Download presentation
Presentation is loading. Please wait.
1
Managing Clinical Pharmacy Services
John M. Allen, PharmD, CPh, BCCCP, BCPS Pharmacy Clinical Coordinator PGY-1 Pharmacy Residency Program Director Medical Center of Trinity
2
Lesson Objectives Differentiate between clinical and operational aspects of institutional pharmacy Describe the purpose of a hospital formulary Discuss principles of formulary management Describe the drug use evaluation process Identify different types of pharmacy practice models Describe the process for implementing new clinical services
3
What are Clinical Pharmacy Services?
Activities and processes that: Ensure optimal therapeutic outcomes Minimize adverse drug events (ADEs) Promote cost-effective strategies Can be provided in all health-settings Not limited to institutional settings
4
Typical Reporting Structure for Hospital Pharmacy
Director of Pharmacy Clinical Coordinator Clinical RPhs Operations Coordinator Pharmacy Technicians
5
Pharmacy Practice: Clinical and Operational Services
Pharmacy Operations Clinical Services
6
Case # 1 Dr. Smith, chief of Internal Medicine at your institution has requested that a new antibiotic Ceftazidime- Avibactam be added to hospital formulary The drug was recently approved by the FDA and has a similar mechanism to other formulary alternatives You as the Clinical Coordinator are asked to review and present the drug at your hospital’s next Pharmacy and Therapeutics (P&T) Committee meeting What things should be considered when evaluating addition of a new drug to formulary?
7
Formulary List of approved medications that can be prescribed within an organization Goal of a formulary is to provide selected list of medications that achieve rationale therapeutic outcomes Minimize duplication Reduce inventory burden Generally, emphasize use of generic medications when possible Can be categorized as closed vs. open Mixed formulary is a hybrid of open/closed formulary
8
Open vs. Closed Formulary
Offer all available medications to be prescribed to any patient Provide little control over inventory In purest sense, not routinely used ($$$) Only drugs on formulary may be prescribed Provides control on medications used within facility Limits prescriber autonomy
9
Mixed Formulary System
Most common type of formulary system used by hospitals and hospital-systems Allows flexibility within formulary Generally, within mixed formulary lies three tiers Open- Any drug on formulary may be prescribed for any patient Restricted- Medication is limited to specific patient population or prescribers (i.e. Chemotherapy) Targeted- Medication requires approval prior to dispensing (i.e. Targeted antimicrobials ID physician or PharmD )
10
Formulary Management When considering adding new agents to formulary, a drug monograph is typically presented Evidence-based review of medical literature Standards exist to guide monograph development Can be developed internally or from outside vendor Facts and Comparison
11
Formulary Management: Monograph Components
Joint Commission ASHP Indication Effectiveness Drug Interactions Potential for errors and abuse Adverse drug events Sentinel event advisories Population served (i.e. pediatrics) Other risks Cost Brand/generic names FDA approval information Pharmacology/MOA FDA-approved indication Non-FDA approved indications (i.e. Off-label) Dosage forms/storage Pharmacokinetics Special population Pregnancy/Breastfeeding Comparison of drug efficacy, safety, convenience versus therapeutic alternatives Clinical trials and critique Med safety assessment (drug interactions, monitoring, look- alike, sound-alike issues) Financial analysis
12
Formulary Management Things to Consider
Efficacy Cost Safety
13
Formulary Management Things to Consider
Efficacy Is new agent better than current formulary options? cIAI- 91.2% efficacy, Meropenem- 93.4% cUTI- 70.4% efficacy, Imipenem- 71.4% Safety Are there additional safety concerns with the proposed new agent vs. current formulary options Serious adverse events- 8.9% vs. 10.8% Cost Is the benefit worth the cost? Ceftazidime-Avibactam- $271/dose ($813/day) Meropenem- $4/dose ($16/day) Cefepime- $6/dose ($18/day) Piperacillin-tazobactam- $5/dose ($20/day)
14
Formulary Management Recommendations
Generally, after review of drug monograph, formulary recommendations made Formulary Decisions Addition without restrictions Addition with restrictions on prescribers, or patient types (i.e. Criteria for use) Addition with required approval prior to dispensing Reject medication for formulary addition 6-to-12 month review for most new medications added to formulary to ensure appropriate use
15
Formulary System Policies and procedures which govern medication use process Policy- Course or plan of action Procedure- Course of action intended to achieve a result; provides details processes Medication use process Drug selection and procurement Ordering and transcribing Preparing and dispensing Administration Monitoring Should be developed in collaboration with multidisciplinary team (i.e. RN, MD, RD, RT, etc.) and evidence-based Policies and procedures to be reviewed periodically
