TEXAS PHARMACY LAW AND RULES UPDATE FOR COMMUNITY PHARMACIES JULIE STRICKLAND, PHARMD

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1 TEXAS PHARMACY LAW AND RULES UPDATE FOR COMMUNITY PHARMACIES JULIE STRICKLAND, PHARMD

2 TEXAS PHARMACY LAW AND RULES UPDATE FOR COMMUNITY PHARMACIES ACTIVITY DESCRIPTION For renewals after January 1, 2015, pharmacists and pharmacy technicians licensed in the state of Texas are now required to obtain one (1) accredited hour of continuing education per renewal period related to Texas pharmacy laws or rules. This monograph explains the adopted rules from the November 28, 2014 Texas State Board of Pharmacy Board meeting and the resulting changes to the Texas Administrative Code Title 22 Examining Boards Part 15 Texas State Board of Pharmacy affecting community pharmacies (class A). At the time of initial publication, this content represents the most recently adopted and publicized edition of the Texas Register. Information contained in this monograph may change depending on future updates to the rules adopted by the Texas State Board of Pharmacy. This knowledge based activity is an ACPE accredited law activity that will fulfill the requirement for one (1) credit hour of Texas Pharmacy Law/Rules for Texas pharmacists and pharmacy technicians. TARGET AUDIENCE The target audience for this activity is pharmacists and pharmacy technicians in hospital, community, and retail pharmacy settings. LEARNING OBJECTIVES After completing this activity, the pharmacist and pharmacy technician will be able to: Identify rule changes for community pharmacies (class A) that have occurred following the November 28, 2014 Texas State Board of Pharmacy meeting. Describe how pharmacy personnel may be affected by the adoption of these new rules. 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&t Credits: 1.0 contact hour (0.1 CEU) Release Date: August 5, 2015 Offline Date: August 4, 2018 ACPE Expiration Date: August 4, 2018 ACTIVITY TYPE Knowledge-Based Home Study Monograph FINANCIAL SUPPORT BY Pharmaceutical Education Consultants, Inc. 1

3 ABOUT THE AUTHOR Julie Strickland is a PharmD graduate of the University of South Carolina College of Pharmacy. She has experience in both chain and independent pharmacy practice, including ownership, with specific interests in patient safety and promoting positive patient outcomes. She now serves in Conway, SC as the Director of Continuing Education here at PharmCon. Julie Strickland, PharmD Director of Continuing Education, PharmCon 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. Julie Strickland 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 Introduction For renewals after January 1, 2015, pharmacists and pharmacy technicians licensed in the state of Texas are now required to obtain one (1) accredited hour of continuing education per renewal period related to Texas pharmacy laws or rules. This monograph explains the adopted rules from the November 28, 2014 Texas State Board of Pharmacy Board meeting and the resulting changes to the Texas Administrative Code Title 22 Examining Boards Part 15 Texas State Board of Pharmacy affecting community pharmacies (class A). At the time of initial publication, this content represents the most recently adopted and publicized edition of the Texas Register. Information contained in this monograph may change depending on future updates to the rules adopted by the Texas State Board of Pharmacy. This knowledge based activity is an ACPE accredited law activity that will fulfill the requirement for one (1) credit hour of Texas Pharmacy Law/Rules for Texas pharmacists and pharmacy technicians. As a general rule, keep in mind that when there is a discrepancy between federal and state laws/rules, always abide by the more stringent law/rule. Under most circumstances state laws and rules will be the most stringent, because they are typically designed with federal laws in mind. Amendment to a Definition: The amendments to adopt the definition of a new prescription drug order. New prescription drug order a prescription drug order that has not been dispensed to the patient in the same strength and dosage form by this pharmacy within the last year. So what has changed regarding definitions? Language referring to transferred prescriptions and discharge prescriptions was removed from the definition of a new prescription drug order to simplify the definition. Prescriptions transferred from another pharmacy and discharge prescription drug orders are no longer automatically considered a new prescription drug order. Discussion: According to the definition, there are several factors to consider when determining whether a prescription drug order is new. The drug strength is the first factor. Even if the drug is the same, a prescription for a different strength falls under the category of a new prescription drug order. The second factor to consider is the dosage form that the patient receives for the medication. If a medication with the same dosage has recently been dispensed in a liquid form and now the prescription is written for tablets, the prescription is considered a new prescription drug order because the dosage form has changed. The length of time since the last dispensing is the third factor. Any drug dispensed, even if the same strength and dosage form, 3

