Download Guide to Understanding Drug Schedules

A guide to Understanding
Drug Schedules
July 2006
Approved by Council September 2006
This document is modified from:
A Guide to Understanding the
Newfoundland and Labrador
Provincial Drug Schedules
February 2006
and
Understanding Alberta’s
Drug Schedules
May 2004
TABLE OF CONTENTS
INTRODUCTION
DRUG SCHEDULING PROCESS ........................................................................ 2
PROCESS FOR REVISIONS TO SCHEDULES .................................................. 4
SCHEDULES ................................................................................................................ 5
STANDARDS OF PRACTICE....................................................................................... 6
Appendices
APPENDIX A - SCHEDULING CRITERIA .................................................................... 7
•
•
•
Schedule I
Schedule II
Schedule III
APPENDIX B - SUMMARY OF SCHEDULES ............................................................ 10
APPENDIX C - VACCINES QUICK REFERENCE...................................................... 16
APPENDIX D - SUPPLEMENTAL STANDARDS OF PRACTICE FOR
SCHEDULE II AND III DRUGS .......................................................... 18
INTRODUCTION
This guide has been prepared to:
• provide pharmacists with information on the drug scheduling process.
• describe New Brunswick’s drug schedules,
• provide a reference to help pharmacists understand the schedules, and
• describe the standards of practice that apply to Schedules 2 and 3.
Excerpt from the Pharmacy Act:
SCHEDULE 1
All drugs and medicines listed in Schedule 1 of the Manual For Canada’s National Drug
Scheduling System published by the National Association of Pharmacy Regulatory Authorities, as
amended from time to time (the “Manual”).
The drugs and medicines in this schedule shall be subject to the selling and dispensing
conditions prescribed under the Manual, as amended from time to time.
No licensed pharmacist, and no licensed certified dispenser or licensed student under the direct
supervision of a licensed pharmacist, shall sell a drug listed in this Schedule except pursuant to a
prescription.
The Standards of Practice respecting dispensing of prescription drugs, as set by regulation, apply
to dispensing of drugs and medicines in this Schedule.
SCHEDULE 2
All drugs and medicines listed in Schedule 2 of the Manual For Canada’s National Drug
Scheduling System published by the National Association of Pharmacy Regulatory Authorities, as
amended from time to time (the “Manual”).
The drugs and medicines in this schedule shall be subject to the selling and dispensing
conditions prescribed under the Manual, as amended from time to time.
No licensed pharmacist, and no licensed certified dispenser or licensed student under the direct
supervision of a licensed pharmacist, shall sell a drug listed in this Schedule except from the
dispensary of a pharmacy.
The Standards of Practice respecting dispensing of non-prescription drugs, as set by regulation,
apply to dispensing of drugs and medicines in this Schedule.
SCHEDULE 3
All drugs and medicines listed in Schedule 3 of the Manual For Canada’s National Drug
Scheduling System published by the National Association of Pharmacy Regulatory Authorities, as
amended from time to time (the “Manual”).
The drugs and medicines in this schedule shall be subject to the selling and dispensing
conditions prescribed under the Manual, as amended from time to time.
No licensed pharmacist, and no licensed certified dispenser or licensed student under the direct
supervision of a licensed pharmacist, shall sell a drug listed in this Schedule except in the area
immediately adjacent to the dispensary.
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A Guide to Understanding Drug Schedules July 2006
The Standards of Practice respecting dispensing of non-prescription drugs, as set by regulation,
apply to dispensing of drugs and medicines in this Schedule.
Drug Scheduling Process
In May 1995, the National Association of Pharmacy Regulatory Authorities
(NAPRA) approved a national scheduling model. To ensure ongoing review and
maintenance of the drugs listed in the model schedules, NAPRA established the
National Drug Scheduling Advisory Committee (NDSAC) in August 1995.
NDSAC includes experts from across Canada as well as other relevant
representatives. NDSAC’s mandate is to advise the provincial regulatory
authorities on matters relating to the placement of drugs within the national
scheduling model and to continually evaluate and maintain the drug scheduling
factors within the model. Drug products are assigned to one of the following
schedules based on set criteria (see Appendix A).
The Canadian Drug Advisory Committee (CDAC) model that NDSAC uses for
making drug scheduling recommendations embodies a “cascading principle” in
which a drug is first assessed using the factors for Schedule 1. Should sufficient
factors pertain, the drug remains in that schedule. If not, the drug is assessed
against the factors for Schedule 2, and if warranted it is subsequently assessed
against the factors for Schedule 3. Should the drug not meet the factors of any
schedule, it becomes unscheduled or non-restricted and available for sale from
any retail outlet. This process promotes the listing of drugs in schedules
corresponding to the conditions of sale, providing for proper drug use and patient
safety.
As a result of applying the cascading principle, four categories of drugs resulted:
Schedule 1:
Drugs that require a prescription as a condition of sale.
Schedule 2:
Drugs that are available only from the pharmacist and without a prescription.
There is no opportunity for patient self-selection.
Schedule 3:
Drugs that are available without a prescription from the self- selection area of a
pharmacy.
Unscheduled:
Drugs not listed in Schedule 1, 2 or 3 that may be sold from any retail outlet.
The CDAC report states that the outcome of drug scheduling should serve the
patient in the best and most sensible and reasonable manner possible in light of
knowledge and practice. Scheduling factors were developed to reflect an
assessment of drug-use risk to the public and to establish the level of
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A Guide to Understanding Drug Schedules July 2006
professional control required to provide safe and effective drug use for patients.
