Compounded Medications in Workers Compensation

Transcription

1 Compounded Medications in Workers Compensation 0

2 ADMINISTRATIVE DETAILS 1

3 To Receive Continuing Education Credit 1. Remain logged on for the entire webinar 2

4 To Receive Continuing Education Credit 1. Remain logged on for the entire webinar 2. Answer all five poll questions 3

5 To Receive Continuing Education Credit 1. Remain logged on for the entire webinar 2. Answer all five poll questions 3. Complete the Learner Feedback/Record of Attendance Form and submit form via to no later than July 28, Once all attendance and participation requirements are verified, certificates of credit/completion will be awarded within 21 days. 4

6 Technical Issues? Immediately to let us know if you experience an issue that causes you to: Log out Miss a poll question Have audio problems Any other technical issue The sooner we know about an issue, the faster we can take the steps needed to make sure you get the continuing education credits you require. 5

7 Webinar Controls Questions will be answered at the end of the presentation as time allows. Sample of Webinar Controls Use this button to expand or collapse the webinar control window Type Questions Here 6

8 Disclosure No planner, presenter, or content expert has a conflicting interest affecting the delivery of this continuing education activity. Helios does not receive any commercial advantage nor financial remittance through the provided continuing education activities. 7

9 Disclaimer The display or graphic representation of any product or description of any product or service within this presentation shall not be construed as an endorsement of that product by the presenter, the California Board of Registered Nursing, Delaware Board of Registered Nurses, CCM, CRC, CDMS, or any accrediting body. Rather, from time to time, it may facilitate the learning process to include/use such products or services as a teaching example. Accreditation of this continuing education activity refers to recognition of the educational activity only and does not imply endorsement or approval of those products and/or services by any accrediting body. 8

10 Medical Disclaimer Medicine is an ever-changing science. As new research and clinical experience broaden our knowledge, new treatment options and approaches are developed. The authors have checked with sources believed to be reliable in their efforts to provide information that is complete and generally in accord with the standards accepted at the time of publication. However, in view of the possibility of human error or changes in medical sciences, neither Helios nor any other party involved in the preparation or publication of this work warrants the information contained herein is in every respect accurate or complete, and are not responsible for errors or omissions, or for the results obtained from the use of such information. Readers are encouraged to confirm the information contained herein with other sources. This educational activity may contain discussion of published and/or investigational uses of agents that are not approved by the FDA. We do not promote the use of any agent outside of approved labeling. Statements made in this presentation have not been evaluated by the Food and Drug Administration. 9

11 Contact Hours Upon completion of this activity, the learner will be awarded 1.0 contact hour This activity is provided by the Helios Continuing Education Services Group The Helios Continuing Education Services Group is approved as a provider by the California Board of Registered Nursing and the Delaware Board of Registered Nurses This activity is approved for CCM, CRC, and CDMS credit in all states and for insurance adjusters in select states This continuing education program is assessed and evaluated annually during the month of July for enhancements in current statistical information. 10

12 Today s Webinar The presentation will last one hour All attendee phones are muted, but you can ask questions using the chat box on the right side of your screen. If we are unable to answer your question during the presentation, we will respond to you via shortly following the webinar There is CE available for this webinar The slide deck will be ed out to all registrants of this webinar At the end of today s webinar, we ask that you complete a short survey to let us know if the information shared today was helpful and what information you d like us to cover in the future 11

13 Discussion Topics Compounding What are Compounded Medications? How Efficacious are Compounded Medications? Typical Compounded Medications in Workers Compensation Injectable Compounded Medications Challenges for Adjusters Examples of Compounded Medications On the Horizon 12

14 Compounding is an age old process used by pharmacists to create personalized medications to patients in need. There is a great amount of chemistry, mathematics and skill that goes into creating compounded medications. Traditional compounding pharmacists would refer to the practice as an art. 13

15 Compounding In recent years, pharmacists have realized that compounding can be a great source of revenue, and the practice has lost some of its tradition. New regulations will undoubtedly be put in place, to control compounding from becoming manufacturing, but there is still much value and desire for the service of compounding. 14

16 Compounding Manufacturers will never be able to produce every medication, in every strength, and every dosage form, that a patient may require, and this is where pharmaceutical compounding can be of great benefit. 15

17 Compounded Medications Utilization % of all prescription medications 0.9% 0.53% 0.60% % of total drug spend 5.6% 3.81% 2.08% 16

18 Compounding Challenges Multistate Outbreak of Fungal Meningitis and Other Infections New England Compounding Center Issues Voluntary Nationwide Recall of All Products Clinical Specialties Compounding Pharmacy Products: Recall - All Sterile Products Recalled Due To Lack of Sterility Assurance Pallimed Solutions, Inc. Sterile Compound Products: Recall - Visible Particulates Observed ApothéCure, Inc. Announces Voluntary Nationwide Recall of All Lots of All Sterile Products Compounded, Repackaged, and Distributed by ApothéCure, Inc. Due to Sterility Assurance Concerns 17

