South Staffordshire Area Prescribing Group
Adult Vitamin D Guidelines
Approved September 2014 Review September 2016
Adult Vitamin D Guidelines This guideline has been developed to help clinicians investigate and manage vitamin D deficiency in adults; recommendations from the National Osteoporosis Society Guidance 20131 are incorporated. Table 1: Who is most at risk of Vitamin D deficiency? Age/Groups ≥75years 50 nmol/ l
Normal range
Fragility fracture, osteoporosis or high fracture risk Antiresorptive therapy for bone disease Symptoms suggestive of low vitamin D Risk of future Vitamin D deficiency due to reduced exposure to sunlight, religious /cultural dress code, dark skin etc. Conditions associated with malabsorption Raised PTH (provided no renal impairment) Treatment with antiepileptics and glucocorticoids Over 65’s who are housebound
Provide lifestyle and dietary advice
Treatment according to National Osteoporosis Society Guidelines (2013) 1. Where rapid correction of vitamin D deficiency is required, such as in patients with symptomatic disease or those about to start treatment with a potent antiresorptive agent (zoledronate or denosumab), the recommended treatment regimen is based on fixed loading doses followed by regular maintenance therapy. 2. Where correction of vitamin D deficiency is less urgent and when co-prescribing vitamin D supplements with an oral antiresorptive agent, maintenance therapy may be started without the use of loading doses.
FINAL version September 2014 ML / MMT /SES&SP CCG
Date of review: September 2016 2
3. Routine monitoring of serum 25-OHD is generally unnecessary, but may be appropriate in patients with symptomatic vitamin D deficiency or malabsorption, and where poor compliance with medication is suspected. 4. Adjusted serum calcium should be checked one month after completing the loading regimen or after starting vitamin D supplementation in case primary hyperparathyroidism has been unmasked. Prescribing Considerations for Use of Licensed Medicines, Unlicensed Medicines or Non-Medicines (Dietary or Nutritional Supplements) Licensed products (Appendix 1) can be used for loading regimes and maintenance doses, and it is recommended that these products are used where appropriate. There is also a large variety of unlicensed medicines and supplements available (Appendix 2). These products are not all subject to the same assurances of quality, safety and efficacy as licensed medicines. It is recognised that the licensed products/regimens may not be suitable for all patients and so prescribers may choose to prescribe an unlicensed product. 1. Medicine or supplement? Many products available are marketed as food supplements, not medicines. These may be suitable for correcting vitamin D levels in patients with insufficiency or deficiency, where the prescriber’s intent is to supplement dietary intake. If the patient has a diagnosed condition that is a consequence of the deficiency e.g. osteomalacia or rickets, then a medicine is considered more appropriate (preferably licensed). 2. Costs The net ingredient costs are shown for all of the listed products in Appendices 1 & 2. Prescribers should be aware that all unlicensed medicines are effectively specials and will also incur an additional dispensing fee of £20. Pharmacies may charge out of pocket expenses (OOPE) for obtaining food supplements. The current average OOPE fee for the CCG is £20 (ranging from below £10 to over £50). In general the product with the lowest acquisition cost should be considered. To minimise these costs, patients could be advised to buy these products over the counter. 3. Specials Prescribers are reminded that pharmacies may choose to fulfil generic prescriptions with specials. Prescribers are strongly recommended not to prescribe an unlicensed vitamin D product generically, unless a special is intended, as a special may cost in the range of £150 to £600.
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4. Unlicensed prescribing Prescribers are reminded that the General Medical Council guidance http://www.gmcuk.org/guidance/ethical_guidance/14327.asp requires a prescriber to consider an unlicensed product only if there is no suitable licensed alternative for the patient and that the prescriber is satisfied that there is an evidence base for prescribing.
