Pharmacy compoundingandohiolaw4 18-2013
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Pharmacy compoundingandohiolaw4 18-2013 Pharmacy compoundingandohiolaw4 18-2013 Document Transcript

  • Page 1 of 12Pharmacy Compounding and Ohio Law12Objectives3After completing this lesson, the pharmacist will be able to:41. Differentiate between five different types of compounding.52. Describe legal requirements for preparing non-sterile Compounded Drugs for Administration6to Patients by Prescribers.73. Describe legal requirements for preparing sterile Compounded Drugs for Administration to8Patients by Prescribers.94. Discuss limits of preparing batches of compounded drugs.105. Discuss using a prescriber’s location as a pick-up-station.1112Introduction13The matter of regulating compounding pharmacies (or compounding by pharmacies) and14manufacturers recently gained renewed attention when an operation in Massachusetts allegedly15prepared and distributed corticosteroids that were administered to patients who subsequently16developed serious fungal infections. Some of these patients died. According to reports from the17Centers for Disease Control and Prevention, the New England Compounding Center and its sister18company (Ameridose) were involved in the production and eventual recall of19methylprednisolone acetate (MPA) and other products in September 2012. Centers for Disease20Control and Prevention. CDC responds to multistate outbreak of fungal meningitis and other21infections. http://m.cdc.gov/en/HealthSafetyTopics/DiseasesConditions/Meningitis/current-22situation Accessed November 10, 2012. The methylprednisolone was particularly prone to23sterility concerns because it was produced without antimicrobial preservatives, a common24practice for medications injected into the fluid of the central nervous system.2526The law regulating compounding includes a series of state and federal regulatory schemes.2728
  • Page 2 of 12Compounding Defined1Ohio state law defines compounding in ORC 4729.01(C) as one or more of five activities.2“Compounding” means the preparation, mixing, assembling, packaging, and labeling of one or3more drugs in any of the following circumstances:4 Pursuant to a prescription issued by a licensed health professional authorized to prescribe5drugs; [ORC 4729.01(C) (1)]6 Pursuant to the modification of a prescription made in accordance with a consult7agreement; [ORC 4729.01(C) (2)]8 As an incident to research, teaching activities, or chemical analysis; [ORC 4729.01(C)9(3)]10 In anticipation of orders for drugs pursuant to prescriptions, based on routine, regularly11observed dispensing patterns; [ORC 4729.01(C) (4)]12 Pursuant to a request made by a licensed health professional authorized to prescribe drugs13for a drug that is to be used by the professional for the purpose of direct administration to14patients in the course of the professional’s practice, if all of the following apply: [ORC154729.01(C) (5)]16(a) At the time the request is made, the drug is not commercially available regardless of17the reason that the drug is not available, including the absence of a manufacturer for the18drug or the lack of a readily available supply of the drug from a manufacturer.19(b) A limited quantity of the drug is compounded and provided to the professional.20(c) The drug is compounded and provided to the professional as an occasional exception21to the normal practice of dispensing drugs pursuant to patient-specific prescriptions.2223Type of Compounding ORC Section DefinedTraditional Prescription ORC 4729.01(C) (1)Consult agreement ORC 4729.01(C) (2)Research ORC 4729.01(C) (3)Batch ORC 4729.01(C) (4)Prescriber for Direct Administration ORC 4729.01(C) (5)24
  • Page 3 of 12Compounded Drugs for Administration to Patients by Prescribers OAC 4729-9-251In addition to complying with ORC 4729.01 (C) (5) as discussed above, compounded drugs must2also comply with OAC 4729-5-25 and OAC 4729-9-25. The Board does not want to see3pharmacies compounding drugs for administration to patients by prescribers as a major type of4routine compounding practice. The pharmacy is limited to five percent (5%) of total5compounding sales, within a twelve (12) month period. See OAC 4729-9-25 (A) (1).67Which compounded drugs may be provided by a pharmacy to the prescriber? The pharmacy8shall only provide those compounded drugs that are not commercially available to a prescriber9which