POLICY STATEMENT Methadne Maintenance Treatment fr Opiid Dependence APPROVED BY COUNCIL: May 2010 PUBLICATION DATE: Dialgue, Issue 2, 2010 Disclaimer: As f May 19, 2018 physicians n lnger require an exemptin frm Health Canada t prescribe methadne. This change is nt yet reflected in the Cllege s Methadne Maintenance Treatment fr Opiid Dependence plicy, but will be incrprated when the plicy is next reviewed. In the meantime, prescribers wh wish t administer methadne and/r delegate the administratin f methadne must cntinue t meet all ther existing requirements set ut in plicy. Relevant cntent in the plicy includes: Administratin Respnsibility fr Dses Transprtatin and Transfer f Custdy Destructin f Unused r Unserviceable Dses Safe and secure strage Recnciling Dses and Accunting fr Lst r Stlen Dse The eliminatin f the exemptin will als result in additinal changes t the Cllege s Methadne prgram. Fr mre infrmatin, see the Cllege s Methadne Prgram page. CPSO Plicy Statement 1
Methadne Maintenance Treatment fr Opiid Dependence DEFINITIONS Methadne maintenance treatment: The daily ral administratin f methadne ver a prlnged perid as an ral substitute fr herin r ther mrphine-like drugs fr patients wh are dependent n r addicted t these drugs. Methadne exemptin: Methadne is a cntrlled drug under the Cntrlled Drugs and Substances Act, S.C. 1996, c. 16. Physicians wh wish t prvide methadne t their patients must btain a special exemptin frm Health Canada. The exemptin can apply t either methadne maintenance treatment fr piid dependence, r t the treatment f malignant and chrnic nn-malignant pain. Physicians wh wish t prvide methadne fr bth methadne maintenance treatment and pain must btain separate exemptins. Physicians wh pssess an exemptin fr methadne maintenance treatment may apply t the Cllege f Physicians and Surgens f Ontari fr additinal permissin t delegate authrity fr the administratin cmpnent f methadne maintenance treatment t ther prperly qualified healthcare prfessinals. Methadne administratin: The prvisin f a dse f Methadne administratin: methadne t a patient fr cnsumptin by the patient under direct bservatin in a medical ffice r clinic, r fr delayed cnsumptin by the patient (in the frm f take-hme r carry dses) fr the treatment f piid dependence. Prperly qualified healthcare prfessinal: In the cntext f this plicy, these are regulated healthcare prfessinals ther than physicians wh pssess the apprpriate knwledge, skill and judgment needed t safely administer methadne t patients, and wh meet the additinal minimum requirements set ut in this plicy. BACKGROUND Methadne maintenance treatment is an effective treatment fr piid dependence. In the interest f ensuring that methadne maintenance treatment is delivered in a safe and cnsistent manner, it is regulated by Health Canada thrugh the Cntrlled Drugs and Substances Act, S.C. 1996, c. 16 (CDSA), in partnership with the prvince f Ontari, the Cllege f Physicians and Surgens f Ontari (CPSO) and the Ontari Cllege f Pharmacists (OCP). Physicians wh wish t prvide methadne maintenance treatment must btain a general methadne maintenance treatment exemptin frm Health Canada under sectin 56 f the CDSA. The general exemptin permits physicians t prescribe, administer r sell methadne. The general exemptin als permits the dispensing f methadne subject t cnditins and limitatins, as set ut in this plicy. Physicians in pssessin f the general exemptin may apply t the CPSO fr a delegatin exemptin, which grants physicians permissin t delegate authrity fr the administratin cmpnent f methadne maintenance treatment t ther prperly qualified healthcare prfessinals. This is intended t imprve access t care. In 2007, the CPSO and the OCP develped the Framewrk fr the Implementatin f the New Delegatin Exemptin: Safety, Security and Transfer f Methadne Dses, which sets ut expectatins fr delegating authrity fr methadne administratin pursuant t a delegatin exemptin. That dcument was intended t cmplement the CPSO s Methadne Administratin in the Treatment f Opiid Dependence plicy. The present plicy replaces bth f thse dcuments. In additin t this plicy, physicians shuld cnsult the Methadne Maintenance Guidelines fr further infrmatin. a change is significant and must be reprted t the Cllege please refer t Appendix 1. 2 CPSO Plicy Statement
