7th and 8th Week Notes PDF

7th week - Policy recommending body to the medical staff - Frequency and length of meeting – done frequently Pharmacy a...

7th week - Policy recommending body to the medical staff - Frequency and length of meeting – done frequently Pharmacy and Therapeutics Committee (PTC) o 69-90 minutes per meeting - Groups of individuals - Done 4-6 times a year – since the drug products and medical literature o Physicians keep on changing. o Pharmacists - Monthly 60-90 minutes meeting are generally recommended. o Medical staff - Meetings can be carried out more efficiently by establishing task forces or - Formulate policies concerning the therapeutics usage of drugs sub committees. - The PTC has 3 major objectives. These are: A typical agenda may consists of the following categories in general: o Drug safety and adverse drug monitoring - As the therapeutic agents are increasing, the scope, knowledge and responsibility of 1. Minutes of the previous meeting. the hospital pharmacist is also increasing. The safety aspects are 2. Review of the contents of the Hospital Formulary for purpose of bringing it more or less taken for granted by pharmacy, medical and nursing up to date, and deleting of products not considered necessary for use. staff. So, one of the main aim of PTC is to improve medication 3. Information regarding new drugs which may have become commercially safety and monitoring adverse drug reactions by monitoring, available. analyzing, reporting ADRs and implementing corrective action. 4. Review of side effects, adverse drug reactions, toxic effects and drug o Advisory role – formulate policies regarding the evaluation, interactions since the last meeting. selection and therapeutic usage of drugs in hospital 5. Review of drug safety in the hospital. o Educational role – helps in various functions to fulfil the 6. Report of various subcommittees. requirements of the professional staff, physicians, nurses, 7. Report of medical audit. pharmacists, and other health care personnel for complete knowledge regarding drug o Medication safety - Also known as pharmacy committee/Therapeutic committee/Drug ▪ Medication safety task force may be charged with review committee/Formulary committee. of adverse drug events and medication errors, their trending and development of plans for prevention of future events. o Drug review panels ▪ Drug review panels particularly focus on a specialty like cardiology, or infectious disease and review drug products and guidelines in that area. o Medication use review ▪ Medication use review task force monitors the medication use reviews and evaluates the data and development plans to optimize the use of specific drugs.  The primary functions are— a. Advising medical, administrative, and pharmacy departments on pharmaceutical related issues b. Developing pharmaceutical policies and procedures c. Evaluating and selecting medicines for the formulary and providing for its periodic revision d. Identifying medicine use problems e. Promoting and conducting effective interventions to improve medicine use (including educational, managerial, and regulatory methods) f. Managing ADRs g. Managing medication errors h. Role of PTC in “Emergency drug list” The PTC’s role is to optimize rational use of medicines by evaluating the clinical use of pharmaceuticals, developing the policies for managing medicine use and administration, and managing the formulary system. The committee has broad Committee membership responsibilities in determining what medicines will be available, at what cost, and - Pharmacists, nurses, physicians, administrators, risk, or quality how they will be used. improvement managers Policies of the PTC in including Drugs into Formulary - Medication management is a multidisciplinary process. - Committee membership – nonphysician members such as nurses, - The PTC develops a formulary of medications and related products to be respiratory therapists, and other health care professionals used in the organization - PTC looks after regular revision and maintenance of the formulary Functions of the PTC - Promotes the rational, clinical applicable, safe and cost effective use of 1) Acts as an advisory council to the medical staff and hospital administration medications regarding the therapeutic use of drugs - PTC also evaluates and selects some medications to be added to or deleted 2) It develops a formulary of drugs and prescriptions to be used in hospitals. from the formulary The items to be included in the formulary are selected based on their The PTC has the following roles in adding or deleting drugs into formulary: therapeutic use, safety, cost etc 3) It suggests written policies and procedures regarding the selection, 1) Addition of a Drug procurement, storage, distribution, and therapeutic use of drugs i) Drugs with unknown formula or composition should not be added 4) It establishes suitable educational schemes for the hospital staff regarding to the hospital formulary. Fixed dosage form combinations of two the therapeutic use of drugs or more agents should not be considered. However, if a 5) It studies the problems related to the distribution and administration of therapeutic advantage is demonstrated and no disadvantages are drugs known, such combinations can be considered. 