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DOSE A Publication of Correct Rx Pharmacy Services, Inc. Volume 1 . Issue 1 . 2007 INSIDE Program Management Clinical Information Meds of Abuse Barcode Scanning Contents 8 Correct Rx Company Profile 10 The Value of the Correct Rx Services On-Site Visit 16 Implementation of a Clinical Pharmacy Program in Correctional Facilities 12 Effective Program Management 18 Grapefruit and Medications: A Potential for Adverse Events 24 Medications of Abuse: Patient Screening Other Features 7 Greetings from the President 23 New Drug Profile: Atripla 26 Barcode Scanning Technology 28 Clinical Management of Hepatitis B Virus Infection 800.636.0501 . 803-A Barkwood Court . Linthicum, MD 21090 . www.correctrxpharmacy.com . [email protected] Dose is published by Innovative Publishing Ink. For more information on how your company can have its own publication, contact Aran Jackson at 502.423.7272. Innovative Publishing Ink . 10629 Henning Way, Suite 8 . Louisville, KY 40241 . 502.423.7272 . www.ipipublishing.com Correct Rx Pharmacy Services, Inc. is neither accountable for the content of paid advertisements nor does it endorse same. No outside parties influenced the text or participated in the editing of this publication. Professional standards of care were taken to ensure accuracy; however, the authors and editors do not attest that the information contained herein is free of errors or omissions. Sound clinical judgment is the responsibility of every professional in addition to full consultation of all prescribing information prior to medication administration. Correct Rx 5 Greetings from the President W elcome to our inaugural edition of Correct Rx’s journal publication. This journal has been in the works for some time, and we are very proud of the results. It is our intent to publish a new edition twice a year. So you, as our valued friend and client, can eagerly look forward to receiving each new issue. The growth has been evident not only in the number of orders being filled, but also in the number of Correct Rx associates. Good Corporate Citizens: Correct Rx is not only an institutional pharmacy recognized for professional excellence, but it is also a company that is made up of good corporate citizens. Being part of an organization that reaches out to the community to help the less fortunate is something to celebrate. Correct Rx is just that kind of company. Although Correct Rx is just barely four years young, we have developed a wonderful clinical and management team whose depth of talent and experience have provided innovative approaches to Making a Difference in the Lives We the institutional pharmacy arena. This Serve: When it comes to reasons to celmanagement team has risen to each new ebrate, nothing is more significant than challenge with vigor and enthusiasm. the fact that the associates at Correct Rx When I challenged them to produce a can positively say what they do and how biannual top-notch publication, they well they perform their job makes a difresponded with an overwhelmingly posiEllen H. Yankellow , Pharm.D. ference. Every day, our associates fill tive reply. This energy and genius will be and dispense essential — and in some the springboard for a journal that will cases, life-saving — medications. Our clinical team address a myriad of informative topics in a professional has been busy developing a model of medication and useful format. therapy management that provides much-needed patient education and therapeutic oversight for the It is natural to begin the president’s letter with a reflecchronically ill. Not many Americans in the worktion of our achievements since our start in 2003, with force wake up every morning and go to their respeca particular focus on the previous year’s accomplishtive places of employment knowing that what they ments. So, in addition to a professional publication, do will improve the lives of their clients and the what do we have to celebrate at Correct Rx? greater society they serve. Awards: 2006-2007 marked another year of business Now this is something to celebrate! awards and recognitions. After 2005, we were not certain that there were any more awards to win, but 2006 I hope you enjoy the first edition and thank you for makproved to be a banner year! Correct Rx won the Ernst ing Correct Rx a nationally recognized “small giant” in and Young Entrepreneur of Year award for Maryland the institutional pharmacy business. A pharmacy that is in the Health Care Category. This award came with a well known for quality, integrity, caring and accuracy. trip to Palm Springs, where we joined all the other There is no doubt Correct Rx’s corporate culture of carregional winners for the national event. Jay Leno was ing and accuracy has served us well and will continue to the host of this gala, and we certainly were excited to be our guiding mission well into the future. be shoulder-to-shoulder with the business elite of this country. Correct Rx was also recognized by the Governor’s Office of Minority Affairs as one of the Top 100 Minority Business Enterprises in Maryland. Continued Growth: Another important reason to celebrate has been our continued healthy growth in both the correctional and senior care marketplace. Correct Rx With sincere thanks, Ellen H. Yankellow President and CEO 7 Correct Rx 8 Correct Rx Correct Rx Pharmacy Services, Inc. is a “small giant” in the institutional pharmacy marketplace, placing emphasis on quality and providing a new paradigm for pharmacy services that includes the following elements: operational efficiency, utilization review, quality assurance initiatives, Web site barcode technology and, most important, clinical programs centered on medication therapy management. The value of Correct Rx Pharmacy’s onsite visits by fully credentialed clinical pharmacists is measured by improved patient outcomes, resulting in fewer complications and reduced overall costs to its clients. This model is certainly not new to pharmacy, but it is significantly different from the Company Profile traditional system, which is based primarily on dispensing and distribution activities. Correct Rx believes this is a prescription to cure rising drug costs for the clients they serve. Jill Molofsky, R.Ph., Ellen H. Yankellow, Pharm.D. and James Tristani, R.Ph. Correct Rx Correct Rx Pharmacy currently provides comprehensive pharmaceutical services in more than 24 states from their state-of-the-art pharmacy, located next to the Baltimore/Washington International Thurgood Marshall Airport. This strategic location was intentionally selected to facilitate a quick response time for all new and refill orders. The close proximity to the airport has provided Correct Rx with a competitive advantage for both transmission and delivery of orders to our customers. Each client is given the same level of attention, whether it is a 15-bed assisted living facility or a 27,000-client statewide correctional system. More than 64 percent of Correct Rx’s clients come from referrals. All of the owners at Correct Rx are licensed pharmacists, with more than 70 years of combined institutional pharmacy experience. In addition, Correct Rx is a certified MBE/DBE business. For more information, contact Ellen H. Yankellow, Pharm.D., President and CEO, at (800) 636-0501, fax (410) 636-9706 or visit our company Web site: www.correctrxpharmacy.com. 9 Do You Know the Value of the Correct Rx Pharmacy Services On-Site Pharmacist Visit? How many times have you heard the phrase “Let me check with my manager”? Correct Rx Pharmacy Services utilizes a unique model to provide on-site pharmacist visits to eliminate barriers to success. The visits are performed by fully credentialed clinical pharmacists with a focus on the safe, reliable and cost-effective utilization of medications. The personal attention and face-to-face interaction our clients receive are instrumental in communicating expectations, discussing issues, and resolving problems. 