Hospital Pharmacy - Outline & Fundamentals PDF

Outline Definition Goals for hospital pharmacy Minimum standards for hospital pharmacy Organizational structure Pharmacy and therapeutics committee The hospital formulary Hospital drug distribution system Dispensing of controlled substances Definition Department of...

Outline Definition Goals for hospital pharmacy Minimum standards for hospital pharmacy Organizational structure Pharmacy and therapeutics committee The hospital formulary Hospital drug distribution system Dispensing of controlled substances Definition Department of hospital which deals with procurement, storage, compounding, dispensing, manufacturing, testing, packaging and distribution of drugs. It is also concerned with education and research in pharmaceutical services. Hospital Pharmacy is controlled by a professionally competent and a qualified pharmacist.  Goals for Hospital Pharmacy Broadly, the major goal is the advancement of rational, patient- oriented drug therapy in hospitals and other organized health care settings Specifically, To provide the benefits of a qualified hospital pharmacist to patients and health care institutions, to the allied health professions, and to the profession of pharmacy To assist in providing an adequate supply of such qualified hospital pharmacists To assure a high quality of professional practice To promote research in hospital pharmacy practices and in the pharmaceutical sciences To disseminate pharmaceutical knowledge Minimum Standards for Hospital Pharmacy Pharmaceutical services in institutions have numerous components, notably The procurement, distribution, and control of all pharmaceuticals used within the facility The evaluation and dissemination of comprehensive information about drugs and their use to the institution's staff and patients The monitoring, evaluation, and assurance of the quality of drug use However, this doesn’t provide detailed instructions for operating a hospital pharmacy Standard 1: Administration Directed by a professionally competent, legally qualified pharmacist The director of pharmaceutical services is responsible for: Setting the long-and short-range goals of the pharmacy Developing a plan and schedule for achieving these goals Supervising the implementation of the plan and the day-to-day activities Determining if the goals and schedule are being met Standard II: Facilities There shall be adequate space, equipment, and supplies for the professional and administrative functions of the pharmacy The pharmacy shall be located in an area (or areas) that facilitate (s) the provision of services to patients Space and equipment, in an amount and type to provide secure, environmentally controlled storage of drugs Space and equipment suitable for the preparation of sterile products and other drug compounding and packaging operations A private area for pharmacist-patient consultations Current drug information resources must be available Standard III: Drug Distribution and Control The pharmacy shall be responsible for the procurement, distribution, and control of all drugs used within the institution This service extends to drugs and related services provided to ambulatory patients Policies and procedures governing these functions shall be developed by the pharmacist with input from other involved hospital staff (e.g. nurses) and committees (pharmacy and therapeutics committee, patient-care committee, etc.). Standard IV: Drug Information The pharmacy is responsible for providing the institution's staff and patients with accurate, comprehensive information about drugs and their use and shall serve as its centre for drug. Standard V: Assuring Rational Drug Therapy An important aspect of pharmaceutical services is that of maximizing rational drug use. In this regard, the pharmacist, in concert with the medical staff, must develop policies and procedures for assuring the quality of drug therapy Standard VI: Research The pharmacist should conduct, participate in, and support medical and pharmaceutical research appropriate to the goals, objectives, and resources of the pharmacy and the institution. Organizational Structure For ease of selection and categorization of employees, it now becomes essential to develop a chart showing the flow of administrative authority In smaller hospitals, one room is required for pharmacy having a combination of dispensing, manufacturing, administrative and all other sections of complete pharmaceutical service. In large hospitals, with 200 or more beds, departmentalization of pharmacy activities is required.  