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Lead Author:
Consultant in Sexual and Reproductive Health
Consultation Group:
See relevant page in the PGD
Approver:
NHSG Medicines Guidelines and Policies Group
Signature:
Signature:
StLitiktet-7
NHS Grampian
Patient Group Direction For The Supply Of Combined Hormonal Contraceptive Pill or Transdermal Patch By Nurses And Midwives
Working Within NHS Grampian
Identifier:
NHSG/PGD/CHC_PillPatch /MGPG913
Review Date:
September 2020
Date Approved:
September 2018
Expiry Date:
September 2021
NHS Grampian have authorised this Patient Group Direction to help individuals by providing them with more convenient access to an efficient and clearly defined service within the NHS Board. This Patient Group Direction cannot be used until
Appendix 1 and 2 are completed.
Uncontrolled when printed
Version 3.1 (Amended March 2019)
Patient Group Direction For Use Within NHS Grampian
UNCONTROLLED WHEN PRINTED Review Date: September 2020 Identifier: NHSG/PGD/CHC_PillPatch/MGPG913 - i - PGD for the Supply of Combined Hormonal Contraceptives – Pill or Transdermal patch by nurses or Midwives - Version 3.1 Template Version 3
Revision History: Date of change
Approval date of PGD that is being superseded
Summary of Changes
Section heading
April 2017 January 2013 2 yearly update to new PGD template. July 2017 January 2013 Updated medical exclusions as UKMEC
2016. Updated medicine interactions as FSRH.
Exclusion
July 2017 January 2013 Specified use with breastfeeding. Precautions July 2017 January 2013 Rewritten storage requirements. Storage July 2017 January 2013 Section re-written to suit template. Adverse
reactions September 2017
January 2013 Transferred to new PGD template Version 2.1.
September 2017
January 2013 FSRH added. Definition of situation/ condition
September 2017
January 2013 Inclusion criteria wording amended to be consistent with previously approved SRH PGDs.
Inclusion criteria
September 2017
January 2013 UKMEC written out in full before use of abbreviation.
Inclusion criteria
September 2017
January 2013 Checklist for CHC described as a consultation checklist.
Inclusion criteria
September 2017
January 2013 Wording regarding UKMEC category 3 and 4 added to be consistent with previously approved SRH PGDs.
Exclusion Criteria
September 2017
January 2013 Exclusion age range amended to reflect wording used on previously approved SRH PGDs.
Exclusion Criteria
September 2017
January 2013 The following were added as exclusions in-line with the SmPCs; delivery of a baby in the last 6 weeks, acute porphyria, valvular and congenital heart disease.
Exclusion Criteria
September 2017
January 2013 BMI range, BP range and age range amended under bullet point 8.
Exclusion Criteria
September 2017
January 2013 Bullet regarding history of migraine expanded.
Exclusion Criteria
September 2017
January 2013 Information regarding the FSRH support for CHC use in breastfeeding added.
Precautions and special warnings
September 2017
January 2013 Combined Hormonal Contraception added along with generic preparations for CHC.
Name form and strength of medicine
Patient Group Direction For Use Within NHS Grampian
UNCONTROLLED WHEN PRINTED Review Date: September 2020 Identifier: NHSG/PGD/CHC_PillPatch/MGPG913 - ii - PGD for the Supply of Combined Hormonal Contraceptives – Pill or Transdermal patch by nurses or Midwives - Version 3.1 Template Version 3
September 2017
January 2013 Risk of VTE advice added. Advice (verbal)
March 2018
January 2013 Statement added regarding first line choice.
Form/Strength
March 2018
January 2013 New contraindication for products containing ombitasvir/paritaprevir/ritonavir and dasabuvir.
Exclusion criteria
June 2018 January 2013 Concurrent medications/drug interactions section removed from PGD.
June 2018 January 2013 Statement added regarding use of CHC with other contraindicated medicines.
Exclusion criteria
August 2018
January 2013 Updated to new PGD template version 3.
August 2018
January 2013 Statement added regarding the unlicensed (off label) use(s) of CHCs.
Legal Status
February 2019
September 2018
Extended use regimes as FSRH CEU guidance January 2019 added.
