Calcium & Vitamin D3 Deficiency Protocol

INTERFACE
Clinical Services

Brighton and Hove PCT

Calcium and Vitamin DDeficiency Clinical Review Protocol

The service is not linked to the use of any particular product. The independent prescriber retains full control over the entire process and can amend, remove or add any aspect.

This protocol outlines the procedures that will be followed for agreed prescribing changes to take place. A hard copy must be given to the practice, prior to work commencing.

Accountability and Management

All Interface personnel involved in the process

are suitably qualified as defined by the ABPI Code of Practice
have received appropriate training as defined within company guidelines
must comply with the Data Protection Act (1998)

Pharmacy Standards

As members of The Royal Pharmaceutical Society of Great Britain, all Interface clinical support pharmacists are bound by a code of ethics and standards as defined in the Medicines, Ethics and Practice Guide for Pharmacists 2008.

Project Aim

The aim of the project is to identify those patients at risk of calcium and vitamin D3 deficiency who may benefit from the addition of a calcium and vitamin D3 supplement in accordance with:

SIGN Guideline (71) *
NICE Technology Appraisal (87) *
RCP Guidance on prevention of glucocorticoid induced osteoporosis (2002) *
RCP Osteoporosis Clinical Guidelines for the Prevention and Treatment of Osteoporosis (2000) *,

and to support therapy intervention where appropriate as directed by the practice.

Practice Authorisation Form

Section 1

Practice Name / Lead GP
Practice Address / Practice Manager
Email:
List Size
Practice Tel number / Practice Clinical System & Version
Agreed Date of Clinical Review / Request for a 12 Month Re-audit

Yes No
Interface contact details / ProStrakan contact details

We hereby authorise Interface Clinical Services to undertake the calcium and vitamin D3 Deficiency Clinical Review and will inform all partners of this agreement. We are duly authorised to sign this form on behalf of the practice.

Lead GP Signature

2nd GP Signature
(if required)

Date / Practice Manager signature
Date
Special Instructions

Section 2

Patient Selection Criteria for Calcium & Vitamin D3 Supplementation

Patient Criteria / Action / Please Tick
Patients with a diagnosis of osteoporosis currently untreated (NICE TA 087) / Initiate calcium and vitamin D3 and list for consideration for additional therapy.
Patients currently treated with a bisphosphonate or strontium and not receiving calcium & vitamin D3 (NICE TA 087) / Initiate calcium and vitamin D3.
All patients who are frail and patients over 65 with history of or at increased risk of falls, housebound or in Care Homes (RCP 2000) (DES 2008/09) / Initiate calcium and vitamin D3.
Patients receiving long term oral corticosteroids (for > 3 months) (RCP 2002) / Initiate calcium and vitamin D3
and list for consideration for additional therapy.
Patients over 65 with a previous low trauma fracture from the age of 50 / Initiate calcium and vitamin D3.
Patients between 50 and 74 with a previous low trauma fracture / Initiate calcium and vitamin D3.
Patients currently non-compliant with Calcium and Vitamin D3 therapy (<80% over last year) / Send educational letter and/or leaflet explaining the rationale for therapy. Consider dissolvable Calcium and Vitamin D3
Current Repeat Rx for a Non Evidence Based Dose of calcium & vitamin D3 / Transfer to practice preferred brand of Calcium & Vitamin D3
(See table 1)
Patients currently prescribed Fosovance/Branded Alendronate / Highlight to GP for transfer to PCT preferred Generic version

Patient Criteria

/ Action / Please Tick
Women aged 65yrs and older with fragility fractures sustained after 1st April 2008 / Compile register to be maintained
women aged 65-74 with
a FF (fragility fracture) in the last 12 months who have had osteoporosis
confirmed by DEXA scan / Compile register and present to GP for consideration for additional therapy.
women aged 65 to 74 with positive osteoporosis
diagnosis confirmed by DEXA (ie number 1 above) who are receiving
treatment with a bone sparing agent / Compile register and present to GP for consideration for additional therapy.
women 75 and over with a FF in the last 12/12
who are receiving treatment with a bone sparing agent. / Compile register and present to GP for consideration for additional therapy.

Clinical Direct Enhanced Services Guidance Criteria

* Tick as appropriate

Initial prescription to be raised and sent to patient?YES/NO**

**Delete as applicable

Treatment to be linked to a Read code YES/NO**

**Delete as applicable

Specifics of Read code to be added if missing______

Section 3

Patient Exclusion Criteria for Calcium & Vitamin D3 Supplementation

Contra-indications (exclude all and list for reference)

hypercalcaemia – caused by myeloma, bone metastases or other malignant bone disease, sarcoidosis, hypervitaminosis D (Read code, clinical values & suspicion)
primary hyperparathyroidism (Read code)
severe renal failure (Read code + clinical values)

Relative contra-indications (list and refer to GP)

osteoporosis due to prolonged immobilization (from notes)
renal stones (Read code)
severe hypercalciuria (Read code + clinical values)

Special precautions (list and refer to GP)

mild to moderate renal failure
mild hypercalciuria
pregnancy and lactation
Dysphagia, swallowing issues, presence of sip feeds or history of issues with chewable preparations

Periodic checks of plasma calcium levels and urinary calcium excretion should be made in patients with mild to moderate renal failure or mild hypercalciuria. Consider calcium & vitamin D3 from other sources.

