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Patient Group Direction For The Administration Of Rotavirus Vaccine Rotarix By Nurses, Midwives and Health Visitors Working Within NHS Grampian

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Patient Group Direction For The Administration Of Rotavirus Vaccine

Rotarix

®

By Nurses, Midwives and Health Visitors Working Within

NHS Grampian

Co-ordinators:

Adapted from National PGD – See Page 1

Consultation Group: See relevant page in the PGD

Approver:

Medicine Guidelines and Policies Group Signature: Identifier: NHSG/PGD/rotaV/ MGPG740 Review Date: June 2017 Date Approved: June 2015

A Patient Group Direction is a specific written instruction for the supply or administration of named medicines in an identified clinical situation. It is drawn

up locally by Doctors, Pharmacists and other appropriate professionals, approved by the Employer and advised by the relevant professional advisory committees. In most cases, appropriate clinical care is provided on an individual

basis by a specific prescriber to a specific individual patient. Patient Group Directions should only be considered where they offer a benefit to patient care

without compromising patient safety in any way.

Uncontrolled when printed

Version 2.1 (Amended November 2015)

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Title: Patient Group Direction for the administration of rotavirus vaccine Rotarix® by Nurses, Midwives and Health Visitorsworking within NHS Grampian

Identifier: NHSG/PGD/rotaV/MGPG740

Replaces: NHSG/PGD/rotaV/MGPG740 – Version 2 Across NHS

Boards

Organisation Wide

Directorate Clinical Service Sub

Department Area

Yes

This controlled document shall not be copied in part or whole without the express permission of the author or the author’s representative.

Author: Health Protection Scotland, adapted for NHS Grampian by Health Protection Nurse, NHS Grampian

Subject Patient Group Direction

Key word(s):

Policy application: NHS Grampian

Purpose: This Patient Group Direction (PGD) authorises appropriately qualified and trained Nurses, Midwives and Health Visitors to administer rotavirus vaccine (Rotarix®) to individuals without the requirement for a patient specific prescription written by a

medical practitioner.

Responsibilities for implementation:

Organisational: Chief Executive and Management Teams

Corporate: Senior Managers

Departmental: Heads of Service/Clinical Leads

Area: Line Managers

Hospital/Interface services:

Deputy General Managers and Group Clinical Directors

Operational

Management Unit:

Unit Operational Managers

Policy statement: It is the responsibility of individual Nurses, Midwives and Health Visitorsand their line managers to ensure that they work within the terms laid down in this PGD and to ensure that staff are working to the most up to date PGD. By doing so, the quality of the services offered will be maintained, and the chances of staff making erroneous decisions which may affect patient, staff or visitor safety and comfort will be reduced. Supervisory staff at all levels must ensure that staff using this PGD act within their own level of competence.

Review: This policy will be reviewed at least every two years or sooner if current treatment recommendations change.

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This document is also available in large print and

other formats and languages, upon request.

Please call NHS Grampian Corporate

Communications on (01224) 551116 or (01224)

552245.

Responsible for review of this document: Health Protection Nurse, NHS Grampian

Responsible for ensuring registration of this document on the NHS Grampian Information/ Document Silo:

Pharmacy and Medicines Directorate

Physical location of the original of this document:

Pharmacy and Medicines Directorate

Job/group title of those who have control over this document:

Pharmacy and Medicines Directorate

Responsible for disseminating document as per distribution list:

Pharmacy and Medicines Directorate

Revision History: Date of change Approval date of PGD that is being superseded

Summary of Changes Section heading

May 2015 June 2014 Updated to new national PGD Nov 2015 June 2015 Amended to include staff groups

Midwives and Health Visitors

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This Patient Group Direction (PGD) has been adapted from a specimen PGD template produced by Health Protection Scotland, April 2015.

This PGD has been produced for NHS Grampian by

Doctor Diana Webster Signature

Pharmacist Craig Rore Signature

Nurse Fiona Browning Signature

Approved on behalf of NHS Grampian by

Medical Director Nick Fluck Signature

Director of Pharmacy David Pfleger Signature

Clinical Governance

Lead/Director of Nursing Rosemary Lyness Signature

Date Approved June 2015

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Patient Group Direction for the Administration Of Rotavirus Vaccine Rotarix® By Nurses, Midwives and Health Visitors Working Within NHS Grampian

Contents Page No

Clinical Situation ... 3

Description of Treatment ... 4

Characteristics of staff authorised under the PGD ... 8

Audit Trail ... 9

Consultative Group ... 10

Appendix 1 - Health Care Professional Agreement To Administer Medicines Under Patient Group Direction ... 11

Appendix 2 - Certificate Of Authorisation To Administer Medicines Under Patient Group Direction ... 12

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Patient Group Direction for the Administration of Rotavirus Vaccine Rotarix® by Nurses, Midwives and Health Visitors Working Within NHS Grampian

Clinical Situation

Indication Active immunisation against rotavirus in line with Scottish Government Health Directorate immunisation programme.

