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Vol. 137, No. 41 — October 11, 2003 Regulations Amending the Food and Drug Regulations (1329 — Schedule F)Statutory Authority Food and Drugs Act Sponsoring Department Department of Health REGULATORY IMPACT Description The Therapeutic Products Directorate (TPD) of Health Canada intends to update Schedule F to the Food and Drug Regulations of the Food and Drugs Act by adding 19 medicinal ingredients to Part I of Schedule F, amending 4 medicinal ingredients in Part I of Schedule F, and transferring 1 medicinal ingredient from Part II to Part I of Schedule F. Schedule F is a list of substances, the sale of which is controlled under sections C.01.041 to C.01.046 of the Food and Drug Regulations. Part I of Schedule F lists substances that require a prescription for both human and veterinary use. Part II of Schedule F lists substances that require a prescription for human use, but do not require a prescription for veterinary use if so labelled or if in a form unsuitable for human use. The review and introduction of new drugs onto the Canadian market necessitates periodic revisions to Schedule F. The Therapeutic Products Directorate's Drug Schedule Status Subcommittee reviews the status of chemical entities proposed for marketing. A decision regarding the necessity for prescription versus nonprescription status was made for each of the substances listed in this proposed amendment on the basis of established and publicly available criteria. These criteria include, but are not limited to, concerns relating to toxicity, pharmacologic properties, and therapeutic applications. Proposed revisions to current listings on Parts I and II of Schedule F are also based on decisions made by this Subcommittee. New listings It is proposed that the following 19 substances be added to Part I of Schedule F: 1. Alteplase and its salts and derivatives — an enzyme used to dissolve blood clots. It is used to restore function to certain intravenous devices by dissolving obstructive blood clots. It is also used as a treatment for acute myocardial infarction (heart attack) and stroke. The safe use of alteplase requires initial physician diagnosis and assessment followed by monitoring for adverse reactions such as bleeding. 2. Anakinra and its salts and derivatives — an interleukin-1 receptor antagonist. Anakinra is used to treat adults with active rheumatoid arthritis to reduce the signs and symptoms of the disease. It can be used alone or in combination with other disease-modifying antirheumatic drugs. This drug should be used in patients only after diagnosis and appropriate assessment by a physician. Appropriate follow-up is required because use of anakinra has been associated with an increased incidence of serious infections. 3. Atipamezole and its salts — an alpha-2 adrenergic receptor antagonist. This drug is used to reverse the effects of alpha-2 adrenergic receptor agonists which are sedative agents for minor surgical or medical procedures or used as pre-anaesthetic agents. This drug should only be administered under the direct supervision of a practitioner. 4. Bimatoprost and its derivatives — a drug to reduce elevated pressure within the eye. Bimatoprost is used to treat patients who have elevated pressure within the eye, including glaucoma. It is for use in patients who cannot be treated with other pressure-lowering medication due to intolerance or insufficient response. Patients using this drug require diagnosis and regular monitoring by a physician. Glaucoma is a major cause of blindness if not diagnosed and treated properly. 5. Carprofen and its salts and derivatives — a non-steroidal anti-inflammatory drug (NSAID). Carprofen is indicated for use in dogs for the relief of pain and inflammation associated with osteoarthritis. Professional veterinary expertise is required to diagnose osteoarthritis in dogs. Carprofen can cause severe (life-threatening) adverse effects at normal therapeutic dosage levels in dogs. Professional veterinary expertise is required to monitor treated dogs for signs of adverse reactions. 