6) It makes recommendations regarding the drugs to be stocked in wards ii) A drug is approved to be added to the formulary only if it fulfills and emergency the following conditions: 7) It advices the pharmacy to implement effective drug distribution and a) It is the only drug effective for the mentioned purpose. control procedures b) It is superior in use to the other drugs in the formulary because of:  Greater efficacy for most patients or for selected patients (considering the varied patient responses), and Decreased toxicity, great patient tolerance, and easier administration method c) Its efficacy and safety is similar to the currently used formulary product. d) It is more cost effective than the formulary product currently in use 2) Deletion of a Drug: Suggestions of deleting drugs from the formulary should be submitted to the PTC by any member of the medical, pharmacy, or nursing staff. To control the growth of hospital pharmacy, some additions are balanced by deletions of existing drugs. 8th week d) Formulation (name of the active ingredient and formulation of the product), Hospital Formulary e) Dose for adults and paediatrics, - Hospital formulary system is a method in which the medical staff of a f) Administration route, and hospital along with the pharmacy and therapeutic committee selects and g) Cost evaluate medical agents and their dosage form which are not considered useful in the patient care. ii) Indexes to the Drug Product Listing: There are two ways - It is not easy for a hospital pharmacy to stock all the medications that of making the indexes included either at the beginning or doctors may want to prescribe to their hospitalised patients. at the end of the section to facilitate the use of - Thus, the hospital pharmacist along with the medical staff of the hospital formulary: makes a hospital formulary, which includes a list of drugs that the hospital a) Generic Name/Brand Name: Proper page number should pharmacy stocks. be given for reference to a particular product. - The formulary also lists the information about each drug. b) Therapeutic or Pharmacological Index: This index is - The hospital staff along with the PTC meets regularly to make changes in based on the therapeutic category, e.g., antihistaminic the formulary and revise it periodically. drugs, anti-infective drugs, etc - The hospital formulary is used by the physicians to check whether or not the medications required to treat a particular patient are available in the 2) Information on Hospital Policies: The formulary provides the hospital. following information regarding the hospital policies and - They also use the formulary to avoid prescribing medications that can procedures for drug usage: undergo dangerous interactions with other medications. i) Various policies and procedures for drug usage and restrictions - The physicians know about specific medications to be prescribed for on drug usage. specific conditions, but a hospital may substitute similar drugs for those ii) PTC and its membership responsibilities. medications. iii) Hospital regulations governing the prescribing, dispensing, - For example, a formulary may contain a less expensive generic version of a administration of drugs, generic names, drug orders, commonly used medication. Also, a hospitalized patient is treated by investigational drug policies, rules to be followed by medical multiple physicians, and each physician prescribes different medications representatives, emergency drug products, etc. for the same patient. iv) Operating procedures (such as hours of services, out-patient prescription policies, prescription labelling, packaging and Objectives practice, in-patient drug distribution procedure, patient education program, etc.). - The hospital formulary aims to provide the hospital staff with the v) Information on the use of formulary, like the procedure for information given below: entry of a drug, the manner of arranging the entries, etc. 1) Information on Drug Products: It provides information on PTC-approved 3) Special Information: The formulary provides information on the drug products and their therapeutic use. This section includes descriptive drug dosage schedule, hospital-approved abbreviation, and special entries for each item to facilitate its use like: information about drugs. The information provided in this section i) Entries in Formulary though varies from hospital-to-hospital, but should be useful to the a) Generic name of drug, hospital staff and should be readily available. It includes: b) Common names (brand names). i) Nutritional products list, c) Dosage forms, strength, and packaging, ii) Equivalent dosage of similar drug, iii) List of hospital-approved abbreviations,  iv) Guidelines for calculating pediatric dose, Prescription Writing v) List of sugar-free drug products, The prescriptions should be written clearly, appropriately, and should vi) Number of items available for emergency boxes, include: vii) Metric conversions and tables, viii) Tables of drug interaction, and 1) The patient's name and address, ix) Poison control distribution 2) The date, 3) The prescribed drug written in the terminology used in the formulary, Limitations 4) The strength of the drug prescribed in the appropriate metric system, The hospital formulary system has the following limitations: 5) The total amount to be dispensed, 6) The "Signa" with instructions for the patient should be mentioned 1) It may prevent the physician's right to prescribe and obtain the drug clearly in simple terms so that the patient can understand it easily, and brand of his choice. 7) If any drug is to be repeated, the physician should clearly mention the 2) In many cases, the system allows the pharmacist to decide which drug number of times the drug is to be taken. If this is not done, the brand is to be purchased and dispensed. pharmacist may not dispense the prescription again. 