Inclusion Criteria

Infants from 6 weeks to 24 weeks (i.e. by 23 weeks and 6 days) as part of a two dose routine schedule.

Valid consent has been given to receive the vaccine. Exclusion

Criteria

Confirmed anaphylactic reaction to a previous dose of rotavirus vaccine. Confirmed anaphylactic reaction to any component of the vaccine.

Practitioners must check the marketing authorisation holder’s summary of product characteristics (SPC) for details of vaccine components.

Over 24 weeks of age (i.e. older than 23 weeks and 6 days).

Infants who have not received their first dose before 15 weeks of age (i.e. older than 14 weeks and 6 days).

Known to have previous history of intussusception.

Known to have a malformation of the gastrointestinal tract that could predispose them to intussusception.

Known to have Severe Combined Immunodeficiency Disorder (SCID). Known to have rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.

Known to have immunosuppression.

Acute severe febrile illness – postpone immunisation until patient has fully recovered.

Acute diarrhoea or vomiting - postpone immunisation until patient has fully recovered. Cautions /Need for further advice/ Circumstances when further advice should be sought from a doctor

Minor illnesses without fever or systemic upset are not valid reasons to postpone immunisation.

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Action if Excluded

Specialist advice must be sought on the vaccine and circumstances under which it could be given. The risk to the individual of not being immunised must be taken into account.

Infants with immunosuppression (other than SCID): the benefits of administration are likely to outweigh any theoretical risks and therefore should be actively considered, if necessary in collaboration with the clinician dealing with the child’s underlying condition.

Temporary exclusion: In case of postponement due to acute severe febrile illness or acute diarrhoea and/or vomiting, arrange a future date for immunisation.

Document in clinical records.

Action if Patient Declines

Advise about the protective effects of the vaccine, the risks of infection and complications. Document advice given and decision reached. In GP practice setting, inform or refer to GP.

Consent Prior to the administration of the drug, consent must be obtained,

preferably written, either from the patient/parent/guardian or person with parental responsibility and documented either in the patient’s medical records/notes or on an administration form (see section 5.2). Consent must be in line with NHS Grampian policy. See link below.

http://intranet.grampian.scot.nhs.uk/ccc_nhsg/15692.html?pMenuID=460&

Description Of Treatment

Name of Medicine

Rotavirus vaccine, Live (Rotarix®).

Form/Strength Oral suspension in a prefilled oral applicator.

Route of administration

Oral use only. Seat the child in a reclining position and gently administer the entire content of the oral applicator into the child’s mouth, towards the inner cheek.

Rotarix® must not be injected.

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Frequency The course consists of two doses with an interval of at least four weeks between the doses.

The recommended age for immunisation is the first dose at two months of age (approximately eight weeks) followed by the second dose at least four weeks after the first dose.

It is preferable that the full course of two doses of Rotarix® be completed before 16 weeks of age.

Infants older than 15 weeks of age (i.e. older than 14 weeks and 6 days), who have not yet received their first dose of Rotarix®, should not be commenced on Rotarix®. Infants who receive the first dose before 15 weeks of age should complete the course by 24 weeks of age (i.e. by 23 weeks and 6 days).

If the course is interrupted it should be resumed but not repeated, provided that the second dose can be given by 24 weeks of age (i.e. by 23 weeks and 6 days).

If the infant spits out or regurgitates most of the vaccine, a single replacement dose can be given at the same vaccination visit.

Duration of treatment

See Frequency section.

Maximum or minimum treatment period

See Frequency section.

Quantity to supply/adminis ter

See Frequency section.

▼ black triangle medicines No Legal Category

PoM – prescription-only Medicine.

Is the use outwith the SPC

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Storage requirements

Vaccine should be stored at a temperature of +2° to +8°C. Store in original packaging, protected from light. Use immediately after opening. If the vaccine has been frozen, it should be discarded.