5 is a new prescription if it has been longer than one (1) year since the patient has received the medication. The last factor to consider is where the medication was last dispensed. The prescription is considered a new prescription drug order if the patient has never received the medication at your pharmacy, even if the patient has received an identical prescription recently from another pharmacy. For clarification, transferred and discharge prescriptions still may be considered new prescription drug orders even though specific language referring to them was removed from the rules. Just think of the factors to consider when determining if a prescription is a new prescription drug order. If the medication being transferred into your pharmacy or the discharge prescription presented to your pharmacy meets any of the criteria of a new prescription drug order (different strength, dosage form, or has been over a year since your pharmacy has dispensed the drug to this patient), then a transferred or discharge prescription is still considered new. On the other hand, if a transferred or discharge prescription is for an identical medication (strength and dosage form) to one filled at your pharmacy within the past year, the prescription is NOT considered a new prescription drug order. Why does it matter if a prescription is considered a new prescription drug order? If a prescription meets the definition of a new prescription drug order, a pharmacist is required to appropriately counsel and document counseling when dispensing the new prescription for the first time. While we often see the need to counsel patients when they receive a new medication for the first time, we often overlook the importance of counseling when the strength of a current medication or the dosage form of a current medication changes. The reality is, many side effects are dose and dosage form related. So changing a dosage or dosage form may mean unexpected side effects. For example, when a patient is prescribed an increase in a statin dose, it is very important to counsel the patient regarding potential side effects. While simvastatin 20 mg may not have caused any muscle related problems with the patient, 40 mg may or may not. The point is that proper counseling will prepare the patient for any potential side effects that may result from increasing the dosage of their medication. Scenario 1: LB is a 67 year old male who presents to your pharmacy with a prescription for hydrocodone/acetaminophen 7.5/325 mg for bladder pain. He informs you that has been diagnosed with bladder cancer and he has received his first dose of Bacillus Calmette-Guerin (BCG) following his surgery to remove the cancer cells. While reviewing his prescription profile you see that about two years ago your pharmacy dispensed hydrocodone/acetaminophen 5/325 mg to LB. Is this prescription considered a new prescription drug order according to the newly adopted definition of a new prescription drug order? 4

6 Continuation of Scenario 1: LB also asks you to transfer his prescription for his nausea medication, ondansetron (Zofran) 4mg, from a pharmacy in the neighboring town. Your pharmacy dispensed ondansetron (Zofran) 4mg to LB six months ago, but has no refills left on that prescription. Is this prescription considered a new prescription drug order according to the newly adopted definition of a new prescription drug order? Amendments to Operational Standards: The amendments to adopt the patient counseling requirements allowing written information about a medication to be provided to patients electronically, eliminate the requirement that the pharmacy have a patient prescription drug information reference text or leaflets available for patients, eliminate the requirement that a patient is offered information about refilled prescriptions, and eliminate the sign regarding the availability of a pharmacist to ask questions. So what has changed regarding operational standards? While the amendments made to the operational standards are straightforward, they deserve a moment in the spotlight to acknowledge the changes. To reiterate; the following amendments have been made: drug information to further support oral patient counseling may be provided to patients in a written or electronic form (such as ). pharmacies are no longer required to provide prescription drug information reference text or leaflets for patients. pharmacy staff is no longer required to offer the patient information about refilled prescriptions. the pharmacy is no longer required to post a sign regarding the availability of a pharmacist to ask questions. Discussion: Recognizing how patients prefer to receive information regarding their medications has played a significant part in the recent amendments to the Texas Register concerning the areas of patient counseling and provision of drug information. Where 15 years ago, we mailed handwritten greeting cards to patients to wish them a happy birthday or send condolences when a loved one passed, now we send e-greetings via or even simply communicate via text messages and social media. While some people may view changes like this as impersonal or even unprofessional, many patients prefer to receive communications, including those regarding drug information, via text or . 5

