A FOCUS ON TOPICS IN OHIO PHARMACY LAW -- OHIO STATE BOARD OF PHARMACY APPROVED DR. SULLIVAN S MONOGRAPH

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1 A FOCUS ON TOPICS IN OHIO PHARMACY LAW -- OHIO STATE BOARD OF PHARMACY APPROVED DR. SULLIVAN S MONOGRAPH

2 A FOCUS ON TOPICS IN OHIO PHARMACY LAW -- OHIO STATE BOARD OF PHARMACY APPROVED ACTIVITY DESCRIPTION This program has been approved by the Ohio State Board of Pharmacy for jurisprudence credit. TARGET AUDIENCE The target audience for this activity is pharmacists in hospital, community, and retail pharmacy settings. LEARNING OBJECTIVES After completing this activity, the pharmacist will be able to: Describe the requirements for drugs compounded by pharmacies for direct administration by a prescriber Describe the requirements of charitable pharmacies in Ohio Describe the requirements for licensure and professional duties of pharmacy interns in Ohio Describe the legal requirements for interns to transfer prescriptions and take oral prescriptions ACCREDITATION PHARMACY PharmCon, Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. NURSING PharmCon, Inc. is approved by the California Board of Registered Nursing (Provider Number CEP 13649) and the Florida Board of Nursing (Provider Number ). Activities approved by the CA BRN and the FL BN are accepted by most State Boards of Nursing. CE hours provided by PharmCon, Inc. meet the ANCC criteria for formally approved continuing education hours. The ACPE is listed by the AANP as an acceptable, accredited continuing education organization for applicants seeking renewal through continuing education credit. For additional information, please visit Universal Activity No.: H03-P Credits: 1 contact hour (0.1 CEU) Release Date: November 20, 2013 Expiration Date: November 20, 2016 ACTIVITY TYPE Knowledge-Based Home Study Monograph FINANCIAL SUPPORT BY Pharmaceutical Education Consultants, Inc. 1

3 ABOUT THE AUTHOR Donnie Sullivan is a professor of pharmacy practice at Ohio Northern University. He received his B.S. in pharmacy from Ohio State University in 1990, his MS from Ohio State University in 1991, and his Ph.D. is Pharmacy Administration from Ohio State University in He has published several peer-reviewed articles and five consumer drug reference books. He has taught courses in pharmacy law, medication error prevention, and OTC products for 15 years. He has done more than 90 professional presentations on pharmacy law, medication error prevention techniques, and OTC products all across the U.S. He has been voted professor of the year by his students in 13 of his 14 years at Ohio Northern University. Donald Sullivan, Ph.D. Professor of Pharmacy Practice, Ohio Northern University FACULTY DISCLOSURE It is the policy of PharmCon, Inc. to require the disclosure of the existence of any significant financial interest or any other relationship a faculty member or a sponsor has with the manufacturer of any commercial product(s) and/or service(s) discussed in an educational activity. Donald Sullivan reports no actual or potential conflict of interest in relation to this activity. Peer review of the material in this CE activity was conducted to assess and resolve potential conflict of interest. Reviewers unanimously found that the activity is fair balanced and lacks commercial bias. Please Note: PharmCon, Inc. does not view the existence of relationships as an implication of bias or that the value of the material is decreased. The content of the activity was planned to be balanced and objective. Occasionally, authors may express opinions that represent their own viewpoint. Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient or pharmacy management. Conclusions drawn by participants should be derived from objective analysis of scientific data presented from this monograph and other unrelated sources. 2

4 Drugs Compounded for Direct Administration by a Prescriber (OAC ) Recently, compounding of prescription drugs have been a hot topic of debate. One issue in particular, pharmacies compounding drug products for use by physicians in their office, has been addressed by the Ohio Board of Pharmacy for some time. Pharmacists may compound a drug from a request made by a prescriber for a drug to be used by that prescriber for the purpose of direct administration to his/her patients in the course of the prescriber s usual professional practice. However, there are several conditions that must be met in order for a pharmacist to do so. A pharmacy can only provide compounded drugs to a prescriber for direct patient administration for those drugs that are not commercially available. In addition, these compounded drugs cannot be sold to another pharmacy or wholesaler. Prescribers cannot dispense these compounded drugs to the patient, cannot sell them to other physicians, and cannot return them to the supplying pharmacy. Specifically, these compounded drugs should only be provided under one of the following specific situations: a) to treat an emergency situation b) for an unanticipated procedure for which a time delay would negatively affect patient outcomes c) for diagnostic purposes Also, a pharmacy may not supply more than a 72-hour supply of these compounded drug products to a prescriber and a prescriber may not have more than a 72-hour supply on hand at any one time. How should the pharmacist and physician determine what constitutes a 72-hour supply? This should be determined by previous administration patterns provided by the prescriber to the pharmacist. A compounded, non-sterile, topical preparation shall be supplied to a prescriber in a single container whose quantity does not exceed 60 grams or 60 milliliters. A prescriber should not have more than one full container at any given time. However, compounded, non-sterile drug preparations intended to treat an emergency situation may be 3

