Hospital Pharmacy Notes Prelims PDF

PHCARE 3105 | HOSPITAL PHARMACY MODULE 1 | INTRODUCTION TO HOSPITAL PHARMACY PRACTICE scope of patient care services TERMINOLOGIES within that setting. INSTITUTIONAL PHARMACY...

PHCARE 3105 | HOSPITAL PHARMACY MODULE 1 | INTRODUCTION TO HOSPITAL PHARMACY PRACTICE scope of patient care services TERMINOLOGIES within that setting. INSTITUTIONAL PHARMACY - A more common role for PRACTICE - provision of distributional pharmacists actually beyond and clinical pharmacy services at a broad prescribing is their duty. to range of institutional settings-hospitals, influence the prescribing of other long-term care, hospice, correctional health professionals. facilities, etc. - Pharmacists indirectly Influence - These institutions that pharmacists prescribing by acting as serve are formally or informally information resources about linked together into Integrated medications, providing feedback health systems. about the quality of prescribing, - At one time, institutional pharmacy and developing prescribing practice referred almost exclusively protocols through the formulary. to service in hospital pharmacies. TRANSCRIBING - process by which a INTEGRATED HEALTH SYSTEM - prescriber's written order is copied and integrates all care under the umbrella, of a either manually or electronically entered central organization. into pharmacy records. - Often includes inpatient/acute care - Pharmacists must understand primary/outpatient care, long-term potential breakdowns in the care, and home care transcribing process and help find ways to minimize errors. HEALTH SYSTEMS - collection of organizations and institutions whose DISPENSING - act of physically mission is to positively impact health transferring the drug product following outcomes. review and approval of the prescription to - Although they are made up of the area responsible for administering the independent entities, they are medication to the patient. systems because the entities are - Also, an area where medication interdependent and unified. errors can occur, including but not limited to wrong drug. wrong dose, PHARMACY'S ROLES IN THE or wrong dosage form errors. MEDICATION USE PROCESS ADMINISTRATION - medication PRESCRIBING - often viewed as administration to the patient in hospitals is something that only physicians are typically managed by nurses. authorized to do. - Last step before patients are given PRIVILEGING - a formalized their medications, and errors at this process in hospitals by which an point cannot be corrected oversight body of a health care - Nurses usually serve as the final organization or other appropriate check in the medication-use provider body, having reviewed an process. individual health care provider's - Pharmacists help improve safety of credentials and performance and medication administration by found them satisfactory, authorizes clearly labeling medications, using that individual to perform a specific bar-coding systems and unit dose packaging, reducing the time and 1 | Maia Lujan, BSPharmacy 3-C PHCARE 3105 | HOSPITAL PHARMACY MODULE 1 | INTRODUCTION TO HOSPITAL PHARMACY PRACTICE effort involved in accessing drugs, - The pharmacist is not actively and using technology that reduces involved with the health care team administrations errors (e-g. smart or in the development of pumps) therapeutic plans for the patient. Therefore, they are not MONITORING - critical phase where accountable for the health pharmacists play a vital role. outcomes of patients and exert - This includes reviewing laboratory little leadership in influencing the values that are correlated with the medication-use process. expected medication- therapy outcomes, as well as other CLINICAL-PHARMACIST-CENTERED objective and subjective factors MODEL that indicate whether the therapy is ➔ CLINICAL PHARMACISTS - effective, or may be having a toxic chiefly involved in clinical activities effect. associated with medical teams. In this model, they accept little or no responsibility for the MEDICATION USE PROCESS 1. Prescribing medication-use or delivery 2. Transcribing systems. 3. Dispensing - Their primary responsibility 4. Administration is to assist physicians and 5. Monitoring other health professionals in avoiding and solving PRACTICE MODELS clinical problems. PRACTICE MODELS - operational ➔ DISTRIBUTIVE PHARMACISTS - structure that defines how and where spend most of their time in drug pharmacists practice, Including the type of distribution, reviewing orders and drug distribution system used, the layout verifying the accuracy of and design of the departments, how medication preparation by pharmacists spend their time, practice technician. functions, and practice priorities. - Since little or no collaboration - It is probably the most important occurs between the two, the latter factor determining the role and are selectively accountable for the effectiveness of the pharmacy medication-use process. department. - It sets the stage and defines the PATIENT-CENTERED INTEGRATED roles MODEL - all pharmacists in the department accept responsibility for all 3 MAJOR TYPES OF PHARMACY elements of the medication-use process PRACTICE MODELS and therefore spend their time on both DRUG-DISTRIBUTION CENTERED clinical and distributive functions. MODEL - pharmacists primarily distribute - Many distribution tasks are drugs and process new medication orders. delegated to well-trained pharmacy - They have a reactive role where technicians, so the pharmacists' they respond to requests of roles in drug distribution are often physicians and nurses but rarely limited. initiates major changes in therapy. - Pharmacists