7 According to the Texas State Board of Pharmacy, patient counseling communication (both oral and written) shall be provided to new and existing patients of a pharmacy with each new prescription drug order. While some patients will still want to receive written information, the amendments make it easier to provide electronic information to patients that prefer electronic methods. The new amendments do not change anything regarding the patient counseling requirement that a pharmacist shall communicate to the patient or the patient s agent, information about the prescription drug or device which in the exercise of the pharmacist s professional judgement the pharmacist deems significant. Depending on the scenario, typical counseling information may include: the name and description of the drug or device the dosage form, dosage, route of administration, and duration of therapy any special directions and precautions for preparation, administration, and use by the patient common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur techniques for self-monitoring of drug therapy proper storage refill information action to be taken in the event of a missed dose This patient counseling requirement should be carried out orally and in person, unless a specific communication barrier prohibits oral communication. The counseling requirement also applies to any prescription drug order, not only new prescription drug orders, any time it is requested by a patient or patient s agent. Documentation of the patient counseling encounter, by recording the initials or identification code of the pharmacist providing the counseling, is required in the prescription dispensing record. This documentation may be kept in any one of four places. Patient counseling documentation can be on the original hard-copy prescription, in the pharmacy s data processing system, in an electronic logbook, or in a hard-copy log. In addition to a pharmacist s oral patient counseling, the rules specify that the communication shall be reinforced with written information relevant to the prescription and provided to the patient or patient s agent. This is the counseling area where the change has occurred. To better meet the needs of the patient, pharmacies are now allowed to provide written information relevant to the prescription to be in an electronic format, such as by . The other amendments made to are also reflective of shifting times and aim to eliminate cumbersome and unnecessary requirements dealing with patient counseling and provision of drug information. The Texas State Board of Pharmacy has removed the requirement of a pharmacy to make available for use by the public a current or updated patient 6

8 prescription drug information reference text or leaflets designed for the patient. In many cases, drug information is readily available from drug manufacturer websites in a language that patients can easily understand and pharmacies already have pharmacists (drug experts!) on hand to answer questions about medications. Therefore, requiring publically available references and leaflets is simply unnecessary. In reality, there are probably very few times in practice that anyone has actually seen a patient ask to use a drug reference. The same goes for requiring a pharmacist to ensure that a patient or patient s agent is offered information about a refilled prescription upon delivery of the refill and posting a sign that states Do you have questions about your prescription? Ask the pharmacist. in both English and Spanish. The patient has already been counseled the first time the medication was dispensed and most pharmacists also make it clear to patients to call or ask any questions that may arise anytime. As we continue to grow in our profession, more and more patients understand that if they have questions about their medications, the pharmacist is ready and willing to take time to help them. It is unnecessary to have a sign posted to express this and it is cumbersome for the patient and pharmacy staff to offer drug information for each refill dispensed. Removal of these requirements not only makes sense, it helps to minimize the amount of unnecessary information that a patient sees and takes in during their pharmacy encounter. Similarly to how pharmacists have to learn to persevere through DUR alert overload, patients could also be affected by the number of signs and information given to them in the short amount of time they are in the pharmacy. When patients leave the pharmacy, we want to ensure that they walk away with pertinent information related to their prescribed medication and they have not been overloaded with irrelevant information. Amendments to Records: The amendments to affect the requirements for transferring prescriptions. So what s changed regarding Records? To bring consistency between the Texas Administrative Code and the Drug Enforcement Administration (DEA) requirements, changes have been made to the Texas Administrative Code affecting the requirements for transferring prescriptions. First, language has been added to the Texas Administrative Code to specify what information must be provided/documented when electronically transferring a prescription. Second, for all transfers, the Texas State Board of Pharmacy has voted to only require the dates and locations of previous refills to be documented when transferring a controlled substance. Also, when transferring a compounded prescription, a pharmacy is required to provide all of the information regarding the compounded preparation including the formula. Lastly, the electronic transfer of multiple or bulk prescription records between two pharmacies is permitted. Discussion concerning prescriptions transferred electronically: 7

