PHARMACY JURISPRUDENCE, L.L.C. Volume 8, Issue 2 Expires: February 5, 2010

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1 PHARMACY JURISPRUDENCE, L.L.C. Volume 8, Issue 2 Expires: February 5, 2010 Ohio Pharmacy Law Review (Ohio Program Number: H03-P) For out-of-state pharmacists who wish to practice pharmacy in the great State of Ohio, one of the mandatory rites of passage is to attend an Ohio State Board of Pharmacy "Reciprocity Candidates Review". Such Reviews are typically held from 1:30 p.m. - 4:30 p.m. on the second day of the Ohio State Board of Pharmacy's (the "Board's") monthly meeting. The purpose of the Reciprocity Candidates Review is to highlight significant aspects of Ohio's pharmacy laws, and to point out some practical differences between practicing pharmacy in Ohio and in other states. In this program, we have transformed an oral, live Reciprocity Candidates Review by the Board's staff into a law CE home-study program for you. This CE home study program is organized into "bite-sized" pieces so that you can do it while standing and filling prescriptions. You can read about a topic or two and answer the applicable questions, then set the program down and come back to it later. We aim to please the practicing Ohio pharmacist. And so we've worked hard to create a thoughtful, well-organized and professional law CE program. Presented in this continuing pharmacy education program are: a) aspects of Ohio pharmacy law commonly covered by the Board's staff during these reviews; and b) a twenty (20) question quiz at the end of the program; and c) an answer sheet for the quiz. Upon successful completion of the quiz, and payment of the $15 fee, you will receive a certificate of participation for 0.10 CEU s in Board-approved jurisprudence. If you are thinking this looks similar to a program you took from us before, it does. In 2004 we offered a program very similar to this one, and we received great comments from Ohio pharmacists about how easy, useful and just plain good it was. So, we updated the program with new laws and rules that have been enacted since then. This program includes a summary of the new PA prescribing rules. But is a different CE program, with a new title and new program number and is approved for Ohio Board-approved jurisprudence. We thank you for reading our programs and using our services. We truly enjoy serving you. Sincerely, Patty Nussle, R.Ph., Esq. This program has been approved by the Ohio State Board of Pharmacy for 1.0 contact hours, or 0.10 CEU s, of Board-approved jurisprudence. Pharmacy Jurisprudence, L.L.C This program contains the intellectual property of Pharmacy Jurisprudence, L.L.C. Unauthorized use is strictly prohibited. 1

2 Objectives: At the conclusion of this program, successful participants should be able to: 1. explain what pharmacists need to do to maintain licensure upon a change of address or change of name; 2. explain the continuing pharmacy education requirements for pharmacists; 3. list who can be in a retail pharmacy, when the pharmacist is not present; 4. explain when a retail pharmacy can make occasional wholesale sales; 5. list what to do if your retail pharmacy experiences a significant loss or theft of drugs; 6. explain what a pharmacist's corresponding liability is all about; 7. understand which out-of-state prescriptions can be filled in Ohio; 8. describe a pharmacy intern's limits of authority, and the pharmacist's role in establishing that authority; 9. understand which prescriptions on a pre-printed prescription form are legitimate and can be filled in Ohio; 10. explain the manual signature requirement in Ohio; 11. list what prescriber demographic information must be on all prescriptions in Ohio; 12. explain the DAW rules in Ohio; 13. explain the time limits for filling controlled substances and all other federal legend drugs; 14. list who can prescribe medications in Ohio; 15. explain how to transfer prescriptions between pharmacies in Ohio ; 16. explain the significance of "positive identification" in Ohio; 17. list which immunizations can be administered by pharmacists in Ohio. A. Change of Address, Change of Employment, or Change of Name During your pharmacy career, it is likely that you will move from your residence at least once. You also may change your place of employment, and/or get married or otherwise have a legal name change. If so, you must notify the Board about these changes. The rules state: Pharmacists and pharmacy interns shall notify the Board of Pharmacy within 30 days of any change of address or place of employment, and within 60 days of any legal change of name. [Rules & , OAC] You make the changes by filing the appropriate form with the Board office, and the forms can be found on the Board's website, which is B. Continuing Pharmacy Education (CPE) Requirements CPE requirements are set by each state. To retain the privilege of practicing pharmacy in Ohio, you must obtain the following CPE: Pharmacists will be required to document sixty hours (6.0 CEUs) of continuing pharmacy education every three years, of which three hours (0.3 CEUs) must be in Board-approved jurisprudence. [Chapter , OAC] Pharmacy Jurisprudence, L.L.C This program contains the intellectual property of Pharmacy Jurisprudence, L.L.C. Unauthorized use is strictly prohibited. 2