3) It does not provide any discount or scheme to reduce the drug cost to the patients which the hospital received while purchasing the drugs in The prescriptions for narcotic drugs, apart from the above information bulk quantity. should also have the patient's age. The prescribing physicians should sign 4) In a hospital pharmacy with no staff pharmacist, the system may allow the prescriptions, and should prepare three copies of the prescription; one purchasing of inferior quality drug. copy of which is retained by him and the other two copies are given to the patient. Normal laboratory values, tables of weights and measures, tables Contents of Hospital Formulary for the calculations of percentages, milliequivalents and dosages, formulas The formulary is composed depending on those who are responsible for its of various diagnostic stains and reagents commonly used in the hospitals publication. A section of prescription writing should be included in the should be included in the formulary. formulary, as it will be useful for young physicians under training period. Format The following contents should be included in the hospital formulary: The daily use and publishing cost of the formulary depends on its format. 1) The prescriptions should be written clearly in a correct manner, and The hospital pharmacist collects the formularies of various hospitals and every prescription should include: decides the format. After the formulary is published, two copies of it are i) The patient's name and address, sent to the American Society of Hospital Pharmacist. ii) The date, The formulary depending on the local need of the hospital should be of a iii) The prescribed drug written in the terminology used in the specific size to make it convenient to use for the physicians. Smaller size formulary, formularies are always preferred. iv) The strength of the drug prescribed in appropriate metric system. Size, Loose Leaf or Bound, Printed or Mimeographed 2) The format. A formulary of sufficiently small size can be carried by the clinicians, 3) Size, loose leaf or bound, printed, or mimeographed. nurses, etc., easily in the pockets of their uniform or laboratory coats. A 4) Index and assigning categories. small-sized formulary can also be carried by the physician in his/her bag along with the blank prescription forms. Many physicians use the formulary in their private clinics also. The hospitals generally determine the size of their formulary. The hospital authorities along with the PTC decide whether the formulary This compiled index should then be placed either in the front or at the back should be in the form of a loose leaf volume or bound book. A loose leaf of the formulary. type formulary can be easily kept, and can be revised whenever required Apart from the general and the pharmacological indexes, the formulary is by printing, distributing, and inserting necessary pages. Bound volumes are divided into specific sections, each separated by a divider. prepared using paper and cardboard covers, or plastic or leather binding. The type of sub-division of sections can be achieved in the following It is also decided whether the formulary will be printed or mimeographed pattern. (a modified version of cyclostyled volume). The appearance of printed formulary is more attractive, and is easier to read. However, a study of 1) Ear, 2) Eye, many formularies has shown that some better formularies are 3) Nose, 4) Rectal. mimeographed. 5) Throat, 6) Vaginal, 7) Skin. 8) Nutritional aids, Some formularies are developed by individuals with a goal of its 9) Oral products, and 10) Injectables. publication or advertisement. They include drawings using coloured inks and colored paper. This approach, however, should be avoided as This sub-division enables the physician to readily refer to the specific agent formulary is a professional publication and should reflect the high ethical used for either automatic entry or to the broad category of oral or standard of the hospital and its staff. Therefore, a white or slightly off- parenteral drugs. white paper and use of black ink is recommended. Selection of Text Indexing and Assigning Categories This is a very important part of the formulary. Selection and scope of the While compiling a formulary, the authorities consider an approach which text under each generic drug should be given appropriately. The amount of will aid the physician to locate an item in the formulary. A formulary text published depends on the goals established by the PTC. It should be contains all the required information, but sometimes data are not easily appreciated by all the readers as insufficient information will not enhance found due to improper indexing. the use and acceptance of the formulary by the staff. On the other hand, the busy practitioner will also not use the formulary if it is a miniature text Index thus is the key to formulary, and the pharmacist should spend efforts book on pharmacology. and time to make it useful so that the desired data can be easily located. Differentiation of Hospital Formulary and Drug List Formularies mostly have a general index at the end of the text. This index is arranged alphabetically by generic names of the drugs and cross-indexed A drug formulary is a manual containing clinically oriented summaries Of with brand names in the text portion of the formulary. General index is an pharmacological information about some of the selected drugs. It may also essential part in a formulary and cannot be missed. include administrative and regulatory information regarding the prescribing