are able to expand their clinical roles to more active 2 | Maia Lujan, BSPharmacy 3-C PHCARE 3105 | HOSPITAL PHARMACY MODULE 1 | INTRODUCTION TO HOSPITAL PHARMACY PRACTICE engagement as part of an interdisciplinary team. PHARMACY TECHNICIANS - integral in - Pharmacists exhibit a high degree the purchasing, stocking, preparation, and of ownership of and accountability compounding of medication which are all for the entire medication process under the direct supervision of the pharmacist. KEY INDIVIDUALS PHARMACISTS - responsible for the HOSPITAL PHARMACY PRACTICE preparation of medications, either directly HOSPITAL PHARMACY SERVICES - are or through supervising the preparatory about providing high-quality patient care work of pharmacy technicians. by bringing expertise on medicines to the DISPENSING PHARMACISTS - most healthcare team. It is about ensuring safe traditional role, play an important role in and effective use of medicines, and verifying that medications are prepared ensuring that resources are widely used - correctly and are dispensed accurately. cost-effective use of medicines. CLINICAL PHARMACISTS - are likely to ➔ On top of a pharmacist's basic serve on Interdisciplinary patient-care responsibility, it includes talking to teams, and interact directly with patents. patients about their drug regimen, - They usually have clinical checking their understanding of pharmacy training and often have how to use their medicines and completed a pharmacy residency. involving them in the decision-making process regarding GENERALISTS - provide clinical their medicine. pharmacy services to a wide range of patients It is vital that services are SPECIALISTS - have a defined expertise patient-focused, not pharmacocentric. in one or more areas (critical care, oncology. etc.) INTEGRATED PRACTICE - the MINIMUM STANDARDS OF pharmacist has both dispensing and PRACTICE clinical roles. ASHP GUIDELINES - Minimum - This Is the most prevalent role in Standard for Pharmacies in Hospitals, Institutional practice. 2012 Pharmacists in management usually MINIMUM STANDARDS OF PRACTICE serve as the supervisor for pharmacy ASHP GUIDELINES : MINIMUM activities or as the director for the STANDARD FOR PHARMACIES IN pharmacy department. HOSPITALS, 2012 ELEMENTS OF CARE Other pharmacist roles are evolving. 1. Practice Management - This include those who 2. Medication-Use Policy are responsible for Development informatics, 3. Optimizing Medication Therapy investigational drug 4. Drug Product Procurement and services; research, Inventory Management sterile compounding, and 5. Preparing, Packaging, and emergency care Labeling Medications 3 | Maia Lujan, BSPharmacy 3-C PHCARE 3105 | HOSPITAL PHARMACY MODULE 1 | INTRODUCTION TO HOSPITAL PHARMACY PRACTICE 6. Medication Delivery 7. Monitoring Medication Use PRACTICE 8. Evaluating the Effectiveness of the VITAL ROLE Medication-Use System ➔ Provision of safe, effective and 9. Research quality pharmaceutical products ➔ Pharmaceutical care GENERAL PRINCIPLE ➔ Drug information The pharmacy is an essential ➔ Patient medication counseling. service of a hospital, responsible ➔ Health promotion for the provision of pharmaceutical Sec. 4 of R.A. 10918 care to patients. SERVICES OF A HOSPITAL UHC - “provide every Filipino the highest PHARMACY quality of healthcare, efficient, equitably Dispensing distributed, fairly financed and Clinical Pharmacy appropriately used by an informed and Drug Information Service empowered public" Compounding Training ➔ Client-friendly pharmacy in Research accordance with its ethical and Administrative professional practice Hospital Pharmacists + other Healthcare Providers = Better Health Outcome of all patients Ensure that quality pharmaceutical care is provided through application standards and methods to which the patients are the prime beneficiary GOALS ➔ Optimal therapeutic outcome and medication safety for all patients ➔ Application of new methods and techniques on pharmaceutical care in relation to patient safety ➔ Elevate pharmacy stature by enhancing its services through the use of automation technology and capacity building of the management and the workforce. 4 | Maia Lujan, BSPharmacy 3-C PHCARE 3105 | HOSPITAL PHARMACY MODULE 2 | HOSPITAL AND ITS ORGANIZATION (DOH A.O. 2012-0012) foundation, religious, NGO, or HOSPITAL AND MEDICAL CENTER others. HOSPITAL - place devoted primarily to the maintenance and operation of health ACCORDING TO SCOPE OF SERVICES facilities for the diagnosis, treatment, and 1. GENERAL - provides services for care of individuals suffering from illness, all kinds of illnesses, diseases, disease, injury, or deformity or in need of injuries, or deformities. It shall obstetrical or other surgical, medical, and provide medical and surgical care nursing care. to the sick and injured, maternity, - It shall also be construed as an newborn, and child care. institution, building, or place where - It shall be equipped with there are installed beds, cribs, or the service capabilities bassinets for twenty-four-hour use needed to support medical or longer by patients in the specialists and other treatment of diseases. licensed physicians rendering services in, but MEDICAL CENTER - hospital staffed and not limited to the following: equipped to care for many patients and for Clinical Services: a large number of kinds of diseases and Fam Med, Pedia, dysfunctions using modern technology. IM, ObGyne, Surgery Emergency CLASSIFICATION OF HOSPITALS Services ★ According to Ownership Outpatient Services ➔ Government Ancillary and ➔ Private Support Services ★ According to Scope of Services such as clinical ➔ General