5 provided to a prescriber in a quantity required to sufficiently treat patients in the event of an emergency situation. All products compounded by a pharmacy and sold to a prescriber for direct administration to his/her patients must contain a beyond use or expiration date. For non-sterile products, this date must be determined by the pharmacy by drug product testing using acceptable practice standards, by published peer-reviewed literature that has been critically reviewed by outside experts, or in compliance with requirements in the current edition of an official compendium such as the United States Pharmacopoeia/National Formulary. For sterile products, this date must be determined by the pharmacy by drug product testing using acceptable practice standards or in compliance with requirements in the current edition of an official compendium such as the United States Pharmacopoeia/National Formulary standards whereas: a) Low risk compounds: 48 hours at controlled room temperature (20-25 degree Celsius), 14 days when refrigerated (2-8 degree Celsius), and 45 days in solid frozen state (-10 to -25 degrees Celsius). b) Medium risk compounds: 30 hours at controlled room temperatures temperature (20-25 degree Celsius), 9 days when refrigerated, (2-8 degree Celsius), and 45 days in solid frozen state (-10 to -25 degrees Celsius). c) High risk compounds: 24 hours at controlled room temperature (20-25 degree Celsius), 3 days when refrigerated (2-8 degree Celsius), and 45 days in solid frozen state (-10 to -25 degrees Celsius). When pharmacies supply these products to prescribers, they also must be labeled properly. Each compounded drug product provided to a prescriber for direct patient administration must include a label with the following information: 4

6 Complete Pharmacy Label a) statement: For direct patient administration only b) statement: Not for resale c) storage conditions d) beyond use date e) name of active and inactive ingredients f) amount or percentage of active drug ingredients g) quantity h) route of administration i) pharmacy name, address, and phone j) pharmacy control number (lot number) Containers of compounded drug preparations for a prescriber too small to bear a complete label must have the following, at a minimum on their label: a) statement: Not for Resale b) the storage conditions if other than room temperature c) beyond use date d) drug name(s) e) drug strength f) route of administration g) pharmacy control number (lot number) h) pharmacy name This too small container must be placed in a larger container with a complete pharmacy label as described above under Complete Pharmacy Label (requirements a-j). 5

7 Charitable Pharmacies (OAC ) For a pharmacy to be considered a charitable pharmacy, it must meet all of the following criteria: 1) It must have a terminal distributor s license 2) It is exempt from federal taxation 3) It is not a hospital When a charitable pharmacy applies for a terminal distributor s license, it must complete an application from the Board of Pharmacy designating the desire to become a charitable pharmacy and provide documentation to support its non-profit (exempt from federal taxation) status. Charitable pharmacies must be legally operated just like any other pharmacy. They must follow all the same requirements regarding security, record keeping, documentation, storage of dangerous drugs, inventory control, labeling, patient confidentiality, counseling, prospective DUR, etc. The main difference between a charitable pharmacy and a standard pharmacy is their ability to accept and dispense prescription medication samples to their patients. There are strict requirements regarding the acceptance of samples by charitable pharmacies that should be followed very closely. These regulations should not be confused with accepting donated drugs under the Ohio Drug Repository Program (OAC ). Charitable pharmacies can accept sample drugs only from the following sources: a manufacturer, a manufacturer s representative, a wholesaler acting on behalf of a manufacturer, or a prescriber practicing in a location that is licensed as a terminal distributor of dangerous drugs unless exempt from licensure pursuant to sections and of the Ohio Revised Code. If the sample is obtained from a prescriber, a record or invoice must be created documenting the transfer of the sample drug(s). This record must include: 1) name and address of the supplying prescriber, 2) name, strength, and quantity of the sample drug(s) received, 3) date of the sample transfer, and 4) name and address of the charitable pharmacy receiving the samples. In addition, the following requirements must also be met. The prescriber shall not transfer a sample drug to a charitable pharmacy unless the sample drug was received directly from a manufacturer, a 6

