Pharmacy Investigational Drug Services for Clinical Research
|
|
- Godwin Pitts
- 8 years ago
- Views:
Transcription
1 Pharmacy Investigational Drug Services for Clinical Research Jennifer Colon, PharmD, MS, MBA Pharmacy Clinical Specialist-Investigational Drug Services Temple University Hospital Adjunct Clinical Professor-Temple University School of Pharmacy
2 Objectives Learn about services provided by Investigational Drug Services (IDS) Pharmacy Understand how using the IDS Pharmacy can assist and enhance research Gain further understanding of operations within the IDS pharmacy
3 Pharmacy Locations Inpatient Pharmacy/Pharmacy Administration/Research Pharmacy; Rock Pavilion Zone B, Basement Inpatient Pharmacy Satellite; Boyer 3 rd Floor Outpatient Cancer Center Pharmacy; 4 th Floor ACC Building Outpatient Pharmacy; 1 st Floor Parkinson s Pavilion
4 IDS Operations Pharmacy Clinical Specialist (Jen Colon) Back Up Pharmacist Regular Operations (Outpatient Studies) Monday through Friday 7:30am 4pm Inpatient Studies 24 hour service through Inpatient Pharmacy (2-8280) On call and special arrangements (Jen)
5 Investigational Drug Definition Agent being considered for commercial marketing, not yet approved by the FDA Approved medication being studied for an unlabeled use or population Investigational drugs can be: new drugs or old drugs with: new indications; new combinations; or new components; or investigational use of commercially available drugs
6 Purpose of the IDS Pharmacy To ensure research involving investigational medicine is conducted appropriately, maximizing patient safety Provide additional support to study teams related to research (randomization, drug accountability and disposition, blinding/unblinding)
7 Regulatory Compliance The IDS pharmacy assures compliance with all federal (FDA, NIH, NCI), state, JCAHO, and IRB regulations concerning investigational medication. The IDS pharmacy also assures compliance with TUHS administrative/nursing/pharmacy policies The IDS Pharmacy assures compliance with USP 797 & 795 guidelines
8 Regulations & Drug Research State of Pennsylvania Dispensing (any legend drugs, including investigational drugs) is limited to a licensed pharmacist, physician, or dentist Pharmacy practice act governs requirements for labeling, documentation of medication dispensing Investigational drugs for inpatient administration must be stored and dispensed from the hospital pharmacy
9 FDA Requirements-Investigational Drug Storage Secure location with limited access Storage conditions according to instructions on drug label or in accordance with the protocol (temperature, humidity, light, min/max temps) Investigator Responsibilities 21 CFR Administer drug only to subjects under personal supervision of primary investigator or sub-i. Access to the drug is limited and not supplied to those not authorized to receive it.
10 Joint Commission Requirements MM.7.40-Investigational medications are safely controlled and administered Pharmacy is responsible for the storage, dispensing, labeling, and distribution of investigational medications. Investigational Drug Data Sheet (IDDS) describing therapeutic indications, AEs, drugdrug interactions, and contraindications must be part of the permanent medical record
11 Investigational Drug Service Basic Activities: Registration of drug s use in hospital Procurement (ordering, returns, inventory management) Storage Preparing/packaging Dispensing Provision of drug information Maintenance of records
12 Compounding and Packaging
13 Packaging-Euclid
14 Packaging-Euclid
15 Packaging-Blister Packs
16 Investigational Drug Service Administrative Responsibilities Reordering investigational drugs* Disposal of used or unused drug in accordance with sponsor s protocol and hospital policy (TUH-ADMIN-930(1).801)* Preparing and maintaining pharmacy binders for each protocol Preparing budget proposals for pharmacy charges for each protocol Billing for IDS services *at the discretion of the primary investigator and study team
17 Investigational Drug Service Administrative Responsibilities IRB Membership at Temple University and Fox Chase Cancer Center Protocol management Staff development and in-servicing education Providing guidance related to compounding and handling of hazardous medications (biologics, chemotherapy, human tissue) Providing tours for site qualification and accommodating all site visits
18 A Quick Tour.. Temple University Hospital Inpatient Pharmacy holds some of the most advanced pharmacy technology in the region. Using these systems helps ensure patient safety and drug delivery efficacy and accuracy. Investigational drugs are stored according to CFR which mandates all investigational drugs must be stored in a securely locked, substantially constructed enclosure, with limited access to prevent theft or diversion
19 Advanced Technology-Talyst
20 Advanced Technology-Intelifil
21 Room Temperature Storage
22 Room Temperature Storage
23 Refrigerated Storage
24 Narcotic Vault
25 Narcotic Vault
26 -20 Degree Freezer
27 Sterile Compounding Room-Positive Pressure Hood
28 Sterile Compounding Room-Positive Pressure Hood
29 Cancer Center Pharmacy-Negative Pressure Hood
30 Cancer Center Pharmacy-Negative Pressure Hood
31 Cancer Center Pharmacy-Positive Pressure Hood
32 Cancer Center Pharmacy- Refrigerated Storage
33 Investigational Drug Service Research and Development Activities: Protocol development-especially drug delivery and monitoring Act as unblinded personnel in single and double blind studies (Pharmacy will break the blind if needed) Randomization (if requested) Pharmaceutical research (formulation & development) Preparation of dosage forms Drug analysis & quality control
34 IDS Pharmacy Services Initial protocol review Access pharmacy s ability to accommodate the protocol (biologic, human tissue, virus) Participate in site qualification, pre-study, monitor visits, and audits Study budgeting for drugs and pharmacy services Pharmacy procedure and IDDS (Investigational drug data sheet) development
35 IDS Pharmacy Services Store, dispense, & account for study medications from initial sponsor shipment through final drug return or destruction Support of investigator initiated projects (study design, randomization, blinding, accountability log development, preparation of double-blind drug and placebos, and patient monitoring) Maintenance of discontinued study documents
36 When is the IDS Pharmacy Required to be Involved? Pharmacy must dispense any inpatient administered investigational medication. Any medication requiring preparation or manipulation of any kind (USP 797 & 795 guidelines) for both outpatient and inpatient studies Any medication requiring repackaging or relabeling (USP 795 guidelines) Any premixed intravenous infusion administered inpatient or outpatient. Compounding of placebo match
37 Exceptions at TUHS Prepackaged oral medications (pills, inhalers) or topical agents for outpatient protocols can be stored in primary investigators department. Medication must be stored in a temperature controlled, locked area of the department with limited access.
