Clinical Pharmacy Services & Sterile Preparations & Compounding Lecture Notes PDF

Clinical Pharmacy Services & Sterile Preparations and Compounding 21 November 2024 D r Ta h a n i A l w i d y a n A s s i s t a n t P r o fe s s o r I...

Clinical Pharmacy Services & Sterile Preparations and Compounding 21 November 2024 D r Ta h a n i A l w i d y a n A s s i s t a n t P r o fe s s o r I n C l i n i c a l P h a r m a c y a n d T h e r a p e u t i c s. Department of Clinical Pharmacy and Pharmacy Practice Faculty of Pharmaceutical Sciences The Hashemite University 11/20/2024 HOSPITAL PHARMACY 1 Outline Part 1. Role of clinical pharmacist in clinical departments. ▪ Background. ▪ Medication therapy management. Part 2. Sterile Preparations and Compounding. ▪ Techniques and standards for IV admixtures and other sterile preparations. 11/20/2024 HOSPITAL PHARMACY 2 Part One: Background ▪ What is Clinical Pharmacy? ▪ How does clinical pharmacy differ from pharmacy? ▪ Clinical Pharmacy – Goal. ▪ Clinical Pharmacy Requirements. ▪ Level of Action of Clinical Pharmacists. ▪ How to Pursue a Profession in Clinical Pharmacy? 11/20/2024 HOSPITAL PHARMACY 3 What is Clinical Pharmacy? ▪ It is a health specialty, which describes the activities and services of the clinical pharmacist to develop and promote the rational and appropriate use of medicinal products and devices. ▪ Clinical Pharmacy includes all the services performed by pharmacists practising in hospitals, community pharmacies, nursing homes, home-based care services, clinics and any other setting where medicines are prescribed and used. ▪ The term “clinical” does not necessarily imply an activity implemented in a hospital setting. ▪ A community pharmacist may perform clinical activities as well as a hospital practitioner. 11/20/2024 HOSPITAL PHARMACY 4 How does clinical pharmacy differ from pharmacy? ▪ The discipline of pharmacy embraces the knowledge on synthesis, chemistry and preparation of drugs. ▪ Clinical pharmacy is more oriented to the analysis of population needs with regards to medicines, ways of administration, patterns of use and drugs effects on the patients. ▪ The focus of attention moves from the drug to the single patient or population receiving drugs (individualized approach). ▪ Pharmaceutical care: is the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient's quality of life. ▪ The outcomes are: ✓ Cure of disease, elimination or reduction of a patient's symptoms, slowing of a disease process, preventing a disease or symptom. 11/20/2024 HOSPITAL PHARMACY 5  Clinical Pharmacy – Goal ▪ The overall goal of clinical pharmacy activities is to promote the correct and appropriate use of medicinal products and devices. ▪ The activities aim at: I. maximising the clinical effect of medicines, i.e., using the most effective treatment for each type of patient. II. minimising the risk of treatment-induced adverse events, i.e., monitoring the therapy course. III. the patient’s compliance with therapy. IV. minimising the expenditures for pharmacological treatments born by the national health systems and by the patients, i.e., trying to provide the best treatment alternative for the greatest number of patients. 11/20/2024 HOSPITAL PHARMACY 6 Clinical Pharmacy Requirements I. Knowledge of drug therapy. II. Knowledge of the disease. III. Knowledge of laboratory and diagnostic skills. IV. Communication skills. V. Patient monitoring skills: ✓ Physical assessment skills. ✓ Drug Information Skills. ✓ Therapeutic Planning skills. ✓ Knowledge of non-drug therapy. 11/20/2024 HOSPITAL PHARMACY 7 Level of Action of Clinical Pharmacists Clinical pharmacy activities may influence the correct use of medicines at three different levels: before, during and after the prescription is written. (1) Before the prescription: 1. clinical trials: participating in ethical committees, study monitoring, dispensation and preparation of investigational drugs 2. Formularies: national and local formularies 3. Drug information. 11/20/2024 HOSPITAL PHARMACY 8 Level of Action of Clinical Pharmacists (2) During the prescription 1. Counselling activity. 