10 Correct Rx The alternative method that includes supporting clients through the telephone and use of contracted consultants is a well-accepted practice; however, these arrangements are not ideal. They often decrease efficiency of communication and have the potenby Helena H. Kim, tial to delay problem resoluPharm.D. tion that threatens the success of our clients. Contracted consultants are not intimately familiar with our policies or our clients. The additional expense of travel to send a member of the management team or a specialized clinical pharmacist from Correct Rx to perform these visits is more than justified to Correct Rx Pharmacy Services. The on-site visit, performed by a Correct Rx pharmacist, is a reflection of our commitment to our clients. Operations The Correct Rx on-site visits are designed to provide valuable insight into the operations at the facility level. The operations management program helps clients to minimize error rates, follow delivery schedules, comply with standards for reports and meetings, perform all CQI initiatives, measure outcomes, review medication room audits, follow safety and security protocols, and adhere to regulations. Our management team has more than 20 years of correctional pharmacy experience to benefit our clients. Inspections and Audits Inspections of medication storage areas, inventory records and administration processes are required by all states as an integral and routine practice to ensure quality, safety and compliance with state and federal laws. Correct Rx Pharmacy is familiar with standards on medication handling and administration established by the National Commission on Correctional Health Care (NCCHC), the American Correctional Association (ACA) and the Joint Commission on Accreditation of Healthcare Organization (JCAHO). The goal is to establish, maintain and even exceed standards in between accreditations — not just prepare for them. Even the best-maintained organizations are faced with the continual challenge of training replacement staff or staying informed of new changes in standards of practice. Our pharmacists are able to identify deficiencies and provide recommendations or specific training to address issues that threaten quality and safety of medication use. Pharmacy and Therapeutics Committee Meetings The Pharmacy and Therapeutics meeting is a forum established and tailored to meet your many needs, Correct Rx including continual monitoring of medication use, applying pharmacoeconomic principles, developing a sound formulary, managing of drug costs, and knowledge regarding standards of care. When comparable medications offer marginally improved therapeutic benefits, clinical pharmacists can help to determine the costutility level at which the additional expense is justified. Because they often have a significant impact on pharmacy expenditures and clinical outcomes in the correctional setting, specific emphasis is placed on HIV, hepatitis C and psychotropic medications. During Pharmacy and Therapeutics meetings, Correct Rx Pharmacy Services provides an analysis of medication utilization data. Correct Rx breaks the information down into formulary costs, non-formulary costs, HIV medications costs, hepatitis C medication costs and psychotropic medication costs. The analysis also presents performance indicators such as cost per patient and number of orders per patient. Medication expenditures are analyzed by chronic disease states such as asthma, hypertension and diabetes. The pharmacists track and trend the utilization data in order to identify changes in prescribing pattern or the patient population. Clinical Newsletter As part of the Pharmacy and Therapeutics meeting, Correct Rx Pharmacy Services provides a clinical newsletter to update providers about new developments in clinical therapeutics. The newsletter contains disease state reviews — focused on the clients’ needs and interests, new drug reviews, journal article reviews and formulary comparisons. Also included are the new medications, new indications, new formulations and new generic medications. This service usually comes at a very high cost; however, our clients receive this service at no additional cost. Correct Rx Pharmacy Services works in collaboration with the providers to make therapeutic recommendations that are designed to get the best possible outcomes. Real Value Correct Rx Pharmacy Services’ clinical department is known for its innovative clinical initiatives, always designed to improve patient care while complying with accreditation standards and assisting with maintaining a budget. Attention to detail and personalized on-site pharmacist visits bring real value to Correct Rx’s clients and the patients they serve. Our clients and their first-line staff have a direct line of communication to our management team for a rapid response to any issues identified or the implementation of an on-the-stop resolution, sometimes by rolling up our sleeves. We like doing things the “Correct Way,” and we know you will, too! 11 Effective Program A short time ago, I was asked to write a few words about effective program management. While I have spent a great deal of time pondering this topic and attempting to place by John R. Nattans, M.C. words around someDirector of Program Services and Quality thing that is often Assurance elusive and malleable, I find the greatest truth to be that you have to first — and above all else — be confident and absolutely sure the organization you are affiliated with provides an optimal service or has a quality product. I have the good fortune to work for one of the premier institutional pharmacies in the nation. My ability to engage in esoteric discussion regarding effective program management would not be possible without the vision and leadership of the owners, the wisdom and talent of our clinical pharmacists, and the dedication to detail and commitment of our employees throughout all phases of operations of Correct Rx Pharmacy Services, Inc. 12 Notwithstanding the aforementioned truths, the key to effective program management boils down to a few essential elements: program understanding, communication, building relationships, managing your personnel, quality assurance (QA) and continuous quality improvement (CQI), and delivering the goods. Program Understanding The primary task of effective program management is to clearly define the program to be managed. One has to examine the expectations of the client and how effectiveness will be operationalized. In other words, what does the contract include? What does the client expect? And how will your organization deliver on each of these items? Line by line, item by item, the program manager must know what is being asked for and how it will be addressed. One word of caution: never underestimate the idiosyncrasies of each contract. The delivery of goods and services may be similar between contracts, but it is never exactly the same. True project understanding requires attention to detail and individualized approaches to contract compliance. There are tried and true methods that will get the job done, but the effec- tive program manager understands the nuances and makes adjustments congruent to the needs of the client, the setting and the population being served. Communication Communication is the lifeblood of effective program management. First, let us examine communication skills and fundamentals. I cannot stress enough the importance of listening. Creative solutions will always present themselves if we spend the time to listen carefully to the problem. One must listen for the content and read the nonverbal cues. As any program manager will tell you, there never seems to be enough hours in the day. When we take the time to listen, however, we learn very quickly the issues to be addressed, the priority, the reinforcements that may be needed and, most importantly, where the industry is headed. Certainly, all individuals should be treated with respect and dignity. One must try not to rush through conversations or finish the thoughts of others — this tends to communicate that the other person is not important or that you do not have time for that individual. It would be Correct Rx Management imprudent to list all the skills needed for effective communication in this article, but rest assured that this topic is well covered in the literature. There are numerous staff development opportunities regarding effective