A Jurisdictional Review of the Profession of Midwifery

Transcription

1 55 St. Clair Avenue West Suite 806 Box 18 Toronto, Ontario, Canada M4V 2Y7 Toll-Free: Telephone: Fax: Web: Prescribing and Use of Drugs by Non-Physician Health Professionals A Jurisdictional Review of the Profession of Midwifery November

2 Prescribing and Use of Drugs by Non-Physician Health Professionals: A Jurisdictional Review of the Profession of Midwifery Table of Contents Page 1) Authority to or Use Drugs in Canadian Jurisdictions 3 2) Authority to or Use Drugs in International Jurisdictions 18 3) Authority to or Use Drugs in U.S.A. Jurisdictions 19 4) Safeguards for the Prescribing or Use of Drugs in Canadian Jurisdictions 23 2

3 1) Authority to or Use Drugs in Canadian Jurisdictions Province Ontario (College of Midwives of Ontario) and/or Administration of drugs Have authority to prescribe and administer drugs Legislative Framework and Authority Standard of Practice/Guidelines/Policies Use of list/ class Regulated Health Professions Act, 1991 Midwifery Act, 1991 Scope of practice 1 3. The practice of midwifery is the assessment and monitoring of women during pregnancy, labour and the post-partum period and of their newborn babies, the provision of care during normal pregnancy, labour and post-partum period and the conducting of spontaneous normal vaginal deliveries. Controlled Acts 2 4. In the course of engaging in the practice of midwifery, a member is authorized, subject to the terms, conditions and limitations imposed on his or her certificate of registration, to perform the following: 1.Managing labour and conducting spontaneous normal vaginal deliveries. 2. Performing episiotomies and amniotomies and repairing episiotomies and lacerations, not involving the anus, anal sphincter, rectum, urethra and periurethral area. 3.Administering, by injection or inhalation, a substance designated in the regulations. 4.Putting an instrument, hand or finger beyond the labia majora during pregnancy, labour and the post-partum period. 5.Taking blood samples from newborns by skin pricking or from women from veins or by skin pricking. 6.Inserting urinary catheters into women. 7.Prescribing drugs designated in the regulations. College of Midwives of Ontario has a Standards of Practice: Essential Equipment, Supplies and Medications College of Midwives of Ontario Policy Statement on Eye Prophylaxis (for newborns). Recommendation for Midwife Certification for Care of Women Receiving Epidural Pain Relief in Labour Identified individually or in lists and route of administration e.g. inhalation, injection, orally. 1 Section 3, Midwifery Act, Section 4, Midwifery Act,

4 Province and/or Administration of drugs Legislative Framework and Authority Standard of Practice/Guidelines/Policies Use of list/ class In the Regulation 3 1.-(1) For the purposes of paragraph 3 of section 4 of the Act, the following substances are designated as substances that a member may administer by injection on the member's own responsibility: - Carboprost - Dimenhydrinate - Diphenhydramine hydrochloride - Epinephrine hydrochloride - Hepatitis B immune globulin - Hepatitis B vaccine - Intramuscular ergonovine maleate - Intramuscular or intravenous oxytocin - Intravenous fluids - Lidocaine hydrochloride with or without epinephrine - Phytonadione - RhD immune globulin 1-(2) For the purposes of paragraph 3 of section 4 of the Act, the following substances are designated as substances that a member may administer by injection on order of a member of the College of Physicians and Surgeons of Ontario: - Antibiotics - Epidural analgesia (continuous infusion maintenance) - Narcotic antagonists - Narcotics - Oxytocics intravenous 2. For the purposes of paragraph 3 of section 4 of the Act, the following substances are designated as substances that a member may administer by inhalation on the member's own responsibility: - Nitrous oxide - Therapeutic oxygen 3. For the purposes of paragraph 7 of section 4 of the Act, the following drugs are designated as drugs that may be prescribed by a member on the member's own responsibility: 3 O. Reg 884/93, DESIGNATED DRUGS 4

5 Province and/or Administration of drugs Legislative Framework and Authority Standard of Practice/Guidelines/Policies Use of list/ class - Clotrimazole - Doxylamine succinate-pyridoxine hydrochloride - Erythromycin ophthalmic ointment - Hepatitis B immune globulin - Hepatitis B vaccine - Hydrocortisone anorectal therapy compound - Miconazole - Nystatin - Oral ergonovine maleate - Phytonadione - RhD immune globulin 4. The following drugs may be used by a member in the course of engaging in the practice of midwifery on order of a member of the College of Physicians and Surgeons of Ontario: - Acetaminophen with codeine - Antibiotics - Antiemetic/sedative agents with narcotic analgesics - Barbiturates - Cervical ripening agents - Sedatives 5. A member may administer, prescribe or order any drug or substance that may lawfully be purchased or acquired without a prescription. Alberta (Ministry of Health and Wellness through the Midwifery Health Disciplines Committee) Have authority to prescribe and administer drugs Health Professions Act Midwifery Regulation, currently under Health Disciplines Act and moving to Health Professions Act In the Act, Scope of Practice 4 In their practice, midwives do one or more of the following: a. provide comprehensive prenatal, labour, birth and postpartum care to clients experiencing normal pregnancy, b. provide counselling, education and emotional support related to the clients Midwifery Health Discipline Standards of Competency and Practice is a document containing several standards and guidelines with one specific guideline called: Guidelines for Prescribing and Administering Drugs (specifying dosages and routes of delivery, and in some cases, including antibiotics, requiring that the drugs be prescribed by a physician, thus limiting the Under approved Midwives Schedule 1 of the Act, drugs are specifically listed or categorized according to their purpose as they relate to midwifery care. 4 Section 3 of Schedule 13, Health Professions Act, R.S.A. 2000, c. H-7. 5 Section 8, ALBERTA REGULATION 328/94, Health Disciplines Act, MIDWIFERY REGULATION. 6 Schedule 2, Midwifery Regulation, Alta. Reg. 328/