Director of Pharmacy Associate director of pharmacy Administrative Unit dose dispensing Education and services division and administration training division  Research pharmacist  Assistant director of  Pharmacist specialist pharmacy  Assistant director of  A/director  Drug information  Assay and quality control pharmacy pharmacy services division  Inpatient services  Departmental  Central supply chain division services  Outpatient services  Purchase and division inventory Fig. Departmental organization in a large university hospital  Intravenous admixture control pharmacy operation division  Manufacturing and packaging Pharmacy and Therapeutics Committee Definition PTC–also called a Drug and Therapeutics Committee Committee designated to ensure the safe and effective use of medicines in the facility or area under its jurisdiction Evaluates the clinical use of medicines Develops policies for managing medicine use Administers and manages the formulary system Why PTCs Are Important? Medicines can save lives and improve quality of life but are expensive (30– 40% budget), widely misused, and can be dangerous (adverse drug reactions [ADRs] are common) Cont.…. Important benefits of a PTC— Selection of effective, safe, high quality, cost-effective medicines for the formulary Monitoring and identification of medicine use problems Improved medicines use, including antimicrobial use Improved quality of patient care and health outcomes Management of antimicrobial resistance Increased staff and patient knowledge Management of ADRs and medication errors Improved medicine procurement and inventory management Management of pharmaceutical expenditures Functions of a PTC To promote better quality of care and more rational use of medicines through— Advising medical, pharmacy, and administrative staff Developing pharmaceutical policies and procedures Evaluating and selecting formulary medicines Identifying medicine use problems Promoting interventions to improve medicine use Managing ADRs and medication errors PTC Advisory Functions Advise medical, administrative, and pharmacy departments Advise and support other hospital organizations on medicine-related issues Participate in hospital committees and departments on all matters concerning medicines Drug Policies and Procedures Lack of policies will adversely affect medicine selection, procurement, distribution, and use The DTC has the most expertise to develop policies on— New, nonformulary, restricted, investigational medicines Monitoring and evaluation of medicine use Interventions to promote rational use of medicines Pharmaceutical management issues in the hospital Pharmaceutical promotion (pharmaceutical representatives and literature) Evaluating and selecting medicine for the Formulary Explicit evaluation criteria Efficacy, relative efficacy, effectiveness Safety, quality, cost Consistent decision-making Evidence-based Local context Transparency Evaluation process uses current literature Primary sources (especially randomized controlled trials) Secondary sources (bulletins and reviews) Reliable and current tertiary sources (textbooks) Identifying medicine use problems Pharmaceutical procurement and availability Pharmaceutical distribution Medicine prescribing Administration and use ADR reports Medication error reports Antimicrobial resistance surveillance reports Identifying medicine use problems (Sources of data and types of analysis) Aggregate consumption data— From records of procurement records, pharmacy stock, patient records ABC, VEN ADR reports Medication error reports Antimicrobial resistance surveillance reports Health facility indicators and hospital antimicrobial indicators— indicate general trends in prescribing Drug use evaluation (DUE)— Indicates whether specific diseases are being treated with the correct medicine or whether specific medicines are being given for the correct indications Includes continuous monitoring and feedback Promoting Interventions to Improve Pharmaceutical Use Educational programs Pharmaceutical bulletins and newsletters In-service education Managerial programs Standard treatment guidelines (STGs) DUE Clinical pharmacy programs Structured order forms, automatic stop orders Regulatory programs Pharmaceutical registration Professional licensing Licensing of outlets Managing ADRs and Medication Errors The PTC should have a plan to— Monitor Assess Report Correct identified problems Prevent ADRs PTC: Structure and Organization Membership from medical, pharmacy, administration, nursing, public health Chief doctor is often the chairman Chief pharmacist is often the secretary Liaison with Infection Control Committee and Antimicrobial Subcommittee Regular meetings and regular attendance with minutes Documented goals, terms of reference, policies, decisions PTC - Structure and Organization Chairman Clinical Director or Executive Secretary, other appointed Director of Pharmacy physician Physician Pharmacy Nursing Administration Public Health Members Members Members Drug Surgeon Information Specialist Director of Administrative Officer Physician OB/Gyn Nursing or other appointee or Nursing Pharma- Representative cologist Internal Medicine/ Family Practice Recording Infectious Diseases Secretary Antimicrobial Subcommittee (To promote better use of antimicrobials) Addresses issues relating to antimicrobials including