Vitamin D Loading Regimens (Adult Patients) – Primary or Secondary Care: Loading regimens should provide a total of approximately 300,000 IU3. NOS guidance includes a variety of regimens, which may include using unlicensed products or food supplements. Prior to prescribing check U&E, renal function, bone biochemistry, LFT and PTH. If eGFR < 30ml/min ; Hypercalcaemia or at risk ; liver / renal disease then refer to secondary care for management. Recommended Loading Regimens (Using Oral Licensed Products within the Terms Of Their Product Licence Product
Licensed dose
Duration
Fultium D3 capsules (colecalciferol)
3200 IU daily
13 weeks (291,200 IU in total)
Desunin tablets (colecalciferol)
4000 IU daily (5 x 800IU tablets)
10 weeks (280,000 IU in total)
Invita D3 (colecalciferol) oral solution
50,000 IU weekly
6 weeks (300,000 IU in total)
Plenachol (colecalciferol) Capsult
40,000 IU weekly
7 weeks (280,000IU in total)
Other Loading Regimen Options NOS guidance includes a variety of loading regimens, which could be considered if the licensed regimens above are not considered optimal for specific patients. These alternative dosage regimens may require the use of unlicensed products and prescribers must be aware of their prescribing responsibilities. Possible regimes are suggested below, with the product information. Any regimen that delivers 300,000 IU over a period of time is likely to be suitable. FINAL version September 2014 ML / MMT /SES&SP CCG
Date of review: September 2016 4
Suggested high dose regimens using products containing 20,000 IU colecalciferol per dose (Hux-D3 or Osteocaps-D3 capsules) • 20,000IU daily for 2 weeks • 20,000 IU two doses given weekly for 7 weeks • 20,000 IU one dose given weekly for 15 weeks
Managing Maintenance Therapy in Primary Care Prescribers should consider recommending lifestyle modifications and over- the- counter supplementation before prescribing maintenance therapy. However, if prescribed follow: •
Deficiency – (maintenance following loading)- prescribe 800 IU daily for 6 months then recommend OTC supplementation
•
Insufficiency (demonstrated by levels and /or fitting criteria for treatment) –prescribe 800 IU daily for 6 months then recommend OTC supplementation
•
Risk factors for future Vitamin D deficiency2 e.g. over 65 years – 400 IU as Adcal-D3 tablets /caplets (or equivalent calcium and vitamin D3)
•
Risk factors for future Vitamin D deficiency e.g. Reduced exposure to sunlight, religious/ cultural dress code, dark skin, etc. recommend OTC supplementation
The prescriber should review the on-going need for supplementation on a regular basis.
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Appendix 1 – Licensed Products Available All products listed below should be prescribed by brand to prevent confusion. Product (in no order of preference)
Desunin Tablets 800 IU (colecalciferol)
Pack size
30
Cost (£) Correct July 14
£3.60
Treatment Dose
1 to 5 tablets daily (800IU – 4000 IU)
Maintenance Dose
1 tablet daily
Fultium D3 capsules 800 IU
30
£3.60
1 to 4 capsules daily
1 capsule daily
3200 IU
30
£13.32
1 capsule daily
N/A
(colecalciferol)
Invita D3 25,000 IU/ ml Oral solution
3* 1ml
£4.45
2 ampoules (50,000 IU)
1 ampoule monthly (25,000IU)
(colecalciferol)
Ergocalciferol
FINAL version September 2014 ML / MMT /SES&SP CCG
NA
- Derived from sheep’s wool fat – however the company has confirmed the product is suitable for vegetarians - Not suitable for vegans - Does not contain soya, peanut oil and gelatine - NOT SUITABLE for those with fructose intolerance - Tablets can be crushed - Does not appear in Drug Tariff, may be subject to out of pocket expenses fee (variable) - Contains peanut oil and gelatine - Gelatine certified halal and Kosher - Not suitable for vegetarians and vegans - Appears in Drug Tariff, may be subject to out of pocket expenses fee (variable) - An olive oil based solution presented in 1ml (25,000 IU) single dose ‘snap and squeeze’ plastic ampoule - Derived from sheep’s wool fat – however the company has confirmed the product is suitable for vegetarians - Gelatine-free, PEG** free, peanut oil free - Available via Focus