PURPOSE This plicy articulates the CPSO s expectatins f physicians wh prvide methadne maintenance treatment, including expectatins fr delegating the authrity fr methadne administratin t ther prperly qualified healthcare prfessinals. SCOPE This plicy applies t physicians wh, pursuant t a methadne maintenance treatment exemptin under sectin 56 f the CDSA, deliver methadne maintenance treatment in medical ffices r clinics utside a pharmacy. It als applies t physicians wh, pursuant t a delegatin exemptin delegate authrity fr methadne administratin t ther prperly qualified healthcare prfessinals. PRINCIPLES 1. Physicians shuld always act in patients best interests t deliver safe and effective care. 2. Physicians shuld carry ut methadne maintenance treatment in an apprpriate manner. This includes fllwing statutry prvisins designed t ensure patient safety and clinical efficacy. 3. Physicians shuld cllabrate with ther healthcare prfessinals as a means f delivering and increasing access t safe and effective care. 4. Physicians are accuntable fr ther healthcare prfessinals t whm they delegate aspects f treatment. Physicians shuld ensure that their delegates are prperly qualified t deliver safe and effective care. POLICY 1. Qualificatins fr the Delivery f Methadne Maintenance Treatment Physicians may nly deliver methadne maintenance treatment if they have btained a general exemptin fr methadne maintenance treatment frm Health Canada pursuant t Sectin 56 f the CDSA. Absent the additinal delegatin exemptin, physicians with the general exemptin cannt delegate the administratin f methadne t ther qualified healthcare prfessinals. Mre infrmatin abut delegatin appears in subsectin 7 Delegating Authrity fr Methadne Administratin and subsectin 8 Prperly Qualified Healthcare Prfessinals f this plicy. 2. Prescriptin Any new dse r change f dse f methadne requires a new prescriptin and must be dispensed by a pharmacist. Once dispensed by the pharmacist, a physician must nt alter individually labeled dses. 3. In certain rare circumstances, a physician may dispense a dse f methadne, subject t the cnditins and limitatins utlined in subsectin 6 Dispensing belw. 4. Administratin Physicians must fllw the requirements fr methadne administratin utlined in the current CPSO Methadne Maintenance Guidelines, as well as thse in this plicy. When administering methadne fr methadne maintenance treatment, physicians must: Ensure that methadne is administered t their patients in the dse and manner that has been prescribed. Witness dses prvided fr immediate cnsumptin. Cnfirm the patient s identity prir t administering dses fr bserved cnsumptin r fr prviding carries in rder t ensure that the methadne is given t the crrect individual. The physician shuld als verbally cnfirm the expected dse with the patient. Infrmatin abut delegating authrity fr administering methadne appears in subsectin 7 Delegating Authrity fr Methadne Administratin and subsectin 8 Prperly Qualified Healthcare Prfessinals f this plicy. CPSO Plicy Statement 3
Methadne Maintenance Treatment fr Opiid Dependence 4. Respnsibility fr Dses Under the OCP s Plicy fr Dispensing Methadne, a pharmacist is respnsible fr the safety and integrity f methadne until such time as he r she has dispensed directly t the patient r transferred custdy f the methadne t an exempted physician r his r her delegate. Transprtatin and Transfer f Custdy OCP plicy requires a pharmacist t transfer custdy f the individually labeled dses f methadne dispensed pursuant t a prescriptin in a secure, tamper-prf manner t a physician wh signs that he r she has received each crrect dse n a daily basis n a patient manifest. The pharmacist must either directly hand the dses f methadne t the physician r his r her delegate, r use a methd f transprtatin that ensures that he r she is aware f and tracks wh has had custdy f the drug at any given time t ensure safekeeping f the methadne while in transit (i.e., a chain-f-signatures and tamper-prf bxes). All methadne must be transprted in such a manner as t avid extremes in temperature r delays in transprt which culd cmprmise the drug. Only the physician r his r her delegate may accept delivery f methadne dses. The physician wh accepts the methadne must sign that he r she has received and has accepted custdy f each dse. A recrd f the transfer f each dse must be maintained. Once the physician has accepted