VITAMIN D PRODUCTS
-WHAT AND WHEN TO PRESCRIBE
Claudette Allerdyce
Principal Pharmacist
Croydon CCG Pharmacy Team
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)Sufficient dose
only suitable for maintenance ?
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.
RISE IN VITAMIN D PRESCRIBING
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??
E
LONDON
R
Trust/PCT
Deficiency
Reference Range
(25OHD)
Insufficiency
Reference Range
(25OHD)
Recommendation for deficiency
Recommendation for insufficiency/maintenance
Barts and
The London
<30nmol/L
31-80nmol/L
OSTEOMALACIA
Give 800-2000IU D3 daily or on a weekly basis.
Give 5 x 2 0,000IUcolecalciferol 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 800-2000IU daily or on a weekly basis.
Guys and St
Thomas
Imperial
College
Healthcare
NHS Trust
0-35nmol/L
<25nmol/L
0-35nmol/L
25-50nmol/L
Give 2 x 20,000IUcolecalciferol for 7 days.
Give 600mg Ca +400IU D3 twice daily.
Then maintenance therapy
If high dietary calcium intake or poor calcium-based tablet
compliance, consider 2x20,000IU D3 monthly or ergocalciferol
injection.
Give 20,000IU colecalciferol once weekly for 12
weeks.
Give 800-2000IU D3 daily depending on weight or give 2 weekly
dose (20,000IU every 2 weeks).
Then maintenance therapy.
Consider ergocalciferol injection 300,00IU two injections spaced
by 3 months in patients with malabsorption.
St George’s
Healthcare
NHS Trust
<25nmol/L
25-50nmol/L
1st line – Colecalciferol 60,000IU
(3x20,000IU) weekly
for 12 weeks.
2nd line – Two of colecalciferol300,00IU IM injections given 3
months apart (if malabsorption or compliance problematic).
3rd line – Colecalciferol150,000IU (50mL of 3000IU/mL liquid) once
daily for 2 days (if capsules or injection not suitable).
Then maintenance therapy in severely deficient patients.
INSUFFICIENCY
Give 1000-2000IU colecalciferol daily for 12 weeks.
MAINTENANCE
1st line – Give 1.5g Ca + 400IU D3
2nd line – Give 1000IU D3 daily (if adequate calcium intake)
CROYDON GUIDELINES RECOMMENDATIONS
First line products in Vitamin D deficiency
(i.e. 25 OHD Vitamin D level of <25mmol/L)
Adults
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
Children
If child < 6 months of
age
3000 units colecalciferol (prescribe
15,000 unit in 5ml solution) once daily
for 8 weeks
If child > 6 months of
age
6000 units colecalciferol (prescribe
15,000 unit in 5ml solution) once daily
for 8 weeks
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
CROYDON GUIDELINES RECOMMENDATIONS
First line products in vitamin D insufficiency
i.e. 25 OHD vitamin D level >25mmol/L<50mmol/L
Adults
800-1000 units colecalciferol once daily long
term.
***Encourage patients to purchase this OTC***
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)
Children
If child < 6 months of
age
If child > 6 months of
age
Calciferol 200-400 units orally daily
Calciferol 400-800 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
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 7-8.5
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.
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
Treatment of deficiency in adults
(levels <25nmol/l)
Recommended Dose Regimen
60,000 units colecalciferol once weekly for 8-12 weeks
(50 caps)
Preparations
Dekristol (colecalciferol) capsules 20,000 units (Expiry: 2 years)
(dose can be divided over three days e.g. mon/wed/frid)
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
People > 65 years or little sunlight
exposure
Colecalciferol 15, 000 units in 5ml solution
3000 units colecalciferol once daily for 8-12 weeks 100ml
6000 units colecalciferol once daily for 8-12 wks
800-1000 units colecalciferol once daily.
If patient > 65 yrs or dietary calcium intake is poor can
consider product contains added calcium
Note: this product now included within the specials drug tariff (min volume
is 100 ml)
Fultium D3® (colecalciferol 800 unit capsules x 30 capsules
Adcal D3® ( colecalciferol 400 units and 1.5g calcium carbonate per
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 200-400 units orally daily
Healthy Start vitamin drops contain colecalciferol 300 IU per 5 drops.
Calciferol 400-800 units orally daily
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
Healthy Start Women’s Vitamin tablets*
Colecalciferol 400 units (≡ 10mcg) once daily throughout
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)
Dalivit ® multivitamin drops Abidec® multivitamin drops contain
Daily vitamin drops that contain vitamin D 7-8.5 mcg of
vitamin D per day.
ergocalciferol 400 IU per 0.6 mL are suitable preparations to meet CMO
recommendations.
•Infants who are fed infant formula will not need vitamin drops
until they are receiving less than 500ml of infant formula a day.
Note: Healthy Start vitamin drops* contains colecalciferol 300 IU per 5
•Breastfed infants may need to receive drops containing
drops, 10mL (280 drops).
vitamin D from one month of age if their mother has not
taken vitamin D supplements throughout pregnancy.
Colecalciferol 400 units (≡ 10mcg)
Advise OTC supplementation
SO WHAT CAN WE DO?
PRESCRIBING INCENTIVE SCHEME 2012-13
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.
PIS 2012-13 VITAMIN D AUDIT TOOL
1.
Vitamin D treatment recommended by
GP or CUH Consultant team / Other Trust/Other
(specify details here
State rationale why vitamin D test was
requested
1.
Vitamin D testing
Vitamin D 25 OH vitamin D level
1.
Vitamin D treatment Dosing
information
State baseline Vitamin D level.
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
PIS 2012-13 VITAMIN D AUDIT TOOL
1.
Was a member of the pharmacy team contacted for advice?
Y/N ( If Y specify name and date)
1.
1.
Date treatment started
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
Y/N
•
•
•
•
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
If Yes go to Q 9a
•
•
•
•
•
a)
a)
1.
Preventative action
a)
a)
Had patient been advised to take
supplements
Was patient they prescribed or
buying OTC prep/ supplements
Has patient now been advised of the
need for long term supplementation
Has any long term maintenance
vitamin D preparation been
prescribed or advice to buy OTC
preparation been documented
If No go to Q 9c
Y/N
Y/N (if yes specify product& dose)
Y/N
Y/N
TAKE HOME MESSAGES
Reassess need for testing
Educate patients
Is testing really necessary?
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.
QUESTIONS