Title of Project:

NHS Dumfries & Galloway -

Medicines Management Review Protocol

Vitamin B Co Strong Review 1

June 2010

Reason for the review Vitamin B Compound Strong is no longer recommended for use in patients with a history of excess alcohol intake due to a lack of efficacy. Thiamine (vitamin B1) may be a more appropriate alternative for those who have a chronic alcohol problem and whose diet is deficient. The NHS D&G Alcohol Withdrawal Guideline recommends thiamine 50mg four times a day, given orally for all patients for 6 months or as long as drinking alcohol continues. Thiamine should be given in divided doses to maximise absorption.

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Inclusion Criteria Search for all patients prescribed the following on repeat prescription within the last 6 months: • Vitamin B Co Strong • Vitamin B Compound • Thiamine .

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Exclusion Criteria • • • •

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Previous switch to an alternative product which caused distress Mental health issues likely to have an effect on ability to accept change of medication Patients with terminal cancer Other as defined by GP

Preparation and planning Implementation of audit in selected GP practices is as follows:

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Protocol to be discussed with all GPs in the practice to ensure that agreement to proceed is reached

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Computer search of all patients according to the inclusion criteria

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Review of patients’ medical notes and repeat prescribing records to check for exclusion criteria

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List of eligible patients to be checked by GP/GPs for any further alterations.

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GP will be notified regarding any compliance issues

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Letter to be sent to eligible patients and switch to be undertaken on the computer system

Action Letters written to all patients outlining the reasons for the switch, or discontinuation of medicine, or change of dose, to ensure they are fully informed and given an opportunity to discuss the change with either their GP or practice pharmacist Admin staff in practices to be made aware of change of repeat medication Local pharmacies to be informed of need to reduce stock and of counselling for patients (copy of patient letters supplied) Report for practices will include number of switches made by the pharmacist/technician and projected cost savings as a result of the recommendations

Review to be undertaken by: .......................................GP Authorisation:.......................... Date: ......................

Patient letter 1 Patient name Address

Dear Mr/Mrs __________

As part of a review of prescribing, NHS Dumfries and Galloway is currently reviewing all patients prescribed vitamin B co strong tablets and thiamine (vitamin B1) tablets. Current evidence suggests thiamine tablets alone are the most effective vitamin B supplement for you. We have therefore removed vitamin B Co strong from your list of repeat medications. The next time you request your prescription it will be for thiamine tablets at a dose of 50mg four times daily. Should you have any queries, please do not hesitate to contact the Surgery on the number above or, alternatively, you can contact a member of the Prescribing Support Team on ………. Yours sincerely,

Name Prescribing Support Technician On behalf of the Doctors

Patient letter 2 Patient name Address

Dear Mr/Mrs __________

As part of a review of prescribing, NHS Dumfries and Galloway is currently reviewing all patients prescribed vitamin B co strong tablets and thiamine (vitamin B1) tablets. Your GP has now confirmed that your treatment is complete. Vitamin B Co strong and/or thiamine (delete as appropriate) has been removed from you repeat medication list. Should you have any queries, please do not hesitate to contact the Surgery on the number above or, alternatively, you can contact a member of the Prescribing Support Team on ………. Yours sincerely,

Name Prescribing Support Technician On behalf of the Doctors

Vitamin B Co Strong Review - Data Collection Sheet SURGERY: ................................................. Patients name & CHI

Drug/dose

DATE: ................... Indication

If Hx excess alcohol- still drinking?