38 What Does Pharmacy Need from the Study Team? IRB and contract approval before study can be opened for dispensing All study materials must be supplied to the pharmacy prior to initiating a study A time period of 6 weeks notice is requested to ensure staff is trained, as appropriate Ensure an IDDS sheet is provided to pharmacy and placed in each inpatient s chart
39 Initiating IDS Services Review of draft protocol or grant IDS cost proposal (usually requested by Arleen Wallen for sponsored projects as part of protocol budget) Access legal requirements and any special needs Evaluate ability to conduct study Ensure that pharmacy fees are included in research contract or grant
40 Requirements Prior to First Dispensing Drug must be onsite Final protocol and investigator s brochure (electronic copies are acceptable) Pharmacy binder or all documents needed to make one (accountability logs, destruction logs, specific temp logs) Notice of IRB approval-irb number (all studies must be approved by the IRB) Grant/study specific account numbers (FOAPAL)
41 I m Ready to Enroll a Patient.How Do I Order an Investigational Drug?
42 Required Medication Order Contents-Inpatient Order Must be entered into MIS/TDS by a physician on the study team as a non formulary type in to prevent insurance from being charged Study name and IRB number must be included in the order Active agent vs. placebo (if blinded) Drug name, dose, route, frequency of administration, quantity, or duration Order states that This drug is for investigational use only Pharmacy will provide you with a summary of how to enter an order for each study
43 Required Medication Order Contents-Outpatient Order A written order or BUMPO (Back up medication physician order) must be submitted to the IDS pharmacist prior to dispensing. Drug study name and IRB number Allergies Patient medical record number Drug name, dose, route, and frequency of administration Quantity or duration Primary investigator signature Date and time the medication is needed
44 This Sounds too Good to be Free How Much Do You Charge for IDS Services?
45 Pharmacy Charges Prior to initiation of any protocol an IDS budget estimate will be provided to the study team and the Clinical Trials Office Each protocol will be invoiced quarterly as appropriate for pharmacy services
46 Pharmacy Charges Development of Dispensing Protocol and Procedures $1,500 Patient Randomization Maintain Drug Inventories Unit-dose Oral or Topical Unit-dose Injection Intravenous Infusion Parenteral Nutrition Antineoplastic Agent Compounded or Packaged Doses Outpatient Dispensing Fee $10/patient $20/month $5/dose $10/dose $15/dose $30/dose $50/dose $40/hour $10/drug Termination of Investigational Study $500
47 How Much Notice is Needed for Site Visits? Monitoring visits/site qualification visits/closure visits-please allow 2 weeks advanced notice to ensure pharmacy can accommodate the visit.
48 Frequently Asked Questions.
49 How Do We Deal With Research that Involves Commercial Product? Sometimes commercially available drug will be supplied by the sponsor. If it is not it is ordered by pharmacy and stored separately from regular stock. We do not use regular pharmacy stock for investigational purposes All investigational drugs are stored separately from regular stock Once the study closes, the drug is destroyed.
50 Do We Mark Up the Price of Medication Acquired for Research? All medication purchased by pharmacy for investigator initiated and federally funded research (NIH, NCI) is provided to the investigator at cost. All medication purchased by pharmacy for a sponsored study is marked up by 30%
51 Why Can t We Reuse Medication Returned to the Pharmacy? Per FDA guidelines and state regulations we can not reuse medications once they are dispensed for patient safety. Storage conditions outside of the pharmacy may allow for loss of integrity. We would no longer have assurance of strength, quality, purity, or identity of the drug. The pharmacist or doctor dispensing a drug is legally responsible for all hazards or contaminations that may arise if they return dispensed drug back into regular stock
52 How Are Temperatures Monitored At TUH? Room temperature-daily manual recorded temps Investigational refrigerators-daily manual recorded temps -20 Freezer-daily electronic recording via a temperature recording disk All devices are alarmed and the manager on call and maintenance are notified if a deviation occurs
53 What is Used to Make Matching Placebo Oral? Our most common compounding procedure is to fill an empty gelatin capsule with an inert substance (lactose monohydrate or starch) We utilize an opaque capsule to maintain the blind. Our capsules come from Medisca, Inc. Placebo tablets can be manufactured by our GMP lab at the School of Pharmacy (separate entity from TUH Pharmacy)
54 How Do Blind Active Medication if it has a Matching Placebo? We ensure both active and placebo medication look (and weigh in the case of capsules) identical prior to packaging or dispensing. For an injectable agent an opaque sleeve may be placed over a bag or syringe if coloring of each agent varies The compound (active/placebo) is documented and a lot number is assigned to differentiate when packaging
55 How Do We Dispose of Investigational Medication? If the investigational drug is a proprietary agent the sponsor usually takes accountability for it upon expiration or study closure Chemotherapy is deidentified and disposed of in yellow chemo waste containers contracted to Stericycle for destruction Investigational medication is deidentified and disposed of in Red Biohazard trash also contracted to Stericycle for destruction
56 How Long are Binders and Study Records Stored? After one year of on site storage binders are compiled and sent to GRM for storage. GRM stores the binders for 25 years then they are destroyed. All study documents can be recalled from GRM within 24 to 48 hours of an investigator s request.