and dispensing of drugs. A National Formulary (N) focuses on For example, a physician has the knowledge of generic and brand names of available and affordable medicines required for the treatment of diseases a number of anticholinergic drugs; he/she will search the index to find a in a particular country. Formularies are frequently created for individual familiar anti-cholinergic drug. This approach is burdensome and time- hospitals for different levels of health care and different sectors. taking, thus the general index should be supplemented with a pharmacological index which will be a matter of finding any particular data in a very short time. Therefore, key pharmacological classification with main headings is only suggested. The pharmacists along with the PTC should classify all the drugs used in the hospital and mention about them in the formulary under each heading. The National Formulary Committee (NFC) decides the final purpose, been applied with a UM, it is indicated with one of the following symbols in structure, content, and format of the NF. The members of this committee a column next to the drug name: should be limited to such number that it functions effectively and follow 1) MDL (Managed Dose Limitations), the endorsement of national policy-making bodies. If an established Essential Drug Programme (EDP) already exists in a country, the existing 2) PA (Pre-Authorisation), and multidisciplinary committee or a sub-committee of it serves the role of NFC. 3) ST (Step-Therapy). Table: enlists the differential points between private and national Preparation and Revision of Hospital Formulary formulary: The very initial step in the development of a hospital formulary for any Comparison between Private and National Formulary hospital is to form a proficient PTC, which makes decision on the following: Private Formulary National Formulary 1) The type of publication of the formulary: Prepared by the clinical staff of Prepared by outstanding clinicians, i) A hospital's own formulary, or hospitals. pharmacologists, and pharmacists ii) A list of drugs, or of the country. iii) A purchased formulary service. Information under each Each monograph contains physical monograph is for local needs and and chemical properties, 2) Fixation of rules which the PTC requires while evaluating drugs for may include related clinical pharmacological responses, uses, matters. toxicology, posology, preparations, admission to the formulary. and contraindications. 3) While preparing a formulary, content in the following sections should Published in a convenient size and Size is big as it contains many also be included: format. drugs. i) Prescription writing, Drugs can be frequently added or Drugs are less frequently added or ii) Use of drugs, deleted deleted iii) Table of metric weights and Apothecary and household equivalents, Drug list is a multi-page article that enlists the names of pharmaceutical iv) Tables of common laboratory values, v) Section on calculation of doses for children, drugs in alphabetical order. There are many drugs having more than one vi) Pharmacological index, and name, and therefore, are listed more than once. The brand names are vii) Section on reagents. differentiated from the generic names by writing the initials for the former in capital. 4) The type of format of the formulary: i) Size, The drug list is organized in sections as per the drug class or medical ii) Loose leaf or bounded. condition. Each section has sub-sections to ease locating of drugs. Most of iii) Printed or mimeographed, the listed generic or brand drugs are formulary drugs. Generic drugs iv) Extent of categorisation and indexing. undergo the same approval process by the Food and Drug Administration (FDA) as the branded drugs and should also fulfil the similar standards of Examples effectiveness and chemical make-up as branded drugs. Autonomic Drugs (Sympathomimetic or Adrenergie Drugs) 1) Ephedrine Sulphate Injection: 1 ml contains 50mg ephedrine sulphate. Some drugs in the drug list require Utilisation Management (UM), i.e., pre- Dispense: 1ml authorisation, managed dose limitations, and step-therapy. If a drug has Route: Subcutaneous and intramuscular  Dose: 25-50mg every 4 hours. Revision - The procedure to add a new drug in the formulary is complex. The 2) Epinephrine Injection: 1ml contains I mg epinephrine. members are not skilled enough to evaluate each therapeutic agent; thus Dispense: 1ml the PTC takes help from other experts for addition of selected special Route: Subcutaneous drugs. Preparations whose formula is not revealed are not entered in the Dose: 0.2-Img every 4 hours. formulary. Some policy guidelines for adding or removing drugs in the formulary have been framed by the PTC in consultation with the medical 3) Epinephrine in Oil Injection: Iml contains 2mg epinephrine. staff. Dispense: 1ml - The formulary should be revised annually as new drugs are added and Route: Intramuscular Dose: 2mg in every 8 and 12 hours. removed from it, some drugs are even removed from the market, and the hospital policies and procedures also changes. A definite system should be 4) Levarterenol Bitartrate Injection: 4ml contains 4mg levarterenol. adopted for the revision of formulary; in one method, formulary Dispense: 4ml Route: Intravenous only by infusion supplement sheets can be attached to the back covers of formulary books; Dose: 4mg is added to 1000ml of 50% dextrose solution, each Iml of the and in the second method, different colours can be used for the cover of dilution contains 4ug Levarterenol. each edition of the formulary to