Route/Method of administration
February 2019
September 2018
Terms patient/patient’s replaced with woman/women.
Throughout
February 2019
September 2018
Term drug replaced with medicine. Throughout
March 2019
September 2018
Cilique added to reference table as previously omitted.
References
NHS Grampian Identifier: NHSG/PGD/CHC_PillPatch/MGPG913, Version 3.1 Replaces: NHSG/PGD/CHC_PillPatch/MGPG913, Version 3 Keyword(s): PGD Patient Group Direction combined hormonal
contraception CHC transdermal patch pill Policy Statement: It is the responsibility of individual Nurse or Midwife and 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 individual, 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. The lead author is responsible for the review of this PGD and for ensuring the PGD is updated in line with any changes in clinical practice, relevant guidelines, or new research evidence. Review date: The review date for a PGD needs to be decided on a case-by-case basis in the interest of safety. The expiry date should not be more than 3 years from the date the PGD was authorised. Document: Drafted: April 2017 Completed: August 2018 Approved: September 2018 (published – November 2018) Amended: March 2019
Patient Group Direction For Use Within NHS Grampian
Organisational Authorisation
This PGD is not legally valid until it has had organisational authorisation.
POD Developed/Reviewed b '
Medical Practitioner Name: Dr Linda Sandilands
Health Board: NHSG
Title: Speciality Doctor in Sexual and Reproductive Health
Contact email: linda.sandiland hs.net _
Signature
Senior representative of the professional group who will provide care under the direction.
Name: Amanda Mackie
Health Board: NHSG
Title: Sexual and Reproductive Health (SRH) Specialist Nurse
Contact email: amanda.mackienhs.net
Signature CL.1.4.clect--sn
Lead Author (if different from above) Name: Dr Sarah Wallage
Health Board: NHSG
Title : Consultant in sexual and reproductive health
Contact email: sarah.wallageamhs.net
Signature L*11.)9(jte,-7 1
Pharmacist Name: Fiona Doney
Health Board: NFISG
Title: Development Pharmacist Medicines Management
Contact email:, 'ona.ditienhs.net
Signaturel atir "vispm.- a. .
Authorised on Behalf of
Subgroup
,
Chair Name Signature Date Signed
NHS Grampian Medicines Guidelines and Policies Group
Lesley Thomson November 2018 4 ,10 en.
---
UNCONTROLLED WHEN PRINTED Review Date: September 2020 Identifier: NHSG/PGD/CHC_PillP3tch/MGPG913 - iii - POD for the Supply of Combined Hormonal Contraceptives - Pill or Transdermal patch by nurses or Midwives - Version 3.1 Template Version 3
Patient Group Direction For Use Within NHS Grampian
UNCONTROLLED WHEN PRINTED Review Date: September 2020 Identifier: NHSG/PGD/CHC_PillPatch/MGPG913 - iv - PGD for the Supply of Combined Hormonal Contraceptives – Pill or Transdermal patch by nurses or Midwives - Version 3.1 Template Version 3
Management and Monitoring of Patient Group Direction PGD Consultative Group The consultative group is legally required to include a medical practitioner, a pharmacist and a representative of the professional group who will provide care under the direction
Frances Adamson Medicines Management Specialist Nurse Fiona Doney Pharmacist: Development Pharmacist Medicines
Management Amanda Mackie Senior Representative of Professional Group: Sexual and
Reproductive Health (SRH) Specialist Nurse Swanny Perrin Medicines Management Pharmacist Dawn Bruce Specialist Pharmacy Technician Formulary Team Dr Linda Sandilands Medical Professional: SRH Specialty Doctor Dr Sarah Wallage Lead Author: Consultant in Sexual and Reproductive Health
Patient Group Direction For Use Within NHS Grampian
UNCONTROLLED WHEN PRINTED Review Date: September 2020 Identifier: NHSG/PGD/CHC_PillPatch/MGPG913 - 1 - PGD for the Supply of Combined Hormonal Contraceptives – Pill or Transdermal patch by nurses or Midwives - Version 3.1 Template Version 3
Patient Group Direction For The Supply Of Combined Hormonal Contraceptive Pill or Transdermal Patch By Nurses And Midwives Working Within NHS Grampian Clinical indication to which this PGD applies Definition of situation/condition
This Patient Group Direction (PGD) will authorise Nurses and Midwives to supply the Combined Hormonal Contraceptive (CHC) pill or transdermal patch to women for contraception. A consultation checklist for CHC supply is available from the Sexual and Reproductive Health (SRH) clinic at the Health Village. This PGD should be used in conjunction with the recommendations in the current British National Formulary (BNF), the individual Summary of Product Characteristics (SmPC) and in the current Faculty of Sexual and Reproductive Healthcare (FSRH) guidelines.
