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Download PEI PROVINCIAL INTERCHANGEABLE DRUG   INTERCHANGEABLE DRUG LIST INTRODUCTION The Provincial Interchangeable Drug List (PIDL) is a listing of interchangeable pharmaceutical

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  • PEI PROVINCIAL

    INTERCHANGEABLE

    DRUG LIST

    QUARTERLY UPDATE

    APRIL 15, 2018

  • PROVINCIAL INTERCHANGEABLE DRUG LIST INTRODUCTION The Provincial Interchangeable Drug List (PIDL) is a listing of interchangeable pharmaceutical products. It is not a benefit formulary and has no relationship to the PEI Pharmacare MRP (Interchangeable/Maximum Reimbursable Price) list or the PEI Pharmacare Formulary. The PIDL identifies groups (interchangeable categories) of commonly used drugs which have therapeutic equivalence, and are listed by ATC code. Drugs which are typically considered hospital use only drugs are not included on this list. An interchangeable pharmaceutical product is defined as one which contains identical amounts of the same active ingredient(s) in a similar dosage form; interchangeable products do not necessarily contain the same non-medicinal ingredients. Submission Process The process for adding medications to the Provincial Interchangeable Drug List (PIDL) became effect July 1, 2012. All submissions for the addition of products to the Provincial Interchangeable Drug List (PIDL) must be made electronically by email only. Fax, paper, or CD (compact disk) submissions will not be accepted. All documents must be in an Adobe Acrobat PDF format. Pre-Notice of Compliance (NOC) submissions will not be accepted. Submissions will be reviewed and the Provincial Interchangeable Drug List (PIDL) updated quarterly. The complete submission must be received at least 30 days in advance. Submissions must be sent to: PEI Pharmacare( PIDL Submissions)

    Health PEI P.O. Box 2000, 20 Fitzroy St. Charlottetown, PE C1A 7N8 email: pharmservices@ihis.org

    The subject of all email submissions must be PIDL Submission. Email submissions must not exceed 5 megabytes in size. Submissions may be sent as compressed zip files. An email confirmation will be sent to manufacturers to notify them that submissions are considered to be complete. Questions regarding the submission will also be sent to manufacturers by email. Submissions will be reviewed by drug program staff. PEI Pharmacare will not be responsible for any errors or omissions in submissions noted by manufacturers.

    mailto:pharmservices@ihis.org

  • Submission Requirements The following information must be contained in the submission and should be compiled in the following order:

    1. Cover Letter or Executive Summary.

    2. The name, phone number, and email address of a person that may be contacted regarding the submission.

    3. Copy of the Notice of Compliance (NOC) issued by Health Canada or, for drug products without a Notice of Compliance, the Drug Notification Form.

    4. At least one of the following types of evidence that each dosage form and strength of the submitted product is interchangeable with the same dosage forms and strengths of the original product:

    a. The dosage form, strength, formula, manufacturing process, and testing standards of the submitted drug product are identical to those of the original drug product to which it is compared (i.e. the new product is an ultra-generic of the original drug product). OR

    b. The drug product is designated by Health Canada as being equivalent to the original product the drug product is being compared with, through designation of the original drug product as the Canadian Reference Product under the Food and Drug Regulations (Canada). OR

    c. If; The drug product that Health Canada identifies in the Notice of Compliance as the

    Canadian Reference Product is not listed as interchangeable in the PEI Pharmacare Formulary. OR

    The drug product has a Health Canada designated DIN however no Notice of Compliance has been issued by Health Canada (neither the brand nor the generic have a Notice of Compliance). OR

    The generic product has a Health Canada designated Notice of Compliance of the New Drug Submission (NDS) type. This Notice of Compliance submission type does not explicitly state any reference, Canadian or otherwise. OR

    The generic product has a non- Canadian Reference Product. OR

    Line extensions. Then;

    The drug product being submitted for interchangeability must be listed as interchangeable in three or more Canadian jurisdictions and at least one of those jurisdictions must be an Atlantic province.

    5. Copy of the Health Canada approved Product Monograph.

    6. A signed letter authorizing unrestricted communication regarding the drug product between PEI

    Pharmacare and a. Other federal, provincial, and territorial (F/P/T) drug programs b. F/P/T health authorities and related facilities c. Health Canada

  • d. Patented Medicine Prices Review Board (PMPRB) e. Canadian Agency for Drugs and Technologies in Health (CADTH)

  • Determination of Interchangeability Products may be designated as being interchangeable if:

    1. The new product contains the same amounts of the same active ingredients in a similar dosage form as the listed products. AND

    2. The manufacturer provides the following evidence of interchangeability with the listed products:

    a. The dosage form, strength, formula, manufacturing process, and testing standards of the

    submitted drug product are identical to those of the original drug product to which it is compared (i.e. the new product is an ultra-generic of the original drug product).

