Food and drug regulations - schedule 1397 - schedule f update
Therapeutic Products DirectorateHolland Cross, Tower “B”6th Floor, 1600 Scott StreetAddress Locator # 3106BOTTAWA, OntarioK1A 0K9
To: Provincial and Territorial Deputy Ministers of HealthProvincial and Territorial Drug Program ManagersDeans of PharmacyRegistrars of Provincial Medical and Pharmacy AssociationsIndustry and Consumer Associations Regulatory and Health Professional Associations Other Interested Parties
Food and Drug Regulations - Schedule 1397 - Schedule F Update
This is to provide you with an opportunity to comment on
the Therapeutic Products Directorate’s intention to updateSchedule F to the Food and Drug Regulations of the Food andDrugs Act by adding 7 medicinal ingredients to Part I of
Schedule F. Once finalized, this amendment would come intoforce on the date of registration and approval for publicationin the Canada Gazette, Part II.
Schedule F is a list of substances, the sale of which are
controlled under sections C.01.041 to C.01.046 of the Food andDrug Regulations. Part I of Schedule F lists substances which
require a prescription for both human and veterinary use. Thereview and introduction of new drugs onto the Canadian marketnecessitate periodic revisions to Schedule F.
The Therapeutic Products Directorate’s Drug Schedule
Status Committee reviews the status of chemical entitiesproposed for marketing. A decision regarding the necessityfor prescription or other scheduled status versusnonprescription status was made for each of the drugs listedon this schedule on the basis of established and publiclyavailable criteria. These criteria include, but are notlimited to, concerns related to toxicity, pharmacologicalproperties and therapeutic applications.
It is proposed that the following 7 substances be added
Adefovir and its salts and its derivatives - a nucleotide
analogue. Adefovir dipivoxil is used to treat chronichepatitis B, a serious and potentially life-threateningviral illness which primarily attacks the liver. Routinelab monitoring and periodic liver biopsies are part oftherapy. Specialized knowledge is required to treathepatitis B and its many potential complications.
Almotriptan and its salts - a selective
Almotriptan malate is used for the acute treatment ofmigraine attacks with or without aura in adults. Activation of receptors in the cranial arteries isbelieved to result in constriction of the arteries andrelief of migraine headache. The safe use of almotriptanrequires that patients receive individualizedinstructions and assessments by a medical practitioner. Cetrorelix and its salts - gonadotropin-releasing hormone
(GnRH) antagonist. Cetrorelix acetate injection is usedto help control the release of eggs from the ovaries ofwomen undergoing assisted conception procedures such asin-vitro fertilization. It acts by inducing a rapid,reversible suppression of gonadotropin secretion and theprevention of premature luteinizing hormone surges inwomen undergoing controlled ovarian hyper stimulation. Cetrorelix acetate injection should be prescribed byphysicians who are experienced in fertility treatment. Although the product may be self-administered, itrequires direct practitioner supervision and continuouslaboratory monitoring. Ketanserin and its salts - serotonin S2 receptor
antagonist. Ketanserin is indicated for the treatment ofwounds in horses on or below the tarsal or carpal jointsand to prevent the formation of excessive granulationtissue at these wound sites. It may require surgicalintervention before use. The use of ketanserin requiresindividualized instructions and direct practitionersupervision. Phenylpropanolamine and its salts and its derivatives - a
sympathomimetic amine consisting of the racemic mixtureof d- and l-norephedrine. Phenylpropanolamine
hydrochloride (PPA) is used in female dogs for thelong-term treatment of urinary incontinence associatedwith sphincter mechanism incompetence. An adequatediagnosis requires veterinary medical expertise. Prescription status would minimize the risk for adiversion of this product to human use.
