Prospective Analysis of Patient Education Time and Administration Errors Associated with Administration of Pegasys versus Peg-Intron

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1 Prospective Analysis of Patient Education Time and Administration Errors Associated with Administration of Pegasys versus Peg-Intron David Finkelman, MD, MBA Janet McRea, LPN Reprint requests to: David Finkelman, MD, MBA 3834 Austell Road, Suite A Marietta, GA Phone: Fax: Dfmex50@aol.com Time and Administration Errors of Pegasys versus Peg-Intron 1

2 Introduction Chronic hepatitis C virus (HCV) infection is one of the leading causes of liver disease in the United States and worldwide 1. It is a common cause of cirrhosis and hepatocellular carcinoma, and is the most frequent indication for liver transplantation. The Third National Health and Nutrition Examination Survey (NHANES) demonstrated that 3.9 million Americans (1.8% of the population) have been infected with HCV, based on the presence of detectable anti-hcv antibodies 2. Probably less than half of these patients have been identified clinically, but recent educational efforts by a number of groups is leading to an increased number of diagnosed cases of chronic hepatitis C. A majority of these patients are candidates for antiviral therapy. There have been significant advances in antiviral therapy for chronic hepatitis C over the past 10 years since the initial availability in 1991 of the standard interferons, interferon alfa-2b (Intron A, Schering-Plough Corporation, Kenilworth, NJ) and interferon alfa-2a (Roferon A, Roche Laboratories, Nutley, NJ). The overall sustained virological response (SVR) rate, i.e., cure, has improved from 5-10% with 24 weeks of standard interferon monotherapy, based on an early meta-analysis 3, to 55-60% with the combination of either peginterferon alfa-2a (Pegasys, Roche Laboratories, Nutley, NJ) or peginterferon alfa-2b (Peg-Intron, Schering-Plough Corporation, Kenilworth, NJ) plus ribavirin (Copegus, Roche Laboratories, Nutley, NJ, or Rebetol, Schering- Plough Corporation, Kenilworth, NJ) 4,5. During this same time period, the SVR rate in patients with genotype 1, the most common and more difficult to treat, has increased from 2-5% to 45-50% with 48 weeks of combination peginterferon plus ribavirin therapy. Patients infected with genotypes 2 or 3 and treated with peginterferon plus ribavirin can expect a 75-80% SVR with only 24 weeks of therapy. It is important to note that treatment duration and ribavirin exposure are not class effects of the peginterferon and ribavirin products. The response ranges presented are based on data from three separate randomized, controlled clinical trials 4, 5, 6. Nevertheless, these improvements in treatment outcomes have led to more enthusiasm among patients and physicians to treat chronic hepatitis C with combination peginterferon plus ribavirin therapy. Appropriate candidates for treatment include patients with persistently or intermittently elevated alanine aminotransferase (ALT) levels, detectable serum HCV RNA, and, if liver biopsy is performed, stages 2 to 4 fibrosis (some also consider stage 0 to 1 fibrosis an indication for treatment if active inflammation is present). 1 With the increasing number of HCV-infected patients receiving antiviral therapy, physicians are seeking methods to economize time committed to the education of patients both prior to therapy and during follow-up care while on therapy. Given the nationwide shortage of nurses, steps that can be taken to optimize productivity and efficiency will allow for more effective use of precious nursing resources. Additionally, methods to increase patient adherence to therapy are critically important to achieve optimal clinical outcomes, especially given the challenges associated with patient management of the combination therapy regimen, along with the need for frequent follow-up monitoring and physician visits 7. A recent study by McHutchison and colleagues demonstrated that adherence to combination peginterferon plus ribavirin therapy enhances sustained virological response in genotype 1 patients with chronic hepatitis C 7. Peg-Intron (peginterferon alfa-2b) is available as a powder that must be reconstituted with diluent prior to injection, and administered immediately following reconstitution. Because of the wide distribution of the drug throughout body fluids and tissues, Peg-Intron must be administered as an individualized dose based on body weight (usually 1.5 µg/kg) 8, 9. Since approximately 30% of patients were reported to have lost weight in the pivotal clinical trial conducted by Manns and colleagues, the weight loss that is fairly commonly seen in patients receiving combination Peg-Intron and ribavirin therapy may lead to confusion with respect to dosing by body weight with resultant dosing errors 5. In contrast, Pegasys (peginterferon alfa-2a) is available as a ready-to-use solution, and is administered as a fixed dose of 180 µg owing to the restricted biodistribution of the drug with highest concentrations occurring in the liver 10. The purpose of this study was to determine the time commitment necessary to educate patients regarding administration of these respective medications, and to assess the number of dosing errors, followup calls and questions and treatment compliance. Methods Consecutive patients with chronic hepatitis C who met standard criteria for treatment and were scheduled to receive Pegasys or Peg-Intron plus ribavirin were asked to participate in this administration study. This study was approved by the Institutional Review Board, and all patients signed informed consent. There were 15 study subjects, with 10 patients 2 Time and Administration Errors of Pegasys versus Peg-Intron

