DIT Education Presentation Athlone


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Presentation given to Pharmacy Technician students on career profiles: Aseptic Unit- Jennifer O\'Meara, Ward ased Technician (WBT) - Caroline McLoughlin, Clinical Trials - Sharon Curran-Rae & Purchasing - Yvonne Sheehan

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  • The Declaration of Helsinki , developed by the World Medical Association , is a set of ethical principles for the medical community regarding human experimentation . It was originally adopted in June 1964 in Helsinki , Finland , and has since been amended multiple times. Nazi human experimentation trials in WW2 Like the Nuremberg Code , the Declaration made informed consent a central requirement for ethical research while allowing for surrogate consent when the research participant is incompetent, physically or mentally incapable of giving consent, or a minor. . The Declaration is important in the history of research ethics as the first significant effort of the medical community to regulate itself. In principle, this document set the stage for the implementation of the Institutional Review Board /independent ethics committee (IRB/IEC) process (Shamoo & Irving, 1993) in USA and ethics committee, ethical review board or Human Research Ethics Committees (HREC) in some other countries.
  • For many years there were numerous sets of GCP guidelines in operation e.g. European, Nordic, Japanese as well as the US code of federal regulations. In May 1996, a harmonised set of GCP guidelines (the ICH GCP guidelines) was finalised and approved by the regulatory authorities & by pharmaceutical industry representatives in Europe, Japan and the USA. These ICH GCP guidelines are now accepted as the required global standard for the conduct of clinical trials. Whilst these were all similar, there was some notable differences in the requirements they contained. This made it difficult to perform a study in one country that was acceptable in all the others.
  • Directive 2001/20/EC or Clinical Trials Directive of 4 April 2001, of the European Parliament and of the Council on the approximation of the laws, Regulations and administrative provisions of the Member States relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. This Directive aims at facilitating the internal market in medicinal products within the European Union , while at the same time maintaining an appropriate level of protection for public health. It seeks to simplify and harmonize the administrative provisions governing clinical trials in the European Community, by establishing a clear, transparent procedure. The Member States had to apply these provisions at the latest with effect from 1 May 2004. GMP principles and guidelines: GMP will mean the part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use. Authorization of manufacture/ importing/ labelling of medical products Application format for an ethics committee opinion and competent authorities. GCP principles and inspections European data base of SUSAR (Eudravigilence)
  • Clinical trials in Ireland are governed by the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations, 2004, SI No 190 of 2004.   The Regulations transposed into Irish law the provision of Council Directive 2001/20/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.  The regulations supersede the Control of Clinical Trials Acts 1987 – 1990 for clinical trials using medicinal products. 
  • As you can see a lot of the roles overlap.
  • IMPs must be stored separately from normal pharmacy stock in an area with restricted access. IMPs that are returned by patients or which have expired should be stored separately from unused IMPs. Regular temp monitoring of IMP storage facilities must be undertaken and these records archived. Suitable archiving must be available for pharmacy files and should allow for prompt retrieval of any pharmacy file or other non-trial specific documentation, temp logs etc
  • Good clear, complete documentation is vital
  • Insert a food note if required
  • Results can not be attributed to a test product unless there is evidence that the subject actually took the medication. Hence estimating compliance is important. Clear instructions must be given to the patient to return the whole pack of medication. The returned subject packs should be retained by the pharmacist. The sponsor will collect unused and returned trial product. This should be documented accurately in the Pharmacy file Occasionally the same drug will be used for different trials. Care must be taken to select the correct trial stock.
  • Trial drugs have to be manufactured in accordance with GMP(Good manufacturing Practice). Important that any details on the label ARE NOT OBSCURED. Any additional labels must be approved by the CRA. They are produced to high quality standards. It is important that trial materials are stored at the correct temperatures & that other environmental conditions are controlled as appropriate. A regular temperature check must be undertaken and the results recorded and signed off by the person undertaking the measurement. Sometimes trials take much longer than expected and retesting of the product and extension of the expiry date or replacement of the stock may be required.