2. Clinical pharmacists can influence the attitudes and priorities of prescribers in their choice of correct treatments. The clinical pharmacist monitors, detects and prevents harmful drug interaction, adverse reactions ad medication errors through evaluation of prescriptions’ profiles. The clinical pharmacist pays special attention to the dosage of drugs which need therapeutic monitoring. Community pharmacists can also make prescription decisions directly, when over the counter drugs are counselled. 11/20/2024 HOSPITAL PHARMACY 9 Level of Action of Clinical Pharmacists Medication-related Problems Adverse drug reactions. 1. Drug interactions. 1. Untreated indications. 2. Medication use without 2. Improper drug selection. indication. 3. Subtherapeutic dosage. 4. Medication Failure to receive. 5. Medication Overdosage. 11/20/2024 HOSPITAL PHARMACY 10 Level of Action of Clinical Pharmacists (3) After the prescription 1. Counselling: improve patients' awareness of their treatments 2. Preparation of personalised formulation. 3. Drug use evaluation. 4. Outcome research. 5. Pharmacoeconomic studies. 6. Monitor treatment response. 7. Check and improve patients' compliance with their medications. 11/20/2024 HOSPITAL PHARMACY 11 How to Pursue a Profession in Clinical Pharmacy Clinical pharmacists have any of the following degree: ▪ Doctor of Pharmacy (Pharm.D.) degree. ▪ Master degree in clinical pharmacy. ▪ Pharmacists who completed one or more years of post- graduated training (e.g. a general and/or specialty pharmacy residency). Many clinical pharmacists also choose to become Board Certified: ✓ Board Certified Pharmacotherapy Specialist (BCPS). ✓ Board Certified Oncology Pharmacist (BCOP). ✓ Board Certified Nuclear Pharmacist (BCNP). 11/20/2024 HOSPITAL PHARMACY 12  Medication therapy management ▪ Medication therapy management (MTM): is a service that optimizes therapeutic outcomes for patients through direct pharmacist-patient interaction and interdisciplinary collaboration. ▪ Objectives: I. Ensure appropriate medication use. II. Improve adherence and therapeutic outcomes. III. Prevent medication errors and adverse drug reactions (ADRs). IV. Support cost-effective treatment. 11/20/2024 HOSPITAL PHARMACY 13  Medication therapy management ▪ Core elements of an MTM service model in pharmacy practice: Reference: Medication therapy management in pharmacy practice: Core elements of an MTM service model (version 2.0) 1) Medication therapy review (MTR). 2) Personal medication record (PMR). 3) Medication-related action plan (MAP). 4) Intervention and/or referral. 5) Documentation and follow-up. Every core element is integral to the provision of MTM; however, the sequence and delivery of the core elements may be modified to meet an individual patient’s need. 11/20/2024 HOSPITAL PHARMACY 14 Medication therapy management ▪ Core elements of an MTM service model in pharmacy practice: 1) Medication therapy review (MTR). ▪ It is a systematic process of collecting patient-specific information, assessing medication therapies to identify medication-related problems (MRPs), and developing a plan to resolve or prevent these issues in collaboration with the patient and healthcare team. ▪ It is a cornerstone of MTM services aimed at optimizing therapeutic outcomes and improving patient safety. 11/20/2024 HOSPITAL PHARMACY 15 Medication therapy management ▪ Components of MTR a. Data Collection ✓Patient Information: Demographics, medical history, allergies, and lifestyle factors. ✓Medication List: Prescription, over-the-counter (OTC), herbal, and dietary supplements. ✓Laboratory Data: Relevant clinical parameters for assessing therapy effectiveness and safety. b. Assessment ✓Appropriateness: Is the drug suitable for the condition? ✓Effectiveness: Is the medication achieving the desired outcomes? ✓Safety: Are there any adverse effects, contraindications, or interactions? ✓Adherence: Is the patient taking the medication as prescribed? 11/20/2024 HOSPITAL PHARMACY 16 Medication therapy management c. Identification of MRPs ✓Unnecessary medications. ✓Inadequate therapy or dosing. ✓Untreated conditions. ✓Nonadherence issues. d. Developing a Plan ✓Recommend changes to the healthcare provider (e.g., dose adjustment, alternative therapy). ✓Educate the patient on the correct use of medications. ✓Monitor outcomes and follow up as needed. 