9 In order to address what information needs to be documented when transferring a prescription electronically, language has been added to the rules regarding the responsibility of the individual electronically transferring a prescription drug order. This information was previously absent and simply needed to be added so that expectations are clearly stated. Specifically, when transferring a prescription drug order electronically, the transferring individual shall ensure that the following information is provided: the date of the original dispensing and prescription number the number of refills remaining and if a controlled substance, the date(s) and location(s) of previous refills the name, address, and if a controlled substance, the DEA registration number of the transferring pharmacy the name of the individual transferring the prescription if a controlled substance, name, address, and DEA registration number, and prescription number from the pharmacy that originally dispensed the prescription, if different Again, these requirements do not differ from the required documentation for other methods of transferring prescriptions, such as verbal or by fax. Since, the use of electronic transfers is now on the rise, it is important to make sure that all of the pertinent information is transmitted or communicated during the transfer. Discussion regarding documentation of dates and location of previous fills: Both the transferring individual and the individual receiving a transfer have documentation obligations to fulfill every time a prescription is transferred by any method. This documentation can be done in the data processing system or on the prescription itself. Consistency in the chosen place of documentation is expected and almost all data processing systems have built in areas to store and display transfer information with the prescription record. Specifically the Texas State Board of Pharmacy has adopted the stand that when transferring prescriptions, the date and location of previous fills only needs to be documented if the transfer is a controlled substance. Non-controlled substances may be transferred without documenting this information. As a review, the following two paragraphs briefly describes the documentation requirements of both the transferring individual and the individual receiving the transfer. For the transfer, individual documentation includes voiding the prescription in the data processing system (or writing void on the face of the prescription), recording the name and address of the pharmacy, name of the receiving individual, the date of the transfer and name of the transferring individual, and if for a controlled substance, the DEA registration number of the pharmacy to which it was transferred. Along with these requirements, the transferring individual now has guidance to provide the appropriate information regarding electronically transferred prescriptions. 8

10 The individual receiving the transferred prescription is responsible for ensuring that they receive all of the information that the transferring individual provides. This includes also indicating that the prescription is a transfer in the data processing system (or writing it on the prescription), reducing the prescription to writing and also including the issue (original) date of the prescription, the prescription number from the transferring pharmacy, the original number of refills on the original prescription drug order, the original date of dispensing, the number of valid refills remaining, the name and address of the pharmacy that originally filled the prescription, and if a controlled substance, the date(s) and location(s) of previous refills. Scenario 2: WD, a local truck driver, requests that you transfer his cholesterol medicine and his medication to help him stay awake from another pharmacy. When the transfer call is made the receiving pharmacist reduces the information to writing. Transfer In Wesley Donovan Main Street, Madeup TX, Lipitor (atorvastatin) 40 mg once daily at bedtime #90 90 remaining Original info: Issue date: 10/28/14 Rx #: refills 1 st fill: 10/28/14- Healthy Life Pharmacy Dr. Mark Prescribalot 12 University Blvd. Madeup TX, Provigil (modafinil) 200 mg once daily in the morning #30 (thirty) 30 remaining Issue date: 5/15/15 Rx #: refills 1 st fill: 5/20/15 Healthy Life Pharmacy DL nd fill: 6/20/15 Healthy Life Pharmacy Dr. Jennifer Waley AW University Blvd. Madeup TX, Pharmacy info: Healthy Life Pharmacy 8934 Breeze Drive, Madeup TX, RX4U Received from: Heather Brown Received by: Julie Strickland Verbal repeat confirmed JBS 7/21/15 9

