Supply Norethisterone 5mg without prescription
This page describes our Period Delay PGD for Pharmacists. Follow the links to proceed to register, train, make payment and use the PGD.
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Features of the Patient Group Direction
- Allows pharmacists to supply norethisterone 5mg tablets without a prescription for women who wish to delay the onset of their menstruation (a period).
- Delay the onset of a period by 16 days (60 tablets).
- Women can self-refer for period delay treatment.
- Pharmacies set their own fee for the service.
PGD training documents
- About Period Delay PGD
- Patient Information Leaflet
- Patient Assessment Form
- Instructions for Pharmacists (SOP)
NOTE: It is an offence and invalidates pharmacy insurance to use PGDs without valid rights.
Once Pharmacists have passed an online assessment of learning questionnaire they can use the PGD straightaway for 12 months, providing payment is up-to-date.
What are consequences of unauthorised PGD use?
How to train and pay to use the PGD
You must register to access the full training documents of the Period Delay (Norethisterone) PGD and complete an online assessment. After successfully completing their online assessment Pharmacists can use the PGDs for a year, providing their payment is up-to-date. Payment can be made online, or by BACS or cheque. Rights to use the PGD must be renewed each year by repeating the online assessment and keeping payment up-to-date. Reminder emails are sent.
Purpose of the PGD
The Period Delay PGD allows Pharmacist to supply norethisterone 5mg tablets to women who wish to delay their periods for up to 16 days (up to 60 norethisterone 5mg tablets) for reasons such as a holiday or participation in a sporting event or for other reasons.
The PGD service is for women who choose to delay their periods and who self-refer. This is a private service. Approval from a trust or commissioning body is not required. Patients make a payment for the service set by pharmacies. A recommendation or prescription from a doctor is not required.
The PGD permits the supply of either generic or branded forms of norethisterone 5mg tablets.
How the PGD is applied
Women who are considering taking norethisterone to delay their periods must first be informed how the treatment works, how to use it and what to expect from treatment. Women must be given a Patient Information Leaflet – Period Delay Tablets. The leaflet outlines important information about delaying periods.
Women provide the information about themselves needed to assess their suitability for period delay treatment by completing a Patient Assessment Form – Period Delay. The assessment form takes a few minutes to complete. Pharmacists may sometimes need to assist women to complete their forms. Completed forms are retained by pharmacies for 8 years as a medical record of the PGD.
There is a quick guide, Instructions for Pharmacists – Period Delay PGD. This guide provides brief prompts to Pharmacists to assist them to apply the PGD and to decide, based on the answers on the assessment form, whether women are eligible for a course of Norethisterone for period delay.
The lining of the womb (endometrium) thickens during the first half of the menstrual cycle (the follicular or proliferative phase). This is followed in the second half of the menstrual cycle (the luteal phase) by a phase in which the thickened lining of the womb is maintained under the influence of the hormone progesterone. At the end of the luteal phase levels of progesterone fall naturally and the lining of the womb is shed in a period (menstruation). The whole cycle takes about 28 days from start to end.
If progesterone type drugs (norethisterone) are administered in high enough amounts continuously in the second half of the menstrual cycle, starting at least 4 days before menstruation, the lining of the womb will not be shed until these drugs are stopped. Women who have taken norethisterone at a dose of 5mg three times daily will not experience a period bleed until they stop taking it.
Some women who are troubled by heavy or irregular or painful periods may be taking norethisterone on a regular or semi-regular basis for control of periods. Women already prescribed norethisterone are not eligible for a supply by PGD for period control.
Oral contraceptive pills, both the standard combined oral contraceptive pills and progesterone only mini-pills, contain hormones with progesterone-like activity. Women taking any form of regular oral contraception or depot or injectable contraception are not eligible for norethisterone by PGD. Information for women who are using hormonal contraception and wish to delay their period can be found at period delay pages NHS Choices website.
Women should be aware norethisterone taken to delay periods is not a form of contraception. This advice is given in the Patient Information Leaflet – Period Delay Tablets supplied to women before they complete their assessment forms.