communication that should be employed by all staff on a regular basis — this includes program managers. These skills require attention. Oral communication should be clear and with purpose. A program manager represents the company (e.g., regularly scheduled meetings, telephone calls, impromptu problemsolving sessions) and should be prepared. One should have a good idea of what will be Program Understanding Communication Building Relationships Managing Staff QA & CQI Delivering the Goods Correct Rx presented before speaking. A word of caution — do not pretend to know something you do not. If you are asked to speak about something for which you are not qualified or not prepared, it is best to withhold your thoughts. In these times, be sure that you understand what is being requested, and then get back to the person with an answer, or get the person in touch with the person who is qualified to answer. For example, Correct Rx has many intelligent, highly trained and experienced clinical pharmacists who are all well equipped to address numerous clinical questions posed by physicians. The program manager should triage clinical questions to the appropriate expert. An effective program manager does not need to have all the answers. Rather, he or she utilizes the most effective resources in resolving issues. The content of your communication is equally important. Make sure your client is well informed regarding your performance — not only those things that are going well. Do not shy away from the issues that are problematic. In fact, most clients appreciate this forthright communication, and it may, in fact, help establish goodwill. Do not be confused, though; there must also be a corrective action plan. Once the plan is in place, it must be executed. Perhaps the most important element of effective program management is honesty and integrity. In this context, it means effectively communicating what you are going to do to resolve an issue and then making sure you follow through. All written communication reflects upon the company. It should always look professional and be informative. Also, it must be timely and accurate. Whether it is a statistical report full of interesting charts and graphs or a narrative summary of events, the document should be neat, accurate, timely, informative and professional. An effective program manager ensures that the client is knowledgeable about what is being provided. If you are going to spend the time to manage an effective program and ensure that you are producing a quality product and service, do not hesitate to share your accomplishments. The unique skills and services your company provides as a value-added bonus should not be left silent. 13 Building Relationships The effective program manager must know how to build positive relationships. There are many different people involved in a contract, each at different times, and all are critical to the delivery of service. Certainly, it is crucial to understand who your client is, the hierarchy of his or her organization, and the appropriate person to whom specific information should be directed — it is perhaps more important to know the people fulfilling the roles and their personal style preferences. Less obvious, yet equally important, are those with whom you need to collaborate and cooperate. In our business, this includes the health care providers and the institutional staff. Without building effective relationships with these people, I am afraid all efforts to deliver a substantive product or service will be thwarted. Always keep in mind that, behind all of our agendas, busy schedules and lists of things to accomplish, there is a shared humanity. Managing Staff Another essential element to being an effective program manager is managing your own personnel effectively. First, you must know what roles are needed in your program design. Once 14 this is established, search for the right people to fill the job vacancies. Be sure you select properly qualified individuals who mesh with your organization’s culture and vision. Cutting corners on talent and/or compensation packages is a critical mistake that prevents some program managers from achieving excellence. There certainly will be a budget, and some negotiations are inevitable, but if the right person comes along at the right time, it may be well worth the investment in your company’s future to bring that person on board. This leads very nicely into the next point — staff retention is the ultimate goal. The ability to retain your employees allows for a focus on staff development, delivering the goods and, ultimately, continuous quality improvement. Staff turnover saps the energy from otherwise effective program designs. Lastly, make sure there is two-way communication. Listening to your employees provides opportunities for understanding that might otherwise go unnoticed. This process also provides the employees with opportunities to invest in the program. Employees who are invested and believe they are making a difference are usually more willing to put forth the extra effort that is needed for optimal performance. An effective program manager may not have all the answers but must know where to find them. Personnel working on the front lines often are the sources of the most useful information. QA & CQI A well designed quality assurance (QA) and continuous quality improvement (CQI) program ensures your clients’ satisfaction and happiness. Quality assurance, in layman’s terms, is the process of guaranteeing the delivery of a good product or service. In definable terms, there has to be a way to measure your performance. These programs should be based upon contractual obligations and professional standards. For example, at Correct Rx, we have specific quality assurance programs that certify the accuracy of the prescription being filled, timeliness of the delivery and clinical initiatives that result in optimal care for our clients. At Correct Rx, we understand that the one way we can distinguish ourselves from our competitors is to make certain that we are not only meeting the industry standards, but we are meeting our own self-imposed Gold Standards. Through the constant monitoring of these key indicators, we can be assured that we are delivering a quality pharmacy service. Correct Rx “ .” The ability to retain your employees allows for focus on staff development, delivering the goods and, ultimately, continuous quality improvement. But being good just isn’t good enough. The status quo will not do. All too often, Continuous Quality Improvement (CQI) programs are simply used to address deficiencies. Let’s not be mistaken: it is essential to address any deficiency through corrective action planning. Sometimes it is inevitable, but an effective quality assurance program should catch any slips well before your program becomes deficient. Rather than being reactive, an effective program manager uses a proactive CQI program. If you want to maintain your edge on your competitors, you must unceasingly look for ways to improve. Finding ways to advance the delivery of goods and services while saving the client money is a good rule of thumb. Implementing a proactive CQI program ensures your customers that you will not only meet expectations, but you will exceed them. Delivering the Goods While one must understand the program, effectively communicate, build relationships, manage your staff, and implement QA and CQI programs, there comes a time when you Correct Rx must deliver the goods. The effective program manager delivers on the promises made when the contract was secured. “Delivering the goods” means doing what you said you are going to do. The contract outlines how the goods and services will be delivered. The program manager must ensure that the client receives what they are paying for and more. In some ways, the program manager is in charge of maintaining clients. The best way to maintain a client is to deliver what you said you would do in the manner you said it would be accomplished. When you fall short, effectively communicate what happened, outline a corrective action plan, and deliver on the revised plan. More importantly, keep searching for ways to improve your