avoid confusion between the latest and past edition. The revised formulary system should be regularly reviewed so 5) Phenylephrine Hydrochloride Injection: Iml contains 10mg phenylephrine that the most cost-effective products are only used. Such reviews result in hydrochloride. the removal of some drugs. Dispenses: 1ml Route: Subcutaneous Addition and Deletion of Drug from Hospital Formulary Dose: 1-10mg every 8 hours. - Adding or deleting a drug from the formulary is an important step in maintenance of hospital formulary. Additions and deletions should be Cardiovascular Drugs (Vasodilators) done by following some specific policies and procedures developed by the 1) Amyl Nitrite (Capsules-glass). Pharmacy and Therapeutic Committee (PTC). A system should be Route: Inhalation developed for taking decisions regarding the addition or deletion of a drug i) 0.3mg Hypodermic Tablets from a formulary. ii) 0.6mg Hypodermic Tablets - Routine reviews of medicine class are important for the maintenance of iii) 0.4mg Hypodermic Tablets formulary. Medicine class review involves evaluating an entire section of medicines (e.g., cephalosporin antibiotics). This review systematically 2) Mannitol Hexanitrate - 30mg tablets evaluates the existing medicines in the formulary so that the complete formulary is reviewed two to three times. This is a difficult task, but review 3) Papaverine Hydrochloride and analysis of formulary medicines is also important in a medical i) 30mg tablet discipline that keeps on changing. Any new medicines having advantages ii) 30mg ampoule over the existing medicines will be evaluated for adding them in the iii) 30mg in i.c.c. for subcutaneous use formulary. iv) Intramuscular or intravenous use - Medicines no longer in use or lacking satisfactory evidence of efficacy, safety, and quality should be recommended for deletion. Medicines no 4) Pentaerythritol Tetranitrate (Peritrate) longer fulfilling the standards of being cost-effective should also be 10 mg tablets evaluated and deleted to be replaced by a satisfactory alternative. The following criteria should be considered while adding into or removing 5) Priscoline Hydrochloride - 25mg tablets drugs from the formulary: 10cc vials 25mg/cc 1) The medical staff should have approved the drug to be added in the For subcutaneous, intramuscular or intravenous use. formulary.  2) The drug should be recognised by the Pharmacopoeias and Formularies approved under Drugs and Cosmetic Act and Rules. 3) The drug manufacturer should hold a license issued under the Drugs and Cosmetic Rules. Also he should not have been punished for any serious offence under any law of Drugs and Medicines. 4) The drug or preparation of secret composition should not be added in the formulary. 5) The drug or preparation containing multiple ingredients should not be added if the same therapeutic effect can be obtained by using a preparation with single ingredient. Must Remember info: 1) The hospital formulary system is a method in which the medical staff of a hospital along with the pharmacy and therapeutic committee selects and evaluate medical agents and their dosage form which are not considered useful in the patient care. 2) Normal laboratory values, tables of weights and measures, tables for the calculations of percentages, milliequivalents and dosages, formulas of various diagnostic stains and reagents commonly used in the hospitals should be included in the formulary. 3) The daily use and publishing cost of the formulary depends on its format. 4) A loose leaf type formulary can be easily kept, and can be revised whenever required by printing, distributing, and inserting necessary pages 5) Bound volumes are prepared using paper and cardboard covers, or plastic or leather binding. 6) Formularies mostly have a general index at the end of the text. This index is arranged alphabetically by generic names of the drugs and cross-indexed with brand names in the text portion of the formulary. 7) A drug formulary is a manual containing clinically oriented summaries of pharmacological information about some of the selected drugs. 8) A National Formulary (NF) focuses on available and affordable medicines required for the treatment of diseases in a particular country. 9) The National Formulary Committee (NFC) decides the final purpose, structure, content, and format of the NF. 10) Drug list is a multi-page article that enlists the names of pharmaceutical drugs in alphabetical order. 11) The formulary should be revised annually as new drugs are added and removed from it, some drugs are even removed from the market, and the hospital policies and procedures also changes. 12) Medicine class review involves evaluating an entire section of medicines (e.g., cephalosporin antibiotics). Rational Drug Use, Formulary Management, Pharmaceutical Care/ o investigation, replacement, modification, or support of the Medication Therapy Management/ Pharmacists’ Patient Care Process anatomy or of a physiological process, o supporting or sustaining life, DEFINE DRUG/MEDICINE, MEDICATION, AND HEALTH TECHNOLOGY o control of conception, - A drug is defined with slight differences in each country’s drug laws. For o disinfection of medical devices, healthcare professionals, drug is synonymous with medicine. Especially as o providing information by means of in vitro examination of “medicine” is also used to represent the practice of physicians, use of specimens derived from the human body. “drug” is preferred for pharmacists in professional communications. For - Moreover, device does not achieve its primary intended action