Drug interactions

Barbiturates
Carbamazepine
Phenytoin
Primidone
Ion exchange resins / vitamin D3 requirements possibly increased / PROCEED AS NORMAL
Thiazide diuretics / increased risk of hypercalcaemia / REFER LISTS TO GP FOR APPROVAL
Cardiac Glycosides / hypercalcaemia must be avoided in digitalised patients
Bisphosphonates
Fluorides
Thyroxine
Tetracycline antibiotics
Zinc
Quinolone antibiotics
Iron / calcium salts reduce absorption / MANAGE BY INSTRUCTION TO PATIENT IN LETTER AND ANNOTATE DIRECTIONS ON REPEAT RX.

Any exclusion criteria specified by the authorising GP.

Section 4 1. The Practice Authorisation Form must be completed in full and signed by an authorised, independent prescriber and the practice manager prior to any work undertaken by Interface personnel. The patient selection criteria, preferred brands, exclusion criteria and specific requests or variance to the protocol may be discussed if necessary with the Interface Clinical Pharmacist at the commencement of the project. Any alterations must be documented and countersigned by the authorising GP.

2. The ProStrakan representative commissioning the project on behalf of the Practice will secure the services of an Interface Clinical Support Pharmacist on a date agreed by the practice. Interface Clinical Services is a service provider to the NHS and has no role in the promotion or sale of pharmaceutical products. ProStrakan will have no role in the service provision beyond reimbursement of Interface Clinical Services.

3. The Interface Clinical Support Pharmacist will conduct a search of the GP clinical system to identify patient cohorts as determined and authorised in the selection criteria.

4. Each patient’s repeat medication file will be viewed on an individual basis and if clinically appropriate, medication will be initiated or altered according to agreed criteria. Only patient information necessary for the safe and effective medication transfer process is viewed and by no one other than the Interface Clinical Support Pharmacist. No information regarding individual patients will leave the practice.

5. In the event of clinical issues arising, including dosages and indications outwith the product license, concomitant medication or other clinical issues that, in the Interface Clinical Pharmacist’s professional judgment, would result in inappropriate initiation or alteration of treatment, the Interface Clinical Support Pharmacist will highlight these to the prescriber and proceed accordingly.

7. All new treatment initiations and alterations to existing therapy initiated by the Interface Clinical Pharmacist will be recorded within the prescribing field and wherever possible linked to indication.

8. No patient will be initiated beyond the scope of the summary of product characteristics (SmPC) unless authorised by the prescriber.

9. A hardcopy of the SmPC for each product initiated will be left with the documentation.

10. Dose and duration of supply for newly initiated treatments will be consistent with other repeat medication for individual patients or, in the absence of other prescribed medication, reflect practice preference.

11. Each patient will be informed of any change to their medication and any additional instructions necessary to ensure appropriate use, in accordance with the wishes of the individual practice. Any written materials, including patient information leaflets and template letters prepared by the Interface Clinical Pharmacist, will be submitted for approval before issue and a copy of the templates retained in the documentation

12. If the patient is under the age of 16 then any information will be addressed to the patient’s parent or guardian.

13. If the patient is a resident in a care home, the Interface Clinical Support Pharmacist will communicate information about the change to relevant personnel at the home in addition to the individual patient.

14. The Interface Clinical Support Pharmacist will communicate information about the review to relevant personnel within the practice (i.e. GP, receptionist, nurses and the practice manager) to ensure that patient queries can be dealt with effectively.

15. On completion of the service, a file will be left with the practice detailing all patients and reviewed and actions taken, copies of any written information to patients, copies of any relevant SmPCs, a copy of the agreement form and contact details for Interface personnel. The practice will be left with a service satisfaction form, to be completed at their convenience.

16. The Interface Clinical Support Pharmacist may record statistics of the review for company administrative purposes and analysis of the review for the practice by means of a service report (see appendix 3). No information regarding individual patients will leave the practice.

17. A courtesy telephone call will be made by Interface Clinical Services 2-3 days after the review has been completed to offer any further support required and obtain practice feedback.

18. The practice will receive an automated email confirmation of the appointment with the practice 2 months prior to the re-audit review date (where requested).

19. The practice will be contacted by Interface Clinical Services to re-confirm the re-audit appointment 4-6 weeks prior to the re-audit review date (where requested).