  • DIT Education Presentation Athlone

    1. 1. Technicians’ Experiences and Career Pathways. AMNCH Presentation to Health ICT Managers/Technical 2003
    2. 2. AMNCH <ul><li>Approx 600 bed hospital employing 3000 staff. </li></ul><ul><li>Provides child-health, adult, psychiatric and age-related healthcare. </li></ul><ul><li>National Urology Centre, Regional Dialysis Centre and a Regional Orthopaedic Trauma Centre. Oncology & Haematology services, Day Wards. </li></ul><ul><li>Pharmacy Department – approx 60 staff incorporating 31 pharmacists, 24 pharmacy technicians, 3 pre-registration pharmacists & 1 pharmacy aide. </li></ul>AMNCH Presentation to Health ICT Managers/Technical 2003
    3. 3. Differences between Community & Hospital Technicians <ul><li>On going education </li></ul><ul><li>Training courses </li></ul><ul><li>Educational meetings </li></ul><ul><li>Management roles </li></ul><ul><li>Rotate through different departments/specialities </li></ul><ul><li>More varied work load </li></ul><ul><li>Larger workforce </li></ul><ul><li>Team support </li></ul><ul><li>Monday to Friday – limited weekend work </li></ul>AMNCH Presentation to Health ICT Managers/Technical 2003
    4. 4. Pharmacy Technician roles within the Pharmacy Dept <ul><li>Management based </li></ul><ul><ul><li>Dispensary Team Leader </li></ul></ul><ul><ul><li>Ward Based Technician Supervisor </li></ul></ul><ul><ul><li>Purchasing Supervisor </li></ul></ul><ul><ul><li>Ward Top-Up Supervisor </li></ul></ul><ul><li>Dispensary based </li></ul><ul><li>Ward based </li></ul><ul><li>Aseptic Unit </li></ul>AMNCH Presentation to Health ICT Managers/Technical 2003
    5. 5. What is an Aseptic Unit? <ul><li>Aseptic = “without sepsis” or infection. </li></ul><ul><li>An Aseptic Unit (AU) minimises the risks associated with the handling, reconstitution and administration of intravenous drugs by providing isolators for their preparation. The isolators provide a balance between operator and product preparation in order to provide high levels of safety for both the patients and the staff. </li></ul><ul><li>The AU prepares all injectable chemotherapy (cytotoxic) and anti-biotics/ant-fungals (non-cytotoxic) for the hospital. This is also known as CIVAS or Centralised Intravenous Additive Service. </li></ul><ul><li>The AU is a 3 roomed suite consisting of the clean room, the preparation room & the office/gowning area. </li></ul>AMNCH Presentation to Health ICT Managers/Technical 2003
    6. 6. Technician Roles within the Aseptic Unit in AMNCH <ul><li>Team Leader </li></ul><ul><li>Microbiology/Quality Control Technician </li></ul><ul><li>Standard Operating Procedure (SOP) writing </li></ul><ul><li>Pre & In-process checking role </li></ul><ul><li>Chemotherapy & CIVAS Compounding </li></ul><ul><li>Prescription processing & drug calculations </li></ul>AMNCH Presentation to Health ICT Managers/Technical 2003
    7. 7. Team Leader (Senior Role) <ul><li>Co-ordinates the work of technical and other staff in the Aseptic Unit ensuring that specialist areas are covered, that all duty rosters are covered and completed. </li></ul><ul><li>Co-ordinates the work of pharmacists rostered in the Aseptic Unit to optimise checking turnaround and workflow and rostering technicians within the Aseptic Unit. </li></ul><ul><li>Processes prescriptions. </li></ul><ul><li>Completes in-process checks within the unit. </li></ul>AMNCH Presentation to Health ICT Managers/Technical 2003
    8. 8. Team Leader contd. <ul><li>Supervises work experience staff in the Aseptic Unit. </li></ul><ul><li>Organises & supervises training of new staff. </li></ul><ul><li>Deals with issues arising in the Aseptic Unit - equipment failure etc. </li></ul><ul><li>Assists the Aseptic Unit Manager with the planning and development of the service. </li></ul><ul><li>Writes, updates and supervises relevant procedures in conjunction with the Aseptic Unit Manager. </li></ul>AMNCH Presentation to Health ICT Managers/Technical 2003
    9. 9. Pre & In-process checking role <ul><li>In-process checking includes checking the technicians diluent and infusion volumes prior to addition to the final container. </li></ul><ul><li>During this check the diluent, drug vial, infusion fluid, equipment and label are checked for appropriateness. </li></ul><ul><li>This check can involve a total of 15 individual checks at two separate steps (diluent checks and final volume checks). </li></ul><ul><li>The worksheet is then signed on completion of each step. </li></ul><ul><li>This is a new role for technicians in AMNCH and involved procedural changes and training. </li></ul>AMNCH Presentation to Health ICT Managers/Technical 2003