16
Pharmacy & Therapeutics (P&T) Committee
Committee that oversees safe, effective, and responsible medication use within hospital Comprised of physicians, nurses, pharmacists, hospital administrators, support staff, Hospital Quality Medical committee NOT Pharmacy Committee Conflict of interest should be disclosed annually Stock investments, Research support, Speakers Bureau, etc. Recommendations are subject to Medical Executive Committee Approval
17
P&T Committee Subcommittees
Provide expert advise on the development and monitoring of processes for specific groups of drugs Antimicrobial subcommittee Anticoagulation committee Pain management committee Pediatrics committee Subcommittees typically complete drug use evaluations (DUEs) and develop evidence-based tools to guide appropriate drug therapy Criteria for Use Orderset development Education materials
18
Case # 1 Revisited When considering a new agent for potential formulary addition, which of the following should be considered: Efficacy Safety issues Cost-effectiveness Based on review, Ceftazidime-Avibactam which action should be recommended: Add to formulary due to improved efficacy compared to formulary options without restrictions Add to formulary due to comparable safety, efficacy, and cost-effectiveness with limitations to ID prescribers only. Re-evaluate use in 6 months Remain non-formulary due to lack of significant benefit compared to current formulary options, and increased acquisition costs
19
What things should you consider when completing a DUE?
Case # 2 The Director of Pharmacy has asked you to evaluate drug spend for the institution and look for opportunities to reduce overall drug spend You notice that Procrit (epoetin alfa) spend is increased significantly from previous year You suspect that Procrit utilization is increased due to inappropriate use and have decided to complete a DUE on Procrit What things should you consider when completing a DUE?
20
Drug Use Evaluation Term used synonymously with Medication Use Evaluation (MUE) Drug Use Evaluation required by The Joint Commission to monitor safety of medications Structured, quality improvement program designed to promote appropriate, safe, and effective medication use
21
Drug Use Evaluation Examples of Medications/High-Risk Medication Related Processes
Neuromuscular blocking agents Anticoagulants Insulin infusion Sedation protocols Stress Ulcer Prophylaxis Albumin Epoetin Alfa Management of Clostridium Difficile Infection
22
Drug Use Evaluation Process
Gain Organizational Authority and Assign Responsibility Identify areas of opportunity Develop criteria and indicators for optimal use Involve practitioners who practice in the setting Collect data and evaluate utilization Develop and implement plans for improvement Monitor and assess plan for improvement
23
Pharmacy Practice Models
Describes how a pharmacy department's resources are deployed to provide patient care Includes pharmacists, technicians, automation, and technology Pharmacy Practice Model Initiative (PPMI), 2010 Sponsored by ASHP Key opinion leaders in pharmacy practice Conclusions centered on moving from pharmacy-centric to patient-centric focus
24
Pharmacy Practice Model Initiative: Recommendations
The imperative that all patients should have a right to the care of a pharmacist The characteristics, requirements, and challenges of optimal pharmacy models Advancing the application of information technology in the medication-use process Advancing the use of pharmacy technicians Successful implementation of new pharmacy practice models
25
Clinical Services UHC 2010 All patients Specialized Services
Med reconciliation Review of non-emergent orders prior to first dose Develop individualized treatment plans Daily monitoring of medication profiles Participation in patient care rounds Educate patients on new medications Communicate discharge plan to outside caregivers Anticoagulation management Resuscitation teams Parenteral nutrition IV to PO conversion Antimicrobial stewardship Pharmacokinetic evaluation, dosing, monitoring Renal dosing adjustments Collaborative drug therapy management Patient education on preventing disease and improving health
26
Pharmacy Practice Models Examples
Pharmaceutical Care Model Integrated practice model Member of interdisciplinary team Includes most pharmacists Patient-focused Clinical Pharmacy Model Rounding with little distributive functions Pharmacist acts as consultant Requires specialized skillset Focus on quality of care Drug Distribution Model Medication order focused No direct patient care No involvement in patient outcomes Focuses on timely delivery
27
Pharmacy Practice Models Choosing a model
