Drug Product Database (DPD)

Terminology

Active Ingredient

An Active Ingredient is any component that has medicinal properties, and supplies pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body of man or other animals.

The name and strength of each active ingredient contained in the product is listed. Information enclosed within brackets represents the salt and identifies how the ingredient is supplied - this information is only included for some ingredients. The number in the strength field refers to the active portion of the drug. For example: calcium (calcium carbonate) 200 milligram (mg) - 200 mg is the strength of elemental calcium, not calcium carbonate.

Health Canada has a reference text hierarchy for ingredient nomenclature. The International Non Proprietary Names (INN) is used as Health Canada's standard to assign the preferred name to ingredients. There are other standards such as the United States Adopted Names (USAN), Martindale, Merck Index, etc., that are used to code ingredients if they are not listed in the INN. They are also used to maintain a synonyms list in our internal database.

For example, if an ingredient is not found in the INN reference text but it is listed in the USAN then Health Canada would use the USAN as their preferred name until INN lists the ingredient in their reference text. If the ingredient is not found in either the INN or the USAN then Health Canada hierarchy would be followed and the Martindale reference text would be used. The process would continue until all resources are exhausted and, in that case, internet reference and/or articles would be used until it is listed in any of the previous reference text.

Please note that before 2005, USAN was considered Health Canada's nomenclature standard. Therefore, there are some exceptions listed on the DPD Online where the ingredients are coded using that standard. For more information on INN, please visit the following link on the  World Health Organization website.

Active Ingredient Group (AIG) Number

The AIG number is a 10 digit number that identifies products that have the same active ingredient(s) and ingredient strength(s). The AIG is comprised of three portions:

• the first portion (2 digits) identifies the number of active ingredients
• the second portion(5 digits) identifies the unique groups of active ingredients(s);
• the last portion (3 digits) identifies the active ingredient group strength. The strength group has a tolerance of -2% to +10%.

The Active Ingredient Group structure is illustrated in the examples provided below:

Table - Active Ingredient Group structure

Active Ingredient Group	Number of Ingredients	Ingredient Group	Strength Group	Products
0302037001	03	02037 acetaminophen caffeine citrate codeine phosphate	001 325mg 30 mg 15 mg	Atasol 15 Exdol 15
0302037002	03	02037 acetaminophen caffeine citrate codeine phosphate	002 325 mg 30 mg 30 mg	Atasol 30 Exdol30
0106827001	01	06827 dimethicone	001 40 mg	Ovol drops 40mg/ml Ovol tablets 40 mg
0106827002	01	06827 dimethicone	002 80 mg	Ovol 80 mg

For those of you familiar with the AIG which was published in the Canadian Drug Identification code book (CDIC) (old AIG), it is important to note that:

• the logic for assigning the AIG Number is based on that used for the old AIG;
• the strength portion has changed from an alpha to a numeric code;
• the old ingredient groups were retained and reused.

This means that the new AIG should match that found in the CDIC (the first 7 digits only), with one exception. Products where the ingredient(s) information includes a salt may now have a different ingredient group. This is a result of a decision to match the strength of the ingredient to the base ingredient rather than the salt as had been done in the CDIC. This primarily affected vitamin products, but may include other products as well.

American Hospital Formulary Service (AHFS)

The American Hospital Formulary Service permits an easy review of information on a group of drugs with similar activities and uses and allows the reader to determine quickly the similarities and differences among drugs within a group.

The classification of a substance in the AHFS system is not a recommendation for use, nor does it imply any judgments about efficacy of drugs and groups of drugs. The name of the drugs are the United States Adopted Names (USAN) and other names described in the USP Dictionary of Drugs.

A guiding principle of the AHFS classification system is that more than one AHFS code can be assigned to a product to reflect different indications.

Anatomical Therapeutical Chemical (ATC) Classification System

The purpose of the ATC system is to be used as a tool for drug utilization research in order to improve quality of drug use. One component of this is the presentation and comparison of drug consumption statistics at international and other levels.

The classification of a substance in the ATC system is not a recommendation for use, nor does it imply any judgments about efficacy of drugs and groups of drugs. In the Anatomical Therapeutical Chemical (ATC) classification system, the drugs are divided into different groups according to the organ or system on which they act and their chemical, pharmacological and therapeutical properties. The drugs are classified in groups at five different levels.