57 Is IRB Approval Sufficient to Activate Dispensing of Investigational Drugs? No. The study must be reviewed by pharmacy to ensure we have the capabilities to store and manipulate the investigational product This is especially relevant as we are seeing more and more biologics, stem cells, and human tissue There are complex storage & compounding capabilities not yet available: -70 freezer & Liquid Nitrogen both being installed tentatively in summer 2014 Viruses can not be manipulated in any pharmacy hoods Studies related to human tissue must be manipulated in the Cytology lab in a purified biological safety cabinet
58 Where Can I Find an IDDS Template to Fill Out? A blank copy of the IDDS template is on file with the research pharmacist. This can be provided to you via upon request. Completed copies are stored electronically and in each pharmacy binder to be placed into the patient s chart prior to the first dose of study drug being administered.
59 What are Common Errors Seen on the IDDS? Members of the study team and primary contact information incorrect or out of date. IRB number missing from the form Information regarding the excipient in placebo excluded (important if patient has a lactose allergy) Drug-drug & drug-food interactions incomplete The research pharmacist can assist you in completing this form and performs the final review
60 Things to Remember. Contact the IDS pharmacist as early as possible when anticipating a new protocol Remember to budget for IDS services Notify the IDS pharmacist about the status of each study (termination, extension, changes in protocol, etc.) Provide plenty of notice for upcoming monitor visits Provide notice regarding patient schedules and visits
61 Things to Remember Provide accurate and up to date grant/foapal numbers and IRB number Inpatient-physician on the study team must enter complete electronic orders in a timely manner Outpatient-Provide complete and signed orders in a timely manner Outsourcing of pharmacy services must be done with the knowledge and approval of the IDS
62 Future IDS Support Digital temperature monitoring devices -70 freezer being installed summer 2014 Liquid nitrogen storage being installed Summer 2014 EPIC inpatient installation Looking into Vestigo electronic IDS management (McCreadie Group) Separate research pharmacy
63 Additional Questions?
64 Contact Information Jennifer Colon, PharmD, MS, MBA Office (215) Cell (267) Pharmacy Administration-Rock Pavilion, Zone B, Basement (across from the cafeteria entrance)
Medical College of Georgia SOP NUMBER: 03 INVESTIGATIONAL DRUG HANDLING Version Number: 1.0, 1.1 Effective Date: 09/12/06, 08/02/10, 3/2/11
Effective Date: 09/12/06, 08/02/10, 3/2/11 Title: 1.0 OBJECTIVE: 1.1 This SOP describes the methods and policies for: Handling investigational drug Dispensing investigational drug 1.2. This procedure applies
More informationInvestigational Drugs: Investigational Drugs and Biologics
: I. PURPOSE The purpose of this policy is to establish procedures for the proper control, storage, use and handling of investigational drugs and biologics to ensure that adequate safeguards are in place
More informationCONNECTICUT. Downloaded January 2011 19 13 D8T. CHRONIC AND CONVALESCENT NURSING HOMES AND REST HOMES WITH NURSING SUPERVISION
CONNECTICUT Downloaded January 2011 19 13 D8T. CHRONIC AND CONVALESCENT NURSING HOMES AND REST HOMES WITH NURSING SUPERVISION (d) General Conditions. (6) All medications shall be administered only by licensed
More informationARKANSAS. Downloaded January 2011
ARKANSAS Downloaded January 2011 302 GENERAL ADMINISTRATION 302.11 Pharmacies operated in nursing homes shall be operated in compliance with Arkansas laws and shall be subject to inspection by personnel
More informationCHAPTER 61-03-02 CONSULTING PHARMACIST REGULATIONS FOR LONG-TERM CARE FACILITIES (SKILLED, INTERMEDIATE, AND BASIC CARE)
CHAPTER 61-03-02 CONSULTING PHARMACIST REGULATIONS FOR LONG-TERM CARE FACILITIES (SKILLED, INTERMEDIATE, AND BASIC CARE) Section 61-03-02-01 Definitions 61-03-02-02 Absence of Provider or Consulting Pharmacist
More informationBOARD OF PHARMACY DIVISION 41 OPERATION OF PHARMACIES (RETAIL AND INSTITUTIONAL DRUG OUTLETS) CONSULTING PHARMACISTS AND OPERATION OF DRUG ROOMS
BOARD OF PHARMACY DIVISION 41 OPERATION OF PHARMACIES (RETAIL AND INSTITUTIONAL DRUG OUTLETS) CONSULTING PHARMACISTS AND OPERATION OF DRUG ROOMS 855-041-6050 Definitions Hospitals with Pharmacies (1) In
More informationINSTITUTIONAL POLICY AND PROCEDURE (IPP) Department: Manual: Section: EFFECTIVE DATE REVIEW DUE REPLACES NUMBER NO. OF PAGES
HOSPITAL NAME INSTITUTIONAL POLICY AND PROCEDURE (IPP) Department: Manual: Section: TITLE/DESCRIPTION POLICY NUMBER MEDICATIONS EFFECTIVE DATE REVIEW DUE REPLACES NUMBER NO. OF PAGES APPROVED BY APPLIES
More informationUTCVM PHARMACY STANDARD OPERATING PROCEDURES
UTCVM PHARMACY STANDARD OPERATING PROCEDURES Updated: 4/5/2004 I. General Procedures A. Hours: The Pharmacy will be open Monday through Friday, 8:00AM to 6:00PM; Saturday 8:00AM to 1:00PM. The Pharmacy
More informationUW School of Dentistry Comprehensive Medication Policy
UNIVERSITY OF WASHINGTON SCHOOL OF DENTISTRY Subject: UW School of Dentistry Comprehensive Medication Policy Policy Number: Effective Date: December 2014 Revision Dates: June 2015 PURPOSE This policy provides
More informationNOTE: In the event that the seal is accidentally broken, the narcotic may be wasted via narcotic wastage procedures.
