LAW & MORTAR LAW INSTITUTE PHARMACY. Current News & Views. Ohio Northern University. Volume XII, No. 2 May 2010

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1 PHARMACY LAW INSTITUTE LAW & MORTAR Volume XII, No. 2 Current News & Views Intravenous Products Recalled By Becton was the headline of an article appearing in the Tuesday, February 9, 2010 issue of The Wall Street Journal. The article was written by reporter Jonathan D. Rockoff and was about a recall of 7.8 million Q-Syte Luer Access devices that hospitals use to deliver fluids intravenously. The company recalled the device and kits or trays containing the device following unconfirmed reports regarding a death and a serious injury. The recall was classified by FDA as Class I, the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the device would result in serious adverse health consequences or death. FDA s website indicated that the device was recalled since its use could result in air bubbles leaking into the infusion system and into the patient s bloodstream, resulting in an air embolism. FDA s website stated that the Q-Syte Luer Access device is intended for use with other infusion therapy products for the purpose of administering therapies, such as intravenous chemotherapy and the parenteral administration of blood. The WSJ article reported that the device costs less than $2 each and that it is a small, yet important, part of a needleless system developed by the company to reduce needle-stick injuries and to minimize bacterial infections in the blood that result from the catheters typically used. Inside This Issue Current News & Views... page 1 CE Article... page 4 The Business of Health Care: Home Infusion Pharmacies CE Test... page 10 A company spokesman was reported to have said that the problem was due to a manufacturing defect which plagued the production of certain device lots from November 2008 to November Home Care Yields Medicare Bounty is the title of an article appearing on the front page of the Tuesday, April 27, 2010 issue of The Wall Street Journal. The article, written by Barbara Martinez, stated that, Home health care - treating sick patients in their homes rather than paying for costly hospitalizations - is the fastest growing area of the health care industry, aimed at saving billions of dollars every year. The article reported on a study that Medicare payments to home health care companies in recent years raised questions about whether some of the companies were taking advantage of the program s reimbursement system. The analysis of Medicare payments for home therapy visits showed that the number of such visits increased after the program began paying an incentive fee of roughly $2,200 when the number of visits surpassed nine. The director of the chronic-care policy group at the Centers for Medicare and Medicaid Services (CMS) was quoted as saying that the incentive was designed so that home healthcare agencies didn t stint on therapy visits. The article pointed out that the generous Medicare reimbursement policy was one reason that the home health care industry had grown so swiftly since the reimbursement policy was instituted in The reporter stated that the number of home health care agencies had increased by approximately 50% since One of the financial officers of a home (continued on page 2)

2 Page 2 Current News & Views (continued from page 1) health care agency, according to the article, stated that the reimbursement policy had a serious flaw in that the incentive encouraged certain home health care companies to seek out patients who had illnesses that required at least 10 visits. He stated that his home health care agency focused on those patients who had hip and knee problems since they tended to need 10 to 13 therapy visits. Home Healthcare and Fraud. An article posted on the Government Technology website ( on March 19, 2010 discussed the use of biotechnology to prevent fraud regarding home health care provided to disabled and elderly residents in California. The article reported that starting April 1, California will conduct a two-month pilot program using high tech devices designed to capture fingerprints and photos of the 460,000 disabled and elderly patients enrolled in the state s In-Home Supportive Services program. Last year, the California legislature authorized the California Department of Social Services to capture the fingerprints of all the individuals enrolled in the program as well as the fingerprints of the providers. The legislation however did not authorize the department to take pictures of the clients. The department argues that in order to prevent fraud, both the picture and fingerprints are necessary. The department argues that having both a picture and fingerprint to match would provide the state with accurate identification for each recipient of in-home care. Cardiology Group Fights Medicare Pay Cuts by Offering Concierge Services is the title of an article posted on the web by HealthLeaders Media on March 19, Reporter Cheryl Clark stated the following in the article. On January 1, the Centers for Medicare and Medicaid Services reapportioned Part B that was allocated to physician services, reallocating