VITAMIN D PRODUCTS -WHAT AND WHEN TO PRESCRIBE. Claudette Allerdyce Principal Pharmacist Croydon CCG Pharmacy Team

Transcription

1 VITAMIN D PRODUCTS -WHAT AND WHEN TO PRESCRIBE Claudette Allerdyce Principal Pharmacist Croydon CCG Pharmacy Team

2 WHAT ARE THE ISSUES? A lack of suitable licensed vitamin D products in the UK for treating deficiency and meeting CMO advice for pregnant women & children <5 yrs Fultium D3 capsule (colecalciferol 800 units)- only suitable for maintenance? Sufficient dose Ergocalciferol tablets and IM Injection- difficulties with sourcing raw material Healthy Start vitamin tablets and children drops- can only be ordered by PCTs This results in increased prescribing of specials which causes: Uncertainty with regards to product quality Unpredictable costs for items not included within specials drug tariff. Limited use of software to support prescribing- e.g. scriptswitch Problems in assuring the supply of safe, effective, and affordable products to meet guidelines and national recommendations.

3 RISE IN VITAMIN D PRESCRIBING

4 OTHER ISSUES No national guidance treatment deficiency Variation in regimens used across London. Lack of awareness of Healthy Start Initiative amongst HPC, patients and the public. Ever increasing range of OTC health supplements available Confusion over what to prescribe & if to prescribe at all??

5 E LONDON R Trust/PCT Deficiency Reference Range (25OHD) Insufficiency Reference Range (25OHD) Recommendation for deficiency Recommendation for insufficiency/maintenance Bartsand The London <30nmol/L 31-80nmol/L OSTEOMALACIA Give 5 x 20,000IUcolecalciferol for 2 days. Second line choice ergocalciferol injection 300,00IU IM if oral therapy not tolerated or compliance poor. If level <80nmol/L in 12 weeks then repeat loading dose. Then maintenance therapy. ASYMPTOMATIC No evidence for high dose treatment. Give IU daily or on a weekly basis. Give IU D3 daily or on a weekly basis. Guys and St Thomas Imperial College Healthcare NHS Trust 0-35nmol/L 0-35nmol/L Give 2 x 20,000IUcolecalciferol for 7 days. Then maintenance therapy <25nmol/L 25-50nmol/L Give 20,000IU colecalciferolonce weekly for 12 weeks. Then maintenance therapy. Give 600mg Ca +400IU D3 twice daily. If high dietary calcium intake or poor calcium-based tablet compliance, consider 2x20,000IU D3 monthly or ergocalciferol injection. Give IU D3 daily depending on weight or give 2 weekly dose (20,000IU every 2 weeks). St George s Healthcare NHS Trust Consider ergocalciferol injection 300,00IU two injections spaced by 3 months in patients with malabsorption. <25nmol/L 25-50nmol/L 1 st line Colecalciferol60,000IU (3x20,000IU) weekly for 12 weeks. 2 nd line Two of colecalciferol300,00iu IM injections given 3 months apart (if malabsorption or compliance problematic). 3 rd line Colecalciferol150,000IU (50mL of 3000IU/mLliquid) once daily for 2 days (if capsules or injection not suitable). INSUFFICIENCY Give IU colecalciferol daily for 12 weeks. MAINTENANCE 1 st line Give 1.5g Ca + 400IU D3 2 nd line Give 1000IU D3 daily (if adequate calcium intake) Then maintenance therapy in severely deficient patients.

6 CROYDON GUIDELINES RECOMMENDATIONS First line products in Vitamin D deficiency (i.e. 25 OHD Vitamin D level of <25mmol/L) Adults Children If child < 6 months of age If child > 6 months of age 60,000 units colecalciferol (prescribe 20,000 capsules x 3) once weekly for 8 weeks dose can be divided & taken over three days e.g. mon/wed/frid (may help if nausea occurs 3000 units colecalciferol (prescribe 15,000 unit in 5ml solution) once daily for 8 weeks 6000 units colecalciferol (prescribe 15,000 unit in 5ml solution) once daily for 8 weeks