correct prescribing Develops policies concerning use of antimicrobials for approval by the PTC and medical staff Assists in evaluating and selecting antimicrobials for the formulary Organizes educational programs for health care staff Monitors antimicrobial resistance patterns  Infection Control Committee Develops and recommends policies and procedures pertaining to infection control Addresses environmental issues including food handling, laundry, hand washing, cleaning Obtains and manages bacteriological data Recognizes and investigates outbreaks of infections in the hospital and community Educates and trains health care workers, patients, and nonmedical caregivers on infection control Liaison between Committees Medical staff executive committee Infection Drug and Control Medical Service Therapeutics Committee Committee Antimicrobial Pharmacy Subcommittee PTC—Guiding Principles Transparent and unbiased decision making Explicit criteria and process Documentation Absence of conflict of interest including pharmaceutical manufacturers and suppliers Development and enforcement of a strict ethics policy for all activities of the committee Objectivity—Evidence-based approach and levels of evidence Consistency —Uniformity between formulary and STGs and between regional and national health care programs Impact orientation —Indicators of process, impact, and outcome Factors Critical to Success Establish clear goals and purpose Obtain wide representation on the committee—prescribers, nurses, pharmacists, and administration; obtain motivated, respected, and dynamic chairperson Permit no relation between committee and pharmaceutical manufacturers or suppliers  Cont.….. Communicate all PTC information, policies, procedures, recommendations, and actions to staff Obtain official status from the administration (local hospital director and regional health bureaus) with strong management support Develop medical and pharmacy departments and local professional schools support Ensure contextual incentives Monitoring PTC Performance: Process Indicators Is there a PTC document that indicates its terms of reference including goals, objectives, functions, and membership? Is there a PTC budget? What percentage of PTC members attend more than half of meetings? How many PTC meetings are held per year? Are there documented criteria for addition and deletion to the formulary? Have STGs been developed, adapted, and implemented? How many education programs were presented in the last year? How many intervention studies to improve medicine use been conducted? How many DUEs have been undertaken? Is there any documented policy for controlling access of pharmaceutical representatives and promotional literature to hospital staff? Monitoring PTC Performance: Impact and Outcome Indicators Medicine selection Number of medicines in the hospital formulary % prescribed drugs belonging to the hospital formulary Number of antimicrobials in the formulary Prescribing quality % of patients treated in accordance with STGs % of pharmaceutical treatments meeting agreed criteria of DUE Drug safety Mortality and morbidity rates per annum due to adverse consequences of medicine use (ADRs and medication errors)  Financial sustainability Cost of PTC activities versus the money saved through improving drug use and decreasing wastage Hospital Formulary Definition Formulary–A list of medicines that are approved for use in the health care system by authorized prescribers Formulary committee–The committee dedicated to selecting, developing, and maintaining a list of approved medicines for the hospital or clinic Formulary system– A system of periodically evaluating and selecting medicines for the formulary, and maintaining it; also providing information in a suitable manual or list Benefits of the formulary system Therapeutic provides the greatest benefit to the patient and physician in that only the most efficient products are listed and available Economic formulary eliminates duplication thus reducing inventory duplication Education significant for the resident staff, nurses and medical students Format and appearance of the formulary The physical appearance and structure of the formulary is an important influence on its use Elaborate and expensive artwork and materials are unnecessary, but the formulary should be visually pleasing, easily readable, and professional in appearance Proper grammar, punctuation, correct spelling, and neatness is obvious Composition of a typical formulary Title page Names and titles of the members of the PTC Table of contents Information on hospital policies and procedures concerning drugs Objectives and operation of the formulary system Hospital regulations and procedures for prescribing and dispensing drugs Hospital pharmacy services and procedures How to use the formulary Composition of a typical formulary Products accepted for use Items added and deleted since the previous edition Generic-brand name cross reference