product or service by listening to the needs of your clients and assessing the results of your QA and CQI programs. This guarantees that you are providing a value added service that exceeds expectations. The effective program manager ultimately is responsible for delivering the goods. All in all, there is a multitude of functions that a program manager performs. Essentially, you must first select a company that provides a quality service or product. Secondly, you must immerse yourself into “that which is to be managed” in order to gain a true understanding and create a clear vision. All managers know that effective communication is a critical component that will need constant attention. The implementation of your program is often completely reliant on the relationships you build with your client, co-vendors and other representatives with whom your service will impact. Your job will be a lot easier if you employ comprehensive quality assurance measures and proactive CQI programs that seek to keep your company on the leading edge of your industry. At some point, it all boils down to “delivering the goods” — making sure that you not only meet expectations but also exceed them. While there are numerous other tasks and skills that are employed by effective program managers, I have identified in this discussion a few I have found to be essential. I hope you find this information useful in your pursuit of effective program management. 15 Implementation of a Clinical Pharma Correct Rx Pharmacy Services has developed and implemented a fullservice clinical pharmacy program for correctional facilities. This clinical service proby Hui W. Seo, Pharm.D. vides a multi-disciplinary approach to chronic care clinics and acute care units. Clinical pharmacy services affect many facets of patient care in communities, institutions and managed care organizations and are considered to be a valuable resource — shown to be effective in improving patient care and related outcomes. The pharmaceutical care concept encompasses a broad range of activities performed by pharmacists. A clinical pharmacy service promotes the safe, efficacious and cost-effective use of medications to achieve positive outcomes and improve the well being of patients’ lives. At one end of the spectrum of pharmaceutical care, pharmacists provide patient counseling in the community to educate patients on appropriate use of medications. On the other end of the spectrum is the pharmacist-provider with prescribing authority, operating under a collaborative practice agreement with physicians. In the middle, there exist services for formulary management, pharmacist-managed coumadin clinics, rounding with medical teams in acute/urgent care units (e.g. surgical intensive care units and medical intensive care units), and clinical research. This list is not all-inclusive. Medicare saw the value of non-distributive pharmacy services in the Omnibus Budget Reconciliation Act (OBRA) in the 1980s. OBRA required pharmacists to complete drug regimen reviews for residents of long-term care facilities. The subsequent OBRA 90 act required pharmacists to provide medication counseling on indication, safe use and potential side effects to Medicare patients. This was later expanded and adopted to include all patients. Today, the term medication therapy management (MTM) is used to describe the clinical pharmacy service provided to patients in long-term care, institutions and the community. MTM is defined by a consensus of pharmacy professional organizations (e.g., American Pharmacists Association, American College of Clinical Pharmacist and the National Association of Chain Drug Stores) as a distinct service or group of services that optimize therapeutic outcomes for individual patients.1 The central focus of MTM is the achievement of improved outcomes through evaluation, modification, monitoring and education related to medication use. MTM is now a reimbursable service under the Medicare Modernization Act of 2003. The Medication Therapy Management principle applied by Correct Rx Pharmacy Services for correctional facilities includes three separate services: chronic care clinics, infirmaries and drug information services. Pharmacist Chronic Care Clinics The goal of clinical pharmacists in chronic care clinics (PCCC) is to improve patient outcomes through systematic and continual medication therapy management. MTM assures appropriate drug selection and dosing while minimizing toxicity and resolving problems that may threaten compliance. The pharmacist reviews medication regimens, meets with the patient to monitor for outcomes (both positive and adverse effects), and provides education to the patients regarding their disease state and medication. PCCC was initially targeted for patients with diabetes, hypertension, hyperlipidemia and other cardiovascular disease states. Since then, the clinical team has expanded PCCC to include patients with asthma, patients on anticoagulant therapy and patients who are HIV-positive. The expansion of the patient groups was a result of the demand for PCCC cy Program in Correctional Facilities by patients and providers who appreciated the value of the service. The successful acceptance by patient and providers results from the acknowledgement that there is a readily available health care provider to assist in patient care. Providers appreciate the pharmacists for being a resource for information and for providing follow-up care. The benefits that patients receive from pharmacists include education, continued reinforcement of medication and disease-state counseling. The Asheville Project in North Carolina demonstrated that a network of community pharmacists providing disease state management for diabetics had a significant impact on achieving hemoglobin A1C goals, decreased sick days and decreased overall medical costs.2 The Asheville Project was the first study to follow diabetic patients during a long period of time — five years. The authors suggest that long-term continuous monitoring and follow-up were major contributing factors to the positive results. The American College of Clinical Pharmacy (ACCP) has published three key reviews regarding the value of clinical pharmacy service. The most recent review, published in 2003, specifically looked at the cost-benefit analysis of clinical pharmacy interventions. They found that, on average, there was a $5 return for every $1 invested in clinical pharmacy services.3 The return was measured in terms of the prevention of hospitalization, prevention of adverse drug events, decrease in hospitalization days, decrease in medication cost through cost-effective medication selection and improvement in medication therapy outcomes. Other examples of pharmacists’ contributions to chronic care include a study published in CHEST that compared patients treated with coumadin through a traditional practice model with patients treated through a centralized pharmacist managed coumadin clinic. The results indicated that patients treated by a centralized pharmacistmanaged clinic had fewer complications while treated with warfarin.4 The patients were 39 percent less likely to experience complications compared to the control group. The results of the study also showed that patients managed by pharmacists spent more time with a therapeutic INR. Rounding in Infirmaries Correct Rx Pharmacy Services’ clinical pharmacists round with medical teams in the infirmaries. The value of a multidisciplinary team that includes a pharmacist in acute care is also well established in most primary, secondary and tertiary medical centers. The clinical pharmacist on infirmary rounds provides prospective medication use review. The assessments include appropriate medication use, dose, indication, monitoring objective parameters (e.g., gentamicin levels and renal function), and adverse effects. This service is especially valuable for monitoring medications with a narrow therapeutic range (e.g. phenytoin, gentamicin, vancomycin, valproic acid and lithium). The pharmacist is able to provide additional attention to the timing of laboratory collection — which is critical in assessing therapy. In recent reports, adverse medication outcomes account