are needed: See OAC 4729-9-25 (A) (2).10 To treat an emergency situation; See OAC 4729-9-25 (A) (2) (a).11 For an unanticipated procedure for which a time delay would negatively affect a patient12outcome; See OAC 4729-9-25 (A) (2) (b).13 For diagnostic purposes. See OAC 4729-9-25 (A) (2) (c).1415Board rules also limit the pharmacy to supplying an amount which will last the prescriber only16seventy-two (72) hours – about three days. See OAC 4729-9-25 (B). The prescriber also may17not have on hand more than a supply that will last the prescriber seventy-two (72) hours. The18rule seems to place the burden on the prescriber for determining the amount that will last the19prescriber for seventy-two (72) hours, since the rule reads that the amount “shall be determined20by previous administration patters provided by a prescriber to the pharmacist.” See OAC 4729-219-25 (B). Indeed, it would be difficult if not impossible for a pharmacist alone to know or22accurately estimate this amount.2324The seventy-two (72) hour supply limitation does not apply to the following supplied to a25prescriber, meaning the following two categories of compounded preparations may be provided26even if the supply may last more than seventy-two (72) hours:27 Small amounts sixty (60) grams or sixty (60) milliliters of non-sterile topical28preparations. See OAC 4729-9-25 (B) (1).29 Non-sterile preparations intended to treat individuals in the event of an emergency. See30OAC 4729-9-25 (B) (2).31
  • Page 4 of 121Pharmacies may not sell a compounded drug to another pharmacy or wholesaler. See OAC24729-9-25 (C). “Sale” and “sell” include delivery, transfer, barter, exchange, or gift, or offer3therefor, and each such transaction made by any person, whether as principal proprietor, agent,4or employee. ORC 4729.01 (J). A prescriber may only administer compounded drugs directly to5patients of the prescriber. Prescribers are not permitted to do any of the four acts: OAC 4729-9-625 (D)7 Dispense a compounded drug to a patient – administration is allowed. See OAC 4729-9-825 (D) (1)9 Sell a compounded drug to another prescriber. See OAC 4729-9-25 (D) (2)10 Sell a compounded drug to a pharmacy. See OAC 4729-9-25 (D) (3)11 Return a compounded drug to the supplying pharmacy. See OAC 4729-9-25 (D) (4)1213For compounded drugs provided to prescribers for patients, beyond-use dates are required. See14OAC 4729-9-25 (E). For non-sterile compounded drugs, “testing pursuant to acceptable practice15standards” is required. Two types of standards are provided:16 published peer reviewed pharmaceutical literature that have been critically reviewed by17unbiased independent experts. See OAC 4729-9-25 (E) (1)18 current edition of an official compendium, such as the United States Pharmacopoeia19(USP) or National Formulary (NF). See OAC 4729-9-25 (E) (1)20Beyond-use dates for sterile compounded drugs must be determined by the compounding21pharmacy through one of the two following types of standards:22 drug product testing pursuant to acceptable practice standards. See OAC 4729-9-25 (E)23(2)24 United States Pharmacopoeia (USP) or National Formulary (NF) standards. OAC 4729-259-25 (E) (2)26The standards account for level of risk of contamination by antimicrobials.27The United States Pharmacopoeia (USP) or National Formulary (NF) standards are further28refined to include low, medium, and high risk level compounded drug preparations as follows:29 Low Risk - beyond use date of not more than forty-eight (48) hours when stored at30controlled room temperature at twenty to twenty-five degrees Celsius, or fourteen (14)31
  • Page 5 of 12days when refrigerated at two to eight degrees Celsius, or forty-five days in solid frozen1state at minus twenty-five to minus ten degrees Celsius. See OAC 4729-9-25 (E) (2) (a).2An example of low risk preparations includes using sterile syringes with sterile needles3to conduct single sterile dose transfers from the manufacturer’s original packaging such4as bottles, bags and vials in an ISO Class 5 cleanroom. An ISO class 5 cleanroom5contains at most 105(or 100,000) particles per cubic meter. See OAC 4729-19-01 (A) (2).6To give perspective, the ambient air outside in a typical urban environment contains735,000,000 particles per cubic meter.8 Medium Risk - beyond use date of not more than thirty (30) hours when stored at9controlled room temperature at twenty to twenty-five degrees Celsius, or