    10. 10. AMNCH Presentation to Health ICT Managers/Technical 2003
    11. 11. South West In-Process Checking Course <ul><li>The course takes place over 2 days in Bristol, UK. </li></ul><ul><li>The main topics covered in the course are: </li></ul><ul><ul><ul><li>the aim of the accuracy assessment </li></ul></ul></ul><ul><ul><ul><li>who can complete the assessment </li></ul></ul></ul><ul><ul><ul><li>what is a check? </li></ul></ul></ul><ul><ul><ul><li>how to complete the assessment </li></ul></ul></ul><ul><ul><ul><li>errors </li></ul></ul></ul><ul><ul><ul><li>legal issues </li></ul></ul></ul>AMNCH Presentation to Health ICT Managers/Technical 2003
    12. 12. Assessment & Accreditation <ul><li>Legality – hospital indemnity scheme checked to ensure that technicians were legally covered to carry out in-process checks in ROI </li></ul><ul><li>In-house training over 4 weeks </li></ul><ul><li>100 in-process checks (drug diluent & volume) carried out – no errors allowed – double checked & signed off by a pharmacist </li></ul><ul><li>Filling in of all relevant paperwork </li></ul><ul><li>Submission of portfolio to South West Medicines Information & Training Board </li></ul><ul><li>Accreditation achieved (transferable) </li></ul>AMNCH Presentation to Health ICT Managers/Technical 2003
    13. 13. Microbiology Quality Control Technician (Senior Role) <ul><li>Ensure that the following QC tests are carried out in accordance with the SOPs (Settle/contact plates, particle counts, air sampling, swab testing, validations). </li></ul><ul><li>Completes a monthly QC report & ensures that it is read by unit staff. </li></ul><ul><li>Organises the validation of all equipment in the aseptic unit. </li></ul><ul><li>Carries out in-process checks. </li></ul>AMNCH Presentation to Health ICT Managers/Technical 2003
    14. 14. Microbiology Quality Control Technician contd. <ul><li>Participate in the training of new or rotating staff, including contract cleaners according to agreed Aseptic Unit SOPs. </li></ul><ul><li>Train other operators/students in relation to all aspects of QC. </li></ul><ul><li>Write and update relevant procedures in conjunction with the Aseptic Unit Team Leader, or the Aseptic Unit Manager. </li></ul><ul><li>Ensuring all pressures in rooms and isolators are within range. </li></ul>AMNCH Presentation to Health ICT Managers/Technical 2003
    15. 15. Continuing Education/Opportunities <ul><li>Aseptic Preparation & Dispensing of Medicines Course, Leeds </li></ul><ul><ul><li>Covers the principles & practice of asepsis & updates the knowledge of standards, practices & QA relating to the aseptic prep & dispensing of medicines. </li></ul></ul><ul><li>Higher Certificate in Good Manufacturing Practice & Technology – BSc Pharmaceutical Technology </li></ul><ul><ul><li>offers operators, team leaders and supervisors an opportunity to acquire a foundation in the sciences relevant to industry and to develop a broad perspective of Good Manufacturing Practice, relevant core science and production management which pertains to a pharmaceutical manufacturing facility or hospital. </li></ul></ul>AMNCH Presentation to Health ICT Managers/Technical 2003
    16. 16. Continuing Education/Opportunities <ul><li>The South West Medicines Information & Training Pre & In-Process checking course (Aseptic Services), UK. </li></ul><ul><ul><li>To enable pharmacy technicians to be assessed in pre & in-process checks with the overall aim of preventing & reducing errors within an aseptic unit. </li></ul></ul><ul><li>http:// www.swmit.nhs.uk/PIPCAseptic.htm </li></ul><ul><li>http:// www.healthcare.leeds.ac.uk /study/CPD/PTQA/APDM/ </li></ul><ul><li>http://www.it-tallaght.ie/PartTimeCourses/Science/Name,17530,en.html </li></ul>AMNCH Presentation to Health ICT Managers/Technical 2003