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300,000 IU/ml injection
1ml* 10
£93.50
Single intramuscular injection 300,000 IU
Pharmaceuticals 01283 495280 - Derived from sheep’s wool fat – however the company has confirmed the product is suitable for vegetarians - IM injections of vitamin D absorption is erratic and hence should be used as a last resort
Plenachol Capsules 20,000 IU
10
£9.00
40,000 IU
10
£15.00
Colecalciferol 400 IU Calcium carbonate 1.5g per dose Adcal-D3 tablets Adcal-D3 caplets Adcal-D3 dissolve
2 capsules weekly
1 capsule monthly
1 capsule weekly
1 capsule monthly
NA 56 112 56
£3.65 £3.65 £5.99
Tablets(chewable) or Dissolve(soluble): 1 tablet twice daily or 2 tablets once daily Caplets: 2 caplets twice daily
- Licensed 12 year and older - Suitable for Vegetarians - Gelatine-free, Soya free, peanut oil free, gluten free - Halal & Kosher certified - Adcal-D3 caplets do not contain gelatine and may be more palatable for those patients who do not like chewable tablets - Adcal-D3 Dissolve should be reserved for those patients with swallowing difficulties. - Contain Soya oil and contraindicated in patients with allergy to Soya or Peanuts
**PEG = Polyethylene Glycol
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Appendix 2 – Unlicensed Products Available Note: Not an exhaustive list Product
Pack size
Hux-D3 20,000 IU capsules (colecalciferol)
£2.66
Food Supplement
30
£3.99
Food Supplement
50ml
£18.90 + VAT
Food Supplement
Aciferol D3 400 iu tablets
*OOPE = Out of Pocket Expenses **PEG = Polyethylene Glycol
FINAL version September 2014 ML / MMT /SES&SP CCG
Legal Status
20
Osteocaps D3 20000 iu Capsules (colecalciferol)
ProD3 Forte Liquid 3,000 IU /ml (colecalciferol)
Cost (£) Correct July 14
90
£9.99
Food Supplement
Additional Information
- Suitable for vegetarians, Muslims (halal), gluten, gelatin free. Alcohol, PEG**, soya, lactose, preservative, salt and yeast free. Does not contain arachis (peanut) oil. - Sourced from sheep wool fat so it may not be acceptable for vegans; there is no vegan source of colecalciferol. - Sugar free, gelatine free, suitable for vegetarians - Does not contain peanut oil or soya - Not subject to OOPE* - Suitable for vegetarians, Muslims (halal), kosher, gluten and gelatin free. - Does not contain arachis (peanut) oil. - Alcohol and PEG** free - Sugar free, gelatine free, suitable for vegetarians - Does not contain peanut oil or soya - Not subject to OOPE*
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Appendix 3 – Over the Counter Products Available Adult Vitamin D preparations available over-the-counter and online without prescription Note: Not an exhaustive list Holland & Barrett Caplets contain gelatin; manufacturers unable to say whether beef / vegetable origin (label states not porcine) Holland & Barrett www.hollandandbarrett.com
Vitamin D3 400 IU tablets
100
£3.55
Food Supplement
Vitamin D3 1000 IU caplets
100
£8.05
Food Supplement
Vitamin D3 400 IU tablets
100
£3.99
Food Supplement
Vitamin D3 1000 IU
100
£4.99
Food Supplement
Nature’s Remedy: www.naturesremedy.co.uk
Vitamin D3 400 IU tablets
90
£2.19
Food Supplement
Suitable for vegetarians
Vitamin D3 1000 IU tablets
90
£5.19
Food Supplement
Boots: www.boots.com
Nature’s Remedy Suitable for vegetarians
Boots
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Appendix 4 – Guideline Summary DOES THE PATIENT HAVE? 1. Symptoms of Vitamin D deficiency • Bone pain and/or tenderness • Proximal muscle weakness or myalgia • Generalised aches and pains 2. Osteomalacia 3. Osteoporosis (and about to start potent therapy eg. Zoledronate, Denosumab)
No
Vitamin D testing not required
Yes CHECK: 25-OH Vitamin D, U+E’s, renal function, bone biochemistry, LFT, and PTH
DO ANY OF THE FOLLOWING APPLY? • eGFR