NHS Grampian guidance on Storage and Handling of vaccines should be observed.

http://www.nhsgrampian.com/grampianfoi/files/NHSGVH.pdf

Additional Information

The vaccine is a colourless liquid and should be inspected visually for any foreign particulate matter and/or abnormal physical appearance. In the event of either being observed, discard the vaccine.

If the infant spits out or regurgitates most of the vaccine, a single replacement dose may be given at the same vaccination visit. Rotarix® can be given at the same time as the other vaccines

administered as part of the childhood immunisation programme including BCG. Rotarix® and BCG can be given at any time before or after each other.

Rotarix® is not interchangeable with other rotavirus vaccines. The same brand should be used for both doses.

Very premature infants (born ≤ 28 weeks of gestation) who are in hospital should have respiratory monitoring for 48-72 hours when given their first routine immunisations, particularly those with a previous history of respiratory immaturity. If the child has apnoea, bradycardia or desaturations after the first routine immunisations, the second

immunisation should also be given in hospital, with respiratory monitoring for 48 - 72 hours. Warnings including possible adverse reactions and management of these

The most common adverse reactions observed after administration of Rotarix® vaccine are diarrhoea and irritability. Other reactions commonly reported are vomiting, abdominal pain, flatulence, skin inflammation, regurgitation of food, fever and loss of appetite.

For full details/information on possible side effects, refer to the marketing authorisation holder’s SPC.

As with all vaccines there is a very small possibility of anaphylaxis and facilities for its management must be available.

In the unlikely event of severe adverse reaction the parent/guardian or person with parental responsibility should be advised to seek urgent medical advice. These reactions include;

• abdominal pain

• vomiting

• passing stools with the appearance of red currant jelly in their nappies.

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Reporting procedure for adverse reactions

Any adverse events that may be attributable to Rotavirus vaccine, Live (Rotarix®)should be reported using the yellow card system on

http://yellowcard.mhra.gov.uk/.

Any serious adverse reaction to the vaccine should be documentedin an individual’s record and the GP should be informed.

Advice to Patient/carer including written information

Supply marketing authorisation holder’s patient information leaflet (PIL) provided with vaccine.

Inform of possible side effects and their management.

Advise parents/guardians or person with parental responsibility to seek urgent medical advice if there is any abdominal pain, vomiting and passing what looks like red currant jelly in their nappies.

Advise parents/guardians or person with parental responsibility that contacts of infants who have had Rotarix® vaccine should observe good personal hygiene, e.g. wash their hands after changing nappies.

Monitoring Following immunisation patients remain under observation in line with NHS Grampian policy. As it is not possible to specify an exact length of time patients should remain on the premises for approximately 10 - 15 minutes.

Follow-up If appropriate remind parents/guardianor person with parental

responsibility that a further dose will be required to complete the course.

Additional Facilities

Injections of IM adrenaline/epinephrine 1:1000 must be available to treat an anaphylactic reaction should this occur. Medical advice must be sought as soon as possible from a doctor if any patient develops any signs of hypersensitivity. If there is a delay in medical support arriving and the condition of the patient is deteriorating then an emergency ambulance must be called on 999 or direct via ambulance control or dial 2222 (hospital internal) according to local procedure, or seek urgent medical advice. (Refer to Patient Group Direction for the administration of adrenaline (epinephrine) in cases of suspected anaphylactic reactions by qualified health professionals).

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Characteristics Of Staff Authorised Under The PGD

Professional qualifications

Nurses, Midwives and Health Visitors working within NHS Grampian and currently registered with the Nursing and Midwifery Council (NMC). Nurses, Midwives and Health Visitors working in GP surgeries can be authorised to administer the drug specified in this PGD by practice GPs. (NB. GP practices must have adopted NHS Grampian PGD for use in their practice).

Nurses, Midwives and Health Visitors working within NHS Grampian can be authorised to administer the drug specified in this PGD by their Nurse Manager.

Specialist competencies or

qualifications

Staff authorised to administer vaccine under the direction of this PGD are those employed either directly by NHS Grampian, or contracted to provide NHS services, or providing services in partnership with NHS Grampian and deemed competent by their manager to do so. They must also: (i) agree to be professionally accountable for their work (Appendix 1). (ii) be competent to assess the patient’s capacity to understand the

nature and purpose of the administration in order for the patient to give or refuse consent.