11 Notice how the amendments affect the documentation that must take place. Circled above are the dates and locations of all previous fills of the controlled substance (modafinil), as well as the DEA number of the pharmacy where the prescription was filled and the DEA number of the prescriber. Also note that it was not necessary to provide the date and location of all previous fills of the non-controlled substance (atorvastatin). Discussion regarding transfer of compounded prescriptions: It can only be assumed that the reason new rules are added is because a situation or multiple situations have arisen to necessitate a board opinion on a particular matter. As pharmacies face growing competition and declining reimbursement rates, retaining business (in the form of prescriptions and even secret formulations for compounds) can be the difference between a thriving pharmacy and a folding business. Although pharmacies (and pharmacists) must find ways to retain business and provide stand out services, they are not allowed to refuse to transfer medications, even if they are compounds. The new rules clearly outline the Texas State Board of Pharmacy s view on the matter. The newly adopted rules concerning transferring compounded prescriptions builds on the rule that an individual may not refuse to transfer original prescription information to another individual who is acting on behalf of a patient. The existing rule also states that the transfer of original prescription information must be done in a timely manner. The new part of the rule is specific to compounded prescriptions. It states that when transferring a compounded prescription, a pharmacy is required to provide all of the information regarding the compounded preparation including the formula unless the formula is patented or otherwise protected, in which case, the transferring pharmacy shall, at a minimum, provide the quantity or strength of all of the active ingredients of the compounded preparation. Scenario 3: The intern at your pharmacy calls to transfer a compounded hormone cream from another pharmacy. The other pharmacy provides her with the name of the compound, Dr. Prescribalot s hot flash cream. The transferring individual seems hesitant to provide any more information about the compounded drug other than the name and directions for use. In the event that Dr. Prescribalot s hot flash cream is a patented product and the pharmacy is not required to disclose the formula, what must they still provide, at a minimum, regarding the compounded drug? What is the best way to obtain the information regarding the compound without dealing with the pharmacy? 10

12 Discussion concerning the electronic transfer of multiple or bulk prescription records: The new rule now allows the electronic transfer of multiple or bulk prescription records between two pharmacies provided that the transferring pharmacy and the receiving pharmacy maintains a record of the transfer in accordance to the rules pertaining to electronically transferring prescriptions (see the section titled Discussion concerning prescriptions transferred electronically ). The new rule also specifies that in the event that the patient or the patient s agent is unaware of the transfer of the prescription drug order record, the transferring pharmacy must notify the patient or patient s agent of the transfer and must provide the patient or patient s agent with the telephone number of the pharmacy receiving the multiple or bulk prescription drug order records. While it may seem efficient to electronically transfer multiple prescriptions, it is important to remember that proper transfer documentation is required for each prescription transferred electronically. Scenario 4: A pharmacy owner that participates in both traditional prescriptions and compounded prescriptions has decided to discontinue his compounding services do to the small volume of compounds and high cost of maintaining compounding accreditation and software. He decides that the best solution would be to electronically transfer his compound prescriptions to a compounding pharmacy nearby. Because the transfer of these compounded prescriptions was not requested by the patients or agents of the patients, what are the actions that the pharmacy owner must take? 11

13 References: 1. Texas State Board of Pharmacy. (2014). Texas Register. (22 TAC , , ). Retrieved July 7, 2015, from NING%20BOARDS.html#45 Texas State Board of Pharmacy. (2014). Texas Register. (22 TAC , , ). Retrieved July 7, 2015, from 12