However, patients have the ultimate responsibility for their health, and they
should have access to self-selected drugs for self-medication or access to the
selection of non-prescription drugs, with the assistance of a pharmacist. The
safety and effectiveness of non-prescription drugs depends on their appropriate
use to treat minor ailments. Consultation must be appropriate in level, scope and
content to the needs of those seeking assistance.
Because drug scheduling using the cascading principle is based on factors of
relative risk associated with taking medications with or without the advice of a
health care professional, the standards of practice also reflect this concept.
The standards of practice for Schedule 2 drugs include activities that must be
undertaken by the pharmacist interacting with a patient desiring to self-medicate
with one of these products.
As patients may self-select Schedule 3 drugs, it is essential for pharmacists to be
available for consultation. Patients should be encouraged to seek consultation on
any concerns regarding the safety and/or effectiveness of either Schedule 2 or
Schedule 3 drugs. Although the required activities may vary for schedule 2 and 3
drugs, the consultation process on all non-prescription drugs is very similar.
The New Brunswick College of Pharmacists will utilize NDSAC's
recommendations to maintain its provincial drug schedules.
For more information about NDSAC recommendations, please refer to the
NAPRA website at www.napra.org .
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Process for Revisions to Schedules
NDSAC meets several times throughout each year to review and analyse submissions from
sponsors requesting scheduling recommendations.
The committee serves to make
recommendations on the placement of drugs within the schedules in response to:
•
•
•
A federal government proposal to deregulate a federal prescription status drug;
A new drug approved for sale in Canada on a non-prescription basis; or
A request from a manufacturer, the public or other stakeholder to reassess or review
the current recommended schedule status of a drug.
Acting as the committee’s Secretariat, NAPRA communicates scheduling recommendations
to the requesting sponsor, provincial pharmacy regulators and other stakeholders immediately
after the meetings.
The Schedules may be accessed on the NAPRA website:
http://www.napra.org/sortdrug.asp
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A Guide to Understanding Drug Schedules July 2006
SCHEDULE I – PRESCRIPTION SALE ONLY
The drugs included in Schedule I require a prescription as a condition of sale. Drugs in this
schedule include all the federally scheduled drugs.
Drugs listed in Schedule I are, therefore, subject to the same regulations as drugs listed in Part I
and II to Schedule “F” of the Food and Drug Regulations (Canada) and the Narcotics and
Controlled Substances Act.
SCHEDULE II – SALE ONLY FROM A NO PATIENT ACCESS AREA OF A
DISPENSARY
The drugs listed in Schedule II do not require a prescription as a condition of sale, but are available
only from a pharmacist, and must be sold from an area of the pharmacy to which there is no public
access and no opportunity for self-selection.
Schedule II drugs are placed in no public access areas to ensure safe drug use. Pharmacists have
a professional responsibility to ensure patients are knowledgeable about the appropriate selection
of a Schedule II drug depending on symptoms, compatibility with other drugs being used, efficacy,
possible adverse drug reactions, expected outcomes and what to do if outcomes are not achieved.
SCHEDULE III – PHARMACY SALE ONLY
The drugs listed in Schedule III do not require a prescription as a condition of sale, but are sold
from the self-selection area of a pharmacy which is operated under the direct supervision of a
pharmacist. A pharmacist shall be available to assist the patient in making an appropriate selfmedication selection with these drugs.
Schedule III drugs are placed in the self-selection area because they present risks for only some
patients. The pharmacist has a professional responsibility to be available, accessible and
approachable to assist the patient in making a selection.
UNSCHEDULED DRUG PRODUCTS
Many drugs have been reviewed by NDSAC and have not been assigned any place in the above
schedules. Also, many drugs that are included in the schedules are included based on specific
parameters such as strength and dosage form. That same drug in another strength or dosage
form may be considered “Unscheduled”.
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A Guide to Understanding Drug Schedules July 2006
Standards of Practice
Standards of Practice have been developed outlining the role of the pharmacist with regard to
Schedule I drug products. These standards were distributed to all pharmacists and are also
available on the Society website.
Standards of Practice have been developed outlining the role of the pharmacist in the sale of
Schedule II and III drug products.
Pharmacists are responsible for ensuring the public is knowledgeable in the safe and appropriate
use of these products before releasing for sale.
These Standards are attached in Appendix D and are also available on the Society website.
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APPENDIX A
SCHEDULING CRITERIA
FACTORS FOR THE INCLUSION OF DRUGS IN SCHEDULE I
1. Indications for use of the drug are identifiable only by the practitioner. Diagnosis of the indication
requires intervention by the practitioner before the drug is used.
2. Use of the drug requires adjunctive therapy or evaluation. Adjunctive therapy could include other
drugs, non-pharmacologic measures, or specialized drug delivery devices. Evaluation could include
indicated laboratory or clinical assessments.
3. Use of the drug may produce dependency. The drug may cause addiction or become habit forming.
Control of access and duration of therapy by a health care professional is required.
4. Serious adverse reactions to the drug are known to occur or have a recognized potential to occur at
normal therapeutic dosage levels. Adverse experiences require special monitoring or intervention by
a health care professional.
5. There exists a narrow margin of safety between the therapeutic and toxic dosages of the drug, either
in the general population, or in identified subpopulations, or in patients with multiple medical
problems. Safe use requires the involvement and intervention of a health care professional.
6. Serious interactions of the drug are known to occur. Such interactions (drug-drug, drug-food, and
drug-disease) require special monitoring or intervention by a health care professional.