6 Province and/or Administration of drugs Legislative Framework and Authority Standard of Practice/Guidelines/Policies Use of list/ class physical, psychological and social needs, and c. provide restricted activities authorized by the regulations. authority granted by the regulations) In the Act, Controlled Acts 5 8 A midwife may (a) provide counselling and education related to childbearing, (b) carry out assessments necessary to confirm and monitor pregnancies, (c) advise on and secure the further assessments necessary for the earliest possible identification of pregnancies at risk, (d) identify the conditions in the woman, fetus or newborn that necessitate consultation with or referral to a physician or other health professional, (e) care for the woman and monitor the condition of the fetus during labour, (f) conduct spontaneous vaginal births, (g) examine and care for the newborn in the immediate postpartum period, (h) care for the woman in the postpartum period and advise her and her family on newborn and infant care and family planning, (i) take emergency measures when necessary, (j) perform, order or interpret screening and diagnostic tests in accordance with Schedule 1, (k) perform episiotomies and amniotomies and repair episiotomies and lacerations not involving the anus, anal sphincter, rectum and urethra, (l) prescribe and administer drugs in accordance with Schedule 2, and (m) on the order of a physician relating to a particular client, administer any drugs by the route and in the dosage specified by the physician. In the Regulation for prescribing & administration 6 1 A midwife may prescribe and administer the following substances in accordance with the guidelines approved by the Board: Antibiotics for prophylactic treatment of Group B streptococcus Antifungal agents considered safe in pregnancy and for newborns Calcium gluconate Carboprost Dimenhydrinate Diphenhydramine hydrochloride Doxylamine succinate-pyridoxine hydrochloride Entonox 6

7 Province British Columbia (College of Midwives of British Columbia) and/or Administration of drugs Have authority to prescribe and administer drugs Legislative Framework and Authority Standard of Practice/Guidelines/Policies Use of list/ class Epinephrine hydrochloride Ergometrine maleate Erythromycin ophthalmic ointment Hepatitis B Immunoglobulin Hydralazine Hydrocortisone Intramuscular or intravenous oxytocin Intravenous fluids Lidocaine hydrochloride with or without epinephrine Magnesium Sulphate Naloxone Phytonadione Promethazine RhD immune globulin Therapeutic oxygen 2 A midwife may administer, prescribe or order any drug or substance that may lawfully be purchased or acquired without a prescription. A regulated profession, under the Health Professions Act (RSBC 1996) Chapter 183 Midwives Regulation BC Reg 256/2005 All regulations made under the Health Professions Act have been repealed and replaced, effective October 17, Under the repealed act, reserved actions are now referred to as Restricted Activities. 7 Scope of Practice 8 Subject to the bylaws, registrants may: (a) assess, monitor, and care for women during normal pregnancy, labour, delivery and the post-partum period, (b) counsel, support and advise women during pregnancy, labour, delivery and the post-partum period, (c) manage spontaneous normal vaginal deliveries, (d) care for, assess and monitor the healthy newborn, and (e) provide advice and information regarding care for newborns and young infants and deliver contraceptive services during the 3 months following birth. College Of Midwives Of British Columbia Standards, Limits & Conditions for Prescribing, Ordering & Administering Drugs Bylaws for the College of Midwives of BC Revised: November 20, 2007 Lists, identified in a variety of ways; specific drugs, categories of drugs, by route, purpose/location of patient. 7 Information on BC s regulatory reform is available at: 8 Section 4(1), Health Professions Act, Midwives Regulation (B.C. Reg. 281/2008). 7

8 Province and/or Administration of drugs Legislative Framework and Authority Standard of Practice/Guidelines/Policies Use of list/ class Restricted Activities 9 5 (1) No person other than a registrant may, for the purposes of midwifery, (a) conduct internal examinations of women during pregnancy, labour, delivery and the post-partum period, (b) manage spontaneous normal vaginal deliveries, (c) perform episiotomies and amniotomies during established labour and repair episiotomies and simple lacerations, (d) prescribe, order or administer drugs and substances specified in Schedule 1 to this regulation, and (e) order, collect samples for, perform or interpret the results and reports of screening and diagnostic tests specified in Schedule 2 to this regulation. In the Regulation, for prescribing and administering 10 1 (1) A midwife may prescribe or administer the following substances: - Cephalexin - Chloroprocaine 2% - Clindamycin - Clotrimazole - Diphenhydramine hydrochloride IM - Domperidone - Doxylamine succinate-pyridoxine hydrochloride - Ergonovine maleate - Erythromycin ophthalmic ointment - Hepatitis B immune globulin - Hepatitis B vaccine - Hydrocortisone anorectal therapy compound - Intravenous fluids normal saline, Ringer's Lactate, 5% dextrose in water - Lidocaine hydrochloride without epinephrine 1% - Measles / Mumps / Rubella (MMR) Vaccine - Miconazole - Misoprostol po or pr - Mupirocin-clotrimizole-nystatin-betamethasone - Nystatin - Oxytocin IV or IM injection 9 Section 5(1), Health Professions Act, Midwives Regulation (B.C. Reg. 281/2008). 10 Schedule 1, Health Professions Act, Midwives Regulation (B.C. Reg. 281/2008). 8

