Download Teriparatide - North East Essex CCG

Shared Care Guidance
Teriparatide for the treatment of Osteoporosis
This shared care agreement outlines the way in which the responsibilities for managing the prescribing of
teriparatide 20 micrograms/80 microlitres solution for the treatment of osteoporosis can be shared between the
Secondary Care Specialist and the General Practitioner.
Indication:
Although teriparatide 20 micrograms/80 microlitres solution (Forsteo®) is also licensed for other indications, it is
only approved for use within North East Essex in postmenopausal women who:


have a contraindication to, or are intolerant of, bisphosphonates; or have an unsatisfactory response to
them, and
who are 65 years or older and have a T-score of –4.0 SD or below, or a T-score of –3.5 SD or below plus
more than two fractures, or who are aged 55–64 years and have a T-score of –4 SD or below plus more
than two fractures.
Dose & Administration:
The recommended dose of teriparatide is 20 micrograms administered once daily, via the pre-filled pen device.
The maximum total duration of treatment with teriparatide should be 24 months; the 24-month course of teriparatide
should not be repeated over a patient's lifetime.
Adverse Effects:
The most commonly reported adverse reactions in patients treated with teriparatide are nausea, pain in limb,
headache and dizziness. A full list of adverse reactions associated with teriparatide can be accessed via the
manufacturer’s SPC.
Contraindication:
Contraindications:
 Hypersensitivity to the active substance or to any of the product excipients
 Pregnancy and breast-feeding
 Pre-existing hypercalcaemia
 Severe renal impairment
 Metabolic bone diseases (including hyperparathyroidism and Paget's disease of the bone) other than
primary osteoporosis or glucocorticoid-induced osteoporosis
 Unexplained elevations of alkaline phosphatase
 Prior external beam or implant radiation therapy to the skeleton
 Patients with skeletal malignancies or bone metastases should be excluded from treatment with
teriparatide
Special warnings/precautions:
 In normocalcaemic patients, slight and transient elevations of serum calcium concentrations have been
observed following teriparatide injection. Serum calcium concentrations reach a maximum between 4 and 6
hours and return to baseline by 16 to 24 hours after each dose of teriparatide. Therefore, if blood samples
for serum calcium measurements are taken, this should be done at least 16 hours after the most recent
teriparatide injection. Routine calcium monitoring during therapy is not required.
 In short-term clinical studies with teriparatide, isolated episodes of transient orthostatic hypotension were
observed. Typically, an event began within 4 hours of dosing and spontaneously resolved within a few
Version: 1
Author: Paul Mills (Principal Pharmacist-CHUFT)
Reviewed by: Dr Paul Byrne (Consultant Rheumatologist) and Sheila Baldwin (Head of Medicines Management, NHS North
East Essex Clinical Commissioning Group)
Approved by: NEEMMC Jan 2015
Next review date: Jan 2017