A guiding principle of the ATC is that only one code can be assigned to a product.

The ATC is now available on the DPD Web Query. Furthermore, here is one brief example of the ATC Classification System:

• A: Alimentary tract and metabolism (1^st level, anatomical main group)
• A10: Drugs used in diabetes (2^nd level, therapeutic subgroup)
• A10B: Oral Blood glucose lowering drugs (3^rd pharmacological subgroup)
• A10BA: Biguanides (4^th level, chemical subgroup)
• A10BA02: Metformin (5^th level, chemical substance)

Brand Name

This is the brand name under which the drug product is marketed.

Class of Drug Product

The class identifies whether the drug is used for either human, veterinary or as a disinfectant.

Description

The description field was added to the "Product Information Page' in order to display important product information and to eliminate confusion with respect to the brand name information. For example, there are potential safety concerns if the information of a certain product is identical with the exception of a preservative. That is, if a product has one formulation with a preservative and another one without, then Health Canada has issued two separate Drug Identification Numbers (DINs). However, the data in the DPD Online Query is identical. Therefore, it is important for users to differentiate between both DINs.

Please note that a retroactive clean-up the Brand Name information will be performed as resources permit and any issues raised will be addressed on a case-by-case basis.

Drug

According to the Food and Drug Act, a drug includes any substance or mixture of substances manufactured, sold or represented for use in:

1. the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state, or the symptoms thereof in man or animal
2. restoring, correcting or modifying organic functions in man or animal, or
3. disinfection in premises in which food is manufactured, prepared or kept

Drug Identification Number (DIN)

A Drug Identification Number (DIN) is a computer-generated eight digit number assigned by Health Canada to a drug product prior to being marketed in Canada. It uniquely identifies all drug products sold in a dosage form in Canada and is located on the label of prescription and over-the-counter drug products that have been evaluated and authorized for sale in Canada.

A DIN uniquely identifies the following product characteristics:

• manufacturer;
• product name;
• active ingredient(s);
• strength(s) of active ingredient(s);
• pharmaceutical form; and
• route of administration.

Drug Statuses

The statuses listed below are a direct representation of the status available in DPD Online Query and the contact of each status is summarized below. For more information on how to search using these new statuses, please refer to the Search Tips page.

• Active: products that are currently being marketed in Canada.
• Discontinued (All): contains all products that were discontinued regardless of the reason (ie: Safety reasons, recalls, marketing decision, Transitional DINs, etc.).
• Discontinued (By Company Post-Market): contains products that were marketed in Canada but are no longer available on the Canadian market as per the company decision. This status is a subset of Discontinued (All).
• Discontinued (Transitioned to Natural Health Products Directorate [NHPD]): contains products that have been discontinued as a result of an NPN Issued. This status is another subset of Discontinued (All).

The Therapeutic Products Directorate (TPD) currently receives weekly updates from the NHPD regarding products which have been authorized for sale and issued a Natural Product Number (NPN) and/or Homeopathic Medicine Number (DIN-HM) via the "Transitional DIN" product licence application stream. TPD subsequently assigns a "Discontinued (Transitioned to NHPD)" status to associated products in the DPD, given that these products have completely transitioned to the NHPD. The status wording for Trans-DIN products will now be shown as "Discontinued (Transitioned to NHPD)" and will be made available to the status pick list in order to further qualify the "Discontinued" status.

Please note that TPD will not continue to house information for natural health products (NHPs) indefinitely.  The deadline for all DIN holders, whose products meet the definition of a NHP; to obtain a product licence via the Transitional-DIN stream was December 31, 2009.  Following that date, the TPD will eventually discontinue all NHPs, including homeopathic medicines, in the DPD. Please note that the DPD will not be able to identify any products as having transitioned from a DIN to a NPN/DIN-HM if they have not applied to the NHPD under the Transitional-DIN stream.

Also note that these products that have applied for an NPN under the Trans-DIN stream and have been authorized by NHPD will retain the same number

Nomenclature Naming

Refer to the Active Ingredient text for a detailed explanation

Number of Active Ingredient(s)

This represents the total number of active (medicinal) ingredient(s) contained in a product.

