Hospital Pharmacy Past Paper Fall 2024-2025 PDF

PD531 HOSPITAL PHARMACY CPP 526 HOSPITAL PHARMACY Fall 2024-2025 Created by Dr. Noha Alaa Hamdy, Pharm D, PhD Modified and presented by Ahmad Abozaid, PhD, Lecturer of Pharmacy Practice  Intended At the end of this lecture, you will be able to…. learn...

PD531 HOSPITAL PHARMACY CPP 526 HOSPITAL PHARMACY Fall 2024-2025 Created by Dr. Noha Alaa Hamdy, Pharm D, PhD Modified and presented by Ahmad Abozaid, PhD, Lecturer of Pharmacy Practice  Intended At the end of this lecture, you will be able to…. learning  Identify the PTC goals, members, functions and responsibilities. outcomes:  Describe the formulary regarding its content and main principles. Noha Alaa, PharmD, PhD 2 LECTURE 2: Pharmacy & Therapeutic committee & formulary system Noha Alaa, PharmD, PhD 3  The first P&T committee was formed at Bellevue Hospital in New York city in the mid- 1930s. While it dealt with true compounding formulas, it was originally founded to ensure quality & efficacy of those products, which is Pharmacy and still a portion of the functions of P&T Therapeutic committees. committee Drug & Therapeutics committee (DTC), also (PTC) known as Pharmacy and Therapeutics committee (PTC), functions typically in institutional (hospital) settings. WHO uses the term DTC, whereas in the United States PTC is more commonly used. Noha Alaa, PharmD, PhD 4  According to WHO, the goal of a DTC is Pharmacy and to ensure that patients are provided with Therapeutic the best possible cost-effective and quality committee of care through determining what drugs (PTC) will be available, at what cost, and how they will be used. Noha Alaa, PharmD, PhD 5  The P&T committee is generally the medical staff committee responsible for managing (reviews, approves, and revises) the formulary system. Pharmacy and The P&T committee provides an evaluative, Therapeutic educational, and advisory service to the medical committee staff and organizational administration in all (PTC) matters pertaining to the use of available medications. The P&T committee should be responsible for overseeing policies and procedures related to all aspects of medication use within an institution. Noha Alaa, PharmD, PhD 6  GOALS & OBJECTIVES To achieve this goal, a DTC will have the following objectives:  Ensure compliance with appropriate standards and state and regulations. Pharmacy and  Develop and implement an efficient and cost-effective formulary Therapeutic system that includes consistent standard treatment protocols. committee  Ensure that only efficacious, safe, cost-effective, and best quality drugs are used (PTC)  Ensure the best possible drug safety through monitoring, evaluating, and thereby preventing, as far as possible, adverse drug reactions (ADRs) and medication errors  Develop and implement interventions to improve drug use by prescribers, dispensers, and patients; this will require the investigation and monitoring of drug use. Noha Alaa, PharmD, PhD 7 MEMBERS  The PTC consists of multiple members Noha Alaa, PharmD, PhD 8  Constitution of Drug and Therapeutics Committee  The DTC is usually constituted with expected competency to MEMBERS perform its duties.  Any committee could have odd numbers of members with voting powers that help in avoiding a draw.  A DTC should include stakeholders from major clinical specialty departments, administrations, and pharmacies.  A small committee could be formed with a minimum of seven members (2-3 doctors, 1-2 pharmacists, 1 nurse, 1 administrator, and another member as per the hospital’s requirement, preferably a medical IT specialist). For a small hospital, a small committee might be suitable. Small committees are less expensive and more easily reach consensus decisions. Noha Alaa, PharmD, PhD 9  MEMBERS Large committees are suitable for large hospitals with extensive pharmacy operations:  Greater expertise by adding professionals with different backgrounds.  Less workload for each member.  Involving more of the hospital staff helps with the implementation of decisions. Noha Alaa, PharmD, PhD 10  The following members could be included based on defined responsibilities:  A representative clinician from each major specialty, including surgery, obstetrics and gynecology, internal medicine, pediatrics, MEMBERS infectious diseases, and general practice (to represent the community)  A clinical pharmacist  A nurse, usually the senior infection control nurse.  A pharmacist (usually the chief or deputy chief pharmacist).  An administrator, representing the hospital administration and finance department  A clinical microbiologist.  A member of the hospital records department.  Some DTCs also include drug information pharmacists.  Common subcommittees of DTC are the infection control committee, procurement committee, patient safety committee, Noha Alaa, PharmD, PhD etc. 11   Direct patient care is the responsibility of clinical staff and the DTC only monitors and suggests how to improve it.  DTC combines evidence, local experience, patient values, and technological support available.  DTC promotes evidence-based clinical practices. Functions of  Develop drug policies, guidelines and plan strategies to implement Drug and new policies. Therapeutics  The policies and procedures addressed generally include purchase, Committee inventory, distribution, rational use, and disposal of pharmaceutical products.  Prepare and manage essential drugs list/hospital formulary and standard treatment guidelines (STGs)/clinical protocols.  