HOSPITAL NAME INSTITUTIONAL POLICY AND PROCEDURE (IPP) Department: Manual: Section: TITLE/DESCRIPTION POLICY NUMBER NARCOTICS AND CONTROLLED DRUGS EFFECTIVE DATE REVIEW DUE REPLACES NUMBER NO. OF PAGES
More information11 MEDICATION MANAGEMENT
1 11 MEDICATION MANAGEMENT OVERVIEW OF MEDICATION MANAGEMENT Depending on the size, structure and functions of the health facility, there may be a pharmacy with qualified pharmacists to dispense medication,
More informationCustodial Procedures Manual Table of Contents
Custodial Procedures Manual Table of Contents Page 1. Drug Policies and Procedures 1 A. Procurement of Prescription Drugs 1 i. Prescription drugs may only be accepted from 1 pharmacies and or practitioners.
More informationIMP management at site. Dmitry Semenyuta
IMP management at site Dmitry Semenyuta TOP 5 FDA inspections finding 1999-2009 Center of Drug Evaluation and Research (CDER) Failure to follow the protocol Failure to keep adequate and accurate records
More informationComplete Pharmacy Technician Certificate Program 230 clock hours
Complete Pharmacy Technician Certificate Program 230 clock hours Course Description Our Pharmacy Technician Career Training Program will give the pharmacy technician the knowledge to achieve the competencies
More informationPREP WORKSHOP #11 Investigational Drug Disposal
PREP WORKSHOP #11 Investigational Drug Disposal Presented by: Ji-Eun Kim, Research Pharmacist Investigational Pharmacy Core, Clinical Research Service Miyuki Yoshida-Hay, RSO, MLSO, CHSP Safety Office,
More informationRole of the Investigational Drug Services (IDS) in the Management of Investigational Drugs
Role of the Investigational Drug Services (IDS) in the Management of Investigational Drugs Charlesworth Rae, BS, PharmD, JD Investigational Drug Pharmacist July 2012 1 Outline of Presentation I. Introduction
More informationGUIDELINES FOR NUCLEAR PHARMACY TECHNICIAN TRAINING PROGRAMS
GUIDELINES FOR NUCLEAR PHARMACY TECHNICIAN TRAINING PROGRAMS Prepared by Ad Hoc Committee on Nuclear Pharmacy Technicians Nuclear Pharmacy Section Academy of Pharmacy Practice and Management American Pharmaceutical
More informationPHARMACY TECHNICIAN SERIES
PHARMACY TECHNICIAN SERIES Occ. Work Prob. Effective Last Code No. Class Title Area Area Period Date Action 4058 Pharmacy Technician I 12 446 6 mo. 02/15/04 Revised 4059 Pharmacy Technician II 12 446 6
More information16.19.10.11 PUBLIC HEALTH CLINICS: A. CLINIC LICENSURE: (1) All clinics where dangerous drugs are administered, distributed or dispensed shall obtain
16.19.10.11 PUBLIC HEALTH CLINICS: A. CLINIC LICENSURE: (1) All clinics where dangerous drugs are administered, distributed or dispensed shall obtain a limited drug permit as described in Section 61-11-14
More informationEssential Documents for the Conduct of a Clinical Trial. Debra Dykhuis Associate Director RSO
Essential Documents for the Conduct of a Clinical Trial Debra Dykhuis Associate Director RSO Introduction Rationale for choosing this topic AHC movement toward setting GCP (Good Clinical Practice) guidelines
More informationPlanning Issues for Hospital Pharmacies with Growing Outpatient Populations
Planning Issues for Hospital Pharmacies with Growing Outpatient Populations In recent years, there has been an increasing emphasis in healthcare on the provision of ambulatory care services. It is predicted
More informationExtemporaneously Prepared Early Phase Clinical Trial Materials
Extemporaneously Prepared Early Phase Clinical Trial Materials Richard Hoffman, MS, RAC Eli Lilly & Co. Regulatory Advisor International Consortium for Innovation & Quality in Pharmaceutical Development
More informationHealth Professions Act BYLAWS SCHEDULE F. PART 2 Hospital Pharmacy Standards of Practice. Table of Contents
Health Professions Act BYLAWS SCHEDULE F PART 2 Hospital Pharmacy Standards of Practice Table of Contents 1. Application 2. Definitions 3. Drug Distribution 4. Drug Label 5. Returned Drugs 6. Drug Transfer
More informationMay 2010 Rhonda Dash, MPH Director, Research Compliance
May 2010 Rhonda Dash, MPH Director, Research Compliance Introduce the new Director of Research Compliance Review Applicable Federal Regulations Review Applicable State Regulations Review UNTHSC new Policies
More informationDEPARTMENT OF LICENSING AND REGULATORY AFFAIRS DIRECTOR S OFFICE PHARMACY PROGRAM FOR UTILIZATION OF UNUSED PRESCRIPTION DRUGS
DEPARTMENT OF LICENSING AND REGULATORY AFFAIRS DIRECTOR S OFFICE PHARMACY PROGRAM FOR UTILIZATION OF UNUSED PRESCRIPTION DRUGS (By authority conferred on the director of the department of licensing and
More informationSchool Based Emergency Medicine Class D Clinic
School Based Emergency Medicine Class D Clinic NM Board of Pharmacy Policy and Procedure Manual School Based Emergency Medicine Class D Clinic REQUIRED FOR COMPLIANCE NM Board of Pharmacy Approved Policy