14 ACTIVITY TEST 1. When practicing the profession of pharmacy, the most stringent rule should be followed if there is a discrepancy between federal law and state law/rules. a. True b. False 2. In scenario 1, is LB s prescription considered a new prescription drug order according to the newly adopted definition of a new prescription drug order? a. It is a new prescription drug order because it is a different strength than previously prescribed. b. It is a new prescription drug order because it is a new written prescription. c. It is not a new prescription because LB has had the same ingredients before. d. It is not a new prescription because he shows you a bottle of the same medicine filled two months ago at another pharmacy. 3. In scenario 1, is this prescription considered a new prescription drug order according to the newly adopted definition of a new prescription drug order? a. It is a new prescription drug order because it is a transfer into your pharmacy b. It is a new prescription drug order because he can tell you all about the drug and side effects c. It is not a new prescription because LB has had the same drug and drug strength at your pharmacy within the previous year d. It is not a new prescription because he shows you a bottle of the same medicine filled two months ago at another pharmacy 4. AJ walks into the pharmacy and sees you removing your sign that states, Do you have questions about your prescription? Ask the pharmacist. He appears concerned and inquires as to whether removal of the sign means that a pharmacist will no longer be available to answer medication questions. What is the best choice for your response to AJ? a. We are simply too busy to address every question that walks though the door, the pharmacist will be glad to answer your questions over the phone. b. We still answer questions about new prescriptions, but not about refills. c. Even though we are no longer required to post a sign, a pharmacist is certainly available during business hours to answer any questions. d. We now answer requests for information about medicine by sending s rather than offering counseling information in person. 13

15 5. Which statement is not correct according to the newly adopted rules? a. Drug information to further support oral patient counseling may be provided to patients on social media Methyl ER b. Pharmacies are no longer required to provide prescription drug information reference text or leaflets for patients c. Pharmacy staff is no longer required to offer the patient information about refilled prescriptions. d. The pharmacy is no longer required to post a sign regarding the availability of a pharmacist to ask questions. 6. When electronically transferring a prescription for losartan (Cozaar), which of the following information is not required to be provided to the receiving pharmacy? a. The date of the original dispensing, prescription number, and number of refills remaining b. The name of the individual transferring the prescription c. The name and address of the pharmacy d. The DEA number of the transferring pharmacy 7. In scenario 2, because WD is on the road so much, his atorvastatin had already been filled at three different pharmacies. Because of the new amendment, it is required that the individual receiving the prescription for his atorvastatin document the date of the first fill and name and address of the original pharmacy filling the prescription, but not the pharmacies and dates of subsequent refills. a. True b. False 8. In scenario 3, in the event that Dr. Prescribalot s hot flash cream is a patented product and the pharmacy is not required to disclose the formula, what must they still provide, at a minimum, regarding the compounded drug?? a. The overall strength of the compound b. The phone number to the patent company for verification of the patent c. A phone number to inform the patient that the prescription cannot be transferred d. The quantity or strength of all the active ingredients of the compounded preparation 14

16 9. In scenario 3, what is the best way to obtain the information regarding the compound without dealing with the pharmacy a. Call the patient and ask them to look at their label from the last fill b. Call the prescriber to directly request the formula for the prescription c. Inform the patient that you will not be able to transfer the prescription d. Look for the formula on the internet 10. In scenario 4, because the transfer of these compounded prescriptions was not requested by the patients or agents of the patients, what is the best answer choice for the actions that the pharmacy owner must take?? a. Nothing. It is the responsibility of the pharmacy receiving the prescriptions to notify the patient b. Pursue compensation for giving another pharmacy extra prescriptions. c. Properly document the required information pertaining to electronically transferring each prescription. d. Properly required information pertaining to electronically transferring each prescription, as well as notify each patient (or patient s agent) and provide the telephone number of the receiving pharmacy Please submit your final responses on freece.com. Thank you. 15