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

Introduction

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 Drugs and Health Products 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, 2012, and The Interchangeable Drug Products Formulary Regulations, 2012.

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. Products listed as interchangeable in the NIDPF have no relation to the Newfoundland and Labrador Prescription Drug Program (NLPDP) benefit listing.

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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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.

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. Please call our claims office at (709) 753-3615 or 1 (888) 724-7760 to report product shortages.

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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Inventory Adjustment

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

30 Day Inventory Adjustment Period:

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.

Inventory Adjustment Allowance:

An inventory adjustment allowance is included in the price of all products listed in the NIDPF. The price listed is the manufacturer price, as per pricing requirements, plus a percentage based inventory adjustment allowance. The schedule is as follows:

Schedule for Inventory Adjustment Allowance:

April 16, 2012 to March 31, 2013 12%
April 1, 2013 to March 31, 2014 15%
April 1, 2014 to March 31, 2015 12%
April 1, 2015 to March 31, 2016 9%

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Publishing of the NIDPF

The NIDPF is officially published on April 1st and October 1st of each year, with supplements occurring on the 1st of each month.

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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Interchangeable Product Submissions

The process for adding products to the NIDPF has been revised effective Feb 28, 2014:
  • In general, drugs are reviewed in order of receipt. The NIDPF is officially published on April 1st and October 1st of each year, with supplements occurring on the 1st of each month.
  • All submissions must be made electronically by email to keithsheppard@gov.nl.ca and jtremblett@gov.nl.ca. Attachments must be in Adobe Acrobat PDF OR MS Word format. Requirements (such as product samples) that cannot be sent electronically should be sent by mail or courier to:

Secretary, the NIDPF Advisory Committee
c/o Pharmaceutical Services Division
 Department of Health and Community Services
Government of Newfoundland and Labrador
Phone (709) 729-6507 or 1-888-222-0533
Fax (709) 729-2851

Mailing Address:
Confederation Building - West Block
P.O. Box 8700 St. John’s, NL A1B 4J6

Courier Address:
45 Major's Path, St. John’s, NL A1A 4Z9

  • Submissions should not be emailed until the product is ready for sale and shipment to NL pharmacies. Pre-Notice of Compliance (NOC) submissions will not be accepted.
  • If the product price is greater than the current price requirement (as per the Interchangeable Drug Products Formulary Regulations , 2012), the manufacturer must also submit a price exemption request providing in detail the reason for the request. The time frame required to review and consider price exemptions requests cannot be guaranteed.

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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

Phone (709) 729-6507 or 1-888-222-0533

Fax (709) 729-2851

Mailing Address:

Confederation Building - West Block

P.O. Box 8700 St. John’s, NL A1B 4J6

Courier address:

45 Majors Path St. John’s, NL A1A 4Z9

To Report Product Shortages:

Phone (709) 753-3615 or 1-888-724-7760

 

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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