Newfoundland and Labrador Prescription Drug Program
New Regulations Governing
The Newfoundland and Labrador
Interchangeable Drug Products Formulary (NIDPF)
The Newfoundland and Labrador Interchangeable Drug Products Formulary (NIDPF) falls under The Pharmaceutical Services Act. 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 a number of years a policy of the NIDPF was that prices submitted by generic manufacturers must be the best offered in the country. New legislation recently introduced in Ontario substantially changed what this ‘best’ price represented. To ensure adherence to this best available price (BAP) policy, legislation was introduced when the Pharmaceutical Services Act was being prepared.
Section 23 (2) of the Act currently states that the guaranteed price for a generic drug shall be the best price available in any other province or territory of Canada and that the guaranteed price shall be the price offered by the manufacturer for that drug to all pharmacies and dispensing physicians in the province. As a recent review of submitted prices has demonstrated clearly that the residents of Newfoundland and Labrador (NL) are not being offered the same generic prices as residents of Ontario, the Department of Health and Community Services has undertaken an analysis of the situation.
We have recently consulted with generic industry and community pharmacy stakeholders, including the Pharmacists’ Association of Newfoundland and Labrador, to discuss the current situation, the requirements of the Act, and the impacts that may result from various approaches that could be considered that would ensure that the residents of NL receive the best available price in the country.
As a result of consultations and analysis to date, Regulations have been prepared to ensure that prices in the January 2008 edition of the NIDPF do indeed provide the same savings to this province as is available in Ontario.
All pharmacy providers are asked to note the following important changes
regarding the (NIDPF) as a result of proclamation of The Pharmaceutical Services
Act and the signing of the Interchangeable Drug Products Formulary Regulations,
2007 governing the NIDPF.
These changes are detailed in the attached introductory pages from the NIDPF
booklet as well as in the attached copy of the Regulations. There will be a
delayed printing of the Volume 53 edition of the NIDPF booklet; however, the
NIDPF Volume 53 edition will be posted in its entirety on the internet and can
be accessed at the following sites: www.health.gov.nl.ca/health/nlpdp and
nlpdp.xwave.com before January 1, 2008.
The key changes are as follows:
New Inventory Adjustment Period
Please pay particular attention to the section, “Maximum Prices” which
details the new inventory adjustment period.
NIDPF policy for Notice Period of Delisting of Products
Products that are non-compliant with the Pharmaceutical Services Act and its
Regulations, may be delisted from the NIDPF. Affected products will be marked
for deletion from the NIDPF effective February 1, 2008 and will cease to be
legally interchangeable at that time. Removal from the benefit list of the
Newfoundland and Labrador Prescription Drug Program (NLPDP) will also be set for
February 1, 2008.
Important Notice Regarding Volume 53 Pricing
Due to significant price changes as a result of the Regulations referenced above for existing categories (i.e. those categories and products which were in Volume 52, including the addendum to Volume 52), the pricing in Volume 53 will not come into effect until February 1, 2008. Volume 52 prices will apply for the time period January 1 – 31, 2008. This delayed pricing implementation applies to Volume 53 only.
For new categories entering Volume 53, MLP charging will become effective 15
days from the effective date of Volume 53.
ECS071221
Attachment (Bulletin #56A NL Regulation 125-07 -Separate Document)
The Newfoundland and Labrador
Interchangeable Drug Products Formulary
Introduction
The Newfoundland and Labrador Interchangeable Drug Products Formulary (NIDPF) is established by the Minister under authority of the Pharmaceutical Services Act and the Interchangeable Drug Products Formulary Regulations 2007. It 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. 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 Formularies apply only to residents who are covered under Government programs; however, all residents of Newfoundland and Labrador benefit from prices published in the NIDPF.
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.
FORMULARY PUBLISHING
The NIDPF is officially published in January and July. Additional supplements are added as requests for new products are received and approved to allow consumers to realize savings as soon as feasible.
In addition to the official publication of the NIDPF and its supplements, it
is also available on the Internet at http://www.gov.nl.ca/health/nlpdp.
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 provisions discussed in the maximum price section.