More informationRoles & Responsibilities of the Sponsor
Roles & Responsibilities of the Sponsor Developed by Center for Cancer Research, National Cancer Institute, NIH Endorsed by the CTN SIG Leadership Group Objectives Funding for clinical research comes from
More informationThe Regulatory Binder/Trial Master File: Essential Records for the Conduct of a Clinical Trial
The Regulatory Binder/Trial Master File: Essential Records for the Conduct of a Clinical Trial Clinical Research Operations & Regulatory Support (CRORS) Ann Glasse, RN, BSN, MBA Director-CRORS Objectives
More informationNurse-Managed Medication Inventory
Nurse-Managed Medication Inventory Information for Employers College of Registered Nurses of British Columbia 2855 Arbutus Street Vancouver, BC Canada V6J 3Y8 T: 604.736.7331 F: 604.738.2272 Toll-free:
More informationEDUCATOR S LESSON PLAN
EDUCATOR S LESSON PLAN Pharmacy Technician Training Program Student Version Orientation Orientation introduces the student to basic terms and definitions. An introduction to the Pharmacy Technician Certification
More informationWest Los Angeles College Pharmacy Technician Program
West Los Angeles College Pharmacy Technician Program I. STERILE PRODUCTS EXTERNSHIP - 2.25 Unit(s) Phrmctk 38 Section: 1632 II. PREPARED BY: Pharmacy Technician Adjunct Faculty III. REVISED FOR: Spring
More informationCHAPTER 6 OUTPATIENT SURGICAL CENTERS 6. 1
CHAPTER 6 OUTPATIENT SURGICAL CENTERS 6. 1 OUTPATIENT SURGICAL CENTERS I. LICENSURE 1. Modified II B Pharmacy license 2. DEA license II. REQUIREMENTS 1. Formulary may be any drugs needed to meet the medical
More informationPHARMACEUTICAL WASTE MANAGEMENT DUKE UNIVERSITY HEALTH SYSTEM
PHARMACEUTICAL WASTE MANAGEMENT DUKE UNIVERSITY HEALTH SYSTEM BLUE BIN DRUGS ONLY NO EMPTY Packages, NO Gloves NO Scissors, Syringes, Needles, IVs Scalpels, Forceps BLUE BIN PROGRAM PURPOSE AND OBJECTIVE:
More informationPHARMACY TECHNICIAN CERTIFICATION PREPARATION Course Syllabus
6111 E. Skelly Drive P. O. Box 477200 Tulsa, OK 74147-7200 PHARMACY TECHNICIAN CERTIFICATION PREPARATION Course Syllabus Course Number: THRP-0423 OHLAP Credit: No OCAS Code: None Course Length: 30 Hours
More informationNEWFOUNDLAND AND LABRADOR PHARMACY BOARD Standards of Pharmacy Practice. Standards for Hospital Pharmacies
NEWFOUNDLAND AND LABRADOR PHARMACY BOARD Standards of Pharmacy Practice Standards for Hospital Pharmacies Approved by the Newfoundland and Labrador Pharmacy Board January 11, 1998 Updated: June 16, 2007
More informationGUIDELINES ON PREVENTING MEDICATION ERRORS IN PHARMACIES AND LONG-TERM CARE FACILITIES THROUGH REPORTING AND EVALUATION
GUIDELINES GUIDELINES ON PREVENTING MEDICATION ERRORS IN PHARMACIES AND LONG-TERM CARE FACILITIES THROUGH REPORTING AND EVALUATION Preamble The purpose of this document is to provide guidance for the pharmacist
More informationADMINISTRATION OF MEDICATIONS POLICY
Policy 6.007. ADMINISTRATION OF MEDICATIONS POLICY It is the policy of Cooperative Educational Services (C.E.S.) that students who require any medications to be administered during school hours, including
More information- 1 - First Time Pharmacy Managers (Revised 02/02/2011)
State of Connecticut Department of Consumer Protection Commission of Pharmacy 165 Capitol Avenue, Room 147 Hartford, CT 06106 - Telephone: 860-713-6070 ALL FIRST-TIME PHARMACY MANAGERS ARE REQUIRED TO
More informationSafetyFirst Alert. Errors in Transcribing and Administering Medications
SafetyFirst Alert Massachusetts Coalition for the Prevention of Medical Errors January 2001 This issue of Safety First Alert is a publication of the Massachusetts Coalition for the Prevention of Medical
More informationDate Submitted: July 20, 2000 Date Reviewed: May 31, 2005 January 17, 2006 March 17, 2009 Subject: Administration of Medication
POLICY SOMERSET COUNTY BOARD OF EDUCATION 1. PURPOSE Date Submitted: July 20, 2000 Date Reviewed: May 31, 2005 January 17, 2006 March 17, 2009 Subject: Administration of Medication Number: 600-32 Date
More informationAdministrative Policies and Procedures for MOH hospitals /PHC Centers. TITLE: Organization & Management Of Medication Use APPLIES TO: Hospital-wide
Administrative Policies and Procedures for MOH hospitals /PHC Centers TITLE: Organization & Management Of Medication Use APPLIES TO: Hospital-wide NO. OF PAGES: ORIGINAL DATE: REVISION DATE : السیاسات
More informationAustin Community College Institutional Pharmacy Practice PHRA 1449 Syllabus
Austin Community College Institutional Pharmacy Practice PHRA 1449 Syllabus Instructor: Office: Office Hours: Length of Program: 16 weeks Total Number of Hours (approximate): 96 Classroom Hours: 48 Laboratory