6. Ganirelix and its salts and derivatives — a gonadotropin-releasing hormone (GnRH) antagonist. Ganirelix is used as part of the treatment for assisted reproduction techniques including in-vitro fertilisation (IVF — fertilization of an egg in a test tube). Ganirelix allows the release of an egg to be controlled so that it occurs at an optimal time for pregnancy to occur. Although the product may be self-administered by the patient, ganirelix requires direct physician supervision and continuous laboratory monitoring. 7. Glimepiride — an oral hypoglycemic agent. Glimepiride is used to lower the blood glucose of patients with type 2 diabetes whose high blood glucose levels cannot be controlled by diet and exercise alone. The safe use of glimepiride requires initial physician diagnosis and assessment followed by regular monitoring of the drug's effectiveness and side effects. 8. Medetomidine and its salts — a alpha-2 adrenergic receptor agonist. Medetomidine is used in animals as a sedative agent for minor surgical or medical procedures or a pre-anaesthetic agent. This drug should only be administered under the direct supervision of a veterinarian. The drug possesses the potential for undesirable or severe side effects at normal therapeutic dosage levels. 9. Moxidectin and its derivatives — an antiparasitic drug. This drug is used for the prevention of heartworm in dogs. The safe use of moxidectin involves testing for existing heartworm infection by a licenced veterinarian before administration of the drug. 10. Orbifloxacin and its salts and derivatives — a synthetic broad spectrum antibacterial agent. Orbifloxacin is used for the treatment of skin and soft tissue infections in dogs and cats and for the treatment of urinary tract infections in dogs. Professional veterinary expertise is required to diagnose and treat infections in these animals. 11. Palivizumab — a humanized monoclonal antibody produced by recombinant DNA technology. This drug is administered by monthly intramuscular injections to high-risk children for the prevention of serious lower respiratory tract disease caused by respiratory synctial virus. The safe and effective use of palivizumab requires initial diagnosis by a physician and monitoring for side effects. 12. Romifidine and its salts — a potent alpha-2 adrenergic receptor agonist. Romifidine is used in animals as a sedative agent and for pain relief during minor surgical or medical procedures or as a pre-anaesthetic agent. This drug should only be administered under the direct supervision of a veterinarian. The drug possesses the potential for undesirable or severe side effects at normal therapeutic dosage levels. 13. Tegaserod and its salts — a 5-HT4 receptor partial agonist. Tegaserod is used to treat the symptoms of irritable bowel syndrome with constipation in female patients whose main symptoms are constipation and abdominal pain and/or discomfort. A physician's diagnosis and supervision is necessary to ensure that the appropriate individuals receive the medication for the appropriate period of time. A physician must monitor the duration and severity of the side effects that may be associated with the use of tegaserod and take corrective action if necessary. 14. Thyrotropin alfa — human thyroid-stimulating hormone produced by recombinant DNA technology. Thyrotropin alfa is a diagnostic tool used in conjunction with other tests in the follow-up of patients with certain kinds of thyroid cancer. The use of thyrotropin alfa should be directed by physicians knowledgeable in the management of patients with thyroid cancer. 15. Tiotropium bromide — anticholinergic agent. Tiotropium bromide is a bronchodilator for the treatment of chronic obstructive pulmonary disease including chronic bronchitis and emphysema. The safe and effective use of tiotropium requires initial diagnosis by a physician, followed by continued supervision to assess effectiveness and monitor for side effects. 16. Tolfenamic acid and its salts and derivatives — a non-steroidal anti-inflammatory drug (NSAID). Tolfenamic acid is used to alleviate inflammation and pain associated with osteoarthritis in dogs with hip dysplasia. It is also used as an aid in the treatment of upper respiratory diseases and as symptomatic treatment of fever in cats. Tolfenamic acid was approved for use without prescription in dogs in 1997 and in cats in 1999. Some adverse reactions with serious consequences have been reported following use in these animals. Changes in product labelling are being required to address target species safety concerns. In addition, the Veterinary Drugs Directorate is recommending that tolfenamic acid be added to Schedule F. Professional veterinary expertise is required for appropriate use of the drug and to monitor treated animals for signs of adverse reactions. 