Prescribing Lactoferrin in the ELFIN Clinical trial

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1 Prescribing Lactoferrin in the ELFIN Clinical trial PAULA JENKINS RESEARCH NURSE NPEU

2 Why Lactoferrin is deemed an Investigational Medicinal Product any substance or combination of substances presented as having properties for treating or preventing disease in human beings a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial Its not just a bit of milk powder!

3 Who can prescribe ELFIN IMP? Medical Staff and Independent Nurse Prescribers All those who will prescribe must be named on the delegation log All those listed to prescribe must have had appropriate ELFIN training BUT Nurse prescribers must check Trust policy for clinical trial IMP prescribing by nurses. Prescribing ELFIN must be within the scope of any Prescriber s competence.

4 When To Prescribe ELFIN IMP Prescribe when a medical decision to dose with ELFIN is made This medical decision to start dosing must be documented clearly and specifically in infant medical notes, including the name of doctor deciding ELFIN dosing may commence Prescribe after consent, enrolment and randomisation has been completed, documented, and randomised ELFIN pack has been identified. Prescribe when the infant is feeding at least 12mls/kg/day of enteral feed

5 How to prescribe ELFIN IMP What you need: Hospital Prescription and Administration Chart Randomisation Sheet Subsequent pack randomisation sheet Dosing Chart

6 Correct wording and content for a prescription is within guidance sheet 3 How to prescribe ELFIN IMP What you need: As per Guidance Sheet 3.

7 How to Prescribe ELFIN IMP What you do The ELFIN web based randomisation programme will identify the specific pack to be allocated to the ELFIN infant. Print off the randomisation sheet indicating the pack number for this infant. Check the randomisation sheet information against the prescription chart information: Right infant Right study number Right pack Prescribe the first or subsequent pack using the information on the infants randomisation sheet.

8 How to Prescribe ELFIN IMP What you do Prescribing must include mls of ELFIN IMP to be given to correlate with the ELFIN DCF dosing form 2 data (in mls) being collected. The working weight used for the prescription and dose calculation should be evidenced on the Dosing Form 2 and in the infant medical notes.

9 How to Prescribe ELFIN IMP What you do

10 Maximum Dose ELFIN has a maximum dose of 300 mg which is 4 ml of the reconstituted IMP, regardless of the infants weight. For example an ELFIN baby of 2.3kg at 33 weeks will still only receive a maximum dose of 300mg or 4mls (ELFIN dose is 150mg/kg/day) This must be indicated on the prescription chart in the recommended way

11 Maximum dose of 300 mg or 4 ml

12 How to Prescribe ELFIN IMP What you do Correct any mistakes in the GCP recommended way, one line through whole prescription, initial and date. PJ 22/05/15 Re-prescribe correctly

13 How to Prescribe ELFIN IMP What you do Write new prescription when infant weight changes (but once initial weight loss has been regained) Cancel prescription when dosing period finishes Cancel prescription when infant is NBM or any decision to stop trial medication

14 How to Prescribe ELFIN IMP What you do If recommencing ELFIN IMP after a period of stoppage re-write the prescription. The medical decision to recommence dosing must be clearly documented in infant notes and by whom (medical practitioner) the decision was made. The new prescription may reflect a different dose according to any weight changes but the original pack and number may still be used to continue dosing.

15 How to Prescribe ELFIN IMP What you do ELFIN has a maximum dosing period to 34 weeks PMA The final dosing date can be found on the first randomisation page which should be found in the notes or attached to the prescription chart This final dosing date must be reflected on the prescription chart.

16 Missed Doses and Stoppages Doses missed or omitted due to infants changed medical condition, or not given in error should be indicated as not given on the prescription chart and ticked as not given on dosing form 2 with reasons for omission. Don t forget your Trust s non-administration record This information is important to the quality of the data collection and for accountability at the end of the dosing period

17 Missed Doses and Stoppages Incident form 8 does not need to be completed for missed or omitted doses, so long as they are clearly recorded on Form 2 Daily Dosing Log. Incident form 8 does need to be completed for overdosing, under-dosing, dosing from a wrong pack, prescribing the wrong pack, doses given beyond 34 weeks, and doses stopped in error before 34 weeks.

18 Transferring Infants Infants transferred to a continuing care site may continue being dosed with ELFIN IMP up to 34 weeks PMA. The Transfer pack will indicate when the final ELFIN IMP dose is to be given. ELFIN IMP is to be prescribed again at the continuing care site by the PI, non medical prescriber or attending consultant provided he/she is satisfied this person understands the trial processes as found in the Transfer Pack enclosures ie Guidance sheets and Acceptance of Transfer..

19 Transferred Infants The Acceptance of Transfer form for signing by the PI ensures they understand their responsibility to continue trial duties such as correct prescribing of ELFIN IMP and any delegation of such a duty to other staff

20 Non Medical Prescribing for ELFIN Clinical Trial SI 2003/696 amends the prescription only Medicine (Human Use) Order 1997 to make provision for nurses and pharmacists who meet certain conditions to prescribe and administer prescription only medicines in accordance with clinical management plans relating to individual patients. Article 3b (ii) of SI 2003/696 includes clinical trials allowing non medical prescribers to prescribe for clinical trials

21 Benefit of Nurse Prescribers for ELFIN Trial Appropriate professional practice More involved in direct care and will therefore be more familiar with individual patient factors Improved care without compromising safety Increased patient access to trial medication Better use of health professionals skills Easier and quicker to get medicines into patients Contributes to flexible team working (Improved patient outcomes Improved health outcomes) May increase numbers of patients recruited within time period A good development within NMP practice

22 Non Medical Prescribing for ELFIN Clinical Trial The responsibility for prescribing must be documented in the delegation log All staff involved with prescribing must be trained to perform the task. The Protocol and Guidance Sheet 14 will reflect the time points when medical input is required for treatment to continue

23 Non Medical Prescribing for ELFIN Clinical Trial It is a medical decision to dose the patient in a Clinical Trial. The medical decision to dose must be recorded by the clinician making the decision. NMPs can issue the prescription, within their competence, following medical decision to dose and ensuring documentation of this.

24 Non Medical Prescribing for ELFIN Clinical Trial There must be documented evidence of follow up by a medically qualified doctor should an ELFIN prescription be temporarily halted or doses to be temporarily omitted for any reason There must be documented evidence of a medical decision to permanently discontinue dosing ELFIN at earlier than 34 weeks by the Principal Investigator on Form 6

25 Non Medical Prescribing for ELFIN Clinical Trial It is recommended the NHS Trust management assesses the risk and decides whether the prescribing process is in line with Trust Policy

26 Contact: NPEU Clinical Trials Unit Trial Coordinator - James Griffiths T: F: Lead Research Nurse - Paula Jenkins T: M: Data Coordinator - Monika Vargova T: E: W: Department of Population Health University of Oxford, Old Road Campus, Oxford, OX3 7LF

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