely, Noted by: Group Leader Noeme D. Ceynas Hospital Pharmacy Instructor