Notice of Consultation - Prescription Drug List (PDL): Veterinary and Human Antimicrobials

Notice of Consultation

Prescription Drug List (PDL): Veterinary and Human Antimicrobials

July 5, 2017
Our file number: 17-106962-472

This Notice of Consultation provides an opportunity to comment on the proposal to: i) amend the “Products for Human Use” part of the Prescription Drug List (PDL) in relation to Erythromycin and Lincomycin (see Table 1a and 1b); and ii) add and amend 14 antimicrobial active ingredients or their salts or derivatives to the “Products for Veterinary Use” part of the PDL, including the removal of Tilmicosin’s and Tylosin’s qualifier (see Table 2a – 2d).

Rationale:

Products for Human Use:

The proposed changes to the "Products for Human Use" part of the PDL are to correct inaccuracies in relation to how some of the derivatives of Erythromycin and Lincomycin appear on the list. Specifically, the derivatives of Erythromycin and Lincomycin will be listed as derivatives, rather than being listed as individual antimicrobial active ingredients. Additionally, Tulathromycin (which is a derivative of Erythromycin), will be deleted from the list since Tulathromycin is currently only used in veterinary medicine, and there are no products approved for human use in Canada containing the ingredient. There are no new proposed additions to the "Products for Human Use" part of the list as a result of this Notice.

Products for Veterinary Use:

The proposed changes to the “Products for Veterinary Use” part of the PDL will strengthen veterinary oversight and promote the prudent use of medically-important antimicrobials in animals. The substances affected by this change belong to Category II and Category III of the Health Canada document entitled Categorization of Antimicrobial Drugs Based on Importance in Human Medicine. Drugs containing these ingredients are authorized for sale for the treatment, prevention and/or control of bacterial disease in animals. The unnecessary use of the affected antimicrobials can lead to resistance in bacteria.

Drugs containing these antimicrobials were authorized for sale as over the counter by Health Canada before antimicrobial resistance was considered a significant public health issue. Requiring that drugs which contain a medically-important antimicrobial be sold only pursuant to a prescription will require veterinarian oversight and improve the prudent use of these drugs. Preserving the effectiveness of medically-important antimicrobials is an important public health objective.

These PDL amendments are part of larger regulatory and policy initiatives led by Health Canada, as outlined in Health Canada’s May 2017 regulatory amendment and the February 2017 Notice to Stakeholders (Update on collaborative efforts to promote the prudent use of Medically-Important Antimicrobials (MIAs) in animals.

Additional information on how Health Canada determines prescription status (or non-prescription status) is available in the Guidance Document: Determining Prescription Status for Human and Veterinary Drugs.

Table 1: Products for Human Use
The proposed amendments to the Products for Human Use part of the PDL are depicted below.

Table 1(a):
The following table depicts the ingredients that are being moved from the “Drugs containing any of the following” column to the “Including (but not limited to)” column since they are derivatives of an ingredient in the Human Listing.

Drugs containing any of the following:	Including (but not limited to)	Qualifier
Deletion of : Azithromycin or its salts or derivatives Clindamycin or its salts or derivatives Gamithromycin Telithromycin or its salts or derivatives
Erythromycin or its salts or derivatives	Addition of: Azithromycin Clarithromycin Gamithromycin Telithromycin
Deletion of: Clindamycin or its salts or derivatives
Lincomycin or its salts or derivatives	Addition of: Clindamycin

Table 1(b)
The following table depicts the ingredient that is being removed from the Human PDL Listing.

Drugs containing any of the following:	Including (but not limited to)	Qualifier
Erythromycin or its salts or derivatives	Deletion of: Tulathromycin

Table 2: Products for Veterinary Use
The proposed amendments to the Products for Veterinary Use part of the PDL are depicted below.

Table 2(a)
The following table depicts the ingredients that are being moved from the “Drugs containing any of the following” to the “Including (but not limited to)” column since they are derivatives of an ingredient listed in the Veterinary Listing.

