Pharmacy Jurisprudence, LLC For pharmacists in states with a pharmacy law continuing education (CE) requirement, we offer our CE booklet without government or commercial funding. Index: 2 Should I Fill This Rx Written by an Ohio Advanced Practice Registered Nurse? Approvals (Pharmacy): On January 28, 2014, the Ohio State Board of Pharmacy stated: This has been approved by the Board of Pharmacy for 1.0 hours of law CE, with an effective [date of] January 28, 2014. The lesson will be good for two years from the effective date. Credit(s): 1.0 contact hours (0.1 C.E.U.) Effective Date: January 28, 2014 Expiration Date: January 27, 2016 Cost: $15.00 Select CE is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
Program Title: Target Audience: Should I Fill This Rx Written by an Ohio Advanced Practice Registered Nurse? Pharmacists and Pharmacy Technicians Release Date: February 6, 2014 Expiration Date: January 27, 2016 Ohio State Board of Pharmacy Program Number: 036-350-14-001-H03 ACPE Program No.: 0487-0000-14-001-H03-P application-based activity 0487-0000-14-001-H03-T application-based activity Select CE is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Media: Enduring print material and test-taking online at www.selectce.org Fee Information: $15.00 Estimated Time to Complete the Activity: 60 minutes Procedures: To receive a Statement of Credit, read this program, complete the post-test questions and evaluation on the Answer Sheet, and either: i) mail the Answer Sheet (page 17) and the program fee of $15.00 to us. You will receive a Statement of Credit mailed to you within 2 weeks. Checks or money orders are encouraged. Mail to: Select CE, P.O. Box 21186, Columbus, Ohio 43221-0186. Refunds are not provided. or ii) use our online test-taking website www.selectce.org. Follow the instructions on the website, using any major credit card to pay the $15 program fee. Upon passing the test, you will receive immediate confirmation via email, and your official Statement of Credit will be sent via U.S. mail within 5 days. Refunds are not provided, unless you mistakenly make too many online payments or some such other snafu. A minimum score of 75% is required to earn a Statement of Credit. Pharmacy Jurisprudence, L.L.C. and Select CE 2014. All rights reserved. Page 2
Faculty: Patricia A. Nussle, R.Ph., J.D., is the founder of Select CE. She is also a healthcare attorney who has written and published continuing education programs in pharmacy law and nursing law for over 200,000 healthcare professionals since 2001. Disclosure of Commercialism, Unlabeled Uses, Bias, Conflicts of Interest: Prior to the delivery of the content, we will disclose any commercial support, and we do so here: No commercial support was requested or accepted for developing or presenting this program. All development, printing, and mailing costs, as well as accreditation services and fees, come solely from your program fees. No unlabeled uses of drugs are discussed in this program. Brand names are not used, unless the judge used the brand name of the drug when writing his/her legal opinion and hence the brand name is used in the legal case. Faculty Patricia A. Nussle, Pharmacy Jurisprudence and Select CE have no real, apparent, or potential conflicts of interest or financial relationships to disclose, other than that Patricia A. Nussle is the owner of Pharmacy Jurisprudence, and she warrants that she presents this information fairly and without bias. Objective: At the conclusion of this program, pharmacists should be able to apply the nursing board guidelines to determine an APRN's scope of practice. Objective: At the conclusion of this program, pharmacy technicians should be able to apply the nursing board guidelines to determine an APRN's scope of practice. Important Note: Colleagues, this is a continuing education program. It is not legal advice. Do not rely on this CPE program as legal authority. If you do have a legal problem or question, please consult an attorney experienced in pharmacy law matters to discuss your specific situation. Thank you! We truly enjoy serving you. Pharmacy Jurisprudence, L.L.C. and Select CE 2014. All rights reserved. Page 3