minutes to a few hours. When transient orthostatic hypotension occurred, it happened within the first
several doses, was relieved by placing subjects in a reclining position, and did not preclude continued
treatment.
Teriparatide should be used with caution in patients with active or recent urolithiasis because of the
potential to exacerbate this condition.
Caution should be exercised in patients with moderate renal impairment
Cautions & Drug Interactions:
There are no known clinically significant drug interactions associated with teriparatide therapy. The manufacturer
does advise caution when giving concomitantly with digoxin therapy but this is a theoretical risk associated with
possible transient changes to calcium levels.
Monitoring Requirements:
The SPC does not identify any specific monitoring requirements for this drug.
Parameters for Intervention:
There are no specific parameters for intervention in terms of blood tests, therapeutic monitoring, etc. Any possible
teriparatide-related adverse effects must be reported back to the Secondary Care Specialist who will then make a
decision as to the clinical appropriateness of continuing therapy.
Shared Care Responsibilities:
Secondary Care Specialist
1. Initiation of teriparatide therapy and provide the patient with one months supply.
2. Discuss the benefits and side effects of treatment with the patient. Ensure the patient is aware that
clinical trials have not demonstrated a significant reduction in the incidence of hip fractures.
3. Provide (in conjunction with pharmacy colleagues at the point of dispensing) injection technique
training to patients about the safe usage of the teriparatide pre-filled pen device, including advice about
the appropriate disposal of sharps and used pens. Ensure that the patient is able to self inject safely.
4. Ensure appropriate patient supplementation with calcium and vitamin D therapy.
5. Send a letter to the GP with the Shared Care Guidelines requesting shared care for the patient.
6. Include in the letter, the last date of prescription supply and a reminder to prescribe supplemental
calcium and vitamin D supplements if dietary intake is inadequate.
7. Ensure cessation of teriparatide therapy after 24 months of treatment; with appropriate communication
to primary care to this effect.
8. Report adverse events to the Medicines and Healthcare Products Regulatory Agency (MHRA).
https://yellowcard.mhra.gov.uk/
9. Act promptly on any communication from GP colleagues requesting advice and support.
Primary Care Practitioner
1.
2.
3.
4.
Submit letter of reply confirming acceptance.
Monitor patient’s overall health and wellbeing.
Prescribe the drug treatment as described within this document.
Report to and seek advice from the Secondary Care Specialist on any aspect of patient care that is of
concern and may affect treatment.
5. Refer patient to the Specialist if the patient’s condition deteriorates.
6. Report any teriparatide-related adverse events to the hospital specialist and MHRA.
7. Stop treatment on the advice of the Secondary Care Specialist after 23 months of prescribing within
primary care.
Version: 1
Author: Paul Mills (Principal Pharmacist-CHUFT)
Reviewed by: Dr Paul Byrne (Consultant Rheumatologist) and Sheila Baldwin (Head of Medicines Management, NHS North
East Essex Clinical Commissioning Group)
Approved by: NEEMMC Jan 2015
Next review date: Jan 2017
Patient (and if appropriate, the carer):
1.
2.
3.
4.
Ensure medication is administered daily as directed
Attend for review with Secondary Care Consultant and GP as required
Share any concerns in relation to treatment with teriparatide.
Report any adverse effects to the Secondary Care Specialist or GP whilst utilising teriparatide therapy.
Contact Numbers for Advice and Support:
Colchester Hospital University NHS Foundation Trust
Consultant Rheumatologist:
Dr Paul Byrne
(01206) 747474 (Switchboard)
(01206) 742165
[email protected]
CHUFT Pharmacy Department
(01206) 742355
CHUFT Medicines Information Help Line:
(01206) 742161
References
Summary of Product Characteristics – Forsteo® (teriparatide) 20 micrograms/80 microlitres solution for injection in
pre-filled pen. Eli Lilly.
https://www.medicines.org.uk/emc/medicine/12561
NICE TA 161: Alendronate, etidronate, risedronate, raloxifene, strontium ranelate and teriparatide for the
secondary prevention of osteoporotic fragility fractures in postmenopausal women. Amended October 2008
http://www.nice.org.uk/guidance/TA161
Guidelines for the Prevention and Treatment of Osteoporotic Fragility Fractures. Approved by North East Essex
Medicines Management Committee February 2014.
Version: 1
Author: Paul Mills (Principal Pharmacist-CHUFT)
Reviewed by: Dr Paul Byrne (Consultant Rheumatologist) and Sheila Baldwin (Head of Medicines Management, NHS North
East Essex Clinical Commissioning Group)
Approved by: NEEMMC Jan 2015
Next review date: Jan 2017
Section A (to be completed by Secondary Care Specialist):
Hospital Number:
NHS No:
Date:
GP Courier No:
GP Name:
Name of patient:
Date of Birth:
Address:
Background:
Medications:
Dear GP,
See attached clinic letter. Please can you sign and return (using the above fax number) to indicate you are in
agreement with the Shared Care Guidelines.
Yours sincerely,
Section B (to be completed by General Practitioner):
The above patient (with associated teriparatide treatment) has been accepted into our monitoring service.
Accepting GP Name:
Accepting GP Signature:
Date:
Practice Stamp:
Version: 1
Author: Paul Mills (Principal Pharmacist-CHUFT)
Reviewed by: Dr Paul Byrne (Consultant Rheumatologist) and Sheila Baldwin (Head of Medicines Management, NHS North
East Essex Clinical Commissioning Group)
Approved by: NEEMMC Jan 2015
Next review date: Jan 2017