3 receiving Pegasys plus ribavirin and 5 patients receiving Peg- Intron plus ribavirin. The demographics of the patients participating in this study and the details of drug administered are displayed in Table 1. All patients participated in an initial treatment orientation that lasted 30 minutes. After completion of this orientation, a designated nurse monitored follow-up questions asked by each patient, and the time that was spent with these interactions. At the completion of the monitoring session, a patient preference survey was administered to each patient. This survey was developed to be at a seventh grade reading level. This survey was repeated at 30 days follow-up. Results The nursing time spent in orientation and follow-up, and the number of mistakes made by the patient during selfadministration as observed by the nurse, are displayed in Table 2. The mean nursing instruction time, administration time, and total nursing communication time with patients were substantially greater for those receiving Peg-Intron versus Pegasys (Figure 1). Figure 2 displays the patient survey results of mean patient preparation time and time to self-inject properly. The first and second survey responses indicated that the time required for proper self-injection was considerably greater for Peg-Intron, and the second patient survey showed that the preparation time as well as time for proper self-injection were both higher for Peg-Intron. Figure 3 displays the number of dosing questions and number of mistakes made during self-administration by patients. The total number of mistakes was greater with Peg-Intron (n=15) compared with Pegasys (n=9). Similarly, the average number of mistakes per patient was substantially greater with Peg-Intron (n=3) compared with Pegasys (n=0.9). There were also a greater number of dosing questions related to Peg-Intron (7.8 versus 4.4). Discussion The majority of patients being treated for chronic hepatitis C are under the care of gastroenterologists, hepatologists, or, in some cases, other physicians such as those with expertise in treating infectious diseases. Most physicians treating a large number of HCV-infected patients in their practice are making efforts to increase the efficiency of the process of managing these patients, including education regarding treatment and monitoring while receiving therapy. This process frequently involves the participation of other health care providers, often a registered nurse, nurse practitioner, or physician s assistant, who plays the major role in the initial orientation and education of patients regarding antiviral therapy, as well as monitoring of questions related to ongoing drug administration or side effects. Another important aspect of caring for patients with chronic hepatitis C is to encourage and monitor adherence to therapy in order to optimize SVR and overall treatment outcomes. In addition to key factors such as the presence of side effects and impact on quality of life, adherence to therapy is influenced by the convenience versus complexity of the dosing regimen. The two currently licensed drugs, Pegasys and Peg-Intron, are different in several respects from the standpoint of drug administration. Peg-Intron is available as a powder, which requires reconstitution with a diluent, and then immediate administration in the proper dose based on body weight. There is a 17-step process involved in administration of Peg- Intron (Table 3), which allows for potential errors at many different steps in the preparation of the drug for subcutaneous injection. In contrast, Pegasys is available as a ready-to-use solution and is administered in a fixed dose in an 11-step process, which should theoretically lead to easier education, preparation and administration. This study demonstrates that the average nursing time spent in educating patients regarding administration of their antiviral drugs was greater for patients receiving Peg-Intron than Pegasys. Patients also reported higher mean times to prepare and inject Peg-Intron versus Pegasys. Finally, there were a greater number of mistakes made in the process of injection with Peg-Intron than Pegasys, and an increase in the average number of dosing questions referred back to the nurse. In summary, Pegasys is easier to administer than Peg-Intron, and its administration is associated with fewer medication errors. Time and Administration Errors of Pegasys versus Peg-Intron 3