Inclusion criteria Women from 13 years with established menstrual cycles up to and including 49 years of age. In general terms CHC pill or transdermal patch can be supplied under this PGD to women with conditions categorised as UK Medical Eligibility Criteria (UKMEC) 1 or 2. See http://www.fsrh.org/ for UK Medical Eligibility Criteria for Contraceptive Use (UKMEC).
Exclusion criteria This PGD is not suitable for women with conditions in UKMEC categories 3 and 4. See http://www.fsrh.org/ for UKMEC guidance. Under this PGD, the CHC pill or transdermal patch should not be supplied to females with the following characteristics: • known anaphylactic hypersensitivity to any of the excipients • pre-menarche or age less than 13 years • post menopausal or age 50 years and over • current pregnancy or suspected pregnancy • delivery of a baby in the last 6 weeks • pregnancy loss ≥12 weeks gestation in the previous 6
weeks • presence or history of arterial thrombosis • presence or history of venous thrombosis • predisposition to venous or arterial thrombosis such as:
o APC-resistance (including Factor V Leiden)
Patient Group Direction For Use Within NHS Grampian
UNCONTROLLED WHEN PRINTED Review Date: September 2020 Identifier: NHSG/PGD/CHC_PillPatch/MGPG913 - 2 - PGD for the Supply of Combined Hormonal Contraceptives – Pill or Transdermal patch by nurses or Midwives - Version 3.1 Template Version 3
o antithrombin-III-deficiency o protein C deficiency o protein S deficiency o Systemic Lupus Erythematosus o family history VTE <45 years old o BMI ≥35kg/m2 o smoker or vaped in last year and aged 35 years or
more o hypertension BP >140/90mmHg o dyslipidaemia o multiple lesser risks, e.g. BMI 31kg/m2 plus smoker
• immobility due to illness or disability. Trauma, orthopaedic, neurosurgery or any surgery lasting more than 30 minutes in the last 6 weeks or planned within next 4 weeks
• cerebrovascular disease – current stroke, history of stroke or prodromal condition (e.g. TIA)
• cardiac disease - cardiomyopathy or arrhythmia • history of migraine with focal neurological symptoms. If any
uncertainty regarding focal symptoms seek medical advice before supply
• diabetes mellitus with vascular, renal, retinal or neurological complications
• acute porphyria • pancreatitis or a history thereof if associated with severe
hypertriglyceridemia • presence or history of severe hepatic disease if liver
function values remain abnormal • active gallbladder disease • presence or history of liver tumours (benign or malignant) • personal history of breast cancer past or current • known carrier of BRCA gene • organ transplant • uninvestigated abnormal vaginal bleeding • currently taking any medications that are contraindicated
for use with CHC. For a full list of medicines - refer to the manufacturer’s SmPC and current BNF
• taken enzyme inducing medicines within the last 28 days • personal or family history of conditions which are of
unknown relevance to the nurse/midwife • where there are queries/anxieties that cannot be
answered/addressed by the Nurse or Midwife • transdermal CHC only - skin lesions affecting large areas
of the trunk or upper limbs • transdermal CHC weight >90kg regardless of BMI -
possible reduced contraceptive efficacy.