9 Province and/or Administration of drugs Legislative Framework and Authority Standard of Practice/Guidelines/Policies Use of list/ class - Phytonadione - PregVit Prenatal/Postpartum Vitamin-Mineral Supplement - Pre-mixed 50/50 nitrous oxide and oxygen - RhD Immune globulin - Therapeutic oxygen - Triamcinolone neomycin sulfate nystatin gramicidin (Kenacomb) - Triple dye (2) Subject to section 6 (2) (a) of the regulation, a midwife may prescribe or administer the following substances: - Ampicillin - Cefazolin - Penicillin G - Vancomycin (3) Subject to section 6 (2) (b) of the regulation, a midwife may prescribe or administer the following substances: - Lorazepam (oral or sublingual) - Oxazepam (oral or sublingual) 2 Subject to section 6 (2) (c) of the regulation, a midwife may order and administer the following drugs: - Carboprost tromethamine - Epinephrine hydrochloride - Naloxone hydrochloride - Nitroglycerin 3 Subject to section 6 (2) (d) of the regulation, a midwife may administer the following drugs: - Acetaminophen with codeine - Antibiotics - Antiemetic/sedative agents with narcotic analgesics - Barbiturates - Cervical ripening agents in hospital only - Sedatives - Epidural analgesia (continuous infusion maintenance) in hospital only - Narcotic antagonists - Narcotics in hospital only - Oxytocin intravenous infusion in hospital only - 9

10 Province and/or Administration of drugs Legislative Framework and Authority Standard of Practice/Guidelines/Policies Use of list/ class 4 A midwife may order, prescribe or administer any drug or substance that may lawfully be purchased or acquired without a prescription. Manitoba (College of Midwives of Manitoba) Have authority to prescribe and administer drugs Midwifery Act Scope of Practice 11 2(1): The practice of midwifery means the assessment and monitoring of women during pregnancy, labour and the post-partum period, and of their newborn babies, the provision of care during normal pregnancy, labour and post-partum period and the conducting of spontaneous vaginal deliveries. 2(2): In the course of engaging in the practice of midwifery, a midwife may (a) order and receive reports of screening and diagnostic tests designated in the regulations, (b) prescribe and administer drugs designated in the regulations (c) perform minor surgical and invasive procedures designated in the regulations. 2(3): A midwife may engage in the practice of midwifery as a primary health care provider who (a) is directly accessible to clients without referral from a member of another health profession; (b) is authorized to provide health services within the practice of midwifery without being supervised by a member of another health profession; and (c) consults with other health professionals, including physicians, if medical conditions exist or arise during pregnancy that may require management outside the scope of the practice of midwifery. College of Midwives of Manitoba Core Competencies Drugs identified primarily by category, but also includes specific drugs, form, dosage and usage Drugs are categorized as those that can be prescribed and administered on own responsibility and those that can be administered under the direction of a physician. Agents are identified as medications and devices. In the Regulation, Practice Requirements for Medication 12 13(1) A midwife may prescribe and administer the medications listed in Part 1 of Schedule B. 13(2) Under a physician's direction, a midwife may administer the medications listed in Part 2 of Schedule B. In the Regulation, for prescribing & administration 13 Medications and devices that a midwife may prescribe and administer: 1. antibiotics for the treatment of vaginal/cervical infections, including gonorrhea, 11 Sections 2(1) 2(3) of the Midwifery Act, C.C.S.M. c. M Section 13 of Midwifery Regulation, Man. Reg. 68/ Schedule B, Part 1, Midwifery Regulation, Man. Reg. 68/ Schedule B, Part 2, Midwifery Regulation, Man Reg. 68/

11 Province and/or Administration of drugs Legislative Framework and Authority Standard of Practice/Guidelines/Policies Use of list/ class chlamydia, bacterial vaginosis, trichomonas and group B streptococcus 2. antiemetic for the treatment of nausea and vomiting in pregnancy 3. anti-fungal agents for maternal vaginal infections and thrush in the infant 4. anti-haemorrhoidal agents with hydrocortisone 5. BCG vaccine 6. crystalloid or colloid intravenous solutions 7. dextrose 10% solution 8. epinephrine 1:10,000 solution and epinephrine 1:1,000 solution 9. hepatitis B immune globulin, hepatitis B vaccine 10. inhalation analgesic eg. nitrous oxide and oxygen (N2O2/O2) 11. intrauterine contraceptive devices, diaphragms, cervical caps % lidocaine solution for injection 13. neonatal ophthalmic prophylaxis 14. oral contraceptive pills, depoprovera 15. oxygen 16. oxytocin and ergometrine for post-partum use 17. prostaglandins F2 18. RH immunoglobulin 19. tryptophan 20. vitamin K for the neonate 21. OTC (over-the-counter) medication commonly used in conditions arising in pregnancy. 22. Sodium bicarbonate for resuscitation of the newborn Northwest Territories (Northwest Have authority to prescribe and administer drugs In the Regulation, for administration 14 Medications that a midwife may administer under the direction of a physician: 1. other antibiotics 2. AZT to HIV positive mothers and their newborns. 3. calcium gluconate 4. cervical ripening agents 5. epidural analgesia e.g. continuous infusion maintenance 6. hydralazine solution 7. magnesium sulphate solution 8. narcotic analgesics (including acetaminophen with 15 mg. and 30 mg. codeine) 9. narcotic antagonists eg. naloxone hydrochloride 10. oxytocic for induction/augmentation of labour 11. sedatives Midwifery Profession Act, S.N.W.T Scope of Practice 15 A registered midwife is entitled to apply midwifery knowledge, skills and judgment: Standards of Practice for Registered Midwives in the NWT have guidelines on what equipment and supplies a midwife must have for a birth outside a hospital. Within this list Drugs are primarily identified individually or in 15 Section 2(1), Midwifery Profession Act, S.N.W.T. 2003, c