19 WHAT ARE COMPOUNDED MEDICATIONS? 18

20 Compounded Medication Combined, mixed, or altered drug prepared for specific needs of one patient Serve as alternatives to FDA-approved commercially prepared drugs Require a prescription Typically used to avoid allergies and other patient problems Largely experimental in use with few randomized controlled trials to determine efficacy or safety 19

21 Types of Compounded Medication Topical Preparations Skin application Local use Oral Preparations No commercially available strength Unique combination of agents Capsules, solutions, suspensions, lozenges, troches Must ensure no impurities 20

22 Types of Compounded Medication Ophthalmic Agents Absence of commercial preparation Avoid adverse reactions Sterility of high importance Injectable Agents Absence of commercial preparation Sterility of high importance 21

23 Compounded Medications in Therapy When a commercial product is unavailable from the manufacturer When treatment of the injury requires a specialty mix of medications When typical administration of the drug therapy is unsuitable or ineffective Side effects Allergies Difficulty swallowing Absorption issues In workers compensation, most compounded medications are pain management medications delivered through topical creams Compounded products administered topically are considered 2nd or 3rd line; primarily recommended for neuropathic pain when trials of antidepressants and anticonvulsants have failed or when an injured worker is allergic to certain inactive ingredients that can be altered in a compounded product Outside of workers compensation, compounded medications are most often used for hormone replacement, dermatology, children s formulations, and anti-cancer treatment 22

24 HOW EFFICACIOUS ARE COMPOUNDED MEDICATIONS? 23

25 Efficacy of compounded medications Compounded medications are created for individual use and are not subject to clinical trials Individual components offer some evidence of efficacy as limited clinical trials have been conducted: Non-Steroidal Anti-Inflammatory Drug (NSAID) Lidocaine Tricyclic Antidepressants (TCAs) - inconsistent results 24

26 Case Study Objective A randomized, double-blind, phase III study evaluated the efficacy and safety of ketoprofen in an ultradeformable vesicle gel compared with ketoprofen-free gel in osteoarthritis (OA) knee pain. 25

27 Case Study - Method A Randomized, Double-blind, Phase III Trial in Moderate Osteoarthritis Knee Pain Comparing Topical Ketoprofen Gel with Ketoprofen-free Gel Patients with American College of Rheumatology-defined OA of the knee and moderate pain were randomized to receive either of the following topical medications, twice daily, for 12 weeks. 100 mg ketoprofen in 4.4 g transfersome gel (IDEA-033) OR 4.4 g ketoprofen-free vehicle (TDT 064) The primary endpoint was mean change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score from baseline to week

28 Case Study - Results A Randomized, Double-blind, Phase III Trial in Moderate Osteoarthritis Knee Pain Comparing Topical Ketoprofen Gel with Ketoprofen-free Gel Results of Patients* from Baseline to Week 12 of Treatment Patients Using IDEA-033 Patients Using TDT 064 (Ketoprofen Free) Mean baseline WOMAC pain scores 5.2 (SD 1.0) 5.3 (SD 1.0) Mean change in WOMAC pain scores *(Mann-Whitney estimator ; p = 0.022) 38.6% 44.6% Experienced progressive decreases in pain Experienced improvements in function and stiffness Mean change in WOMAC function score 5.4 to to 3.1 Achieved 50% decrease in WOMAC pain score 41.2% (95% CI ) 50.5% (95% CI ) Note: Mild skin and subcutaneous tissue disorders were the most frequently reported treatment-related adverse events. *Patients (n = 555) were randomized and treated. 27

29 Case Study - Conclusion A Randomized, Double-blind, Phase III Trial in Moderate Osteoarthritis Knee Pain Comparing Topical Ketoprofen Gel with Ketoprofen-free Gel IDEA-033 was inferior to the drug-free gel, TDT 064 in relieving moderate OA knee pain and improving joint function (Clinical Trials NCT ). 1 (First Release Sept ; J Rheumatol 2013;40:1742 8; doi: /jrheum ) 28

30 TYPICAL COMPOUNDED MEDICATIONS IN WORKERS COMPENSATION 29

31 Compounded Medications in Workers Compensation Most are topical, used in pain management, and have low-risk potential. Oral preparations Injectables at hospitals or physician s office 30

