Physician Assistant Prescribing

Transcript

Lindon & Lindon, LLC Pharmacy Law Physician Assistant Prescribing Learning Objectives After completing this lesson, the pharmacist will be able to: 1. Discuss requirements for regulating Physician Assistant prescribing. 2. Discuss duties of a supervising physician. 3. Discuss educational requirements for prescriptive authority. 4. Discuss standards for prescribing. 5. Identify the three types of treatment in the Physician Assistant formulary. Background According to the Bureau of Labor Statistics, Physician Assistants held about 66,000 jobs in 2006 with projected employment of 83,000 jobs by 2016. Median annual earnings of wage-and-salary Physician Assistants were $74,980 in May 2006. The middle 50 percent earned between $62,430 and $89,220. Physician Assistants programs usually last at least 2 years; admission requirements vary by program, but many require at least 2 years of college and some health care experience. All states, including Ohio, require Physician Assistants to complete an accredited education program and to pass a national exam in order to obtain a license. Ohio Recently allowed Physician Assistants to prescribe under specified conditions. On May 17, 2006 new legislation was enacted that changed how Physician Assistants work in Ohio. Notable changes included allowing Physician Assistants to see new patients with new conditions, identifying the Physician Assistants' scope of practice in statute and allowing Physician Assistants' prescriptive authority. The rules proposed by the Physician Assistant Policy Committee (PAPC), except for Formulary rule, became effective October 31, 2007. Physician Assistant Regulations (4730-1-02) OAC Chapter 4730-1 contains the regulations regarding Physician Assistant prescribing. The regulations provide that the Physician Assistant must practice under the supervision, control, and direction of a supervising physician with whom the Physician Assistant has Page 1 of 14 Copyright 2008 James Lindon (may duplicate with answer sheet) Lindon & Lindon, LLC Pharmacy Law an approved supervision agreement. The pharmacist should contact the supervising physician if the pharmacist is uncertain as to whether the Physician Assistant is prescribing under the supervision, control, and direction of a supervising physician – though this should typically only be needed in limited situations. The Physician Assistant may enter into supervision agreements with any number of supervising physicians. The Physician Assistant’s practice must be in a practice setting in which the supervising physician routinely practices. A Physician Assistant may not perform certain activities regardless of the practice setting. The Physician Assistant may not prescribe any drug or device to perform or induce an abortion, or otherwise perform or induce an abortion. The Physician Assistant also may not administer, monitor, or maintain any form of anesthesia except for local anesthesia. The Physician Assistant also may not engage in the practice of optometry, except to the extent of authorization to perform routine visual screening, provide medical care prior to or following eye surgery, or assist in the care of diseases of the eye. The Physician Assistant may execute medical orders. The Physician Assistant must include specified information with each written medical order. The Physician Assistant must provide a signature and the time and date that the order is written. The Physician Assistant must also include the name of the physician under whose supervision the Physician Assistant was practicing at the time the order was written. Duties of a Supervising Physician (OAC 4730-1-03) In general, the legal liability of the pharmacist in filling a prescription for a Physician Assistant will typically be the same as if the order was written by the supervising physician. The physician supervising a Physician Assistant assumes legal liability for the services provided by the Physician Assistant under an approved supervision agreement. A supervision agreement is terminated if the supervising physician fails to renew the supervision agreement or notifies the State Medical Board of Ohio, in writing, that the supervision agreement has been terminated. The supervision agreement also terminates if Page 2 of 14 Copyright 2008 James Lindon (may duplicate with answer sheet) Lindon & Lindon, LLC Pharmacy Law the certificate to practice held by either the physician or the Physician Assistant becomes inactive. A supervising physician may enter into supervision agreements with any number of Physician Assistants, but can not supervise more than two Physician Assistants at any one time. It would typically be difficult for a community pharmacist to determine whether a paticular Physician Assistant prescription is authorized by the supervising physician. One limitation the pharmacist should be aware of is that the Physician Assistant prescription can only be authorize to the degree the supervising physician would be authorized to issue that same prescription. Thus, if the supervising physician is not authorized to prescribe controlled substances, the Physician Assistant also could not prescribe controlled substances. The supervising physician must: (1) Personally and actively review the Physician Assistant’s professional activities; (2) Regularly review the condition of the patients treated by the Physician Assistant; (3) Regularly perform any other reviews of the Physician Assistant that the supervising physician considers necessary; (4) Establish, in consultation with each Physician Assistant supervised by the physician, implement, and maintain a quality assurance