A client is free to choose a specific brand within a category if he/she
wishes; however, the pharmacist must notify the patient of the difference in
price of the brand chosen from that of the lowest price that is listed in the
NIDPF. The client or his/her insuring agency is responsible for the difference
in the price of the drug chosen and the price listed in the NIDPF.
WHERE THE LOWEST PRICE IS NOT AVAILABLE
Where due to exceptional circumstances (such as production and distribution problems) the lowest priced drug may not be generally available to pharmacies within the Province, a dispenser may supply or charge for the next lowest price listed in the NIDPF.
PROFESSIONAL COMMITTEE
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 Pharmacists Association of Newfoundland and Labrador. The Professional Committee has the responsibility to advise the Minister on matters relating to the NIDPF.
The Department of Health and Community Services recognizes there is a need for pharmacies to have time to adjust their inventories for new drugs being added to the Formulary.
New Drug Categories: Whenever a new drug category is added to the NIDPF, pharmacies are given a 15 day period to adjust their inventories and advise their clients of any change in status of current therapies. For new drug categories added to the NIDPF, mandatory charging of the lowest price is effective 15 days from the actual effective date of the NIDPF publication or addendum.
New Drugs added to Existing Categories: Whenever a new drug is added to an existing category to the NIDPF, pharmacies are given a 15 day period to adjust their inventories and advise their clients of any change in status of current therapies. For new additions to existing drug categories added to the NIDPF, mandatory charging of the lowest price is effective 15 days from the actual effective date of the NIDPF publication or addendum.
Both of the above policies are enacted by government such that all payers
(patients, government, and third party insurers) are held to the policy. Where
indicated to comply with the 15 day policy, the mandatory charge date is listed
at the end of each category.
Quoted prices to the NIDPF must meet the requirements of Section 23 of the Pharmaceutical Services Act which states:
23) (1) Where a drug is to be included on the formulary, the manufacturer of that drug shall provide a guaranteed price for that drug for the time period required by the minister.
(2) The guaranteed price for a generic drug under subsection (1) shall be the best available price available in any other province or territory of Canada.
(3) The guaranteed price of a drug referred to in subsection (1) shall be the price offered by the manufacturer for that drug to all pharmacies and dispensing physicians in the province.
Section 5 of the Interchangeable Drug Products Formulary Regulations, 2007 under the Pharmaceutical Services Act specifies,
5) (1) In accordance with section 23 of the Act, the maximum price listed for a drug in the formulary shall not exceed the price listed for the same drug as published in the formulary to the Ontario public drug program, plus an inventory adjustment fee set by the minister.
(2) A guaranteed price submitted by a manufacturer under subsection 23(1) of the Act which exceeds the price listed for that drug published in the formulary to the Ontario public drug program does not comply with subsection 23 (2) of the Act and that price shall not, under the authority of subsection (1), be accepted by the minister as a price at which to list the drugs in the formulary.
(3) Where a guaranteed price submitted by a manufacturer is not accepted by the minister under subsection (2), for the purpose of setting the maximum price at which a drug may be listed in the formulary, the minister may substitute as the price for that drug the price listed for the drug as published in the formulary to the Ontario public drug program, plus an inventory adjustment fee.
(4) Notwithstanding subsection (3),
(a) a manufacturer may choose to withdraw a guaranteed price submitted to the minister where that manufacturer chooses not to proceed with an application for the inclusion of a drug in the formulary; or
(b) the minister may, where the guaranteed price submitted by a manufacturer exceeds the price listed for that drug as published in the formulary to the Ontario public drug program,
(i) refuse to list a drug in the formulary, or
(ii) in accordance with subsection 19(4) of the Act, remove a drug from the formulary.
Important Notice Regarding Volume 53 Pricing:
Due to significant price changes as a result of the Regulations referenced above for existing categories (i.e. those categories and products which were in Volume 52, including the addendum to Volume 52), the pricing in this volume will not come into effect until February 1, 2008. Volume 52 prices will apply for the time period January 1 – 31, 2008. This delayed pricing implementation applies to Volume 53 only.
For new categories entering Volume 53, MLP charging will become effective 15
days from the effective date of Volume 53.
Contact Information:
Department of Health and Community Services
Pharmaceutical Services
P O Box 8700
Confederation Building - West Block
St. John’s, NL
A1B 4J6