Enhanced Authority for the Pharmacist to Prescribe Drugs in Collaborative Practice Environments

1. Enhanced Authority for the Pharmacist to Prescribe Drugs in Collaborative Practice Environments Review PAS Conference April 29, 2011 R. J. (Ray) Joubert, Registrar

2. Objectives Objectives • Overview and review requirements – Levels I and II • Early lessons learned • Next steps • Minor Ailments Approach – cases, questions and answers

3. Legislation - Framework Prescriptive Authority Amendments In force Mar. 6/11

4. Role Change – Consultant/Advisor to Decision Maker Traditional Model Collaborative Model Decision Makers Navigating the Grey (“Best Option”)

5. Decision Making Framework (Modified from Lessons Learned) Notify the prescriber 7. Notification Document rationale What and Why 6. Documentation Does the patient understand & agree? 5. Informed Consent Best interest of the patient? Legal? Ethical? 4. Appropriateness Is my BSP/pt./MD relationship collaborative? 3. Relationships 2. Appropriate Information Sufficient Information (Assessment)? 1. Pharmacist’s Competence/Confidence Do I have sufficient knowledge, skills (condition, drug, patient)?

6. Main Guiding Principles • Interdependent (not dependant or independent) prescriptive authority in collaborative practice environments (team relies upon one another to achieve common goal of optimal pharmacotherapy)

7. Guiding Principle #1 (cont’d) What is a “collaborative practice environment”? • Exists when practitioner can reasonably rely upon: • The basic skills of the pharmacist • To prescribe in best interests of patient • Communicate to practitioner (prescribing decision or referral) • Presumed to exist when prescribing under the bylaws • Within limits and meet competency, assessment, documentation, communication and transparency requirements • Does NOT exist when practitioner communicates otherwise

8. Main Guiding Principles (cont’d) • Competency based (optimize use of current competencies - not expanded scope of practice) • Current standards remain (monitoring, follow-up, continuity of care) • Compatible with current health system • Enabling legislation with limits • Accountability framework • Self-regulation (ethics, standards) • Transparency through communication (PIP and PAR) and collaboration

9. Level I Review Characterized as “Basic” • Leverages the existing skills of all pharmacists • Conventional interdisciplinary collaboration

10. Case – Avalide 300/25 Shorted Options • Avalide 150/12.5 – take 2 tablets • Multiple prescription - Avapro 300mg (irbesartan) and HCT 25 mg – take one of each Decision Making Framework 1. Competence/Confidence – Yes – condition, drug, regular patient with satisfactory results

11. Case – Avalide 300/25 Shorted • Information/Assessment • Precedents? Prior law, contact MD • New law – opportunity under prescriptive authority • Check patient profile in PIP - reasonable compliance, no complications • Stabilized on Avapro 300 mg. & HCT 25 mg. before Avalide • Confirm with product monograph • Option - switch to Avalide 150/12.5 – take 2 tablets per dose • Dispense in one vial (less confusing) • Price advantage? • In stock and available, Avalide 300/25 shortage not long • Option - switch to Avapro 300 mg. & HCT 25 mg. 2 prescriptions, take 1 tablet of each. • Product monograph, SK Formulary, SDIS - reasonable expectation of a similar therapeutic response • Formulary - 4 generics Avapro at less than half the cost

12. Case – Avalide 300/25 Shorted 3. Relationships • Patient - long time, regular approximate monthly refills • PIP profile – no other pharmacies • MD habits – switch back to Avalide 300/25 when supplied 4. Interests of Patient/Legal/Ethical • Age, health, economic and social status – control hypertension • Legal opportunities – interpretation “increasing suitability of a drug“? May alter dosage form, not dosage amount without a “formal CPA, or otherwise”. • Dosage amount is the same, changing the dosage form? • Federal law “drug” = DIN (in dosage form, particular product) • Changing can mean altering the dosage form – same molecules • Different molecules “therapeutic substitution” under Level II (CPA) • Nothing prevents Level 1 under Collaborative Practice Agreements (third option) • Other ethical factors - charges for dispensing/prescribing? Privacy?

13. Case – Avalide 300/25 Shorted • Informed Consent • Discuss options with patient – Understands implications • Prefers the Avalide 150/12.5 & agrees • Cost differentials important, not critical • Confidence in product - 2 tablets a minor inconvenience • Documentation PIP/PAR as per Level I training • Record prescription in PIP • Avalide 150/12.5 take two tablets • SIG field “Increasing suitability of drug – Avalide 300/25 shorted, will switch back when supplies available”

14. Case – Avalide 300/25 Shorted 7. Notification • Print PAR from PIP • Ask MD to sign attached CPA to help address drug shortages • Consult the SCP web site - CPA template • Complete and sign it • Describes three options: • Combination products dividing Rxs into multiples of active ingredients; and/or • Multiple/fractional combination product; and/or • Therapeutic substitution • Same class • Reasonable expectation of a similar therapeutic response • Consulted with the SDIS and/or their web site • Other pharmacists sign, last faxes PAR and CPA to MD

15. Case – Avalide 300/25 Shorted • Questions? • Dialogue – what would you do?

16. Cases – Questions and Answers Q – Incomplete prescriptions – Prescribing to complete, carry over refills? A – Yes • Federal law, Pharmacy Act/bylaws have similar wording • Act, prescriptions means “an authorization…directing that a stated amount of any drug….specified in it be dispensed for the person….named in the authorization” • Bylaws in part “…..no pharmacist shall refill such a prescription more times than the number of times prescribed by the practitioner • Therefore, legally the refill is separate from the prescription • prescriptive authority, “adapt” the prescription • Practitioner’s intent is clear

17. Cases – Questions and Answers Q – Continuing medication limits not long enough while the physician is on a leave of absence (e.g. extending refills for 34 day drugs, can only extend amount last dispensed which does not work if the physician is away for more than a month) A – Limits continue • Continuity of care is a medical standard • Advise to deal with replacement physician • Collaborative Practice Agreement (no override)?