system, in accordance with the requirements of OAC 4730-1-05; (5) Only grant prescriptive authority to a Physician Assistant in compliance with the formulary adopted in rule by the State Medical Board of Ohio; (6) Supervise the Physician Assistant’s provisional period of prescriptive authority in accordance with rule 4730-2-04 of the Administrative Code; and (7) Maintain a written record of any conditions placed upon a specific Physician Assistant’s practice in an office-based practice and any limitations imposed in addition to any limitations applicable under the policies of a health care facility. Page 3 of 14 Copyright 2008 James Lindon (may duplicate with answer sheet) Lindon & Lindon, LLC Pharmacy Law OAC 4730-1-04 provides specific requirements for supervision of the Physician Assistant. While such supervision may involve a pharmacist, it should not impact most day to day community pharmacy operations. OAC 4730-1-05 provides that a quality assurance system must be developed to assess the Physician Assistant’s performance. While such a quality assurance system may involve a pharmacist, it should not impact most day to day community pharmacy operations. Educational Requirements for Prescriptive Authority (OAC 4730-2-02) In order to prescribe, a Physician Assistant must have both a certificate to practice as a Physician Assistant and a certificate to prescribe (CTP) issued by the State Medical Board of Ohio. To obtain prescriptive authority, the Physician Assistant must complete a course of study which includes a minimum of thirty contact hours of training in pharmacology that includes pharmacokinetic principles and clinical application and the use of drugs and therapeutic devices in the prevention of illness and maintenance of health. The Physician Assistant must also complete a minimum of twenty contact hours of clinical training in pharmacology and a minimum of fifteen contact hours including training in the fiscal and ethical implications of prescribing drugs and therapeutic devices and training in the state and federal laws that apply to the authority to prescribe. The requirement for clinical training in pharmacology is specifically defined. This type of clinical training is acceptable only if it is conducted under the on-site supervision and direction of a supervising physician and includes a process for regular interaction between the supervising physician and the Physician Assistant for on-going discussion concerning the Physician Assistant’s prescriptive decisions. The clinical training must also include evaluation of the Physician Assistant’s learning of the principles of the use of drugs and therapeutic devices in the prevention of illness and maintenance of health and require the Physician Assistant to apply pharmacologic principles and precepts in prescribing for a variety of medical conditions. Clinical training can also be carried over from another jurisdiction where the Physician Assistant was granted physician-delegated prescriptive authority. Page 4 of 14 Copyright 2008 James Lindon (may duplicate with answer sheet) Lindon & Lindon, LLC Pharmacy Law Provisional Period of Physician-Delegated Prescriptive Authority (OAC 4730-2-04) The first certificate to prescribe is a “provisional” certificate to prescribe for a “provisional” period of time. Think of the provisional period kind of like a type of “probation.” The provisional period lasts a minimum of one thousand hours and a maximum of one thousand eight hundred hours, and lasts for at least six months but not longer than twelve months. The supervising physician may extended the provisional period for no longer than another twelve months - for a total of twenty-four months. The first five-hundred hours of the provisional period must be under on-site supervision [meaning the supervising physician is required to be physically present in the same location as the Physician Assistant, but does not require the supervising physician’s physical presence in the same room.] The remaining five-hundred plus hours of the provisional period may be conducted under off-site supervision [meaning the supervising physician must be continually available for direct communication with the Physician Assistant and no more than one hour away.] Basically, as the Physician Assistant gains experience, supervision decreases. During the provisional period, each supervising physician who supervises the Physician Assistant in the exercise of physician-delegated prescriptive authority must review and evaluate the Physician Assistant’s competence, knowledge, and skill in pharmacokinetic principles and the application of these principles to the Physician Assistant’s area of practice. The review and evaluation must be documented by the supervising physician’s signing of patient charts in a legible manner. The supervising physician may also document the review and evaluation by use of an electronically-generated signature provided that reasonable measures have been taken to prevent the unauthorized use of the electronically generated signature. During the first five hundred hours of the provisional period, the review and evaluation must be completed and documented on every chart by each supervising physician who provided supervision within a reasonable period of time after the Physician Assistant rendered service to a patient. During the remainder of the provisional period, the review and evaluation must be completed and documented on at least fifty percent of the patient Page 5 of 14 Copyright 2008 James Lindon (may duplicate with answer sheet) Lindon & Lindon, LLC Pharmacy Law charts by each supervising physician who provided supervision within