    17. 17. Medicine management <ul><li>Medicine management is a method of working that aims to prevent, detect and address medicines related problems and to achieve the optimum use of medicines and ensure patient focused care. </li></ul><ul><li>Medicine management course done with southwest medicine information and training in Bristol </li></ul><ul><li>Its an accredited training scheme for pharmacy technicians </li></ul><ul><li>Course is designed to facilitate the development of pharmacy technicians into performing ward based roles in the uk. </li></ul>
    18. 18. The Framework <ul><li>pre course work </li></ul><ul><ul><ul><ul><ul><li>Essential and recommended reading </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>8 tasks & activities </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>Read up on your policies and procedures </li></ul></ul></ul></ul></ul><ul><li>Post course supervised Training period – you have a mentor to facilitate the local implementation of the scheme and to provide support guidance and feedback </li></ul>
    19. 19. The Framework <ul><li>Ranges of experience for each module </li></ul><ul><li>Final work based assessment with mentor </li></ul><ul><li>Regional assessment interview – panel interview you. Usually 20 to 30mins. Discuss your portfolio and your practise activity. </li></ul><ul><li>Receive your certificate of achievement which means you are accredited for 2 years. </li></ul>
    20. 20. Medicines management four modules <ul><li>Managing supply of non- stock medicines </li></ul><ul><li>Assessment of Patients own medicines </li></ul><ul><li>Managing the supply of one stop dispensing </li></ul><ul><li>Drug History Taking </li></ul>
    21. 21. Ward Based Technicians (WBT) In AMNCH <ul><li>In Tallaght Hospital we are not set up to do all four modules so I have completed module 2 managing supply of non stock medicines. </li></ul><ul><li>There are 3 ward which have a Ward based Technician-WBT </li></ul><ul><li>There are two trained WBT’s in AMNCH </li></ul>
    22. 22. WBT Responsibilities <ul><li>Daily visit to the allocated ward each day - first point of contact between pharmacy and the ward </li></ul><ul><li>Review all patients’ prescription charts and order any non stock medications required including nutritional feeds, blood products and dressings </li></ul><ul><li>WBT’s endorse all prescription charts stock , non-stock, MDA, Patients Own Medicines, Fridge item </li></ul><ul><li>WBT’s liaise with the ward pharmacist with regard to any medication errors/queries found on ward/chart </li></ul><ul><li>Ward stock top up </li></ul>
    23. 23. Advantages of service to the Department <ul><li>Improves workflow – pharmacy workload controlled </li></ul><ul><li>Risk management – issues relating to drug administering, transcription errors and communication have been addressed </li></ul><ul><li>Improves pharmacy standards </li></ul><ul><li>Improves working relationships between pharmacy and ward </li></ul>
    24. 24. Advantages for technicians <ul><li>Increased job satisfaction </li></ul><ul><li>Feel more involves and responsible </li></ul><ul><li>More job variety and interest </li></ul><ul><li>Improves motivation </li></ul><ul><li>Reconigition of their skill </li></ul><ul><li>Team building </li></ul>
    25. 25. Benefits of service for Patients <ul><li>They receive a more efficient and seamless service </li></ul><ul><li>Patient care is improved by more pharmacy clinical input </li></ul><ul><li>Medicines should arrive from pharmacy in a more timely way </li></ul><ul><li>Patients receive more counselling on drugs and feel more empowered </li></ul><ul><li>Should reduce medication errors </li></ul><ul><li>Gives the patient a positive image of the service </li></ul><ul><li>Patient benefits from having a regular medicine review </li></ul>
    26. 26. Future <ul><li>We hope to roll out the WBT service to other wards and eventually throughout the hospital </li></ul><ul><li>Take on drug History taking and then the clinical pharmacist can be involved in more clinical work at ward level </li></ul>
    27. 27. The Role of the Pharmacy Technician in Purchasing, A.M.N.C.H. Yvonne Sheehan Senior Pharmacy Technician I.I.P.M.M 27 March 2010
    28. 28. Aim of Presentation <ul><li>Background on purchasing in Public Sector. </li></ul><ul><li>Purchasing roles: order placement to payment </li></ul><ul><li>The fundamentals of purchasing : the 5 rights </li></ul><ul><li>Future roles for Purchasing Technician. </li></ul>