11/20/2024 HOSPITAL PHARMACY 17 Medication therapy management ▪ Role of Hospital Pharmacists in MTR ✓Multidisciplinary Collaboration: Working with doctors, nurses, and other healthcare professionals. ✓Patient-Centered Approach: Engaging patients in discussions about their therapy. ✓Special Populations: Focus on patients with complex conditions (e.g., geriatrics, oncology, ICU). ✓Utilization of Tools: ❖Electronic Health Records (EHR): Centralize patient data for easy access. ❖Medication Reconciliation Forms: Help track changes in therapy. ❖Clinical Guidelines: Ensure evidence-based recommendations. ❖Medication Databases: Identify interactions, duplications, and alternative therapies. 11/20/2024 HOSPITAL PHARMACY 18 Medication therapy management Medication Reconciliation: is a standardized process whereby the most complete and accurate list possible of a patient’s medications is communicated to the next provider of service. Importance: to reduce duplicate medications listed in patient records. Medication Reconciliation occurs at: ▪ Time of Admission. ▪ Change in level of care. ▪ Upon Discharge. The compilation of a complete and accurate list of medications the patient is currently taking at home. 11/20/2024 HOSPITAL PHARMACY 19 Medication Reconciliation comprises five steps: (1) develop a list of current medications. (2) develop a list of medications to be prescribed. (3) compare the medications on the two lists. (4) make clinical decisions based on the comparison. (5) communicate the new list to appropriate caregivers and to the patient. 11/20/2024 HOSPITAL PHARMACY 20 Medication Reconciliation Example Form 11/20/2024 HOSPITAL PHARMACY 21 Medication therapy management Issues Identified During MTR: Case Example for Discussion: A 68-year-old male with diabetes, ✓Safety: NSAID use (ibuprofen) contraindicated in chronic hypertension (145/90 mmHg), kidney disease. and chronic kidney disease. ✓Effectiveness: Blood pressure not controlled at 145/90 mmHg. Medications: ✓Adherence: Patient often forgets evening dose of metformin. ▪ Metformin 500 mg twice daily. Issues Identified During MTR: ▪ Lisinopril 10 mg daily. ✓Safety: NSAID use (ibuprofen) contraindicated in chronic ▪ Furosemide 40 mg daily. kidney disease. ▪ OTC ibuprofen for back pain. ✓Effectiveness: Blood pressure not controlled at 145/90 mmHg. ✓Adherence: Patient often forgets evening dose of metformin. 11/20/2024 HOSPITAL PHARMACY 22 Medication therapy management ▪ Core elements of an MTM service model in pharmacy practice: 2) Personal medication record (PMR). ▪ PMR is a comprehensive, patient-specific document that contains detailed information about all the medications a patient is currently taking, including: Prescription medications Over-the-counter (OTC) drugs Herbal products Dietary supplements 11/20/2024 HOSPITAL PHARMACY 23 Medication therapy management ▪ Importance of PMR in Pharmacy Practice 1. Enhances Patient Understanding ◦ Provides a clear, organized list of medications. ◦ Helps patients understand the purpose, dosing, and potential side effects of their medications. 2. Improves Medication Adherence ◦ By providing accessible information, the PMR encourages patients to follow prescribed regimens. 3. Facilitates Interprofessional Communication ◦ A PMR is a valuable tool for communication between pharmacists, physicians, nurses, and other healthcare providers. 4. Promotes Patient Safety ◦ Reduces the risk of medication errors, such as duplications, interactions, or contraindications. 5. Supports Emergency Care ◦ In emergency situations, the PMR provides healthcare professionals with a quick reference for the patient’s medication history. 11/20/2024 HOSPITAL PHARMACY 24 Medication therapy management ▪ How Pharmacists Create and Maintain a PMR 1. Patient Interview ◦ Gather detailed medication history from the patient or caregiver. 2. Review of Medical Records ◦ Cross-check with medical records and prescriptions. 3. Medication Reconciliation ◦ Verify and update the PMR at every patient encounter. ◦ Note: while PMR can be used as a reference during medication reconciliation, it is not the reconciliation process itself. 4. Patient Education ◦ Provide a copy of the PMR to the patient and explain its importance. 