Patient Group Direction For Use Within NHS Grampian
UNCONTROLLED WHEN PRINTED Review Date: September 2020 Identifier: NHSG/PGD/CHC_PillPatch/MGPG913 - 3 - PGD for the Supply of Combined Hormonal Contraceptives – Pill or Transdermal patch by nurses or Midwives - Version 3.1 Template Version 3
Precautions and special warnings
CHC pill or transdermal patch can be used by breastfeeding women once feeding is established and the baby is 6 weeks old. The FSRH supports use of CHC by breastfeeding women as there is no evidence of any effect on lactation or infant growth or development. See FSRH Clinical Guidance Contraception After Pregnancy January 2017. CHC may affect the required dose of hypoglycaemic medicines. Increased monitoring may be needed while the method is established. Current NHSG child protection guidance must be followed if the woman is under 16 - see link below http://nhsgintranet.grampian.scot.nhs.uk/depts/ChildProtection/Pages/default.aspx
Action if excluded from treatment
Medical advice should be sought – refer to General Practitioner/Consultant (relevant medical practitioner). The reason why the woman was excluded under the PGD will be documented in the appropriate medical record.
Action if treatment is declined
The woman should be advised of the risks and consequences of not receiving treatment. Refer to General Practitioner/Consultant (relevant medical practitioner). Record outcome in Patient Medication Record if appropriate, or relevant medical record.
Description of treatment available under the PGD Name form and strength of medicine
Combined Hormonal Contraception (CHC) pill or transdermal patch available as; Cilique® or Cilest® Ethinylestradiol 35 micrograms, norgestimate 250 micrograms (pack size 3 x 21). Gedarel 20/150® Ethinylestradiol 20 micrograms, desogestrel 150 micrograms (pack size 3 x 21). Gedarel 30/150® Ethinylestradiol 30 micrograms, desogestrel 150 micrograms (pack size 3 x 21).
Patient Group Direction For Use Within NHS Grampian
UNCONTROLLED WHEN PRINTED Review Date: September 2020 Identifier: NHSG/PGD/CHC_PillPatch/MGPG913 - 4 - PGD for the Supply of Combined Hormonal Contraceptives – Pill or Transdermal patch by nurses or Midwives - Version 3.1 Template Version 3
Loestrin 20 ® Ethinylestradiol 20 micrograms, norethisterone acetate 1mg (pack size 3 x 21). Loestrin 30 ® Ethinylestradiol 30 micrograms, norethisterone acetate 1.5mg (pack size 3 x 21). Rigevidon® or Microgynon® Ethinylestradiol 30 micrograms, levonorgestrel 150 micrograms (pack size 3 x 21). Evra® Ethinylestradiol 33.9 microgram per 24 hour, norelgestromin 203 microgram per 24 hour (pack size 9 patches). This PGD is for the initial supply of; 1) CHC pill containing 30 micrograms ethinylestradiol and 150
micrograms levonorgestrel. Or 2) transdermal patch containing ethinylestradiol
33.9 microgram per 24 hour, norelgestromin 203 microgram per 24 hour.
Rigevidon® Ethinylestradiol 30 micrograms, levonorgestrel 150 micrograms (pack size 3 x 21) should be prescribed first line in conjunction with the current NHSG Formulary recommendations. N.B. The decision to supply either the CHC pill or the transdermal patch is dependent upon the woman’s personal preference after receiving information and counselling with a trained nurse/midwife. Repeat supply This PGD allows repeat supply of CHC pill or patch. An alternative CHC pill or the patch may be supplied if the woman has suffered side effects with a 30 microgram ethinylestradiol + 150 microgram levonorgestrel preparation.
Legal status
CHC is a Prescription-only Medicine (PoM). In accordance with the MHRA all medicines supplied under a PGD must either be from over-labelled stock, or be labelled appropriately in accordance with the regulatory body guidelines for the labelling of medicines for the professional providing the supply.
Patient Group Direction For Use Within NHS Grampian
UNCONTROLLED WHEN PRINTED Review Date: September 2020 Identifier: NHSG/PGD/CHC_PillPatch/MGPG913 - 5 - PGD for the Supply of Combined Hormonal Contraceptives – Pill or Transdermal patch by nurses or Midwives - Version 3.1 Template Version 3
This PGD includes unlicensed (off label) use(s) for many different types and brands of CHC listed above. It is not practical to list these individually within this PGD and Nurses or Midwives working to this PGD should ensure they are familiar with any unlicensed indications prior to supplying CHC.