by the public, the term “drug” is commonly used as a substance of abuse; use pharmacological, immunological, or metabolic means, in or on the human of the term “medicine” is preferred for pharmacists while communicating body, but may be assisted in its intended function by such means. with the public. Many agencies, including the World Health Organization - Note: Products that may be considered to be medical devices in some (WHO), recommend using the term medicine. In healthcare regulations of jurisdictions but not in others include the following: many countries, the term drug is still commonly used for medicinal o disinfection substances, products. In the United States, the drug regulatory agency is called the o aids for persons with disabilities, Food and Drug Administration (FDA), whereas in the European Union, it is o devices incorporating animal and human tissues, and called the European Medicines Agency. o devices for in vitro fertilization or assisted reproduction - The US FDA defines a drug as follows: technologies. o A substance recognized by an official pharmacopeia or formulary. Drug Names o A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Drugs have generic names and brand names. For example, atorvastatin is the o A substance (other than food) intended to affect the structure or generic name and Lipitor is a brand name. Brand names are assigned by the any function of the body. pharmaceutical companies, and the generic name is selected by WHO. o A substance intended for use as a component of a drug but not a Pharmaceutical companies keep both brand and generic names on the product device or a component, part or accessory of a device. labels. The brand name is also called a proprietary name, and the generic name is o Biological products are included within this definition and are an International Nonproprietary Name.3 When a company develops and releases a covered by the same laws and regulations, but differences exist new drug into the market, they will have market exclusivity protected by patent regarding their manufacturing processes (chemical process vs. law. Once the patent expires, generic or branded versions of the same biological process). bioequivalent product could be released by any companies following approval by an - A newer way of defining all pharmaceutical products together is by calling appropriate regulatory agency. If a drug is marketed by the generic name, without a them “health technology.” This includes drugs and medical devices. WHO brand name, it is called as a generic product. The generic version of a biological defines a medical device as any instrument, apparatus, implement, product is called a biosimilar.4 When we write these names within a sentence, a machine, appliance, implant, reagent for in vitro use, software, material, or brand name starts with a capital letter and generic names start with a small letter. other similar or related article, intended by the manufacturer to be used, Another unique name for the pharmacological product is International Union of alone or in combination, for human beings, for one or more of the specific Pure and Applied Chemistry (IUPAC) name, a detailed chemical name.5 Aspirin was medical purpose(s) of: originally the brand name of acetylsalicylic acid, but it is now commonly used as its o diagnosis, prevention, monitoring, treatment, or alleviation of generic name. The generic name is the same for most drugs throughout the world. disease, However, there are exceptions. In the United States, the generic name for o diagnosis, monitoring, treatment, alleviation of, or compensation paracetamol is acetaminophen, salbutamol is called albuterol, and pethidine is for an injury, meperidine. The problem does not stop here. In different languages such as German, Spanish, etc., the names are spelled and pronounced differently. To solve this problem, WHO assign a unique international code for each drug as per the pharmacy practice. A drug and therapeutics committee (DTC) could Anatomical Therapeutic and Chemical (ATC) classification system. Some drugs may function to improve the rational use of drugs in a hospital. have more than one ATC code for their different therapeutic uses. For ibuprofen, - WHO advocated 12 key interventions to promote more rational use: the ATC code is “M01AE01.” “M” stands for the musculoskeletal anatomical system, o Establishment of a multidisciplinary national body to coordinate “01A” stands for nonsteroidal antiinflammatory and antirheumatic therapeutic policies on drug use class, “E” stands for propionic acid derivative chemical class, and the last number o Use of clinical guidelines “01” stands for ibuprofen differentiating it from other nonsteroidal o Development and use of a national essential drugs list antiinflammatory drugs (NSAIDs) in the class. o Establishment of drug and therapeutics committees in districts and hospitals OVERVIEW RATIONAL DRUG USE IN CLINICAL PRACTICE o Inclusion of problem-based pharmacotherapy training in Rational use of drugs is defined by WHO as “patients receive medications undergraduate curricula appropriate to their clinical needs, in doses that meet their own individual o Continuing in-service medical education as a licensure requirements, for an adequate period of time, and at the lowest cost to them and requirement their community.” o Supervision, audit, and feedback o Use of independent information on drugs Some of the WHO/International Network for the Rational Use of Drug (INRUD) drug o Public education about medicines use indicators for primary healthcare facilities (WHO, 