nine (9) days10when refrigerated at two to eight degrees Celsius, or forty-five days in solid frozen state11at minus twenty-five to minus ten degrees Celsius. See OAC 4729-9-25 (E) (2) (b). An12example of medium risk preparations includes preparation of Total Parenteral Nutrition13(TPN) solutions using automated or manual compounders.14 High Risk - beyond use date of not more than twenty-four (24) hours when stored at15controlled room temperature at twenty to twenty-five degrees Celsius, or three (3) days16when refrigerated at two to eight degrees Celsius, or forty-five days in solid frozen state17at minus twenty-five to minus ten degrees Celsius. See OAC 4729-9-25 (E) (2) (c). An18example of high risk preparations includes dissolving non-sterile bulk drug powders for19solution preparation that will be terminally sterilized.20Labeling a Compound Drug for Administration by Prescriber OAC 4729-9-25 (F) (1-10)21The labeling of a compounded drug preparation must contain the following:22(1) The statement “For direct patient administration only” displayed prominently;23(2) The statement “Not for resale” displayed prominently;24(3) Proper storage conditions;25(4) Beyond use dates pursuant to OAC 4729-9-25 (E);26(5) The name(s) of the active and inactive ingredients;27(6) The amount or percentage of active drug ingredients;28(7) The quantity of compounded drug provided;29(8) The route of administration;30
  • Page 6 of 12(9) The pharmacy name, address, and telephone number;1(10) The pharmacy control number assigned to the compounded drug preparation.23For a container that is too small, it is permissible for the labeling to omit the quantity of drug4provided [OAC 4729-9-25 (F) (7)] and the notation “for direct patient administration only”5[OAC 4729-9-25 (F) (1)]. In all cases, a complete label meeting the requirements of paragraph6(F) of this rule must be applied to the outside container in which such compounded preparation is7supplied. OAC 4729-9-25 (G).89The sale of a compounded drug preparation to a prescriber is considered a wholesale sale as10defined in section 4729.01 of the Revised Code. OAC 4729-9-25 (H). A pharmacy is required to11follow record keeping requirements for wholesale sales. See OAC 4729-9-16 (H). The types of12records include:13 source of the drugs, including the name and principle address of the seller or transferor,14and the address of the location from which the drugs were shipped. OAC 4729-9-16 (H)15(1) (a)16 identity and quantity of the drugs received and distributed or disposed of. OAC 4729-9-1716 (H) (1) (b)18 dates of receipt and distribution of the drugs. OAC 4729-9-16 (H) (1) (c)19 system of records and procedures which prevent the sale or other distribution of20dangerous drugs to any person not authorized by division (B) of section 4729.51 of the21Revised Code. OAC 4729-9-16 (H) (1) (d)22These records must be retained for at least three years. OAC 4729-9-16 (H) (2)2324Drugs Compounded in a Pharmacy for Dispensing to Patients OAC 4729-9-2125Most community pharmacists are primarily concerned with compounding relatively small26amounts of non-sterile preparations, for specific patients, having a prescription from a physician.27These are typically oral or topical preparations provided directly to patients, not physicians.2829For all compounded prescriptions, the pharmacist must:30 Inspect and approve the compounding process. OAC 4729-9-21 (C) (1)31
  • Page 7 of 12 Perform the final check of the finished product. OAC 4729-9-21 (C) (2)1 Maintain all compounding records. OAC 4729-9-21 (D) (1)2 Ensure the proper maintenance, cleanliness, and use of equipment. OAC 4729-9-21 (D)3(2)45Personnel engaged in the compounding of drugs need to wear clean appropriate clothing – for6protection and to prevent contamination. See OAC 4729-9-21 (E). The prescription must be7compounded and dispensed only pursuant to a specific order for an individual patient issued by a8prescriber. A limited quantity may be compounded in anticipation of prescription drug orders9based on routine, regularly observed prescribing patterns. See OAC 4729-9-21 (F). Containers10for compounded prescriptions dispensed must be labeled in the same matter as any other11prescription medication dispensed. See OAC 4729-9-21 (G) and OAC 4729-5-16 [labeling of12drugs dispensed on prescription].1314The pharmacist may need a substantial amount of chemicals and time to prepare a batch of