a reasonable period of time after the Physician Assistant rendered service to a patient. Provisional period hours completed under the supervision of a supervising physician may be transferred to a provisional period under a subsequent supervising physician, though the specifics of that transfer are not particularly relevant to most pharmacy practices and can be found in OAC 4730-2-04 (E) if the reader is interested in those details. If the Physician Assistant does not successfully complete the provisional period, the State Medical Board of Ohio must immediately revoke the provisional certificate to prescribe. A provisional certificate to prescribe is valid for up to one year after issuance, which may be extended for an additional limited amount of time if requested by the supervising physician. After the Physician Assistant successfully completes the provisional period of physician-delegated prescriptive authority, the Physician Assistant may apply for a certificate to prescribe from the State Medical Board of Ohio. See OAC 4730-2-05. If granted, the certificate to prescribe may be renewed. Standards for Prescribing (OAC 4730-2-07) A Physician Assistant who holds a current valid certificate to prescribe who has been granted physician-delegated prescriptive authority by a supervising physician must prescribe in a valid prescriber-patient relationship. A valid prescriber-patient relationship exists when the Physician Assistant completes at least the following six steps: (1) Obtains a thorough history of the patient; (2) Conducts a physical examination of the patient; (3) Renders or confirming a diagnosis; (4) Prescribes medication, ruling out the existence of any recognized contraindications; (5) Consults with the supervising physician when necessary; and (6) Properly documents these steps in the patient’s medical record. A Physician Assistant holding a current valid certificate to prescribe and who has been granted physician-delegated prescriptive authority by a supervising physician to prescribe Page 6 of 14 Copyright 2008 James Lindon (may duplicate with answer sheet) Lindon & Lindon, LLC Pharmacy Law controlled substances must apply for and obtain the United States Drug Enforcement Administration (DEA) registration prior to prescribing any controlled substances. A Physician Assistant may not prescribe any drug or device to perform or induce an abortion. A Physician Assistant may not prescribe any schedule II controlled substance. Where a schedule III-V controlled substance is prescribed, the Physician Assistant must include on each prescription the certificate number of the Physician Assistant’s certificate to prescribe and the Physician Assistant’s DEA number. The supervising physician may or may not consent to the Physician Assistant prescribing controlled substances under the supervision of that supervising physician. The Physician Assistant must include on each prescription the certificate number of the Physician Assistant’s certificate to prescribe. Their supervising physician is not required to co-sign prescriptions. The supervising physician may only grant prescriptive authority in compliance with the formulary and may not grant prescriptive authority that exceeds that of the supervising physician, nor exceeds what is specified in the formulary. All rules in Chapter 4731 of the Ohio Administrative Code concerning prescriptive practices are applicable to Physician Assistant prescribing. Until a Physician Assistant has his or her own DEA number, the Physician Assistant may not prescribe any controlled substances. Physician assistant prescriptions for controlled substances and certain dangerous drugs will be tracked, along with those of other prescribers, in the OARRS (Ohio Automated Rx Reporting System) program, which can he accessed at www.ohiopmp.gov. As of May 23, 2008, all prescribers will be required to have a National Provider Identifier (NPI) number for billing of electronic transactions. It is intended to replace currently used numbers, such as DEA number. Updates on Physician Assistant prescribing privileges and the formulary may be found at www.med.ohio.gov. You will find CTP numbers information, statute, rules, a calendar and minutes of PAPC meetings and FAQs. Information on licensed physician assistants and supervising physicians can be accessed through the Ohio e-License Center from the State Medical Board's website through licensee profile & status under Professionals Credential & Research. Rules regulating Page 7 of 14 Copyright 2008 James Lindon (may duplicate with answer sheet) Lindon & Lindon, LLC Pharmacy Law Physician Assistant professional practice and prescriptive authority are promulgated and regulated by the State Medical Board (www.med.ohio.gov). A Quick Summary of Physician Assistant Prescriptive Authority is included on the website, as well as the Physician Assistant formulary. Standards for Personally Furnishing Drugs and Therapeutic Devices (OAC 4730-2-08) Personally furnishing drugs and therapeutic devices by Physician Assistants will be limited. The Physician Assistant who holds a certificate to prescribe and who has been granted physician-delegated prescriptive authority by a supervising physician must maintain a written record of all drugs and devices personally furnished by the Physician Assistant. Personally furnishing drugs and therapeutic devices is limited to a federally funded comprehensive primary care clinic, a nonprofit health clinic or program, or a specified health department. Thus, the locations for “personally furnishing” are fairly limited. The Physician Assistant may only personally furnish antibiotics, antifungals, scabicides, contraceptives, prenatal