3 In case you're wondering, ALL of Pharmacy Jurisprudence's programs are Board-approved for jurisprudence credit including the one you are reading. Not a word gets published prior to Board approval. C. Who Can Be in the Pharmacy? In Ohio, when the pharmacy is open there must be personal supervision by a pharmacist of the dangerous drugs (which is, as you know, all prescription drugs) at all times. And, anyone who is in the pharmacy is under the personal supervision of the pharmacist. The law states: In a pharmacy, there must be personal supervision by a pharmacist of the dangerous drugs at all times; except, whenever personal supervision is not provided by a pharmacist, there must be in place a physical or electronic barrier approved by the Board of Pharmacy. (A) All poisons, needles and syringes, and dangerous drugs, including filled prescriptions awaiting patient pick-up, exempt narcotics, and insulin, must be under the personal supervision of the pharmacist or within the approved barrier. (B) No item, product, record, or equipment that must be accessible to anyone other than a pharmacist may be stored in the prescription department. (C) No person may be within the physical confines of the pharmacy department unless under the personal supervision of the pharmacist, except as provided in Chapter of the OAC. [Sec , ORC; Rules (I), , , & , OAC] The Board is trying to say, in all that language above, that nobody is permitted in a pharmacy unless a pharmacist is present. This rule is why there is always a pharmacist present when the pharmacy is open. And, just what is personal supervision? The Board modified its definition in late 2007, so that "personal supervision" or direct supervision means a pharmacist shall be physically present in the pharmacy, or in the area where the practice of pharmacy is occurring, and provide personal review and approval of all professional activities. See OAC (I). D. Occasional Wholesale Sales From time to time, while in a retail pharmacy you may get requests from a local physician or other pharmacy for a bulk quantity of prescription medication. There's a natural tendency to treat this as a typical prescription, write it on a prescription pad as an oral prescription, give it a prescription number and fill it. But this is different. Because you are not dispensing to a patient, this is a wholesale order. So, do not write out a prescription. Instead, you should create an invoice for this wholesale order. Wholesale sales like this are permissible as long as the total wholesale sales of the pharmacy do not exceed 5% of the total cost of the drugs purchased by the pharmacy. The rules state: Ohio's Dangerous Drug Distribution Act requires a licensed terminal distributor of dangerous drugs to purchase dangerous drugs for resale only from a registered wholesale distributor of dangerous drugs; except, a licensed terminal distributor may make an occasional purchase from another licensed terminal distributor, or a licensed terminal distributor having more than one Pharmacy Jurisprudence, L.L.C This program contains the intellectual property of Pharmacy Jurisprudence, L.L.C. Unauthorized use is strictly prohibited. 3

4 establishment licensed may transfer or receive dangerous drugs between these licensed terminal distributors. [Sec (D), ORC; Rule , OAC] Before a wholesale distributor of dangerous drugs may make a sale of a dangerous drug to a terminal distributor of dangerous drugs, the wholesale distributor must obtain a copy of the current certificate of license as a terminal distributor from the purchaser. [Sec , ORC; Rule , OAC] A licensed terminal distributor of dangerous drugs acting as the sole supplier of any dangerous drug to a prescriber or other licensed terminal and/or wholesale distributor must be licensed as a wholesale distributor of dangerous drugs only if the total wholesale sales of the pharmacy exceed 5% of the total cost of dangerous drugs purchased by the pharmacy. [Sec (C)&(D), ORC; Rule , OAC] For controlled substances, the Drug Enforcement Administration ("D.E.A.") has a 5% rule too. But the D.E.A.'s 5% rule is based on the number of units sold, not on a sales/cost basis like Ohio's wholesale rules. E. Loss or Theft of Dangerous Drugs This is what the law and the rule says: Notify the Board of Pharmacy immediately, by telephone, of any theft or loss of dangerous drugs. Notify the Board of Pharmacy, the local law enforcement agency, and the D.E.A. if appropriate, within 30 days, in writing, following the discovery of such theft or loss. [Sec (b), CFR; Sec , ORC; Rule , OAC] The requirement to notify the D.E.A. would be appropriate only if a controlled substance was stolen or lost. F. Corresponding Responsibility Now, we're not talking about insurance companies' or PBM's or Medicare's or Medicaid's claim filing rules. We're talking about a pharmacist's corresponding liability, along with the prescriber, to ensure that each prescription is issued only for legitimate medical purposes and within the course of the prescriber's professional practice. For most of the time for most pharmacists, this corresponding liability should not be a concern that bogs you down. It comes with the territory, and it is a part of your professional service every day. But when you see dentists writing for prescriptions to treat ailments outside the oral cavity, when you see pediatric nurse practitioners writing prescriptions for adult patients, or when you see just plain odd prescriptions, then it's time to remember that you are responsible for ensuring that each prescription must be issued only for a legitimate medical purpose and only within the course of the prescriber's professional practice. You are within your professional obligation to question the facts behind the prescription, the patient, and/or the prescriber until you get the comfort level you need to meet your corresponding responsibility. Asking questions will not hurt anyone, especially when you use your kindness and tact to do it. But your failure to ask appropriate questions could hurt your patient and your license status. And finally, remember that there is nothing in the Ohio Board's rules or Ohio's pharmacy laws that forces you to fill a prescription, although your employer's policies may be another matter. The Board's material states: Pharmacy Jurisprudence, L.L.C This program contains the intellectual property of Pharmacy Jurisprudence, L.L.C. Unauthorized use is strictly prohibited. 4