for $47 billion per year in unintended health care costs.5 This figure most likely under-represents the real cost of adverse medication events. Most of the costs usually involve drug interactions, drug overdose/ super-therapeutic drug levels and failed intended goals of medication therapy. Additionally, the pharmacist is able to provide real-time recommendations regarding formulary management to postively impact patient care and costs. Drug Information Services Drug information services are provided to benefit health care providers and overall medical costs. The benefit is derived through avoidance of adverse medication events and formulary management. In a review of economic benefit of clinical pharmacy services, a drug information service provided a return of $192.58 for every $1 spent on clinical services.4 Inquiries usually range from how medications are used to finding alternatives to nonformulary medications. This service will eventually be offered to all provider-clients of Correct Rx Pharmacy. Summary Correct Rx Pharmacy Services’ clinical programs have definitive economic and humanistic value. Considering that the correctional population is “sicker” and in need of more attention than other patient groups, the opportunities for clinical interventions are abundant. The correctional population is in greater need of clinical pharmacy services to provide a collaborative approach to affect positive outcomes associated with medication therapy. References: 1. Medication Therapy Management in Community Pharmacy Practice. Core Elements of an MTM Service. Version 1.0. A Joint Initiative of the American Pharmacists Association and the National Association of Chain Drug Stores Foundation. April 29, 2005. 2. Cranor, CW; Bunting, BA; Christensen DB. The Asheville Project: Long-Term Clinical and Economic Outcomes of a Community Pharmacy Diabetes Care Program. 3. Schumock, GT; Butler, MG; Meek, PD; Vermulen, LC; Arondekar, BV; Bauman, JL. Evidence of the Economic Benefit of Clinical Pharmacy Services: 1996-2000. Pharmacotherapy 2003; 23 (1): 113-132. 4. Witt, DM; Sadler, MA; Shanahan, RL; Mazzoli, G; Tillman, DJ. Effect of a Centralized Clinical Pharmacy Anticoagulation Service on the Outcomes of Anticoagulation Therapy. CHEST May 2005; 127 (5): 1515-1522. 5. Briceland, LL. Medication Errors: An Expose of the Problem. Medscape Pharmacists 1 (1), 2000. Medscape. Patients frequently are treated with multiple medications concurrently to treat one or more medical problems. Concomitant intake of two or more drugs can alter the by Akilah Streets, influences of each Pharm.D. individual drug. An interaction takes place when the effects of one drug are changed by the presence of another drug, food, drink or by some environmental chemical agent. Grapefruit carries the American Heart Association’s healthy “heart-check” food mark and contains compounds that may reduce atherosclerotic plaque formation and inhibit cancer cell proliferation. Grapefruit juice is purchased by 21 percent of all households in the United States. Unlike other citrus fruit juice, grapefruit juice interacts with a multitude of prescription medications, raising the potential for concern (Kane, GC, et al., 2000). Eighteen years ago, an investigation was designed to evaluate a possible interaction Grapefruit and A Potential for 18 Correct Rx between ethanol intake and felodipine, a dihydropyridine calcium channel blocker. Grapefruit juice was used as a flavor supplement in order to mask the alcohol taste. The concomitant intake of non-intoxicating amounts of ethanol and felodipine resulted in several fold higher felodipine concentrations than observed in other investigations of felodipine pharmacokinetics. In addition, lower blood pressure and higher frequencies of adverse effects were measured compared with felodipine alone (Bailey, et al., 1989). An examination for possible causes failed to explain this surprising observation until a CYP form in the human small intestine (Kolars, et al., 1992). The main mechanism for the enhanced bioavailability of drugs by grapefruit juice is presumably through the inhibition of CYP3A4 in the small intestine, resulting in a significant reduction of drug pre-systemic metabolism. Lundahl, J; Regardh, C; Johansson, G; et al. examined the effect of grapefruit juice on the metabolism of felodipine administered intravenously and orally. The study was a randomized, four-way, crossover design in 12 healthy males. Single doses of felodipine Medications: Adverse Events pilot research in a single volunteer was conducted to assess the role of the juice (Bailey, et al., 1998). Further follow-up studies confirmed that grapefruit juice dramatically elevated felodipine’s bioavailability and could alter pharmacokinetic and pharmacodynamic parameters of the drug (Bailey, et al., 1991). This incidental discovery has led to the publication of numerous articles regarding the interaction between grapefruit juice and various drugs, focusing on different aspects: interaction mechanisms, grapefruit juice constituents that are responsible for the interaction, drugs exhibiting the interaction and the clinical relevance. Cytochrome P-450 (CYP450) is a large family of enzymatic proteins that catalyze the oxidation of substrate molecules. Many endogenous compounds and foreign compounds — including drugs — are metabolized by CYP450 through this oxidative biotransformation. The isoenzyme cytochrome P-450 3A4 (CYP3A4) is the predominant Correct Rx were given either as an intravenous infusion for one hour (1.5 mg) or as an oral extended release (ER) tablet (10 mg). Patients were randomized to ingest grapefruit juice (150 ml) or water 15 minutes prior to drug intake. Whereas the grapefruit juice ingestion combined with oral administration of felodipine had increased the mean area under the curve (AUC), Cmax, and mean absolute bioavailability by 72 percent, 173 percent and 112 percent respectively, the juice did not significantly alter the pharmacokinetics of intravenously administered felodipine. The fraction of oral felodipine dose reaching the portal system was increased from 45 percent to 80 percent when grapefruit juice was taken prior to medication administration. The pharmacokinetics of the primary metabolite, dehydrofelodipine, was affected by the intake of juice — resulting in a 46 percent increase in Cmax. Juice intake immediately before oral felodipine resulted in more pronounced haemodynamic effects of the drug as measured by diastolic blood pressure and heart rate; however, the haemodynamic effects of the intravenous administration were not affected. Vascular-related adverse events were reported more frequently when oral drug administration was preceded by juice intake when compared with the control treatment. Taking grapefruit juice immediately prior to intravenous felodipine administration did not cause any alteration in the adverse event pattern. It has been concluded that only intestinal CYP3A4 is inhibited by grapefruit juice, while liver CYP3A4 enzymes are not affected. In addition to grapefruit juice, the fruit itself should also be consumed with caution or avoided altogether. Several studies now indicate that grapefruit juice should be avoided in patients taking interacting drugs until their physician or pharmacist has counseled them. References: Kane, GC, & Lipsky, JJ (2000): Drug-grapefruit juice interactions. Mayo Clin. Proc. 75, 933-942. Bailey, DG; Malcolm, J; Arnold, O; & Spence, JD (1998): Grapefruit juice — drug interactions. Br. J. Clin. Pharmacol. 46, 101-10. Bailey, DG; Spence, JD; Edgar, B; Bayliff, CD; & Arnold, JM (1989): Ethanol enhances the hemodynamic effects of felodipine. Clin. Invest. Med. 12, 357-362. Bailey, DG; Spence, JD; Munoz, C; & Arnold, JM (1991): Interaction of citrus juices with felodipine and nifedipine. Lancet 337; 268-69. Kolars, JC; Schmiedlin, Ren P; Schuetz, JD; Fang, C; & Watkins, PB (1992): Identification of rifampin-inducible P450IIIA4 (CYP3A4) in human small bowel enterocytes. J. Clin. Invest. 90; 1871-78. Lundahl, J; Regardh, CG; Edgar, B; & Johnsson, G (1997): Effects of grapefruit juice ingestion æ pharmacokinetics and haemodynamics of intravenously and orally administered felodipine in healthy men. Eur. J. Clin. Pharmacol. 