12 Province Territories Ministry of Health and Social Services) and/or Administration of drugs Legislative Framework and Authority Standard of Practice/Guidelines/Policies Use of list/ class a. to provide counselling and education related to childbearing; b. to carry out assessments necessary to confirm and monitor pregnancies; c. to advise on and secure the further assessments necessary for the earliest possible identification of pregnancies at risk; d. to identify the conditions in the woman, fetus or newborn that necessitate consultation with or referral to a medical practitioner or other health care professional; e. to care for the woman and monitor the condition of the fetus during labour; f. to conduct spontaneous vaginal births; g. to examine and care for the newborn in the immediate postpartum period; h. to care for the woman in the postpartum period and advise her and her family on newborn and infant care and family planning; i. to take emergency measures when necessary; j. to perform, order or interpret prescribed screening and diagnostic tests; k. to perform episiotomies and amniotomies and repair episiotomies and lacerations not involving the anus, anal sphincter, rectum and urethra; l. to prescribe and administer drugs authorized in the Midwifery Practice Framework; and 18 m. on the order of a medical practitioner relating to a particular client, to administer any drugs by the route and in the dosage specified by the medical practitioner. Controlled Acts See above scope of practice section In the Regulation, for prescribing and administration The drugs that a registered midwife may prescribe and administer under paragraph 2(1)(l) of the Act are (a) the drugs set out in the Schedule to the Registered Midwife Prescription Regulations made under the Pharmacy Act; and (b) the drugs set out in Part 1 of the Schedule. Part 1 of the Schedule: 1.Bacillus Calmette-Guerin vaccine 2.Betamethasone are 6 classes of medication. It also provides the guideline for midwives to inform a woman the risks and benefits of medications used. during practice. NWT Midwifery Practice Framework defines the model of practice for midwives in NWT. Within this document it contains the list of drugs and substances midwives are authorized to prescribe and administer. 17 lists, as well as by route, strength and purpose. 16 Prescribing and Regulation of Drugs and other Substances Regulations, N.W.T. Reg

13 Province and/or Administration of drugs Legislative Framework and Authority Standard of Practice/Guidelines/Policies Use of list/ class 3.Blood products 4.Calcium gluconate in injectable form for parenteral administration 5.Carboprost 6.Crystalloid and colloid intravenous fluids 7.Dexamethasone 8.Dextrose in concentrated solutions for parenteral injection 9.Epinephrine and its salts 10.Ergot alkaloids and their salts 11.Ferrous gluconate (oral and injectable) 12.Ferrous sulphate (oral and injectable) 13.Hepatitis B adult vaccine 14.Hepatitis B immune globulin 15.Hepatitis B pediatric vaccine 16.Hydralazine and its salts 17. Indomethacin 18.Lidocaine hydrochloride without epinephrine, up to 2% 19.Magnesium sulfate in injectable form for parenteral administration 20. MMR adult and pediatric vaccine n.b. Nitrous oxide permitted but identified as a substance (not a drug). Nova Scotia (Midwifery Regulatory Council of Nova Scotia [in formation]) Not regulated Prescribing with limitations (not in force) Midwifery Act, S.N.S. 2006, c. 18 (not yet in force) Midwifery legislation (Bill 107) was passed in November 2006 and implementation is anticipated for Scope of Practice 19 The practice of midwifery means: (i) the assessment and monitoring of the health of a mother and her baby during pregnancy, labour and the post-partum period, Section 2(i), Midwifery Act, S.N.S. 2006, c. 18 (not yet in force). 13

14 Province and/or Administration of drugs Legislative Framework and Authority Standard of Practice/Guidelines/Policies Use of list/ class (ii) the provision of care in the normal course of pregnancy, labour and the post-partum period, (iii) the management of vaginal deliveries, (iv) the ordering and interpreting of screening and diagnostic tests and the recommending, prescribing or re-ordering of drugs restricted to actual delivery and care, blood products and related paraphernalia respecting the provision of care in the normal course of pregnancy, labour and the post-partum period, and (v) invasive procedures restricted to actual delivery and care, as prescribed by regulation, either within or outside of a hospital setting and research, education, consultation, management, administration, regulation, policy or system development relating to subclauses (i) to (v). Quebec (Ordre des sages-femmes du Québec, Office des professions du Québec) Have authority to prescribe and administer drugs Code des Professions, c.c-26, 1991 Loi sur les Sage-Femmes, LRQ chapitre S-0.1 In the Act, Scope of Practice Any act the purpose of which is to provide the professional care and services required by a woman during normal pregnancy, labour and delivery and to provide a woman and her child with the professional care and services required during the first six weeks of a normal postnatal period constitutes the practice of midwifery. The professional care and services concerned consist of: 1) monitoring and assessing a woman and her child during pregnancy, labour, delivery and the first six weeks of the postnatal period, and include the provision of preventive care and the detection of any abnormal conditions in the woman or child ; 2) conducting spontaneous deliveries ; and 3) performing an amniotomy, performing and repairing an episiotomy and repairing a first or second degree perineal tear or laceration. In accordance with regulations and by-laws, the Bureau (Council in other provinces) of the Order of Midwives, is responsible for determining the standards relating to the form and content of the verbal and written prescriptions made by a midwife. A list of permitted drugs is established by the Office des professions du Quebec after consultation with the Order of Midwives of Quebec, the order of Physicians of Quebec and the Order of Pharmacists of Quebec. A regulation identifying permitted drugs is under development. Section 59 of the Act authorizes midwives to practice midwifery using drugs that have been used in previous midwifery pilot projects. Emergency procedures. In addition, in an emergency, while awaiting the required medical intervention or in the absence of medical intervention, applying suction, conducting a breech delivery, performing manual placental extraction followed by digital exploration of the uterus or 20 Sections 6, 7, 8 and 9 of the Loi sur les Sages Femmes, L.R.Q. cs-0.1 (Midwives Act,) R.S.Q. c. S Schedule 2, Regulation respecting the standards and conditions of practice for conducting home deliveries. 22 Schedule 1 and 2, Regulation respecting drugs that a midwife may prescribe or administer in the practice of midwifery. 14

