Drug Bulletin - October 2001

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The Non-Insured Health Benefits (NIHB) Program provides supplementary
health benefits,prescription and non-prescription drugs, for registered
Indians, and recognized Inuit and Innu throughout Canada.

Additions to the Drug Benefit List (Full Benefits)
(Effective October 1, 2001)

1. Eprosartan, tablet, 300mg, 400mg, 600mg (Teveten - Solvay)
   
   Eprosartan is the sixth angiotension II receptor antagonist in Canada and has similar efficacy, tolerability and side effect profile as the others. It is indicated for the treatment of mild to moderate essential hypertension, alone or concomitantly with thiazide diuretics. It is normally used in patients in whom treatment with diuretics or beta blockers is contraindicated or found to be ineffective or in patients who have experienced side effects with ACE inhibitors. Other "sartans" covered by NIHB include candesartan, irbesartan, losartan, telmisartan and valsartan.
   
   
2. Ethinyl estradiol / norethindrone acetate, tablet, 5mcg / 1mg (FemHRT - Pfizer)
   
   This product delivers a continuous combined estrogen-progestin combination regimen via the oral route. FemHRT is indicated in women with an intact uterus for the relief of menopausal and postmenopausal symptoms in naturally or surgically induced estrogen deficiency states; for the prevention of osteoporosis in naturally or surgically induced estrogen deficiency states; for symptomatic treatment of vulvular and vaginal atrophy associated with menopause. As this product is more costly than other listed oral hormone replacement therapy, it should be used when these agents are not tolerated.
   
   
3. Estradiol / norethindrone acetate, transdermal patch, 0.51mg / 4.8mg; 0.62mg / 2.7mg (Estalis - Novartis)
   
   Estalis is indicated for the relief of menopausal and postmenopausal symptoms occurring in naturally or surgically induced estrogen deficiency states. Estalis is the first combination estrogen/ progestin transdermal patch developed for use in a continuous-wear dosage regimen. It offers an alternative to the sequential-wear transdermal patches for postmenopausal women; however, it can be used in a sequential regimen in combination with an estradiol-only transdermal delivery system. Estalis should be used only in patients with an intact uterus. As this product (as well as other transdermal products) is more costly than oral hormone replacement therapy, it should be used when oral hormone replacement therapy is contraindicated or not tolerated.
   
   
4. Conjugated estrogens, tablet, 0.625mg and medroxyprogesterone acetate, tablet, 2.5mg (PremPlus - Wyeth-Ayerst)
   
   PremPlus provides conjugated estrogens and medroxyprogesterone as separate tablets in compliance packaging. PremPlus is indicated in women with an intact uterus for the relief of menopausal and postmenopausal symptoms in naturally or surgically induced estrogen deficiency states; for the prevention of osteoporosis in naturally or surgically induced estrogen deficiency states; for treatment of vulvular and vaginal atrophy associated with menopause.
   
   
5. Levonorgestrel, intrauterine device, 52mg (Mirena - Berlex)
   
   Mirena is a levonorgestrel releasing intrauterine system, indicated for contraception. It is effective for up to 5 years. It is not the contraceptive method of first choice for young nulligravid women.
   
   
6. Exemestane, tablet, 25mg (Aromasin - Pharmacia)
   
   Exemestane is an oral irreversible aromatase inhibitor. It is indicated for the hormonal treatment of advanced breast cancer in women with natural or artificially induced postmenopausal status whose disease has progressed following antiestrogen therapy.

New Limited Use Benefits
(Effective October 1, 2001)

Pioglitazone, tablet, 15mg, 30mg, 45mg (Actos - Eli Lilly)

Pioglitazone, the second "glitazone" available on the Canadian market, is indicated as monotherapy in patients with type 2 diabetes mellitus who are not controlled by diet and exercise alone. The cost of both, pioglitazone and rosiglitazone, is significantly greater than that of other listed oral hypoglycemic drugs. The criteria for coverage are: for treatment of type 2 diabetic patients who are not adequately controlled by or are intolerant of metformin and sulfonylureas or for whom these products are contraindicated.

CORRECTION OF CRITERIA

Please note that the criteria for coverage for
Ciprofloxacin/ hydrocortisone ear drops, 2mg/ 10mg per ml (Cipro HC Otic-Alcon) are:

• failure to respond to other listed antibiotics
• contraindications to other listed antibiotics

Chloral Hydrate Status Changing from Full Benefit to Exception Drug (Effective November 1, 2001)

Effective November 1, 2001, chloral hydrate will no longer be available as a full benefit. It will be available as an exception drug with requests for coverage considered on an individual basis.

A review of the utilization trends of chloral hydrate by the NIHB Program indicates that a small number of clients are receiving large numbers of prescriptions and large quantities of chloral hydrate per prescription. According to the product monograph in the Compendium of Pharmaceuticals and Specialties (CPS) 2001, chloral hydrate should be use as a hypnotic for short term use only, usually 2 to 7 days. Because of the propensity of chloral hydrate for rapid development of tolerance, fatalities by overdose, development of physical and psychological dependence, withdrawal syndromes and significant drug interactions, the NIHB Program is changing the status of this drug from a full benefit to one that requires prior approval.

Note: Sudden withdrawal after prolonged use may result in hallucinations and symptoms similar to delirium tremens. This can be serious and even fatal. It is recommended that to avoid these types of reactions, the dose of chloral hydrate should be reduced gradually over several days. If additional supply is required, the Drug Exception Centre should be contacted to obtain prior approval for this drug. An emergency supply can be provided when timely access to the Centre is not possible (e. g. statutory holidays).