7. Use of the drug has contributed to, or is likely to contribute to, the development of resistant strains of
micro-organisms. Appropriate use, and/or the decision to continue treatment, requires evaluation by
the practitioner.
8. The mechanism of action of the drug is known but the consequences of widespread use are not
adequately established. Unexpected effects of the drug must be evaluated and reported by a health
care professional.
9. The therapeutic effects of a newly released drug are based on new or unknown mechanisms of
action, but the consequences of widespread use are not adequately established. Close monitoring
of the patient is required by a health care professional for unanticipated effects.
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A Guide to Understanding Drug Schedules July 2006
FACTORS FOR THE INCLUSION OF DRUGS IN SCHEDULE II
1. The initial need for a drug is normally identified by the practitioner, in addition chronic, recurrent, or
subsequent therapy must be monitored by the pharmacist. A prescription should not be required to
obtain a drug if the patient can understand directions for continued use through the intervention of
the pharmacist. Therefore, the patient should have access to the drug for subsequent treatment and
use following the first diagnosis and prescription by the practitioner. This collaborative approach
enhances patient care.
2. The drug must be readily available under exceptional circumstances when a prescription is not
practical. Such a drug might be required for a serious medical situation and the patient should have
access to it to prevent a possible health emergency. An example of such an exceptional
circumstance is availability of injectable epinephrine for anaphylactic reactions.
3. The drug is intended for administration in a health care setting or under direction of a health care
professional, or is in an injectable dosage form and is not otherwise included in Schedule I.
Examples include preoperative or diagnostic agents and products used for immunization or
desensitization.
4. Evidence of abuse of the drug has been reported, due to its inherent pharmacological action which
has the potential for abuse. Monitoring by a health care professional is necessary.
5. The selection of the drug requires intervention by the pharmacist to confirm that an appropriate selfassessment has been made by the patient. Dosage form, for example, may be an important
consideration.
6. Use of the drug may delay recognition or mask the symptoms of serious disease. Intervention by the
pharmacist is necessary to ensure appropriate referral to the practitioner.
7. The drug may cause important adverse reactions, including allergies, or interacts with other drugs,
foods, or disease states that cannot be adequately addressed through product labelling. Intervention
by the pharmacist is necessary to assess patient risk to prevent such problems for an individual
patient through interpretation and clarification of labelling.
8. Use of the drug requires reinforcement or an expansion of the directions for use, through pharmacist
- patient dialogue. Such reinforcement and expansion may include the explanation of the use of a
drug delivery system.
9. The drug is a new ingredient for self-medication and monitoring by the pharmacist is necessary to
facilitate observation and reporting of any unexpected event.
10. The maximum labelled dosage directions exceed the generally accepted or usual limits for Schedule
III status.
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A Guide to Understanding Drug Schedules July 2006
FACTORS FOR THE INCLUSION OF DRUGS IN SCHEDULE III
1. The initial need for a drug is normally identified by the patient, physician, or pharmacist, but chronic,
recurrent, or subsequent therapy can be monitored by the pharmacist.
2. The maximum recommended duration of use of the drug is limited and specified on the product
label. The pharmacist is available to explain that the consequences of not following the period of
use may be serious and that persistence of symptoms may suggest an underlying ailment.
3. The maximum recommended duration of use of the drug is not specified on the label, but continued
use may delay recognition or mask the symptoms of serious disease. The pharmacist is available to
help in interpretation of symptoms, to assist in selection of alternative therapy, or to provide
appropriate referral.
4. The drug is used to treat a persistent, chronic or recurring condition and the availability of the
pharmacist to provide advice can promote appropriate use. The pharmacist should be available to
direct the patient to a practitioner for assessment if the treatment period has been inappropriate or
the therapy has been ineffective.
5. The drug is used for self-treatment of self-limiting ailments; however, where product selection has
been identified as likely to cause patient confusion and the availability of the pharmacist to provide
advice can promote appropriate use. Many product selections may be confusing for the patient.
These choices are further complicated by the different forms of available therapy or dosage forms.
6. The drug demonstrates adverse effects, including allergies, or interacts with other drugs, foods, or
disease states that can be identified in product labelling, but appropriate product selection and
explanation of risk may require the advice of the pharmacist. For example, individuals taking a
traditional monoamine oxidase inhibitor are aware that certain drugs should be avoided (e.g., cold
products) but might require assistance in selecting a safe product to use.
7. The drug is a new ingredient for self-selected self-medication and the availability of the pharmacist to
provide advice can promote appropriate use. The pharmacist is available to answer questions about
this new ingredient.
8. The drug has inherent pharmacologic action which has the potential for non-medical use which may
result in adverse patient outcomes.
9. The maximum labelled dosage directions exceed the generally accepted or usual limits for
unscheduled status.
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APPENDIX B
SUMMARY OF SCHEDULES
DRUG PRODUCT DISTRIBUTION REQUIREMENTS
Pharmacy and Non-Pharmacy Outlets
January 2006
This document consists of three lists:
Unscheduled
Professional Products Area Items
Professional Service Area Items
non-pharmacy distribution permitted
pharmacy distribution required
pharmacy distribution required
Within each list, product names are categorized according to their common indications for use. The lists are subject to
revision and are not necessarily comprehensive but are meant to include representative examples.
Questions or requests for clarification may be directed to the Board office.