15 Province and/or Administration of drugs Legislative Framework and Authority Standard of Practice/Guidelines/Policies Use of list/ class performing resuscitation procedures on the woman or newborn also constitutes the practice of midwifery. 7. The practice of midwifery by a midwife also includes the provision of 1) counselling and information on parenting, family planning, contraception, preparation for delivery and breastfeeding, the usual care to be provided to a child up to the age of one year, in particular as regards diet, hygiene and accident prevention, and on the resources available in the community ; and 2) counselling and information to the public on perinatal health care. 1999, c. 24, s. 7. Medication. 8. For the purpose of providing the professional care and services referred to in section 6, a midwife may prescribe or administer a drug designated on the list established by a regulation made under the first paragraph of section 9, according to such conditions as may be fixed in the regulation. 9. The Office des professions du Québec shall, after consultation with the Conseil du médicament, the Ordre des sages-femmes du Québec, the Collège des médecins du Québec and the Ordre des pharmaciens du Québec, establish, by regulation, a list of the drugs that may be prescribed or administered by a midwife pursuant to the first paragraph of section 8 and determine, if necessary, the conditions according to which the drugs may be prescribed or administered. Authorized Acts See above In the Regulation 21 : List Of Equipment, Supplies And Medications Required For Home Birth: - The essentials for maternal and fetal monitoring ; - The essentials for a delivery, including sterile instruments ; - The essentials for neonatal resuscitation, including intubation ; - The essentials for suturing, including sterile instruments ; - The essentials for blood samples, injections and intravenous infusions ; - The essentials for bladder catheterization ; - A container to dispose of biomedical waste ; - The following medications : oxytocics, local anaesthetics, replacement solutions for intravenous infusion, oxygen, ophthalmic prophylaxis, vitamin K, epinephrine. 15

16 Province and/or Administration of drugs Legislative Framework and Authority Standard of Practice/Guidelines/Policies Use of list/ class In the Regulation 22 : Schedule 1 provides a list of 50 drugs midwives can prescribe and administer with the specifications and conditions for each individual drug listed. Saskatchewan (Saskatchewan College of Midwives) Have authority to prescribe and administer drugs Schedule 2 provides list of 13 drugs midwives can prescribe and administer to a newborn child with the specifications and conditions indicated for each individual drug listed. Midwifery Act The Midwifery Act was proclaimed in March, 2008 The Drug Schedules Regulations, 1997 Scope of Practice 23 (a) assess and monitor women during normal pregnancy, labour and the post-partum period; (b) conduct the spontaneous normal vaginal delivery of a baby; (c) provide care to a woman and her healthy baby during a normal pregnancy, labour and post-partum period; and (d) for the purposes of clauses (a) to (c): (i) prescribe, dispense or administer drugs in accordance with the regulations, the regulatory bylaws made pursuant to this Act and The Drug Schedules Regulations, 1997; (ii) order, perform or interpret diagnostic tests in accordance with the regulations, the regulatory bylaws made pursuant to this Act and The Medical Laboratory Licensing Act, 1994; and (iii) perform invasive procedures that are prescribed in the regulations and the regulatory bylaws made pursuant to this Act. Under the regulations Schedules 1, 11 or 111 that are intended for the purpose of midwifery; permitted drugs are identified primarily by category. The Midwifery Amendment Act, 2008 inserted clauses (a), (b) and (c) above in place of the following language: act as a primary caregiver in managing pregnancy and labour, including the spontaneous normal vaginal delivery of a baby. Authorized Act See above In the Regulation: Section 23(1) of the Midwifery Act, S.S. 1999, c. M

17 Province and/or Administration of drugs Legislative Framework and Authority Standard of Practice/Guidelines/Policies Use of list/ class 3(1) Subject to the Act, the Controlled Drugs and Substances Act (Canada), The Drug Schedules Regulations, 1997, the bylaws and any terms and conditions set out in the member s licence, a member may, for a purpose that is within the scope of the practice of midwifery: (a) prescribe or administer a drug that is: (i) set out in Table 1 of the Appendix; or (ii) a member of a category of drugs set out in Table 1 of the Appendix; or (b) administer a drug that is prescribed by a practitioner who is a member of a category of practitioners authorized to prescribe the drug. Authorized Drugs and Categories of Drugs: 25 analgesics, antibiotics, antiemetics, antifungals, antihaemorrhoidal agents, antihistamines, contraceptives*, crystalloid or colloid Intravenous solutions, epinephrine, Ergometrine*, Human Papilloma virus vaccine (HPV), Influenza vaccine, Local anaesthetics, Narcotic antagonists, non prescription drugs, Oxygen, Oxytocin*, Prostaglandins*, Rho (D) Immune globulin, Rubella/mumps/rubella vaccine, Sodium bicarbonate, Vitamin K Certain drugs are only permitted by College of Midwives to those midwives authorized to perform acts requiring advanced competencies. The advanced competencies are: - pharmacologic augmentation of labour, - induction of labour for post dates pregnancy, prescribing contraceptives. 24 Section 3(1), CHAPTER M-14.1 REG 1, The Midwifery Act. 25 Appendix, Table 1, CHAPTER M-14.1 REG 1, The Midwifery Act. 17