Drugs containing any of the following:	Including (but not limited to)	Qualifier
Deletion of: Azithromycin or its salts or derivatives Gamithromycin Telithromycin or its salts or derivatives Tulathromycin
Addition of: Erythromycin or its salts or derivatives	Addition of: Azithromycin Gamithromycin Telithromycin Tulathromycin
Deletion of: Amoxicillin or its salts or derivatives Ampicillin or its salts or derivatives Azlocillin or its salts or derivatives Benzathine penicillin or its salts or derivatives Carbenicillin or its salts or derivatives Cloxacillin or its salts or derivatives Hetacillin or its salts or derivatives Methicillin or its salts or derivatives Mezlocillin or its salts or derivatives Nafcillin or its salts or derivatives Ticarcillin or its salts or derivatives
Addition of: Penicillin or its salts or derivatives	Addition of: Amoxicillin Ampicillin Azlocillin Benzathine penicillin Carbenicillin Cloxacillin Hetacillin Methicillin Mezlocillin Nafcillin Ticarcillin
Deletion of: Tildipirosin, Tilmicosin
Change from: Tylosin or its salts To: Tylosin or its salts or derivatives	Addition of: Tildipirosin, Tilmicosin

Table 2(b)
The following table depicts the deletion of the qualifiers from the ingredient Tilmicosin and for the Tylosin listing.

Drugs containing any of the following:	Including (but not limited to)	Qualifier
Tylosin or its salts or its derivatives	Tilmicosin	Deletion of: except when sold in premix form
Tylosin or its salts or its derivatives		Deletion of: when sold for the treatment of chronic colitis in dogs

Table 2(c)
The following table depicts the addition of derivatives under the column “Including but not limited to” of the Veterinary PDL Listing.

Drugs containing any of the following:	Including (but not limited to)	Qualifier
Penicillin or its salts or derivatives	Additions of: Dicloxacillin Penicillin G (benzylpenicillin) Procaine penicillin G
Tylosin or its salts or derivatives	Addition of: Tylvalosin

Table 2(d)
The following table depicts additions of antibiotics and derivatives to both the columns “Veterinary Listing” and “Including (but not limited to)” on the PDL.

Drugs containing any of the following:	Including (but not limited to)	Qualifier
Addition of: Apramycin or its salts
Addition of: Bacitracin or its salts or derivatives
Addition of: Lincomycin or its salts or derivatives	Addition of: Clindamycin
Addition of: Neomycin or its salts or derivatives
Addition of: Spectinomycin or its salts or derivatives
Addition of: Streptomycin or its salts or derivatives	Addition of: Dihydrostreptomycin
Addition of: Sulphonamides or its salts or derivatives	Addition of: Sulfadiazine Sulfadoxine Sulfaguanidine Sulfamerazine Sulfamethazine Sulfanilamide Sulfapyridine Sulfaquinoxaline Sulfathiazole
Addition of: Tetracycline or its salts or derivatives
Addition of: Chlortetracycline or its salts
Addition of: Oxytetracycline or its salt
Addition of: Tiamulin or its salts	Addition of: Tiamulin fumarate
Addition of: Virginiamycin or its salts or derivatives

Comments on this proposed change to the PDL should be provided to Health Canada, preferably in electronic format, within 75 days from the date of this notice.

Next steps:

Health Canada will review and consider all comments received during this consultation and will subsequently aim to publish a Notice of Intent to Amend the PDL indicating the changes, later in 2017.

Please send your comments to:

Health Canada
Prescription Drug Status Committee
Address Locator 3102C3
Holland Cross, Tower B
1600 Scott Street
Ottawa, Ontario
K1A 0K9

Telephone: 343-998-9304
Facsimile: 613-941-1812
E-mail: drug_prescription_status-statut_d'ordonnance_des_drogues@hc-sc.gc.ca