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.
MAXIMUM PRICES
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.
Contact Information:
Department of Health and Community Services
Pharmaceutical Services
P O Box 8700
Confederation Building - West Block
St. John’s, NL
A1B 4J6
|