4 References 1. National Institutes of Health Consensus Development Conference Statement: Management of Hepatitis C: June 10-12, Hepatology 2002;36(suppl.1):S3-S Alter MJ, Kruszon-Morand D, Nainon OV et al. The prevalence of hepatitis C virus infection in the United States, 1998 through N Engl J Med 1999;341: Poynard T, Leroy V, Cohard M et al. Meta-analysis of interferon randomised trials in the treatment of viral hepatitis: effects of dose and duration. Hepatology 1996;24: Fried MW, Shiffman ML, Reddy KR et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med 2002;347: Manns MP, McHutchison JG, Gordon SC et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: A randomised trial. Lancet 2001;358: Hadziyannis SJ et al. Peginterferon alfa-2a (40 KD) (PEGASYS) in combination with ribavirin (RBV): efficacy and safety results from a phase III, randomized, double-blind multicentre study examining effect of duration of treatment and RBV dose. J Hepatol 2002;36:(S1)p3. 7. McHutchinson JG, Manns M, Patel K, et al. Adherence to combination therapy enhances sustained response in genotype-1-infected patients with hepatitis C. Gastroenterology 2002;123: Lindsay, KL, Trepo C, Heintges T et al. A randomized, double-blind trial comparing pegylated interferon alfa-2b to interferon alfa-2b as initial treatment for chronic hepatitis C. Hepatology 2001;34: Peginterferon alfa-2b product monograph. 10. Modi MW, Fulton JS, Buckmann DK etal. Clearance of pegylated (40 kda) interferon alfa-2a is primarily hepatic. Hepatology 2000;32(suppl):371A (Abstract). 4 Time and Administration Errors of Pegasys versus Peg-Intron

5 Table 1. Demographics and drug information of 15 study subjects. Drug Height (in.) Weight (lb.) Gender Dosage Vial size Pegasys 5'6" 185 F 1 cc 180 mcg Pegasys 5'6" 178 F 1 cc 180 mcg Pegasys 5'5" 136 F 1 cc 180 mcg Pegasys 5'4" 166 F 1 cc 180 mcg Pegasys 5'4" 106 F 1 cc 180 mcg Pegasys 5'2" 155 F 1 cc 180 mcg Pegasys 6'5" 225 M 1 cc 180 mcg Pegasys 5'8" 174 M 1 cc 180 mcg Pegasys 6'0" 225 M 1 cc 180 mcg Peg-Intron 6'0" 223 M.5 cc 150 mcg Peg-Intron 5'11" 212 M.5 cc 150 mcg Peg-Intron 5'6" 139 F.5 cc 80 mcg Peg-Intron 6'8" M.5 cc 150 mcg Peg-Intron 5'3" F.5 cc 120 mcg Pegasys 5'1" 194 F 1 cc 180 mcg Table 2. Nursing education and communication time and mistakes with patient self-administration of study drug. Drug No. of No. of Nurse Nurse Total No. of Follow-up Total Dosing Mistakes Instruction Administration Nurse Follow-up Time in Nurse Questions Made Time Time Orientation Phone Minutes Communication in First During Self- Time Calls Time Orientation Injection Pegasys Pegasys Pegasys Pegasys Pegasys Pegasys Pegasys Pegasys Pegasys Pegasys Mean Peg-Intron Peg-Intron Peg-Intron Peg-Intron Peg-Intron Mean Time and Administration Errors of Pegasys versus Peg-Intron 5

