Understanding the Challenges of Managing Mental Health in the Workplace With a Focus on ADHD

Transcription

1 Understanding the Challenges of Managing Mental Health in the Workplace With a Focus on ADHD Dr. Martin Katzman, BSc, MD, FRCPC Clinic Director: Staff Psychiatrist: Centre for Addiction and Mental Health Assistant Professor: Faculty of Medicine, University of Toronto, Department of Psychiatry

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3 Health Canada Bioequivalence Standard Bioequivalence: 90% confidence interval: % Area Under the Curve (AUC) and Concentration Maximum (C max ) vs. innovative brand product. Therapeutic Equivalence: A health care professional requirement. What are the needs of your patient? Concerns about abuse/diversion?

4 Methylphenidate (ng/ml) Pharmacokinetic Profiles for Ritalin SR and CONCERTA OROS CONCERTA OROS and Ritalin SR have similar AUC 0- and C max values Could be deemed bioequivalent despite very different PK profiles C max Ritalin SR 20 mg (Normalized to 18mg) CONCERTA 18mg (Reference) 3 2 AUC Time (h) 2 CONCERTA (methylphenidate HCI) ER Tablets Citizen Petition. McNeil Consumer & Specialty Pharmaceuticals. 2004

5 Does Bioequivalence Always Equal Clinical Equivalence? Reference Product Test Product Bioequivalent? Clinically Equivalent? Reference Celexa generic citalopram Yes Cmax, AUC 12% of patients (n=20/172) with emergence of: depressive symptoms suicide ideation anxiety symptoms obsessive thoughts Van Ameringen et al, J Psychopharm 2007 Clozaril generic clozapine Yes Cmax, AUC 28% (n=7/25) of patients with emergence of: psychotic symptoms Mofsen & Balter. Clin Therapeutics 2001 Effexor XR venlafaxine (Tevapharm) Yes Cmax, AUC 3x more side effects reported with Teva-venlafaxine vs Effexor XR (n = 12) Chenu et al J Clin Psych 2009 Wellbutrin XL Buproprion (Budeprion XL) Yes Cmax, AUC Over 6 months, 85 postmarketing reports: loss of antidepressant effect worsening of side effects Foster BC. J Pharm Pharmaceut Sci 11 (4) 2008 Tegretol generic carbamazepine Yes Cmax, AUC Different toxicity profile (n=16) Tothfalusi et al. Br J Clin Pharm 2007

6 CONCLUSION: Further studies are needed to test the efficacy of generic forms of medications to ensure that they are sufficient to use as a replacement for the original medications

7 Food and Drug Administration announced that two of the three available Concerta generics, one made by Mallinckrodt Pharmaceuticals and the other by UCB, could no longer be considered the equivalent of the brand and, in most states, could not be automatically 7 substituted by pharmacies for the brand name.

8 ODPRN DRAFT REPORT Bioequivalence Due to the complexities of the extended release products, traditional bioequivalence metrics that have been used for generic products may not adequately represent the specific immediate- or sustained response components. One study showed that the in vivo pharmacokinetic profiles of Concerta and Novo-Methylphenidate were distinct and proposed that partial AUC be used as additional criteria to measure therapeutic equivalence.

9 ODPRN DRAFT REPORT Summary: Bioequivalence of methylphenidate extended release products: Current determination of bioequivalence in Canada has concluded that Concerta and generic methylphenidate extended release products are bioequivalent. However, there have been isolated case reports and a retrospective study that have suggested that patients who switch from Concerta to the generic methylphenidate extended-release may have a loss in efficacy. Four guidelines on the treatment of ADHD in adults were reviewed. All guidelines emphasize the need for a multi-pronged approach to treatment which includes education, psychotherapy and pharmacotherapy.

10 Summary Health Care Professionals and Regulators globally recognize that certain Brand name mental health products should be differentiated from the generic product. Utilizing additional bioequivalence metrics has been recommended to ensure therapeutic equivalence and interchangeability of these products.

11 IMPACT OF ADHD ON THE WORKPLACE SURVEY

12 Goals Methodology & Goals To explore the professional challenges faced by ADHD sufferers To determine the time and productivity cost of employee ADHD, and to examine how workplaces accommodate ADHD sufferers Fielded Completion Time From the Benefits Canada 2013 ADD/ADHD in the Workplace study, made possible by Janssen, n=100 April May 2013 Via online survey 8 minutes Survey Audience Canadian Adults with ADHD Nationally representative sample N=100 respondents

