Clinical Pharmaceutical Science Scientist Training Programme (STP)

What is STP? Postgraduate entry programme leading to more senior scientific roles Employed by NHS Trust for duration of training National recruitment and placement Part of the Modernising Scientific Careers Programme The MSC programme ensures that the healthcare science workforce will be fit to respond to future scientific and technological advances and to meet the demographic, epidemiological and financial challenges facing the health and social care system. Very simply, MSC is about making sure that those working in healthcare science can deliver quality services to patients and continue to play a major role in healthcare

Programme Structure

Completion of training programme STP Trainee Journey Completion of training programme REGISTRATION University Work Base (NHS Trust) Assessment Programme (OLAT, OSFA)

Themed Healthcare Science Divisions

Clinical Pharmaceutical Scientists work in 4 areas of technical pharmacy Quality Control and Quality Assurance Production Units Aseptic Dispensing and Preparation Radiopharmacy Healthcare Science staff in Clinical Pharmaceutical Science work to ensure the medicines a patient receives are SAFE and FIT FOR PURPOSE

Quality Control and Quality Assurance We can’t always detect a problem with a medicine until it’s too late Potentially very hazardous to patient Element of trust Cannot test the whole batch

Good Manufacturing Practice (GMP) 10 Basic Rules Having detailed written instructions before any job is started Following instructions exactly Ensure the correct products and materials are being used Ensure that the correct equipment is being used and that it is clean Prevent contamination and mix up Always guard against labelling errors Always work accurately and precisely Keep things clean and tidy Be on the lookout for mistakes, errors, and bad practices and report them immediately 10) Make clear and accurate records of what has been done and the checks carried out

Quality Control and Quality Assurance Newcastle upon Tyne Hospitals (NUTH) Manufacture Specials Traditional Pharmaceuticals Advanced therapies Radiopharmaceuticals MHRA Regulate Manufacture IMP’s Prepare medicines for use within NUTH Parenteral Nutrition, chemotherapy etc. EL auditors Regulate Production QAQC

STP activities – Quality Control and Quality Assurance Packaging quality assessments Quality Management System reviews and updates Qualification of equipment Analytical Method Development Shelf life literature review and assessments Audits Analytical and Microbiological testing Product Quality Review Investigations and root cause analysis Change Control

Production FACILITIES – EQUIPMENT What is thought process in selecting a new item of production equipment e.g replacing an old LAFC or Isolator What factors need to considered? Space – How will it fit into intended space Services – How will it connect to power / water/ gas /other Who is responsible for connecting to services Training of staff Specification and qualification User Requirement Specification How to decide which features functions are essential and which are desirable DQ IQ/ OQ/PQ Re Qualification – Servicing / Engineers calibration certificates Consider something as simple as a measuring cyclinder in a dispensary. What should this be constructed of etc, grade A glassware/ marked with government stamp of approval. Or installation of a new fridge – what functionality might you want to include – alarms, remote monitoring. How would you qualify?

STP Activities - Production General Manufacture Label Design Validations Stock checks Production Planning Investigation reporting Planned Preventative Maintenance New Product Introduction MRS Microbiology Monitoring System For environmental monitoring compliance