8 manufacturer s representative or by a wholesaler acting on behalf of a manufacturer. The prescriber and charitable pharmacy must keep copies of all these records for 3 years and be stored in a readily retrievable manner. Finally, the sample drug and packaging must not show any physical signs of tampering or adulteration. Just as there are very strict requirements for obtaining samples, there are a few legal requirements regarding what types of samples can be provided to a charitable pharmacy. First, the sample drug must be in the original manufacturer s container and the drug must be clearly marked as a sample. Second, the sample drug must have been stored under proper conditions to prevent contamination and deterioration. Third, the sample drug must be clearly marked with an expiration date and lot number. Charitable pharmacies should never accept samples of expired drugs, even if they are to be used as part of a medical mission in a foreign country. Finally, charitable pharmacies cannot accept samples of controlled substances. Before a charitable pharmacy dispenses a sample drug, they must have a valid prescription for that medication. The sample medication must be dispensed to the patient free of charge. This is different than the Drug Repository Program where donated drugs dispensed by a pharmacy can be charged a handling fee. The charitable pharmacy may dispense the sample medication in the original container it was placed in by the manufacturer where the container is clearly marked sample or placed in another prescription container with the appropriate labeling requirements clearly stating that this drug is a sample. No matter which of the two methods is used, the charitable pharmacy must still label it with all the same information as a regular, outpatient prescription. As for the eligibility requirements for which patients can receive samples from the charitable pharmacy, each individual charitable pharmacy is responsible for developing their own eligibility criteria and requirements. Internship (OAC ) Pharmacy internships play a crucial role in exposing pharmacy students to the practice of pharmacy and training them to take care of patients. By definition, pharmacy internship is the supervised practical experience required for licensure as a registered pharmacist. The purpose is to provide pharmacy students with the knowledge and practical experience to function as a 7

9 capable and effective registered pharmacist. The Ohio State Board of Pharmacy laws and rules regarding pharmacy internship have changed over the last few years as the practice of pharmacy continues to evolve. Ohio pharmacists who precept pharmacy interns need to stay up-to-date with the most current information. One of the biggest changes over the last few years is the requirements for a pharmacy intern s license in Ohio. To become a licensed intern in the State of Ohio, pharmacy students must meet the following requirements: 1) be actively working towards the requirements for licensure as a pharmacist; 2) must have successfully completed 60 semester hours or 90 quarter hours of college coursework; and 3) have begun taking professional classes directly related to the practice of pharmacy. The 60 semester hours or 90 quarter hours do not need to be in pharmacy courses like medicinal chemistry, therapeutics, pharmacology, etc. Any college course work, such as psychology, zoology, chemistry, biology, sociology, etc., will count toward the total. Once a pharmacy student has met these requirements, they must complete the Pharmacy Intern Registration Application. The form is available on the Ohio State Board of Pharmacy website at pharmacy.ohio.gov. In addition to this form, the pharmacy student must include a head and shoulders photograph taken within the last six months (name and date taken must be on the back), an original transcript certifying that the applicant has completed a minimum of 60 semester hours or 90 quarter hours of college coursework, a certificate of enrollment from a school or college of pharmacy certifying that the individual has enrolled in a school of pharmacy and begun taking professional classes directly related to the practice of pharmacy, and a check or money order for $22.50 payable to Treasurer, State of Ohio. Finally, the pharmacy student must submit to a criminal records check. Ohio law requires the pharmacy student to submit fingerprints to the Ohio Bureau of Criminal Identification and Investigation (BCI&I) and the Federal Bureau of Investigation (FBI). The results of the criminal records check then must be forwarded to the Board of Pharmacy for review before an intern s license will be issued. The Ohio Board of Pharmacy s website has a detailed document describing this process. To access this document, Criminal Records Check Required for Initial Licensure, go to: 8