UNSCHEDULED – Non-pharmacy distribution permitted
Analgesics
acetaminophen (in immediate release
tablets, capsules, suppositories or
liquid)
Abenol suppositories
Atasol products
Excedrin / Excedrin Extra Strength
Novo-Gesic / Novo-Gesic Forte
Tempra Products
Tylenol Regular Strength caplets, tablets
Tylenol Extra Strength caplets, tablets
Tylenol Children's Chewable Tablets
Tylenol Children's Suspension
Tylenol Infant’s Suspension Drops
Tylenol Ultra Relief
Various generic and store brands
acetaminophen in sustained release
formulations (up to and including 650
mg per unit) in package sizes
containing no more than 50 units
Tylenol Arthritis (24’s & 50’s)
acetylsalicylic acid and its salts (in
products for oral use in strengths of
325mg and 500mg per dosage unit)
Alka-Seltzer products
Anacin products
Aspirin Regular Strength caplets, tablets
Aspirin Extra Strength caplets, tablets
Aspergum
Bufferin products
Entrophen Regular / Extra Strength
Novasen 325mg
Various generic and store brands
ibuprofen and its salts (when sold in
strengths of 200mg or less per
dosage form) [Note: 200mg or
less per solid form or per 5ml
liquid]
Advil Regular Strength products
Advil Children’s products
Motrin IB Regular Strength products
Motrin Children’s products
Various generic and store brands
Antacids/Acid Controllers
Alka-Seltzer products
Diovol products
Gaviscon products
Maalox products
Milk of Magnesia
Mylanta products
Ovol
Pepcid AC / Pepcid Complete
Pepto Bismol
Phazyme products
Rolaids
Tums
Zantac 75
NeoCitran Colds & Flu / Extra Strength
Colds & Flu / Colds & Sinus
powders
Reactine adult products (single-entity)
Robitussin / Robitussin Extra Strength
Vicks Vaporub
Dental Products
Amosan
Anbesol (except baby products)
Dequadin
Fletcher's Sore Mouth Medicine
Orabase
Orajel (except baby products)
Diarrhea Products
Fowler’s Tablets and Suspension
Imodium products
Kaopectate products
Pepto Bismol
Cough, Cold and Allergy
Aerius adult products
Balminil Expectorant
Benylin E Extra Strength
Buckley's Mixture
Calmylin Expectorant
Chlor-Tripolon products (single-entity)
Claritin adult products (single-entity)
Dimetapp Cold products
Dimetapp Oral Infant Cold Drops /
Cold & Fever Drops
Jack and Jill Cough Syrup
Koffex Expectorant
Eye Preparations
Afrin products
Albalon
Artificial Tears
Bausch & Lomb Allergy Drops
Claritin Allergy Eye Drops
Clear Eyes
Mydfrin
Naphcon Forte / Naphcon A
Opcon A
Optrex Drops
Prefin / Prefin A
Vasocon
Visine products
Zincfrin
Foot Care
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A Guide to Understanding Drug Schedules July 2006
Canestan Topical Cream
Clotrimaderm Cream
Compound W products
Dr. Scholl’s Athlete’s Foot Cream
Duofilm Patch / Plantar Patch / Gel for
Kids
Duoforte 27 Gel
Duoplant
Freezone Liquid, Pads
Micatin Cream, Spray
Monistat Derm Cream
Oxizole Cream
Scholl Clear Away Wart Remover
products
Scholl Corn, Callous and Wart Remover
products
Soluver / Soluver Plus
Tinactin
Trans-Plantar
Trans-Ver-Sal
Laxatives
Colace products
Correctol Stool Softener
Ex-Lax products
Glycerin Suppositories
Lansoyl
Metamucil
Mineral Oil
Prodium products
Senokot products
Soflax Capsules / Pediatric Drops /
Syrup / C
Liniments and Muscle Rubs
A-535 products
Absorbine products
Aspercreme / Extra Strength
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Ben-Gay products
Deep Cold & Deep Heating products
Heet products
Lakota Pain Reliever
Menthacin Cream
Minard’s Linement
Myoflex products
Tiger Balm Linement
Zostrix / Zostrix HP
Lozenges
Bentasil
Bionet
Bradosol
Cepacol
Cepastat
Chloraseptic
Dequadin
Halls
Strepsils
Sucrets (except Cough Control)
Vicks Cough Drops
Medicated Shampoos / Tar-Based
Products
Balnetar
Denorex Regular Strength
Doak Oil / Doak Oil Forte
Nizoral Shampoo
P & S Plus Gel
Tar-Gel
Menstrual Pain Relief
Midol products
Pamprin PMS / Pamprin Extra
Strength
Tylenol Menstrual
Nasal Spray, Drops, Inhalers
Claritin Nasal Spray
Dristan spray products
Drixoral Nasal Spray
Otrivin products
Vicks Sinex Decongestant Nasal Spray
Topical First Aid Products
Abreva
Afterburn
Aveeno products
Baciguent Topical Ointment
Bacimyxin Ointment
Bacitracin Zinc Ointment
Bactine spray
Banana Boat Sooth-A-Caine
Caladryl lotion
Calamine lotion
Gold Bond Medicated Cream
Johnson & Johnson First Aid Ointment
Lanacane Medicated Cream /
Ointment / Spray
Ozonol products
Polyderm
Polysporin products
Polytopic
Sarna P Lotion
Solarcaine products
Vitamins, Tonics, Food
Supplements
Non-pharmacies are permitted to sell
vitamins, tonics and food
supplements, provided that the
concentration of active ingredients
does not exceed those referred to in
the Drug Schedules.
A Guide to Understanding Drug Schedules July 2006
PROFESSIONAL PRODUCTS AREA ITEMS - Pharmacy distribution required
The products listed below contain drugs listed in Schedule III of the Drug Schedules
These products can be sold only from a licensed pharmacy.