1993) are as follows: o Avoidance of perverse financial incentives o Use of appropriate and enforced regulation Prescribing indicators: o Sufficient government expenditure to ensure availability of drugs - Average number of drugs prescribed per patient encounter and staff. - drugs prescribed by generic name DETAIL THE CONSTITUTION AND FUNCTIONS OF A DRUG AND THERAPEUTICS - encounters with an antibiotic prescribed COMMITTEE - encounters with an injection prescribed - drugs prescribed from an essential drugs list or formulary - DTC, also known as pharmacy and therapeutics committee (PTC), functions - Patient care indicators: typically in institutional (hospital) settings. Similar committees could also o Average consultation time work at public health (governmental and nongovernmental agencies) levels o Average dispensing time to develop state/national formularies and advice on the rational o % drugs actually dispensed management of drugs in the region. DTC formulates policies and guidelines o % drugs adequately labeled for the rational use of drugs and other pharmaceutical products. WHO uses o % patients with knowledge of correct doses the term DTC, whereas in the United States PTC is more commonly used. - Facility indicators: - According to WHO, goals and objectives of the DTC are as follows: The goal o Availability of essential drugs list or formulary to practitioners of a DTC is to ensure that patients are provided with the best possible o Availability of clinical guidelines cost-effective and quality of care through determining what drugs will be o % key drugs available Complementary drug use indicators: l available, at what cost, and how they will be used. Average drug cost per encounter - To achieve this goal, a DTC will have the following objectives: o % prescriptions in accordance with clinical guidelines. o to develop and implement an efficient and cost-effective - These indicators are usually assessed by drug use evaluations (DUEs). formulary system that includes consistent standard treatment Irrational drug use may be any clinically significant inappropriate use of protocols, a formulary list, and formulary manual drugs such as no drugs when required, unnecessary drugs, overuse, o to ensure that only efficacious, safe, cost-effective, and best underuse, ineffective drugs, unsafe drugs, etc. Irrational drug use can be quality drugs are used identified, prevented, or managed by the methods developed through  o to ensure the best possible drug safety through monitoring, o a clinical microbiologist or a laboratory technician where there is evaluating, and thereby preventing, as far as possible, adverse no microbiologist drug reactions (ADRs) and medication errors o a member of the hospital records department. o to develop and implement interventions to improve drug use by - Some DTCs also include drug information pharmacists, trainees, consumer prescribers, dispensers, and patients; this will require the representatives, etc. Common subcommittees of DTC are the infection investigation and monitoring of drug use. control committee, procurement committee, patient safety committee, etc. Constitution of Drug and Therapeutics Committee - The DTC is usually constituted with expected competency to perform its duties. Any committee could have odd numbers of members with voting Functions of Drug and Therapeutics Committee powers that help in avoiding a draw. A DTC should include stakeholders - DTC teams up with other committees and professionals in the hospital to from major clinical specialty departments, administrations, and manage the purchase, inventory, distribution, rational use, and disposal of pharmacies. A small committee could be formed with a minimum of seven pharmaceutical products in the hospital. DTC’s functions are mostly members (2e3 doctors, 1e2 pharmacists, 1 nurse, 1 administrator, and advisory. It also develops policies and guidelines and plans strategies to another member as per the hospital’s requirement, preferably a medical IT implement change. Direct patient care is the responsibility of clinical staff specialist). The number shall vary based on the hospital’s organizational and the DTC only monitors and suggests how to improve it. Some of the structure. The following points should be considered to decide the key functions of DTC are as follows: committee to be small or large. For a small hospital, a small committee o Advice healthcare professionals, administrators, and other might be suitable. Small committees are less expensive and more easily committees on any issues related to pharmaceutical products. reach consensus decisions. DTC has a pool of experts with technical expertise that could - Large committees are suitable for large hospitals with extensive pharmacy prepare guidance documents combining evidence, local operations: experience, patient values, and technological support available. o Greater expertise by adding professionals with different DTC promotes evidence-based clinical practices. backgrounds. o Develop drug policies and plan strategies to implement new o Less workload for each member. policies. The policies addressed generally include purchase, o Involving more of the hospital staff helps with the implementation inventory, distribution, rational use, and disposal of of decisions. pharmaceutical products. Examples of some specific policies - The following members could be included based on defined include reduce the drug budget, procure drugs only from responsibilities: manufacturers that follow good manufacturing practices and o a representative clinician from each major