MRS Microbiology Monitoring System Aseptic Services PARENTERAL NUTRITION Indications Patients requiring PN Peripheral vs Central Consider constituents Costs Risks Formulation -Complex Nutritional requirements vs Formulation stability Order of mixing – Calcium /Phosphate/ Divalent ions interactions Administration Filtration Duration Patients - Four broad groups of patients premature babies may have poorly developed gut/liver/enzyme systems patients with cancer (esp children) may not feel like eating, or gut not working due to chemo long term patients (eg Crohn’s, short bowel) may need to be on PN for months or rest of life short term patients (eg bowel surgery) may only require 4-14 days Peripheral vs central line short term use - long terms use Glucose concentration, thrombophlebitis – osmolality Central line infection – consequences Constituents Costs of treatment Risks – contamination incidents – Farwell, ITH etc etc Complex formulation AAs, Glucose, Electrolytes,Trace elements, Vitamins – Fat and water soluble Nutritional requirements – can be difficult to match patients exact nutritional requirements due to formulation stability limitations. Consider All in one bags are EMULSIONS Glucose fat ratios etc etc Nutritional needs can be very individual – consider a burns patient, neonates with little or no reserves Mixing – Interactions precipitation- inorganic vs organic phosphate – can’t see precipitate in fat bags vitamin degradation – consequence to patient – multilayer bags Administration Commonest problems are: metabolic catheter infections But death has occurred in patients due to precipitates particles bacteria Filters remove particles, ppts, bacteria (except lipid filters), fungi & air. - Filters For non-lipid PN, use 0.2m filter Fat globs are 0.3 - 0.8 m diam, so use 1.2 m filter for emulsions (C. Albicans is 2 - 4 m diam) 1994 - 2 deaths in US periph AIO mixtures with Calc Phos ppt diffuse microvascular pulm emboli camouflaged by lipid FDA recommend filters as result of this Typical ITU patient may get 3 mill particles >2 micrometres in 24 hours. cf 3kg infant 37,000 particles >2 microm Post mortem lung sections of long-term IV receivers show granulomata with cellulose fibres. MRS Microbiology Monitoring System For environmental monitoring compliance

STP Activities - Aseptic Services Staff Training Dispensing Process Validation Written validation protocols Documentation review and updates Change Control Investigation and Root cause analysis MRS Microbiology Monitoring System For environmental monitoring compliance

Radiopharmacy Pharmaceutical A radiopharmaceutical has two essential components: A pharmaceutical, something that goes to the part of the body you want to look at tagged on to something that emits radiation – a radionuclide Pharmaceutical

MRS Microbiology Monitoring System Radiopharmacy What are radiopharmaceuticals used for? Range of clinical indications Diagnostic Radiopharmaceuticals Therapeutic Radiopharmaceuticals Radiopharmacy is an interdisciplinary science which applies physical and biological sciences. Applications include: Production and properties of the radionuclide Incorporation into a carrier Formulation Quality control Adverse effects Drug interactions MRS Microbiology Monitoring System For environmental monitoring compliance

Radiopharmacy – Patient Pathway Radionuclide Production Patient dose preparations Interpretation Patient Injection and Scanning MRS Microbiology Monitoring System For environmental monitoring compliance

Radiopharmacy – Day to day Implementing improvements Dispensing Staff training Documentation review and updates Validation of new equipment Investigations Routine Calibration of equipment Radiation safety MRS Microbiology Monitoring System For environmental monitoring compliance

Rotations – Clinical Pharmaceutical Science Year 1 Rotations Quality Assurance & Quality Control Production Aseptic Preparation Radiopharmacy Years 2 and 3 Specialism Quality Assurance & Quality Control 2 Production 2 Aseptic Preparation 2 Radiopharmacy 2

DOPs (Direct Observation of Practical Skills) Assessments DOPs (Direct Observation of Practical Skills) Manual Skills learnt and demonstrated CBDs (Case Based Discussions) Understanding and integration of knowledge from various sources Competencies Skills/Knowledge/Understanding OCEs (Observed Clinical Events) Performance

Competency Examples 5 competencies covered in the completion of 1 MSc assignment!

Competency Examples What? Why? When things go wrong? Learning Outcome: Observe, assist and where appropriate perform, under supervision, a range of processes and procedures in accordance with local practice in order to manufacture products safely. What? Why? When things go wrong?

Elective

Potential roles upon completion • Qualified Person • Medical Gas Testing • Radionuclide Radiotherapy • Pharmaceutical Microbiology • Pharmaceutical Stability Testing • Pharmaceutical Formulation Science PET Radiochemistry

Any Questions?