17. Unoprostone and its salts and derivatives — a drug to reduce elevated pressure within the eye. Unoprostone is used to treat patients who have elevated pressure within the eye, including glaucoma. It is for use in patients who cannot be treated with other pressure-lowering medication due to intolerance or insufficient response. Patients using this drug require diagnosis and regular monitoring by a physician. Glaucoma is a major cause of blindness if not diagnosed and treated properly. 18. Valdecoxib and its salts — a nonsteroidal anti-inflammatory drug (NSAID). Valdecoxib is used to treat the signs and symptoms of osteoarthritis and rheumatoid arthritis in adults. It is also indicated for the relief of menstrual pain. The safe and effective use of valdecoxib requires the supervision of a physician to monitor side effects and adverse reactions. 19. Valganciclovir and its salts and derivatives — an antiviral agent. Valganciclovir is used to treat inflammation of the retina of the eye caused by cytomegalovirus (CMV) in patients with acquired immunodeficiency syndrome (AIDS). Specialized ophthalmology equipment and knowledge are required to make the diagnosis of CMV retinitis. There is a narrow margin of safety between therapeutic and toxic doses of this drug. Close monitoring of blood counts while on therapy is important. Revised listings It is proposed that the listings of five ingredients presently included in Schedule F be revised: Amfebutamone It is proposed that "Amfebutamone and its salts" be removed from Part I of Schedule F and replaced with "Bupropion and its salts." International Nonproprietary Names (INN) are assigned by the World Health Organization and are the only internationally accepted generic names for medicinal ingredients. When available, the INN is used exclusively in identifying medicinal ingredients on Schedule F. Amfebutamone was the INN assigned in 1973 for the medicinal ingredient also known as bupropion. In 2001, bupropion was adopted as the INN for this medicinal ingredient to replace amfebutamone. To be consistent, Health Canada is amending Part I of Schedule F to reflect this change. Melarsomine As no human use has been identified for this ingredient, it is proposed that the listing of Melarsomine be amended to exclude human use on Part I of Schedule F. Therefore, the amended description would now be: Melarsomine and its salts, when sold for the treatment of heartworm in dogs.
Omeprazole It is proposed that Omeprazole in Part I of Schedule F be amended to include its salts: Omeprazole and its salts
Praziquantel This drug currently is listed in Part I of Schedule F without any qualifications or exceptions. That means a prescription is required for all human and veterinary uses. Praziquantel is an antiparasitic drug. The indications for use of this drug have been extended to include treatment of horses infected with the tapeworm Anoplocephala perfoliata. This use is not considered to require veterinary supervision. It is therefore proposed that this use in horses be excluded from Part I of Schedule F. The proposed wording is: Praziquantel, except when sold for the treatment of the tapeworm Anoplocephala perfoliata in horses.
Ivermectin Ivermectin is listed currently in Part II of Schedule F as:
It is proposed that the listing in Part II of Schedule F be moved to Part I while keeping the same status regarding its use in horses and dogs. This is in keeping with an ongoing clean-up of Schedule F to eliminate inconsistencies and to remove potentially confusing "exception listings" from Part II. In addition, it is proposed to amend the listing in Part I to include the derivatives of ivermectin and to add a restriction regarding veterinary use in cats. The proposed new listing is: Ivermectin and its derivatives, for human use or for veterinary use when sold for intramuscular injection into horses or for oral administration to dogs and cats.