laboratory, imaging ➔ Specialty facility, and ★ According to Functional pharmacy Capacity ➔ Level 1 2. SPECIALTY - specializes in a ➔ Level 2 particular disease or condition or in ➔ Level 3 one type of patient. It may be devoted to the treatment of any of ACCORDING TO OWNERSHIP the following: 1. GOVERNMENT - created by law. It Treatment of a particular may be under the national type of illness or for a government, DOH, LGU, DND, particular condition PNP, DOJ, SUCs, and others. requiring a range of 2. PRIVATE - owned, established, treatment. and operated with funds through Treatment of patients donation, principal, investment, or suffering from diseases of a other means by any individual, particular organ or group of corporation, association, or organs organization. It may be a single Treatment of patients proprietorship, partnership, belonging to a particular corporation, cooperative, 1 | Maia Lujan PHCARE 3105 | HOSPITAL PHARMACY MODULE 2 | HOSPITAL AND ITS ORGANIZATION (DOH A.O. 2012-0012) group such as children, ➔ A DOH-licensed level I imaging women, elderly, and others facility with the services of a consulting radiologist ACCORDING TO FUNCTIONAL ➔ A DOH-licensed pharmacy CAPACITY GENERAL HOSPITAL LEVEL 2 LEVEL 1 LEVEL 2 - it shall have as a minimum, all LEVEL 1 - it shall have as minimum the of Level 1 capacity, including, but not services stipulated under Rule V. B. 1. b. limited to, the following: 1. of this Order, including. but not limited ➔ An organized staff of qualified and to the following: competent personnel with a Chief ➔ A staff of qualified medical, allied of Hospital/Medical Director and medical, and administrative appropriate board-certified Clinical personnel headed by a physician Department Heads duly licensed by PRC ➔ Departmentalized and equipped ➔ Bed space for its authorized bed with the service capabilities capacity in accordance with DOH needed to support board Guidelines in the Planning and certified/eligible medical specialists Design of Hospitals and other licensed physicians ➔ An operating room with standard rendering services in the equipment and provision for specialties of Medicine, Pediatrics, sterilization of equipment and obstetrics and Gynecology, supplies in accordance with: Surgery, their subspecialties, and a. DOH Reference Plan in the ancillary services Planning and Design of an ➔ Provision for general ICU for Operating Room/Theater critically ill patients; (Annex A). ➔ Provision for NICU b. DOH Guidelines on ➔ Provision for HRPU Cleaning, Disinfection, and ➔ Provision for respiratory therapy Sterilization of Reusable services Medical Devices in Hospital ➔ A DOH-licensed tertiary clinical Facilities in the Philippines laboratory (Annex B); ➔ A DOH licensed level 2 imaging ➔ A post-operative recovery room facility with mobile x-ray inside the ➔ Maternity facilities, consisting of institution and with capability for the ward(s), room(s), a delivery contrast examinations. room, exclusively for maternity patients and newborns LEVEL 3 ➔ Isolation facilities with proper LEVEL 3 - it shall have as a minimum, all procedures for the care and control of Level 2 capacity, including, but not of infectious and communicable limited to, the following: diseases as well as for the ➔ Teaching and/or training hospital prevention of cross infections with accredited residency training ➔ A separate dental section/clinic program for physicians in the four ➔ Provision for blood station (4) major specialties namely: ➔ A DOH-licensed secondary clinical Medicine, Pediatrics, Obstetrics laboratory with the services of a and Gynecology, and Surgery consulting pathologist; 2 | Maia Lujan PHCARE 3105 | HOSPITAL PHARMACY MODULE 2 | HOSPITAL AND ITS ORGANIZATION (DOH A.O. 2012-0012) ➔ Provision for physical medicine - Each clinical department shall and rehabilitation unit meet the membership ➔ Provision for the ambulatory requirements of the concerned surgical clinic specialty/subspecialty society ➔ Provision for dialysis facility recognized by the Philippine ➔ Provision for blood bank Medical Association. ➔ A DOH-licensed tertiary clinical ➔ Department of Internal laboratory with standard Medicine equipment/reagents/supplies ➔ Department of necessary for the performance of Anesthesiology histopathology examinations ➔ Department of Obstetrics ➔ A DOH licensed level 3 imaging and Gynecology facility with interventional radiology. ➔ Department of Pediatrics CHIEF OF HOSPITAL - supports and approves all requirements necessary for the operation and management ADMINISTRATIVE OFFICE ADMINISTRATIVE OFFICER - supervises the over all operations and regulatory compliance MEDICAL SERVICE DOCTORS (CLINICAL DEPARTMENTS) - closely coordinate with the pharmacists through the PTC on the selection, rational drug use, and other drug and pharmacy related matters NURSING SERVICE NURSES (NURSING UNITS) - participate in the regular pharmacy monitoring of medicines stored in the wards (proper storage, movement and utilization of medicines), - Provide data on medication errors, adverse drug experiences and other drug-related concerns MEDICAL-SOCIAL SERVICE - help patients in acquiring financial aid - Provide information on the financial DEPARTMENT capability of the patients and DEPARTMENT - administrative units in a availability of sources for the hospital with a clearly articulated mission pharmaceutical requirements of that includes education, research, and the patients in the service wards. clinical service in the field of medicine. 