Abstracts - BIS

medicinal ingredients as natural health products pursuant to the Natural Health Products Regulations.Description of the medicinal ingredients:Dopamine and its salts — The current listing for dopamine and its salts would be revised to retainprescription status for injectable (parenteral) forms of dopamine and its salts. All other dosage forms androutes of administration at any strength and for any use would be exempt from prescription status.Dopamine is inactive in the body when administered orally. Therefore, there are no oral drug productscontaining dopamine on the market in Canada. Revising the prescription status of dopamine would mitigateissues with the licensing of orally administered natural health products with ingredients that might naturallycontain trace amounts of dopamine.Dopamine is administered by intravenous injection to treat kidney failure, septic shock and acute heartfailure resulting from a heart attack. It works by increasing blood pressure, heart rate and force of heartcontraction, and by causing constriction of blood vessels. Administration of dopamine by injection requiresdirect supervision by a practitioner and can cause serious adverse effects in the therapeutic dosage range.Retaining prescription status for injectable forms of dopamine and its salts is therefore recommended.Gold and its salts — The current listing for gold and its salts would be revised to retain prescription status forinjectable (parenteral) forms of gold and its salts and derivatives. The revised listing would be worded sothat it would not change the status of auranofin, an orally administered gold derivative that is listedseparately in Schedule F. Gold and its salts and derivatives in any other dosage form or route ofadministration at any strength and for any use would be exempt from prescription status.Gold is naturally occurring in trace amounts in nature, so it is appropriate to add qualifiers to the listing onSchedule F to avoid unintentionally subjecting products containing trace amounts of gold to prescriptionrequirements where it is not necessary.As prescription drugs, gold compounds are administered parenterally (by injection) to treat rheumatoidarthritis in patients for whom other treatments have been unsuccessful. Gold compounds administered bythe parenteral route can have undesirable side effects at normal therapeutic dosage levels and requiredirect practitioner supervision and routine laboratory monitoring.Lovastatin — The current listing for lovastatin would be revised to retain prescription status for all strengthsand dosage forms except when lovastatin is sold in oral dosage form that provides less than 1.0 mg perdosage unit or per daily dose. Oral dosage forms containing less than 1.0 mg of lovastatin would be exemptfrom prescription status.The proposed exemption for less than 1.0 mg is only 10% of the lowest therapeutic dose of 10 mg oflovastatin. This would allow red yeast rice products containing only trace amounts of lovastatin to bemarketed as natural health products in Canada. Red yeast rice is derived from yeast grown on rice and isused as food in some Asian countries. It contains several substances, including lovastatin, known to reducecholesterol.As a prescription drug, lovastatin is available in Canada and is used to treat high cholesterol and is usuallygiven in an initial dose of 10 to 20 mg daily, increased, if necessary, over a period of time to 80 mg daily toachieve target cholesterol levels.Uracil and its salts — The current listing for uracil and its salts would be revised to retain prescription statusfor uracil and its salts when sold for the treatment of cancer. Uracil and its salts for other uses at anystrength, dosage form or route of administration would be exempt from prescription status. Uracil is found inall living organisms so its listing in Schedule F without qualifiers is inappropriate.Uracil has been used as a prescription drug in conjunction with other anti-cancer drugs to enhanceantitumour activity and to reduce adverse effects. However, this therapeutic use is not currently in practicein Canada. If uracil were used in the treatment of cancer it would require the supervision of a practitionerand laboratory monitoring.Schedule F is a list of medicinal ingredients, the sale of which is controlled under sections C.01.041 toC.01.049 of the Food and Drug Regulations. Part I of Schedule F lists ingredients that require a prescriptionfor human use and for veterinary use. Part II of Schedule F lists ingredients that require a prescription for10