vitamins, antihypertensives, drugs and devices used in the treatment of diabetes, drugs and devices used in the treatment of asthma, or drugs used in the treatment of dyslipidemia that are also included in the formulary established by rule 4730-2-06 of the Administrative Code. The Physician Assistant must affix to the container or device a label showing all of the following information: (1) The name, address, and certificate to prescribe number of the prescribing Physician Assistant; (2) The name of the patient for whom the drug or device is intended; (3) Name and strength of the drug; (4) Directions for use; and (5) Date furnished. Page 8 of 14 Copyright 2008 James Lindon (may duplicate with answer sheet) Lindon & Lindon, LLC Pharmacy Law Standards for Personally Furnishing Samples of Drugs and Therapeutic Devices (OAC 4730-2-09) Personally furnishing samples by Physician Assistants will also be possible in somewhat limited circumstances. The Physician Assistant must maintain a written record of all samples of drugs and devices personally furnished by the Physician Assistant. The Physician Assistant may not sell, impose a charge, or accept a fee for the sample or for furnishing it. The amount of the sample furnished may not exceed a seventy-two hour supply, except when the minimum available quantity of the sample is packaged in an amount that is greater than a seventy-two hour supply, in which case the Physician Assistant must furnish the sample in the packaged amount. The Physician Assistant may not personally furnish samples of controlled substances – even if the Physician Assistant can prescribe controlled substances. The samples of drugs and devices must be included among the drugs and devices for which the supervising physician has granted prescriptive authority to the Physician Assistant. Where the directions for use by a particular patient are different from the directions on or in the sample container, the Physician Assistant must provide, in written format, the name of the prescribing Physician Assistant and the name of the physician under whose supervision the Physician Assistant is authorized to write the prescription. The Physician Assistant must provide the name of the patient and directions for use of the drug or therapeutic device. The Physician Assistant may only personally furnish the samples in accordance with the requirements of section 3719.81 of the Revised Code. Basically, this means that the sample drug; (1) is furnished free of charge by a manufacturer, manufacturer’s representative, or wholesale dealer in pharmaceuticals to a licensed health professional authorized to prescribe drugs, or is furnished free of charge by such a professional to a patient for use as medication; (2) is in the original container in which it was placed by the manufacturer, and the container is plainly marked as a sample; Page 9 of 14 Copyright 2008 James Lindon (may duplicate with answer sheet) Lindon & Lindon, LLC Pharmacy Law (3) has been stored under the proper conditions to prevent its deterioration or contamination prior to its being furnished; (4) is provided in container that is plainly marked with the date beyond which the sample drug is unsafe to use, and the date has not expired on the sample furnished (if the sample drug is of a type which deteriorates with time); and (5) is distributed, stored, osr discarded in such a way that the sample drug may not be acquired or used by any unauthorized person, or by any person, including a child, for whom it may present a health or safety hazard. The Formulary (OAC 4730-2-06) The formulary is established for individuals who hold a current and valid certificate to practice as a Physician Assistant and either a current and valid provisional certificate to prescribe or a certificate to prescribe issued by the State Medical Board of Ohio and who have been authorized to prescribe pursuant to a State Medical Board of Ohio approved supervisory plan or the policies of the health care facility in which the Physician Assistant is practicing. The formulary does not authorize a Physician Assistant to prescribe any schedule II controlled substance or any drug or device used to perform or induce an abortion. For formulary may be viewed and downloaded at the State Medical Board of Ohio website. The forumulary is a list of treatments that is divided into three columns. Basically, each column indiates whether (1) the treatment may be prescribed, or (2) may not be prescribed, or (3) may be prescribed but only after the supervising physician initiates treatment after personally evaluating the patient. In the third case, the treatment may also be prescribed after the Physician Assistant consults with the supervising physician by direct, real time communication prior to initiating the drug. This third type of treatment is deemed physician-initiated or physician-consultation. Page 10 of 14 Copyright 2008 James Lindon (may duplicate with answer sheet) Lindon & Lindon, LLC Pharmacy Law For medications that are denoted “Physician initiated/consultation,” two requirements apply. The supervising physician's initiation of the drug or the prior consultation between the Physician Assistant and the supervising physician must be documented in the patient record. Also, the Physician Assistant must consult with the supervising physician before changing the dosage of the drug or before renewing a prescription when there is a change in patient status. The consultation must be documented in the patient record. Let us consider a concrete example of Physician Assistant prescribing of antibiotics from the formulary. The authorized Physician