    29. 29. Purchasing in the Public Sector <ul><li>The hospital is a non-profit making organization. </li></ul><ul><li>Pharmacy accounts for 8 – 10% hospital budget </li></ul><ul><li>Pharmacy generates a small income through clinical trials </li></ul><ul><li>Funded by the tax payer </li></ul><ul><li>Transparent. </li></ul><ul><li>Ethical (conflicts of interest; tendering process) </li></ul><ul><li>Best Value for money. </li></ul><ul><li>(optimum combination of cost + quality) </li></ul>
    30. 30. The Pharmacy Service <ul><li>Pharmacy is a patient focussed service </li></ul><ul><li>The core aim of the pharmacy service is to deliver: </li></ul><ul><li>The correct drug </li></ul><ul><li>In the correct form </li></ul><ul><li>To the right person </li></ul><ul><li>At the right time </li></ul><ul><li>At the most economic cost to the health economy. </li></ul>
    31. 31. Purchasing roles Purchasing to payment. <ul><li>Order Placement </li></ul><ul><li>Reactive Supply on Demand </li></ul><ul><li>Proactive Planning, controlling, cost reduction. Best value for money. </li></ul>
    32. 32. The Five Rights of Purchasing <ul><li>Right Quality – fitness for purpose, specifications, legislative req’r </li></ul><ul><li>Right Quantity- Minimum order levels </li></ul><ul><li>Right Place- Transportation, delivery points </li></ul><ul><li>Right Time - Total lead times </li></ul><ul><li>Right Price- Different types of cost, negotiation, contracts. </li></ul>
    33. 33. Proactive Purchasing Purchase to payment . <ul><li>Supplier Selection. Sourcing (unlicensed medicines) </li></ul><ul><li>Supplier Management- measure, control, relationship. </li></ul><ul><li>New Products- meetings, journals, Medicines information, requests from customers. New product development. </li></ul>
    34. 34. Proactive Purchasing Purchase to payment <ul><li>Negotiation: contracts, legal implications, tendering. </li></ul><ul><li>Meeting with customers. Defining specifications. Service level agreements </li></ul>
    35. 35. Materials Management Purchase to payment. <ul><li>Stock Control Inventory = Money </li></ul><ul><li>Stock takes , valuation reports (data integrity) </li></ul><ul><li>Locations </li></ul><ul><li>Product recalls. Obsolete stock. New products </li></ul><ul><li>IT system </li></ul><ul><li>Pharmacy aide </li></ul><ul><li>Policies and Procedures </li></ul>
    36. 36. Invoice reconciliation and Payment <ul><li>Contract Prices. Variances in invoices. Queries </li></ul><ul><li>Credits. Finance reports </li></ul>
    37. 37. Future Roles for Purchasing Technicians <ul><li>Group buying for hospitals. </li></ul><ul><li>More tendering and contract management. </li></ul><ul><li>Electronic ordering systems. </li></ul><ul><li>Bar coding, automation. </li></ul><ul><li>Management of IT systems. </li></ul>
    38. 39. Pharmaceutical Technicians and Clinical Trials <ul><ul><li>Pharmaceutical Technician Conference </li></ul></ul><ul><ul><li>27 March 2010 </li></ul></ul>
    39. 40. Points to be covered <ul><li>Introduction to clinical research </li></ul><ul><li>Principles of ICH GCP </li></ul><ul><li>Technician responsibilities </li></ul><ul><li>Examples of Audit findings </li></ul>
    40. 41. Introduction to clinical research <ul><li>Clinical research is part of the complex procedure to demonstrate the effectiveness, safety and value for money of drugs and other products of the pharmaceutical industry. </li></ul>
    41. 42. Introduction to clinical research <ul><li>Of 100,000 chemicals screened for potential clinical activity, only about 15 will be looked at for further study Out of these 15 only about 5 will enter into clinical trials in humans. </li></ul><ul><li>Of these 5 only on average one drug will eventually be licensed and be available to all on prescription. </li></ul><ul><li>It costs about 800 million euros and takes about 11 years to develop one drug. </li></ul>
    42. 43. Introduction to clinical research <ul><li>Phase I </li></ul><ul><li>Conducted in human volunteers. </li></ul><ul><li>Provide an early evaluation of short-term safety and tolerability </li></ul><ul><li>Can provide pharmacodynamic and pharmacokinetic information needed to choose a suitable dosage range and administration schedule for initial exploratory therapeutic trials. </li></ul>