18. Cases – Questions and Answers Q – Insufficient Information – Prescribing where there is no quantity (e.g. Topicort mitte: 1 tube) or no dosage form HC 1% in the prescription A – Yes. Under “Insufficient Information” bylaws allow • Insert “legally necessary information’ where missing • But satisfied with prescriber’s intent, and • Information was unintentionally omitted • Both cases, information is missing (legal definition of a prescription) • Judgement needed • Information and assessment • Satisfied with clarity of intent of the physician’s intent • Factors quantity/strength depend upon e.g. diagnosis, area and location to be treated • Second case depend upon e.g. impact of cream/ointment on the therapeutic response and side effects. • Remember decisions under a “collaborative practice environment” transparency by communication via PIP and PAR to the physician

19. Cases – Questions and Answers Q – Prescribing when we insert directions when the physician prescribes “as directed”  A – Perhaps • “Insufficient Information” as per previous question • Challenge - “as directed” not permitted by COPSS bylaws unless information on label/package insert • May insert “legally necessary information” • Missing, satisfied that prescriber’s intent is clear, unintentionally omitted • Information gathering and patient assessment important • No if the label/insert contains information and direct the patient thereto • Yes, if label/insert does not contain sufficient information, it could be prescribing if you are satisfied with the prescriber’s intent and that the directions were inadvertently omitted. • Remember decisions under a “collaborative practice environment” transparency by communication via PIP and PAR to the physician • Reports without PIP and PAR unacceptable

20. Case – Macrobid 4 Tabs for UTI Dr. K. asked to continue Rx for Macrobid. She consulted PIP - original Rx with no repeats dispensed around time prescribed about 6 weeks ago Called patient - admitted pharmacist had advanced 4 tablets Concern for resistance, forced to treat a suspected UTI (no culture) and continued the Macrobid Saw her patient, diagnosed bacterial vaginosis/ prescribed concomitant antibiotic Asked for our perspective before discussing with pharmacist Agreed to communicate with members

21. Case – Macrobid 4 Tabs for UTI Perspective • Collaborative practice environment – relationship/physician/relies upon the pharmacist to prescribe according to training/communicate decisions/refer where appropriate. No referral. • Pharmacist prescribed under the bylaws - Dr. K. view the prescription in PIP/received a PAR. Neither occurred. • Dr. K. suggested possible emergency provisions. Not entirely the case. Pharmacists may continue existing prescriptions in emergencies if: • Consulting PIP indicates chronic and stabilized use “….regardless of the drug being used acutely, sporadically or an on as-needed basis…” • Pharmacist “….has taken steps to ensure that the patient is in an emergency situation” • Uncertain of the former, difficult to rationalize use when the original course was complete therapy without repeats • CPE deemed to exist – prescribe under the bylaws - must be followed. UTI not minor ailment for patient self-diagnosis. Medical diagnosis needed to initiate therapy unless Level II

22. Case – Macrobid 4 Tabs for UTI • Questions? • Dialogue – what would you do? What do you think is appropriate?

23. Level II Review Characterized as “Advanced” • Leverages advanced skills of some pharmacists • More highly functioning or sophisticated interdisciplinary collaboration (teams)

24. Initiate Therapeutic substitution Altering dosage and/or dosage regimen * Collaborative Practice Environment a pre-requisite Receive diagnosis, therapeutic goal, select drug therapy Patient requests a less expensive PPI 3. Community warfarin dosage adjustment program Level II – Collaborative Practice Agreements* Only

25. Level II Review Where to start? Resources available at new SCP web site www.saskpharm.ca or www.napra.ca (click SK) • Framework • Template (pdf file for copy/paste)

26. Next Steps Minor Ailment prescribing according to Council approved guidelines • Indication • Drug • Limits • When to refer • Training mandatory to use guidelines safely

27. Next Steps Interdisciplinary Advisory Committee (pharmacists, physicians, nurses, optometrists, midwives, Ministry of Health plus CPDP and SDIS as advisors) • Advises appointing org’ns on the resolution of issues • Met April 18/11 – Minor Ailments prescribing • Agreed to proceed with mild acne, insect bites, cold sores • Training June 5 (Regina) and 12 (Saskatoon) on how to use guidelines safely • Balance of 14 approved guidelines for review/reconsideration deferred pending success with first three

28. Minor Ailments Prescribing Conditions • Green (Implement) – acne, cold sore, insect bites • Amber (Review) - allergic rhinitis, atopic dermatitis, oral aphthous ulcers (canker sores), diaper dermatitis, tinea infections (pedis, corporis, cruris), musculoskeletal pain, stiffness, spasm, oral thrush, superficial bacterial skin infections • Red (Reconsider) – dysmenorrhea, GERD, hemorrhoids

29. Other Questions • Physicians “opting out? • Communicate to pharmacist patient or class (specific) • Physician signs PAR? • Intent? Advisory Committee – Standardize • Physician leave of absence – batch PARs? • Not recommended – send to “covering” MD “immediately or as soon as reasonably possible”

30. Other Questions • Can interns prescribe? • Yes, but under the supervision of licensed pharmacist (under that PIP account) • Physician asks to stop sending PARs • Continue anyway – bylaw requirement. MD to treat document like any other received from a HCP (SMA Communication)

31. Conclusion Thank you! Questions? Feedback welcome! Information – Prescriptive Authority tab at new SCP web sitewww.saskpharm.ca or www.napra.ca (click SK)