7 SPECIAL CONSIDERATIONS Alternative Options for Patients with: Mal-absorption conditions (e.g. short bowel, crohn s disease) IM Ergocalciferol Injections Adults with swallowing difficulties Treatment courses Steriferol ergocalciferol 20,000 unit/ml) Maintenanance Vigantoletten dispersible tablets (colecalciferol 1000 units) Vegans Use ergocalciferol preparations rather than colecaciferol, but will need to check with manufacturers Persistent compliance issues but symptomatic patients Consider injections

8 CROYDON GUIDELINES RECOMMENDATIONS First line products in vitamin D insufficiency i.e. 25 OHD vitamin D level >25mmol/L<50mmol/L Adults units colecalciferol once daily long term. ***Encourage patients to purchase this OTC*** Children If child < 6 months of age If child > 6 months of age If prescribing Fultium D3 (colecalciferol 800 unit capsules x 30 capsules If patient > 65 yrs or dietary calcium intake is poor Adcal D3 ( colecalciferol 400 units and 1.5g calcium carbonate per tablet) Calciferol units orally daily Calciferol units orally daily Dalivit and Abidec multivitamin drops contain ergocalciferol 400 IU per 0.6 ml (Note Abidec contains arachis oil so avoid in peanut allergy) Healthy Start vitamin drops* contain colecalciferol 300 IU per 5 drops

9 POST GUIDELINE UPDATES TO NOTE UK launch of Fultium D3 Colecalciferol 800 unit capsules. Issue of CMO Letter Feb 2012 Advice on supplements for at risk groups DH Recommendations All pregnant and breastfeeding women should take a daily supplement containing 10mcg of vitamin D. All infants and young children aged 6 months to 5 years should take a daily supplement containing vitamin D in the form of vitamin drops, containing micrograms of vitamin D per day. However, those infants who are fed infant formula will not need vitamin drops until they are receiving less than 500ml of infant formula a day. Breastfed infants may need to receive drops containing vitamin D from one month of age if their mother has not taken vitamin D supplements throughout pregnancy. People aged 65 years and over and people who are not exposed to much sun should also take a daily supplement containing 10 micrograms of vitamin D 400 units.

10 Vitamin D Management Guide Summary Lifestyle measures- Promote Safe Sun Exposure Sun exposure is the main source of vitamin D, enjoying the sun safely, while taking care not to burn, can help provide the benefits of vitamin D without unduly raising the risk of skin cancer. When it comes to sun exposure, little & often is best; regularly going outside for a matter a minutes around the middle of the day without sunscreen should be enough. Sunbeds do not grant protection against vitamin D deficiency and any benefits are greatly outweighed by the risks. Indication Recommended Dose Regimen Preparations Treatment of deficiency in adults (levels <25nmol/l) 60,000 units colecalciferol once weekly for 8-12 weeks (50 caps) Dekristol (colecalciferol) capsules 20,000 units (Expiry: 2 years) Treatment of deficiency in children (levels <25nmol/l) If child < 6 months of age If child > 6 months of age Insufficiency in adults (<50nmol/l but > 25nmol/l). Insufficiency in children (level> 25nmol< l50nmol/l) If child < 6 months If child > 6 months Supplementation in High Risk Groups Supplementation in pregnant women infants and young children aged 6 months to 5 years (dose can be divided over three days e.g. mon/wed/frid) Colecalciferol 15, 000 units in 5ml solution 3000 units colecalciferol once daily for 8-12 weeks 100ml Note: this product now included within the specials drug tariff (min volume 6000 units colecalciferol once daily for 8-12 wks is 100 ml) units colecalciferol once daily. Fultium D3 (colecalciferol 800 unit capsules x 30 capsules If patient > 65 yrs or dietary calcium intake is poor can Adcal D3 ( colecalciferol 400 units and 1.5g calcium carbonate per consider product contains added calcium tablet) x 60 chewable tablets. Advise OTC health supplements if not exempt from Rx charges Dalivit multivitamin drops contain ergocalciferol 400 IU per 0.6 ml Abidec multivitamin drops contain ergocalciferol 400 IU per 0.6 ml Calciferol units orally daily Calciferol units orally daily Healthy Start vitamin drops contain colecalciferol 300 IU per 5 drops. Patients known to be at risk of vitamin D should be advised of the need for long term supplementation and encourage them to purchase OTC preparations Colecalciferol 400 units ( 10mcg) once daily throughout Healthy Start Women s Vitamin tablets* pregnancy Contains 10 mcg Vitamin D3; 70 mg Vitamin C and 400 mcg Folic Acid Pregnacare Range Contain10 mcg Vitamin D3 plus a variety of other constituents (excluding preparations marketed for use pre-conception) Daily vitamin drops that contain vitamin D mcg of vitamin D per day. Infants who are fed infant formula will not need vitamin drops until they are receiving less than 500ml of infant formula a day. Breastfed infants may need to receive drops containing vitamin D from one month of age if their mother has not taken vitamin D supplements throughout pregnancy. Dalivit multivitamin drops Abidec multivitamin drops contain ergocalciferol 400 IU per 0.6 ml are suitable preparations to meet CMO recommendations. Note: Healthy Start vitamin drops* contains colecalciferol 300 IU per 5 drops, 10mL (280 drops). People > 65 years or little sunlight exposure Colecalciferol 400 units ( 10mcg) Advise OTC supplementation