Pharmaceutical Form

The pharmaceutical form is the form of presentation in which the product is supplied. It is the combination of the form in which a pharmaceutical product is presented by the manufacturer (form of presentation) for example (e.g.) tablet, capsule, powder, etc., and the form in which it is administered including the physical form (form of administration) e.g. powder for solution.

A product can have more than one dosage form when it is a kit (e.g. tablet, capsule).

Prescribing Information (PI)

Drugs regulated solely under Division 1 of the Food and Drug Regulations are not required to have a product monograph (PM); rather, many Division 1 drugs have PI. PI includes important information that may be required for the optimal, safe and effective use of a drug product, such as mode of action; indications and contraindications of use; and dosage instructions. It helps inform health care professionals and the general public of the authorized conditions of use of a drug. Often, PI is similar to the package insert included in drug products.

Product Monograph (PM)

A PM is a factual, scientific document on the drug product that, devoid of promotional material, describes the properties, claims, indications, and conditions of use for the drug, and that contains any other information that may be required for optimal, safe, and effective use of the drug. A PM should include appropriate information respecting the name of the drug, its therapeutic or pharmacologic classification, its actions and/or clinical pharmacology, and its indications and clinical uses.

The monograph should also include contraindications, warnings, precautions, adverse reactions, drug interactions and effects on laboratory tests, symptoms and treatment of overdosage, dosage and administration, storage and stability, pharmaceutical information, dosage forms, pharmacology, toxicology, microbiology, special handling instructions, information on clinical trials, information for the consumer, references, and the dates of the initial printing and current revision.

Route of Administration

Indicates the part of the body on which, through which or into which the product is to be introduced. (e.g.: oral, topical, intramuscular, rectal)

A product can have more than one route of administration (e.g.: intravenous, intramuscular, intra articular).

Schedule

Each drug is assigned one or more of the following schedules, according to the Food and Drug Regulations, and the Controlled Drugs Substances Act.

Schedule F (prescription drugs)

Schedule F (Recommended) Undergoing Regulatory Amendment to add this new substance to Schedule F to the Food and Drug Regulations.

Schedule G (control drugs)

Schedule G (Controlled Drugs and Substances Act [CDSA] III)

Schedule G (CDSA IV)

Schedule D (biological products)

Narcotic (Narcotic Control Act)

Narcotic (CDSA I )

Narcotic (CDSA II)

Targeted (CDSA IV)

CDSA (Recommended) - Undergoing Regulatory Amendment to add this new substance to Controlled Drugs Substances Act.

Drugs that do not appear on a schedule or are not recommended to appear on any schedule have been classified as follows:

• Homeopathic
• Over the Counter (OTC)

Ethical: a drug that in accordance with Federal Legislation does not require a prescription, but that is generally prescribed by a medical practitioner. Ethical products are unscheduled nonprescription professional use products (e.g., MRI contrast agents and hemodialysis solutions) and a few emergency use products (e.g., nitroglycerine).

Status Date

This new field displays the date when the product was either marketed or discontinued in Canada. If users are in the 'Active' Module, the date represents the marketed date when the product was first introduced on the Canadian market. If users are in the 'Discontinued' module, the date will show the date the product was discontinued from the Canadian market.

It is important to note that the date for older products may be listed as a generic date. For example, if the marketed date is listed as 1972.12.31, it represents the year the products was marketed in Canada and not necessarily the actual date of December 31, 1972. This strictly happens for older products that were marketed prior to September 1996. This is due to the migration of data from an old system to the DPD. The format of the status date was converted from 'YYYY' to 'YYYY.MM.DD' format. Therefore, in order to accommodate the DPD date format, a default date of December 31 was picked therefore any products marketed within that year will show December 31, 19XX.

Strength

This refers to the strength of the active (medicinal) ingredient. If the strength is reported per a dosage unit (e.g.: 5 millilitre [mL] or 15 mL), this information will immediately follow the strength (e.g., 10 mg/5 mL).

Veterinary Species

This new field was recently added to display additional information for certain veterinary products.  It will provide the type of species for a certain veterinary products (e.g.: sheep, dog, cattle, poultry).