Introduction In this CE offering, we explore the scope of practice of advanced practice registered nurses (APRN's), the nationally accepted term now used to refer to registered nurses who have attained this advanced degree of licensing and certification. We chose this topic after discussion with a staff member of a board of pharmacy, in which she indicated the pharmacy board receives a significant number of questions from pharmacists on the theme of "Can I fill this particular prescription written by this particular APRN?" The answer to that question lies, in large part, on the scope of practice of the advanced practice nurse, and the purpose of this CE activity is to give the practicing pharmacist and pharmacy technician the tools needed to help answer that question. The Pharmacist's Corresponding Responsibility - Federal In all states, a pharmacist has a responsibility to fill only those controlled substance prescriptions issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his or her professional practice. The source of this requirement is federal law, which states in Title 21 of the Code of Federal Regulations: 1 1306.04 Purpose of issue of prescription. (a) A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances. 1 http://www.deadiversion.usdoj.gov/21cfr/cfr/1306/1306_04.htm Pharmacy Jurisprudence, L.L.C. and Select CE 2014. All rights reserved. Page 4
(b) A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients. (c) A prescription may not be issued for detoxification treatment or maintenance treatment, unless the prescription is for a Schedule III, IV, or V narcotic drug approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment and the practitioner is in compliance with requirements in 1301.28 of this chapter. The Pharmacist's Corresponding Responsibility - Ohio In addition, some states expand the pharmacist's corresponding responsibility to include more than controlled substance prescriptions. In Ohio a pharmacist's corresponding responsibility for all prescriptions mimics the federal rule regarding controlled substances: Ohio Administrative Code Rule 4729-5-21 (A) A prescription, to be valid, must be issued for a legitimate medical purpose by an individual prescriber acting in the usual course of his/her professional practice. The responsibility for the proper prescribing is upon the prescriber, but a corresponding responsibility rests with the pharmacist who dispenses the prescription. An order purporting to be a prescription issued not in the usual course of bona fide treatment of a patient is not a prescription and the person knowingly dispensing such a purported prescription, as well as the person issuing it, shall be subject to the penalties of law. The Pharmacist's Professional Judgment - New Jersey In contrast to Ohio, many states such as New Jersey do not expand a pharmacist's corresponding responsibility. Instead, some states expressly grant professional judgment to pharmacists when filling prescriptions. For example, the law in New Jersey says: 13:39-7.13 Professional judgment in dispensing drugs Pharmacy Jurisprudence, L.L.C. and Select CE 2014. All rights reserved. Page 5
The pharmacist shall have the right to refuse to fill a prescription if, in his or her professional judgment, the prescription is outside the scope of practice of the practitioner; or if the pharmacist has sufficient reason to question the validity of the prescription; or to protect the health and welfare of the patient. The Nurse Can Prescribe Only in Their Scope of Practice - Ohio Question 1: "A pharmacist has a responsibility to fill only those controlled substance prescriptions issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his or her professional practice" is true: a. only in Ohio and New Jersey; b. in some states, depending on each state's law; c. in all states, because every state has adopted it as law; d. in all states, because it is federal law. Question 2: The "corresponding responsibility" of a pharmacist refers to the pharmacist's duty to: a. get the patient's diagnosis prior to dispensing; b. verify the prescriber's rationale for the prescription; c. verify the patient's treatment plan; d. comply with federal and Ohio-specific laws regarding whether a prescription is valid. Question 3: In Ohio and New Jersey, a pharmacist should refuse to fill a prescription if the prescription is for a foot fungus medication written by a dentist. a. True; b. False. Pharmacy Jurisprudence, L.L.C. and Select CE 2014. All rights reserved. Page 6