5 A pharmacist considering filling a prescription must remember: A prescription, to be effective, must be issued for a legitimate medical purpose by a prescriber acting in the usual course of his/her professional practice. The pharmacist has a corresponding responsibility to see that this requirement is met. [Sec (a), CFR; Rule (A), OAC] In 2007, the Board sanctioned Ohio pharmacists for failing to follow the corresponding responsibility rule. Notably, the Board did not focus on an individual prescription from an individual patient filled by an individual pharmacist, and conduct an investigation into whether the prescription was for a legitimate medical purpose and from a prescriber acting in the usual course of his/her professional practice. Instead, the Board staff used aggregate prescription data from a particular pharmacy, and argued to the Board members (who are the decision-makers) that such a large number of narcotic prescriptions from a certain prescriber could not possibly all be for legitimate medical purposes. The sheer volume of similar prescriptions from a particular prescriber should have alerted the pharmacist to conduct further investigation into each prescription to determine whether there was a legitimate medical purpose and the prescriber was acting in the usual course of his/her professional practice. G. Which Out-of-State Prescriptions Can be Filled in Ohio? Here is the rule: A non-resident prescriber who is licensed and authorized to issue prescriptions for drugs in the course of his/her professional practice in a state other than Ohio is authorized to write prescriptions in that state for drugs to be dispensed in the state of Ohio. [Rule (C), OAC] Since you probably remember more biology and chemistry than geography, here's a reminder that Territories of the United States of America include Guam and Puerto Rico. H. What Are Pharmacy Interns Permitted to do in Ohio? We have a new rule regarding the professional functions of pharmacy interns. The new rule states: Pharmacy intern professional functions. In addition to assisting a pharmacist with technical functions, a pharmacy intern may perform the following professional functions under the direct supervision of a pharmacist. These activities must be documented with positive identification of both the supervising pharmacist and the pharmacy intern. (A) The sale of schedule V controlled substances pursuant to rule of the Administrative Code. (B) The receipt of oral prescriptions pursuant to paragraph (D)(3) of rule of the Administrative Code. (C) The transfer of a prescription copy pursuant to paragraph (G) of rule of the Administrative Code. (D) The act of patient counseling pursuant to paragraph (B) of rule of the Administrative Code. (E) The administration of influenza immunizations to individuals eighteen years of age and older pursuant to section of the Revised Code. Pharmacy Jurisprudence, L.L.C This program contains the intellectual property of Pharmacy Jurisprudence, L.L.C. Unauthorized use is strictly prohibited. 5

6 (F) The documentation of informed consent to administer an immunization pursuant to section of the Revised Code and paragraph (O) of rule of the Administrative Code. It is important to remember that pharmacy interns still cannot take new and transferred prescriptions over the telephone for controlled substances. There is a limitation on a pharmacy intern's ability to take phone prescriptions or refills, and it is you. The rule states that the pharmacist on duty must approve of the telephone practice for each particular intern. After all, the pharmacist is ultimately responsible for the prescriptions dispensed, and this rule helps to ensure that the pharmacist is comfortable with the practice going on in his or her pharmacy. And on any given day, or for any given prescriber or patient or drug, the pharmacist on duty can limit the intern's authority to take oral prescriptions. For example, the pharmacist on duty can say that today he/she wants to take all the oral prescriptions from a particular prescriber. Or all the coumadin prescriptions. Or all the prescriptions for a particular patient. The key is that the pharmacist on duty is the decision-maker concerning if and when the intern working with him or her can take oral prescriptions. The applicable rule states: (D) Oral transmission by the prescriber or the prescriber s agent of original prescriptions and refills authorized by a prescriber, pursuant to the requirements of this rule, may be transmitted by telephone only to: (1) A pharmacist. (2) A recording device within the pharmacy if the pharmacist is unavailable. The pharmacist must remove the prescription from the recorder and reduce it to writing. The pharmacist is responsible for assuring the validity of the prescription removed from the recorder. (3) A licensed pharmacy intern if the pharmacist on duty who is supervising the activity of the intern determines that the intern is competent to receive telephone prescriptions. [Rule (D), OAC] I. Pre-Printed Prescriptions. Are pre-printed prescriptions allowed in Ohio? The rule, which reflects some slight changes since 2004, states: (A) No pharmacist shall dispense dangerous drugs pursuant to a written outpatient prescription unless the following conditions are met: (1) The prescription is issued in compliance with rule of the Administrative Code. (2) If handwritten or typewritten, there are no more than three noncontrolled substance prescription orders per prescription form. (3) If preprinted with multiple drug name and strength combinations: (a) There are no controlled substances among the choices; (b) There is only one prescription order selected per form. (B) No prescriber shall write and no pharmacist shall dispense controlled substances pursuant to a written outpatient prescription unless the following conditions are met: (1) The prescription has been issued in compliance with rule of the Administrative Code. (2) The prescription contains only one prescription order per prescription form, whether hand-written or preprinted. (3) The quantity has been written both numerically and alphabetically. (4) If preprinted, there is only one drug and strength combination printed on the form. Pharmacy Jurisprudence, L.L.C This program contains the intellectual property of Pharmacy Jurisprudence, L.L.C. Unauthorized use is strictly prohibited. 6