Alternatives This recommended degree of regulatory control coincides with the risk factors associated with each specific substance. The review of the information filed by the sponsor of these drugs has determined that prescription status is required at this time. Advice from a medical practitioner is necessary to ensure that consumers receive adequate risk/benefit information before taking the medication. Any alternatives to the degree of regulatory control recommended in this initiative would have to be established through additional scientific information and clinical experience. No other alternatives were considered. Benefits and Costs The amendment would impact on the following sectors: Public Prescription access to the drugs affected by Schedule 1329 would benefit Canadians by decreasing the opportunities for improper use, and by ensuring professional guidance and care. The Pharmaceutical Industry The classification of these drugs as prescription products would limit their sale subject to the provision of the advice of a practitioner, thereby reducing misuse and decreasing liability to the manufacturer. Health Insurance Plans These drugs, when assigned prescription status, may be covered by both provincial and private health care plans. Provincial Health Care Services The provinces may incur costs to cover physicians fees for services. However, the guidance and care provided by the physicians would reduce the need for health care services that may result from improper use of the drugs. The overall additional costs for health care services should therefore be minimal. Consultation The manufacturers affected by this proposed amendment were informed of the intent to recommend these substances for inclusion on Schedule F at the time of market approval of the drugs. Direct notice of this regulatory proposal was provided to the Provincial Ministries of Health, medical and pharmacy licensing bodies, and industry associations on July 10, 2003, with a 30-day comment period. This initiative was also posted on the Therapeutic Products Directorate Web site. No comments from external stakeholders were received. A 75-day comment period will be provided upon prepublication in the Canada Gazette, Part I. Compliance and Enforcement This amendment would not alter existing compliance mechanisms under the provisions of the Food and Drugs Act and the Food and Drugs Regulations enforced by the Health Products and Food Branch Inspectorate. Contact Karen Ash, Policy Division, Bureau of Policy, Therapeutic Products Directorate, 1600 Scott Street, Holland Cross, Tower B, 2nd Floor, Address Locator 3102C5, Ottawa Ontario K1A 1B6, (613) 957-6455 (Telephone), (613) 941-6458 (Facsimile), Karen_Ash@hc-sc.gc.ca (Electronic mail). PROPOSED REGULATORY TEXT Notice is hereby given that the Governor in Council, pursuant to subsection 30(1) (see footnote a) of the Food and Drugs Act, proposes to make the annexed Regulations Amending the Food and Drug Regulations (1329 — Schedule F). Interested persons may make representations with respect to the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Karen Ash, Policy Division, Bureau of Policy, Therapeutic Products Directorate, Address Locator 3102C5, 1600 Scott Street, Holland Cross, Tower B, 2nd Floor, Ottawa, Ontario K1A 1B6 (tel.: (613) 957-6455; fax: (613) 941-6458; e-mail: Karen_Ash@hc-sc.gc.ca). Persons making representations should identify any of those representations the disclosure of which should be refused under the Access to Information Act, in particular under sections 19 and 20 of that Act, and should indicate the reasons why and the period during which the representations should not be disclosed. They should also identify any representations for which there is consent to disclosure for the purposes of that Act. Ottawa, October 9, 2003
EILEEN BOYD
REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1329 — SCHEDULE F) AMENDMENTS 1. The reference to Amfebutamone and its salts Amfébutamone et ses sels in Part I of Schedule F to the Food and Drug Regulations (see footnote 1) is repealed. 2. The reference to Melarsomine and its salts, for human use, or for veterinary use in the treatment of heartworm in dogs
in Part I of Schedule F to the Regulations is replaced by the following: Melarsomine and its salts, when sold for the treatment of heartworm in dogs
3. The reference to Omeprazole
in Part I of Schedule F to the Regulations is replaced by the following: Omeprazole and its salts
4. The reference to Praziquantel
in Part I of Schedule F to the Regulations is replaced by the following: Praziquantel, except when sold for the treatment of the tapeworm Anoplocephala perfoliata in horses
5. Part I of Schedule F to the Regulations is amended by adding the following in alphabetical order: Alteplase and its salts and derivatives
Anakinra and its salts and derivatives
Atipamezole and its salts
Bimatoprost and its derivatives
Buproprion and its salts
Carprofen and its salts and derivatives
Ganirelix and its salts and derivatives
Glimepiride
Ivermectin and its derivatives, for human use or for veterinary use when sold for intramuscular injection into horses or for oral administration to dogs and cats
Medetomidine and its salts
Moxidectin and its derivatives, when sold for the prevention of heartworm in dogs
Orbifloxacin and its salts and derivatives
Palivizumab
Romifidine and its salts
Tegaserod and its salts
Thyrotropin alfa
Tiotropium bromide
Tolfenamic acid and its salts and derivatives
Unoprostone and its salts and derivatives
Valdecoxib and its salts
Valganciclovir and its salts and derivatives
6. The reference to Ivermectin, except when sold or recommended for intramuscular injection into horses or for administration to dogs
in Part II of Schedule F to the Regulations is repealed. COMING INTO FORCE 7. These Regulations come into force on the day on which they are registered. [41-1-o] S.C. 1999, c. 33, s. 347 C.R.C., c. 870 |
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