Microsoft word - levonorgestrel pgd august 12 final
East Riding of Yorkshire and Hull Primary Care Trusts PATIENT GROUP DIRECTION (PGD) FOR Levonorgestrel (Levonelle 1500) Clinical Condition Indication
Emergency contraception for females who meet Fraser Guidelines
Inclusion criteria
• Female patient who has had unprotected sexual intercourse or
a failure of a contraceptive method within the last 72 hours
Exclusion criteria
• Hypersensitivity to levonorgestrel or any of the excipients
• Severe hepatic dysfunction • Porphyria
• Unprotected sex more than 72 hours previously since last
normal period (regardless of earlier use of levonorgestrel).
• Patients taking liver enzyme inducing drugs (carbamazepine,
eslocarbazipine, griseofulvin, modafinil, nelfinavir, nevirapine,oxcarbazepine, phenytoin, phenobarbital, primidone, ritonavir, St John’s Wort, topiramate, rifamycins)
Action if patient is
Urgent referral to one of the following services GP, Out of hours GP
excluded
service (if appropriate) or Family Planning Clinic with a completed ‘excluded client options form’
• Inform patient of reason for exclusion
• Document in patient’s clinical notes
• Refer for medical advice if appropriate
Action if patient declines
• Advise patient of possible consequences to care
• Document in patient’s clinical notes
• Refer for medical advice if appropriate
Review date: 01/07/2012 Ref: Levonorgestrel PGD August 12 Expiry date: 31/08/2014
East Riding of Yorkshire and Hull Primary Care Trusts PATIENT GROUP DIRECTION (PGD) FOR Levonorgestrel (Levonelle 1500) Drug Details Name, form & strength of medicine
Route/Method
One tablet to be taken as soon as possible after unprotected intercourse, (up to 72 hours afterwards). However clients must first be informed regarding the availability of (1) The emergency Copper IUD) and (2) Ulipristal tablets from their GP/FP clinic And the superior efficacy of the copper IUD compared to other methods of emergency contraception. Frequency Duration of treatment Maximum or minimum
Single dose (see note below re. additional dose if vomiting occurs)
treatment period Quantity to supply/administer
NB. One additional tablet can be supplied if vomiting occurs within 2
Side effects Advice to patient/carer
• Refer to current BNF and SPC
• Possible side-effects (menstrual irregularities, nausea, low
abdominal pain, fatigue, headache, dizziness, breast
• Failure rate in relation to timing of dose and in relation to
• What to do if vomiting occurs within 2 hours
• Effects on timing of next period and action necessary if next
period is unusually light, heavy, brief or is absent
• Risk of sexually transmitted diseases after unprotected sex
• Need to perform a pregnancy test 3 weeks later if
menstruation lighter/ different from normal or has not occurred
• Severe malabsorption syndromes may affect absorption (i.e.
crohn’s disease, short bowel syndrome)
• Breastfeeding: lactation not affected. Levonorgestrel is
Review date: 01/07/2012 Ref: Levonorgestrel PGD August 12 Expiry date: 31/08/2014
East Riding of Yorkshire and Hull Primary Care Trusts PATIENT GROUP DIRECTION (PGD) FOR Levonorgestrel (Levonelle 1500) Referral Arrangements and Audit Trail Referral arrangements Records/audit trail The following should be recorded in the patient’s clinical notes. • Patient’s name, address, date of birth and consent given
• Batch number and Expiry Date • Any advice or warnings given to the patient
• Any adverse drug reactions occurring after administration
• Referral arrangements made (including self care)
• Name and signature of health professional administering drug
• Completion of Gillick competence were appropriate
Staff Characteristics Professional
• The Appropriately Registered Health Professional will ensure they
Responsibility
have the relevant training and are competent in all aspects of
care. They will attend training updates as requested and maintain their own CPD in this area.
• The Appropriately Registered Health Professionals will have due
regard for their Code of Conduct/Ethics, Scope of Professional Practice and Standards for administration
Continuing training &
The practitioner should be aware of any change to the
education
recommendations for the medicine listed. It is the responsibility of the individual to keep up-to-date with continued professional development and to work within the limitations of individual scope of practice.
References:
• HSC 2000/026 Patient Group Directions
• Emergency Hormonal Contraception Information Booklet; CPPE. (HMSO 2005)
• Summary of Product Characteristics – Levonelle 1500 ™
• Faculty of Family Planning and Reproductive Healthcare Clinical Effectiveness Unit
• “Emergency Contraception” (June 2003)
• “Contraceptive Choices for Women with Inflammatory Bowel Disease” (July 2003)
• Faculty of sexual and reproductive healthcare clinical guidance:
contraception Clinical Effectivness unit (August 2011).”
Review date: 01/07/2012 Ref: Levonorgestrel PGD August 12 Expiry date: 31/08/2014
East Riding of Yorkshire and Hull Primary Care Trusts PATIENT GROUP DIRECTION (PGD) FOR Levonorgestrel (Levonelle 1500)
Review date: 01/07/2012 Ref: Levonorgestrel PGD August 12 Expiry date: 31/08/2014
East Riding of Yorkshire and Hull Primary Care Trusts PATIENT GROUP DIRECTION (PGD) FOR Levonorgestrel (Levonelle 1500)
This patient group direction must be agreed to and signed by all health care professionals involved in its use. The NHS Trust should hold the original signed copy. The PGD must be easily accessible in the clinical setting
Organisations NHS East Riding of Yorkshire The Maltings Health House Silvester Square Grange Park Lane Silvester Street Willerby Authorisation Lead Doctor
Name: Position: Medical Director Signature: Date:
Lead Nurse
Name: Position: Lead Nurse Signature: Date:
Lead Pharmacist
Name: Position: Chief Pharmacist Signature: Date:
GP Authorisation (for GP Practice Use Only)
Review date: 01/07/2012 Ref: Levonorgestrel PGD August 12 Expiry date: 31/08/2014
East Riding of Yorkshire and Hull Primary Care Trusts PATIENT GROUP DIRECTION (PGD) FOR Levonorgestrel (Levonelle 1500) Individual Authorisation
PGDs DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY.
It is the responsibility of each professional to practice only within the bounds of their own competence and in accordance with their own Code of Professional Conduct.
Note to Authorising Managers: authorised staff should be provided with an individual copy of the clinical content of the PGD and a photocopy of the document showing their authorisation. I have read and understood the Patient Group Direction and agree to supply/administer this medicine only in accordance with this PGD.
Name of Professional Signature Authorising Manager
Review date: 01/07/2012 Ref: Levonorgestrel PGD August 12 Expiry date: 31/08/2014
REF: 2001810 P E D I M E N T O NUM. PEDIMENTO: 12 17 3696 2001810 T.OPER: EXP CVE PEDIMENTO: V1 REGIMEN: EXD CERTIFICACIONES DESTINO: 7 TIPO CAMBIO: 12.78400 PESO BRUTO: 55120.550 ADUANA E/S: 170 MEDIOS DE TRANSPORTE VALOR DOLARES: ENTRADA/SALIDA: ARRIBO: SALIDA: VALOR ADUANA: PRECIO PAGADO/VALOR COMERCIAL: DATOS DEL IMPORTADOR/EXPORTADOR RFC:
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