hundreds of millions of dollars from cardiologists to dermatologists, anesthesiologists, ophthalmologists, and primary care doctors. Additionally, CMS eliminated cardiology consult codes, re-categorizing them as patient visits, which are reimbursed at a lower rate. Pacific Heart Institute in Santa Monica, CA is a medical corporation of nine cardiologists. The corporation notified their patients that they are charging patients between $500 and $7500 a year beginning April 1 for special extended access services and same day appointments. Patients can choose one of the following four plans for care. First option: Patients pay no participation fee Second option: called Select, Patient pays $500 a year for priority appointments, warfarin adjustments, defibrillator and pacemaker follow-up, notification of non-urgent lab, and test results Third option: called Premier, Patient pays $1,800 a year, for everything included in the Select option and receives the following additional extended patient services: communication with their doctor, same-day visits during regular office hours, priority lab testing and scheduling of diagnostics, free attendance at speaker seminars on cardiovascular issues, and a dedicated phone line to reach an institute nurse Fourth option: the Concierge plan, Patients who pay $7,500 a year receive those extended patient services included in the Premier plan plus direct 24-hour access to a cardiologist via pager, , text message, plus the patient s PHI cardiologist s personal cell phone, annual personalized cardiovascular wellness screening, night and weekend access to a PHI cardiologist for hospital or emergency services, (regardless of whether he or she is on call), same-day visits with the cardiologist, evening and weekend office appointments and personal calls from the cardiologist. The medical corporation communicated to patients, in the letter notifying them of the four options, that: Medicare and most insurance plans slashed cardiology payments on an unprece-

3 Page 3 dented scale. In 2009, Medicare paid $ for a mid-level new patient evaluation, for which the Institute typically scheduled one hour; the current payment is $ In March, it is scheduled to be cut to $68.78, and These amounts are incompatible with maintaining a viable practice unless ancillary services and the time allotted for office visits are substantially reduced. We feel such reductions would not meet your expectation of comprehensive personalized care. Drug Prices Jumped Last Year, Ahead of Federal Health Overhaul appeared in the Tuesday, April 20, 2010 edition of The Wall Street Journal. The article was based on information provided by Express Scripts, Inc. in its annual drug-trend report for The report is 112 pages in length and is available at Wall Street Journal reporter Anna Wilde Mathews stated that the pharmaceutical manufacturers, Sharply raised prices last year, ahead of increased rebates they must pay to Medicaid and other expenses tied to the federal health overhaul passed last month. The article also reported the following information regarding drug prices: a) prices for brand name pharmaceuticals rose 9.1% in 2009, the biggest increase in at least a decade (7.4% increase in 2008); b) prices for specialty drugs, a category that is largely biotech products, increased 11.5% (9.4% increase in 2008). The article quoted an Eli Lilly spokesman that its pricing policies last year weren t affected by the health bill, and such decisions take into account benefits for patients as well as marketplace conditions and recovery of our R&D costs. The reporter noted that Lilly did caution shareholders that rebates to Medicaid, as well as other provisions in the law, would lower its 2010 revenue by $350 million to $400 million, and 2011 revenue by $600 million to $700 million. Law & Mortar is published quarterly in February, May, August, and November by: The Robertson-Evans Building, Room 225 Ada, Ohio phone fax Subscription price: $40 per year (includes CE quiz processing). Non-subscription price is $15 per issue which includes CE quiz grading fee. The views expressed in this publication are not intended as legal advice and do not reflect the policy of The or. Pharmacists should consult their own attorney when they have specific questions. Franklin Z. Wickham, D.Pharm., M.S., R.Ph., Director

4 Page 4 Continuing Education: Pharmacy Law The Business of Health Care: Home Infusion Pharmacies Goals. This issue of Law & Mortar continues the discussion of the federal and state laws and rules impacting home infusion pharmacies, as well as national standards regarding sterile product compounding. Objectives. At the conclusion of this article, the participant should be able to: 1. outline the evolution of outpatient infusion companies, the services they provide, and staffing; 2. explain the national standards and regulations for sterile products and home infusion pharmacies set by USP and the Ohio Board of Pharmacy; 3. list organizations accrediting compounding pharmacies and other home infusion providers; and 4. explain restricted distribution programs and state regulations for high risk drugs and medical devices. Home Infusion Pharmacies and