11/20/2024 HOSPITAL PHARMACY 25  Comparison Table: MTR vs. PMR Aspect Medication Therapy Review Personal Medication Record (MTR) (PMR) Definition A systematic review of a patient’s A comprehensive, patient-specific medications to identify and document listing all current resolve medication-related medications. problems. Purpose To optimize medication therapy To empower patients with an by assessing appropriateness, organized reference for their effectiveness, safety, and medications. adherence. Outcome Identifies issues and proposes Provides a clear, static record of actionable recommendations to current medications for patient improve therapy. use. 11/20/2024 HOSPITAL PHARMACY 26  Comparison Table: MTR vs. PMR Aspect Medication Therapy Review Personal Medication Record (MTR) (PMR) Focus Pharmacist-led evaluation and Patient-centered reference tool. therapy optimization. Includes Assessment Yes, includes an evaluation of No, simply lists medications therapy appropriateness, safety, without evaluation. and effectiveness. Includes Recommendations Yes, contains recommendations No, serves as a static document to improve therapy. for patient reference. Patient Involvement Patients may participate in Patients primarily use the PMR as discussing problems and a reference for understanding implementing recommendations. and managing their therapy. 11/20/2024 HOSPITAL PHARMACY 27  Comparison Table: MTR vs. PMR Aspect Medication Therapy Review Personal Medication Record (MTR) (PMR) Timing Conducted during clinical Created and updated regularly; interactions or at transitions of used for ongoing patient care. reference and emergency situations. Use Used to identify and resolve Used as a reference for patients therapy-related problems. and healthcare providers. Content Includes detailed assessment, Includes medication names, identification of problems, and doses, indications, and other key actionable solutions. details, but no assessments. Who Benefits Most Healthcare providers and patients Patients benefit from having a benefit from resolving therapy clear, accessible list of issues and optimizing outcomes. medications. 11/20/2024 HOSPITAL PHARMACY 28 Medication therapy management ▪ Core elements of an MTM service model in pharmacy practice: 3) Medication-related action plan (MAP). ▪ It is a patient-specific document that provides actionable steps for the patient to follow in managing their medications. ▪ Key Features: Action-Oriented: Focused on actions the patient needs to take to optimize their therapy. Goal: To empower the patient with clear guidance for achieving therapeutic outcomes. 11/20/2024 HOSPITAL PHARMACY 29 Medication therapy management ▪ Contains: ✓ Identified medication-related issues. ✓ Specific, step-by-step instructions for resolution. ✓ Follow-up plan or goals. ▪ Output: ✓ The MAP complements the PMR by outlining how the patient should address identified medication-related issues. 11/20/2024 HOSPITAL PHARMACY 30 Feature MTR PMR MAP Focus Reviewing and analyzing Listing medications for Providing actionable steps medications patient use for the patient Purpose Identify and resolve MRPs Provide a comprehensive Empower patient to medication list manage their therapy Audience Healthcare provider Patient Patient Primary Content Assessment of therapy Medication names, doses, Steps to resolve MRPs and purposes optimize therapy When Used Initial step in MTM Ongoing patient reference Post-MTR or as part of the MTM process Dynamic Updates Based on clinical needs Regular updates as Updated as therapy goals medications change evolve Example Identify a potential drug List includes all current "Take medication X with interaction medications food to reduce side effects" 11/20/2024 HOSPITAL PHARMACY 31 Medication therapy management ▪ Core elements of an MTM service model in pharmacy practice: 4) Intervention and/or referral. ▪ Interventions involve identifying and resolving medication-related problems directly, while referrals involve collaborating with other healthcare professionals to address issues beyond the pharmacist’s scope. ▪ Importance in Hospital Pharmacy: ✓ preventing ADEs. ✓ reducing hospital readmissions. ✓ enhancing therapeutic outcomes. 