Analgesics and Muscle
Relaxants
acetaminophen (in sustained
release formulations)
Tylenol Arthritis Pain
acetylsalicylic acid and its salts (in
products intended for oral adult
use in strengths of 81mg per
dosage unit and 650mg or
greater per dosage unit, and in
rectal preparations containing
more than 150mg per dosage
unit)
Asaphen 81 mg, E.C. 81mg
Aspirin 81 mg
Aspirin Arthritis Pain Relief
Entrophen Super Extra Strength
Novasen 650mg
ibuprofen and its salts (in strengths
greater than 200mg but not
exceeding 400mg per dosage
unit)
Advil Extra Strength
Motrin IB Extra Strength / Super
Strength
Various generic and store brands
Antifungals
Candistatin powder
Canesten Vaginal products
Clotrimaderm Vaginal products
Monistat Vaginal products
Mycostatin cream, ointment,
powder
Nyaderm cream, ointment
Antinauseants
Bonamine
Gravol oral products
Various generic and store brands
of dimenhydrinate
Baby Medications
Anbesol Baby Gel
Baby Orajel / Nighttime /
Teething swabs
Zilactin Baby (Teething Gel)
Back Pain
Acetazone Forte
Back-Aid Forte
Dodd’s Back Ease / Extra Strength
Methoxacet / Methoxisal
Norflex / Norgesic / Norgesic Forte
12
Parafon Forte
Robaxacet / Robaxisal / Robaxin
Tylenol Aches & Strains
Various generic and store brands
Cough, Cold and Allergy
Preparations
Actifed products
Advil Cold & Sinus / Cold & Sinus
Plus
Advil Children’s Cold
Aerius Kids syrup
Allegra / Allegra D
Balminil DM products / Cough &
Flu / Nighttime
Benadryl products (except topical)
Benylin1 All-in-One Cold & Flu
products
Benylin products (except Benylin2,
Benylin E and Benylin D for
Infants)
Buckley's DM / DM Decongestant /
Cough, Cold & Flu / Bedtime
Chlor-Tripolon Decongestant
tablets / ND
Claritin Allergy + Sinus / Kid’s
Syrup
Contac products (except 12-hour
Non-Drowsy)
Coricidin II Cough & Cold / Extra
Strength Cold & Flu
Delsym
Dimetapp Daytime Cold
Drixoral Cold and Sinus
Formula 44 products
Jack and Jill products
NeoCitran Cough powders
NeoCitran syrups
NeoCitran thinstrips
Reactine Allergy + Sinus / Kid’s
syrup
Robitussin products (except for
plain & Extra Strength)
Sinutab products
Sudafed Cold & Sinus / Sinus
Advance / Cold & Cough / Cold
& Flu
Tavist
Triaminic products
Tylenol Allergy Sinus / Allergy-D /
Cold / Cough / Flu / Sinus
products
Vicks DayQuil / NyQuil products
Auralgan
Cerumenex
Cromolyn Eye Drops
Opticrom
Zincfrin A
Fluoride
Fluor A Day 0.55mg, 1.1mg
Fluor A Day Lozenges
Laxatives
Carters Little Pills
Citro-Mag
Correctol
Dulcolax
Gentlax / Gentlax S
Royvac Bowel Evacuant Kit
Soflax Ex.5 / Ex.10
Various generic and store brands
of bisacodyl
Various generic and store brands
of lactulose
Skin Care Products
Acetoxyl Gel 2.5 / 5
Benzac products
Benzagel 5 products
Clearasil BP Plus Acne Treatment
Cream
Johnson’s Clean & Clear Persa Gel
Neo Strata Astringent Acne
Treatment
Neo Strata Blemish Spot Gel
Neutrogena Acne Mask
Neutrogena On-The-Spot Acne
Treatment
Oxy 2.5 / Oxy 5 products
Oxyderm Lotion 5%
Solugel 4
Sleeping Aids
Nytol (except Natural Source)
Simply Sleep
Sleep-Eze D (except V Natural)
Sominex
Unisom
Smoking Cessation Products
Habitrol patches
Nicoderm patches
Nicorette gums
Nicorette Inhaler
Nicotrol patches
Prostep patches
Eye and Ear Preparations
Albalon A
A Guide to Understanding Drug Schedules July 2006
Topical First Aid Products
Betadine Ointment / Shampoo /
Skin Cleanser / Solution
Claritin Skin Itch Relief
Duofilm liquid
13
EMLA products
Lipactin
Phenergan Cream
Proviodine Detergent, Solution
Various generic and store brands
of hydrocortisone 0.5%
A Guide to Understanding Drug Schedules July 2006
PROFESSIONAL SERVICE AREA ITEMS - Pharmacy distribution required
The products listed below contain drugs listed in Schedule II of the Drug Schedules.
The products can be sold only from within the dispensary area of a licensed pharmacy.
The pharmacist must be directly involved with the sale of the products, and the public cannot
have direct physical access to the products until the pharmacist has evaluated the request or need.