More information105 CMR: DEPARTMENT OF PUBLIC HEALTH 105 CMR 210.000: THE ADMINISTRATION OF PRESCRIPTION MEDICATIONS IN PUBLIC AND PRIVATE SCHOOLS
105 CMR 210.000: THE ADMINISTRATION OF PRESCRIPTION MEDICATIONS IN PUBLIC AND PRIVATE SCHOOLS Section 210.001: Purpose 210.002: Definitions 210.003: Policies Governing the Administration of Prescription
More informationIntroduction 2. 1. The Role of Pharmacy Within a NHS Trust 3. 2. Pharmacy Staff 4. 3. Pharmacy Facilities 5. 4. Pharmacy and Resources 6
Index Index Section Page Introduction 2 1. The Role of Pharmacy Within a NHS Trust 3 2. Pharmacy Staff 4 3. Pharmacy Facilities 5 4. Pharmacy and Resources 6 5. Prescription Charges 7 6. Communication
More informationQuality Systems Appropriate for Extemporaneously Prepared Early Phase Clinical Trial Materials. Agenda Topics for Discussion
Quality Systems Appropriate for Extemporaneously Prepared Early Phase Clinical Trial Materials Richard Hoffman, MS Eli Lilly & Co. Principal Consultant - Regulatory PDA/FDA Joint September 20 th, 2011
More informationEducational Outcomes for Pharmacy Technician Programs in Canada
Canadian Pharmacy Technician Educators Association (CPTEA) Educational Outcomes for Pharmacy Technician Programs in Canada March 2007 Educational Outcomes for Pharmacy Technician Page 1 of 14 Framework
More informationUSE OF CONTROLLED SUBSTANCES AN OVERVIEW FOR RESEARCHERS
USE OF CONTROLLED SUBSTANCES AN OVERVIEW FOR RESEARCHERS APPLICABILITY (WITH REGARD TO CONTROLLED SUBSTANCES) This presentation is applicable to: Animal and non-animal research This presentation is mostly
More information03 PHARMACY TECHNICIANS
03 PHARMACY TECHNICIANS 03-00 PHARMACY TECHNICIANS REGISTRATION/PERMIT REQUIRED 03-00-0001 DEFINITIONS: A. PHARMACY TECHNICIAN: This term refers to those individuals identified as Pharmacist Assistants
More informationPhilosophy: Although sample medication may be helpful in patient care, drug samples:
Title: Policy on Sample Medication Policy #: 450.80 Adopted: 1/90, 7/00 Revised: 3/95, 5/98, 7/00, 10/01 Reviewed: 7/00, 10/01, 02/03 This policy is applicable to the following Henry Ford Health System
More informationExceptions to the Rule: A Pharmacy Law Presentation. Objectives DISCLAIMER 10/16/2015
Exceptions to the Rule: A Pharmacy Law Presentation Eric Roath, Pharm.D. Director of Professional Practice Michigan Pharmacists Association Objectives 1. Identify basic legal frameworks that govern the
More informationPHARMACEUTICAL MANAGEMENT PROCEDURES
PHARMACEUTICAL MANAGEMENT PROCEDURES THE FORMULARY The purpose of Coventry Health Care s formulary is to encourage use of the most cost-effective drugs. The formulary is necessary because the cost of prescription
More informationDevice Accountability in Clinical Research
Office of Human Research Device Accountability in Clinical Research Managing research device inventory & tracking Objectives Define device accountability Review the two main categories of research devices
More informationPharmacy Technician Structured Practical Training Program Logbook
Pharmacy Technician Structured Practical Training Program Logbook This logbook outlines the activities that pharmacy technician learners are required to complete in order to demonstrate competencies as
More informationCHAPTER 6 PROCUREMENT AND SUPPLY OF PHARMACEUTICAL PRODUCTS IN THE PUBLIC AND PRIVATE MEDICAL SECTORS
CHAPTER 6 PROCUREMENT AND SUPPLY OF PHARMACEUTICAL PRODUCTS IN THE PUBLIC AND PRIVATE MEDICAL SECTORS Overview 6.1 This chapter sets out the Review Committee s findings and recommendations on procurement
More informationIAC 10/5/11 Pharmacy[657] Ch 40, p.1 CHAPTER 40 TECH-CHECK-TECH PROGRAMS
IAC 10/5/11 Pharmacy[657] Ch 40, p.1 CHAPTER 40 TECH-CHECK-TECH PROGRAMS 657 40.1(155A) Purpose and scope. The board may authorize a hospital pharmacy to participate in a tech-check-tech program. The board
More informationA Outpatient Services A1 AMBULATORY CARE CENTRE A1(d) Cancer Centre Clinical Trials Office
A1(d) CANCER CENTRE CLINICAL TRIALS OFFICE A1(d).1 SERVICE DESCRIPTION A1(d).1.1 Scope of Clinical Services This section A1(d) sets out the requirements for the centralized facilities for the Clinical
More informationMASSACHUSETTS. Downloaded January 2011
MASSACHUSETTS Downloaded January 2011 150.007 NURSING SERVICES (G) Nursing and Supportive Routines and Practices. (2) No medication, treatment or therapeutic diet shall be administered to a patient or
More informationRULE. The Administration of Medication in Louisiana Public Schools
RULE The Administration of Medication in Louisiana Public Schools Developed in 1994 by The Louisiana State Board of Elementary and Secondary Education and The Louisiana State Board of Nursing Amendments
More informationVerbalize knowledge of laws and policies for administration of prescribed and over the counter medication to students.