Back to Ohio, where the nursing board rules make clear that APRN's can only prescribe within their scope of practice. This rule is found in OAC 4929-9-10(E), which states: (E) The ability to prescribe the drug or therapeutic device must be within the nurse's scope of practice. Therefore, in Ohio as well as in other states with similar laws, pharmacists can only fill valid prescriptions and that means only those Rx's written by APRN's acting within their scope of practice. Ohio's Laws and Rules Regarding APRN Scope of Practice How is the average pharmacist to know if the prescribing APRN is acting within his or her scope of practice? This question has become especially important with the growth in the number of APRN's as prescribers. In Ohio, the Ohio Board of Nursing has issued guidelines to help determine if an APRN is prescribing within his/her scope of practice. The "Decision-Making Guide For Determining Individual APRN Scope of Practice" was created by the Board to help APRN's determine their own individual scope of practice. The Guide does not have the force of law. However, this 6-question Guide is the best tool available help pharmacists and technicians determine the APRN's scope of practice. A Decision-Making Guide for Determining Individual APRN Scope of Practice Question 4: The Decision-Making Guide For Determining Individual APRN Scope of Practice in Ohio: a. is the law in Ohio; b. was created by the Ohio Board of Nursing to help determine an APRN's scope of practice; c. is strictly enforced by the DEA; d. is strictly enforced by the Board of Pharmacy. Pharmacy Jurisprudence, L.L.C. and Select CE 2014. All rights reserved. Page 7
First Question: Is the procedure/activity prohibited by any section of the Ohio Revised Code or the Ohio Administrative Code? Second Question: Is the procedure/activity consistent with the Ohio Nurse Practice Act, rules regulating the practice of nursing, practice statements of the Board, and the CTP Formulary? Third Question: Do practice guidelines of a national specialty or advanced practice organization support inclusion of this procedure or activity in the APRN's particular practice? Fourth Question (2-parts): 1. Does the APRN possess the depth and breadth of knowledge to perform this procedure/activity safely? AND 2. Does the APRN possess the depth and breadth of knowledge to respond appropriately to complications or untoward effects of the procedure/activity? At this step of the decision-making process: The APRN must be able to provide documentation, upon request of the Board, to show evidence of his/her knowledge to perform the procedure/activity. Such knowledge is generally obtained through education emanating from a recognized body of knowledge relative to the care to be provided. Documentation could include: APN educational programs; Preceptorship, fellowship, or internship; and/or Other formally organized educational experience Fifth Question (2 parts): 1. Does the APRN possess the depth and breadth of current skills and clinical competence to perform this procedure/activity consistently and safely? AND 2. Does the APRN possess the depth and breadth of current skills and clinical competence to respond appropriately to complications or untoward effects of the procedure/activity? At this step of the decision-making process: Pharmacy Jurisprudence, L.L.C. and Select CE 2014. All rights reserved. Page 8
The APRN must be able to provide documentation, upon request of the Board, to show evidence of her/his skills and abilities to perform the procedure/activity. Documentation could include: APN educational programs; Formally organized educational experience; and/or Return demonstrations or skills check-off Sixth Question (2 parts): 1. Is this an accepted standard of care? Would a reasonable, prudent APRN perform this activity in this setting and under these circumstances? AND 2. Will the APRN assume accountability for providing safe care in performing the procedure/activity? If YES to all of the above 6 questions, the APRN can conclude that the procedure/activity is within the APRN's scope of practice. Question 5: The Decision-Making Guide For Determining Individual APRN Scope of Practice in Ohio (the APRN Guide): a. permits an APRN to prescribe medications outside of his/her scope of practice; b. permits an APRN to prescribe any medication needed by his/her patient; c. encourages an APRN to choose a specific practice area; d. informs an APRN that they must be able to provide documentation of his/her knowledge, skills, and clinical competence to show to the Board, upon request. Pharmacists' Use of the APRN Guide Pharmacy Jurisprudence, L.L.C. and Select CE 2014. All rights reserved. Page 9