Dosage/Maximum Total Dose
Oral Tablet One oral tablet should be taken daily for 21 days followed by a seven day pill free interval. The oral tablet has immediate efficacy if started in the first 5 days of the menstrual cycle. The oral tablet has immediate contraceptive efficacy if started within 5 days of a pregnancy loss under 12 weeks gestation. The oral tablet can be started at any time if it is reasonably certain that the woman is not pregnant. In this situation, the woman must use condoms or abstain for the first 7 days until there is contraceptive cover and a pregnancy test after 4 weeks is advised. Recommendations for switching from other contraceptive methods are detailed in the SmPC. Women supplied the oral tablet can be advised to have a shorter 4 day pill free interval or to take 63 pills without a break and then have a 4-7 day pill free interval, or to take pills continuously (at least 21 pills) and only have a 4 day pill free break after 4 days breakthrough bleeding. This constitutes an off-label use of oral CHC, but is supported by FSRH to help compliance and reduce symptoms associated with withdrawal bleeds if the woman prefers this. Women should be informed prior to the supply that this use is off-label. Patch One patch should be applied on the first day of the menstrual cycle to clean dry skin on the upper arms, thigh or trunk but avoiding the breasts. The patch should be removed after 7 days and a new patch applied immediately to a different area of skin. A patch should be applied on three consecutive weeks, i.e. day 1,8,15. The third patch is removed on day 22 followed by a 7-day patch free interval. It has immediate efficacy if started on day one of the menstrual cycle.
Patient Group Direction For Use Within NHS Grampian
UNCONTROLLED WHEN PRINTED Review Date: September 2020 Identifier: NHSG/PGD/CHC_PillPatch/MGPG913 - 6 - PGD for the Supply of Combined Hormonal Contraceptives – Pill or Transdermal patch by nurses or Midwives - Version 3.1 Template Version 3
The patch has immediate contraceptive efficacy if started within 5 days of a pregnancy loss that occurs before 12 weeks gestation. The combined contraceptive patch can be started at any time if it is reasonably certain that the woman is not pregnant. In this situation, the woman must use condoms or abstain for the first 7 days until there is contraceptive cover and a pregnancy test after 4 weeks is advised. Women supplied with the patch can be advised to have a shorter 4 day patch free interval or to use up to 9 consecutive patches without a break and then have a 4-7day patch free interval, or to change patches every 7 days and only have a 4-7 day patch free interval after 4 days breakthrough bleeding. This constitutes an off-label use of CHC patch, but is supported by FSRH to help compliance and reduce symptoms associated with withdrawal bleeds if the woman prefers this. Women should be informed prior to the supply that this use is off-label. Oral Tablets and Patch CHC cannot be supplied under this PGD until 6 weeks after a delivery at ≥12 weeks gestation or more because of the variable thromboembolism risks which depend on multiple obstetric factors.
Frequency of dose/Duration of treatment
Initial supply provides 3 months of treatment. For repeat supply the CHC can be supplied under PGD for as long as it is required and the woman meets the PGD inclusion criteria.
Maximum or minimum treatment period
CHC can be supplied under PGD for as long as it is required and the woman meets the PGD inclusion criteria.
Route/Method of administration
Oral tablet daily - see dosage above. Transdermal patch applied weekly to the skin of the upper arms, thigh or trunk but avoiding the breasts. See dosage above. Patch should be applied to clean, dry, hairless skin. Should not be applied on red, irritated or cut skin.
Quantity to be supplied and/or administered
Initial supply provides 3 months of treatment. Thereafter CHC can be supplied under this PGD for as long as it is required and the woman meets the PGD inclusion criteria.
Storage requirements
The CHC pill does not require any special temperature storage conditions.
Patient Group Direction For Use Within NHS Grampian
UNCONTROLLED WHEN PRINTED Review Date: September 2020 Identifier: NHSG/PGD/CHC_PillPatch/MGPG913 - 7 - PGD for the Supply of Combined Hormonal Contraceptives – Pill or Transdermal patch by nurses or Midwives - Version 3.1 Template Version 3
Do not refrigerate or freeze patches. Store the pill blister pack and patch sachets in the original packaging in order to protect from light and moisture.
