Common use of Action to be Taken Clause in Contracts

Action to be Taken. WBC <4.0X10 9/1 withhold until discussed with rheumatology team Neutrophils <2x109/1 withhold until discussed with rheumatology team Platelets <150x109/1 withhold until discussed with rheumatology team >2-fold rise in AST, ALT (from upper limit of reference range) withhold until discussed with rheumatology team Unexplained fall in albumin withhold until discussed with rheumatology team Rash or oral ulceration withhold until discussed with rheumatology team New or increasing dyspnoea or cough withhold until discussed with rheumatology team MCV>105fl Investigate and if B12 or folate low start appropriate supplementation Significant deterioration in renal function Reduce dose Abnormal bruising or sore throat Withhold until FBC result available Please note that in addition to absolute values for haematological indices a rapid fall or a consistent downward trend in any value should prompt caution and extra vigilance. SUPPORTING INFORMATION The National Patient Safety Agency has published actions to reduce the risks associated with oral methotrexate (see website). Side Effects Low-dose methotrexate may be associated with a number of serious adverse effects, including: • hepatotoxicity • pulmonary toxicity • bone-marrow toxicity Other common non-life-threatening adverse effects of low-dose methotrexate are those affecting the gastrointestinal system (nausea, diarrhoea and stomatitis), and the central nervous system (headaches, drowsiness, blurred vision). The risk of minor adverse effects may be reduced by giving regular folic acid. An annual influenza vaccination is recommended. Guidance for Women of child-bearing age Methotrexate is teratogenic and female patients of child-bearing age should be prescribed or offered contraception. If patients wishes to start a family, it is advised that they stop the methotrexate for 3 to 6 months before conception. Drug interactions Methotrexate is extensively protein-bound and may be displaced by other protein-bound drugs (e.g. diuretics, salicylates, hypoglycaemics), with a potential for increased toxicity. Concomitant use of other drugs with nephrotoxic or hepatotoxic potential (including alcohol) should be avoided. Folate antagonists such as trimethoprim should not be given concomitantly. The British Society for Rheumatology Guidelines state that NSAIDs are not contraindicated with the above doses of methotrexate. References Prescribing and monitoring of Disease. DMARDs for inflammatory arthritis. Arthritis Research Council, No 8 May 2002 National Guidelines for the Monitoring of Second Line Drugs. British Society for Rheumatology. July 2000. MTRAC guidance VS97/15. National Patient Safety Agency. xxx.xxxx.xxx.xx Wyeth Pharmaceuticals. Methotrexate sodium tablets 2.5 mg. Summary of Product Characteristics 2003.

Action to be Taken. WBC <4.0X10 9/1 withhold until discussed with rheumatology team Neutrophils <2x109/1 withhold until discussed with rheumatology team Platelets <150x109/1 withhold until discussed with rheumatology team >2-fold rise in AST, ALT (from upper limit of reference range) withhold until discussed with rheumatology team Unexplained fall in albumin withhold until discussed with rheumatology team Rash or oral ulceration withhold until discussed with rheumatology team New or increasing dyspnoea or cough withhold until discussed with rheumatology team MCV>105fl Investigate and if B12 or folate low start appropriate supplementation Significant deterioration in renal function Reduce dose Abnormal bruising or sore throat Withhold until FBC result available Please note that in addition to absolute values for haematological indices a rapid fall or a consistent downward trend in any value should prompt caution and extra vigilance. SUPPORTING INFORMATION The National Patient Safety Agency has published actions to reduce the risks associated with oral methotrexate (see website). Side Effects Low-dose methotrexate may be associated with a number of serious adverse effects, including: •  hepatotoxicity •  pulmonary toxicity •  bone-marrow toxicity Other common non-life-threatening adverse effects of low-dose methotrexate are those affecting the gastrointestinal system (nausea, diarrhoea and stomatitis), and the central nervous system (headaches, drowsiness, blurred vision). The risk of minor adverse effects may be reduced by giving regular folic acid. An annual influenza vaccination is recommended. Guidance for Women of child-bearing age Methotrexate is teratogenic and female patients of child-bearing age should be prescribed or offered contraception. If patients wishes to start a family, it is advised that they stop the methotrexate for 3 to 6 months before conception. Drug interactions Methotrexate is extensively protein-bound and may be displaced by other protein-bound drugs (e.g. diuretics, salicylates, hypoglycaemics), with a potential for increased toxicity. Concomitant use of other drugs with nephrotoxic or hepatotoxic potential (including alcohol) should be avoided. Folate antagonists such as trimethoprim should not be given concomitantly. The British Society for Rheumatology Guidelines state that NSAIDs are not contraindicated with the above doses of methotrexate. References Prescribing and monitoring of Disease. DMARDs for inflammatory arthritis. Arthritis Research Council, No 8 May 2002 National Guidelines for the Monitoring of Second Line Drugs. British Society for Rheumatology. July 2000. MTRAC guidance VS97/15. National Patient Safety Agency. xxx.xxxx.xxx.xx Wyeth Pharmaceuticals. Methotrexate sodium tablets 2.5 mg. Summary of Product Characteristics 2003.