Until 2001, PPA was widely used in humans as a nasaldecongestant in a large number of cough and cold, sinusand allergy medications. During the 1990s, a link betweenPPA and haemorrhagic stroke was suspected. This was basedon cases reported to the United States FDA and manyinvolved young women using PPA as an appetitesuppressant, often as the first dose. PPA was notapproved for use as an appetite suppressant or weightloss product in Canada. However, an association was alsofound in women taking a first dose of cough and coldmedications containing PPA. Men were considered also tobe at risk. By late 2000, studies confirmed a linkbetween PPA and haemorrhagic stroke. Given the risk of aserious event such as haemorrhagic stroke and the factthat PPA containing medications were used in Canada forrelatively mild conditions and only provide temporaryrelief, Health Canada advised consumers not to use anyproducts containing PPA until a full medical andscientific evaluation was completed. In 2001, HealthCanada completed the evaluation and initiated a recall ofall remaining PPA containing products from the wholesaleand retail market. Consumers were advised not to use anyproducts containing PPA. All remaining productscontaining PPA were removed from the market.
The chemical structure of PPA is such that it has thepotential to be used in the manufacture of illicit drugs. Since January 1, 2003, PPA has been listed on Schedule VIof the Controlled Drugs and Substances Act (CDSA) and issubject to the requirements of the Precursor Control
Regulations (PCR). As such, there is no requirement fora prescription but there are controls over import/export,production, distribution and sale. This scheduling underthe CDSA and PCR does not prevent PPA from being placedon schedule F of the Food and Drug Regulations as well. Schedule VI relates to precursor chemicals and it isrecognized that these chemicals have a variety of usesthat are not medically related. For this reason, it hasbeen deemed acceptable to have a substance on CDSA VI tocontrol its potential use in the manufacture of illicitdrugs and at the same time, on schedule F to control itsuse as a pharmaceutical agent. Having dual schedulingadds additional import/export, production controls e.g. requirement to have licence under PCR and permits toimport/export. Tadalafil and its salts - a potent, selective, and
reversible inhibitor of cyclic guanosine monophosphate(cGMP)-specific phosphodiesterase type5 (PDE5). Tadalafilis indicated for the treatment of male erectiledysfunction (ED) at oral doses of 10 and 20 mg oncedaily. Tadalafil must be administered under thesupervision of a medical practitioner. Teflubenzuron - antiparasite. Teflubenzuron is indicated
for the treatment of parasitic infestations caused by thedeveloping chalimus and pre-adult stages ofLepeophtheirus salmonis on Atlantic salmon (Salmo salar). Individualized instructions, adjunctive therapy andprofessional monitoring by a veterinarian are requiredfor the successful treatment of parasitic infestations. Alternatives
The degree of regulatory control coincides with the risk
factors associated with each specific substance. The reviewof the information filed by the sponsor of these drugs hasdetermined that prescription status is required at this time. Advice from a medical practitioner is necessary to ensure thatconsumers receive adequate risk/benefit information beforetaking the medication.
Any alternatives to the degree of regulatory control
recommended in this regulatory initiative would need to beestablished through additional scientific information andclinical experience.
No other alternatives were considered. Benefits and Costs
The amendment would impact on the following sectors:
Prescription access to the drugs by Schedule 1397 would
benefit Canadians by decreasing the opportunities for improperuse, and by ensuring professional guidance and care. Pharmaceutical Industry
The classification of these drugs as prescription
products would make their sale subject to professionalintervention, thereby reducing misuse and decreasing liabilityto 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 thephysicians would reduce the need for health care service thatmay result from improper use of the drugs. The overalladditional costs for health care services should therefore beminimal. Compliance and Enforcement
This amendment would not alter existing compliance
mechanisms under the provisions of the Food and Drugs Act andRegulations enforced by the Health Products and Food Branch
The manufacturers affected by this proposed amendment
were made aware of the intent to recommend these substancesfor inclusion on Schedule F during the review of the New DrugSubmission and at the time of market approval of the drugs.
This letter is being sent by email to stakeholders and is
also being posted on the TPD website athttp://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/index_drugs_regulations_e.html.
Any comments regarding this proposed amendment should be
addressed to Alexandra Bray, Policy Division, Policy Bureau, Therapeutic Products Directorate, 1600 Scott Street, Holland Cross, Tower ‘B’, 2nd Floor, Address Locator 3102C5, Ottawa, Ontario, K1A 1B6, by facsimile at 613-941-6458 or by email to [email protected] within 30 days.
Robert G. Peterson, MD, PhD,MPHDirector General
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