Pharmacists and technicians are not expected to be proficient in the rules regulating the practice of nursing, or in the guidelines of nursing organizations. Therefore some of these 6 questions could be difficult for pharmacists and pharmacy technicians to answer. But, you can still use this APRN Guide as a tool, recognizing that in the end of the 6-step analysis the scope of practice will depend on if the APRN has the knowledge, skills and clinical competence to prescribe the particular drug for the particular patient and if doing so is an accepted standard of care. Questions 1 and 2 - Laws, Rules, Practice Statements, Formulary Question 6: In the 1st and 2nd steps of the decision-making process, the APRN Guide asks if the procedure or activity: a. is prohibited by the Ohio Revised Code or Ohio Administrative Code; b. is consistent with the Ohio Nurse Practice Act and rules regulating the practice of nursing; c. is consistent with the practice statements of the Board of Nursing and the Certificate to Prescribe (CTP) Formulary; d. all of the above are true. Question 7: In the 4th step of the decision-making process, the APRN Guide asks if the particular APRN possesses the: a. depth and breadth of knowledge to perform the procedure/activity safely; b. depth and breadth of knowledge to respond appropriately to complications or untoward effects of the procedure/activity; c. documentation to show the APRN has sufficient depth and breadth of knowledge to perform the activity/procedure; d. all of the above are true. Pharmacy Jurisprudence, L.L.C. and Select CE 2014. All rights reserved. Page 10
The first 2 questions ask about the prescribing floor set forth by law, rule, practice statements, and formulary. Some common minimum requirements for APRN prescribing in Ohio are: Lack/Lapsed of Certificate of Authority to Prescribe (CTP): An APRN must have an active CTP. You can verify whether a particular APN holds current prescriptive authority by accessing the Board s website: http://www.nursing.ohio.gov and clicking on Verification. Committee on Prescriptive Governance (CPG) Formulary: Drug products listed on the CPG Formulary are the only drugs that can be prescribed by APRNs. The CPG Formulary is very expansive, and most all FDA-approved drugs can be prescribed. The CPG Formulary can be found at: www.nursing.ohio.gov, and then clicking on the APRN Practice link, and then clicking on the Formulary with Index for CTP Holders (January 6, 2014), or a more recent Index that may appear after publication of this lesson. Family member prescribing: A CTP holder may ONLY prescribe in a valid prescriber-patient relationship. A CTP holder shall not prescribe for family members or for individuals for whom the nurse s personal or emotional involvement may render the nurse unable to exercise detached professional judgment in making diagnostic or therapeutic decisions, and in the medical board rules this includes boyfriends and girlfriends. The prescription must be in accordance with the nurse s scope of practice and standard care arrangement, and documented in the patient s record, Rule 4723-9-09 OAC. A CTP holder may not prescribe controlled substances for a family member. Weight loss: An APRN cannot exceed a physician's authority, and a physician's authority to prescribe weight loss medications is limited. First, Ohio's rule in OAC 4723-9-09 (B) states that: The nurse's prescriptive authority shall not exceed the prescriptive authority of the collaborating physician, including but not limited to any restrictions imposed on the physician's practice by action of the United States drug enforcement administration or the state medical board. Pharmacy Jurisprudence, L.L.C. and Select CE 2014. All rights reserved. Page 11
Second, the Ohio Medical Board has rules governing the use of Schedule II and IV controlled substances to assist in weight loss. These rules are lengthy, and can be found at OAC 4731-11-04. Anabolic steroids: Ohio law regarding controlled substances prohibits prescribing or dispensing anabolic steroids in ORC 3719.06 (B): No licensed health professional authorized to prescribe drugs shall prescribe, administer, or personally furnish a schedule III anabolic steroid for the purpose of human muscle building or enhancing human athletic performance and no pharmacist shall dispense a schedule III anabolic steroid for either purpose, unless it has been approved for that purpose under the "Federal Food, Drug, and Cosmetic Act," 52 Stat. 1040 (1938), 21 U.S.C.A. 301, as amended. Also, Ohio law regarding physicians prohibits physicians, and by extension APRN's, from prescribing any drug to enhance athletic ability: 4731-11-05 Use of drugs to enhance athletic ability. (A) A physician shall not utilize anabolic steroids, growth hormones, testosterone or its analogs, human chorionic gonadotropin (HCG), or other hormones for the purpose of enhancing athletic ability. Abortifacients: