z_4-/01/11 ,c.,u V clf..rm-t PGD for the administration of Phytomenadione (Konakion MM Paediatric 2mg/0.2ml solution for injection) via the oral route

Transcription

1 PGD for the administration of Phytomenadione (Konakion MM Paediatric 2mg/0.2ml solution for injection) via the oral route PGD Ref: p G- D f j Effective From: Feb 2.0 }9 Expiry: Feb J by Paediatrics and obstetrics in Maternity Originator: Stephanie Stirling Place of Work: Pharmacy Professional Qualification:Lead Pharmacist for Women and Children This Patient Group Direction has been approved by: Name: Balaji Suryanarayanan Sign rr re a{). Senior Doctor participating in the PGD developmen/ /y Name: Gill Valentine Director of Midwifery / Sign_ature:,c.,U V clf..rm-t.- Date: -1- I 9, Name: Stephanie Stirling (nee' Horsburgh) Lead Pharmacist for Women and Children Date: z_4-/01/11 Name: Microbiologist (required for PGD's written for antimicrobials) Signature: Name: Sakeb Hussain Signature: ) On behalf of the Drugs and Therapeutics Committee Date: Date: ) 'L)) \

2 Direction for the administration of: Purpose of the treatment: Indication for use, if medicine is 'black triangle' or used outside of its licensed use (see development guidelines) Listed in BNFC Ward or Department to which the PGD applies: Vitamin K (Phytomenadione) Neonatal prophylaxis of vitamin-k deficiency bleeding Neonatal prophylaxis of vitamin-k deficiency bleeding in healthy babies who are not at particular risk of bleeding disorders where parents have requested the oral route for administration. Yes Maternity and Paediatrics Clinical condition Clinical condition I situation: Inclusion Criteria: Exclusion Criteria: Action if patient excluded: Action if patient declines treatment Oral administration of neonatal prophylaxis of vitamin-k deficiency at parental request Healthy babies who are not at particular risk of bleeding disorders Babies who are born pre-term, are at risk of bleeding disorders, have cholestatic jaundice or are otherwise unwell. Should be administered vitamin K (where appropriate) parenterally whilst in the hospital setting. Contact paediatric neonatal team for further advice Staff criteria Professional qualifications required: Specialist/additional qualifications, experience or training required: Registered Midwife I 2

3 Treatment Name, strength and formulation of medicine: Legal status of medicine: Name: Phytomenadione Form: Solution for injection Strength: 2mg/0.2ml Dose/dose 2mg range For oral administration Route: POM L Details of administration/special instructions: For oral administration, oral dispensers are provided in the pack. After breaking the ampoule open, 0.2 ml of solution should be withdrawn into the oral dispenser until it reaches the mark on the dispenser (0.2 ml= 2 mg vitamin K). Drop the contents of the dispenser directly into the baby's mouth by pressing the plunger. Minimum and maximum total doses: Frequency of administration : Maximum and minimum treatment periods: Follow up actions required: Written and verbal advice given to patients Pre or post treatment: Relevant warnings, including potential adverse reactions/contraindications: Identification and management of adverse reactions: Initially 2 mg for 1 dose at birth, then 2 mg after 5-7 days for a further 1 dose, then 2 mg for a further 1 dose 1 month after birth (if exclusively breast fed) 0-28 days of life None Verbal advice and written advice regarding how and when to administer the doses. At the time of use, the ampoule contents should be clear. Following incorrect storage, the contents may become turbid or present a phase-separation. In this case the ampoule must no longer be used. Infants with cholestatic disease must receive Konakion MM Paediatric by intramuscular or intravenous injection since oral absorption is impaired in these patients. 3

4 Requirements for continuing training and education: CPD 4

5 Circumstances in which further advice should be sought from a Doctor and arrangements for referral: Record of supply/administration and details to be kept for audit (show indication) Reporting procedure of adverse reactions/ incidents: Key POM Prescription only L Licensed Further advice should be sought from the oncall obstetric or neonatal registrar via the hospital switchboard EPMA and CMIS Online datix reporting system P Pharmacy only GSL General Sales List OL Used outside of licence BT Black Triangle 5

6 Patient Group Direction PGD Ref: 118 Patient Group Direction for the administration of: Phytomenadione Solution for injection 2mg For oral administration Ref No: PGD118 Expiry Date: February 2021 Department: Paediatrics & Obstetrics in Maternity - The following Staff members are authorised to administer medication under this Patient Group Direction having been assessed as competent to do so. Name Professional Status Date Signature Managers Signature 6

7 Patient Group Direction PGD Ref: 118 Patient Group Direction for the administration of: Phytomenadione Solution for injection 2mg for oral administration Ref No: PGD118 Expiry Date: February 2021 Department: Paediatrics & Obstetrics in Maternity Record of Administration Patient Details Medication Details Date Time Signature Name, Address, DOB, Hospital No. Name, Dose, Route, Batch, Expiry Date of person supplying and administering. - 7