6 Table 3. Comparison of administration instruction steps Pegasys vs Peg-Intron (adapted from Pegasys and Peg-Intron Medication Guides) PEGASYS 1. Collect materials (Pegasys Convenience Pack includes Pegasys, safety syringes and needles with needle-stick protection device attached, and alcohol pads) 2. Check expiration date on carton and check medicine for cloudiness, discoloration, particles (Pegasys should be clear liquid) 3. Gently warm medicine by rolling in palms of hands for ~ 1 minute 4. Wash hands with soap and water 5. Decide where to give injection 6. Prepare skin for injection; clean area using alcohol pad 7. Flip off plastic top covering Pegasys vial opening and clean rubber stopper on top of vial with different alcohol pad 8. Remove clear protective cap from end of needle; pull plunger back so end is to the mark on the syringe barrel that matches dose prescribed; push needle through center of stopper on vial; slowly inject air from syringe into air space above solution; keep needle inside vial and turn both upside down, holding vial and syringe straight up; slowly pull back on plunger until medicine is in syringe up to the mark that matches dose; take syringe and needle out of rubber stopper on vial 9. Remove air bubbles from syringe PEG-INTRON 1. Check expiration date on carton and inspect contents of vial (Peg-Intron should appear as white tablet-shaped solid that is whole or in pieces or white powder) 2. Wash hands with soap and water 3. Collect supplies and place on a clean work area (Peg-Intron package contains vial of Peg-Intron powder, a 1-mL vial of DILUENT, 2 disposable syringes and alcohol pads) 4. Remove protective wrapper from ONE of syringes provided and use for steps Remove protective plastic cap from tops of both DILUENT and Peg-Intron vials; clean rubber stopper on top of both vials with alcohol swab 6. Remove protective cap from needle and fill syringe with air by pulling plunger to 0.7 ml; hold DILUENT vial upright; insert needle through rubber stopper of DILUENT vial and inject air in the syringe into the vial; turn vial upside down and make sure tip of needle is in liquid. Withdraw only 0.7 ml of DILUENT by pulling plunger back to exactly 0.7 ml; remove needle from vial and discard remaining DILUENT 7. Insert needle through rubber stopper of PEG- Intron vial; place needle tip against glass wall of vial. Slowly inject 0.7 ml DILUENT so that stream of DILUENT runs down glass wall of vial. Remove needle from vial; pull safety guard over needle and dispose per step 17 below. A new syringe will be used for injection of the medication. To dissolve Peg-Intron, gently swirl vial in circular motion until Peg-Intron completely dissolved 8. After solution has settled and all bubbles have risen to top, solution should be clear, colorless and without particles. Solution should be used immediately. 9. After Peg-Intron powder is dissolved, clean rubber stopper again with alcohol swab 6 Time and Administration Errors of Pegasys versus Peg-Intron

7 Table 3. Continued PEGASYS PEG-INTRON 10. Give injection of Pegasys 11. Cover needle with needle-stick protection device; place used syringes/needles in puncture-resistant container 10. Unwrap second syringe provided. Remove protective cap from needle and fill syringe with air by pulling plunger to number (ml) that corresponds to prescribed dose. Hold Peg-Intron vial upright; insert needle into vial containing Peg- Intron solution and inject air into the vial 11. Turn Peg-Intron vial upside down; be sure tip of needle in Peg-Intron solution. While holding vial and syringe with one hand, slowly pull plunger back to withdraw into syringe the exact amount of Peg-Intron prescribed 12. Remove needle from vial and check for air bubbles on syringe; remove air bubbles as needed 13. Select site for injection 14. Clean skin where injection is to be given with alcohol swab 15. Give injection of Peg-Intron 16. Press alcohol swab over injection site for several seconds 17. Cover needle with needle-stick protection device. Discard syringe and needle in Sharp s container supplied Minutes Pegasys PEG-Intron Instruction Administration Follow-up Total Time Time Time Communication Time Patients Enrolled: Pegasys = 10; PEG-Intron = 5 Figure 1. Average nursing communication time with patients. Time and Administration Errors of Pegasys versus Peg-Intron 7

8 Minutes Pegasys PEG-Intron Prep Time Proper Self-Injection Prep Time Proper Self-Injection (1 st Survey Patient Response) (2 nd Survey Patient Response) Patients Enrolled: Pegasys = 10; PEG-Intron = 5 Figure 2. Patient survey results for average patient preparation time and time to self-inject properly Total Number Pegasys PEG-Intron # of Dosing # of Mistakes Avg. # of Avg. # of Questions Dosing Questions Mistakes Patients Enrolled: Pegasys = 10; PEG-Intron = 5 Figure 3. Number of dosing questions and mistakes made during self-administration by patients. 8 Time and Administration Errors of Pegasys versus Peg-Intron

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