Assistant may prescribe penicillin. The authorized Physician Assistant may not prescribe chloramphenicol. The authorized Physician Assistant may prescribe parenteral aminoglycosides (like gentamicin) but only after the supervising physician initiates treatment after personally evaluating the patient or the Physician Assistant consults with the supervising physician by direct, real time communication prior to initiating the drug. Drugs may be prescribed for purposes other than Food and Drug Administration approved indications when those purposes are supported by current peer review literature, which emanate from a recognized body of knowledge and prescribing for those purposes are authorized by the supervising physician under whom the Physician Assistant is prescribing or the policies of the health care facility in which the Physician Assistant is prescribing. In order for a Physician Assistant to prescribe a combination medication, each component drug must be listed on the formulary as “CTP holder may prescribe” or the combination medication itself must be listed on the formulary as “CTP holder may prescribe.” Page 11 of 14 Copyright 2008 James Lindon (may duplicate with answer sheet) Lindon & Lindon, LLC Pharmacy Law Questions 1. To be granted a certificate to prescribe, the Physician Assistant must complete a course of study which includes a minimum of thirty contact hours of training in pharmacology that includes pharmacokinetic principles and clinical application and the use of drugs and therapeutic devices in the prevention of illness and maintenance of health. a. True b. false 2. To be granted a certificate to prescribe, the Physician Assistant must complete a minimum of fifteen contact hours including training in the fiscal and ethical implications of prescribing drugs and therapeutic devices and training in the state and federal laws that apply to the authority to prescribe. a. True b. false The supervising physician must: a) Personally and actively review the Physician Assistant’s professional activities; b) Regularly review the condition of the patients treated by the Physician Assistant; c) Only grant prescriptive authority to a Physician Assistant in compliance with the formulary adopted in rule by the State Medical Board of Ohio; d) Supervise the Physician Assistant’s provisional period of prescriptive authority in accordance with rule 4730-2-04 of the Administrative Code; e) All of the above 4. The Physician Assistant having a valid DEA number and a certificate to prescribe may prescribe Percocet under the direct supervision of a supervising physician. a. True b. false The supervising physician may enter into supervision agreements with no more than two Physician Assistants. a. True b. false The first certificate to prescribe granted to a Physician Assistant lasts for a minimum of 1,800 hours of supervision by a supervising physician. a. True b. false A Physician Assistant must conduct a physical examination of a patient in order to prescribe in a valid prescriber-patient relationship. a. True b. false 3. 5. 6. 7. Page 12 of 14 Copyright 2008 James Lindon (may duplicate with answer sheet) Lindon & Lindon, LLC Pharmacy Law 8. A Physician Assistant may use the supervising physician’s DEA number when prescribing controlled substances. a. True b. false A Physician Assistant must supply a CTP (certificate to prescribe) number on each prescription for the prescription to be valid. a. True b. false The supervising physician must cosign all Physician Assistant prescriptions for controlled substances for those prescriptions to be valid. a. True b. false 9. 10. Page 13 of 14 Copyright 2008 James Lindon (may duplicate with answer sheet) Lindon & Lindon, LLC  Lesson number 036-368-08-001-H03 Answer Sheet: Expires July 31, 2010 Approved for one contact hour of Ohio Jurisprudence by the Ohio Board of Pharmacy Pharmacy Law Physician Assistant Prescribing Answer Sheet – circle the one correct best answer. Credit will be granted with seven correct answers. Question Answer Question Answer 1 True False 6 True False 2 True False 7 True False 3 A B C D E 8 True False 4 True False 9 True False 5 True False 10 True False  Please return by mail with check for $20 payable to James Lindon at: James Lindon 35104 Saddle Creek Cleveland (Avon), Ohio 44011-4907 Phone 440-333-0011 Fax 419-710-4925 Please fax, e-mail, or mail [specify one, please] my continuing education certificate to: Pharmacist Name ___________________________________ Street Address _____________________________ City ________________________ State _________ Zip _______ E-Mail ___________________________________ Phone ___________________________________ Ohio Pharmacist License Number _____________________ Please Check one: ‫۝‬ Yes, Please e-mail me your free pharmacy law newsletter ‫۝‬ No, Do not e-mail me your free pharmacy law newsletter Copyright 2008 James Lindon, Lindon & Lindon LLC Any views expressed are not necessarily those of the author or the law firm of Lindon & Lindon. Program Evaluation (circle one response to each question): 1. How would you rate this educational program overall? excellent very good Good Fair Poor 2. How well did this program achieve its educational objectives? excellent very good Good Fair Poor 3. How well did this program improve your knowledge of the subject matter? excellent very good Good Fair Poor 4. How useful and relevant will this lesson be in your practice? Very Somewhat Not much Not at all 5. About how much time did it take you to complete the lesson and exam? 30 minutes 45 minutes 60 minutes 90 minutes Over 90 minutes Page 14 of 14 Copyright 2008 James Lindon (may duplicate with answer sheet)