O. Reg. 485/05: GENERAL

 

ontario regulation 485/05

made under the

drug interchangeability and dispensing fee act

Made: August 29, 2005
Filed: August 30, 2005
Printed in The Ontario Gazette: September 17, 2005

Amending Reg. 935 of R.R.O. 1990

(General)

1. (1) The definition of “Formulary” in subsection 1 (1) of Regulation 935 of the Revised Regulations of Ontario, 1990 is revoked and the following substituted:

“Formulary” means the Ministry of Health and Long-Term Care publication titled “Drug Benefit Formulary/Comparative Drug Index” (No. 39) dated September 27, 2005;

(2) Subsections 1 (2), (3), (4) and (5) of the Regulation are revoked.

(3) Section 1 of the Regulation is amended by adding the following subsections:

(2) For the purposes of this Regulation, Items 1339, 1341, 1342, 1343, 1344, 1345, 1346, 1347, 1348, 1349, 1350, 1351, 1352, 1353, 1354, 1356, 1357, 1360 and 1361 of Part III of the Formulary are revoked.

(3) For the purposes of this Regulation, Items 1330, 1331 and 1332 of Part III of the Formulary shall be read as follows:

 

1330	00030783	Depo-Testosterone 100mg/mL Oily Inj Sol-10mL Pk	UPJ	23.2100
1331	00029246	Delatestryl 1000mg/5mL Oily Inj Sol-5mL Pk	THE	22.8500
1332	00782327	Andriol 40mg Cap	ORG	0.9400
	Reason for Use Code	Clinical Criteria
	397	For male patients with confirmed low morning serum testosterone levels associated with documented, symptomatic hypothalamic, pituitary or testicular disease, or in HIV-infected patients.
		Note: Older males with nonspecific symptoms of fatigue, malaise, depression who have a low normal random testosterone level do not satisfy these criteria. LU authorization period:  1 year

(4) For the purposes of this Regulation, Items 1333, 1334, 1335, 1336, 1337, 1358 and 1359 of Part III of the Formulary shall be read as follows:

 

1333	02242878	Premplus 0.625mg/2.5mg Tab-28 Day Pk	WAY	7.0000
1334	02242879	Premplus 0.625mg/5mg Tab-28 Day Pk	WAY	7.0000
1335	02043394	Premarin 0.3mg Tab	WAY	0.1058
1336	00265470	C.E.S. 0.625mg Tab	ICN	0.0774
	02043408	Premarin 0.625mg Tab	WAY	0.1215
1337	00265489	C.E.S. 1.25mg Tab	ICN	0.1293
	02043424	Premarin 1.25mg Tab	WAY	0.2163
1358	02089769	Ogen 1.25 1.5mg Tab	UPJ	0.2804
1359	02089777	Ogen 2.5 3mg Tab	UPJ	0.4435
	Reason for Use Code	Clinical Criteria
	398	For short-term use in women who are experiencing symptoms of menopause.
		Note: Recent evidence has demonstrated that use of hormone replacement therapy (HRT) increases the rate of coronary events, breast cancer, dementia, stroke, venous thromboembolism and referrals for abnormal vaginal bleeding.  These risks should be discussed with patients and reviewed periodically. LU authorization period:  1 year

2. (1) Section 6 of the Regulation is amended by adding the following subsection:

(5.1) For the purposes of subsection (5), if a drug product has been designated by Health Canada as equivalent to the original product or to another listed interchangeable product with which it would be designated as interchangeable, the drug product shall be deemed to be pharmaceutically equivalent to the original product and to demonstrate the same physicochemical properties of the original product.

(2) Subsections 6 (6) and (7) of the Regulation are revoked and the following substituted:

(6) Clause (1) (c) does not apply with respect to a product that has been designated by Health Canada as equivalent to the original product or to another listed interchangeable product with which it would be designated as interchangeable unless the product is described in subsection (5).

(7) Clause (1) (h) does not apply to a product that is a solid oral dosage form for systemic effect and that has been designated by Health Canada as equivalent to the original product or to another listed interchangeable product with which it would be designated as interchangeable.

3.  (1)  Subject to subsections (2) and (3), this Regulation comes into force on filing.

(2)  Subsections 1 (1) and (2) and section 2 come into force on September 27, 2005. 

(3)  Subsection 1 (3) comes into force on March 1, 2006.