7 (C) A prescription for a controlled substance issued by a medical intern, resident, or fellow as defined in paragraph (B) of rule of the Administrative Code may not be dispensed unless the prescription is issued in compliance with this rule and rule of the Administrative Code and unless it bears the identification number issued by the employing hospital or institution pursuant to rule of the Administrative Code. (D) A prescription for a controlled substance issued by a staff prescriber of a hospital may not be dispensed unless the prescription is issued in compliance with this rule and rule of the Administrative Code and unless it bears the identification number issued by the employing hospital or institution pursuant to rule of the Administrative Code. [Rule , OAC] Pre-printed prescriptions are permitted in Ohio, as long as the above rules are followed. This means that controlled substances can never appear on pre-printed prescriptions that have more than one drug choice on the form. It also means that of all the non-controlled substances pre-printed on the form, only one (1) drug can be selected by the prescriber to be dispensed. So, for example, a pre-printed form with five (5) non-controlled substances listed on the form is possible, as long as only one (1) of the non-controlled substances is selected by the prescriber. A pre-printed form with more than one (1) non-controlled substances checked for dispensing is not a legitimate prescription in Ohio. Prescriptions for controlled substances can be typed or pre-printed under the following conditions. First, as noted above, it must be the only drug on the pre-printed prescription. If any other drug also appears on the prescription, the prescription is not valid. Second, the quantity is written out both numerically and alphabetically. For example, "thirty (30)" is a quantity with both the alphabetical and numerical description of the quantity. Third, there is only one drug and strength combination on the pre-printed form. In other words, a typed prescription for "diazepam" with options for a check-mark next to "10 mg", "20 mg" and "40 mg" is not a legitimate prescription in Ohio. Do not confuse pre-printed prescriptions with pre-printed orders ; the latter is used only in the hospital or institutional setting: "Preprinted order" is defined as a patient specific, definitive set of drug treatment directives to be administered to an individual patient who has been examined by a prescriber and for whom the prescriber has determined that the drug therapy is appropriate and safe when used pursuant to the conditions set forth in the preprinted order. Preprinted orders may be used only for inpatients in an institutional facility as defined in Chapter of the Administrative Code. [ (J); OAC] J. Manual Signatures on All (or Almost All) Prescriptions The rule states: (B) All prescriptions issued by a prescriber shall: (14) For prescriptions issued to a patient by a prescriber, be: (a) Manually signed on the day issued by the prescriber in the same manner as he/she would sign a check or legal document. [Rule (B)(14)(a), OAC] Sometimes, prescribers will sign prescriptions with a signature that is difficult to read. Is this acceptable? The answer depends, and it depends on whether or not this is the way the prescriber typically signs a check or other legal document, including other prescriptions. If yes, then the manual signature requirement is met. Oral prescriptions and electronic prescription systems are exempt from this manual signature requirement. Pharmacy Jurisprudence, L.L.C This program contains the intellectual property of Pharmacy Jurisprudence, L.L.C. Unauthorized use is strictly prohibited. 7

8 K. Prescriber's Phone Number and Professional Title on All Prescriptions This phone number rule was new in But the professional title rule is new as of November These new rules should help you fulfill your corresponding responsibility duty in light of the increasing number and types of prescribers in Ohio. Prescribers can only write within the scope of their practice, and your corresponding responsibility duty requires you to fill only from a prescriber acting in the scope of his or her usual practice. But how can a pharmacist even begin to do that, unless they know at least which type of prescriber wrote the prescription? And how will you contact the prescriber with questions or concerns? These rules are to help you determine the scope of practice of the prescriber, and to contact the prescriber, and thereby help your patients. The full rule states: B) All prescriptions issued by a prescriber shall: (1) Be dated as of and on the day when issued. (2) Contain the manually printed, typewritten, or pre-printed full name, professional title, and address of the prescriber. (3) Indicate a telephone number where the prescriber can be personally contacted during normal business hours. (4) Indicate the full name and address of the patient. (5) Indicate the drug name and strength. (6) Indicate the quantity to dispense. (7) Indicate the appropriate directions for use. (8) Specify the number of times or the period of time for which the prescription may be refilled. If no such authorization is given, the prescription may not be refilled except in accordance with section of the Revised Code. A prescription marked "Refill P.R.N." or some similar designation is not considered a valid refill authorization. (9) Not authorize any refills for schedule II controlled substances. (10) Authorize refills for schedules III and IV controlled substances only as permitted by section of the Revised Code. (11) Not authorize a refill beyond one year from the date of issuance for schedule V controlled substances and for dangerous drugs that are not controlled substances. (12) Identify the trade name or generic name of the drug(s) in a compounded prescription. (13) Not be coded in such a manner that it cannot be dispensed by any pharmacy of the patient's choice. (14) For prescriptions issued to a patient by a prescriber, be: (a) Manually signed on the day issued by the prescriber in the same manner as he/she would sign a check or legal document. (b) Issued in compliance with rule of the Administrative Code. (15) For a controlled substance, indicate the drug enforcement administration registration number of the prescriber pursuant to Title 21 CFR (enacted on June 23, 2005). (16) If issued by a clinical nurse specialist, certified nurse-midwife, or certified nurse practitioner with prescriptive authority, contain the nurse s prescriber number found on the certificate to prescribe issued by the state board of nursing pursuant to rule of the Administrative Code. (17) Be issued in compliance with all applicable federal and state laws, rules, and regulations. [ (B), OAC] Pharmacy Jurisprudence, L.L.C This program contains the intellectual property of Pharmacy Jurisprudence, L.L.C. Unauthorized use is strictly prohibited. 8