32 Common Topical Ingredients On average, there are four to five individual ingredients in compounded prescriptions. Therapeutic Classes Commonly used agents NSAIDs Opioids Local anesthetics Antidepressants Anticonvulsants Skeletal muscle relaxants Other topical analgesics Ibuprofen, diclofenac, ketoprofen, flurbiprofen Tramadol Lidocaine, benzocaine, ketamine Amitriptyline, nortriptyline Gabapentin, Lyrica Cyclobenzaprine, baclofen Capsaicin, menthol, methyl salicylate, clonidine 31

33 MTUS Chronic Pain Guidelines Related to Topical Analgesics Ingredient Recommendation Gabapentin Ketoprofen Capsaicin Cyclobenzaprine Lidocaine Ketamine Flurbiprofen Baclofen Not recommended. There is no peer-reviewed literature to support use. Not recommended. It has a high incidence of photocontact dermatitis. Topical treatment can result in systemic effects comparable to the oral forms. [OTC] Recommended only as an option in patients who have not responded to or are intolerant of other treatments. [Not addressed in topical application] Cyclobenzaprine as an oral form is recommended as an option, using a short course of therapy. The addition of cyclobenzaprine to other agents is not recommended. Further research is needed to recommend for treatment of chronic neuropathic pain disorders. Only recommended for treatment of neuropathic pain in refractory cases in which all primary and secondary treatment have been exhausted. [NSAID not expressly addressed in guidelines] Not recommended. There is no peer-reviewed literature to support use. * MTUS: Chronic Pain Medical Treatment Guideline 32

34 Best Practices: Prior to Approval Consider comorbid conditions that might prevent oral therapy Determine if first line oral agents are unavailable Does the claimant have documented allergy to commercially available product Compare individual compound ingredients to current oral medications to prevent duplicate therapy Consider escalating to internal resources (regional medical director or nurse case manager) Consult one of our pharmacists 33

35 INJECTABLE COMPOUNDED MEDICATIONS 34

36 Sterile Injectable Compounding Taken from ASHP Discussion Guide on USP Chapter 797 for Compounding Sterile Products, page 4, accessed online

37 Sterility Importance and Problems USP 797 Accepted June 2008 as guidelines and standards for compounded sterile products (CSP) Guidance for compounding of sterile products for injectable administration of final products Outlines professional personnel responsibilities in compounding process Establishes product risk category for contamination Designed to reduce harm to patients from: Microbial contamination and excessive bacterial endotoxins Variability in the intended strength of correct ingredients Unintended chemical and physical contaminants Ingredients of inappropriate quality Recognized by Joint Commission on Accreditation of Healthcare Organizations (JCAHO) 36

38 Injectables in Workers Compensation Use is typically pain medications in implantable pumps Compounded due to stability/sterility issues with the medication or delivery Medications are administered in clinics, outpatient centers, physician s offices, and rarely via home infusion companies Locally delivered in most instances Hospital or independent pharmacies compound or mix the medication for instillation into implanted pumps for administration over time Medication examples: Morphine Hydromorphone Fentanyl Clonidine Baclofen 37

39 Best Practices Avoid utilization unless: Commercially manufactured products are unavailable Commercial products are on back-order or recalled Injured worker has an understanding of the risks and benefits to injectable medication Other therapies have documented failures Medication is obtained from reputable pharmacy experience and licensed for sterile product compounding Clinical resource consult states otherwise 38

40 CHALLENGES FOR ADJUSTERS 39

41 Medical Necessity MONITOR, MONITOR, MONITOR Is the product medically necessary? Information on this is best obtained from the prescriber Is there documented failure of commercially available preparations? Consult with a Clinical Pharmacist or review available medical records and/or prescription history Are there patient specific issues that makes use of commercially prepared agents harmful? 40

42 Cost Most compounded medications fall outside of state fee schedules and have historically been billed using the NDC of highest priced ingredient. Recent regulatory changes by states are aimed at controlling the costs of compounded medications and ensuring patient safety 41

43 Billing Standards Billing standards now accommodate ingredient level billing for compounded medications on billing forms, and require the following for each ingredient: NDC Quantity Cost 42

44 States with Ingredient Level Billing Arizona California Colorado Georgia Idaho Kansas Michigan Mississippi New York North Dakota Ohio Oklahoma Rhode Island South Carolina Tennessee Texas Washington Wyoming 43