Medication Administration for Non-Licensed School Staff Canton City Schools School Health Issues: A federal mandate created in the 1970s obligated schools to provide children with medical services, including
More informationHealth Professions Act BYLAWS SCHEDULE F. PART 3 Residential Care Facilities and Homes Standards of Practice. Table of Contents
Health Professions Act BYLAWS SCHEDULE F PART 3 Residential Care Facilities and Homes Standards of Practice Table of Contents 1. Application 2. Definitions 3. Supervision of Pharmacy Services in a Facility
More informationWest Los Angeles College Pharmacy Technician Program
West Los Angeles College Pharmacy Technician Program I. IN PATIENT PHARMACY EXTERNSHIP - 2.25 Unit(s) Phrmctk 36 Section: 1630 II. PREPARED BY: Pharmacy Technician Adjunct Faculty III. REVISED FOR: Spring
More informationOutpatient Prescription Drug Benefit
Outpatient Prescription Drug Benefit GENERAL INFORMATION This supplemental Evidence of Coverage and Disclosure Form is provided in addition to your Member Handbook and Health Plan Benefits and Coverage
More informationPharmacy and Therapeutics Committee Policies and Procedures
Pharmacy and Therapeutics Committee Policies and Procedures I. Charter... p 2 II. Formulary Principles... p 3 III. Drug Review Process... p 4 7 A. When are Medications Reviewed B. How Are Medications Reviewed
More informationPolicy for the Storage and Administration of Medication in Custody Suites
Not Protectively Marked Policy for the Storage and Administration of Medication in Custody Suites Policy Reference No. P22:2000 Portfolio Holder Assistant Chief Constable Policy Owner Superintendent Donnell
More informationPHARMACY TECHNICIAN COURSE DESCRIPTIONS
PHARMACY TECHNICIAN COURSE DESCRIPTIONS OCCUPATIONAL COMPLETION POINTS AND PROGRAM LENGTH: * Basic Healthcare Worker OCP A 90 Hours (COURSE #HSC 0003) * Community Pharmacy Technician OCP B 360 Hours (COURSE
More informationState Regulations Pertaining to Pharmacy Services
State Regulations Pertaining to Pharmacy Services Note: This document is arranged alphabetically by State. To move easily from State to State, click the Bookmark tab on the Acrobat navigation column to
More informationSafe Handling of Oral Chemotherapy and targeted Agents. ภญ.อภ รมย เหล าเจร ญเก ยรต ฝ ายเภส ชกรรม โรงพยาบาลศ ร ราช
Safe Handling of Oral Chemotherapy and targeted Agents. ภญ.อภ รมย เหล าเจร ญเก ยรต ฝ ายเภส ชกรรม โรงพยาบาลศ ร ราช Chemotherapy Agent. Low therapeutic index. -Increase risk for medication error. Hazardous
More informationPHARMACEUTICAL WASTE UPDATE ON HANDLING AND DISPOSAL ASTSWMO MEETING August 11, 2011
PHARMACEUTICAL WASTE UPDATE ON HANDLING AND DISPOSAL ASTSWMO MEETING August 11, 2011 Pharmaceutical Waste Getting the attention it deserves Are there Federal, State and Local laws & regulations to comply
More informationInventory Management
Inventory Management Chapter Outline Inventory Management Inventory Systems Computer & Inventory Ordering Forms Stocking & Storing Inventory Management Inventory A listing of medication of the goods or
More informationEvolution of a Closed Loop Medication Use Process
Evolution of a Closed Loop Medication Use Process Paul J. Vitale, Pharm.D. pvitale@mdmercy.com Vice President and Chief Pharmacy Officer The Mercy Medical Center Baltimore, Maryland Agenda Hospital Background
More informationMichael D. Bullek BSP Rph. Commissioner, New Hampshire Board of Pharmacy
Michael D. Bullek BSP Rph. Commissioner, New Hampshire Board of Pharmacy Legislative changes PDMP program changes 503B outsourcing facilities Rules changes Ph800 review Ph300 Ph400 Ph700 Current issues
More informationThe following Good Compounding Practices (GCPs) are meant to apply only to the compounding of drugs by State-licensed pharmacies.
1 NABP Model State Pharmacy Act & Model Rules Appendix B Good Compounding Practices Applicable to State Licensed Pharmacies The following Good Compounding Practices (GCPs) are meant to apply only to the
More informationExCPT Certified Pharmacy Technician (CPhT) Detailed Test Plan* 100 scored items, 20 pretest items Exam time: 2 hours 10 minutes
ExCPT Certified Pharmacy Technician (CPhT) Detailed Test Plan* 100 scored items, 20 pretest items Exam time: 2 hours 10 minutes # scored items 1. Regulations and Pharmacy Duties 35 A. Overview of technician
More informationADMINISTRATION OF MEDICATION
ADMINISTRATION OF MEDICATION IN SCHOOLS MARYLAND STATE SCHOOL HEALTH SERVICES GUIDELINE JANUARY 2006 (Reference Updated March 2015) Maryland State Department of Education Maryland Department of Health
More informationDIVISION OF CORPORATIONS, BUSINESS AND PROFESSIONAL P.O. BOX 110806 JUNEAU, ALASKA 99811-0806 ALASKA STATE BOARD OF PHARMACY
DIVISION OF CORPORATIONS, BUSINESS AND PROFESSIONAL P.O. BOX 110806 JUNEAU, ALASKA 99811-0806 ALASKA STATE BOARD OF PHARMACY Remote Pharmacy Owner Name: DBA Name: Address: Telephone Number: Fax Number:
More informationGuidance on the content of a pharmacy manual to support clinical trial protocols
Guidance on the content of a pharmacy manual to support clinical trial protocols This guidance has been produced to help investigators with the content of pharmacy manuals for clinical trials. We gratefully
More informationA Guide to Pharmacy Documentation For Clinical Trials
A Guide to Pharmacy Documentation For Clinical Trials Roy Sinclair Clinical Trials Pharmacist St. George s Hospital (to Sep 2007) Lecturer Kingston University January 2008 A Guide to Pharmacy Documentation
More informationTitle 16. Board of Pharmacy Proposed Text
Title 16. Board of Pharmacy Proposed Text Proposal to add new Article 9.1 of Division 17 of Title 16 of the California Code of Regulations and a new Article title as follows: Article 9.1. Prescription
More informationHealth Products and Food Branch. www.hc-sc.gc.ca
Health Products and Food Branch 1 HEALTH CANADA PART C DIVISION 5 - DRUGS FOR CLINICAL TRIALS INVOLVING HUMAN SUBJECTS Part C - Division 5 2 Part A: Part B: Part C: Part D: Part E: Part G: Part J: Administration