13 Many co-morbid conditions are experienced by ADHD sufferers; those unemployed are more likely to experience problems In addition to ADD/ADHD. 63% experienced depression 58% reported anxiety 75% Of Currently Employed 95% Of Currently Unemployed 22% had suffered drug or alcohol addiction 16% had bipolar disorder Suffer from at least 1 other condition From the Benefits Canada 2013 ADD/ADHD in the Workplace study, made possible by Janssen, n=100

14 Those taking medication to manage their ADHD tend to perform better on the job Taking Medication Not Taking Medication 67% 74% I find that it takes me longer to complete tasks than it does for others. When I have a task that requires a lot of thought I often avoid or delay getting started. 73% 79% From the Benefits Canada 2013 ADD/ADHD in the Workplace study, made possible by Janssen, n=100

15 Half of respondents missed time at work or school due to their ADHD 51% missed time 30% took time off to be alone 17% took time off for doctors appointments 10% took time off to participate in testing 7% took time off for other reasons Only 32% of missed time is made up for, overall 4 in 5 sufferers make up less than half of the time they miss due to their ADHD From the Benefits Canada 2013 ADD/ADHD in the Workplace study, made possible by Janssen, n=100

16 Those taking medication miss less time at work/school then those who do not 57% 46% of those taking medication of those not taking say they miss time at medication say they miss while work/school as a result of time at work/school as a their ADD/ADHD result of their ADD/ADHD From the Benefits Canada 2013 ADD/ADHD in the Workplace study, made possible by Janssen, n=100

17 With few exceptions, ADHD symptoms negatively affect performance While suffering symptoms of ADHD, the average respondent feels they work at 2/3 of their full capacity. Only 5% say they are able to function at full capacity. 78% said they were mentally exhausted at the end of the day 76% said that they put off projects that they knew require substantial amounts of thought 66% had trouble wrapping up the final details of a project after the challenging parts were complete 28% said they were unable to multitask successfully From the Benefits Canada 2013 ADD/ADHD in the Workplace study, made possible by Janssen, n=100

18 2 in 5 have quit a job or scholastic program due to difficulty 38% Quit a job / school due to difficulty 30% Reported having taken sick days 29% Said they had left their work area for an extended period of time during the workday/school day As a result of their ADD/ADHD. 26% 27% Reported having lost a job as a result of their condition Have quit a job/school due to need for new challenges 25% Reported having reduced their work/study hours From the Benefits Canada 2013 ADD/ADHD in the Workplace study, made possible by Janssen, n=100

19 Those taking medication feel a greater sense of job security Taking Medication Not Taking Medication I am afraid of losing my job 31% as a result of my ADD/ADHD. 43% Approximately 1/3 of respondents take medication for their ADHD, while 2/3 do not From the Benefits Canada 2013 ADD/ADHD in the Workplace study, made possible by Janssen, n=100

20 Only half believe their school or employer accommodates their ADHD, while only a third indicate that all of the medication they require is covered on their benefits plan 48% of respondents indicated that their employer or school accommodates their needs that result from their ADD/ADHD 65% of respondents wish their employer/school offered more resources to accommodate their ADD/ADHD Only 43% say that they are allowed to take breaks when they need them 32% indicated that all of the medication they need is covered by their benefits plan 17% responded that a portion of the medication they need is covered by their benefits plan 13% said that their job/school involves them being physically active From the Benefits Canada 2013 ADD/ADHD in the Workplace study, made possible by Janssen, n=100

21 MENTAL HEALTH SURVEY

22 Goal Methodology & Goals To better understand the risks of generic interchangeability in mental health products Fielded Completion Time Sept- Oct 2015 Via online survey 15 minutes Survey Audience* Canadian Patients and Caregivers suffering from various mental health conditions Nationally representative sample N=397 respondents *Patient Associations: CADDAC, Mood Disorders of Canada, Schizophrenia Society of Canada, Tourette Society

23 Completion of Survey: Breakdown of Respondents N=319 (survey completions)

24 Age Bracket of Person with Mental Health Condition

25 Primary Mental Health Condition

26 Percent (n=319) Co-existing Mental Health Conditions

27 Drug Coverage of Respondents 26% Have public drug plan 13% Have no drug plan coverage 55% Have private drug plan coverage 6% Are unsure 3

28 Treatment Options/Accommodations Base: Total Respondents n=319 % Parent/caregiver receiving education on condition Person with condition receiving education on their condition Home accommodations School accommodations Workplace accommodations 4.39 Medication 79 Cognitive Behaviour Therapy Psychotherapy/Family therapy Coaching Tutoring Mindfulness None 4.39 Other % of respondents have NOT been able to access all treatments/accommodations that have been recommended 54% felt that the cost of non-medication treatment is prohibitive 15% have not been able to access the recommended medication

29 Mental Health Survey Of 308 respondents, 59% have had experience with taking or being prescribed the generic version of a drug 37% of respondents stated that their physician has written No Sub on the prescription