11/20/2024 HOSPITAL PHARMACY 32 Medication therapy management ▪ Types of Interventions in MTM Adjusting Therapy: Example: Adjusting anticoagulant doses based on renal function or INR results. Patient Education: Example: Explaining the use of insulin pens or inhalers. Addressing Drug-Drug Interactions: Example: Substituting a medication to avoid harmful interactions (e.g., avoiding NSAIDs in patients on warfarin). Monitoring and Follow-Up: Example: Regularly checking vancomycin or aminoglycoside levels in hospitalized patients. 11/20/2024 HOSPITAL PHARMACY 33 Medication therapy management ▪ Core elements of an MTM service model in pharmacy practice: 5) Documentation and follow-up. ▪ What is Documentation? o The systematic recording of patient care activities and interventions. ▪ Why Document? o Continuity of Care: Ensures consistent communication across healthcare providers. o Legal and Professional Standards: Meets legal requirements and ensures accountability. o Clinical Value: Tracks progress, identifies trends, and evaluates outcomes. o Reimbursement: Supports billing for MTM services. 11/20/2024 HOSPITAL PHARMACY 34 Part two: Sterile Preparations and Compounding ▪ Techniques and standards for IV admixtures and other sterile preparations. ✓ An IV admixture is the preparation of a sterile solution by combining one or more medications with a compatible diluent or base solution, such as saline or dextrose, to be administered intravenously. ✓ This process ensures that the resulting mixture is safe, effective, and tailored to the patient’s specific therapeutic needs. ✓ Purpose: To deliver medications directly into the bloodstream for rapid action. ✓ Preparation: Must be performed in a sterile environment to prevent contamination. ✓ Examples: Antibiotics, chemotherapy drugs, and parenteral nutrition solutions. It involves precise calculations and adherence to aseptic techniques to ensure safety and efficacy. 11/20/2024 HOSPITAL PHARMACY 35 Importance of IV Admixtures and Sterile Preparations ▪ Applications: Chemotherapy for cancer patients. Total parenteral nutrition (TPN) for malnourished patients. IV antibiotics for severe infections. ▪ Risks if not prepared properly: Contamination leading to infections. Medication errors affecting patient outcomes. Physical or chemical incompatibilities. 11/20/2024 HOSPITAL PHARMACY 36 International Standards Followed in Jordan ▪ USP : Provides sterile compounding guidelines. ▪ WHO Good Manufacturing Practices (GMP): Ensures safety, quality, and efficacy. ▪ ISO Standards: ✓ Classification of cleanrooms. ✓ E.g., ISO Class 5 required for laminar airflow hoods (LAFH). ▪ Cleanroom Design: Restricted access to prevent contamination. Positive airflow and HEPA filtration systems. 11/20/2024 HOSPITAL PHARMACY 37  Techniques: Aseptic Techniques and PPE ▪ Aseptic Techniques: ✓ Hand washing for at least 30 seconds with antimicrobial soap. ✓ Use of sterile syringes and needles. ✓ Disinfection of vial stoppers and ampule necks with alcohol. ▪ Personal Protective Equipment (PPE): ✓ Sterile gowns, gloves, masks, and shoe covers. ✓ Regular glove sanitization with 70% isopropyl alcohol. 11/20/2024 HOSPITAL PHARMACY 38  Techniques: Preparation Methods 1. Manual Compounding: ✓ Direct preparation using syringes, vials, and ampules. ✓ Requires high skill and attention to detail. 2. Automated Compounding Devices (ACDs): ✓ Frequency used for TPN preparation. ✓ Ensure accuracy, reduces errors, and saves time. 11/20/2024 HOSPITAL PHARMACY 39 Quality Assurance Processes ▪ Testing and Validation: ✓ Media fill tests to simulate sterile compounding conditions. ✓ Regular environmental monitoring (air, surface, and personnel). ▪ Double-Check Systems: ✓ Verifying ingredients, volumes, and labels. ✓ Conducted by multiple pharmacists to minimize errors. 11/20/2024 HOSPITAL PHARMACY 40 Regulatory Oversight in Jordan ▪ Jordan Food and Drug Administration (JFDA): - Regulates and inspects hospital compounding practices. ▪ Hospital Accreditation Standards (HCAC): - Focus on maintaining aseptic conditions and thorough documentation. 11/20/2024 HOSPITAL PHARMACY 41  Thank you Dr Tahani Alwidyan [email protected] [email protected] http://staff.hu.edu.jo/tahanialwidyan 11/20/2024 HOSPITAL PHARMACY 42