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Journal of Intellectual Disability Research
doi: 10.1111/jir.12123
1
Brief report
The relationship between living arrangement and adherence to antiepileptic medications among individuals with developmental disabilities C. L. Hom,1 P. Touchette,2 V. Nguyen,3 G. Fernandez,1 A. Tournay,2 L. Plon,4 P. Himber5 & I. T. Lott6 1 Department of Psychiatry and Human Behavior, University of California, Irvine, Orange, CA, USA 2 Department of Pediatrics, University of California, Irvine, Orange, CA, USA 3 Department of Statistics, University of California, Irvine, Orange, CA, USA 4 Department of Pharmaceutical Sciences, University of California, Irvine, Orange, CA, USA 5 Regional Center of Orange County, Santa Ana, CA, USA 6 Departments of Pediatrics and Neurology, University of California, Irvine, Orange, CA, USA
Abstract Background Non-adherence to antiepileptic drugs (AEDs) is associated with considerable morbidity and mortality in the general population but little is known about adherence in individuals with intellectual disability (ID). Method Using the records of a closed pharmacy billing system over a 30 month period, we examined the medication non-adherence rates for AEDs among 793 individuals with ID. We calculated the medication possession ratio (number of days each Correspondence: Professor Ira T. Lott, University of California, Irvine Medical Center, 101 City Drive, zot 4482 Orange, CA 92868, USA (e-mail: [email protected]). This research was supported in part by grants from the Department of Developmental Services, Regional Center of Orange County, and National Institutes of Health, AG 49721, HD 21912 and HD 065160.
participant was in possession of an AED), and defined non-adherence as 25% or more of the exposure days without the possession of an AED. All participants studied had filled prescriptions for AEDs spanning at least 6 months. Results Controlling for age and gender, we found non-adherence rates varied by living arrangement. Compared with those living in group homes, individuals with ID living in family homes or in semiindependent settings were significantly less adherent to AEDs (P < 0.0003). Conclusion Non-adherence to AEDs is a potential medical risk for individuals with ID that is significantly impacted by the type of community living arrangement. Keywords adherence, antiepileptic drugs, group homes, intellectual disability, living arrangement, medication possession ratio
© 2014 MENCAP and International Association of the Scientific Study of Intellectual and Developmental Disabilities and John Wiley & Sons Ltd
Journal of Intellectual Disability Research 2 C. L. Hom et al. • Living arrangement and medication non-adherence
Background Non-adherence to antiepileptic medications (AEDs) has been associated with increased morbidity (Bassili et al. 2002), sudden unexpected death (Leestma et al. 1989) and increased costs to the health care system (Davis et al. 2008; Faught et al. 2008; Ettinger & Baker 2009; Ettinger et al. 2009; Faught 2012). Additionally, poor adherence is associated with increased number of visits to the emergency department, hospitalisations and injuries as a result of uncontrolled seizures (Ettinger et al. 2009). In the general population, factors associated with medication non-adherence have included race, socioeconomic status, beliefs about medication, cognitive functioning and medication side effects (Bautista et al. 2011; Modi et al. 2011). Individual beliefs that medication may be intrinsically harmful and/or minimally beneficial have also been associated with lower adherence rates (Sweileh et al. 2011). In an elderly population, cognitive impairment is associated with non-adherence to AEDs, and certain AEDs appear to impart a differential risk of non-adherence (Zeber et al. 2010). AEDs that produce weight gain or cognitive side effects may adversely affect adherence. Complicated medication regimens also increase the risk for AED nonadherence (Asadi-Pooya 2005) as adherence rates are usually correlated with the number of times per day that an individual has to take a medication (Garnett 2000). Poor medication adherence has been reported among home-based individuals who do not have access to consistent pharmacy transportation (Welty et al. 2010). Little is known about AED adherence in individuals with intellectual disabilities (ID) despite a seizure prevalence of up to 27% (Airaksinen et al. 2000; Camfield & Camfield 2007; Berg et al. 2008) in this population. AEDs for seizure control are the most frequently prescribed medications in individuals with ID even with the exclusion of AEDs prescribed for mood control or behavioural problems (Carvill et al. 1999; van Blarikom et al. 2006). One of the variables that may affect AED nonadherence is the type of community residential living arrangement. While not studied with respect to AED adherence, certain types of living arrangement for community-based individuals with ID have been associated with unmet health care needs
(Martinez-Leal et al. 2011), misdiagnosis (Ali & Hassiotis 2008) and failure to treat both common and severe medical conditions (Baxter et al. 2006; van Schrojenstein Lantman-de Valk et al. 2007; van Schrojenstein Lantman-de Valk & Walsh 2008). Living arrangements have also been shown to affect several mental health characteristics in individuals with ID (Chaplin et al. 2010). For adults with ID, clinical decision-making regarding medication adherence has been viewed as a 3-way relationship between a parent-proxy, the adult lacking decisionmaking capacity, and a clinician (Redley et al. 2013). Within this context, we questioned whether living arrangements might be related to AED compliance – i.e. whether those living in a more structured supervisory setting would have better compliance than those living in a family home or a semi-independent arrangement. Access to pharmacy records for a large cohort of community-based individuals with ID allowed us to explore this relationship.