Pharmacist Care Home infusion pharmacies developed as a new business model when it was no longer economically feasible for hospitals to provide long term therapy for severe infections, cancer chemotherapy, chronic diseases, etc. The federal government implemented the DRG (Diagnostic Related Group) payment system for hospital care in the 1980s which replaced the fee-for-service system for Medicare patients. This system moved patient care for this population from the hospital to outpatient clinics, hospices, ambulatory care centers or into the patient s home. Patients requiring long term treatment with drugs administered parenterally could now be serviced by a home infusion pharmacy. Home infusion pharmacies are closed door pharmacies, not open to the public. Patients are referred to them by physicians, hospital discharge planners, case managers, nursing agencies, or the patient s insurer. Home infusion pharmacists may provide the following professional activities: review of the patient s medication profile upon referral for home infusion therapy; participation with the pharmacy s referral intake team in evaluating whether or not home infusion therapy is appropriate and therapeutically effective; participation in developing and coordinating the overall care plan; compounding and labeling of the sterile product prescription; selection of appropriate supplies for drug administration; coordination of packing of the medications and supplies for delivery; ensuring that all required documentation is in accordance with federal and state laws/regulations; selection of the appropriate infusion pump and programming of the pump to ensure administration of the correct dose at the right time; education of the patient or caregiver on what to do if problems occur with the infusion pump, adverse drug reaction, infection, etc.; maintenence of equipment for proper refrigeration or handling. Home infusion pharmacies are required to store the drugs where temperatures are maintained to ensure the integrity of the drugs prior to their dispensing or administration as stipulated by the USP/NF and/or the manufacturer s or distributor s labeling (OAC Rule (B)(2)). Home Infusion Pharmacy Reimbursement Infusion pharmacies submit professional services claims with CMS (Centers for Medicare and Medicaid Services) for home infusion therapy services. Third party payers require that home infusion businesses

5 Page 5 be accredited. In addition, they also require documentation regarding plans of care, prescriber orders, and nurses notes. Billing and coding is complex. Due to unique characteristics of specialty pharmaceuticals and the requirements of insurance plans, reimbursement may be paid through a pharmacy or medical benefit claim. Staffing by Pharmacy Technicians Pharmacy technicians may be employed to assist home infusion pharmacists in compounding sterile prescription products. Ohio law now requires that home infusion pharmacies must ensure that their pharmacy technicians are qualified to compound sterile prescription products pursuant to Ohio Revised Code and Ohio Administrative Code Chapter The technicians must: (1) be 18 years or older; (2) possess a high school diploma or a certificate of high school equivalence; (3) have submitted to a criminal records check indicating that the individual has not been previously convicted of, or pleaded guilty to, any felony in Ohio, or any other state; and (4) have passed an examination approved by the State Board of Pharmacy. This new law places the responsibility for ensuring that the pharmacy technicians are qualified to engage in sterile compounding on the technician s employer. Technicians can perform these duties for up to 12 months if they are participating in, or have completed, a training program that meets State Board standards. Staffing by Nurses Many of the specialty pharmaceuticals and compounded sterile prescriptions require administration by qualified health professionals. The patients need to be monitored for adverse reactions while the drugs are being infused. Home infusion pharmacies employ nurses qualified to provide infusion therapy services. Nursing services of home infusion pharmacies include visits to the patient s home prior to initiation of infusion therapy to assess whether infusion therapy may be safely carried out there under aseptic conditions. Once infusion therapy has been started in the home, additional visits are necessary to monitor the administration of the drug; ensure that the venous access ports are being successfully maintained; deliver additional drugs for administration if needed; and ascertain that the drug administration site remains free from infection. It may be necessary for the nurses to draw periodic blood samples to monitor the effectiveness of therapy and to ascertain that the patient isn t experiencing any adverse drug effects. These nurses also provide education and training for the patient so that infusion therapy can continue without the nurse being present. Additional training of the caregivers may also be provided during these visits if needed. The Infusion Nurses Certification Corporation (INCC) was established in 1983 to develop a credentialing program to