52; 139-45. Pharmacist Letter/Prescriber Letter (2007): Potential Drug Interactions with Grapefruit. 23:1-3. 19 Potential Drug Interactions with Grapefruit Drugs Grapefruit Juice Influence Potential Risk Amitriptyline (Elavil) None None Amiodarone (Cordarone) Increases AUC by 50 percent Arrthymias Benzodiazepines Diazepam (Valium) Midazolam (Versed) Quazepam (Doral) Triazolam (Halcion) Increases AUC and plasma concentrations. No interaction seen with IV midazolam. Alprazolam does not appear to interact. Increased sedaton Budesonide (Entocor ECt) Increases oral absorption Hypercorticism Buspirone (BuSpar) Increases absorption and plasma concentration Not clinically significant Caffeine Decreases caffeine clearance Increased nervousness or insomnia Calcium Channel Blockers Amlodipine (Norvasc) Diltiazem (Cardizem) Felodipine (Plendil) Nicardipine (Cardene) Nifedipine (Procardia) Nimodipine (Nimotop) Nisoldepine (Sular) Verapamil (Calan) Increases AUC and serum concentrations, most likely the result of grapefruit inhibiting the intestinal metabolism by CYP3A4. No data on Isradipine (DynaCirc) Flushing, headache, tachycardia, hypotension Carbamazepine (Tegretol) Increases AUC, peak and trough concentrations Dizziness, ataxia, drowsiness, nausea, vomiting, tremor agitation Carvedilol (Coreg) Increases bioavailability of a single dose by 16 percent Not clinically significant Cilostazol (Pletal) Increases peak Not clinically significant Cisapride (Propulsid) Increases AUC None Clarithromycin (Biaxin) Delays absorption Not clinically significant Clomipramine (Anafranil) Increases plasma concentration Dry mouth, somnolence, dizziness, fatigue Clozapine (Clozaril) None None Cyclosporine (Neoral) Increases AUC Nephrotoxicity, hepatotoxicity, increased immunosuppression Desloratidine (Clarinex) None None Dextromethorphan (Robitussin) AUC increased Drowsiness Digoxin (Lanoxin) Slight increase in AUC Not clinically significant Fluvoxamine (Luvox) Peak and AUC increased Nausea HMG CoA Reductase Inhibitors Atorvastatin (Lipitor) Lovastatin (Mevacor) Simvastatin (Zocor) Increases absorption and plasma concentration Headache, GI complaints, muscle pain Haloperidol (Haldol) None None Losartan (Cozaar) Reduces AUC of active metabolite Hypotension, dizziness, tachycardia, syncope, hyperkalemia Methadone (Dolophine) Increases peak levels and AUC Not clinically significant Saquinavir (Fortovase) Increases absorption and plasma concentration Fatigue, headache, insomnia, anxiety Sertraline (Zoloft) Increases serum concentration Unknown Sildenafil (Viagra) Increases AUC Hypotension, tachycardia Tacrolimus (Prograf ) Increases trough Hypertension, headache, tremor, insomnia Theophylline (Theo-Dur) Decreases AUC and delays time to peak None Warfarin (Coumadin) No effect up to three glasses a day Increased INR with > than 3 glasses 20 Correct Rx New Drug Profile ATRIPLA On July 12, 2006, through a joint venture by Bristol-Myers Squibb and Gilead Sciences, Atripla was developed as the first once-daily single tablet regimen for adults with HIV-1 infection. Atripla is the result of the FDA’s push to simplify the dosing of HIV medications for patients. Efavirenz, emtricitabine and tenofovir as a single pill administered once daily is shown to be equally efficacious and safe as administering the three medications individually. The U.S. Department of Health and Human Services (DHHS) lists the three components of Atripla to be among the preferred agents for the treatment of HIV-1. The cost of taking Atripla is equivalent to taking the three medications individually or taking the emtricitabine/tenofovir combination with the efavirenz. Description: Atripla is a fixed-dose combination containing 600 milligrams of efavirenz, 200 milligrams of emtricitabine and 300 milligrams of tenofovir DF. Dose: One tablet orally once daily on an empty stomach. Dosing at bedtime can improve the tolerability of nervous-system symptoms. Patients with CrCl < 50 mL/min should not receive Atripla. Mechanism of Action: • Efavirenz is a non-nucleoside reverse transcriptase inhibitor. • Emtricitabine is a synthetic nucleoside analog of cytidine. Correct Rx • Tenofovir disoproxil fumarate is an acyclic nucleoside phosphate analog of adenosine 5’-monophosphate. FDA-Approved Indication: Use alone as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. Warnings: • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination with other antiretrovirals. • Atripla is not indicated for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of Atripla have not been established in patients coinfected with HBV and HIV. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued Emtriva or Viread. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue Atripla and are coinfected with HIV and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted. Drug Interactions: • Atripla should not be administered concurrently with astemizole, cisapride, midazolam, triazolam or ergot deriva- • • • • • tives because competition for CYP3A4 by efavirenz could result in inhibition of metabolism of these drugs and create the potential for serious and/or lifethreatening adverse events (eg, cardiac arrhythmias, prolonged sedation or respiratory depression). Atripla should not be administered with voriconazole because efavirenz significantly decreases voriconazole plasma concentrations. Atripla should not be coadministered with lamivudine, including Combivir, Epivir, Epivir-HBV, Epzicom or Trizivir. Patients should avoid taking St. John’s Wort when taking Atripla due to decreased efavirenz plasma levels. Rifabutin concentrations are decreased by 50 percent. Consider doubling rifabutin dose in regimens where rifabutin is given two or three times a week. See package insert for complete drug interactions. Adverse Reactions: See individual package insert for side-effect profile. Most significant adverse reactions include nervous system symptoms, psychiatric symptoms and rash. Lab Interactions: The efavirenz portion of Atripla can cause false positive tests for cannabinoids when the DEDIA DAU Multilevel THC assay is used. Please refer to www.atripla.com for more information. 23 Medications of Abuse: A 2004 survey administered by the Bureau of Justice Statistics stated that, based on the DSMIV criteria, 55 percent of state inmates and 45 percent of federal inmates were identified with issues by Kesha N. O’Reilly, Pharm.D. stemming from substance dependency or abuse. The majority of these individuals had an extensive criminal record, consisting of at least three prior sentences of probation or incarceration. More than a third of state and a fourth of federal inmates committed crimes while under the influence of drugs. In addition, 17 percent of state and 18 per- 24 cent of federal prisoners committed crimes to obtain money for drugs1. Agents of substance abuse may be illicit drugs, alcohol or prescription medications. including their past patterns of alcohol, illicit drug and prescription drug use. Consequently, screening results may impact the medical providers’ prescribing habits.2, 3 Substance abuse does not discontinue once inmates enter the correctional facilities. Inmates may manipulate policies and procedures to demand medication under the guise of controlling their addiction. Medical screening plays an important role in identifying substance-use history. Medical providers must integrate basic screening questions into all histories and physical examinations. Medical conditions, such as acute or chronic pain, anxiety disorders and attention-deficit disorders, may contribute to substance abuse. Physicians treating such patients must ask them about their substance-use history, Prescription medications are common agents of abuse in the community and correctional settings. Opioid analgesics, sedative hypnotics and stimulants are common medications that have a high potential for abuse. In addition, abuse has been documented in anticholinergics, such as benztropine (Cogentin®), trihexyphenidyl (Artane®), and diphenhydramine (Benadryl®)2, 3. There have been several reports of increased illicit use of newer prescribed psychotropic medications