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 Pharmacists
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 Formularies apply only to
residents who are covered under Government programs; however, all residents
of Newfoundland and Labrador benefit from prices published in the Formulary.
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.
Submission Requirements for the
Newfoundland Interchangeable Drug Products Formulary (NIDPF)
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.
Submission Requirements for the
Newfoundland Interchangeable Drug Products Formulary (NIDPF)
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.
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
An algorithm detailing the above can be viewed at
www.gov.nl.ca/health/nlpdp
under “Drug Products Formulary”.
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.
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
Fax (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
FORMULARY PUBLISHING
The NIDPF is officially published in
January and July. Additional 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 and its supplements are also available on the Internet at
http://www.gov.nl.ca/health/nlpdp.
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 the Formulary.
New Drug Categories: Pharmacies are given a 30 day period from the
date of interchangeability before mandatory charging of the lowest price
becomes effective, to allow time to adjust inventory and advise their clients of
any change in status of current therapies.
New Drugs Added to Existing Categories: When a new drug is added
to an existing category, its price will be based on the current lowest price for
that category. Should the new product be lower priced than the category’s
current lowest price, the category price will be set at the new product’s price.
This price 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
mandatory charge date 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 Formulary 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.
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.
WHERE THE LOWEST PRICE IS NOT
AVAILABLE
Where due to exceptional
circumstances (such as production and distribution problems) the lowest priced
drug is not available to pharmacies within the Province, a dispenser may supply
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.
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