(iii) be aware of current treatment recommendations and be competent to discuss issues about the drug with the patient.

(iv) have been trained and assessed as being competent in the

administration of the drug. All staff will have access to the current PGD.

(v) have undertaken an NHS e-anaphylaxis training session which covers all aspects of the identification and management of

anaphylaxis. This can be accessed via eKSF or the AT Learning® tool.

(vi) be competent in basic life support which is required to be updated annually.

(vii) have immediate access to the appropriate equipment and drugs to treat anaphylaxis and have access to the current PGD for the management and treatment of anaphylaxis should this occur. (viii) maintain their skills, knowledge and their own professional level of

competence in this area according to their individual Code of Professional Conduct.

(ix) agree to work within the terms of the NHS Grampian PGD.

Continuing education and training

The practitioner must be familiar with the Green Book chapters for all vaccines administered in accordance with this PGD. It is the

responsibility of the individual to keep up to date with all aspects of immunisation and in the recognition and management of anaphylaxis.

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Audit Trail

Record/Audit Trail The approved practitioner must maintain accurate records of each vaccine administered and may be required to share information with appropriate parties in line with confidentiality protocols. The

information relating to immunisation of each individual must include as a minimum:

• Name and address of patient/parent/guardian or person with parental responsibility, patient CHI No

• Date of birth

• Consultant/General Practitioner details

• Risk group, if appropriate

• Physical examination required, if appropriate

• Exclusion criteria, record why drug not administered

• Reason for giving

• Consent to the administration (if not obtained elsewhere)

• Drug manufacturer, batch number, expiry date

• Site where drug administered, dose and route of administration

• Signature and name in capital letters of practitioner who administered the drug

• Date drug given

• Record of adverse effects (advise patient’s doctor). All records must be clear, legible and, ideally, in an easily retrievable format. Depending on the clinical setting where vaccination is undertaken, the information should be recorded manually or electronically, in one (or more) of the following systems, as appropriate:

• GP practice computer

• Individuals GP records

• Child Health Systems (e.g. SIRS)

• Personal Held Child Record (red book).

Additional references

Practitioners operating the PGD must be familiar with:

Department of Health (2006): Immunisation against Infectious Disease [Green Book]

https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book

Immunisation against Infectious Disease [Green Book] Rotavirus chapter 27b.

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(Hard copies of the Green Book should be destroyed as out of date).

Current edition of British National Formulary.

Marketing authorisation holder’s Summary of Product Characteristics.

All relevant Scottish Government Health Directorate advice including the relevant CMO letter(s).

NMC (2015) Code of Professional Conduct.

NMC (2010) Standards for Medicines Management

Authorising Body

Scottish Government Health Department Consultative Group

Fiona Browning Health Protection Nurse Specialist Eunice Chisholm Head of Nursing Aberdeenshire CHP

Linda Harper Associate Director of Practice Nursing/Lead Nurse G-Med Caroline Hind Deputy Director of Pharmacy and Medicines Management Diana Webster Consultant in Public Health Medicine

Alison Work Public Health Nursing Team Leader & Immunisation Co-ordinator Hilary Young Service Manager, Lead Health Visitor Aberdeen city CHP

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Appendix 1 Health Care Professional Agreement To Administer Medicines Under Patient

Group Direction

I: (Insert name)

Working within: e.g. CHP, Practice

Agree to administer medicines under the direction contained within the following Patient Group Direction

Patient Group Direction for the administration of rotavirus vaccine

Rotarix

®

by Nurses, Midwives and Health Visitors working within

NHS Grampian

I have completed the appropriate training to my professional standards enabling me to administer medicines under the above Patient Group Direction. I agree not to act beyond my professional competence nor outwith the recommendations of the Patient Group Direction.

Signed:

Print Name: Date:

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Appendix 2

Certificate Of Authorisation To Administer Medicines Under Patient Group Direction

This authorises:

Working within: e.g. CHP, Practice

To administer medicines under the following Patient Group Direction

Patient Group Direction for the administration of rotavirus vaccine

Rotarix

®

by Nurses, Midwives and Health Visitors working within

NHS Grampian

The above named person has satisfied the training requirements and is competent to administer medicines under the above Patient Group Direction. The above named person has agreed not to act beyond their professional competence nor outwith the recommendations of the Patient Group Direction

Signed: Authorising Manager/Doctor

Print Name: Date:

References

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