Ohio rule in OAC 4723-9-09(F) says that an APRN shall not prescribe any drug or device to perform or induce an abortion. Drug dependency: No APRN may prescribe an opioid for the treatment of drug addiction. Federal law requires that opioids for the treatment of drug addiction be prescribed by physicians only. (Source is pages 15-16 of the CPG Formulary.) Controlled Substances: APRN may only prescribe C-II's analgesics for a maximum 14-day initial course of therapy, or at an institutional setting in accordance with the institution's standards. This means that APRN's may prescribe for a longer-than-14-day supply, if it is not for an initial course of therapy and the practice location requirement of page 14 of the CPG Formulary is met. APRN's may only prescribe C-II stimulants after a formal, established medical diagnosis. (Source is pages 15-16 of the CPG Formulary.) Pharmacy Jurisprudence, L.L.C. and Select CE 2014. All rights reserved. Page 12
Botulinum toxoid for cosmetic purposes: APRN's can prescribe this only if it is included in the standard care arrangement between the APRN and collaborating physician. (Source is page 20 of the CPG Formulary.) Question 8: In Ohio, APRN's might be able to properly prescribe: a. only drugs listed on the CPG Formulary; b. without a Certificate to Prescribe (CTP); c. for his or her girlfriend or boyfriend; d. weight loss drugs without limitation. Question 9: In Ohio, APRN's might be able to properly prescribe: a. growth hormones for enhancing athletic ability; b. ibuprofen for an athletic injury; c. a drug or device to induce an abortion; d. an initial course of therapy of a 30-day supply of a Schedule II narcotic. Question 10: In Ohio, APRN's might be able to properly prescribe: a. opioids used to treat drug dependency; b. C-III anabolic steroids for muscle building; c. C-I analgesics for athletes; d. botulinum toxin for cosmetic purposes, if the APRN and collaborating physician include it in their standard care arrangement. Pharmacy Jurisprudence, L.L.C. and Select CE 2014. All rights reserved. Page 13
Question 3 - Inclusion/Support by National Practice Organizations The national practice organization for each of the APRN specialties can be found on the Board of Nursing's website at www.nursing.ohio.gov, then click Practice APRN, and then click Approved National Certifying Organizations. All of the national practice organizations for APRN's support medication prescribing authority, and so this step is not likely to help define the scope of practice of a particular APRN. Questions 4 and 5 - Knowledge, Skills and Clinical Competence These 2 questions get at the core of the APRN's scope of practice: does the prescriber know what he or she is doing? One way to assess whether an APRN has the knowledge, skills and clinical competence to prescribe a particular medication for a patient can be to ask the APRN: 1) what is your scope of practice, or 2) what is the usual course of your professional practice; or 3) do you have the knowledge, skills and clinical competence to be prescribing this drug for this patient? These are questions that can be asked on the telephone, or in a check-off sheet that is faxed to the APRN and sent back to the pharmacy. If the APRN's response is "my scope of practice is mental health" or "I am an acute care NP" or "I am certified nurse-midwife" or if you get no response at all, then you as the pharmacist must evaluate the response in light of the prescription in front of you. If the prescription is for an oncology drug, it would be difficult for the prescription to fall into any of these scopes of practice. If the prescription is for an anti-depressant, it could reasonably fall within each of these scopes of practice. Of course, in real life, the questions you face when filling prescriptions are often much more difficult to answer. Should you fill an antibiotic prescription written by a mental health practitioner? Does it matter if the prescription is for amoxicillin? Vancomycin? Pharmacy Jurisprudence, L.L.C. and Select CE 2014. All rights reserved. Page 14