45 New Regulations Georgia: Compounded medications shall be billed by the compounding pharmacy. Reimbursement shall only be considered for preparations that contain not < 1, nor > 3 active ingredient(s); Active ingredient(s) must be FDA approved. Maximum allowable reimbursement for compounds = sum of AWP for each active ingredient - 50%, + a single $20 compounding fee. Hawaii: Payment for compounded prescription drugs = the sum of 140% of AWP by gram weight of each underlying drug. AWP shall be that set by the original manufacturer. Kansas: Compounded medications reimbursed same as pharmacies - based on original manufacturer NDC (also require prior approval of employer / carrier). Michigan: Topical compounded medications billed using specific amount of each component drug and original manufacturer's NDC. Reimbursement = max of AWP -10% of original manufacturer's NDC. Components without NDCs not reimbursed. Single dispense fee for non-sterile compound = $12.50; Provider shall dispense a 30-day supply/rx Reimbursement for custom compound limited to max of $600 (charges exceeding must be accompanied by original component manufacturers' invoice pro-rated for each component amount used, for review by carrier). Ohio: State indicated compounds billed & reimbursed based on ingredient NDCs (no reimbursement for ingredients w/ no NDC). Max product cost component reimbursement for any 1 compounded Rx = $600. Dispense fee for non-sterile compounds = $12.50; Dispense fee for sterile compounds = $25. 44

46 EXAMPLES OF COMPOUNDED MEDICATIONS 45

47 Compounded Medication Examples Compound A - $1, for a 30 day supply Gabapentin Ketamine Amitriptyline Bupivacaine PCCA Lipoderm cream Anticonvulsant Local anesthetic Antidepressant Local anesthetic Base Points of consideration Compounded medication contains multiple agents to treat neuropathic pain, including two local anesthetics What other medications is the claimant taking? (Potential for therapeutic duplications) Has the claimant tried and failed first-line therapy (oral anticonvulsants or antidepressants such as gabapentin and amitriptyline)? 46

48 Compounded Medication Examples Compound B - $1, for a 30 day supply Diclofenac Baclofen Cyclobenzaprine Lidocaine PCCA Lipoderm cream Anti-inflammatory Skeletal Muscle Relaxant Skeletal Muscle Relaxant Topical anesthetic Base Points of consideration Compounded medication contains multiple skeletal muscle relaxants What other medications is the claimant taking? (Potential for therapeutic duplications) Has the claimant tried and failed first-line therapy (oral anti-inflammatory and/or skeletal muscle relaxant)? 47

49 ON THE HORIZON 48

50 New Oversight 2012 contamination in Massachusetts brings draft federal legislation April 2013 draft proposal HELP Senators FDA oversight over compounded medication manufacturers Compounded medications are new drugs subject to the Federal Food, Drug and Cosmetic Act (FFDCA) Compounded products must meet standards 49

51 Registration of Pharmacies 2013 Drug Quality &Security Act, H.R The Drug Quality & Security Act is voluntary. Drug compounding pharmacies will be encouraged to not required to register with the FDA (Food and Drug Administration). If they do, they will be subject to fees and be required to: Comply with current good manufacturing practices Be inspected by the FDA according to risk based schedule Meet certain other conditions such as reporting adverse events and providing the FDA with certain information about the products they compound Registration with the FDA also means the agency will classify them as an outsourcing pharmacy, which enables them to sell bulk drugs to hospitals and other healthcare facilities. 50

52 What to Do? Red flags, alerts, and assistance for the adjuster when making decisions regarding compounded medications Utilize system alerts as a indicator that additional evaluation is needed Utilize Clinical Pharmacists to discuss and/or obtain answers to questions Evaluate Medical Necessity by requesting supporting documentation on safety and efficacy of the compound ingredients for the compensable condition Request a nurse case manager or medical director consult Use available medication guides for reference 51

53 Considerations Summarized Has the patient had an adequate trial and failure of commercially available drugs? Was the patient experiencing significant side effects from a commercially available product that necessitated use of a compounded formulation? Is the prescriber requesting a specific combination that is part of an established protocol? Does the prescriber have any literature/clinical trials that support the use of the compounded product being prescribed? Does the prescriber have an established relationship with the pharmacy that compounds the product? Does the patient have documented improvement in function and/or quality of life after initiating treatment with the compound? How long does the prescriber plan on using the compound medication? Will a compound cost less long-term than multiple oral medications? 52

54 References USP Chapter <797> Pharmaceutical Compounding Sterile Preparations: (accessed July 2015) USP Chapter <795> Pharmaceutical Compounding Nonsterile Preparations: (accessed July 2015) Rother, M., & Conaghan, P. G. (2013). A randomized, double-blind, Phase III trial in moderate osteoarthritis knee pain comparing topical ketoprofen gel with ketoprofen-free gel. The Journal of rheumatology, 40(10), The Official Disability Guidelines (ODG): (accessed July 2015) MTUS: Chronic Pain Medical Treatment Guidelines pdf (accessed July 2015) ASHP Discussion Guide on USP Chapter <797> (accessed July 2015) Helios Legislative Review (accessed July 2015) 2013 Drug Quality & Security Act, H.R (accessed July 2015) 53

55 Learner Feedback/Record of Attendance Form Please complete the Learner Feedback/Record of Attendance Form and submit via to no later than Tuesday, July 28,

56 Thank You! Questions? PHM