in correctional facilities. Bupropion (Wellbutrin®, GlaxoSmithKline), Correct Rx Patient Screening gabapentin (Neurontin®, Pfizer), olanzapine (Zyprexa®, Eli Lilly), and quetiapine (Seroquel®, AstraZeneca) are on the wish lists of many inmates seeking a quick fix. In addition, these medications become very popular commodities for negotiation. Olanzapine and quetiapine are abused for their sedative and anxiolytic activity. Inmates want to sleep and dissociate themselves. Bupropion, an antidepressant with dopaminergic and noradrenergic properties, is crushed and snorted for stimulant effects. The contents of a gabapentin capsule are inhaled intranasally to numb the irritating nasal effect of bupropion4, 5. There have been several reports of inmates — those with documented mental health issues and in need of these medications — finding themselves on the wrong end of an addict’s Correct Rx solution. The drug abusers harass, sometimes verbally and physically, inmates with legitimate need of these medications. When all else fails, some prisoners falsely display symptoms of mental health problems in hopes of obtaining the pills directly6. How do we solve this growing epidemic? Preventative steps must be explored to better monitor the aforementioned issues of drug abuse in the prison system. The mismanagement of inmate care has a lasting effect on the overall rehabilitation module, with each case spawning monetary and social consequences. We, as pharmacists and medical administrators, must do all we can do proactively to solve this medicinal riddle. Sources: 1. Mumola, CJ; Karberg, JC. Bureau of Justice Statistics Special Report: Drug Use and Dependence, State and Federal Prisoners, 2004. NCJ October 2006 2. Longo, LP, et al. Addiction: Part II. Identification and Management of the Drug-Seeking Patient. Am Fam Physician 2000; 61:2401-8 3. Christensen, RC. Screening for anticholinergic abuse in patients with chronic mental illness. Am J of Emerg Med. 2003; 21(6):508 4. Christensen, RC; Garces, LK. The growing abuse of commonly prescribed psychiatric medications. Am J of Emerg Med. 2006; 24(1):137-8 5. Pierre, JM; et al. Intranasal Quetiapine Abuse. Am J Psychiatry. 2004; 161(9):1718 6. Della Volpe. Intervention Reduces Abuse of Psychotropic Medications in Correctional Facility. Pharmacy Practice News. 2005; 32:09 25 barcode scanning technology In an effort to provide improved services to our customers, Correct Rx Pharmacy Services embarked on a project to investigate the utility of advanced technology. The goal was to enhance the process of delivering services to by Don Bossle our customers and ease the processing of orders by the facilities. After much research, Correct Rx determined that barcode scanning technology would provide the greatest benefit. Internal Process Improvements Barcode scanning improves both the timeliness and the accuracy of the shipping department. Correct Rx ships thousands of orders a day from our centralized pharmacy. Prior to imple- 26 menting the barcode scanning technology, each order had to be manually inspected before being placed into the shipping container. Phase 1: Internal Verification of Orders Phase 1 of the barcode scanning project was implementing the use of radio-frequency scanners in our shipping department. The scanners communicate with the main computer system to verify that the order being scanned is a valid order and that the medication is being placed into the proper shipping carton. The scanner indicates a conflict by displaying a visual alert on the scanner screen in addition to an auditory alert. A shipping manifest is printed for the facilities once the orders for the day have been completed. The report identifies the pharmacy personnel that scanned each order into the carton; the report also shows orders that have not yet been scanned. A supervisor then investigates any discrepancies. Due to the implementation of the barcode scanning technology, Correct Rx has experienced increased accuracy in the shipping department with the benefit of accountability for each medication order. Correct Rx has received positive feedback from all of our customers. Customer Enhancements In addition to Correct Rx improving our own internal process, the barcoding technology was developed to assist the customers at the facility level. As a result of Phase 1, Correct Rx can post shipping reports electronically on our Web site after the orders are completed. Customers can login on a secure site with a personal identification and password and see the shipping report before they even receive the shipment. The facility can also view discrepancies — and their reason — via the Web site. This allows the clients to be Correct Rx proactive in handling any potential problems with their medications. Phase 2 of the barcode project involved using the scanners to check in the orders received from Correct Rx. At a large facility, Correct Rx found that the barcode scanner can reduce a twohour process to less than 15 minutes per day. Phase 3 of the barcode project allowed refills to be reordered via the Internet. Phase 2: Checking in Orders Prior to the use of scanners, the facilities manually checked the orders in by comparing each medication label against the printed manifest that was included with their daily shipment. This was very time-consuming for the health care staff. Phase 2 of the barcode project was to install barcode scanners at the facility, so the health care staff could use the scanners to check in the orders online. The scanning program is a Web-based application and does not require software that has to be loaded onto the computer. Once the facility processes the shipment, staff members can verify if any orders were missing. Any missing items in the shipment are alerted to show in red on the computer. These reports are maintained electronically for 30 days. Phase 3: Medication Reorders Phase 3 of the barcode scanning project made online medication reordering possible. Before the scanners were in use, refills were reordered by removing the refill stickers from the original label, affixing them to a reorder form, photocopying the form (so as to not jam the fax machine), and faxing that form to the pharmacy. Now, facilities utilizing a scanner can log into our Web site, choose the reorder function, and scan the barcodes. Reorders can be processed in bulk or as each group of patients are reviewed. The reorders are electronically transmitted to Correct Rx, and a report is generated for the facility. This report acts as a confirmation in the verification process. Scanning reorders via the Internet saves nursing time and reduces the possibility of error in the reorder process. Barcode & Data Collection Systems Let us analyze your applications today! Inventory control Lab management Order validation (RF and web) Asset tracking Workflow Admissions Cycle count Med cart automation Services: Products: Functional analysis Software development Integration Barcode printers Support and service Scanners Equipment maintenance Portable terminals Warehousing, RF infrastructure, RFID Future Enhancements Correct Rx foresees additional technological enhancements in the future. With the coming of electronic medical records, we will be able to use the same scanners to document the delivery of the medication directly to the patient. Correct Rx is very excited about the results of this project and is looking into other technologies that we can adopt to improve service to our customers. We believe that the use of barcode technology has propelled Correct Rx to the forefront of our industry and has given us a competitive advantage in the marketplace. We must continue to investigate electronic tools that will make it easier for clients to transact business with Correct Rx. Please stay tuned for future technological improvements. Correct Rx Custom and stock labels 301-596-7500 9693 Gerwig Lane, Suite J Columbia, MD 21046 [email protected] 27 Clinical Management of Hepatitis B Virus Infection 28 Correct Rx Hepatitis B virus (HBV) is a public health problem worldwide; approximately 30 percent of the world’s population has serologic evidence of past infection. by Sankung Sise, Pharm.D. HBV is the cause