9 L. Generic Substitution and DAW on Written Prescriptions In Ohio, we have a wonderful mechanism in place to make sure that exactly what the doctor ordered is dispensed, and that is our DAW rule. This rule has been in place for many years, and every time I hear a patient complain that The pharmacy didn t dispense what my doctor ordered; I got a generic instead., I wince. Then I explain what a generic medication is. And then I explain that if the doctor wants any specific brand name medicine dispensed and the patient wants to pay for it then the doctor is to write the letters DAW on the prescription. And then the patient will get exactly what the doctor ordered. It is that simple. 1 In order to be effective, any "DAW" or "dispense as written" designation must be in the prescriber's manual handwriting. Pre-printed boxes or secondary signature lines, as can be found in other states, are not effective to "dispense as written" in Ohio. It has to be the affirmative choice of the prescriber. The purpose is to provide the pharmacist with the ability to use generic medications and for the patient to benefit from the lower cost of the generic medication - except when the prescriber has affirmatively indicated by means of his/her manual handwriting that the brand name drug is to be dispensed. For practical reasons, oral prescriptions are exempt from this hand-written DAW requirement, although if during the course of giving an oral prescription the prescriber indicates that he or she wants the brand name drug dispensed, then the brand name drug is to be dispensed. When generic substitutions are made, the rule states that the purchaser should be informed that a generic drug is being dispensed. Also, the purchaser should be told the retail price difference between the brand name drug and the generic drug dispensed. Finally, the purchaser should be informed that he or she has the choice to refuse the generic medication, and may obtain if they want to pay for it - the brand name medication instead. This ability to refuse the generic and pay for the brand name product does not apply, however, in hospitals, nursing homes, and similar facilities such individual requests would be unworkable, or when the State is paying for the prescription. Finally, when a generic substitution is made, the label or prescription bottle should contain an indication that a generic substitution was made. The applicable statute states: ORC Selecting generically equivalent drugs. A) Unless instructed otherwise by the person receiving the drug pursuant to the prescription, a pharmacist filling a prescription for a drug prescribed by its brand name may select a generically equivalent drug, as defined in section of the Revised Code, subject to the following conditions: (1) The pharmacist shall not select a generically equivalent drug if the prescriber handwrites dispense as written, or D.A.W., on the written prescription, or, when ordering a prescription electronically or orally, the prescriber specifies that the prescribed drug is medically necessary. These designations shall not be preprinted or stamped on the prescription. Division (A)(1) of this section does not preclude a reminder of the procedure required to prohibit the selection of a generically equivalent drug from being preprinted on the prescription. (2) The pharmacist shall not select a generically equivalent drug unless its price to the patient is less than or equal to the price of the prescribed drug. 1 As long as, of course, it is for a legitimate medical purpose and from a prescriber acting in the usual course of his/her practice. Pharmacy Jurisprudence, L.L.C This program contains the intellectual property of Pharmacy Jurisprudence, L.L.C. Unauthorized use is strictly prohibited. 9

10 (3) The pharmacist, or the pharmacist s agent, assistant, or employee shall inform the patient or the patient s agent if a generically equivalent drug is available at a lower or equal cost, and of the person s right to refuse the drug selected. Division (A)(3) of this section does not apply to any: (a) Prescription that is billed to any agency, division, or department of this state which will reimburse the pharmacy; (b) Prescriptions for patients of a hospital, nursing home, or similar patient care facility. (B) Unless the prescriber instructs otherwise, the label for every drug dispensed shall include the drug s brand name, if any, or its generic name and the name of the distributor, using abbreviations if necessary. When dispensing at retail a generically equivalent drug for the brand name drug prescribed, the pharmacist shall indicate on the drug s label or container that a generic substitution was made. The labeling requirements established by this division are in addition to all other labeling requirements of Chapter of the Revised Code. (C) A pharmacist who selects a generically equivalent drug pursuant to this section assumes no greater liability for selecting the dispensed drug than would be incurred in filling a prescription for a drug prescribed by its brand name. (D) The failure of a prescriber to restrict a prescription by specifying dispense as written, or D.A.W., pursuant to division (A)(1) of this section shall not constitute evidence of the prescriber s negligence unless the prescriber had reasonable cause to believe that the health condition of the patient for whom the drug was intended warranted the prescription of a specific brand name drug and no other. No prescriber shall be liable for civil damages or in any criminal prosecution arising from the interchange of a generically equivalent drug for a prescribed brand name drug by a pharmacist, unless the prescribed brand name drug would have reasonably caused the same loss, damage, injury, or death. As you can see in the last section, prescribers are civilly and criminally protected from prosecution in the event they fail to write DAW, or in the event of a generic interchange from a pharmacist. There are efforts underway in Ohio to change the DAW rule to exempt certain classes of drugs from the rule. Some large pharmaceutical companies and the Epilepsy Foundation believe that drugs to treat epilepsy, for example, have such a narrow therapeutic index that generic substitutions should only be permitted if both the patient and the physician sign a special document, and present it to pharmacist at the time of sale. This dualsigned document would be a pre-requisite for a pharmacist to substitute amongst available generics as well. It seems as if groups that back such efforts must not be aware of the DAW rule in Ohio, which already provides a mechanism to achieve exactly what the doctor ordered by the simple use of the three letters DAW on the face of the prescription. M. Refills In many pharmacies, the refill label is automatically generated for you. The software does the work of figuring out if it is refill too soon and the like. As a result, you don t have to think about the refill rules. Because of this automation, you may forget what the refill rules are. For first fills and refills of controlled substances, Ohio follows the federal law. Schedule II's cannot be refilled. Refills can be made up to 5 times in 6 months for C-III and C-IV controlled substances, and controlled substance prescriptions are valid for 6 months from the date written. Notably, nothing in federal law restricts Schedule II prescriptions in terms of time to first fill and quantity limits. So, technically, nothing in federal law directly prevents you from filling a Schedule II prescription long after it was written and/or for a large quantity. And Ohio has no quantity limit either. However, your professional judgment will always be part of the prescription filling process and is likely to be the tool you will use to help the patient avoid overuse and misuse. Pharmacy Jurisprudence, L.L.C This program contains the intellectual property of Pharmacy Jurisprudence, L.L.C. Unauthorized use is strictly prohibited. 10