specialty, including holding the WHO prequalification certificate, hospital formulary surgery, obstetrics and gynecology, internal medicine, pediatrics, management, prescribe only from the hospital formulary and in infectious diseases, and general practice (to represent the generic names of drugs, pharmacovigilance practices, safety community) culture, medical reconciliation in transitions of care, return or o a clinical pharmacist dispose expired drugs without polluting groundwater or air, etc. o a nurse, usually the senior infection control nurse, or nursing o Prepare essential drugs list/hospital formulary and standard superintendent treatment guidelines (STGs)/clinical protocols. o a pharmacist (usually the chief or deputy chief pharmacist) or a o Perform DUE studies of drug-related problems such as medication pharmacy technician where there is no pharmacist errors and ADRs and suggest improving better utilization of o an administrator, representing the hospital administration and resources for rational drug use. finance department  o Conduct pharmacoeconomics evaluations to assure cost-effective medicines are regarded as essential remains a national responsibility. WHO and affordable drug use in the hospital. essential medicines list is a model that countries use in making their o Monitor information management system in the hospital to essential list. Hospital formularies are made by hospitals referring to the protect patient privacy and confidentiality in the system. The DTC state/ country/WHO formularies. For a hospital, the more relevant list of could also monitor potential legal and ethical violations in clinical medicines is the hospital formulary that is made to address the healthcare practice in collaboration with other bodies in the hospital. needs of the majority population that the hospital serves. Regional o The DTC also works with the quality assurance committee to variations and nature of hospital policies (corporate, not-for-profit, etc.) ensure the hospital follows international patient safety goals and shall result in significant variations in the population availing its services. A accreditation standards. It also self-evaluates its performance to corporate and charity hospital in the same city shall have a significantly deliver better services to the hospital and the community. different essential medicines list or formulary. - For a DTC to function, it should have a multidisciplinary, transparent - It is difficult to achieve efficiency in the hospital pharmaceutical system if approach, technical competence, and an official mandate. Being there are too many medicines. All aspects of medicines management, multidisciplinary reflects different professionals and departments that including procurement, storage, distribution, and use, are easier if fewer have the competency to advise other professionals or bodies in the items are managed. hospital. A collaborative clinical practice work environment requires - The WHO Model List of Essential Medicine (EML), which serves as a guide teamwork between different healthcare professionals. The transparent for the development of national and institutional essential medicine lists, is approach is essential for providing a clear understanding of the situation updated and revised every 2 years by the WHO Expert Committee on by unbiased assessment and decision making. Finally, the official mandate Selection and Use of Medicines. The EML was first published in 1977 and is essential to implement a change. Otherwise, advice shall be ignored by the Model List of Essential Medicines for Children (EMLc) was first the workforce. (E.g., if the prescribers ignore the advice to prescribe in published in 2007.9 The 20th EML and sixth EMLc, published on June 6, generic names, the committee should have the support of the hospital 2017, mark the 40th anniversary of this flagship WHO tool to expand administrator to warn or impose the advice as a rule.) The committee is for access to medicines. this reason inclusive of administrative staff. This does not mean the - The 20th EML adds 30 medicines for adults and 25 for children and committee is adamant on its decisions but is sensitive to recognize practice specifies new uses for 9 already-listed products, bringing the total to 433 difficulties and suggest relaxations of or revisions to the advice. medicines deemed essential for addressing the most important public health needs globally. DISCUSS ESSENTIAL MEDICINES POLICY AND FORMULARY MANAGEMENT - Most countries have national lists, and some have provincial or state lists - In this section, to have consistency the term medicine is used under this as well. National lists of essential medicines guide the procurement and objective instead of drug. Essential medicines policy and formulary supply of medicines in the public sector, schemes that reimburse medicine management principles and procedures are promoted by WHO. WHO costs, medicine donations, and local medicine production. defines essential medicines as those that satisfy the priority healthcare needs of the population. The essential medicines list is also called a formulary list. They are selected with due regard to public health relevance, evidence on efficacy and safety, and comparative cost- effectiveness. Essential medicines are intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality and adequate information, and at a price the individual and the community can afford. - The implementation of the concept of essential medicines is intended to be flexible and adaptable to many different situations; exactly which