30 Medications for which the physician wrote No Sub on the Prescription Medication name % Concerta Vyvanse 6.03 Straterra 6.03 Adderall 5.17 Wellbutrin 5.17 Effexor 3.45 Seroquel 2.58 Ritalin 2.58 Abilify 2.58 Invega 2.58 Biphentin 2.58 Cipralex 1.72 Ativan 1.72 Clozapine 1.72 Risperdal 1.72 Zoloft 1.72 Prozac 1.72 Modafinil 0.86 Olanzapine 0.86 Dexedrine 0.86 Lipitor 0.86 Fanapt 0.86 Clonidine 0.86 Nexium 0.86 Intuniv 0.86

31 Mental Health Survey, cont d. 60.4% of respondents stated that their physician writes No Sub on the prescription because he/she prefers the brand name version of this product based upon past experiences 20% of respondents stated that their physician writes No Sub on the prescription because they asked their physician to do so.

32 Mental Health Survey, cont d. 82 respondents had taken both brand and generic versions of: Base: Total Respondents n=82 Medication: % Concerta (27) Wellbutrin (8) 6.35 Cipralex (7) 5.56 Strattera (7) 5.56 Ritalin (7) 5.56 Seroquel (7) 5.56 Olanzapine (6) 4.76 Effexor (5) 3.96 Prozac (4) 3.17 Clozapine (4) 3.17 Paxil (3) 2.38 Zoloft (3) 2.38 Ativan (3) 2.38 Biphentin (1) 1.59 Adderall (1) 1.22 Imovane (1) 1.22 Lipitor (1) 1.22 Lithium (1) 1.22 Vyvanse (1) 1.22 Other (28) 22.22

33 Mental Health Survey, cont d % of the 82 respondents stated that, based on the differences experienced between brand and generic versions, the brand name version was better: 20% felt the generic was either ineffective or not as effective as the brand 14.17% felt that there were increased side effects with the generic version of the drug 7.5% felt that the effects of the generic did not last as long as the brand 38.33% stated minimal differences

34 Mental Health Survey, cont d. Of the 82 respondents who had taken both brand and generic versions of the same medication: 20.49% stated that the changes in symptom control were tolerable while 22.85% stated that the changes in symptom control were intolerable % stated that changes were experienced in functioning (at school, work or home) 23.53% experienced difficulties focusing/increased hyperactivity 17.65% experienced more fatigue on the generic 5.88% experienced increased anxiety 2.94% experienced mood changes 42.98% switched back to the brand name version of the drug

35 Mental Health Survey, cont d. Only 42.15% said their symptoms restabilized after switching back to the brand

36 Mental Health Survey, cont d % of respondents stated that they were not informed when their pharmacist substituted with a generic 41.25% stated that the pharmacist does not inform their physician regarding a substitution to a generic medication. 37.5% stated that their pharmacist switched to a generic due to the policies of their private drug plan 10% stated that their pharmacist switched to a generic due to the policies of their public drug plan 33.75% stated that they were unsure why

37 Mental Health Survey, cont d % of respondents stated that they had never requested a generic version of a medication before 38.85% stated that they had paid additional costs to be on a brand name product. The brand medications they paid additional costs for: Base: Total Respondents n=241 % Not sure Name(s) of medication Concerta (28) Wellbutrin (7) 7.69 Vyvanse (7) 1.10 Adderall (6) 6.59 Biphentin (6) 6.59 Ritalin (4) 4.40 Straterra (4) 4.40 Seroquel (3) 3.29 Effexor (2) 2.20 Other (24) % paid more for the brand name product based upon their past experiences with generic products

38 Mental Health Survey, cont d % of respondents are not aware of how to know whether a medication they were prescribed was substituted by a generic product 93.28% responded that they would like to be informed when a pharmacist makes a switch to a generic version of the medication

39 Conclusions of Mental Health Survey 68.91% of respondents are not aware of how to know if they were switched to a generic, while 93.28% of respondents would like to know if they were switched to a generic: Concerta was the most prescribed medication in which the physician wrote No Sub (44.83%), followed by Vyvanse (6.03%) % of individuals paid an additional cost to receive branded Concerta, followed by Wellbutrin (7.69%).

40 Conclusions of Mental Health Survey, cont d % reported intolerable changes in symptom control after being switched to the generic version 43.80% experienced changes in functioning when switched to the generic version 42.98% of respondents switched back to the brand after being switched to generic Only 42.15% reported their symptoms restabilized after switching back to the brand There are potential impacts on the workplace of being switched to a generic, including: absenteeism, decreased productivity, presenteeism, even STD or LTD.

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