Analgesics
acetylsalicylic acid and its salts (in
oral preparations containing
80mg or less per dosage unit
and intended for pediatric use
OR rectal preparations
containing 150mg or less per
dosage unit, in package sizes
containing no more than 1.92 g
of acetylsalicylic acid)
Asaphen Chewable 80mg
Children's Aspirin
Various generic and store brands
of ASA tablets 80mg or
suppositories 150mg
codeine and its salts (in
preparations exempted from the
Regulations to the Controlled
Drugs and Substances Act
[8mg or less per solid dosage
form or 3.3mg or less per 5ml
liquid])
Acetazone Forte C8
Atasol 8
Benylin2 Cold & Flu
Calmylin / Calmylin with codeine
Exdol-8
Lenoltec No.1
Methoxacet C8 / Methoxisal C1/8
Robaxacet C8 / Robaxisal C1/8
222 tablets
Sinutab with Codeine
Tylenol No.1
Various generic and store brands
AC&C
Various generic and store brands
Acetaminophen with Codeine
Anthelmintics
Combantrin
Cough, Cold & Allergy
2
Benylin Cold & Flu
Benylin D for Infants
14
Calmylin / Calmylin with codeine
Congest Aid Tab 30 mg
Contac Cold 12 hour Non-drowsy
Drixoral ND long-acting tab
Decon NS
Eltor 120 - sustained release caplet
Sinutab with Codeine
Sudafed Decongestant Children's
Chewable Tablet / Extra Strength
Tablet / 12-hour Caplet
Triaminic Pediatric Oral Cold Drops
Eye and Ear Preparations
Lidomyxin
Lidosporin Ear Drops
Optimyxin Eye/Ear Drops, Eye
Ointment
Polysporin Eye/Ear Drops, Eye
Ointment
Gastrointestinal Products
Bentylol
Buscopan
Diarr-eze Liquid
Dom-Loperamide Solution
Gravol IV / IM
Levsin
PMS-loperamide solution
Transderm V
Iron Preparations (more than
30 mg of iron per solid
dosage unit or 5 mL of liquid)
Complete Multi Pre- and Post-Natal
Fer-in-Sol Drops
Ferodan
Fero-Grad
Iberet 500
Jamieson Iron 50mg Timed
Disintegrating
Maternity One Multivitamin with
Minerals
Neo-Fer / Neo-Tinic
Orifer F
Palafer / Palafer CF
Slow Fe / Slow Fe-Folic
Various generic and store brands
of ferrous fumarate, ferrous
gluconate and ferrous sulphate
Various generic and store brand
Prenatal vitamins and minerals
Lice and Scabies Treatment
Eurax Cream
Hexit lotion / shampoo
Kwellada P lotion, cream rinse
Nix cream rinse, dermal cream
Lindane products
Pronto Lice Killing Shampoo
R & C Shampoo, conditioner, spray
Skin Care Products
Anthraforte 1 / 2
Anthranol cream
Anthrascalp lotion
Denorex Extra Strength / Extra
Strength with Conditioner
Eldopaque / Eldopaque Forte
Eldoquin / Eldoquin Forte
Esoterica products
Glyquin XM
Lustra / Lustra-AF
Neo Strata HQ Gel / Neo Strata HQ
Plus Gel & Cream
Norfemac cream, ointment
Oxipor lotion
Solaquin Forte
Ultraquin products
Topical First Aid Products
Benadryl Cream
Betadine Vaginal douche /
suppositories
Xylocaine products
Zilactin-L
Many generic and store brand
allergy creams and lotions
Other
Plan B (Emergency Contraception)
A Guide to Understanding Drug Schedules July 2006
APPENDIX C
VACCINES AND IMMUNE GLOBULINS QUICK REFERENCE
SCHEDULE I
(PRESCRIPTION SALE ONLY)
Vaccines that are NOT part of routine
immunization:
¬ Bacillus Calmette-Guerin
¬ Cholera (when not used for
prophylaxis against Traveler’s
Diarrhea due to enterotoxigenic
escherichia coli [ETEC])
¬ Encephalitis (Japanese)
¬ Hepatitis A
¬ Hepatitis B Adult
¬ Lyme Disease
¬ Rabies
¬ Typhoid
¬ Varicella (Chicken Pox)
¬ Yellow Fever
Immune Globulins
¬ Cytomegalovirus immune globulin
¬ Hepatitis B immune globulin
¬ Rabies immune globulin
¬ Rho D immune globulin
¬ Tetanus immune globulin
¬ Varicella Zoster immune globulin
15
SCHEDULE II
(NO PUBLIC ACCESS AREA OF
DISPENSARY)
Vaccines that are part of routine
immunization:
¬ Diptheria toxoid
¬ Tetanus toxoid
¬ Pertussis
¬ Pneumococcal 7-valent conjugate
¬ Poliomyelitis
¬ Haemophilus influenzae Type B
¬ Measles
¬ Mumps
¬ Rubella
¬ Hepatitis B Pediatric
¬ Influenza
Vaccines requiring special enhanced
public access due to disease outbreaks
¬ Meningococcus
¬ Pneumococcus
Cholera (when used for prophylaxis
against Traveler’s Diarrhea due to
enterotoxigenic escherichia coli [ETEC])
A Guide to Understanding Drug Schedules July 2006
Supplemental
Standards
of Practice
for
Schedule II and III
Drugs
JJuunnee 22000055
Supplemental
Standards
of Practice
for
Schedule II and III
Drugs
Contents
1
Introduction
2
• Standard #1
3
• Standard #2
4
• Standard #3
5
• Standard #4
6
• Standard #5
7
Appendix A
9
Appendix B
Introduction
On May 12, 1995 the National Association of Pharmacy Regulatory Authorities
(NAPRA) adopted Harmonized Drug Schedules in Canada: the Final Report of the
Canadian Drug Advisory Committee (CDAC). The report included background
information on the drug schedule harmonization process in Canada, a discussion of the
cascading principles for drug scheduling, an outline of the scheduling factors, and
recommendations for three schedules of drugs. One of the recommendations of the
committee was the need to establish standards of practice for the pharmacist when
consulting on the use of medications in each drug schedule. The original Standards of
Practice1 were adopted by the NAPRA council in 1995.