    43. 44. Introduction to clinical research <ul><li>Phase II </li></ul><ul><li>The first time the drug is tested in patients . </li></ul><ul><li>Usually only conducted in small numbers of patients. </li></ul><ul><li>The major aim of this stage is to evaluate the dose and regimen for further studies. In addition further safety and efficacy parameters are evaluated. </li></ul>
    44. 45. Introduction to clinical research <ul><li>Phase III </li></ul><ul><li>Larger scale studies of efficacy & safety. </li></ul><ul><li>Confirm the efficacy and safety of the drug in large numbers of patients. </li></ul><ul><li>Application for a product authorisation. </li></ul><ul><li>Includes all Phase I to IV data and all pre-clinical data </li></ul>
    45. 46. Introduction to clinical research <ul><li>Phase IV </li></ul><ul><li>Begins after product license has been granted by the regulatory authorities. Must be related to the approved indication. Commonly conducted studies include additional drug-drug interaction, dose-response or safety studies and studies designed to support use under the approved indication, eg mortality/morbidity studies. </li></ul>
    46. 47. WHAT IS GCP <ul><li>Good Clinical Practice is an international ethical & scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. </li></ul>
    47. 48. Why have GCP? <ul><li>Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki </li></ul>
    48. 49. Dates and Laws <ul><li>1964 Declaration of Helsinki </li></ul><ul><li>1974 Belmont report </li></ul><ul><li>1960’S - 1970’S Fraudulent clinical data </li></ul><ul><li>1977 USA GCP (FDA) </li></ul><ul><li>1977 - 1987 Applied to international studies by many pharmaceutical companies </li></ul><ul><li>1987 France GCP guidelines </li></ul><ul><li>1987 Germany conduct of clinical trials </li></ul><ul><li>1987(1990) Ireland Clinical Trials act </li></ul><ul><li>EU Directive became law 1 st May 2004 </li></ul>
    49. 50. OBJECTIVE OF ICH GCP <ul><li>The objective of the International Conference of Harmonisation GCP guidelines is to provide a unified standard for the European Union, Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions </li></ul>
    50. 51. EC Clinical Trial Directive (2001/20/EC) <ul><li>Key Objectives </li></ul><ul><ul><li>To extend the principles of Good Manufacturing Practice to IMPs </li></ul></ul><ul><ul><li>To provide “mutual recognition” for notification & approval </li></ul></ul><ul><ul><li>To harmonise & mutually recognise procedures for inspection & enforcement </li></ul></ul><ul><ul><li>To establish a harmonised procedure for clinical safety reporting </li></ul></ul>
    51. 52. Irish Law <ul><li>EU regulations transposed into Irish Law in 2004 </li></ul><ul><li>SI No 190 of 2004 </li></ul><ul><li>Superseded the Control of Clinical Trials Act 1997 </li></ul>
    52. 53. EU Directive definitions <ul><li>Investigational Medicinal Product </li></ul><ul><ul><li>A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorisation but used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unlicensed indication or when used to gain further information about the authorised form. </li></ul></ul>
    53. 54. ICH PRINCIPLES <ul><li>There are thirteen principles; </li></ul><ul><li>These state as follows: </li></ul>
    54. 55. ICH PRINCIPLE 1 <ul><li>Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s) </li></ul>
    55. 56. ICH PRINCIPLE 2 <ul><li>Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks </li></ul>
    56. 57. ICH PRINCIPLE 3 <ul><li>The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society </li></ul>
    57. 58. ICH PRINCIPLE 4 <ul><li>The available nonclinical and clinical information on an investigational product should be adequate to support the proposed trial. </li></ul>
    58. 59. ICH PRINCIPLE 5 <ul><li>Clinical trials should be scientifically sound, and described in a clear, detailed protocol </li></ul>
    59. 60. ICH PRINCIPLE 6 <ul><li>A trial should be conducted in compliance with the protocol that has received prior independent ethics committee approval </li></ul>
    60. 61. ICH PRINCIPLE 7 <ul><li>The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist. </li></ul>
    61. 62. ICH PRINCIPLE 8 <ul><li>Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s) </li></ul>
    62. 63. ICH PRINCIPLE 9 <ul><li>Freely given informed consent should be obtained from every subject prior to clinical trial participation </li></ul>
