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Introduction to the Newfoundland and Labrador Interchangeable Drug Products Formulary (NIDPF)

The Newfoundland and Labrador Interchangeable Drug Products Formulary (NIDPF) is a list of commonly used drugs which have therapeutic equivalence to a reference product, and are listed alphabetically by generic name.

The drugs listed in the NIDPF have been produced in accordance with sound manufacturing principles and found, on adequate testing, to conform to official Canadian standards and are under continuous review. Changes will be made, where necessary, on the basis of new information. All drugs listed in the NIDPF have conformed to the standards of manufacturing and qualitative assessment of the Health Products and Food branch of Health Canada, and have met the Provincial requirements for inclusion in the NIDPF.

The NIDPF was initially established by regulations on the advice of the Advisory Committee to the Minister of Health and Community Services, Province of Newfoundland and Labrador. This Advisory Committee was originally appointed in accordance with the provisions of The Pharmaceutical Association Act 1994, Chapter P-12.1. The NIDPF and the Advisory Committee now fall under The Pharmaceutical Services Act 2006, and The Interchangeable Drug Products Formulary Regulations, 2007.

The Act provides for the establishment of a Professional Committee which is appointed by the Minister of Health and Community Services in consultation with the Newfoundland and Labrador Medical Association and the Pharmacist’s Association of Newfoundland and Labrador. The Professional Committee has the responsibility to advise the Minister on matters relating to the NIDPF.

The objective of the legislation is to assist the people of Newfoundland and Labrador to obtain prescription drugs of acceptable quality at reasonable prices. For some provinces, prices published in the Interchangeable Formulary apply only to residents who are covered under Government programs; however, all residents of Newfoundland and Labrador benefit from prices published in the NIDPF.

Definition of Interchangeable Drug Products

The definition of Interchangeable Drug Products, as outlined in the Act, is as follows:

Interchangeable drug products means pharmaceutical equivalents or pharmaceutical alternatives that are the therapeutic equivalents of and that have the same route of administration as a reference product.

Pharmaceutical alternatives means drug products that contain the same or similar amount of the same or similar medicinal ingredients, in comparable dosage forms but do not necessarily contain the same non-medicinal ingredients;

Pharmaceutical equivalents means drug products that contain the identical amounts of the identical medicinal ingredients, but do not necessarily contain the same non-medicinal ingredients;

Therapeutic equivalents mean pharmaceutical equivalents or pharmaceutical alternatives that have been shown to be bioequivalent to a reference product as demonstrated by bioavailability, pharmacodynamic or clinical studies.

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Maximum Prices

The Department of Health and Community Services recognizes there is a need for pharmacies to have time to adjust their inventory when additions or deletions or other changes are made to the NIDPF.

New Drug Categories: Pharmacies are given a 30 day period from the date of interchangeability before the mandatory lowest price (MLP) becomes effective. This 30 day period is to allow time to adjust inventory and advise their clients of any change in status of current therapies.

New Products Added to Existing Categories: When a new product is added to an existing category, its price will be based on the current MLP for that category. Should the new product be lower in price than the category’s current MLP, the new product’s price will become the MLP. The new MLP will become effective 30 days from the date of interchangeability.

Both of the above policies are enacted by government such that all payers (patients, government, and third party insurances) are held to the policy. Where indicated to comply with the 30 day post interchangeability policy, the date on which MLP is effective is listed at the end of each category.

Prices published in the NIDPF are the best available prices submitted by a drug manufacturer for the purpose of inclusion in the NIDPF regardless of package size and are also inclusive of a 9% inventory adjustment charge. This inventory adjustment charge is to compensate pharmacies for circumstances when inventory must be purchased from a source where the best available price is not available. The prices published are the maximum prices a pharmacy may charge a client.

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Mandatory Substitution/Charge of Lowest Price

A person legally authorized to dispense drugs, when presented with a prescription for a drug listed in the NIDPF, must dispense either the lowest price brand of the drug within a category listed in the NIDPF or another approved substitute brand of that drug at the lowest price listed in the NIDPF, in accordance with the 30 day provision discussed in the Maximum Price section.

A client is free to choose a specific brand within a category if they wish; however, the pharmacist must notify the patient of the difference in price between the brand chosen and that of the lowest price listed in the NIDPF for that category. The client or their insuring agency is responsible for the difference in the price of the drug chosen and the lowest price listed in the NIDPF.

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Where the Lowest Price Is Not Available

Where due to exceptional circumstances the lowest priced drug is not available to pharmacies, a dispenser may supply and/or charge for the next lowest price listed in the NIDPF. The Secretary of the NIDPF Advisory Committee must first be advised of product unavailability so that payment for the next lowest price can be arranged.

If a discontinued DIN is the lowest priced product in a category and has been listed as DOD (Discontinued On Depletion of Inventory) in a previous volume, the next lowest price in that category will be the Mandatory Lowest Price (MLP).

If a discontinued DIN is the lowest priced product in a category and has not been listed as DOD in a previous volume of the NIDPF, the discontinued DIN’s price will continue to be the MLP, until the next volume of the NIDPF or until confirmation of inventory depletion (whichever occurs first).

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Publishing of the NIDPF

The NIDPF is officially published in April and October. Supplements may be added as requests for new products are received and approved to allow consumers to realize savings as soon as feasible.

The NIDPF is available electronically on our website at: www.health.gov.nl.ca/health/prescription/idf.html

Supplement notifications are posted under Bulletins at: https://nlpdp.xwave.com/GeneralBulletins.aspx

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Requirements for Consideration of Listing in the NIDPF
-Participating Manufacturer Status

Prior to any drug manufacturer having its drug products considered for inclusion in the NIDPF, the manufacturer must be approved by the NIDPF Advisory Committee as a Participating Manufacturer.