Action to be Taken. WBC <4.0X10 9/1 withhold until discussed with rheumatology gastroenterology team Neutrophils <2x109/1 withhold until discussed with rheumatology gastroenterology team Platelets <150x109/1 withhold until discussed with rheumatology gastroenterology team >2-fold rise in AST, ALT (from upper limit of reference range) withhold until discussed with rheumatology gastroenterology team Unexplained fall in albumin withhold until discussed with rheumatology gastroenterology team Rash or oral ulceration withhold until discussed with rheumatology gastroenterology team New or increasing dyspnoea or cough withhold until discussed with rheumatology gastroenterology team MCV>105fl Investigate and if B12 or folate low start appropriate supplementation Significant deterioration in renal function Reduce / Stop dose and consult with hospital team. Abnormal bruising or sore throat Withhold until FBC result available and consult with hospital team. Please note that in addition to absolute values for haematological indices a rapid fall or a consistent downward trend in any value should prompt caution and extra vigilance. SUPPORTING INFORMATION The National Patient Safety Agency has published actions to reduce the risks associated with oral methotrexate (see website). Side Effects Low-dose methotrexate may be associated with a number of serious adverse effects, including: • hepatotoxicity • pulmonary toxicity • bone-marrow toxicity Other common non-life-threatening adverse effects of low-dose methotrexate are those affecting the gastrointestinal system (nausea, diarrhoea and stomatitis), and the central nervous system (headaches, drowsiness, blurred vision). The risk of minor adverse effects may be reduced by giving regular folic acid. An annual influenza vaccination is recommended. Guidance for Women of child-bearing age Methotrexate is teratogenic and female patients of child-bearing age should be prescribed or offered contraception. If patients wishes to start a family, it is advised that they stop the methotrexate for several ( at least 3 to 6 ) months before conception. Drug interactions Methotrexate is extensively protein-bound and may be displaced by other protein-bound drugs (e.g. diuretics, salicylates, hypoglycaemics), with a potential for increased toxicity. Concomitant use of other drugs with nephrotoxic or hepatotoxic potential (including alcohol) should be avoided. Folate antagonists such as trimethoprim should not be given concomitantly. The British Society for Rheumatology Guidelines state that NSAIDs are not contraindicated with the above doses of methotrexate. References Prescribing and monitoring of Disease. DMARDs for inflammatory arthritis. Arthritis Research Council, No 8 May 2002 National References: ECCO Consensus Guidelines for the Monitoring IBD 2010. El-Matary W, Vandermeer B, Xxxxxxxxx AM. Methotrexate for maintenance of Second Line Drugsremission in ulcerative colitis. British Society Cochrane Database of Systematic Reviews 2009, Issue 3. Art. No.: CD007560. DOI: 10.1002/14651858.CD007560.pub2. Xxxxx V, XxxXxxxxx XX, XxXxxxxx JWD, Xxxxxx N. Methotrexate for Rheumatologymaintenance of remission in Crohn's disease. July 2000Cochrane Database of Systematic Reviews 2009, Issue 4. MTRAC guidance VS97/15Art. No.: CD006884. DOI: 10.1002/14651858.CD006884.pub2. BNF 59 March 2010 National Patient Safety Agency. xxx.xxxx.xxx.xx Wyeth Pharmaceuticals. Methotrexate sodium tablets 2.5 mg. Summary of Product Characteristics 2003.