Follow-up (if applicable)
For first prescription give 3 months supply. For repeat supply – See after the first 3 months of use and then annually. Update medical/drug/smoking history and check for contraindications to ongoing supply. Specifically enquire about migraines and bleeding pattern. Record blood pressure and BMI. Refer to doctor if any concerns. Give sufficient supply to maintain contraceptive cover if there will be a delay before the woman can see the doctor. Give 12 month supply if all well. Women are advised to contact the Nurse/Midwife at any time if they have concerns or questions. They will have written contact details for the Nurse/Midwife.
Advice (Verbal) Advice should be given on how to take the tablet or apply the patch as appropriate. Advice should be given on what to expect and what to do for major and minor reactions. The decision to prescribe CHC should take into consideration the individual woman's current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with combined hormonal contraceptives compares to other forms of contraception.
Advice (Written) The Patient Information Leaflet (PIL) contained in the medicine(s) should be made accessible to the woman, parent, guardian, or person with parental responsibility. Where this is unavailable, or unsuitable, sufficient information should be given in a language that they can understand. Copies of PIL and SmPCs for medicines can be found at http://www.medicines.org.uk or http://www.mhra.gov.uk/spc-pil/index.htm Information regarding the use of contraception should also be provided in writing.
Identifying and managing possible adverse reactions
Women receiving CHC, both the pill and transdermal patch need to be informed about possible side effects and action to take.
Patient Group Direction For Use Within NHS Grampian
UNCONTROLLED WHEN PRINTED Review Date: September 2020 Identifier: NHSG/PGD/CHC_PillPatch/MGPG913 - 8 - PGD for the Supply of Combined Hormonal Contraceptives – Pill or Transdermal patch by nurses or Midwives - Version 3.1 Template Version 3
Frequent minor side effects include breakthrough bleeding, nausea, breast tenderness, headache and mood change. These side effects may settle in 2 - 3 months and it is reasonable to continue the CHC during this time. Women may develop skin irritation at the site of transdermal patch application. If this is persistent and affects different areas of skin she needs to seek medical advice and may need to consider another method of contraception. There is no evidence for a causal association with weight gain. Serious side effects may occur that require medical attention. These include chest pain, breathlessness, haemoptysis, painful swollen leg, weakness or numbness of the face or a limb, unusual headaches/migraines that are new, worse or more frequent, sudden problems with speech or eyesight, jaundice, severe abdominal pain. Women should inform medical or dental staff that they are using CHC if they are starting a new medication or have planned or emergency hospital admission for any reason or if they have reduced mobility due to injury/illness. Epidemiological studies have demonstrated increased rates of breast and cervical cancer and reduced risks of endometrial and ovarian cancer in current and past users of oral CHC. There is no evidence on risks related to the transdermal patch but rates are expected to be similar to those for oral preparations. This list is not exhaustive. Please also refer to current BNF/BNFC and manufacturers SmPC for details of all potential adverse reactions. BNF/BNFC: https://www.bnf.org SmPC/PIL and risk minimisation materials: https://www.medicines.org.uk/emc/ http://www.mhra.gov.uk/spc-pil/index.htm https://www.medicines.org.uk/emc/rmm-directory If an adverse reaction does occur give immediate treatment and inform relevant medical practitioner as soon as possible. Report the reaction to the MHRA using the Yellow Card System. https://yellowcard.mhra.gov.uk/
Patient Group Direction For Use Within NHS Grampian
UNCONTROLLED WHEN PRINTED Review Date: September 2020 Identifier: NHSG/PGD/CHC_PillPatch/MGPG913 - 9 - PGD for the Supply of Combined Hormonal Contraceptives – Pill or Transdermal patch by nurses or Midwives - Version 3.1 Template Version 3
Facilities and supplies required
The following should be available at sites where the medication is to be supplied: • Appropriate storage facilities • An acceptable level of privacy to respect woman’s right to
confidentiality and safety • Access to medical support (this may be via the telephone) • Clean and tidy work areas, including access to hand
washing facilities • Copies of the current PGD for the medicine specified in the
PGD.