18 2) Authority to or Use Drugs in New Zealand, and the United Kingdom Jurisdiction New Zealand (Midwifery Council of New Zealand) Prescribing and/or administration of drugs Authority to prescribe and/or administer drugs Prescribing Health Practitioners Competence Assurance Act 2003 All prescribing in New Zealand is regulated by the Medicines Act and Regulations. 27 The 1990 amendment to the Medicines Act allows midwives to prescribe prescription medicines, and may regulate the manner in which drugs are prescribed. Standard of Practice/ Guidelines/ Policies Information about the Midwifery Council Health Practitioners Competence Assurance Act 2003 and Notice of Scopes of Practice and Related Qualifications d by the Midwifery Council is available. 28 Consensus Statements: The New Zealand College of Midwives Consensus Statements provide the profession s position on any given situation. The guidelines are designed to educate and support best practice. Selected consensus statements relevant to NPP issues include the following: Prescribing; the use of complementary (alternative) health practices; Group B Streptococcus; and the administration of vitamin K to newborn babies. 29 Use of formulary/ list/class There is no defined list of medicines a midwife may prescribe, but the regulations set limits as to when a midwife can prescribe. These regulations are set out in an amendment to Regulation 39 of the Medicines Regulations It states that; no registered midwife shall prescribe any prescription of medicine otherwise than for antenatal, intra partum, and postnatal care. This is generally accepted as covering a period up to six weeks after the birth of the baby. Approval process for new drugs Medicines Classification Committee (a ministerial advisory committee) makes recommendations to the Minister of Health regarding classification of medicines as prescription medicines, restricted medicines or pharmacy-only medicines & also considers and reports to the Minister on any matter concerning the classification of medicines and access to medicines by health professionals and the public /act/public/1981/ 0118/latest/DLM53790.html 27 reprints/ r.txt 28 content/library/gazette_ Notice_scope quals.pdf

19 3 Authority to or Use Drugs in Selected United States Jurisdictions The Drug Enforcement Administration (DEA) of the U.S. Department of Justice enforces the provisions of the Controlled Substances Act (CSA). The DEA issues registrations to Practitioners or Mid-level Practitioners; midwifery is not included in its list of Mid-level Practitioners. Information about the DEA(Diversion Control Program) is available at State Colorado and/or administer drugs Direct Entry Midwives are not authorized to prescribe Framework Authority Use of list/class Specific health profession statute In the COLORADO Midwives Statute: Prohibited acts - practice standards informed consent - emergency plan - risk assessment - referral. A direct-entry midwife shall not dispense or administer any medication or drugs except for required eye prophylactic therapy. (13) It shall be lawful for a registered direct-entry midwife to purchase, possess, carry, and administer oxygen. In the Rules and Regulations, MINIMUM PRACTICE REQUIREMENTS, General Authority C.R.S : 1. RESTRICTIONS 1.1 The registered direct-entry midwife shall not provide care to any woman whose medical history shows the following: a. Diabetes mellitus or gestational diabetes; b. Hypertensive disease (BP greater than 140/90 at rest); c. Pulmonary disease or cardiac disease which interferes with activities of daily living; d. A history of thrombophlebitis or pulmonary embolism; e. Blood dyscrasia, for example sickle cell anemia; f. Seizures controlled by medication if the mother has seized within the last year; g. Hepatitis B, HIV positive or AIDS; h. Current use of psychotropic medications; i. Current substance abuse (drugs or alcohol); j. Rh sensitization (positive antibody titre), an incompetent cervix; or previous uncontrollable postpartum hemorrhage; or k. The midwife shall not provide care to any woman who has had a previous cesarean section whose emergency plan does not include the ability to transport, within 30 minutes, to a facility able to perform a cesarean section or, l. Infants who were premature, stillborn, or neonatal deaths associated with maternal health or genetic anomaly without an intervening normal pregnancy 1.2 The registered direct-entry midwife shall not: a. Perform any operative or surgical procedures; b. Utilize any instruments or mechanical means of delivery, other than hemostats to clamp the cord; c. Perform versions; or d. Administer any medications except for eye prophylaxis of the newborn. 19

20 State and/or administer drugs Michigan Authorities come from nursing certifications Framework Authority Use of list/class Specific health profession statute Nurse Midwives are licensed by the Michigan Board of Nursing. 31 The Michigan Board of Nursing may issue a nurse specialty certification to a currently licensed Michigan registered nurse if the applicant meets the state certification requirements. Nurses who go on to the Nurse Midwife Specialty Certification examination receive the professional designation of certified nurse-midwife (CNM). 32 Oregon Authorized to purchase and administer certain legend drugs Specific health profession statute 33 Under the Oregon Statute: Chapter 687 Massage Therapists; Direct Entry Midwives, 2001 EDITION "Licensed direct entry midwife" defined. As used in ORS to , "licensed direct entry midwife" means a person who: (1) Supervises the conduct of labor and childbirth; (2) Advises the parent as to the progress of the childbirth; and (3) Renders prenatal, intrapartum and postpartum care. [1993 c.362 1] A limited list of drugs, listed individually and by category, is authorized Authority to purchase and administer certain legend drugs and devices. (1) A midwife licensed under ORS to may purchase and administer authorized scheduled legend drugs and devices that are used in pregnancy, birth, postpartum care, newborn care or resuscitation and that are deemed integral to providing safe care to the public by the State Board of Direct Entry Midwifery by rule. (2) Legend drugs authorized under subsection (1) of this section are limited: (a) For neonatal use to prophylactic ophthalmic medications, vitamin K and oxygen; and (b) For maternal use to postpartum antihemorrhagics, Rh o (D) immune globulin, epinephrine, intravenous fluids, local anesthetic and oxygen. (3) Legend devices authorized under subsection (1) of this section are limited to devices for injection of medications, for the administration of intravenous fluids, for adult and infant resuscitation and for rupturing the amniotic membranes. (4) A pharmacist who dispenses drugs and devices to a licensed midwife as authorized by this section and in conformity with the provisions of ORS chapter 689 is not liable for any adverse reactions caused by administration of the legend drugs and devices by the midwife. [2001 c.462 2] In the Rules Access to and Administration of Legend Drugs and Devices Pursuant to ORS , a licensed direct entry midwife who satisfactorily completes prescribed education outlined in OAR is authorized access to and administration of specific legend drugs and devices listed in OAR , , and The following requirements shall be adhered to: (1) Licensed midwives, shall comply with all local, state and federal laws and regulations regarding the mdch_nurs_spec_cebroc_89401_7.pdf 33 Licensure in Oregon is voluntary, and unlicensed midwives may practice in Oregon. However, Oregon Revised Statute (ORS) allows reimbursement under the Oregon Health Plan only if a licensed midwife provides birthing assistance. Only LDMs are legally authorized to administer legend drugs and devices. ( 20