promote optimal patient health outcomes, advocate Certified Registered Nurse Infusion (CRNI ) credentials, and support continuing infusion nursing education and research. Since 1985, INCC has offered a comprehensive, evidence-based infusion certification program for nurses. The CRNI is accredited by the Accreditation Board for Specialty Nursing Certification (ABSNC). Accreditation status is granted for a period of five years. It is one of two nationally recognized organizations to accredit nursing certificate programs. The other is the American Nurses Credentialing Center (ANCC), a subsidiary of the American Nurses Association (ANA). The Infusion Nurses Society (INS) is recognized as the global authority in infusion therapy. Its mission is to: (1) develop standards of practice; (2) provide professional development opportunities and quality education; (3) advance the specialty through evidence-based practice and research;

6 Page 6 (4) support professional certification; and (5) advocate for the public. Compounding of Sterile Drug Products The majority of prescriptions handled by home infusion pharmacies are for intravenously administered, compounded sterile drug products. These prescriptions are considered to be high risk, especially if they require non-sterile ingredients. High-risk level compounding occurs when: non-sterile ingredients are used in compounding sterile prescription products; compounded sterile preparations are prepared from sterile ingredients in an environment that is not ISO Class 5; more than six hours passes between compounding and sterilization; and the purity of compounds used in compounding a sterile product are not verified by documentation. Home infusion pharmacists must have the didactic knowledge, training, experience and testing to ensure that they can competently and safely compound and/or supervise the compounding of sterile products. Home infusion pharmacists must be knowledgeable about extended drug stability as well as the compatibility of the ingredients used within a wide range of venous access devices. The compatibility of the solution used to flush vascular access devices is also an important consideration that the home infusion pharmacist must take into account to safely and effective administer a drug or compounded sterile prescription by infusion. Sterility of these prescriptions is also a concern because of the time period between compounding and administration. National Standards and State Regulations for Sterile Products and Home Infusion Pharmacies National standards for the compounding of prescriptions for sterile products have been developed by the United States Pharmacopeia (USP), and are under periodic revision. The Ohio pharmacy board has incorporated language from USP Chapter <797> (Pharmaceutical Compounding-Sterile Preparations) in sections of the Ohio Administrative Code Chapter (Sterile Product Prescriptions). OAC Rule was amended by the board to include <797> language regarding quality assurance requirements (effective in 2005); as well as language describing equipment used to maintain sterile environments for areas where cytotoxic drugs are used in compounding, and for areas where sterile prescriptions that do not include cytotoxic drugs are compounded (effective 1/1/2010). Home infusion pharmacies must meet the minimum standards for institutional pharmacies (OAC Rule ); and prepare and maintain a current policy and procedure manual regarding the compounding, dispensing, and delivery of sterile product prescriptions (OAC Rule (B)). These written policies and procedures must include the following: (1) A quality assurance program for the purpose of monitoring personnel qualifications, training and performance, product integrity, equipment, facilities, and guidelines regarding patient education; (2) justification for the chosen beyonduse dates of compounded products; and (3) handling of cytotoxic waste, if applicable. Paragraph (H) of this rule requires home infusion pharmacies to have a documented, ongoing quality assurance control program that monitors personnel performance, equipment, finished compounded drug products, and facilities. This paragraph further requires that, at a minimum, the written quality assurance program address the following items: adequate training and continuing competency monitoring of all personnel in personal cleansing, proper attire, aseptic technique, proper clean room conduct, and clean room disinfecting procedures (instructors must have the appropriate knowledge and experience necessary to conduct the