some15compounded medications. Likewise, the equipment and compounding process involved may16dictate that compounding small quantities are simply impractical. For example, if a pharmacist17wants to prepare medicated suppositories, a melt-able solid medium must be heated and melted18in a receptacle. Active ingredients must be obtained, weighed, and added to the melted medium.19The melted mixture must be poured into a suppository mold and allowed to cool. The cooled20product must be removed from the mold. The mold and other equipment must be cleaned and21stored. All this takes time. Suppose the mold may be adapted to form no less than one hundred22(100) units at a time. Does the pharmacist have to postpone compounding activities until one or23more prescriptions are in hand for exactly one hundred suppositories – and then compound only24exactly one hundred suppositories?2526Fortunately, the answer is “no.” A limited quantity may be compounded in anticipation of27prescription drug orders based on routine, regularly observed prescribing patterns. See OAC284729-9-21 (F). If a batch is made, the portion dispensed to patients and the stored portion must29be labeled. See OAC 4729-9-21 (H). Labels for the stored medication must contain at least the30following information:31
  • Page 8 of 12 The name, strength, and quantity of each drug used in the compounded prescription.1OAC 4729-9-21 (H) (1)2 The identification of the repackager by name or by the final seven digits of its terminal3distributor of dangerous drugs license number. OAC 4729-9-21 (H) (2)4 Pharmacy control number. OAC 4729-9-21 (H) (3)5 The pharmacy’s expiration date or beyond use date. OAC 4729-9-21 (H) (4)67Using a Prescriber’s Location as a Pick-Up-Station See OAC 4729-5-108Suppose the pharmacist wants to compound a drug for a patient that is not going to be picked up9at the pharmacy. It is also not going to be administered to a patient by the prescriber. Can it be10delivered to a prescriber’s office and picked up by a patient there? Yes. See OAC 4729-5-10.11To offer this service, a request form (available on the Board website at12http://pharmacy.ohio.gov/) must be completed and approved by the Board. Basically, there are13five requirements for such a pick-up station:14 The site is appropriately licensed pursuant to Chapter 4729 of the Revised Code. See15OAC 4729-5-10 (B) (1).16 The receipt, storage, control, and distribution of prescriptions or drugs are in the full and17actual charge of a health care professional licensed pursuant to Ohio Revised Code18Chapter 4715 [dentist], 4723 [nurse], 4729 [pharmacist], 4730 [physician assistant], 473119[physician], or 4741 [veterinarian]. See OAC 4729-5-10 (B) (2).20 An appropriate recordkeeping system is in place that will provide accountability for21proper receipt, delivery, and return of all prescription medications. See OAC 4729-5-1022(B) (3).23 There is a documented method in place to ensure compliance with rule 4729-5-22 of the24Administrative Code. See OAC 4729-5-10 (B) (4).25 The state board of pharmacy has approved the site for such activity due to clear and26convincing evidence that delivery of prescription medication directly to the patient would27result in:28o Danger to public health or safety, [See OAC 4729-5-10 (B) (5) (a)] or29o Danger to the patient without increased involvement by a health care professional30in the patient’s drug therapy. [See OAC 4729-5-10 (B) (5) (b)]31
  • Page 9 of 12CPE Quiz1Questions – credit will be provided with correct responses to at least seven questions:21. The labeling of compounded drugs sold to physician for administration to a patient of the3physician must contain name of patient.4a) true5b) false672. Compounding a drug in batches can be done in anticipation of prescriptions:8a) Based on routine prescribing patterns9b) Based on regularly observed patterns10c) Based on buying patterns11d) Both A and B are correct12133. Compounding a drug in a pharmacy for administration to a patient by a prescriber is14permitted when:15a) The drug is commercially available – false16b) The drug is provided as a principal source of income for the pharmacy – false17c) A supply of the drug is not readily available from a manufacturer18d) The drug is provided directly to the patient – false19204. Compounding a drug in a pharmacy for administration to a patient by a prescriber is21permitted when the compounded drug is to be used:22a) To treat an emergency situation.23b) For an unanticipated procedure for which a time delay would negatively affect a patient24outcome.25c) For diagnostic purposes.26d) All of the above2728