3 | Maia Lujan PHCARE 3105 | HOSPITAL PHARMACY MODULE 2 | HOSPITAL AND ITS ORGANIZATION (DOH A.O. 2012-0012) persons with physical and/or cognitive MEDICAL RECORDS impairment and disability HOSPITAL HEALTH INFORMATION - collects and safe keeps patients' medical RESPIRATORY THERAPY UNIT records (CARDIO-PULMO UNIT) - has the - Provide drug information and necessary equipment needed for the database on Patient's Medication provision of respiratory care. Records whenever necessary RADIOLOGY DIETARY - provide referrals (on request) for total parenteral nutrition and information on any drug-food interactions FINANCE - analyze the financial reports submitted by the pharmacists that are used as a basis for the hospital pharmacy budget estimate. PROPERTY AND SUPPLY - facilitate the procurement of supplies and materials needed LABORATORY LABORATORY - provide the pharmacist’s information on antimicrobial resistance and susceptibility necessary for drug procurement and dispensing. OTHER HOSPITAL UNITS ★ Dental Clinic ★ Emergency Department ★ Intensive Care Unit (ICU) ★ Physical Medicine and Rehabilitation Unit ★ Respiratory-Therapy Unit (Cardio-Pulmo Unit) ★ Radiology INTENSIVE CARE UNIT - where patients require close monitoring. continuous attention and intensive/critical care are kept. ➔ NICU ➔ PICU ➔ SIC PHYSICAL MEDICINE AND REHABILITATION UNIT - involves the diagnosis, evaluation, and management of 4 | Maia Lujan HOSPITAL PHARMACY PCare 3105 – SC 1739 competence, and for compliance with licensing MODULE 3: HOSPITAL PHARMACY DEPARTMENT requirements. Organization Three Major Categories The Hospital Pharmacy is organized in accordance 1. Management - Chief Pharmacist and/or Supervising with the minimum requirements set by the FDA, and the One- Pharmacist/s - Responsible for the procurement, Stop Shop Licensure of the Health Facilities and Services distribution, and control of all drug products used within Regulatory Bureau (HFSRB), Philippine Drug Enforcement the hospital; in the management of pharmacy personnel; Agency (PDEA), and Professional Regulation Commission and in the maintenance and proper implementation of (PRC). established standards in the operations. One-Stop Shop (OSS) - a strategy employed by the 2. Professional/Technical Staff - Senior and Staff DOH to harmonize the licensure of hospitals and other health Pharmacists - Procure, distribute, and control drug facilities including, but not limited to, their ancillary and support products; provide clinical pharmacy service; and supervise services. support staff. The Hospital Pharmacy has been structures in a way 3. Support Staff - Provide assistance to the pharmacist. that it can manifest and specify administrative line of authority, functional responsibilities, accountabilities, and designation of Competencies employees. *2015 Philippine Practice Standards for Pharmacists PhilPSP) Practice Area4: Level 1: Pharmacist II Competency Standard No.1 - Provides quality medicines and Pharmacist I other health products appropriate to the needs of the client/ Administrative Aide IV patient. Level 2: Competency Standard No. 2 - Compounds products in a Pharmacist III manner that ensures product, quality, safety, and efficacy. Pharmacist I Competency Standard No.3 - Counsels client/patient on the Administrative Aide II safe and judicious use of medicines and other health products. Level 3: Competency Standard No. 4 - Engages actively in Pharmacist V client/patient safety and health promotion activities. Pharmacist IV Pharmacist II Competency Standard No. 5 - Ensures business Administrative Aide II sustainability through efficient processes and systems. For Government-owned and Controlled Corporation (Specialty Hospitals): Qualifications Pharmacist VI - head of the Ancillary Services Dept. Chief Pharmacist Supervising Pharmacists Pharmacy Support Personnel: Clinical Pharmacists Pharmacy Aide Staff Pharmacists Pharmacy Assistant Pharmacy Assistant Pharmacy Technician. Administrative Assistant Personnel Job Descriptions Pharmacists must be licensed in accordance with PRC. Chief Pharmacist - responsible for the overall operation of the Support personnel must have basic educational hospital pharmacy. qualifications and training. Supervising Pharmacist - assists the Chief Pharmacist in the All personnel are provided with regular continuing management and administrative of the pharmacy. education and training to maintain proficiency, Dispensing Supervisor Clinical Supervisor Condino, kane aldriCh C. 1|Page Bsphar 3-a HOSPITAL PHARMACY PCare 3105 – SC 1739 Dispensing Service Pharmacy Location, Practices and Premises Considered as the main function of the Pharmacy. The pharmacy should be located within a suitable Where technical abilities of the pharmacists are utilized. area of the hospital, which is accessible and visible to in and Requires expertise in the pharmacology, pathophysiology, out patients, business offices, frontline services and to the therapeutics, patient care and basic communication skill. general public. *The knowledge in medicines and their actions is the A work flow chart must be posted in a conspicuous fundamental contribution to health care by a dispensing area within the vicinity. pharmacist. The pharmacy must be compliant to the following FDA and Clinical Service international regulatory standards and requirements such as: This service includes: GMP Drug product information - collection, organization, GDP retrieval, interpretation and evaluation of the applicable GSP literature in an appropriates fashion. GCP Collection of the pharmacy patient data base Cold-chain management Patient education/counseling Drug Utilization Review (DUR) Other Requirements Adverse Drug Reaction (ADR) detection, reporting and Required by the FDA monitoring Records/e-file (e.g. distribution records, Patient Medication May not be directly associated with the dispensing of Profile, Senior Citizen and Person with Disability records) medicines, but has become part of the overall pharmacy Standard Operating Procedures of: activity. o Pharmacovigilance Also requires comprehensive knowledge on medicines, o Procurement of stocks diseases, patient and drug product variables, and the o Dispensing of pharmaceutical products ability to interact with other health care professionals. o Distribution of stocks to different stations/areas o Extemporaneous compounding /Non-sterile Job Descriptions compounding Clinical Pharmacist - direct interaction with patients, and work o Storage of stocks including temperature monitoring collaboratively with health care team. and retention of monitoring records (per DOH Administrative Order No. 2013-0027) Staff Pharmacist - undertake all other pharmacy activities. o Cold chain management o Handling complaints, product recall, and returned Pharmacy Assistant/ Administrative Assistant - assist to products expedite acquisition of administrative needs/ requirements and o Destruction/disposal of pharmaceutical products facilitate provision of pharmaceutical services. (expired, damaged, unusable stocks) o Disposal of used empty vials Operational Requirements o Sanitation program indicating the frequency of Statutory and Regulatory requirements of the: cleaning and the methods to be used Health Facility Services and Regulatory Bureau o Programme projects/ programs (e.g. Donated (HFSRB) products, Anti-TB, etc.) FDA o Hospital Formulary PDEA o Maximum Drug Retail Price/ Government Medicated Other regulatory bodies access prices o Temperature and relative humidity monitoring record Requirements in Securing LTO o Certificate of calibration of equipment (e.g. DOH A.O. No. 2018-0015 - Revised Guidelines in the Thermometer, thermohygrometer, etc.) Implementation of the One-Stop-Shop Licensing o Information, Education and communication materials System (properly displayed) FDA Circular 2014-025 o Risk Management Plan (per FDA Circular No. 2018- A.O. No. 2021-0017 0013) A.O. 2014-0034 Other pertinent existing rules and regulations Condino, kane aldriCh C. 2|Page Bsphar 3-a HOSPITAL PHARMACY PCare 3105 – SC 1739 Relevant Reference Materials o Republic Acts o WHO Good Dispensing Practice and Good Storage Practice Guide o Philippine National Formulary, latest edition o United States Pharmacopoeia/ National Formulary (US-NF), latest edition o Standard Practice Guidelines o Pharmacovigilance-related references Condino, kane aldriCh C. 3|Page Bsphar 3-a HOSPITAL PHARMACY PCare 3105 – SC 1739 labeling and packaging practices, in patient drug distribution procedures, handling of drug requests). MODULE 4: HOSPITAL FORMULARY Contents of a Hospital Formulary Hospital Formulary System Information on using the formulary Process in which the list of drug products of formulary of the Pharmacologic category of medicines hospital is developed. Brief description of the PTC Policies on pharmaceutical company representatives It is the method where the medical staff of a hospital working Procedures on reporting ADEs and Medication errors with the PTC evaluates, appraises, and selects from among the numerous available medicinal agents and dosage forms Drug Product List – Heart of the formulary those that are considered most useful in patient care. At a minimum each entry must include: The system provides the pharmacists time to work with: Generic name Medical Staff - selection, evaluation of new drug products and Dosage form(s), strength(s), packaging(s) and size(s) critical use of therapeutic agents, and in the promotion of stocked at the Pharmacy rational drug therapy. Formulation (active ingredients) of a combined product Nursing Staff - avoid practices and procedures which may Entries may be arranged: lead to medication errors Alphabetically, by generic name Alphabetically, within therapeutic class Both medical and nursing staff - implementation of policies A combination of the two systems where most are listed concerning the use of drug products in the hospital. alphabetically in a general section which is then supplemented by several special sections. Objectives It serves to educate physicians on the relative merits of Drug listing indices - by generic name or available medicines to provide rational therapeutics and therapeutic/pharmacologic index promote quality patient care. Appendices It serves as a teaching aid to the interns and other medical Pharmacologic/ Therapeutic Index staff by providing essential information. Special information which are not readily available in other It prevents unnecessary duplication, wastage and sources confusion on prescribed medications, thus promote List of hospital-approved abbreviations savings to both the hospital and patient. Table of sodium content of antacids It promotes safe, intelligent, and effective therapy in a List of the contents of the E-cart hospital. Dosage guides for patients with impaired renal function Metric conversion scales and tables Examples of request for deletion/inclusion and Hospital Formulary prescription forms Cornerstone of drug management in the hospital, and is Provisions of the Generics Act the principal concern of the PTC. Table of drug interactions A continually revised compilation of pharmaceuticals, which reflects the current clinical judgment of the medical Poison antidote charts staff and the relevant policies on medication. It is tailored to fit the needs of the hospital and reflects departmental consensus on the first choice treatment from the national list. It should be