Characteristics of staff authorised to supply medicine under PGD
Professional qualifications
Registered Nurses and Midwives as recognised by the Nursing and Midwifery Council (NMC).
Specialist competencies
Approved by the organisation as: • Competent to assess the woman’s capacity to understand
the nature and purpose of the supply in order for them to give or refuse consent
• Having undertaken appropriate training to carry out clinical assessment of women leading to a diagnosis that requires treatment according to the indications listed in the PGD
• Aware of current treatment recommendations and be competent to discuss issues about the medicine with the woman.
Ongoing training and competency
All professionals working under this PGD must: • Maintain their skills, knowledge and their own professional
level of competence in this area according to their Code of Professional Conduct
• Must be familiar with the SmPC for all medicines supplied in accordance with this PGD
Professional managers/Lead Nurses will be responsible for:
Ensuring that the current PGD is available to staff providing care under this direction. Ensuring that staff have received adequate training in all areas relevant to this PGD and meet the requirements above. Maintain up to date record of all staff authorised to supply the medicine specified in PGD.
Patient Group Direction For Use Within NHS Grampian
UNCONTROLLED WHEN PRINTED Review Date: September 2020 Identifier: NHSG/PGD/CHC_PillPatch/MGPG913 - 10 - PGD for the Supply of Combined Hormonal Contraceptives – Pill or Transdermal patch by nurses or Midwives - Version 3.1 Template Version 3
Documentation Authorisation of supply
Nurses and Midwives working within NHS Grampian can be authorised to supply the medicine specified in this PGD by their Nurse or Midwifery Manager/Consultant/practice GPs. All authorised staff are required to read the PGD and sign the Agreement to Supply Medicines Under PGD (Appendix 1). This should be held in the individual practitioners records, or as agreed locally. A Certificate of Authorisation (Appendix 2) signed by the authorising doctor/manager and staff working to the PGD, should be held as agreed locally.
Record of supply An electronic or paper record for recording the screening of women and the subsequent supply of the medicine specified in this PGD must be completed in order to allow audit of practice. This should include as a minimum: • Date and time of supply • Woman’s name and CHI • Details of parent/guardian, or person with parental
responsibility where applicable • Exclusion criteria, record why the medicine was not
supplied • Consent to the administration (if not obtained elsewhere) • Signature and name in capital letters of practitioner who
supplied the medicine • Record of any adverse effects (advise woman’s doctor).
Audit All records of the medicine(s) specified in this PGD will be filed with the normal records of medicines in each practice/service. A designated person within each H&SCP/practice/service will be responsible for auditing completion of drug forms and collation of data.
References
Electronic Medicines Compendium http://www.medicines.org.uk Brand name Content SPC version
Rigevidon®
Consilient (pack size 3 x 21)
Ethinylestradiol 30 micrograms, levonorgestrel 150 micrograms
04/12/17
Patient Group Direction For Use Within NHS Grampian
UNCONTROLLED WHEN PRINTED Review Date: September 2020 Identifier: NHSG/PGD/CHC_PillPatch/MGPG913 - 11 - PGD for the Supply of Combined Hormonal Contraceptives – Pill or Transdermal patch by nurses or Midwives - Version 3.1 Template Version 3
Microgynon 30®
Bayer (pack size 3 x 21)
Ethinylestradiol 30 micrograms, levonorgestrel 150 micrograms
06/07/2015
Ovranette® Pfizer
(pack size 3 x 21)
Ethinylestradiol 30 micrograms, levonorgestrel 150 micrograms
16/03/2017
Cilest® Janssen-Cilag (pack size 3 x 21)
Ethinylestradiol 35 micrograms, norgestimate 250 micrograms
30/01/2018
Cilique®
Consilient (pack size 3 x 21)
Ethinylestradiol 35 micrograms, norgestimate 250 micrograms
12/03/2019
Gedarel® 20/150 Consilient (pack size 3 x 21)
Ethinylestradiol 20 micrograms, desogestrel 150 micrograms
29/09/2017
Gedarel® 30/150 Consilient (pack size 3 x 21)
Ethinylestradiol 30 micrograms, desogestrel 150 micrograms)
02/10/2017
Loestrin 20® Galen (pack size 3 x 21)
Ethinylestradiol 20 micrograms, norethisterone acetate 1mg
29/01/2018
Loestrin 30 ® Galen (pack size 3 x 21)
Ethinylestradiol 30 micrograms, norethisterone acetate 1.5mg
29/01/2018
Evra® patches Janssen Cilag (pack size x 9 patches)
Daily dose norelgestromin 203 micrograms, ethinylestradiol 33.9 micrograms.