21 State and/or administer drugs Framework Authority Use of list/class administration, distribution, storage, transportation and disposal of approved legend drugs and devices listed in OAR through (2) Approved legend drugs must be inventoried and securely stored by the midwife at all times the product is not in use, including samples or any remaining portion of a drug. (3) Records regarding approved legend drugs and devices shall be maintained for a period of three (3) years. Records shall be kept on the business premises and available for inspection upon request by the Health Licensing Office Enforcement Officers. Upon request by the Board or Agency, a licensed midwife shall provide a copy of records. Records shall include, but not be limited, to the following: (a) Name of drug, amount received, date of receipt, and drug expiration date; (b) Name of drug and to whom administered; date and amount of drug administered to client; (c) Name of drug, date and place or means of disposal; (4) Expired, deteriorated or unused legend drugs shall be disposed of in a manner that protects the licensee, client and others who may come into contact with the material during disposal. Stat. Auth.: ORS 183, ORS & ORS Stats. Implemented: ORS 183, ORS & ORS Hist.: DEM (Temp), f. & cert. ef thru ; DEM , f cert. ef Approved Legend Drugs For Maternal Use Licensed Direct Entry Midwives may administer the following legend drugs as approved by the Board for maternal use: (1) Anti-Hemorrhagics for use by intramuscular injection includes: (a) Synthetic Oxytocin (Pitocin, Syntocin); (b) Methylergonovine Maleate (Methergine); (c) Ergonovine Maleate or Ergometrine Maleate (Ergotrate); or (2) Anti-Hemorrhagics by intravenous infusion is limited to Synthetic Oxytocin (Pitocin, Syntocin). (3) Anti-Hemorrhagics for oral administration is limited to Methylergonovine Maleate (Methergine). (4) Anti-Hemorrhagics for rectal administration is limited to Misoprostel (Cytotec). (5) Resuscitation is limited to medical oxygen and I.V. fluid replacement. (6) Intravenous fluid replacement includes: (a) Lactated Ringers Solution; (b) 0.9% Saline Solution; (c) D5LR (5% Dextrose in Lactated Ringers); or (d) D5W (5% Dextrose in water). (7) Anaphylaxis for subcutaneous injection is limited to Epinephrine. (8) Local Anesthetic includes: (a) Lidocaine HCI (1% and 2%) (Xylocaine); (b) Benzocaine (Cetacaine); and (c) Procaine HCl (Novocain and Unicaine). (9) Rhesus Sensitivity Prophylaxis is limited to Rho(d) Immune Globulin (Rhogam). 21

22 State and/or administer drugs Framework Authority Use of list/class Stat. Auth.: ORS 183, ORS & ORS Stats. Implemented: ORS 183, ORS & ORS Hist.: DEM (Temp), f. & cert. ef thru ; DEM , f cert. ef Approved Legend Drugs For Neonatal Use Licensed Direct Entry Midwives may administer the following legend drugs as approved by the Board for neonatal use: (1) Eye Prophylaxis for disease of the newborn is limited to Erythromycin Ophthalmic (1%) Ointment. (2) Prophylaxis for hemorrhagic disease of the newborn for oral use is limited to Mephyton. (3) Prophylaxis for hemorrhagic disease of the newborn for intramuscular injection includes: (a) AquaMephyton; and (b) Konakion. (4) Resuscitation is limited to medical oxygen. Stat. Auth.: ORS 183, ORS & ORS Stats. Implemented: ORS 183, ORS & ORS Hist.: DEM (Temp), f. & cert. ef thru ; DEM , f cert. ef

23 4 Safeguards Concerning the Prescribing Use of Drugs in Canadian Jurisdictions Midwifery education in Canada currently leads to a baccalaureate level degree in midwifery. All Registered Midwives are assessed against consistent required competencies regardless of the jurisdiction within which they are registered to practice. These competencies are laid out in provincial/territorial regulation, legislation and standards of practice. Each jurisdiction requires their members to submit information about their practice on an annual basis 34 Under the Agreement on Internal Trade, Chapter 7 Labour Mobility, Canadian Midwifery Colleges have agreed that an applicant who provides proof of good professional conduct from a Canadian jurisdiction in which they are currently registered will be eligible for registration without additional assessment. 35 The following information from the midwifery program at Ryerson University is included as an example of curricula. 36 Ryerson University Midwifery Program Bachelor of Health Sciences The Bachelor of Health Sciences in Midwifery degree can be completed in four to six years at Ryerson. Students can enroll part-time in the non-clinical courses which comprise the first three semesters but requires a full-time commitment for the clinical placements in the final six semesters. Students attend a minimum of 60 births, acting as primary caregiver for at least 40 births in home and in hospital settings. Students also participate in providing prenatal and postpartum care in midwifery clinics and in women's homes. 37 Course of Study 38 The course of study is divided into 4 levels. Initially, students complete academic coursework on a full-time or part-time course load basis. Academic course loads may vary depending on transfer credits. All academic courses must be completed before beginning clinical courses. Clinical segments of the program cannot be completed on a part-time basis. Clinical placements/practicums can involve being on call 24 hours a day, and students must organize their work and life schedules to accommodate the demands of clinical work. Clinical segments of the program include Midwifery Care I, II, III, IV and Clerkship as well as a Community Placement. Students are also required to do regular coursework during their placements. Course Descriptions relevant to Prescribing and Using Drugs 34 Canadian Midwifery Regulators Consortium, 35 (