list Pharmacological/therapeutic index with relative cost codes Descriptions of formulary drug products by pharmacology therapeutic class Appendix Central service equipment and supply list Rules for calculating pediatric doses Nomogram for estimating body surface area Schedule of standard drug administration times Hospital Drug Distribution System Changes in the hospital drug distribution system Traditional methods of drug distribution in hospitals are now undergoing re-evaluation Some of the proposed changes for an optimal design for the drug distribution systems include: Before the initial dose of medication is administered the pharmacist should review the prescriber’s order Drugs dispensed should be as ready for administration to the patient and must bear adequate identification (e.g. name (s) of drug, strength, route, frequency) Facilities and equipment used to store drugs should be designed to facilitate routine inspection of the drug Cont’d… There are four systems in general use for dispensing and distributing drugs i) Individual prescription order system. (ii) Complete floor stock system. (iii) Combination of (i) and (ii). (iv) The unit dose method. Individual prescription order system Used by the small and/or private hospital because of the reduced manpower requirement and the desirability for individualized service Possible delay in obtaining the required medication and the increase in cost to the patient Advantages of this system: All medication orders are directly reviewed by the pharmacist Provides for the interaction of pharmacist, doctor, nurse and patient Provides closer control of inventory Complete floor stock system The nursing station pharmacy carries both “charge” and “non-charge” patient medications Usually expensive drugs are omitted from floor stock but are dispensed upon the receipt of a prescription or medication order Most often applicable in governmental, general hospital Advantages of this system: Ready availability of the required drugs Elimination of drug returns Reduction in the number of drug order transcriptions Reduction in the number of pharmacy personnel required Complete floor stock system Disadvantages of this system: Medication errors may increase Increased drug inventory on the pavilions. Greater opportunity for pilferage. Increased hazards associated with drug deterioration. Lack of proper storage facilities on the ward may require capital outlay to provide them. Greater inroads are made upon the nurse's time However, all of the above disadvantages will disappear if this system is operated as a decentralized pharmacy under the direct supervision of a pharmacist. Combination of individual prescription order system and complete floor stock system Implies that hospitals use the individual prescription order system as their primary means of dispensing, but also utilize a limited floor stock Most commonly used in hospitals today and is modified to include the use of unit dose medications Unit dose system Definition: Medications which are ordered, packaged, handled, administered and charged in multiples of single dose units containing a predetermined amount of drugs or supply sufficient for one regular dose application or use Cont.…. Advantages of this system: Improved pharmaceutical service 24 hours a day and are charged for only those doses Allows the nurse more time for direct patient care Reduce medication errors Eliminates excessive duplication of orders and paper work More efficient utilization of staff Unit dose system: Advantages Reduces revenue losses Conserves space in nursing units Eliminates pilferage and drug waste Extends pharmacy coverage and control Improved communication of medication orders and delivery systems The pharmacists can get out of the pharmacy Unit dose system: Distribution and control For reasons of safety and economy, the preferred method to distribute drugs in institutions is the unit dose system Differ in form depending on specific needs, resources, type of institution – but 4 elements are common: Medications are contained in, and administered from, single unit or unit-dose packages Medications are dispensed in ready-to-administer form For most medications, not more than a 24-hour supply of doses is provided to or available at the patient care area at any time A patient medication profile is concurrently maintained in the pharmacy for each patient Unit dose system: Distribution and control (Writing order) Medications should be given only on the written order of a qualified physician or other authorized prescriber Prescribers should specify the date and time medication orders are written Medication orders should be written legibly in ink and should include: Patient’s name and location Name (Generic) of medication Dosage expressed in the metric system Frequency of administration. Route of administration. Signature of the physician. Date and hour the order was written Unit dose system: Distribution and control (Medication order sheets) The pharmacist must receive the physician’s original order or a direct copy of the order before the drug is dispensed Permits the pharmacist to resolve problems with drug order before the drug is dispensed and administered Eliminates transcription errors Several methods by which the pharmacy may receive physician’s orders include: Self-copying order forms Electromechanical Computerized Unit dose system: Distribution and control (Special orders) Special orders (i.e., “stat” and emergency orders, and those for non- formulary drugs, investigational drugs, restricted-use drugs or controlled substances) should be processed according to specific written procedures meeting all applicable regulations and requirements.  