custdy f the methadne, the physician assumes respnsibility fr the safety and security f thse methadne dses. The physician maintains respnsibility and is fully accuntable fr all dses until prvided t the patient fr bserved cnsumptin, r as a carry. If a dse is unused, the physician maintains respnsibility and is fully accuntable until the dse is returned t the pharmacy. Destructin f Unused r Unserviceable Dses All unused r unserviceable dses must be returned t the dispensing pharmacy fr destructin n a daily basis. These dses must be transferred in a secure manner in accrdance with the guidelines fr transprtatin and custdy set ut abve. Once the pharmacist accepts custdy f the unused r partially used dses, the pharmacist is respnsible fr the safety, security and destructin f thse dses. Safe and Secure Strage Under sectin 55(f ) f the federal Narctic Cntrl Regulatins, physicians must take adequate steps t prtect any quantities f methadne n the premises r under their cntrl against theft r lss. The term adequate is nt defined in the Narctic Cntrl Regulatins, C.R.C., c. 1041. The CPSO is unable t ffer advice n hw this term may be interpreted. It is, hwever, the expectatin f the CPSO that physicians will ensure that all methadne dses are stred in a lcked cabinet r refrigeratr in a secure area within the physician s ffice r clinic. Further, as required under s. 55(d) f the Narctic Cntrl Regulatins, physicians must permit an inspectr t check all stcks f narctics in their ffice r clinic. Recnciling Dses and Accunting fr Lst r Stlen Dses The physician r his r her delegate must cnduct a daily recnciliatin f dses received, administered and returned t the pharmacy. Preferably, this will ccur bth befre the first dse and after the last dse fr that day have been administered. Any lss f methadne (stlen r spilled) must be reprted within 10 days f its discvery t the Cmpliance Mnitring Liaisn Divisin, Office f Cntrlled Substances, by calling 613-954-1541, as required by sectin 55(g) f the Narctic Cntrl Regulatins. 5. Dcumentatin Maintenance f accurate and cmplete medical recrds is a crucial cmpnent f methadne maintenance treatment. Fr general dcumentatin requirements, physicians shuld refer t the CPSO s Medical Recrds plicy. Dcumentatin requirements specific t methadne maintenance treatment are as fllws: The patient s infrmed cnsent t methadne maintenance treatment. The patient s name, daily dse, and time and place where administratin was bserved. Results f assessment prir t methadne administratin, including, where applicable, signs f intxicatin, bserved abnrmal behaviur, and symptms f ver- medicatin with methadne. Recrd f urine sample, if prvided, and results. The name f the healthcare prfessinal administering the dse. 4 CPSO Plicy Statement
Sign-ff f drink and/r carry dses, including the date and time when methadne was given. Missed dses, including refusal and vmiting f dses. Partial dses taken. Lst r stlen carry dses. Suspected diversin f dses. Guest dsing arrangements. Other prescribed medicatins that may interfere with methadne. In additin t the freging, sectin 69 f the Narctic Cntrl Regulatins requires physicians t keep and retain fr a perid f tw years frm the date f the making f the recrd, a recrd f: the date and quantity f methadne received; the name and address f the persn frm whm the methadne was received; and the particulars f the use t which the methadne was put. Sectin 69 f the Narctic Cntrl Regulatins als requires that physicians prvide access t these recrds, as well as furnish any infrmatin respecting methadne as may be required by the federal Minister f Health. Physicians must als ensure that all dsing infrmatin is prvided t the pharmacy t ensure accuracy and cmpleteness f patient histry. This shuld be dne with the cnsent f the patient. Where a physician delegates authrity fr methadne administratin t ther prperly qualified healthcare prfessinals, the physician must ensure that the patient cnsents t the delegatin. This cnsent shuld be btained and recrded each time methadne is administered by the delegate. The physician shuld als dcument the delegate s qualificatins and training. 