11 SO WHAT CAN WE DO?

12 PRESCRIBING INCENTIVE SCHEME Vitamin D Component Three elements to this component of the scheme: 1. Practice must : Nominate a GP to attend the Vitamin D educational event. 2. The nominated clinical champion must: Submit a completed competency assessment form. 3. The Practice must: Provide evidence that the nominated champion has shared the learning wwithin the practice with appropriate staff by: a. Submitting evidence of how learning and information was shared b. Submit action plan outlining three actions the practice has implemented following the educational event that will improve appropriate management of vitamin D (i.e. reduce inappropriate testing; promote Healthy Start, reduce prescribing of inappropriate specials) c. Undertake an audit of all patients started on high dose treatment courses between 1 November 2012 and 30 Jan 2012.

13 PIS VITAMIN D AUDIT TOOL 1. Vitamin D treatment recommended by GP or CUH Consultant team / Other Trust/Other (specify details here 1. Vitamin D testing State rationale why vitamin D test was requested Vitamin D 25 OH vitamin D level State baseline Vitamin D level. 1. Vitamin D treatment Dosing information Preparation Formulation Strength Dosing schedule Duration 1. Was treatment course a following preferred option: Adults and children over?? 60,000 units colecalciferol once weekly for 8 weeks. Children: < 6 months: 3000 units colecalciferol once Daily for 8 wks. >6 months <12 years 6000 units colecalciferol once DAILY for 8 wks Y/N

14 PIS VITAMIN D AUDIT TOOL 1. Was a member of the pharmacy team contacted for advice? Y/N ( If Y specify name and date) 1. Date treatment started 1. Has patient has previous vitamin D treatment courses before? (within last 24 months Y/N (If Y specify dates and treatment courses 1. Is patient from any of the following groups known to have increased risk of vitamin D deficiency Pregnant /breastfeeding women Children under the age of 5 years Black and Asian people. People who cover up when outside (e.g. women who wear veils, burqa). Strict sunscreen use for medical reasons Housebound or institutionalised individuals vegans People with malabsorption conditions (e.g. Crohn s). On medication that can increase metabolism or reduce absorption of vitamin D a) Had patient been advised to take supplements a) Was patient they prescribed or 1. Preventative action buying OTC prep/ supplements a) Has patient now been advised of the need for long term supplementation a) Has any long term maintenance vitamin D preparation been prescribed or advice to buy OTC preparation been documented Y/N If Yes go to Q 9a If No go to Q 9c Y/N Y/N (if yes specify product& dose) Y/N Y/N

15 TAKE HOME MESSAGES Reassess need for testing Is testing really necessary? Educate patients Self care ; diet; safe sun exposure Take preventative action Identification of at risk patients Promotion of lifestyle advise & use of OTC supplements. Promote use of Healty Start vitamins to eligible patients. Flag requests for non recommended vitamin D treatment courses to PCT pharmacy team.

16 QUESTIONS