Dose and Repeats
Women who wish to delay their periods start norethisterone tablets 5mg three times daily, starting 4–5 days before the expected first day of their period, and continue for up to 16 days. Norethisterone is stopped after the desired days of period delay. Period bleeding normall starts a day or few days later.
Norethisterone supply by PGD for period delay is limited to 60 tablets which is a sufficient number of tablets to delay a period for up to 16 days. Doctors sometimes prescribe norethisterone for longer periods and even in some circumstances on a continuous basis. The restriction to a maximum of 60 norethisterone 5mg tablets is put in place by the authors of the PGD. Women seeking longer period delay should consult and doctor.
Norethisterone for period delay is widely prescribed by doctors, usually without significant adverse effects; however, norethisterone supply by PGD for period delay is restricted to one course of treatment (maximum of 60 tablets per course) in any 6 month period. Women who wish to delay their period more frequently (more than once every 6 months) should consult a doctor.
Pharmacists using the Period Delay PGD should be familiar with the ‘Summary of Product Characteristics’ of at least one brand of norethisterone 5mg, e.g. SPC of Utovlan and a manufacturer's ‘Patient Information Leaflet’, e.g. PIL of Utovlan.
Most questions women will have about taking norethisterone will be answered in the manufacturer's PIL. Women are required as part of their assessment to agree to read the PIL supplied with their tablets.
Contraindications to the use of norethisterone for period delay are checked for as part of the PGD assessment process. There is a ‘quick guide’, Instruction for Pharmacists – Period Delay PGD, which provides prompts to Pharmacist whilst the PGD is administered.
In addition to an SPC and PIL, Pharmacists supplying norethisterone by PGD should be aware of the following guidance of the BNF (British National Formulary) – copied below (Aug 2012).
- Progestogens should be used with caution in conditions that may worsen with fluid retention e.g. epilepsy, hypertension, migraine, asthma, or cardiac dysfunction, and in those susceptible to thromboembolism (particular caution with high dose). Care is also required in those with a history of depression. Progestogens can decrease glucose tolerance and patients with diabetes should be monitored closely.
- Side-effects of progestogens include menstrual disturbances, premenstrual-like syndrome (including bloating, fluid retention, breast tenderness), weight change, nausea, headache, dizziness, insomnia, drowsiness, depression, change in libido; also skin reactions (including urticaria, pruritus, rash, and acne), hirsutism and alopecia. Jaundice and anaphylactoid reactions have also been reported.
Advice to Patients
The following information taken from the PIL of Utovlan (a branded formulation of norethisterone) is included as part of the Patient Information Leaflet – Period Delay Tablets supplied to women before they complete their assessment form:
Reasons for stopping norethisterone treatment immediately
Very rarely, norethisterone may cause a severe allergic reaction which can be life-threatening in some cases and requires emergency medical attention. You can get some or all of the following symptoms:
- difficulty breathing
- feeling faint
- swelling of the face or tongue
- swelling of the hands and feet
- intense itchy skin rash
Risk of Venous Thromboembolism (VTE)
All women have a small chance of having a blood clot in the veins of the leg, in the lung or other part of the body. The chances of getting a clot are very slightly higher if you are taking a hormone medicine like norethisterone. You are more likely to get a clot whether or not you are taking norethisterone if you:
- are very overweight
- have had a blood clot in the veins or lungs before
- have relatives who have had blood clots
- are unable to move for long periods of time (for example after an operation)
- have a serious injury or have major surgery
- have a history of repeated miscarriage
Restrictions to PGD use
- ONLY patients in person can complete and sign PGD patient assessment forms, NOT representatives.
- ONLY patients in person can be supplied with medication, NOT representatives.
- ONLY Pharmacists with PGD rights can supply medication and sign for its supply, NOT delegates.
- GPhC regulations and pharmacy insurance require Pharmacists to use only valid PGDs. Regular training, update and audit are required for our PGDs to be valid.
Completed assessment forms are a record of the PGD and of the supply of norethisterone. Completed forms should be retained for 8 years.
Women are not required to provide the contact details of their doctor. Where women choose to provide details, and women agree, a copy of the completed assessment form should be faxed or posted to surgeries within three months.
See NHS Choices norethisterone (patient directed information).
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