As outlined in The Interchangeable Drug Products Formulary Regulations, 2007, the following are the Requirements for Consideration of Participating Manufacturer Status:

3.1 (1) A drug manufacturer, to be eligible to make submissions for its product to be included in the formulary, shall be approved by the minister as a participating manufacturer.

(2) Where the advisory committee considers that

(a) a drug manufacturer has not fulfilled the requirements contained in subsection (3) to the satisfaction of the advisory committee in order to be designated as a participating manufacturer, it shall not recommend that designation to the minister; or

(b) a drug manufacturer has fulfilled the requirements contained in subsection (3) to the satisfaction of the advisory committee in order to be designated as a participating manufacturer, it shall recommend that designation to the minister.

(3) A drug manufacturer, to be recommended by the advisory committee as a participating manufacturer, shall

(a) demonstrate that it is currently conducting business in the province;

(b) have the ability to provide the drug to all retail pharmacies in the province;

(c) provide a listing of drugs with pricing, sales policy, and the distribution network in the province; and

(d) provide any other information required by the advisory committee.

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Requirements for Consideration of Listing in the NIDPF
-Submission Requirements

As outlined in The Interchangeable Drug Products Formulary Regulations, 2007, the following are the Submission Requirements for Consideration of NIDPF listing:

3.2 (1) A participating manufacturer shall provide the following before the advisory committee will consider its submission for a drug to be included in the formulary:

(a) a list of the applicable Health Canada guidance documents on the assessment of bioavailability and bioequivalence of the drug;

(b) details of the percent savings versus the innovator's product, which shall be a minimum of 25% less than the innovator price;

(c) a Notice of Compliance from Health Canada if one has been issued;

(d) confirmation of the manufacturer's ability to supply the drug to the provincial market;

(e) consent from the manufacturer permitting the province to contact Health Canada and other federal, provincial or territorial departments or agencies for additional information where necessary;

(f) a completed request for generic drug substitution in the form prescribed by the minister;

(g) a product sample for any drug contained in a device or apparatus for the purpose of drug delivery;

(h) where the submission relates to an ultra-generic or cross licensed drug, confirmation of the arrangement from the company with whom the arrangement is in place; and

(i) the quoted price for the drug, which shall be

(i) equal or less than the best available price required by section 23 of the Act, and

(ii) quoted in smallest unit pricing irrespective of package size.

(2) Notwithstanding paragraph (1)(b), where a submission relates to an addition to existing categories where an innovator lowers its price after the drug becomes interchangeable, a submission received after that time shall include a price for the product which is less than or equal to the current lowest price in that category.

(3) Where a drug is approved for addition to an existing category under subsection (2), it shall not be included in a supplement to the formulary but shall be added to the formulary at its next publication.

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Additional Requirements

In addition to the specific submission requirements noted above, the criteria to be considered by the NIDPF Advisory Committee for inclusion into the NIDPF include, but are not limited to:

 

  1. The definition of Interchangeable Drug Products as set out in the Act.
  2. The drug product must be of consistent satisfactory quality and safety.
  3. The manufacturer’s methods, facilities and documentation must be acceptable to the NIDPF Advisory Committee.
  4. Drug products must conform to the drug quality which is in accordance with standards of manufacturing and qualitative assessment of the Health Products and Food Branch of Health Canada.
  5. The formulation of the drug product must be acceptable to the NIDPF Advisory Committee and all the active ingredients must be capable of identification and qualitative analysis in the finished dosage form.
  6. Drug products listed must be of a proven therapeutic value.

Failure to comply with any reasonable request from the NIDPF Advisory Committee or the Government of Newfoundland and Labrador may result in product rejections or deletions.

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Review Process

If the submission requirements are met, the manufacturer will be notified that the submission is complete and which of the following review processes apply:

Standard Review Process applies to:

a) Drugs with a Health Canada Declaration of Equivalence to a Canadian Reference Product

b) All ultra-generics

c) All cross-licensed drugs where the other drug is currently listed in the NIDPF

Expert Review Process applies to:

a) Drugs without a Health Canada Declaration of Equivalence to a Canadian Reference Product

b) Any drugs which have been reviewed under the Standard Review Process and about which the committee has a clinical concern shall be referred by the Advisory Committee for expert analysis of bioequivalence, bioavailability and other applicable data

2011 Schedule for Submissions

Cut off date for submission receipt Meeting date
Thursday, December 30, 2010 Thursday, January 13, 2011
Thursday, February 3, 2011 Thursday, March 3, 2011 Thursday, March 3, 2011
Thursday, March 10, 2011 Thursday, April 7, 2011
Thursday, April 7, 2011 Thursday, May 5, 2011
Thursday, May 5, 2011 Thursday, June 2, 2011
Thursday, August 18, 2011 Thursday, September 15, 2011
Thursday, October 13, 2011 Thursday, November 10, 2011

Submissions should be directed to the Secretary of the NIDPF Committee, as per the schedule listed above.

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NIDPF Contact Information

Submissions should be directed to:

Secretary, the NIDPF Advisory Committee
c/o Pharmaceutical Services Division
Department of Health and Community Services
Government of Newfoundland and Labrador
Tel:  1-709-729-6507
Fax: 1-709-729-2851

Mailing Address:

Confederation Building - West Block
P.O. Box 8700
St. John's, NL
A1B 4J6

Courier address:

Belevedere Building
57 Margaret's Place
St. John's, NL A1C 3Z3

Website

Information regarding the NIDPF is available on our website at: http://www.health.gov.nl.ca/health/prescription/idf.html

Bulletins regarding the NIDPF including supplements can be found at: https://nlpdp.xwave.com/GeneralBulletins.aspx

 
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