Dispensing of Controlled Substances Definition Addict: Any individual who habitually uses any narcotic drug so as to endanger the public morals, health, safety or welfare, or who is so far addicted to the use of narcotic drugs as to have lost the power or self control with reference to his/her addiction Controlled Substances: A drug or other substance, or immediate precursor, included in schedule I, II, III, IV or V of scheduled drugs, and having a potential for abuse. It dose not includes distilled spirits, wine, malt beverages or tobacco. Definition Depressant or stimulant substance: A drug which contain any quantity of (1) barbituric acid or any of the salts of barbituric acid; or (2) any derivative of barbituric acid ;or A drug which contains any quantity of (1) amphetamine or any of its optical isomers; (2) any salt of amphetamine or any salt of an optical isomer of amphetamine; or (3) any substance designated as having habit-forming because of its stimulant effect on the CNS Lysergic acid diethylamide; or Any drug which have a potential for abuse because of its depressant or stimulant effect on the CNS or its hallucinogenic effect Definition Narcotic Drug: Any of the following, whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis. Opium, coca leaves and opiates. A compound, manufacture, salt, derivative, or preparation of opium, coca leaves or opiates A substance which is chemically identical with any substance mentioned above Excluded are decocainized coca leaves or extracts of coca leaves, which do not contain cocaine. Schedules for Controlled Substances Schedule I E.g. cannabis Schedule II E.G. morphine, pethidine, oxycodone Schedule III E.g. midazolam Schedule IV E.g. ketamine, cholrdiazepoxide Schedule V E.g. codeine Controlled substances: Prescriptions In dispensing of controlled substances, the following requirements should be considered with prescriptions: Except when dispensed Drugs may be dispensed on the oral prescription in an emergency situation Prescription shall be retained in conformity with the requirements of the law  No prescription for a controlled substance in Schedule II may be refilled Schedule III or IV may not be dispensed without a written or oral prescription in conformity Such prescriptions may not be filled or refilled more than 6 months Regulations of controlled substances Standard operating procedures: Who has access to CDs Where and how CDs are stored How CDs are transported within the organisation How CDs are destroyed and disposed of Who is alerted if complications or concerns arise or incidents occur What records need to be maintained, including relevant CD register requirements How records of schedule 2 drugs that have been returned by patients are kept and managed  Cont.… Routine monitoring and audit By pharmacy staff at least every 3 months Both audit and reconciliation - detect discrepancies between amounts supplied and amounts prescribed Periodic checks of pharmacy-held CD by appropriate personnel Regulations of controlled substances Medicines management Storage: Adequate degree of security (e.g. CD cabinet) Opened by a person who can lawfully be in possession of CDs CD cupboards should not be used to store anything else Minimal access to other staffs  Cont.… Ordering and transport: Supplies order book for CDs must be stored securely Verify that the person placing the order is authorised to order A retrievable record when a CD moves from the authorised possession of one person to another Administration: A record of the administration of CDs should be made in patient specific documentation Regulations of controlled substances CD record-keeping requirements A record should be kept of all CDs that are received or issued Stock balance of all medicines entered in the CD record book should be checked CD record books can vary and purpose specific records books are also used (e.g. theatre CD record book and patients’ own medicines CD record book) Record information about the identity of the person collecting CDs CD prescribing Doctors and dentists Nurse and pharmacist independent prescribers  Cont.… CD destruction Unwanted or out-of-date stock CD medicines Authorized person under regulation Witness for destruction Summary???