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ESSENTIAL FOR THE EXAM
BNF CSM WARNINGS

ESSENTIAL CSM WARNINGS YOU NEED TO KNOW FOR THE EXAM

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Osteoporosis
Those at risk of osteoporosis should maintain an adequate intake of calcium and vitamin D and any defieciency should be corrected by increasing dietary intake or taking supplements.

Bisphosphonates (Alendranate, risadronate)
Bisphosphonates are recommended as treatment options for the secondary prevention of osteoporotic fractures in susceptiblepostmenopausal women. In women who cannot take a bisphosphonate or who have suffered a fragility fracture despite treatment for a year and whose bone mineral density declines below the pre-treatment level, the selective oestrogen receptor modulator raloxifene is an alternative. The parathyroid hormone fragment teriparatide is recommended for women over 65 years who cannot take a bisphosphonate (or in whom bisphosphonates has failed to prevent a fracture) and have:

bulleteither an extremely low bone mineral density
bulletor a very low bone mineral density, sufferent more than 2 fractures, and have other risk factors for fractures (e.g body mass index under 19kg/m2, premature menopause, prolonged immobility, history of mineral hip fracture under the age of 75 years)

 

Induction of labour
Dinoprostone is preferable to oxytocin for induction in women with intact membranes, regardless or parity or cervical favourability.

Parental progesterone-only contraceptive
The CSM has advised that:

bulletin adolescents, medroxyprogesterone acetate (Deop-provera) be under only when other methods of contraception are inappropriate.
bulletIn all women, benfits of using medroxyprogesterone beyond 2 years should be evaluated again risks.
bulletIn women with risk factors for osteoporosis a method of contraception other than medroxyprogesterone acetate should be considered.

Spermicial contraceptives
Products such as petroleum jelly (Vaseline), baby oil and oil-based vaginal and rectal preparations are likely to damage condoms and contraceptive diaphragms made from latex rubber, and may render them less effective as a barrier method of contraception and as a protection from sexually transmitted diseases (including HIV).

CRM guildelines on handling cytotoxic drugs:

  1. Trained personnel should reconstitute cytotoxics;
  2. Reconstitution should be carried out in designated area;
  3. Protective clothing (including gloves) should be worn;
  4. The eyes should be protected and means of first aid should be specified;
  5. Pregnant staff should not handle cytotoxics
  6. Adequate care should be taken in the disposal of waste material, including syringes, containers, and absorbent material.

Most cytotoxic drugs are teratogenic and all may cause life-threatening toxicity; administration should, where possible be confined to those experienced in their use.
Because of the complexity of dosage regimens in the treatment of malignant disease, dose statements have been omitted from some of the drug entries in this chapter. In all cases detailed specialist literature should be consulted.
Presciptions should not be repeated except on the instructions of a specialist.

Ciclosporin
Because of differences in bioavailability, the brand of oral ciclosporin to be dispensed should be specified by the prescriber.

Anastrozole
The aromatase inhibitors anastrazole, exemestane, and letrozole, within their licensed indications, are recommended as options for the adjuvant treatment of early oestrogen-receptor-postitive invasive breast cancer in postmenopausal women.

Drugs with definite risk of haemolysis in most G6PD-deficient individuals (from Afriva, Asia, Oceania,? and from south Europe):
Dapson and other sulphones, Methylthionium chloride, Nitrofurantion, Pamaquin, Primaquin, Quinolones, Sulphonamides.
Possible risk:
Aspirin, Chloroquine, Menadione, Probenecid, Quinidine, Quinine

 

Thiamine
Although potentially serious allergic adverse reactions may rarely occur during, or shortly after, parenteral administration, the CHM has recommended that:

  1. This should not preclude the use of parenteral thiamine in patients where this route of administration is required, particularly in patients at risk of Wenicke-Korsakoff syndrome where treatment with thiamine is essential;
  2. Intravenous administration should be by infusion over 30 minutes;
  3. Facilities for treating anaphylaxis (including resuscitation facilities) should be available when parental thiamine is administered.