30/06/2017
British National Formulary and British National Formulary for Children https://www.bnf.org accessed 12/03/19.
Patient Group Direction For Use Within NHS Grampian
UNCONTROLLED WHEN PRINTED Review Date: September 2020 Identifier: NHSG/PGD/CHC_PillPatch/MGPG913 - 12 - PGD for the Supply of Combined Hormonal Contraceptives – Pill or Transdermal patch by nurses or Midwives - Version 3.1 Template Version 3
FSRH Drug Interactions with Hormonal Contraception January 2017 http://www.fsrh.org FSRH UKMEC Guidance 2016 http://www.fsrh.org FSRH Contraception After Pregnancy 2017 http://www.fsrh.org
UNCONTROLLED WHEN PRINTED Review Date: September 2020 Identifier: NHSG/PGD/CHC_PillPatch/MGPG913 - 13 - PGD for the Supply of Combined Hormonal Contraceptives – Pill or Transdermal patch by nurses or Midwives - Version 3.1 Template Version 3
Appendix 1
Healthcare Professional Agreement to Supply Medicines Under Patient Group
Direction I:
(Insert name)
Working within:
e.g. H&SCP, Practice
Agree to supply medicines under the direction contained within the following Patient Group Direction
Patient Group Direction For The Supply Of Combined Hormonal Contraceptive Pill or Transdermal Patch- By Nurses And Midwives
Working Within NHS Grampian I have completed the appropriate training to my professional standards enabling me to supply medicines under the above Patient Group Direction. I agree not to act beyond my professional competence nor out with the recommendations of the Patient Group Direction. Signed:
Print Name:
Date:
Professional Registration No:
UNCONTROLLED WHEN PRINTED Review Date: September 2020 Identifier: NHSG/PGD/CHC_PillPatch/MGPG913 - 14 - PGD for the Supply of Combined Hormonal Contraceptives – Pill or Transdermal patch by nurses or Midwives - Version 3.1 Template Version 3
Appendix 2
Healthcare Professionals Authorisation to Supply Medicines Under Patient Group Direction
The lead nurse/professional of each clinical area is responsible for maintaining records of their clinical area where this PGD is in use, and to whom it has been disseminated. The manager who approves a healthcare professional to supply medicines under the patient group direction, is responsible for ensuring that he or she is competent, qualified and trained to do so and for maintaining an up-to-date record of such approved persons in conjunction with the Head of Profession. The healthcare professional who is approved to supply medicines under the direction is responsible for ensuring that he or she understands and is qualified, trained and competent to undertake the duties required. The approved person is also responsible for ensuring that supply is carried out within the terms of the direction, and according to his or her code of professional practice and conduct.
Patient Group Direction For The Supply Of Combined Hormonal Contraceptive Pill or Transdermal Patch- By Nurses And Midwives
Working Within NHS Grampian Local clinical area(s) where these healthcare professionals will operate under this PGD: Name of Healthcare Professional
Signature
Date
Name of Manager
Signature
Date
UNCONTROLLED WHEN PRINTED Review Date: September 2020 Identifier: NHSG/PGD/CHC_PillPatch/MGPG913 - 15 - PGD for the Supply of Combined Hormonal Contraceptives – Pill or Transdermal patch by nurses or Midwives - Version 3.1 Template Version 3
Patient Group Direction For The Supply Of Combined Hormonal Contraceptive Pill or Transdermal Patch- By Nurses And Midwives
Working Within NHS Grampian Name of Healthcare Professional
Signature
Date
Name of Manager
Signature
Date