11 Also, the Medical Board has special prescribing rules for weight loss drugs, and these rules will govern your filling practice as well. But, for all prescriptions filled in Ohio, the first fill of the prescription must be made within 6 months of the date written, and the last fill must be within 12 months of the date written. This is the rule in Ohio for all prescriptions, controlled or non-controlled. In Ohio, the phrase "refill prn" is not acceptable. A firm number of refills or a firm time period must be specified by the prescriber on the face of the prescription. The laws state: Limit authorized refills of Schedule III and IV controlled substance prescriptions to five times and for a period not exceeding six months from the date the prescription is issued by the prescriber. [Sec , CFR; Sec , ORC] No prescription may be dispensed for the first time beyond six months from the date it was issued nor refilled beyond one year from the date that it was issued. [Rule , OAC] All prescriptions must specify the number of times or the period of time for which the prescription may be refilled. A prescription marked "Refill P.R.N." or some similar designation is not considered a valid refill authorization. [Rule , OAC] N. Who Can Prescribe in Ohio; It's Not Just for Physicians Anymore In Ohio, advanced practice nurses ("APN's") who hold a certificate to prescribe ("CTP") are authorized to prescribe medications. For a current list of APN's with a CTP, see the nursing board's website at In Ohio, physician assistants ( PA s ) are also authorized to prescribe medications on the formulary approved by the medical board and pursuant to a supervisory plan each PA has with their physician. As of October 31, 2007, the administrative rules for PA s became effective, meaning that PA s can now prescribe. The prescribing law and rules can be found in the Ohio Revised Code 4730 and Ohio Administrative Code section 4730, but a summary of these rules is provided below: 1. In order to prescribe, a PA must have both a certificate to practice as a PA and a certificate to prescribe issues by the State Medical Board of Ohio ( Medical Board ). 2. The PA s prescriptive practice is limited to the authority granted by the supervising physician and must be in accordance with all conditions placed on the PA s prescribing by the supervising physician. 3. The supervising physician may only grant prescriptive authority in compliance with the formulary adopted by the Medical Board Formulary Rule (the PA Formulary ). Note: The Medical Board expects its PA Formulary to be approved in late February Until the PA Formulary is approved, PA s may prescribe substances included on the APN s CTP Formulary. For the APN CTP Formulary, effective February 1, 2008, see and check this site often for updates. See also for PA Formulary updates. Pharmacy Jurisprudence, L.L.C This program contains the intellectual property of Pharmacy Jurisprudence, L.L.C. Unauthorized use is strictly prohibited. 11