Pyridoxine Hydrochloride
Pyridoxine is used to treat isoniazid neuropathy. However prolonged use of pyridoxine in dose of 10mg daily is considered safe but the long-term use of pyridoxine in a dose of 200mg or more daily has been associated with neuropathy. The safety of long-term pyroxidine supplements with doses above 10mg daily has not been established.

NSAIDS and cardiovascular events
COX-2 selective inhibitors are associated with an increased risk of thrombotic events (e.g MI and stroke) and should not be used in preference to non-selective NSAIDS except when specifically indicated (i.e for patients at a particularly high risk of developing gastroduodenal ulceration or bleeding) and after assessing their cardiovascular risk.
Non-selective NSAIDs may also be associated with a small increased risk of thrombotic evens particularly when used at high doses and for long-term treatment. Diclofenac (150mg daily) and ibuprofen (2.4g daily) are associated with an increased risk of thrombotic events. The increased risk for diclofenac is similar to that of licensed doses of etoricoxib. Naproxen is associated with an increased risk of myocardial infarction. A small increased thrombotic risk cannot be excluded for other NSAIDs.
The lowest effective dose of NSAID or COX-2 selective inhibitor should be prescribed for the shortest period to control symptoms and that the need for long-term treatment should be reviewed periodically.

Piroxicam
The CHMP has recommended restrictions on the use of piroxicam because of the increased risk of gastro-intestinal side effects and serious skin reactions. The CHMP has advised that

bulletPiroxicam should be initiated only by physicians experienced in treating inflammatory or degenerative rheumatic diseases
bulletPiroxicam should not be used as first-line treatment
bulletIn adults, use of piroxicam should be limited only to the symptomatic relief of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis
bulletPiroxicam dose should not exceed 20mg daily
bulletPiroxicam should no longer be used for the treatment of acute painful and inflammatory conditions
bulletTreatment should be reviewed 2 weeks after initiating piroxicam and periodicallt therafter
bulletConcomitant administration of a gastro-protective agent should be considered

Topical preparations containing piroxicam are not affected by these restrictions

Tiaprofenic acid
May cause sever cystisis, stop treatment if symptoms occur.

Methotrexate
In view of reports of dycrasias (including fatalities) and liver cirrhosis with low-dose methotrexate, the CSM has advised:

bulletFull blood count and renal and liver function tests before starting treatment and repeated weekly until theraphy stabilised, thereafter patients should be monitored every 2-3 months
bulletThat patients should be advised to report all symptoms and signs suggestive of infection, especially sore throat.

Treatment with folinic acid(calcium folinate) may be required in acute toxicity.

The patient must be warned to report immediately the onset of any feature of blood disorders (e.g sore throat, bruising, and mouth mulcers), liver toxicity (e.g nausea, vomiting, abdominal discomfort, and dark urine), and respiratory effects (e.g shortness of breath)

Co-cyprindiol
Venous thromboembolism occurs more frequently in women taking co-cyprindiol than those taking a low-dose combines oral contraceptive. The CSM has reminded prescribers that co-cyprindiol is licensed for use in women with severe acne which has not responded to oral antibacterials and for moderately severe hirsutism; it should not be used solely for contraception. It is contra-indicated in those with a personal or close family history of venous thromboembolism. Women with severe acne or hirsutism may have an inherently increased risk of cardiovascular disease.
Contra-indicated in pregnancy and a predisposition to thrombosis.

Sun-screen
For optimum photoprotection, sunscreen preparations should be applied thickly and frequently (approx 2 hourly). In photodermatoses, they should be used from spring to autumn. As maximum protection from sunlight is desirable, preparations with the highests SPF should be prescribed.

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ESSENTIAL CSM WARNINGS YOU NEED TO KNOW FOR THE EXAM

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