handy, complete, concise and easy to use. Contents of a Hospital Formulary Title page Names and titles of the members of the PTC Table of Contents Information on hospital policies and procedures concerning drugs/medicines. Objectives and operation of the formulary system Hospital policies regarding the prescribing, dispensing, and administration of drug products, including administration times. Pharmacy operating procedures (hours of service, out patient prescription policies, charging system, Condino, kane aldriCh C. 1|Page Bsphar 3-a HOSPITAL PHARMACY PCare 3105 – SC 1739 Drug Interactions Formularies can be categorized by their access to Dosage Range medications: Dosage Form and Cost Summary Open Formulary - Generally large and has no limitation to Recommendation access to a medication. References Closed Formulary - Limited list of medications; It may limit Outcome Assessment drugs to specific physicians, patient care areas, or disease Drug Use Evaluation (DUE) states via formulary restrictions. A systematic process used to assess the appropriateness of drug therapy by engaging in the evaluation of data on drug use Formulary Restriction in a given health care environment against predetermined The act of limiting the use of specific formulary medications to criteria and standards. specific physicians based on areas of expertise, patient disease state, or hospital location. Medication Use Evaluation (MUE) Encompasses the goals and objectives of the DUE, with an It does not necessarily translate to optimal medication emphasis on improving patient outcomes. management. Therefore, the key is to carefully consider the potential impact of formulary restrictions prior to Due Criteria implementation and to monitor the actual impact after Diagnosis-related DUE criteria - identify indications for implementation. which select drug/s may be appropriate for a given disease state. Therapeutic Equivalents Prescriber-related DUE criteria - identify the specific Drug products with different chemical structure but are of the physicians whom the PTC has determined may use same pharmacologic and/or therapeutic class and are certain drugs. expected to have similar therapeutic effects and adverse Drug-specific DUE criteria - focus on specific aspects of effects. a select drug such as the dose or dosing frequency. Therapeutic Interchange Medication Use Formularies Authorized exchange of therapeutic alternatives in accordance Formulary Management with previously established and approved written guidelines. Formulary policies should include information on who may use a specific agent , how a drug is added or deleted from Establishment of therapeutic equivalents extends beyond the the formulary, how a drug is stocked, and which drugs are chemical entity. It must include the dosage strength, dose stocked and who gets to decide. frequency, and route of administration for the interchange. The formulary restriction policy should specifically define how items are selected for formulary restriction, rationale for selecting approved prescribers, and a method for managing the process. A formulary policy should describe the method for drug addition and deletion as well as nonformulary drug use. PTC - The policy should address the committee membership, operation, and responsibilities. Medication Prescribing, Dispensing, and Administration Organizational policies on the prescribing, dispensing, and New Product Evaluation administration of pharmaceuticals are required and necessary Pharmacists have the opportunity to assume a leadership role to ensure safe medication use. Such policies should address in the selection of agents to the formulary. The evaluation of an all aspects of the medication use process. agent should consider the indications for use, pharmacokinetics, safety, and cost. The published formulary should provide information on the medications approved for use, basic therapeutic information Development of a standard format for new drug evaluations is about each item, information on medication use policies and useful in facilitating PTC discussions. Standard elements procedures, and special information about medications such as include: dosing guidelines among others. Generic Name Trade NameDrug Interactions Therapeutic or Pharmacological class Pharmacology Pharmacokinetics Indications for Use Clinical Studies Adverse Effects/Warnings Condino, kane aldriCh C. 2|Page Bsphar 3-a HOSPITAL PHARMACY PCare 3105 – SC 1739 senior manager (executive director) and to the board of MODULE 5: PHARMACY MANAGEMENT AND CONTROL directors for all aspects of medicine management. Hospitals are extremely complex organizations that depend on Effective management of pharmacy services demands high experienced, well-trained managers and clinicians with good levels of leadership and team work. The chief pharmacist is not management skills for the development and delivery of high- only required to lead the pharmacy service but also to act as quality, efficient and patient-centered services. an advocate for and representative of the service within the organization as a whole. Leadership and management are two distinct but related activities. They are often confused because they both seek to bring about change in organizations by influencing behavior. The distinction between the two may be irrelevant but it can highlight different strategies employed in influencing individuals. Organizations need individuals who are both good leaders and managers. What is Leadership? It is the process through which an individual attempts to intentionally influence another individual or group in order to achieve a goal. It is more