DRUG PRODUCT DATABASE (DPD)

TERMINOLOGY

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 number assigned by Health Canada to a drug product prior to being marketed in Canada. It consists of eight digits (numbers) generated by a computer system in the Submission and Information Policy Division.

The following product characteristics will identify a product as unique.

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

BRAND NAME

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

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 mg - 200 mg is the strength of elemental calcium, not calcium carbonate.

No OF ACTIVE INGREDIENT(S)

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

STRENGTH

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

CLASS OF DRUG PRODUCT

The class identifies whether the drug is used for either HUMAN, VETERINARY or as a DISINFECTANT.

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) 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).

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, etc.)

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

PACKAGING

This section includes the package sizes as well as other product information, when available, including flavors, fragrances, etc that are available for that product.

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 (CDSA III)

Schedule G (CDSA IV)

Schedule D (biological products)

Narcotic (Narcotic Control Act)

Narcotic (CDSA I )

Narcotic (CDSA II)

Targeted (CDSA IV)

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, eg. nitroglycerine.

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 judgements 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 judgements 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.

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 AIG structure is illustrated in the examples provided below:

AIG	No of Ingredients	Ingredient Group	Strength Group	Products
0302037001	03	02037 acetaminophen caffeine citrate codeine phosphate	001 325mg 30mg 15mg	Atasol 15 Exdol 15
0302037002	03	02037 acetaminophen caffeine citrate codeine phosphate	002 325mg 30mg 30mg	Atasol 30 Exdol30
0106827001	01	06827 dimethicone	001 40mg	Ovol drops 40mg/ml Ovol tablets 40mg
0106827002	01	06827 dimethicone	002 80mg	Ovol 80mg

For those of you familiar with the AIG that 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.

PRODUCT MONOGRAPH (PM)

A product monograph 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 product monograph 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.