12 4. The supervising physician may only grant prescriptive authority in compliance with the PA Formulary. 5. A PA may not prescribe any drug or device to perform or induce an abortion. 6. The first certificate to prescribe will be a provisional certificate to prescribe. a. It entitles the holder to participate in a provisional period of physician-delegated prescriptive authority. b. The provisional period shall be, at a minimum, 1,000 hours during at least six months and no longer than 1,800 hours during a one (1) year period, but may be extended by the supervising physician for up to one additional year. c. The first 500 hours must be under the on-site supervision of the supervising physician. d. The remaining hours of the provisional period may be conducted under off-site supervision or another level of supervision specified by the supervising physician. e. If the Medical Board receives notice that a PA did not successfully complete the provisional period, the provisional certificate to prescribe shall be immediately revoked. 7. Once the PA successfully completes the provisional period, the PA may apply for a certificate to prescribe. 8. All rules in Chapter 4731 of the Administrative Code concerning prescriptive authority practices are applicable to PA prescribing. 9. The PA who holds a certificate to prescribe and has been granted prescriptive authority for controlled substances shall apply for an obtain DEA registration. The PA may not prescribe Schedule II controlled substances. 10. The PA shall include on each prescription the certificate number of the PA s certificate to prescribe, and, if applicable, the PA s DEA number. 11. The PA who holds a certificate to prescribe may be authorized to personally furnish a sample of a drug or therapeutic device in accordance with Section of the Revised Code and other applicable state and federal laws, where the drug is listed on the Formulary. 12. The PA who holds a certificate to prescribe may be authorized to personally furnish a complete or partial supply of drugs and therapeutic devices in accordance with applicable state and federal laws, where the drug is listed on the Formulary. In addition to APN s and PA s, Ohio rule states that the following categories of health care professionals may prescribe dangerous drugs: (1) Chapter of the Revised Code: dentist. (2) Chapter of the Revised Code: optometrist, if that person holds a current "therapeutic pharmaceutical agents certificate" as defined in division (H) of section of the Revised Code. Pharmacy Jurisprudence, L.L.C This program contains the intellectual property of Pharmacy Jurisprudence, L.L.C. Unauthorized use is strictly prohibited. 12

13 (3) Chapter of the Revised Code: doctor of medicine, doctor of osteopathic medicine and surgery, and doctor of podiatry. (4) Chapter of the Revised Code: doctor of veterinary medicine. (B) Those persons pursuing an approved internship, residency, or fellowship program in this state are authorized to write prescriptions only when acting within their scope of employment in the hospital(s) or institution(s). Approved internship and residency programs are those accredited by the "Accreditation Council for Graduate Medical Education (ACGME)" or the "American Osteopathic Association (AOA)". Approved clinical fellowships are those at institutions which have a residency program in the same or a related clinical field which is accredited by the ACGME or the AOA. (C) A nonresident prescriber whose license is current and in good standing and who is authorized to issue prescriptions for drugs in the course of their professional practice in a state, as defined in division (G) of section 1.59 of the Revised Code, other than Ohio is authorized to write prescriptions in that state for drugs to be dispensed in the state of Ohio. (D) An advanced practice nurse approved pursuant to section of the Revised Code may prescribe those drugs which have been approved by the committee on prescriptive governance for advanced practice nurses and pursuant to the standard care agreement for that advanced practice nurse. (E) A physician assistant approved pursuant to section of the Revised Code may prescribe those drugs approved in rule by the medical board and pursuant to the physician supervisory plan for that physician assistant. [ ; OAC ; underlining used for emphasis purposes only] While at least 18 other states have some form of pharmacist-prescribing, this has not happened in Ohio yet. In any event, all prescribers are only authorized to prescribe within the scope of their practice. This means that dentists can prescribe for the oral cavity, and ophthalmologists can prescribe for the visual cavity, but prescriptions that do not appear to be related to these treatment sites should raise questions. Likewise, APN's practicing in a specialty such as pediatrics or geriatrics should raise red flags if they appear to be prescribing outside the scope of their practice. If you have concerns, ask questions! Your questions are often the last line of defense before harm can come to the patient. Then try and document that you asked the question. In most of our experiences, prescribers welcome the opportunity to explain what they are doing. O. Transfer of Prescriptions Transfers of prescriptions in Ohio are similar to other states' transfer rules. For controlled substances, the transfer must be between licensed pharmacists. Controlled substance prescriptions can only be transferred one time, unless pursuant to a shared, real-time, online database. You still have to write VOID on the face of the original prescription, unless using a Board-approved alternate record-keeping system. You can transfer by faxing an original prescription to another pharmacy, but still must comply with the other sections of this rule. You can even now transfer prescriptions that you never filled, if certain conditions are met pursuant to section E below. This rule went through some changes in 2007, and now states: OAC Transfer of Prescriptions (A) A pharmacist may transfer a copy of a prescription; a pharmacist may refill a copy of a prescription; such actions must be in accordance with the following: (1) Copies of prescriptions shall be transferred only between pharmacists except as provided in paragraph (G) of this rule; copies of prescriptions for controlled substances pursuant to sections , , and of the Revised Code shall be communicated directly Pharmacy Jurisprudence, L.L.C This program contains the intellectual property of Pharmacy Jurisprudence, L.L.C. Unauthorized use is strictly prohibited. 13