concerned with finding direction and purpose in the face of critical challenges. What is Management? It is about organizing to achieve desired purposes efficiently, effectively and creatively. Leaders focus on getting people to commit to a common goal, while Managers concentrate on getting people to take action toward that goal. A good manager will require leadership skills, but leadership must be displayed by staff at all levels if they are to navigate local circumstances and deliver the best care possible for patients. Pharmacy managers make a critical contribution to patient care by applying a wide variety of skills, expertise and experience to the delivery and development of clinical and support services that are compatible with the overall aims of the hospital. Chief pharmacist - where overall managerial responsibility for the pharmacy service will rest, who, in turn, is accountable to a Condino, kane aldriCh C. 1|Page Bsphar 3-a PCARE 3105 | HOSPITAL PHARMACY POST-ACTIVITY (PRELIMS) or for patients with renal or hepatic MEDICINE MONOGRAPH KEY impairment. MEDICINE MONOGRAPH KEY - PRECAUTIONS - details harmful summarizes and describes the types of conditions related to the use of the information contained in this edition that medicine (e.g., exacerbations, increased physicians and dentists can utilize in risk of adverse effects), and disease prescribing medicines for their patients. states or patient populations where - This key also shows the format of caution is advised. how the prescribing information is - This may also include precautions arranged. for breastfeeding mothers and nursing infants. - Black Box Warnings are included. ➔ Generic name ADVERSE DRUG REACTIONS - denotes ➔ Brand name ➔ Dosage form/ strength side effects and adverse drug reactions ➔ Indication/s (ADRs) listed in the official FDA-approved ➔ Contraindications labeling. ➔ Dose - Only Common ADRs are listed in ➔ Dose adjustment/s this Formulary. ➔ Precautions - A complete listing of ADRs can be ➔ Adverse drug reactions ➔ Administration viewed on the online copy of the ➔ Drug interaction/s formulary. ➔ Pregnancy category DRUG INTERACTION/S - effects and ➔ ATC code implications of the concomitant administration of different medicines, or INDICATIONS - Philippine FDA-approved their use together with food. indications. ADMINISTRATION - recommendations on - In addition, the indications listed for the proper intake or administration of the Anti-Infective Agents are the medicines. restricted to those included in the PREGNANCY CATEGORY - based on the most current local clinical practice US FDA Pregnancy Risk Categories. guidelines that were made ATC CODE - based on the WHO available to the editors and/or the ATC/DDD Index 2016. (WHO latest published recommendations Collaborating Centre for Drug Statistics of the Philippine Antimicrobial Methodology). Resistance Surveillance Program (ARSP). PHILIPPINE GENERAL HOSPITAL CONTRAINDICATIONS - details disease OWNERSHIP : Public states where and patient populations for SCOPE OF SERVICES : General whom the medicine should not be used. FUNCTIONAL CAPACITY : 3 DOSE - lists dosages of the medicines for SAN LAZARO HOSPITAL adult, child, and elderly patients, if OWNERSHIP : Public specified, as indicated in the official SCOPE OF SERVICES : Specialty FDA-approved labeling and/or other main (Infectious Diseases) references. FUNCTIONAL CAPACITY : 3 DOSAGE ADJUSTMENT/S - gives dosage adjustment recommendations for DR. JOSE FABELLA MEMORIAL the elderly, HOSPITAL 1 | Maia Lujan PCARE 3105 | HOSPITAL PHARMACY POST-ACTIVITY (PRELIMS) - Thus, standard treatments become OWNERSHIP : Public ineffective, allowing infections to SCOPE OF SERVICES : Specialty (Maternity and Children) persist and spread. FUNCTIONAL CAPACITY : 3 - It is a consequence of the use or misuse of antimicrobials. It WESTERN VISAYAS MEDICAL develops when an organism CENTER mutates or acquires a resistance OWNERSHIP : Public gene. SCOPE OF SERVICES : General FUNCTIONAL CAPACITY : 3 ANTIBIOTICS CLASSIFICATION WESTERN VISAYAS STATE ACCORDING TO WHO UNIVERSITY MEDICAL CENTER ➔ In 2017, WHO introduced the OWNERSHIP : Public AWaRe Classification of antibiotics SCOPE OF SERVICES : General - Access, Watch, Reserve. FUNCTIONAL CAPACITY : 3 AWARE CLASSIFICATION - tool for ST. PAUL’S HOSPITAL ILOILO antibiotic stewardship aiming to reduce OWNERSHIP : Private antimicrobial resistance and to ensure SCOPE OF SERVICES : General appropriate treatment. FUNCTIONAL CAPACITY : 3 ACCESS THE MEDICAL CITY ILOILO ACCESS - antibiotics that have activity OWNERSHIP : Private against a wide range of commonly SCOPE OF SERVICES : General FUNCTIONAL CAPACITY : 2 encountered susceptible pathogens while also showing lower resistance potential WESTERN VISAYAS SANITARIUM than antibiotics in the other groups. OWNERSHIP : Public - 48 antibiotics SCOPE OF SERVICES : General FUNCTIONAL CAPACITY : 1 ➔ Most Penicillins ILOILO MISSION HOSPITAL ➔ 1st Gen Cephalosporins OWNERSHIP : Private ➔ B-lactam-B-lactamase inhibitor SCOPE OF SERVICES : General ➔ Aminoglycosides FUNCTIONAL CAPACITY : 3 - Amikacin, Gentamicin NATIONAL KIDNEY AND ➔ Lincosamides TRANSPLANT INSTITUTE - Clindamycin OWNERSHIP : Public ➔ Amphenicols SCOPE OF SERVICES : Specialty - Chloramphenicol, (Renal disease & Organ transplant) Thiamphenicol FUNCTIONAL CAPACITY : 3 ➔ Nitroturantoin ➔ Tetracycline AMR - Tetracycline, Doxycycline ANTIMICROBIAL RESISTANCE - ➔ Aminocyclitol resistance of a microorganism to an - Spectinomycin antimicrobial agent to which it was ➔ Metronidazole IV and PO previously sensitive. (Imidazole) - Resistant organisms withstand ➔ Trimethoprim attack by antimicrobials ➔ Sulfonamide-TMP combinations (antibacterials, antivirals, etc.). 