7 Page 7 training); continued verification of compounding accuracy including physical inspection of end products; continued verification of automated compounding devices; continued verification that appropriate beyond use dates are being assigned to compounded products; end product testing including, but not limited to, the appropriate sampling of products if microbial contamination is suspected; (Additionally, if bulk compounding of parenteral or sterile products is performed using non sterile chemicals, extensive end product testing must be documented prior to the release of the product from quarantine. This process must include appropriate tests for particulate matter and testing for pyrogens.) the operational efficiency of all clean rooms, laminar flow hoods, and other primary engineering devices must be environmentally monitored for operational efficiency and performed at least every six months. (The pharmacy must have a plan in place for immediate corrective action if operational efficiency is not certified. Records certifying operational efficiency must be maintained for at least three years.) Home infusion pharmacies deliver medications, equipment and supplies to the patient s home. OAC Rule requires pharmacies compounding parenteral or sterile product prescriptions to include policies and procedures that assure the environmental control of all products shipped to the patient. This pharmacy board rule also requires that the pharmacy maintain an inventory of appropriate temperature controlled transport containers. Timing of the delivery is critical in order to ensure that the medications and supplies are available prior to arrival of the home infusion nurse and in time for the next dose to be administered. Accreditation of Compounding Pharmacies Many third party payers, both private and government, are requiring home infusion pharmacies to be accredited. Accreditation organizations have been formed to establish quality standards and to monitor the home infusion pharmacy for compliance with standards of patient care. The Pharmaceutical Compounding Accreditation Board (PCAB), is now accrediting pharmacies which compound prescriptions. In order to be accredited by PCAB, the pharmacy must submit an application with a current copy of their policies and procedures. The application is reviewed by PCAB staff, or an independent third party designated by PCAB, and includes an in-pharmacy survey of the pharmacy. If the pharmacy is granted accreditation, it is authorized to display the PCAB Seal of Accreditation in their pharmacy, on the pharmacy s website and in advertisements. The PCAB Seal of Accreditation on an accredited pharmacy s website must include a link to PCAB s website. This link provides consumers access to PCAB s website where they may obtain an accreditation summary for the pharmacy. This summary lists PCAB s standards and indicates those standards met or exceeded by the compounding pharmacy. The accreditation summary includes a Compounding Scope of Practice Report, which provides the dates the pharmacy was first accredited and of the last inpharmacy survey conducted by PCAB. The report also includes a chart indicating the quality standards that were tested and if the pharmacy passed those standards regarding the types of compounding provided by the pharmacy. Pharmacies must meet the following PCAB standards in order to receive accreditation for the compounding of high risk sterile products: meet state requirements for sterile compounding (OAC Chapter ; Chapter ) have appropriate area(s) for the compounding of aseptic preparations that meets or exceeds USP Chapter <797>. have policies and procedures to monitor and test sterile preparations for ste-

8 Page 8 rility, pyrogenicity and potency, according to USP <797> standards. At the time of writing this article, no home infusion pharmacy located in Ohio was currently accredited by PCAB. Home infusion pharmacies currently operating in Ohio that are associated with a hospital or home health care agency are accredited by the Joint Commission, formerly known as the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). The Joint Commission is a not-for-profit organization that accredits health care organizations and programs. Unlike PCAB, the Joint Commission accredits all of the services provided by the home health care agency involving patient care, not just pharmacy services. The Joint Commission s standards for infusion therapy are applicable to the compounding of sterile parenteral drug products by home infusion pharmacies, as well as hospital pharmacies. This organization currently has accreditation programs for the following health care entities: Ambulatory Care, Behavioral Health Care, Critical Access Hospitals, Home Care, Hospitals, Laboratory Services, Long Term Care and Office-Based Surgery. HomeReach is an example of an infusion pharmacy, accredited by the Joint Commission, that is associated with a hospital system. HomeReach is a division of Ohio- Health. Hospitals located in Columbus, Ohio that are part of the OhioHealth system include Riverside Methodist Hospital, Grant Medical Center, Dublin Methodist, and Doctors Hospital. Critical Care Systems is a home infusion pharmacy that is not associated with a hospital, but is accredited by the Joint Commission. Critical Care Systems is a wholly owned subsidiary of Accredo Health Group Inc., a subsidiary of Medco Health. Some of the home infusion pharmacies that are not associated with a home health care agency or hospital are accredited by the Accreditation Commission for Health Care (ACHC), an organization whose accreditation programs are tailored specifically for the home care and alternate site health care industry. Some are accredited by both Joint Commission and ACHC. Walgreens- OptionCare, Inc., for example, is a division of the