Review new drugs, drug classes, new clinical indications, therapeutic advantages, new chemical entities, and new safety information. Noha Alaa, PharmD, PhD 12   Perform DUE studies of drug-related problems such as medication errors and ADRs and suggest improving better utilization of resources for rational drug use.  Conduct pharmacoeconomics evaluations to assure cost-effective Functions of and affordable drug use in the hospital. Drug and  Monitor information management system in the hospital to protect patient privacy and confidentiality in the system. Therapeutics  The DTC could also monitor potential legal and ethical violations Committee in clinical practice in collaboration with other bodies in the hospital.  The DTC also works with the quality assurance committee to ensure the hospital follows international patient safety goals and accreditation standards. It also self-evaluates its performance to deliver better services to the hospital and the community. Noha Alaa, PharmD, PhD 13   Reduce the drug budget Examples of  Procure drugs only from manufacturers that follow good manufacturing practices, holding the WHO prequalification some specific certificate policies  Hospital formulary management include:  Prescribe only from the hospital formulary and in generic names of drugs  Pharmacovigilance practices, safety culture  Medical reconciliation in transitions of care  Return or dispose expired drugs without polluting groundwater or air, etc. Noha Alaa, PharmD, PhD 14   Planning future agendas including medications, policies and procedures quality assurance and other subjects to be addressed  Gathering data to create drug monographs and other necessary documents Areas where  Evaluating medications for formulary adoption or deletion  Preparing and conducting quality assurance programs ( including drug usage Pharmacists evaluation and monitoring of adverse effects and medication errors) should be  Preparing policies and procedures supporting a  Communicating the pharmacy and therapeutics committee decisions to other areas of the institution pharmacy and  Creating hard copy and electronic version of the formulary therapeutic  The pharmacy should also investigate which medication’s need specific committee policies and procedures developed to guide the use and monitoring  Finally it is extremely important for the pharmacy and therapeutics committee to make sure that physicians are informed about the actions taken off and the pharmacy is heavily involved in providing the information to physicians Noha Alaa, PharmD, PhD 15 Noha Alaa Hamdy, PharmD, PhD 16  WHO defines essential medicines as those that satisfy the priority healthcare needs of the population. The essential medicines list is also called a formulary list. ESSENTIAL They are selected with regard to public health MEDICINES relevance, evidence on efficacy and safety, and POLICY AND comparative cost-effectiveness. FORMULARY MANAGEMENT Essential medicines are intended to be available within the 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. Noha Alaa, PharmD, PhD 17   The EML was first published in 1977 and the Model List of Essential Medicines for Children (EMLc) was first published in 2007.  The 20th EML and sixth EMLc, published on June 6, Essential 2017.  The 20th EML adds 30 medicines for adults and 25 Medicines for children and specifies new uses for already-listed List products, bringing the total to 433 medicines deemed essential for addressing the most important public health needs globally.  Most countries have national lists, and some have provincial or state lists as well depending on disease prevalence. 18 Noha Alaa, PharmD, PhD   The WHO Expert Committee on Selection and Use of Essential Medicines meets every 2 years to review the latest scientific evidence on the efficacy, safety, and cost- effectiveness of medicines.  Committee members are selected from WHO Expert WHO Criteria Advisory Panels based on equitable geographical for Selection of representation, gender balance, and professional Essential competencies to provide a representation of practical Medicines List experience from all regions of the world.  Most essential medicines should be formulated as single compounds. Fixed dose combination products are selected only when the combination has a proven advantage in therapeutic effect, safety, adherence, or in decreasing the emergence of drug resistance in malaria, tuberculosis (TB), and HIV/AIDS. Noha Alaa, PharmD, PhD 19   MEETINGS  The PTC meets on a monthly basis, bimonthly or at least quarterly according to the hospital policies. Pharmacy and  Pharmacy and therapeutics committee meeting room for Therapeutic the meeting should be carefully selected committee  The agenda should be prepared in advance by the (PTC) committee secretary and sent to the members  Pharmacy and therapeutics committee functions can also include investigational drug studies however that is often delegated to the Institutional Review Board that oversees all the investigational activities in the hospital Noha Alaa, PharmD, PhD 20   A conflict of interest (COI), financial or otherwise, may interfere with professionals’ ability to make evidence-based decisions.  Professionals participating in the P&T committee should disclose financial relationships with pharmaceutical CONFLICT OF manufacturers, medical supply vendors, other health care provider organizations, and other commercial interests. INTEREST  Conflict of interest ( i.e., would receive some direct or indirect (COI) compensation from having a drug available, e.g., stock in a company, honoraria for speaking, consulting fees, and gifts or grants from a company).  