2 | Maia Lujan PCARE 3105 | HOSPITAL PHARMACY POST-ACTIVITY (PRELIMS) infections due to multi-drug resistant WATCH organisms. WATCH - antibiotics that have higher - Last resort resistance potential and include most of - Accessible but use should be the highest priority agents among the tailored to highly specific patients Critically Important Antimicrobials for and settings when all alternatives Human Medicine and/or antibiotics that have failed or are not suitable. are at relatively high risk of selection of - 22 antibiotics bacterial resistance. - They should be prioritized as key ➔ 3rd gen cephalosporin targets of stewardship programs - Ceftazidime-avibactam and monitoring. ➔ 5th Gen Cephalosporins - 110 antibiotics - Certaroline fosamil - Ceftobiprole medocaril ➔ Penicillins - Ceftolazone-tazobactam - Azlocillin, Mezlocillin, ➔ Monobactam Pheneticillin, Piperacillin, - Aztreonam Sulbenicillin ➔ Penem ➔ 2nd, 3rd, and 4th Gen - Faropenem Cephalosporins except for one ➔ Carbapenem ➔ B lactam-B-lactamase inhibitor, - Meropenem-vaborbactam anti-pseudomonal ➔ Aminoglycoside - Piperacillin-Tazobactam - Plazomicin ➔ Carboxypenicillins ➔ Glycopeptides - Carbenicilin, Temocilin, - Oritavancin, Telavancin Ticarcilin ➔ Tetracyclines ➔ Carbapenems except for one - Eravacycline, Minocycline ➔ Most Aminoglycosides IV, Omadacycline ➔ Fluoroquinolones ➔ Glycylcycline ➔ Macrolides - Tigecycline ➔ Glycopeptides ➔ Oxazolidinones - Teicoplanin, Vancomycin - Linezolid, Tedizolid (IV and PO) ➔ Streptogrammins ➔ Most Tetracyclines - Dalfopristin-quinupristin ➔ Streptogrammins ➔ Polymyxins - Pristinamycin - Colistin, Polymyxin B ➔ Rifamycins ➔ Lipopeptides ➔ Phenol derivatives - Daptomycin - Clofoctol ➔ Fosfomycin IV ➔ Fosfomycin PO ➔ Spiramycin/Metronidazole AMS PROGRAM OF DOH ➔ Fusidic Acid NATIONAL ANTIMICROBIAL STEWARDSHIP (AMS) PROGRAM - RESERVE concerted implementation of systematic, RESERVE - antibiotics and antibiotic multidisciplinary, multi-pronged classes that should be reserved for interventions in both public and private treatment of confirmed or suspected hospitals in the Philippines to improve 3 | Maia Lujan PCARE 3105 | HOSPITAL PHARMACY POST-ACTIVITY (PRELIMS) appropriate use of antimicrobials, which is - Streamlining or essential for preventing the emergence de-escalation and spread of AMR. - IV to PO switch - It gives structure and direction to 4. Prospective Audit of healthcare facilities to adopt a Antimicrobial Prescribing and proactive multidisciplinary Direct Intervention and approach to promote rational Feedback antimicrobial use. ANTIMICROBIALS FOR AUDIT ➔ 3rd Gen Cephalosporins CORE ELEMENTS ➔ Fluoroquinolones ➔ Aminoglycosides ➔ Clindamycin ➔ Extended-Spectrum Penicillins ➔ Fluconazole COMPASSIONATE DRUGS COMPASSIONATE DRUGS - drugs unregistered in the FDA COMPASSIONATE SPECIAL PERMIT - special permit issued by the FDA granting a hospital the privilege to avail of an CORE ELEMENTS unregistered drug, medical device, or food 1. Leadership product through a licensed importer for a 2. Policies, Guidelines, Pathways specific kind/type of patients, specific 3. Survillance AMU & AMR volume and period. 4. Action 5. Education 6. Performance & Evaluation AS OF 2016 ➔ Colistimethate Na - 1M unit vial ➔ Dipyridamole 10m/2mL amp CORE ELEMENT 4 – ACTION ➔ Glycery trinitrate 10mg/10ml 1. Antimicrobial Restriction and amp Pre-Authorization - requires ➔ Protamine sulfate 50m/5ml vial clinicians to obtain approval for use ➔ Vasopressin 20urits/mil. vial of selected antimicrobials before ➔ Adenosine Emg/2ml vial prescribing. ➔ Phorilechrine 1% 10mg/mL. vial 2. Seventh Day Automatic Stop ➔ Esmoldl HCI 10mg/ml, 10mL. Order vial - LD and missed doses are ➔ Mirinone lactate 10g/mL. vial counted ➔ Dantrolene Na 20mg/65ml. vial Continue on counting if route was changed IND Reset counting if INVESTIGATIONAL DRUGS - DC or on hold for pharmaceutical form of an active more than 24 hours ingredient or placebo being tested or used 3. Point-of-Care Interventions as a reference in clinical trial, including a - Dose optimization product with a marketing authorization 4 | Maia Lujan PCARE 3105 | HOSPITAL PHARMACY POST-ACTIVITY (PRELIMS) when used or assembled (formulated or - Head of Office for National Health packaged) in a way different from the Programs approved form, or when used for an unapproved indication, or when used to Only the requesting facility shall gain further investigation about an be allowed to procure the approved use. exempted medicine. The certificate of exemption has a validity of 1 year. ➔ Remdesivir ➔ Chloroquine LIST OF RESISTANCE ANTIMICROBIALS ➔ Hydroxychloroquine ➔ Lopinavir/Ritonavir PNDF/ PNF PHILIPPINE NATIONAL FORMULARY/ PHILIPPINE NATIONAL DRUG FORMULARY - contains the list of essential medicines that can be procured by the government. - It also serves as the basis of PhilHealth reimbursement for both public and private health facilities. PERSONS WHO CAN APPLY TO INCLUDE PRODUCTS IN THE PNF - PTC of both public and private hospitals - Professional medical societies recognized by the PMA - Patient groups - National health programs ➔ Aztreonam - Formulary Executive Council ➔ Cefepime ➔ Colistin - National Antibiotic Guidelines ➔ Ertapenem Committee ➔ Linezolid ➔ Meropenem ➔ Vancomycin ➔ Amphotericin B CAN YOU USE THE PRODUCTS NOT ➔ Micafungin LISTED IN THE PNDF? ➔ Voriconazole Yes - By application for exemption from E.O. No. 49 s. 1993 E.O #49 s. 1993 - “The health facility shall completely accomplish the PNF form for exemption”, then signed by the : - PTC Chair for hospitals 5 | Maia Lujan