10 0for%20Interns%20and%20Pharmacists.pdf. Note: This same process must be repeated before any initial licensure with the Board. This includes pharmacy interns and pharmacists. Therefore, the intern will have to complete the criminal records check again before they are licensed as a pharmacist. Since the transition to the all Pharm D. degree, pharmacy academic degree programs require students to complete approximately 1440 hours of experiential education in their last year of pharmacy school. In 2007, the accreditation body for colleges and schools of pharmacy (ACPE) began requiring an additional hours of introductory professional practice experience (IPPE) before students begin their Pharm D. rotations. This brings the total of academic experiential education of a pharmacy student to more than 1680 hours. Because of this, many Boards of Pharmacy realized that documentation of internship hours may not be necessary, including the Ohio State Board of Pharmacy. As of December 31, 2006, documentation of internship hours with the Board of Pharmacy is no longer required. The Board has determined that the required amount of pharmacy internship credit for licensure examination is deemed to be completed if the individual has graduated with a doctor of pharmacy degree (Pharm D.) after December 31, 2006 as long as the program of study is accredited by ACPE and approved by the Ohio Board of Pharmacy. A student who does not meet this requirement, must still document the completion of 1500 hours of internship with the Ohio Board of Pharmacy. This situation is likely to only impact foreign pharmacy graduates. Pharmacy interns must renew their license annually just like pharmacists. The renewal date for an intern s license is the same as for pharmacists, September 15 th. Interns are also required to sign their identification card and carry it with them at all times while working as an intern. Once licensed as a pharmacy intern, he/she must comply with the same requirements as pharmacists regarding change of employment, address, and name. If an intern changes employment sites or home address, the Board must be notified within 30 days of the change. If an intern changes his/her name, the Board must be notified within 60 days of the change and provide proper documentation. 9

11 Even though documentation of hours by interns is not required, interns are still required to complete a Statement of Preceptor form when beginning work as a pharmacy intern. This form is located on the Board of Pharmacy s website at m.pdf. It is best for preceptors to have the intern bring this form to work on their first day and have the preceptor complete it right away. Interns must file a Statement of Preceptor form within 30 days of beginning work as an intern at a specific site. If the preceptor of an intern changes or the intern changes employment site, a new Statement of Preceptor form must be filed within 30 days of the change. In addition, a pharmacy intern, must immediately notify his/her current employer and any subsequent employer where practicing as a pharmacy intern if he/she is no longer enrolled in a school of pharmacy. The person should immediately return his/her pharmacy intern certificate and pocket identification card to the state board of pharmacy. Any licensed pharmacist can be a preceptor for a pharmacy intern, unless the Board has specifically determined otherwise. Pharmacists are not required to complete any special forms or receive any specific training to become a preceptor. The preceptor is responsible for ensuring that the intern is properly supervised and exposed to all areas of the internship. If the intern is documenting hours, there has been some misinterpretation that the intern can only count hours worked with the preceptor. This is not true. The preceptor only oversees the intern s experience. The intern can work with and count hours from other pharmacists working at that site. Finally, a pharmacist can be a preceptor for an unlimited number of interns. For example, the hospital pharmacy director may be the preceptor for 12 interns at a large hospital. However, there is a pharmacist to intern ratio. A pharmacist cannot supervise more than two interns at one time. For example, if there are two pharmacists working in a community pharmacy at one time, four interns could be working with them. NEW: Interns can register as a delegate of the pharmacist at their place of employment and request OARRS reports for the pharmacist. However, it has to be a paid internship. Pharmacy interns on IPPE or APPE rotations cannot register as a pharmacist s delegate and cannot access OARRS. 10

12 Professional Functions of an Intern (OAC ) Interns and technicians have always had different duties and activities they could perform under the direct supervision of a pharmacist. A few years ago, the Board of Pharmacy defined several different professional duties an intern could perform in addition to assisting the pharmacist with technician functions. The pharmacist supervising the activity of a particular intern will determine if an intern is competent to perform any of these professional functions. The professional functions of a pharmacy intern under the direct supervision of a pharmacist as defined by the Board of Pharmacy are as follows: 1) sell schedule V controlled substances under OAC rule ) receive oral prescriptions 3) transfer prescriptions for non-controlled substances 4) provide patient counseling 5) administer influenza immunizations to patients 18 years of age and older, provided they have met the requirements of of the Revised Code, including Board-approved immunization certification training 6) document informed consent to administer immunizations under section of the Revised Code and OAC Prescription Transfers and Interns (OAC ) Licensed interns can send or receive transfers of prescriptions. Under no circumstances can interns take or give prescription transfers for controlled substances. This information has to be directly communicated between two pharmacists. Interns can take or give prescription transfers under the following circumstances: 11