UNDERTAKEN BY: ............................................................ Compliance Thiamine Excluded prescribed? Past 6 from months change

Proposed change

GP approved Action ed

Appendix 1. Indications for Vitamin B Supplements As described above, thiamine 50mg qds is recommended in the NHS D&G Alcohol Withdrawal Guidelines for the prevention of Wernicke’s encephalopathy1. Vitamin B Compound and Compound Strong are not recommended due to lack of evidence of efficacy. There is some evidence that thiamine-derivatives improve vibration detection in patients with peripheral neuropathy and that vitamin B supplements may result in short-term reduction in pain and improvement in paraesthesiae. The studies were conducted in patients with alcoholic and diabetic peripheral neuropathy. However there have been few high quality trials and the B vitamins provided varied. Overall, the evidence is insufficient to determine whether vitamin B supplementation is beneficial2. The NICE guidelines for the pharmacological management of neuropathic pain, published in March 20103, make no reference to vitamin B supplementation for peripheral neuropathy, nor do the SIGN guidelines for diabetes4 (also published March 2010) nor the NICE guidelines on alcohol-use disorders (June 2010)5. Patients receiving Vitamin B Compound for peripheral neuropathy and alcoholism should have their prescription changed to thiamine. In the absence of a history of alcohol excess, patients receiving vitamin B for peripheral neuropathy should be referred to the GP for review. This review should determine whether there has been subjective improvement. If treatment is to continue, changing to thiamine 50mg qds should be considered, as higher doses of vitamin B have been associated with better results2. Vitamin B supplements are NOT recommended for use in the following circumstances: o

o o o o

Post ischaemic stroke6 (SIGN 108 – “Vitamin supplementation is not recommended in patients following ischaemic stroke. There is insufficient evidence to make a recommendation about vitamin therapy to prevent recurrent stroke. A study of Vitamin B12, B6 and folic acid therapy is ongoing” NB: these are not constituents of Vitamin B Compound or thiamine (Vit B1)). Leg cramps7 (“There is limited evidence that Vitamin B Complex improves leg cramps in elderly people n=28) Preventing insect bites8 Carpal tunnel9 Nausea and vomiting in pregnancy10

References

1. 2. 3. 4. 5. 6. 7. 8. 9.

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McGinley W et al. NHS D&G Alcohol Withdrawal – Identification and Treatment Guideline June 2010. Ang CD, Alviar MJM, Dans AL, Bautista-Velez GGP, Villaruz-Sulit MVC, Tan JJ, Co HU, Bautista MRM, Roxas AA. Vitamin B for treating peripheral neuropathy. Cochrane Database of Systematic Reviews 2008, Issue 3. NICE Guideline 96 Neuropathic Pain –the pharmaceutical management of neuropathic pain in adults in rd non-specialist settings. March 2010. www.nice.org.uk accessed 23 June 2010 rd SIGN Guidelines 116 Management of Diabetes, March 2010 www.sign.ac.uk accessed 23 June 2010 rd NICE guidelines 100 Alcohol Use Disorders, June 2010 www.nice.org.uk accessed June 23 2010 SIGN guidelines 108 Management of patients with stroke or TIA: assessment, investigation, immediate rd management and secondary prevention. December 2008. www.sign.ac.uk accessed June 23 2010 NHS Clinical Knowledge Summaries – Clinical Topic; Leg Cramps http://www.cks.nhs.uk/leg_cramps/management/scenario_leg_cramps/view_full_scenario accessed 23rd June 2010 NHS Clinical Knowledge Summaries – Clinical Topic; Malaria Prophylaxis http://www.cks.nhs.uk/malaria_prophylaxis/management/detailed_answers/measures_not_recommend rd ed_for_prevention# accessed 23 June 2010 NHS Clinical Knowledge Summaries – Clinical Topic; Carpal Tunnel Syndrome http://www.cks.nhs.uk/carpal_tunnel_syndrome/evidence/supporting_evidence/non_surgical_treatment rd _other_than_corticosteroid_injections_alone# Accessed 23 June 2010 NHS Clinical Knowledge Summaries – Clinical Topic; Nausea and vomiting in pregnancy http://www.cks.nhs.uk/nausea_vomiting_in_pregnancy/management/detailed_answers/treatments_not _recommended Accessed 23rd June 2010