Walgreens Company and is accredited by ACHC. ACHC is the only national health care accrediting organization started at the grass-roots level by a few home care providers endeavoring to create a viable option of accreditation sensitive to the needs of small providers. ACHC provides the following accreditation programs related to home infusion: Pharmacy Services: Pharmacies that distribute medical supplies to patients without any ongoing rentals fall under the Medical Supply Provider program. This includes product such as diabetic strips, ostomy supplies, canes, walkers, or any other items that can be sold to the end user. If a pharmacy does simple non-sterile compounding of ointments, eye ointments, salves or creams, they fall into this category. If these are the only services offered by the pharmacy, they fall into the Medical Products category and only have to meet the accreditation standards for this category. Specialty Pharmacy: a pharmacy that dispenses medications (usually self injectable biotechnology drugs) to a client s home, physician s office, or clinics specializing in certain chronic disease states. Infusion Pharmacy: a pharmacy that provides parenteral (e.g. intravenous, subcutaneous, intramuscular) medications for patients in alternate settings. This service includes clinical monitoring by the pharmacy, and may include nursing services as well. Infusion Nursing: Infusion nursing services are the administration of parenteral medications via various accesses and ports by an RN specifically trained in these specialized services. This service can be performed in a variety of settings. Ambulatory Infusion Center: a centralized location where a patient receives infusion therapy. The facilities are staffed by

9 Page 9 nurse(s) and in some cases, a pharmacist. Services provided are directed by a physician. A pharmacist must compound and provide the medications and the nurse must administer the medication. If chemotherapeutic prescriptions are compounded, the pharmacy must have separate equipment or areas for compounding, which must meet pharmacy board requirements (OAC Chapter ). National standards that ensure compounded prescriptions are sterile and free of any contaminants, including bacterial endotoxins (USP Chapter <797>), must be met. Distribution Programs. Home infusion pharmacies in Ohio are licensed by the pharmacy board as a Fluid Therapy Pharmacy/Home Health Care (FTHH). These pharmacies are subject to regulation by OAC Chapter Manufacturers of specialty pharmaceuticals, such as recombinant humanized monoclonal antibodies (e.g., infliximab [Remicade ] and natalizumab [Tysabri ]), restrict distribution through special programs. Patients must be enrolled and meet program requirements before the drugs may be administered to them. An example is the TOUCH Prescribing Program developed by the manufacturer of Tysabri. The program is referred to as a Risk Evaluation and Mitigation Strategy (REMS). The federal Food and Drug Administration Amendments Act (FDAAA) of 2007 provided FDA with the authority to require such a program for drugs that would otherwise be withdrawn from the marketplace due serious adverse events. This act was one of the most important pieces of legislation for the biotech companies marketing these products. A REMS program may include the following Elements to Assure Safe Use. Health care providers who prescribe the drug must have training, experience, or certification. Pharmacies, practitioners or health care providers who dispense the drug must be specially certified. The drug is dispensed to patients only in certain health care settings. The drug is dispensed with documentation of safe use conditions, such as favorable lab results. Each patient taking the drug is subject to monitoring. Each patient using the drug must be enrolled in a registry. Medical Devices. Home infusion pharmacies provide various legend medical devices required for the infusion of the compounded prescriptions, such as infusion pumps and supplies required to safely establish vascular access for the administration of the specialty pharmaceuticals and/ or sterile compounded prescriptions. OAC Rule (Minimum Standards for Compounding Parenteral or Sterile Product Prescriptions) requires the home infusion pharmacy to carry infusion devices and equipment, when appropriate. Hospitals are now discharging patients with chronic medical conditions requiring sophisticated medical devices at home. In some instances, this could lead to serious health risks. FDA is now considering working with professional associations and accrediting bodies to qualify health care professionals in the teaching of patients and family members in safely using the medical devices. Ohio Administrative Code Rule states that, whenever possible, a pharmacist shall be involved in discussing with each patient receiving an outpatient parenteral or sterile product prescription, or the caregiver of such individual, the following matters: (1) dosage form, dosage, route of administration, and duration of drug therapy; (2) special directions and precautions for preparation and administration; (3) proper storage; and (4) stability or incompatibilities of the medication.