    63. 64. ICH PRINCIPLE 10 <ul><li>All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification </li></ul>
    64. 65. ICH PRINCIPLE 11 <ul><li>The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the regulatory requirements(s) </li></ul>
    65. 66. ICH PRINCIPLE 12 <ul><li>Investigational products should be manufactured, handled, and stored in accordance with GMP. They should be used in accordance with the approved protocol </li></ul>
    66. 67. ICH PRINCIPLE 13 <ul><li>Systems with procedures that assure the quality of every aspect of the trial should be implemented </li></ul>
    67. 68. The Research Team <ul><li>Sponsor </li></ul><ul><li>Chief Investigator </li></ul><ul><li>Principal Investigator </li></ul><ul><li>Research Nurse </li></ul><ul><li>Pharmacy </li></ul>
    68. 69. Pharmacy’s role <ul><li>Delegation of product accountability </li></ul><ul><li>Receipt </li></ul><ul><li>Storage </li></ul><ul><li>Dispensing </li></ul><ul><li> Returns </li></ul><ul><li>Destruction </li></ul>
    69. 70. Pharmacy Responsibilities <ul><li>To safeguard trial subjects, staff and the hospital </li></ul><ul><li>To ensure IMPs are used as per protocol </li></ul><ul><li>To ensure our procedures comply with current guidelines and regulations </li></ul>
    70. 71. Pharmacist Responsibilities <ul><li>Protocol Review </li></ul><ul><li>Negotiation with investigator/sponsor </li></ul><ul><li>Establishment of pharmaceutical implications </li></ul><ul><li>Liaison with other sections within the pharmacy </li></ul><ul><li>Preparation of S.O.P.’s </li></ul><ul><li>Ongoing liaison with investigator/sponsor </li></ul>
    71. 72. Technician Responsibilities <ul><li>Daily management of ongoing studies </li></ul><ul><li>Monitoring of storage conditions </li></ul><ul><li>Ordering and receipt of drug supplies </li></ul><ul><li>Dispensing of prescriptions </li></ul><ul><li>Processing of patient’s drug returns </li></ul><ul><li>Drug accountability </li></ul><ul><li>Maintance of records </li></ul><ul><li>Supervision of CRA visits </li></ul>
    72. 73. Facilities <ul><li>Adequate storage for IMPs & returns </li></ul><ul><li>Environment monitoring systems </li></ul><ul><li>Storage & management of study files & prescriptions </li></ul>
    73. 74. Documentation <ul><li>“ If it wasn’t written down then it never happened” </li></ul><ul><li>Responsibility to provide proof of IMP audit trail during lifetime of study at site from initial receipt to removal </li></ul>
    74. 75. Pharmacy File-Documentation <ul><li>Good, clear, complete documentation </li></ul><ul><li>Black Pen </li></ul><ul><li>Remember to initial & date all corrections </li></ul><ul><li>NO correction fluid- all alterations must be legible </li></ul><ul><li>Staff signature/initial list </li></ul>
    75. 76. Dispensing Logs <ul><li>Should identify which drug was dispensed to which patient, when and by whom. </li></ul><ul><li>Record batch numbers & expiry dates </li></ul><ul><li>All drugs returned from the patient must be documented (partially used, used & unused) </li></ul><ul><li>Document issues with drugs dispensed but not given to the patient. </li></ul><ul><li>Document issues with reconstitution of drug. </li></ul><ul><li>Dispense trial stock </li></ul>
    76. 77. Management of IMPs <ul><li>Drugs are manufactured to GMP standards and are labelled in accordance with Annex 13. </li></ul><ul><li>Daily temperature check. </li></ul><ul><li>Refrigerators should have alarms to sound if product goes out of temperature range. </li></ul><ul><li>Temp excursions need to be documented & guidance sought for whether the product is suitable for use. </li></ul><ul><li>Expiry dates need to be checked. </li></ul>
    77. 78. Examples of audit findings in pharmacy <ul><li>Unable to track all IMPs </li></ul><ul><li>Errors on dispensing logs-issues with accountability </li></ul><ul><li>Documentation issues </li></ul><ul><li>Missing receipts & prescriptions </li></ul><ul><li>Temperature logs not completed </li></ul>
    78. 79. Examples of audit findings in pharmacy (2) <ul><li>Lack of training of personnel on trial-related issues or poorly documented training </li></ul><ul><li>No training of staff on recall procedures </li></ul><ul><li>Non compliance with SOPs </li></ul><ul><li>CVs for personnel missing or not dated </li></ul>