The drug schedules are based on cascading principles. First, a drug is assessed against
factors for Schedule I. If sufficient factors pertain, it remains in Schedule I. If not, the
drug is assessed against factors for Schedule II and so on. Schedule II drugs require
professional intervention from the pharmacist at point of sale and possibly referral to
another practitioner. The drugs must be retained in an area that does not allow for self
selection. Schedule III medications may present certain risks to specific populations.
They are sold in a self selection area of the pharmacy under the direct supervision of a
pharmacist, subject to any local professional discretionary requirements which may
increase the degree of control. This area is known as the “professional services area”. The
pharmacist is accessible and approachable to assist the patient in medication selection. A
description of the factors for Schedule II and III, currently used by the National Drug
Scheduling Advisory Committee (NDSAC), is included in Appendix A.
Since 1995, the pharmacy environment has changed regarding many practice issues:
prescribing by pharmacists, increased access to consumer information about selfmedication, and new drugs with potential for abuse. These changes, coupled with the
development of a new document entitled Model Standards of Practice for Canadian
Pharmacists (April 2003), necessitated the development of these Supplemental Standards
of Practice for Schedule II and III Products. They were prepared with the input of the
National Advisory Committee on Pharmacy Practice and the National Advisory
Committee on Pharmacy Operations (see Appendix B) between August 2004 and March
2005. These Standards then were reviewed by the NAPRA Executive Committee and the
Council of Pharmacy Registrars of Canada before being sent to 19 academic, regulatory,
and professional organizations for external review. The NAPRA Board of Directors
adopted the Supplemental Standards of Practice for Schedule II and III Drugs in June
2005.
1
Allen, B.E., Suveges L.G., Standards of Practice – Nonprescription Drugs: A Report to NAPRA [Endorsed October 1995]
Supplemental Standards of Practice for Schedule II and III Drugs – June 2005
1
Standard #1
The pharmacy manager shall ensure that nonprescription products are located in the area
of the pharmacy which is consistent with the appropriate drug schedule classification
stated in the legislation.
•
Schedule II drugs will be located in the prescription service department or in an
area adjacent to the prescription service department ensuring there is no
opportunity for self selection by the patient.
•
Schedule III drugs shall be located in an area adjacent to the prescription service
department. This area shall provide self selection to the patient but also the
opportunity for patient-pharmacist consultation.
Compliance Requirements
•
The pharmacy manager shall ensure that pharmacy personnel are knowledgeable
regarding:
- the availability and location of Schedule II, Schedule III, and unscheduled
products;
- the reasons for the location of products; and
- the necessity of pharmacists to consult with patients about Schedule II
products.
•
The pharmacy manager shall ensure that when written information is available, it
is made available to the patient and is easily accessible.
•
The pharmacy manager shall encourage patients to access the pharmacist. This
may be done through signage or by assigning a pharmacist to be physically
located in the nonprescription drug area.
•
The pharmacist shall be easily distinguished from other pharmacy personnel.
•
Pharmacy personnel shall refer all health related questions to the pharmacist.
Supplemental Standards of Practice for Schedule II and III Drugs – June 2005
2
Standard #2
The pharmacist shall respect the patient’s right to privacy and confidentiality.
Compliance Requirements
•
The pharmacist shall consult in an area where the patient feels comfortable. This
could be a private consultation area, a semi-private area, or a quiet, secluded
portion of the pharmacy.
Supplemental Standards of Practice for Schedule II and III Drugs – June 2005
3
Standard #3
When the patient requests a consultation regarding a Schedule II or III product, the
pharmacist shall collect information to assess the patient’s knowledge and needs before
providing advice.
Compliance Requirements
•
The pharmacist shall introduce themselves to patients seeking advice or patients
exhibiting behavior suggesting confusion over product selection.
•
The pharmacist shall question the patient regarding:
- the symptoms or condition being treated;
- the history of the complaint including, but not limited to, length of time
symptoms have been present, other therapies tried, and seriousness of
illness;
- the patient’s pertinent medical history including, but not limited to,
past/present medications, current disease states, sensitivities, allergies and
adverse reactions, dietary restrictions; and
- confirmation of pregnancy, possible pregnancy, or breast feeding.
•
The pharmacist shall consider all the information before recommending a therapy
for the patient, including but not limited to:
- potential or actual drug interactions with current medications; and
- potential or actual age/food/disease related interactions.
•
The pharmacist shall use other methods to determine health status, as per
provincial law, such as:
- available lab values;
- other health indicators, such as blood pressure; and
- referring to the patient’s medication profile or electronic health record, if
appropriate.
•
The pharmacist shall refer the patient to another health care professional when the
pharmacist has deemed the condition to be one of a serious nature, is unsure of the
diagnosis, or cannot be treated appropriately with non-prescription medications.
•
Once the pharmacist recommends a treatment, they shall advise the patient to
contact the pharmacist, or another health care professional if there is no
improvement, or worsening of symptoms.
•
When the patient asks for a product by name the pharmacist shall use this
opportunity to assess the patient’s knowledge about the product and provide
additional information if required.
Supplemental Standards of Practice for Schedule II and III Drugs – June 2005
4
Standard #4
The pharmacist shall take the necessary steps to fulfill their professional obligations when
recommending Schedule II, Schedule III, or unscheduled products.