10 Page 10 Continuing Education Test Questions The Business of Health Care: Home Infusion Pharmacies 1. Home infusion pharmacists may provide all of the following professional activities EXCEPT: a. medication profile review. b. billing patients for products and services. c. coordination of packing medications and supplies for delivery. d. patient and caregiver education. 2. Ohio law places the responsibility for ensuring that pharmacy technicians are qualified on: a. the technician s employer. b. the State Board of Pharmacy. c. the approved national examination administrator. 3. Which of the following organizations offers a comprehensive evidence-based infusion certification program for nurses? a. American Nurses Credentialing Center b. Accreditation Board for Specialty Nursing Certification c. American Nurses Association d. Infusion Nurses Certification Corp. 4. The Ohio Board of Pharmacy has incorporated language from USP Chapter <797> in sections of OAC regarding sterile product prescriptions. a. True b. False 5. Pharmacies providing home infusion services in Ohio must maintain written policies and procedures which include all of the following EXCEPT: a. a quality assurance program. b. justification for chosen beyond-use dates of compounded products. c. PCAB accreditation credentials. d. handling of cytotoxic waste, if applicable. 6. The PCAB Seal of Accreditation on an accredited pharmacy website must include a link to PCAB s website. a. True b. False 7. Which of the following is a not-for-profit organization that accredits health care organizations and programs? a. Ohio State Board of Pharmacy b. United States Pharmacopeia c. Pharmaceutical Compounding Accreditation Board d. The Joint Commission 8. The Accreditation Commission for Health Care provides all of the following accreditation programs related to home infusion EXCEPT: a. Specialty Pharmacy. b. Pharmacy Services. c. Behavioral Health Care. d. Infusion Nursing. 9. Patient enrollment is not required in specialty pharmaceutical restricted drug distribution programs such as TOUCH. a. True b. False 10. OAC Rule requires the home infusion pharmacy to carry infusion devices and equipment, when appropriate. a. True b. False The College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

11 Page 11 Continuing Education Answer Sheet The Business of Health Care: Home Infusion Pharmacies Test Instructions Circle the correct answer. Fill out the identification form at bottom and mail to: CE Quiz The Robertson-Evans Building, Room 225 Ada, OH (Your subscription fee, or payment for this individual issue, covers grading costs.) This program has been approved by the Ohio State Board of Pharmacy for jurisprudence credit. 1. a b c d 6. a b 2. a b c 7. a b c d 3. a b c d 8. a b c d 4. a b 9. a b 5. a b c d 10. a b Name Address City State Zip Phone ( ) License No. State A passing grade of 80% (eight correct) must be attained to receive continuing education credit. CE statements of credit for successful participants will be mailed within four weeks of receiving the answer sheet. You must return your test answers prior to the July 19, 2012 expiration date of this article. Program H03-P 0.1 CEU Release Date: Expiration Date: Program Evaluation 1. Rate program content (Excellent = 5; poor = 1) 2. Did this program meet each of the following objectives? 1. outline the evolution of outpatient infusion companies, the services they provide, and staffing; yes no 2. explain the national standards and regulations for sterile products and home infusion pharmacies set by USP and the Ohio Board of Pharmacy; yes no 3. list organizations accrediting compounding pharmacies and other home infusion providers; and yes no 4. explain restricted distribution programs and state regulations for high risk drugs and medical devices. yes no 3. Comment on program improvement, future topics, etc.

12 Page 10 The Robertson-Evans Building, Room 225 Ada, Ohio Yes, enroll me for a one-year subscription to Law & Mortar today at the rate of $40. (Includes 4 issues and no additional cost for CE credit.) My payment of $40 is enclosed. Make check or money order payable to: or charge my: VISA MasterCard Credit Card No. Law & Mortar Subscription Renewal Form Discover Expiration date Signature Name Address City State Zip Telephone ( ) Address R.Ph. License No. Return to: The Robertson-Evans Building, Room 225 Ada, OH 45810