At first glance, it seems well-settled that antibiotics are not used to treat mental health conditions. And so as an Ohio pharmacist your instinct is to ask yourself about your own duty of corresponding responsibility: Is this prescription issued for a legitimate medical purpose, by an individual prescriber acting in the usual course of his/her professional practice? If you cannot answer this question using your own professional judgment, then it is time to ask the APRN any of the following: 1) what is your scope of practice, or 2) is prescribing [this particular drug] a usual course of your professional practice; or 3) do you have the knowledge, skills and clinical competence to be prescribing this drug for this patient? Even if the APRN does not respond, you should document in your patient files that you asked the question. Why? Because this shows that you made an attempt to determine the APRN's scope of practice. If the APRN does not respond, you can try to ascertain his/her scope of practice from the Ohio Board of Nursing's website. Under the Licensing and Registration section at www.nursing.ohio.gov/verification.htm, it will tell you if the APRN has a Certificate to Prescribe (CTP). It may also show you the particular specialty the APRN practices in, such as NP- Pediatric Primary Care or NP - Family or NS - Adult Psych or NP- Women's Health or NP-Acute Care. Document whatever response the APRN provides. If the APRN provides a meaningful and positive response to these questions, that's good. While a positive response is not proof that the APRN actually does possess the requisite knowledge, skills and clinical competence, it is proof that the APRN believes they have it. Question 6 - Is This The Accepted Standard of Care? This question is a hard one for anyone to answer, because the answer relies knowing the facts and circumstances, and applying professional judgment to those facts and circumstances. The answer can rarely be found in a book or in a law. It will not be found in the laws and rules of Pharmacy Jurisprudence, L.L.C. and Select CE 2014. All rights reserved. Page 15
the Ohio State Board of Pharmacy or the Ohio Board of Nursing. It is often debatable, and most medical malpractice litigation seeks to answer this question. At that point experts are brought in, and opine on what should have been done. However, at the point of filling a prescription, pharmacists and pharmacy technicians do not have those resources. Instead, you can ask yourself these questions: 1) do I feel professionally comfortable filling this prescription? 2) have I seen other APRN's write these sorts of prescriptions? 3) would other RPh's fill this prescription? In asking these questions, you are seeking the profession's standards. The closer your answers are to "yes", the closer you are to knowing the APRN is providing an acceptable standard of care, and satisfying the 6th and last question in determining in the APRN's scope of practice. Pharmacy Jurisprudence, L.L.C. and Select CE 2014. All rights reserved. Page 16
Return this ANSWER SHEET with the $15.00 Program Fee to: NAME: ADDRESS: CITY, STATE and ZIP: EMAIL: Pharmacy Jurisprudence, LLC P.O. Box 21186 Columbus, Ohio 43221-0186 NABP e-profile #: Month and Day of Birth: ANSWERS: Should I Fill This Rx Written by an Ohio Advanced Practice Registered Nurse? (Expires January 27, 2016) 1. a b c d 6. a b c d 2. a b c d 7. a b c d 3. a b 8. a b c d 4. a b c d 9. a b c d 5. a b c d 10. a b c d 11. For Pharmacists: After completing this program, I am able to apply the nursing board guidelines to determine an APRN's scope of practice: OR Yes No 11. For Pharmacy Technicians: After completing this program, I am able to apply the nursing board guidelines to determine an APRN's scope of practice: Yes No 12. Did this activity meet your educational needs? Yes No 13. Did you like the activity s format? Yes No 14. Was the content appropriate for you? Yes No 15. Was this specific to law related to pharmacy practice? Yes No 16. The faculty quality was: Great OK Needs to Improve 17. The usefulness of the material was: Great OK Needs to Improve 18. Effectiveness of teaching and learning methods, including active learning: Great OK Needs to Improve 19. The appropriateness of the learning assessment activity (post-test) was: Great OK Needs to Improve 20. If you perceived bias, promotion or advertisement of commercial products in this activity, please describe: 21. The time it took you to complete the whole program: Pharmacy Jurisprudence, L.L.C. and Select CE 2014. All rights reserved. Page 17
Pharmacy Jurisprudence, LLC Doing business outside Ohio as Select CE P.O. Box 21186 Columbus, Ohio 43221-0186 PRSRT STD U.S.POSTAGE PAID COLUMBUS, OH PERMIT NO. 8301 Good for pharmacy law CE in Ohio, as well as all other states where ACPE accreditation is accepted. As we have done in Ohio since 2001, and nationwide since 2008, we provide pharmacy law CE programs without commercial or government funding. Questions? Need more law CE? Call us at (614) 481-8711 or visit us on the web at www.selectce.org