Compliance Requirements
•
The pharmacist shall provide the following information to the patient:
- name of the drug(s) and dosage;
- expected length of therapy;
- expected benefit(s) and when improvement shall be noticed;
- adverse effects, allergic reactions;
- expected outcomes of the disease process and suggested therapy;
- nonpharmacological measures, if any; and
- an alternate plan if the therapy is not palliative or the symptoms change or
worsen.
Supplemental Standards of Practice for Schedule II and III Drugs – June 2005
5
Standard #5
The pharmacist shall document the patient interaction on the patient profile if deemed
appropriate.
Compliance Requirements
•
Documentation shall occur as part of ongoing therapy on the patient profile.
•
The pharmacist is responsible for documenting the interaction or may delegate the
documentation to other personnel.
•
The documentation shall include, but not be limited to:
- name of individual;
- contact information;
- allergies, sensitivities;
- medical conditions;
- recommended therapy;
- counseling provided;
- outcomes expected;
- follow up date if required;
- communication with other health care professionals as appropriate for
continuity of care or if abuse is suspected; and
- other information pertinent to the situation that is necessary for
continuity of care.
Supplemental Standards of Practice for Schedule II and III Drugs – June 2005
6
Appendix A
Factors Considered by NDSAC for National Drug Schedule Recommendations
Factors for Schedule II
1. The initial need for a drug is normally identified by the practitioner, in addition
chronic, recurrent, or subsequent therapy must be monitored by the pharmacist.
2. The drug must be readily available under exceptional circumstances when a
prescription is not practical.
3. The drug is intended for administration in a health care setting or under direction
of a health care professional, or is in an injectable dosage form and is not
otherwise included in Schedule I.
4. Evidence of abuse of the drug has been reported, due to its inherent
pharmacological action which has the potential for abuse.
5. The selection of the drug requires intervention by the pharmacist to confirm that
an appropriate self-assessment has been made by the patient.
6. Use of the drug may delay recognition or mask the symptoms of serious disease.
7. The drug may cause important adverse reactions, including allergies, or interacts
with other drugs, foods, or disease states that cannot be adequately addressed
through product labeling.
8. Use of the drug requires reinforcement or an expansion of the direction for use
through pharmacist-patient dialogue.
9. The drug is a new ingredient for self medication and monitoring by the pharmacist
is necessary to facilitate observation and reporting of any unexpected event.
10. The maximum labeled dosage directions exceed the generally accepted or usual
limits for Schedule III status.
Supplemental Standards of Practice for Schedule II and III Drugs – June 2005
7
Factors for Schedule III
1. The initial need for the drug is normally identified by the patient, physician, or
pharmacist, but chronic, recurrent, or subsequent therapy can be monitored by the
pharmacist.
2. The maximum recommended duration of use of the drug is limited and specified
on the product label.
3. The maximum recommended duration of use of the drug is not specified on the
label, but continued use may delay the recognition or mask the symptoms of
serious disease.
4. The drug is used to treat a persistent, chronic, or recurring condition and the
availability of the pharmacist to provide advice can promote appropriate use.
5. The drug is used for self-treatment of self-limiting ailments; however, where
product selection has been identified as likely to cause patient confusion and the
availability of the pharmacist to provide advice can promote appropriate use.
6. The drug demonstrates adverse effects, including allergies, or interacts with other
drugs, foods, or disease states that can be identified in product labeling, but
appropriate product selection and explanation of risk may require the advice of
the pharmacist.
7. The drug is a new ingredient for self-selected self-medication and the availability
of the pharmacist to provide advice can promote appropriate use.
8. The drug has inherent pharmacologic action which has the potential for nonmedical use which may result in adverse patient outcomes.
9. The maximum labeled dosage directions exceed the generally accepted or usual
limits for unscheduled status.
Supplemental Standards of Practice for Schedule II and III Drugs – June 2005
8
Appendix B
National Advisory Committee on Pharmacy Practice
Ronald Guse (Chair)
Manitoba Pharmaceutical Association
Celine Corman
Canadian Society of Hospital Pharmacists
Ron Elliott
Canadian Pharmacists Association
Carole McKiee
Canadian Society of Consultant Pharmacists
Dr. Glen Pearson
Alberta College of Pharmacists
Margot Priddle
Newfoundland and Labrador Pharmacy
Board
Dr. Brenda Schuster
Saskatchewan College of Pharmacists
Tinka von Keyserlingk
College of Pharmacists of British Columbia
Catherine Biggs
NAPRA staff resource
National Advisory Committee on Pharmacy Operations
Janet Bradshaw (Chair)
Saskatchewan College of Pharmacists
Merv Blair
Alberta College of Pharmacists
Tim Fleming
Canadian Association of Pharmacy
Technicians
Wally Kowalchuk
Prince Edward Island Pharmacy Board
Nancy Roberts
New Brunswick College of Pharmacists
Shelley Stepanuik
Canadian Pharmacists Association
Catherine Biggs
NAPRA staff resource
Supplemental Standards of Practice for Schedule II and III Drugs – June 2005
9
© National Association of Pharmacy Regulatory Authorities, 2005. All rights
Reserved. No part of this document may be reproduced in any form by any
Photographic, electronic, mechanical or other means, or used in any information
Storage and retrieval system, without the written permission of the author.
The National Association of Pharmacy Regulatory Authorities (NAPRA)
222 Somerset St. W., Suite 402
Ottawa, ON, K2P 2G3
Tel: (613) 569-9658 Fax: (613) 569-9659 E-mail: [email protected]
Supplemental Standards of Practice for Schedule II and III Drugs – June 2005
1