24 MWF Life Sciences for Midwifery: This course is divided into two sections: the Nature of Matter, and the Nature of Life. This course provides an overview of basic concepts relating to chemistry, biochemistry and microbiology. Content areas will include practical applications of clinical chemistry, specimen collection, related disease entities and pathologies, and laboratory values. A variety of evaluation methods will be used. Lect: 3 hrs. Lab. 2 hrs. Co-requisite: BLG 10A/B. Course Weight: 1.00 MWF 114 Midwifery: Pharmacotherapy: Lect: 3 hrs. This course introduces concepts of pharmacotherapeutics. This course provides an overview of basic concepts in pharmacology, pharmacy and therapeutics relevant to the practice of midwifery in Ontario. Unifying concepts include pharmacokinetics, toxicology, adverse reactions in pregnancy and lactation and the neonate. A variety of evaluation methods will be used. Co-requisite: BLG10A/B. Course Weight: 1.00 MWF 250 Midwifery: Clinical Skills: This course is an introduction to the clinical skills and competencies necessary for the practice of normal midwifery care as preparation for the first midwifery clinical placement in the following term. Students will be introduced to a variety of skills utilized in prenatal, intrapartum and postpartum care, including well woman and newborn physical assessment, monitoring fetal and maternal well being in labour, conducting births, collection of laboratory specimens, and universal precautions. Lect: 3 hrs./lab: 6 hrs. Prerequisite: MWF 150. Course Weight: 1.00 Clinical Courses MWF Midwifery Care I: This clinical placement course focuses on prenatal and postnatal assessment skills, providing labour support and monitoring maternal and fetal wellbeing during labour. Also included is an intro to hands-on skills for the birth and the role of the second midwife. There are weekly situation-based, small group tutorials. This course is graded on a pass/fail basis. Lect: 3 hrs./lab: 12 hrs. Prerequisites: MWF150, MWF11A/B, MWF109, MWF113, MWF114 and MWF201. Course Weight: 1.00 MWF Midwifery Care II: This clinical course provides the student with an extended period of clinical experience, primarily within a midwifery practice, under the supervision of a midwife preceptor. The course begins with all students in one location for one week, and then moves to individualized topics. The placement focuses on clinical skills in prenatal, labour and birth, postpartum and newborn care. Students begin to undertake the role of primary caregiver for childbearing women and their newborn infants. A weekly tutorial based on case situations and self-study materials will cover topics in preconception, antepartum, intrapartum, postpartum and newborn care. This course is graded on pass/fail basis. Lect: 3 hrs./lab. 12 hrs. Prerequisite: MWF 120. Course Weight: 1.00 MWF Midwifery Synthesis Paper: Each student will submit an academic paper concerning either a clinical or a social aspect of midwifery. Students will be invited to present their papers to their peers. Lect. 3 hrs. Prerequisite: MWF 220. Course Weight: 1.00 MWF Midwifery Care III: This course begins with a one-week intensive, followed by a clinical placement under the supervision of a midwife preceptor. The students will further develop their knowledge and skills relating to preconception, antepartum, intrapartum, postpartum and newborn care. Both the intensive and tutorials focus on common complications, situations which involve consultation with other care providers and on the development of decision making skills and clinical judgment. This course is graded on pass/fail basis. Lect: 3 hrs./lab: 12 hrs. Prerequisite: MWF 220. Course Weight:

25 MWF Community Placement: Three experiences of one month each are planned. A placement of one month each will be organized with an obstetrician and a labour and delivery nurse. The purpose is to obtain familiarity with maternity care in the hospital setting, and observe referral obstetric care provided by an obstetrician. These placements provide the opportunity to foster collegial relationships and participate as a care provider in a variety of maternity care settings. The third placement is an elective and will be organized by the student and may take place within or outside the province. International experiences will be encouraged whenever possible. This course is graded on pass/fail basis. Lab: 9 hrs. Prerequisite: MWF 220. Course Weight: 2.00 MWF Midwifery Care IV: By completion of this term the student will have integrated theoretical and clinical content progressively and have acquired a sound knowledge base and the clinical skills to provide primary midwifery care under supervision throughout the child bearing cycle. Students will continue to develop decision making skills, emergency management and clinical judgment. Tutorial situations focus on situations which involve transfer of care and relationships with other health care providers. This course is graded on a pass/fail basis. Lect: 3 hrs./lab: 12 hrs. Prerequisite: MWF 320. Course Weight: 1.00 MWF Midwifery Care Clerkship: This course begins with a three to five day intensive. In this final term of clinical practice the emphasis will be on clinical judgment and decision-making skills. The student will be expected to act as a primary caregiver and provide midwifery care in all phases of childbirth care in all settings. Students will plan care and make clinical decisions with minimal supervision. Students participate in seminars which focus on case review and reflective practice. This course is graded on a pass/fail basis. Lect: 3 hrs/lab: 12 hrs. Prerequisite: MWF 420. Course Weight: 1.00 Midwifery is regulated in six provinces and one territory. Summary information about patient safety is provided below. Province Entry Level Requirements Curricula (see information above) & educational institutions Ontario To be eligible for registration with the College of Midwives of Ontario [you] must: Be a graduate of the Ontario Midwifery Education Program (MEP), be a graduate of the International Midwifery Preregistration Program (IMPP) or be a general registrant in another province of Canada. The Ontario Midwifery Education Laurentian University, Ryerson University, McMaster University Required Additional Education/ Training Professional Misconduct Rules ONTARIO REGULATION 858/93 PROFESSIONAL MISCONDUCT. 7. Prescribing, dispensing or selling drugs for an improper purpose Conflict of Interest Regulations/Guidelines No specific Conflict of Interest guideline CMO has a publicly available Code of Ethics Mandatory Referral Information College has a document which describes indications for mandatory discussions QA & Continuing Competency Policies currently under review: Within the 2 of the last 4 years: 60 births, 40 of which as primary midwife, 30 as continuity of care, 10 births as midwife outside of hospital, 5 of which as primary midwife, 10 births in hospital, 5 of which as primary midwife. Mandatory Liability Insurance Required 39 /registration.pdf 25