More informationThe Study Site Master File and Essential Documents
The Study Site Master File and Essential Documents Standard Operating Procedure Office of Health and Medical Research Queensland Health SOP reference: 002 Version number: 1 Effective date: 01 June 2010
More information2013 -- H 5230 S T A T E O F R H O D E I S L A N D
======= LC00 ======= 01 -- H 0 S T A T E O F R H O D E I S L A N D IN GENERAL ASSEMBLY JANUARY SESSION, A.D. 01 A N A C T RELATING TO HEALTH AND SAFETY - THE RETURN OR EXCHANGE OF DRUGS ACT Introduced
More informationAmbulatory Surgical Centers Frequently Asked Questions
Ambulatory Surgical Centers Frequently Asked Questions Index Top General Definitions Compliance with State Licensure Laws Governing Body and Management Surgical Services Quality Assessment and Performance
More informationHow To Write A Binder Tab
Tool Summary Sheet Tool: Extramural Essential Documents Binder/File Tabs Purpose: To provide an organizational framework and guidance for filing paper versions of essential study documents (or referencing
More information247 CMR: BOARD OF REGISTRATION IN PHARMACY
247 CMR 9.00: CODE OF PROFESSIONAL CONDUCT; PROFESSIONAL STANDARDS FOR REGISTERED PHARMACISTS, PHARMACIES AND PHARMACY DEPART- MENTS Section 9.01: Code of Professional Conduct for Registered Pharmacists,
More informationTable of Contents. 2 P a g e
Table of Contents Introduction... 3 Important Contact Information... 3 Pharmacy Rights... 3 Claims Adjudication... 3 Reversals... 4 Required Data Fields... 4 Identification cards... 4 Required Identification
More informationNational Patient Safety Agency. Risk Assessment of Injectable Medicines. STEP 1 Local Risk Factor Assessment. STEP 2 Product Risk Factor Assessment
NPSA Injectable Medicines Risk Assessment Tool National Patient Safety Agency Risk Assessment of Injectable Medicines STEP 1 Local Risk Factor Assessment. Carry out a baseline assessment in a near patient
More informationNH Laws / Rules Regarding Limited Retail Drug Distributors
NH Laws / Rules Regarding Limited Retail Drug Distributors 318:1, VII-a. "Limited retail drug distributor'' means a distributor of legend devices or medical gases delivered directly to the consumer pursuant
More informationADMINISTRATION OF MEDICATION
SOUTH LYON COMMUITY SCHOOLS 5330/page 1 of 6 ADMINISTRATION OF MEDICATION Definitions Medication includes both prescription and non-prescription medications including those taken by mouth, inhaler, injection,
More informationTable of Contents. FACT Quality Handbook, Second Edition. Table of Contents
Table of Contents INTRODUCTION... i ACKNOWLEDGEMENTS... ii 1. Quality Management Program Overview... 1 Diagram of Quality Program Elements... 9 Sample Quality Management Performance Summary: Colorado Blood
More informationMedication Administration for Non-Licensed School Staff
Medication Administration for Non-Licensed School Staff School Health Issues A federal mandate created in the 1970s obligated schools to provide children with medical services, including medication administration.
More informationPolicies and Procedures. Number: 1127
Policies and Procedures Title: NARCOTIC CONTROL: DOCUMENTATION AND COUNT Authorization: [X] Pharmacy/Nursing Committee [X] SHR Nursing Practice Committee Number: 1127 Source: Pharmacy/Nursing Cross Index:
More informationHealth Care Job Information Sheet #10. Pharmacy
Health Care Job Information Sheet #10 Pharmacy A. Occupations A. Occupations 1) Pharmacist 2) Pharmacy Technician/ Assistant B. Labour Market Prospects C. ITPs in the Field D. Links 1) Pharmacist Regulated
More informationSafe Handling of Oral Chemotherapy. Rick Abbott Regional Pharmacy Manager, Systemic Therapy Eastern Health, NL Rick.abbott@easternhealth.
Safe Handling of Oral Chemotherapy Rick Abbott Regional Pharmacy Manager, Systemic Therapy Eastern Health, NL Rick.abbott@easternhealth.ca Conflict of Interest Declaration I have developed and delivered
More informationREGULATION 3 PHARMACY TECHNICIANS
REGULATION 3 PHARMACY TECHNICIANS 03-00 PHARMACY TECHNICIANS REGISTRATION/PERMIT REQUIRED 03-00-0001 DEFINITIONS (a) Pharmacy technician means those individuals, exclusive of pharmacy interns, who assist
More informationPharmaceutical Wholesaler Site Inspection Checklist
Pharmaceutical Wholesaler Site Inspection Checklist Date and time of inspection: Legal business name and plant name: Location (address): Phone number: Fax number: Email address: Web site URL: Contact Person:
More informationGUIDELINES FOR DRUG-USE CONTROL
GUIDELINES FOR DRUG-USE CONTROL PREFACE These guidelines were originally published by the Canadian Society of Hospital Pharmacists (CSHP) as the CSHP Standards of Practice (1993). With the revision of
More informationPurpose... 2. What s new?... 2. Role of pharmacists and pharmacy technicians in physician-assisted death... 3
Table of Contents Purpose... 2 What s new?... 2 Role of pharmacists and pharmacy technicians in physician-assisted death... 3 Complying with ACP s Standards of Practice for Pharmacists and Pharmacy Technicians...
More informationUNIVERSITY OF WISCONSIN HOSPITAL AND CLINICS DEPARTMENT OF PHARMACY SCOPE OF PATIENT CARE SERVICES FY 2014 October 1 st, 2014
UNIVERSITY OF WISCONSIN HOSPITAL AND CLINICS DEPARTMENT OF PHARMACY SCOPE OF PATIENT CARE SERVICES FY 2014 October 1 st, 2014 Department Name: Department of Pharmacy Department Director: Steve Rough, MS,
More informationMicrobiology and Auditing. Don Singer
Microbiology and Auditing Don Singer ASQ Northeast Pharmaceutical GMP/Quality Conference 2011 Through the eyes of a Microbiologist Microbiology Audit = Inspection / Investigation Systematic Auditing Planning
More informationDisposal of Pharmaceuticals, and their empty containers, in the Workplace
Disposal of Pharmaceuticals, and their empty containers, in the Workplace Prepared by Bio-Team Mobile LLC There is a lot of misinformation being circulated about disposal of pharmaceuticals ever since
More information