6.Dispensing Dispensing methadne is typically dne by a pharmacist. Hwever, Health Canada recgnizes that in certain rare circumstances, it may be apprpriate fr a physician t dispense methadne. These rare circumstances are thse wherein the physician determines it is necessary t dispense methadne due t a risk f withdrawal r verdse, and n pharmacist is able t prvide the necessary dse in a perid f time which wuld nt cmprmise patient safety. Fr example, it may be apprpriate fr the physician t dispense methadne when a patient has already missed three r mre cnsecutive days f dsing and requires stabilizatin t prevent further withdrawal, r when a patient has vmited a dse under direct bservatin, particularly in the case f pregnant patients where withdrawal may cmprmise the wellbeing f the fetus. Methadne fr inductin wuld nt be viewed as a rare circumstance. A physician wh dispenses methadne in apprpriate rare circumstances must d s in accrdance with the requirements set ut in the Drug and Pharmacies Regulatin Act, R.S.O. 1990, c.h.4, this plicy and the CPSO s Dispensing Drugs plicy. Additinal guidance can be fund in the OCP splicy fr Dispensing Methadne. 1 Premeasured dses f methadne must be purchased frm an accredited pharmacy and mixed by the physician with the apprpriate diluent (e.g., Tang beverage) prir t ingestin. When dispensing methadne in apprpriate rare circumstances, the physician must nly administer ne dse. The physician must then immediately reprt t the pharmacy r clinic where the patient usually received methadne and ensure that the necessary arrangements are made fr subsequent dses t be administered at the pharmacy. 7.Delegating Authrity fr Methadne Administratin Only a physician wh pssesses the delegatin exemptin is permitted t delegate authrity fr methadne administratin t ther prperly qualified healthcare prfessinals under his r her cntrl. Methadne administratin is the nly cmpnent f methadne maintenance treatment that may be delegated. Authrity fr prescribing, dispensing and selling methadne cannt be delegated. Where a physician delegates authrity fr methadne administratin, the physician must adhere t the directin set ut in the CPSO s Delegatin f Cntrlled Acts plicy and this plicy. 1 http://www.cpinf.cm/regulatins-standards/plicies-guidelines/methadne2/ CPSO Plicy Statement 5
Methadne Maintenance Treatment fr Opiid Dependence Accuntability and respnsibility fr methadne administratin rests with the physician at all times. The physician must ensure that if he r she delegates authrity fr methadne administratin t ther prperly qualified healthcare prfessinals, he r she must ensure that thse delegates have the knwledge, skill and judgment t d s. This includes taking reasnable steps t ensure that delegates understand and cmply with ffice r clinic plicies and prcedures regarding methadne administratin. The physician must als prvide the level f supervisin necessary t ensure that delegates administer methadne safely and effectively. Office/clinic plicies and prcedures fr methadne administratin must be accessible at all times and must clearly state that individuals administering methadne are charged with the fllwing respnsibilities: i. T administer methadne nly when the patients des nt exhibit any signs f sedatin r intxicatin. ii. Where direct bservatin is prescribed, t bserve the patient cnsuming the methadne and ensure that the dse has been cnsumed. iii. T administer methadne precisely as prescribed by the physician. Other Healthcare Prfessinals Individuals must: i. Be anther healthcare prfessinal regulated under Ontari s Regulated Health Prfessins Act, 1991, SO. 1991, c. 18. ii. Have successfully cmpleted the Methadne Treatment Wrkshp at the Centre fr Addictin and Mental Health r equivalent training apprved by the CPSO in the safe and apprpriate administratin f methadne. iii. Have demnstrated t the satisfactin f the physician an understanding f methadne maintenance treatment, including the risks assciated with it. 8. Prperly Qualified Healthcare Prfessinals Prperly qualified healthcare prfessinals are thse wh pssess the apprpriate knwledge, skill and judgment needed t safely administer methadne t patients. The fllwing are the minimum requirements that individuals must pssess: Nurses Individuals must: i. Be either a Registered Practical Nurse r a Registered Nurse, including a Registered Nurse in the Extended Class. ii. Have demnstrated t the satisfactin f the physician an understanding f methadne maintenance treatment, including the risks assciated with it. 80 COLLEGE STREET, TORONTO, ONTARIO M5G 2E2