13 1) The pharmacist who is supervising the activity of a particular intern will determine if that intern is competent to send or receive a prescription transfer. Again, this decision for each intern is made by each individual pharmacist and may be different for different interns. 2) The pharmacist who is supervising the intern is responsible for the accuracy of the prescription transfer that is sent or received. 3) The supervising pharmacist must be immediately available to answer questions or discuss the prescription transfer with the caller. 4) The pharmacist or intern receiving a prescription transfer must document the full names of the intern giving the transfer and of his/her supervising pharmacist. The intern giving a prescription transfer must give his/her full name and the full name of the supervising pharmacist to the person receiving the prescription transfer. 5) When an intern receives a transfer, he/she must immediately reduce the prescription to writing and review it with the supervising pharmacist. Before dispensing the prescription, positive identification (signature or initials for example) must be made on the prescription by both the intern who received the transfer and the supervising pharmacist. Oral Prescriptions and Interns (OAC ) Interns can take oral prescriptions for controlled and non-controlled substances over the phone or from a recording device, such as an answering machine or voic . A licensed pharmacy intern may receive oral prescriptions or refill authorizations from a prescriber or the prescriber s agent as long as they meet the following conditions: 1) The pharmacist on duty who is supervising the intern is responsible for the accuracy of the oral prescription taken by the intern. 2) The pharmacist on duty who is supervising the activities of a specific intern will determine if that particular intern is competent to receive oral prescriptions. This is a pharmacist-bypharmacist decision. One pharmacist may feel very comfortable letting a particular intern take oral prescriptions over the phone, but another pharmacist may not. No one can make this 12

14 decision for the pharmacist supervising the intern. For example: A district manager cannot mandate which interns a pharmacist must let take oral prescriptions over the phone. 3) When an intern is taking an oral prescription, the supervising pharmacist must be immediately available to answer questions or discuss the prescription with the caller. 4) The intern shall immediately reduce the prescription to writing and shall review the prescription with the supervising pharmacist. Before dispensing the prescription, positive identification (signature or initials for example) must be made on the prescription by both the intern and the supervising pharmacist. 13

15 ACTIVITY TEST 1. Which of the following are true regarding compounding drugs for physicians to use in their office? A. Pharmacists can supply no more than a 10 day supply. B. A pharmacist could provide a drug to a physician to treat an emergency situation. C. The expiration date for a medium risk compound is 30 hours at room temperature or 9 days when refrigerated at 2 to 8 degrees Celsius. D. a and c are true E. b and c are true 2. The maximum quantity of a topically compounded product that can be supplied for direct administration by a prescriber is. A. 30 grams B. 60 grams C. 90 grams D. 120 grams E. There is no limit 3. Dr. X buys a compounded product from Discount Pharmacy to be used in his office for direct administration to his patients. Dr. Y needs some of this compound for his patients. Can Dr. X sell some of this compound to Dr. Y? A. Yes B. No 4. Which of the following are true regarding charitable pharmacies? A. Samples of controlled substances can be dispensed from a charitable pharmacy. B. Physicians can donate samples if they are licensed as a terminal distributor. C. Hospitals cannot operate charitable pharmacies. D. b and c are true E. all of the above are true 5. Which of the following are true regarding charitable pharmacies? A. They must have a valid prescription before dispensing a sample medication. B. They cannot charge a dispensing fee when dispensing samples. C. To be licensed as a charitable pharmacy it must be exempt from federal taxes. D. a and c are true E. a, b, and c 14

16 6. Which of the following are true regarding internship? A. A student must be taking classes directly related to the practice of pharmacy to apply for an intern s license. B. Interns can transfer prescriptions for controlled substances. C. Interns must file a Statement of Preceptor form with the board within 30 days of working at a specific site. D. a and c are true E. a, b and c 7. An intern is working at XYZ Pharmacy. The intern is being paid $12.00 an hour. Can this intern register as a pharmacist s delegate and request OARRS reports? A. Yes B. No 8. When taking an oral prescription from a nurse, the prescription must document both the intern s full name and the full name of the pharmacist supervising the intern. A. True B. False 9. Which of the following are considered to be professional duties of an intern under Ohio Law? Assume the intern is being supervised by a pharmacist. A. Patient counseling B. Administering a flu vaccine to patients 18 years and older C. Receiving oral prescriptions D. a and b only E. a, b and c 10. A pharmacist can be a preceptor for number of interns, but can only supervise no more than interns at one time. A. 2; 2 B. 2; 1 C. unlimited; 1 D. unlimited; 2 E. unlimited; 3 Please submit your final responses on freece.com. Thank you. 15