14 between two pharmacists and shall be transferred only one time. However, pharmacies electronically sharing a real time, online database may transfer a controlled substance prescription up to the maximum number of refills permitted by law and the prescriber's authorization pursuant to paragraph (A)(4) of this rule. (2) The copy transferred shall be an exact duplicate of the original prescription except that it shall also include: (a) Serial prescription number assigned to the prescription; (b) Name and address (and "D.E.A." number for controlled substance prescriptions) of the pharmacy transferring the copy; (c) Date of issuance of the prescription; (d) Date of original dispensing of the prescription; (e) Original number of refills; (f) Date of last refill; (g) Number of valid refills remaining; and (h) The full name of the transferring pharmacist. (3) Copies transferred for nonrefillable prescriptions shall be marked on the face of the prescription or orally noted by the transferring pharmacist "For Information Purposes Only" and are not valid prescriptions for the dispensing of drugs. (4) The pharmacist transferring a copy of a prescription must: (a) Cancel the original prescription by writing the word "void" on the face of the prescription in such a way as to avoid destroying any of the original information contained on the prescription; (b) Record on the reverse side of the original written prescription: (i) Date of transfer; (ii) His/her signature; and (iii) When transferring an oral prescription, the name and address (and "D.E.A." number for controlled substance prescriptions) of, and full name of the pharmacist at, the receiving pharmacy. (c) Except, if an alternate record keeping system is being used pursuant to rule of the Administrative Code, copies of prescriptions may be transferred by a pharmacist if the prescription record in the system is invalidated to prevent further dispensing at the original site. The prescription record in the system must contain the date of transfer, name of pharmacist making transfer, and the name and address of the pharmacy receiving the copy. Also, original written prescriptions for controlled substances must be canceled as required in paragraphs (A)(4)(a) and (A)(4)(b) of this rule. (5) The pharmacist receiving a copy of a prescription must: (a) Exercise reasonable diligence to determine validity of the copy; (b) Reduce an oral prescription to writing by recording all of the information transferred (must include all information required in paragraph (A)(2) of this rule) and write the word "transfer" on the face of the prescription; (c) Record date of transfer on the face of the prescription. (B) A prescription copy may be transferred between two pharmacies if the two pharmacies are accessing the same prescription records in a centralized database or pharmacy computers linked in any other manner. The computerized systems must satisfy all information requirements of paragraphs (A)(2) and (A)(4)(c) of this rule. This shall include invalidation of the prescription record in the system to prevent further dispensing at the original site and, if a controlled substance prescription, the canceling of the original written prescription as required in paragraphs (A)(4)(a) and (A)(4)(b) of this rule. A system must be in place that will allow only authorized access to these computerized prescription records by a pharmacist and indicate on the prescription record when and by whom such access was made. Pharmacy Jurisprudence, L.L.C This program contains the intellectual property of Pharmacy Jurisprudence, L.L.C. Unauthorized use is strictly prohibited. 14

15 (C) A prescription copy may be transferred between two pharmacists by the use of a facsimile machine. This facsimile may be considered to be a copy of a prescription if all information requirements of paragraph (A) of this rule, including invalidation of the original prescription or computer records, are met. A system must be in place that will show on the facsimile positive identification of the transferring and receiving pharmacists which must become a part of the prescription record. Facsimile copies must be recorded in writing pursuant to section of the Revised Code, or stored in such a manner that will allow retention of the prescription record for three years from the date of the last transaction. (D) Information on a prescription is the property of the patient and is intended to authorize the dispensing of a specific amount of medication for use by the patient. Original copies of prescriptions shall be maintained by pharmacies for the purpose of documenting the dispensing of drugs to a particular patient. (1) In the event that the pharmacy is not able to provide the medication when needed by the patient pursuant to an authorized refill, the pharmacist shall, upon the request of the patient, transfer the prescription information to the pharmacy designated by the patient. (2) No pharmacy shall refuse to transfer information about a previously dispensed prescription to another pharmacy when requested by the patient. Prescription information shall be transferred in accordance with this rule as soon as possible in order to assure that the patient s drug therapy is not interrupted. (E) Prescriptions entered into a computer system but not dispensed may be transferred to another pharmacy if all of the following conditions are met: (1) The complete prescription information has been entered into the computer system; (2) The information is displayed on the patient s profile; (3) There is positive identification, either in the computer system or on the hard copy prescription, of the pharmacist who is responsible for entering the prescription information into the system; (4) The original prescription is filed in accordance with rule of the Administrative Code; (5) All requirements of this rule are met for the transfer of the prescription. (F) Transfer of prescription information between two pharmacies which are accessing the same real time, online database pursuant to the operation of a board approved central filling operation shall not be considered a prescription copy and, therefore, is not subject to the requirements of this rule. (G) A licensed pharmacy intern may send or receive copies of prescriptions pursuant to the following: (1) The pharmacist on duty who is supervising the activity of the intern will determine if the intern is competent to send or receive a prescription copy. (2) The pharmacist on duty who is supervising the activity of the intern is responsible for the accuracy of a prescription copy that is sent or received by an intern. (3) The supervising pharmacist must be immediately available to answer questions or discuss the prescription copy that is sent or received by an intern. (4) The intern may not send or receive a prescription copy for a controlled substance. (5) The pharmacist or intern receiving a prescription copy from an intern must document the full names of the sending intern and his/her supervising pharmacist. The receiving intern shall immediately reduce the prescription copy to writing and shall review the prescription with the supervising pharmacist. Prior to dispensing, positive identification of the intern and the supervising pharmacist shall be made on the prescription to identify the responsibility for the receipt of the copy. (6) The pharmacist or intern sending a prescription copy to an intern must document the full names of the receiving intern and his/her supervising pharmacist. There must be Pharmacy Jurisprudence, L.L.C This program contains the intellectual property of Pharmacy Jurisprudence, L.L.C. Unauthorized use is strictly prohibited. 15