of nearly 1 million deaths per year. There are 350 million chronic carriers worldwide. HBV is common in Asia, Africa and the Middle East. In North America, the incidence of known carriers is about one person in a 1,000. In the United States, more than 1 million individuals are reported to have chronic HBV infection. Carriers of HBV are at increased risk of developing cirrhosis, hepatic decompensation and hepatocellular carcinoma. Transmission The hepatitis B virus is transmitted by the exchange of body fluids (e.g., blood, semen, breast milk and saliva). In Southeast Asia, China, and sub-Sahara Africa, the virus is usually transmitted perinatally or in early childhood. In the United States and the Western world, the virus is transmitted through unprotected sexual intercourse, intravenous drug abusers who share needles and syringes, health care workers in contact with potentially contaminated blood or body fluids, and anyone in intimate contact with an infected person. The hepatitis B virus is a DNA virus that replicates within infected liver cells (hepatocytes). The DNA particle is enclosed in a nucleocapsid, or core antigen, which is surrounded by a spherical envelope (surface antigen). If the virus gets past the immune system, its initial response when entering the body of a new host is to infect a liver cell. After it attaches to the membrane of a hepatocyte, the core particle enters the cell and releases its contents of DNA and DNA polymerase into the liver cell nucleus. From within the cell nucleus, the hepatitis B DNA, via messenger RNA, causes the liver cell to produce surface proteins (HBs), the core protein (HBc), DNA polymerase, the HBe protein, HBx protein, and possibly other as yet undetected proteins and enzymes. The incubation of the hepatitis B virus is about six to 25 weeks. Correct Rx Acute Hepatitis B Infection Acute hepatitis B occurs in approximately 35 percent of infected adults. Acute hepatitis can be categorized as mild, severe or fulminant. Signs and symptoms of acute HBV include fever, jaundice, nausea, abdominal pain and malaise. A diagnosis is made by serologic detection of IgM anti-HBc and hepatitis B surface antigen (HBsAg). No effective therapies are available for acute HBV infection; treatment is based on supportive therapy. Individuals with acute HBV should be monitored during convalescence and prevent development into chronic HBV infection. Chronic Hepatitis B Infection Diagnosis of chronic HBV infection is confirmed by the serologic detection of HBsAg on two separate occasions, six months apart. Alternatively, diagnosis for HBV may be made with the onetime detection of HBsAg, if patient is total-HBcpositive, IgM anti-HBc-negative and has elevated ALT level for three consecutive months (ALT levels more than 1.3 times the upper limit of normal). The goal is to prevent the spread of virus to other people, improve the patient’s quality of life, and cure the disease where possible. Treatment Indications • HBsAg-positive documented for 6-12 months • Active viral replication (HBV DNA >10 5 cps/mL) • Chronic liver inflammation by elevated ALT level • Necroinflammation of liver biopsy References: Befeler, A.S., and Di bisceglie, A.M. Hepatitis B. Infect Dis Clin North Am 2000; 14:617-32. Lok, A.S., and Mcmahon, B.J. Chronic Hepatitis B ASSLD practice guidelines. Lok, A.S., and Mcmahon, B.J. Chronic hepatitis B: Update of recommendations. Hepatology 2004:39:857-61. 29 Medication Indication Comments Adefovir Hepsera Treatment of chronic hepatitis B in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases or histologically active disease • 10mg PO QD without regard to food • Dosage adjustment necessary in renal impairment • Optimal duration of treatment is unknown • Black Box warning on acute exacerbations of hepatitis in patients who have discontinued anti-hepatitis B therapy. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. • Black Box warning on nephrotoxicity in patients who have underlying renal problems • Black Box warning on the emergence of HIV resistance in chronic HBV patients with unrecognized or untreated HIV infection • Black Box warning on lactic acidosis and severe hepatomegaly with steatosis Entecavir Baraclude Treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases or histologically active disease • > 16 years: 0.5 mg PO QD on empty stomach • History of hepatitis B viremia while receiving lamivudine or known lamivudine resistance mutations: 1mg PO QD • Dosage adjustment is necessary in renal impairment. • Black Box warning on lactic acidosis and sever hepatomegaly with steatosis • Optimal duration of treatment is unknown. • Black Box warning on severe acute exacerbations of hepatitis B has been reported in patients who have discontinued anti-hepatitis B therapy. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. Lamivudine Epivir HBV Treatment is indicated for the treatment of chronic hepatitis B associated with evidence of hepatitis B viral replication and active liver inflammation • 100mg PO QD • Same drug to treat HIV in lower doses. Dose appropriately. If patient is co-infected, the higher dosage is indicated. • Dosage adjustment necessary in renal impairment • Optimal duration of treatment is unknown. • Black Box warning on lactic acidosis and severe hepatomegaly with steatosis • Black Box warning on severe acute exacerbations of hepatitis B has been reported in patients who are co-infected with HBV and HIV and have discontinued Epivir. Hepatic function should be monitored closely, with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. Telbivudine Tyzeka Treatment of chronic hepatitis B in adult patients with evidence of viral replication and either evidence of persistent elevations in serum aminotransferases or histologically active disease • 600mg PO QD regardless of food • Dosage adjustment necessary in renal impairment • Optimal duration of treatment is unknown. • Black Box warning on lactic acidosis and severe hepatomegaly with steatosis • Black Box warning on acute exacerbations of hepatitis in patients who have discontinued anti-hepatitis B therapy. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. Interferon alfa-2b Intron A Treatment of chronic hepatitis B in patients 1 year of age or older with compensated liver disease. Patients who have been HBsAg-positive for at least 6 months and have evidence of HBV replication with elevated serum ALT • Adults: 30 to 35 mIU SQ or IM QW dosed either as 5mIU QD or 10mIU TIW for 16 weeks • Children: 3mIU/m2 SQ TIW x 1 week then dose escalation to 5mIU/m2 SQ TIW (max:10 mIU TIW) for 16 to 24 weeks. • Dosage adjustments necessary if decreased WBC, granulocyte count or platelet count • Prior to treatment, it is recommended that liver biopsy be performed to establish the presence of chronic hepatitis and the extent of liver damage. • Baseline CBC and platelet counts should be done prior to therapy Pegylated interferon alfa-2a Pegasys Treatment of adult patients with HBeAg-positive and HBeAg-negative chronic hepatitis B virus infection who have compensated liver disease and evidence of viral replication and liver inflammation • 180mcg SQ QW for 48 weeks in abdomen or thigh • In patients with end-stage renal disease requiring hemodialysis: dosage of 135mcg is indicated • Black Box warning may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic and infectious disorders. Biologic and Immunological Agents Drug Class Antivirals Hepatitis B Treatment Options 30 Correct Rx 32 Correct Rx Correct Rx 33 To be successful in any business, you need the right kind of help. Let us help you create a quality publication that you can be proud of. For more information, contact Aran Jackson at 502.423.7272 or [email protected]. www.ipipublishing.com 34 Correct Rx A Prescription to Cure Rising Drug Costs Medication Therapy Management • Collaborative Interventions • Ask a Pharmacist - Clinical Drug Information Service Formulary Management • On-Site Visits by Experienced Clinical Pharmacists • Innovative Web-Based Technology 1.800.636.0501 Ellen H. Yankellow, PharmD, President and CEO www.correctrxpharmacy.com “If it’s the right way, it’s the correct way.” “If it’s the right way, it’s the correct way.”