  • Page 10 of 125. Compounding a drug in a pharmacy for administration to a patient by a prescriber may be1supplied in an amount that will last more than seventy-two (72) hours when:2a) No more than sixty (60) grams of a non-sterile topical preparation is supplied to the3prescriber.4b) No more than sixty (60) milliliters of a non-sterile topical preparation is supplied to the5prescriber.6c) A non-sterile preparation intended to treat individuals in the event of an emergency is7supplied to the prescriber.8d) All of the above9106. When labeling a compound drug for administration to a patient by a prescriber in a11container that is too small to bear a complete label, the label must still include all but:12a) the statement, “for direct patient administration only”13b) the statement, “not for resale”14c) the route of administration15d) the pharmacy name16177. A pharmacy is required to follow record keeping requirements for wholesale sales,18including sales of a compounded drug preparation to a prescriber, including all except:19a) source of the drugs20b) collection of sales taxes and amounts21c) identity and quantity of the drugs received and distributed or disposed of22d) dates of receipt and distribution of the drugs23248. When acting as a wholesaler, a pharmacy is required to retain records for sales of a25compounded drug preparation to a prescriber for five years.26a) True27b) False2829
  • Page 11 of 129. For all compounded prescriptions, the pharmacist must do all of the following except:1a) Inspect and approve the compounding process2b) Personally perform every step in the compounding process3c) Maintain all compounding records4d) Ensure the proper maintenance, cleanliness, and use of equipment5610. For a limited quantity of drug compounded in anticipation of receiving a prescription,7when a batch is made, the stored portion must be labeled with all but the following:8a) The name, strength, and quantity of each drug used in the compounded prescription.9b) The initials of the pharmacist.10c) Pharmacy control number.11d) The pharmacy’s expiration date or beyond use date.121314
  • Page 12 of 12Lesson number 036-368-13-001-H03 Answer Sheet: Expires April 18, 20151Approved for one contact hour of Ohio Jurisprudence by the Ohio State Board of Pharmacy2Pharmacy Compounding and Ohio Law3Answer Sheet – circle the one best answer4Question Answer Question Answer1 True False 6 A B C D2 A B C D 7 A B C D3 A B C D 8 True False4 A B C D 9 A B C D5 A B C D 10 A B C D       5Please return by mail with check for $20.00 payable to James Lindon at:6Pharmacy Law, 35104 Saddle Creek, Avon, Ohio 44011-4907, 440-333-0011, 419-710-4925 (fax)7You may also send payment via PayPal (account not needed) to JLindon@LindonLaw.com8You may also send credit card number, expiration and CVV to JLindon@LindonLaw.com910Please fax or e-mail [circle one, please] my continuing education certificate to:1112Pharmacist Name ___________________________________1314Street Address _____________________________1516City ________________________ State _________ Zip _______1718E-Mail for CPE Certificate ___________________________________ Fax ______________________1920Phone ___________________________________2122Ohio Pharmacist License Number _____________________2324NABP ID Number _____________________2526After completing this lesson I can achieve the lesson objectives: Yes No27This program was an effective way for me to learn: Yes No28I liked the program’s format: Yes No29This program fostered my mental participation: Yes No30This was a “user-friendly” way for me to learn: Yes No31I could sense some commercialism in this program: Yes No32If yes, please describe: ______________________________________________33The faculty quality was: Great OK Needs to Improve34The learning material quality was: Great OK Needs to Improve35How long did it take to complete this program? _______________________36What other topics would you like to see? ____________________________37Comments welcome: ____________________________________________3839Any views expressed are not necessarily those of the author or Lindon & Lindon, LLC.40Copyright 2013 James Lindon, Lindon & Lindon LLC (may freely copy and distribute, in whole)41