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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. 1 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 2 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 . 3 A Guide to Understanding Drug Schedules July 2006 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 4 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”. 5 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. 6 A Guide to Understanding Drug Schedules July 2006 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. 7 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. 8 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. 9 A Guide to Understanding Drug Schedules July 2006 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 10 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 11 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