Some health care organizations exclude heath care professionals with COIs from P&T committee membership, whereas others allow participation in committee discussions but prohibit voting on particular items. Noha Alaa, PharmD, PhD 21  22 Noha Alaa, PharmD, PhD  DEFINITION  A formulary is a continually updated list of medications and related information, representing the clinical judgment of physicians, pharmacists, and other experts in the diagnosis, HOSPITAL prophylaxis, or treatment of disease and promotion of health. FORMULARY FORMULARY CONTENT A formulary includes, but is not limited to:  A list of medications and medication-associated products or devices,  Medication-use policies,  Important ancillary drug information,  Decision-support tools, and organizational guidelines. Noha Alaa, PharmD, PhD 23   A formulary system is the ongoing process through which a health care organization establishes policies regarding the use of drugs, therapies, and drug-related products.  Formulary may be arranged alphabetically or by therapeutic class (American Hospital Formulary Service AHFS HOSPITAL classification) FORMULARY  Formulary systems are used in many different settings, including:  Hospitals,  Acute care facilities,  Home care settings, and  Long-term-care facilities,  as well as by payers such as Insurance companies, and managed care organizations. Noha Alaa, PharmD, PhD 24   The formulary manual (e.g., WHO Model Formulary, British National Formulary, hospital formulary) is usually published as a small book that has the essential medicines list with short clinical profiles of each medicine.  Since its first publication in 2002, the WHO Model Formulary Formulary has become a source of independent information on essential medicines for pharmaceutical policy-makers and prescribers worldwide.  For each medicine, the formulary provides information on use, dosage, adverse effects, contraindications, and warnings, supplemented by guidance on selecting the right medicine for a range of conditions. Noha Alaa, PharmD, PhD 25   Proven effectiveness documented in the medical literature (Evidence-based information).  Maximizing safety and minimizing the potential for errors. FORMULARY  Optimizing pharmacoeconomics. PRINCIPLES  Significant improvements in patient’s quality of life (adherence & satisfaction).  The formulary will support drug protocols and other treatment algorithms.  Long term stability of formulary decisions. Noha Alaa, PharmD, PhD 26   The criteria used for approving addition of a drug to a formulary need to minimally include the following  Indication for use Evaluating  Effectiveness drugs for  Risks ( adverse effects, drug interactions, and formulary potential for medication errors (ease of preparation/ use )) inclusion  Cost and other appropriate items not anecdotal physician experience Noha Alaa, PharmD, PhD 27 Noha Alaa, PharmD, PhD 28 Noha Alaa, PharmD, PhD 29  Products are permitted to be used for unlabeled indications where there is adequate literature Unlabeled support and conversely may not be permitted to uses be used at least without special approval within the institution for FDA indications when there may be more appropriate drugs available Noha Alaa, PharmD, PhD 30   Authorized exchange of therapeutic alternatives in accordance with previously established and approved written guidelines or protocols within a formulary system  An example would be the use of cefazolin in specific doses Therapeutic whenever any other first generation injectable cephalosporin is ordered interchange  Genetic substitution can also be considered by the pharmacy and therapeutics committee but many pharmacies consider Generic genetic substitution to be one of their responsibilities and do not take such decisions to P& T committee for approval the Substitution one exception maybe drugs with narrow therapeutic index example anticonvulsants where a P&T committee may determine a list of products where generic substitution is not allowed although the FDA insists that such precautions are unnecessary Noha Alaa, PharmD, PhD 31   Nonformulary usage many institutions track the drug use patterns of prescribers specilally to nonformulary drugs.  Annually a list of non-formulary products and expenses should be made available to the pharmacy and therapeutics committee it’s helpful Nonformulary if the pharmacy director can report the total cost usage of nonformulary items as a percent of the total budget  It is good to check on whether non-formulary drug usage has led to medication errors Noha Alaa, PharmD, PhD 32  When new drug products are added to the formulary it is best to prepare physicians nurses and others Initially it is necessary to inform affected individuals that the drug will be available as New product of a specific date introductions In some cases it is necessary for specific equipment to be obtained and installed If the product use is complicated dangerous or prone to misuse several methods of instruction and prescribing restrictions should be employed Noha Alaa, PharmD, PhD 33   Thomas D. Clinical pharmacy education, practice and research, elsevier.2019  Malone P, et al. Drug Information: A guide for pharmacists, 5th edition, Mc Graw Hill Education. 2014 REFERENCES  Cole SW, May JR, Millares M, Valentino MA, Vermeulen JR LE, Wilson AL. ASHP guidelines on the pharmacy and therapeutics committee and the formulary system. Am J Health-Syst Pharm. 2008 Jul 1; 65:1272-83. Noha Alaa, PharmD, PhD 34 Noha Alaa, PharmD, PhD 35