Appendix 1

Service Satisfaction Feedback Form

Unsatisfactory Satisfactory Good Excellent

The project was carried out with minimal disruption

to the practice.

The project sign off forms were clear and easy to

complete.

The practice was clearly informed of the project

details prior to the day of implementation.

The Interface personnel were polite and professional

prior to and on the day of implementation.

Queries regarding individual patients medication were

handled effectively.

Queries regarding computer systems were resolved

effectively.

The documentation left with the practice clearly

details the work that has been carried out.

The project was completed within the time scale

that was agreed.

Unlikely Likely Very Likely

How likely would the practice be to use the Interface

service again.

Please use the box below to add any comments or suggestions you would like to make regarding the service provided to the practice by Interface Clinical Services.

Please return the completed questionnaire to:

Interface Clinical Services

Customer Services Department

Unit 7/7a

Drill Hall Business Centre

Ilkley

West Yorkshire

LS29 8EZ

Appendix 3

Data Collection Sheet

AUDIT LIST / Practice name:
Lead GP
Practice Address / Contact name:
Computer system:
Search Criteria / Dose/Presentation / Audited Patients / Recommendations / Patient No highlighted
Total Practice Population / N/A / Baseline Population / N/A
Total population with a diagnosis of osteoporosis / N/A / Baseline osteoporosis population / N/A
Patients with a diagnosis of osteoporosis currently untreated (Untreated defined as not receiving bisphosphonates/strontium/
Calcium only/CaD3/Raloxifene) / N/A / Initiate preferred calcium and vitamin D therapy / No. initiated onto preferred CaD3
Exclusions: (detailed)
Ratio of treated osteoporosis patients versus untreated osteoporosis patients / N/A / Treated versus untreated (%) / For practice information only / N/A
Total population receiving bisphosphonates / Oral / Baseline bisphosphonate population / N/A
Total bisphosphonate pop not receiving concomitant Ca/vit D3 / Oral / Initiate preferred calcium and vitamin D3 therapy / No. initiated onto preferred Ca/vit D3
Exclusions: (detailed)
Ratio of bisphosphonates and Ca/vit D3 versus patients on bisphosphonate not receiving Ca/vit D3 / N/A / Treated versus untreated (%) / For practice information only / N/A
All patients who are frail, and patients over 70 in care homes, with a history of or at increased risks of falls or housebound / Oral / Initiate preferred calcium and vitamin D3 therapy / No. initiated onto preferred Ca/vit D3
Exclusions: (detailed)
Patients currently receiving oral corticosteroids for longer than 3 months / Oral / Initiate preferred calcium and vitamin D3 therapy / No. initiated onto preferred Ca/vit D3
Exclusions: (detailed)
Total Practice Population Over 75 / N/A / Baseline Population / N/A
Patients over 65 with a fragility fracture since the age of 50 years / N/A / Prevalence expressed as % / For practice information only / N/A
Patients over 75 with a fragility fracture since the age of 50 years not receiving active Ca/vit D3 therapy / Oral / Initiate preferred calcium and vitamin D3 therapy / No. initiated onto preferred Ca/vit D3
Exclusions: (detailed)
Patients between 50 and 74 with a fragility fracture / N/A / Prevalence expressed as % / For practice information only / N/A
Patients between 50 and 74 with a fragility fracture not receiving active Ca/vit D3 / Oral / Initiate preferred calcium and vitamin D3 therapy / No. initiated onto preferred Ca/vit D3
Exclusions: (detailed)
Patients currently non-compliant with calcium & vitamin D3 therapy defined as missing 1 Rx in 5 / Oral / Send educational letter and/or leaflet explaining the rationale for therapy / No. letters forwarded to patients
Exclusions: (detailed)
Patients currently non-compliant with bisphosphonate therapy defined as missing 1 Rx in 5 / Oral / Send educational letter and/or leaflet explaining the rationale for therapy / No. letters forwarded to patients
Exclusions: (detailed)
Patients on non-evidenced based calcium and vitamin D3 supplement or non practice-preferred calcium and D3 supplement / As defined by practice / Initiate preferred calcium and vitamin D3 therapy / No. initiated onto preferred Ca/vit D3
Exclusions: (detailed)
Total / Total number of patients reviewed / Total no. initiated onto preferred Ca/vit D3
Total no. compliance letters forwarded to patients
Total no. referred to GP for further review or consultation
Search Criteria / Dose/Presentation / Audited Patients / Recommendations / Patient No highlighted
women aged 65-74 with
a FF (fragility fracture) in the last 12 months who have had osteoporosis
confirmed by DEXA scan
women aged 65 to 74 with positive osteoporosis
diagnosis confirmed by DEXA (ie number 1 above) who are receiving
treatment with a bone sparing agent
women 75 and over with a FF in the last 12/12
who are receiving treatment with a bone sparing agent.