    OR

    b. The drug product is designated by Health Canada as being equivalent to the original product the drug product is being compared with, through designation of the original drug product as the Canadian Reference Product the Food and Drug Regulations (Canada). OR

    c. If; The drug product that Health Canada identifies in the Notice of Compliance as the

    Canadian Reference Product is not listed as interchangeable in the PEI Pharmacare Formulary. OR

    The drug product has a Health Canada designated DIN however no Notice of Compliance has been issued by Health Canada (neither the brand nor the generic have a Notice of Compliance). OR

    The generic product has a Health Canada designated Notice of Compliance of the New Drug Submission (NDS) type. This Notice of Compliance submission type does not explicitly state any reference, Canadian or otherwise. OR

    The generic product has a non- Canadian Reference Product. OR

    Line extensions. Then;

    The drug product being submitted for interchangeability must be listed as interchangeable in three or more Canadian jurisdictions and at least one of those jurisdictions must be an Atlantic province.

    PEI Pharmacare may refuse to designate a product as being interchangeable, although it meets the above conditions, if drug program staff considers it advisable in the public interest to do so.

  • The ATC Classification System

    All medications are classified according to the Anatomical Therapeutic Chemical (ATC) Classification System

    which is used by the World Health Organization for pharmacoepidemiological purposes and by the Patented

    Medicine Prices Review Board for pricing purposes.

    The ATC Classification System groups chemically similar products according to their site of action and

    facilitates the comparison of new medicines with previously available medicines. There are fourteen main

    groups in the ATC system:

    A Alimentary tract and metabolism

    B Blood and blood forming organs

    C Cardiovascular system

    D Dermatologicals

    G Genito-urinary system and sex hormones

    H Systemic hormonal preparations, excluding sex hormones

    J General antiinfectives, systemic

    L Antineoplastic and immunomodulating agents

    M Musculo-skeletal system

    N Nervous system

    P Antiparasitic products, insecticides and repellents

    R Respiratory system

    S Sensory organs

    V Various

    Each group is subdivided into anatomical, therapeutic and chemical subgroups as shown in the Legend.

    A drug may be given more than one ATC code. If it is available in two or more strengths or formulations with

    clearly different therapeutic uses, the drug would appear in various categories depending on its different forms.

    If a drug has more than one clinical indication, the main indication is chosen for the listing of the various brands

    and strengths of this drug.

  • Legend

    1. Therapeutic Main Group 2. Therapeutic Subgroup 3. Chemical/Therapeutic Subgroup 4. Subgroup for Chemical Substance 5. Interchangeable Product Heading 6. Drug Identification Number (DIN) 7. Abbreviation of Manufacturer (see Appendix I) 8. Interchangeable Product Category

    A04 ANTIEMETICS AND ANTINAUSEANTS

    A04A ANTIEMETICS AND ANTINAUSEANTS

    A04AA SEROTONIN (5 HT3) ANTAGONISTS

    A04AA01 ONDANSETRON

    ondansetron 4mg/5ml o/l

    Apo-Ondansetron 4mg/5ml o/l 02291967 AAA

    Zofran 4mg/5ml o/l 02229639 GSK

    ondansetron 4mg tab

    Mar-Ondansetron 4mg tab 02371731 MAR

    Novo-Ondansetron 4mg tab 02264056 NOP

    RAN-Ondansetron 4mg tab 02312247 RAN

    Sandoz Ondansetron 4mg tab 02274310 SDZ

    Jamp-Ondansetron 4mg tab 02313685 JPC

    ratio-Ondansetron 4mg tab 02278529 RPH

    pms-Ondansetron 4mg tab 02258188 PMS

    Zofran 4mg tab 02213567 GSK

    MYLAN-Ondansetron 4mg tab 02297868 MYL

    phl-Ondansetron 4mg tab 02278618 PHL

    CO Ondansetron 4mg tab 02296349 COB

    Apo-Ondansetron 4mg tab 02288184 APX

    Ondansetron-Odan 4mg tab 02306212 ODN

    MINT- Ondansetron 4mg tab 02305259 MNT

    1

    3

    2

    4

    8

    5

    6 7

  • Additions to the QuarterlyProvincial Interchange

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