Depends on host of factors Logistical issues Utilization/deployment of pharmacy technicians Automation/Technology Pharmacist training Scope of pharmacy practice Standardized model not yet developed Agreement in some aspects Patient-centered care avoids/reduces med errors Involvement in patient centered care improves collaboration with physicians
28
Specific Practice Model: Critical Care Pharmacy
Fundamental Distributive Order entry/verification Desirable Formal nutrition consults Respond to resuscitation events Didactic lectures to healthcare professionals Develop implement ICU policies/protocols Present case reports Optimal Assist providers with therapeutic decision making Coordinate or direct residency training Develop new pharmacy programs Perform clinical research
29
Specific Activities: Critical Care Pharmacy
Prospective evaluation of all drug therapy Evaluation of appropriateness of therapy Define goals of therapy Documentation of services Reporting of ADEs Provision of drug info Participation in educational and institutional activities Contribute to P&T committee Activities on cost- containment Drug dosing adjustments Monitoring and preventing DDI and ADEs Nutritional assessment Check compatibilities of IV medications Prevention and treatment of life-threatening infections Safe and optimal use of technology
30
Documentation of Services
Documentation shows diversity, effectiveness, cost and outcome of activities Outcomes of documentation Establish additional clinical services Expand roles of existing services Assess new processes Provide data for quality assurance or research Accreditation purposes Promotional reasons Assessment of financial impact
31
Implementing New Services: Overview
Four stages to developing plan for new clinical services Complete assessment of current clinical services Review of literature supporting clinical services Development of clinical services Implementation and assessment of new services
32
Implementing New Services: Assessment
Appraise current type of practice model Assess performance of model Number/Types of interventions Type of direct patient care Analyze productivity of pharmacists Medication orders reviewed/verified Clinical Interventions Evaluate use of technology within department/hospital Review culture of physicians and nurses toward pharmacy
33
Implementing New Services: Review of current literature
Summary of literature regarding clinical pharmacy service Impact of pharmacist intervention Identify and review pertinent health-system related data Patient outcome most associated with readmission rates Patient outcomes associated with reduction in payment from payors
34
Implementing New Services: Development
Need clear vision and description of activities and expectation Mission statement Job description with clear expectations for clinical activities Metrics need to be developed to demonstrate effectiveness of clinical services Should be developed in concert with key stakeholders Example: Number/type of interventions, number of patients educated, number of med recs completed, drug cost avoided, time to verification
35
Implementing New Services: Implementation
Most difficult phase Should include timeline for implementation Orientation and training of staff involved Electronic/logistical updates Development of infrastructure Ongoing monitoring and feedback to pharmacists about clinical services Ongoing shadowing and coaching of clinical pharmacists
36
Managing Clinical Practitioners
Required duty of pharmacy management Leadership and management skills Requires understanding of roles and responsibilities Self-reflection on state of clinical services Maintenance of relationships with key hospital personnel
37
What things should you consider when completing a DUE?
Case #2 Revisited The Director of Pharmacy has asked you to evaluate drug spend for the institution and look for opportunities to reduce overall drug spend You notice that Procrit (epoetin alfa) spend is increased significantly from previous year You suspect that Procrit utilization is increased due to inappropriate use and have decided to complete a DUE on Procrit What things should you consider when completing a DUE?
38
Case #2 Revisited Review appropriate utilization of Epoetin alfa
KDIGO Clinical Practice Guidelines Review appropriateness criteria with nephrologists Collect data and evaluate the information Develop opportunity for potential actions
39
Summary Formulary management is a key aspect to promoting safe, effective and responsible medication use within a hospital P&T Committee recommends formulary additions, formulary deletions, and processes designed to improve or guide medication use Drug Use Evaluations are a tool used to observe and identify opportunities to improve medication use Various practice models exist each with different areas of focus Implementation of new clinical services should be performed in a systematic way
40
Email: john.allen@hcahealthcare.com
Questions?
Similar presentations
![[Hospital Name | Presenter name and title | Date of presentation]](/19/5722524/big_thumb.jpg "[Hospital Name | Presenter name and title | Date of presentation]>")