Method Materials and procedure Data from two separate sources were combined. The first data set consisted of Medicaid pharmacy billing records for individuals in the community between the years 2000–2002. The second set was Regional Center of Orange County client data, which contained demographic and living arrangement information. Regional Centers are non-profit private corporations contracted with the Department of Developmental Services to coordinate services for individuals who have ID or conditions that require treatment and services similar to an individual with ID such as autistic spectrum disorder. By matching social security numbers, we extracted a subset of pharmacy records for Medicaid individuals who are also clients of the Regional Center of Orange County. Personal identifiers were eliminated from the database prior to analysis. Data from participants living in one of three types of living arrangements were included: (1) group home, (2) semi-independent setting, or (3) family home. Group homes are community care facilities licensed to provide 24-hour residential care (State Of California, Health and Human Services Agency,
© 2014 MENCAP and International Association of the Scientific Study of Intellectual and Developmental Disabilities and John Wiley & Sons Ltd
Journal of Intellectual Disability Research 3 C. L. Hom et al. • Living arrangement and medication non-adherence
Department of Social Services 2008). Semiindependent settings consist of individuals living in their own apartment or house while receiving supported living services from an agency, ranging from daily to weekly staff assistance. Family homes are defined as any home in which the participant’s primary caregiver is a relative. We considered AEDs collectively as a class and identified participants who had AED prescription fills that spanned at least 6 months. This allowed us to define a meaningful endpoint even in the presence of two potential confounds. First, physicians may have changed a participant’s prescription from one AED to another for various reasons including lack of efficacy or side effects. Second, physicians may have prescribed multiple AEDs to treat a chronic condition. Thus, our calculation of the medication possession ratio (MPR), a widely accepted and well-documented method for measuring adherence (Andrade et al. 2006), is based on access to any AED during the study period. We calculated the number of days each participant had access to an AED (exposure period E) by using the first and last prescription fill dates. Nonadherence (called N) was defined as the number of days in which a participant did not have access to any AED during the exposure period. The MPR was then calculated as (E-N)/E, and the medication non-possession ratio (MNPR) as 1 – MPR (a higher ratio corresponded to more days that a participant did not refill any AED prescription). We classified each participant as non-adherent if the MNPR was greater than 0.25 (i.e. had 25% or more of their exposure days without access to any AED). The list of AEDs utilised by the participants in our study is presented in Table 1. The study was approved by the Institutional Review Board at the University of California, Irvine.
Results Our sample consisted of 793 participants: 107 children (13.49%), 479 males (60.40%) and 563 Caucasian (71%). The majority resided in group homes (69.86%), followed by family homes (23.46%), lastly semi-independent settings (6.68%). Most adults lived in group homes (74.3%), but most children lived in family homes (58.8% of participants
Table 1 Antiepileptic drugs (AED) prescription fills
Generic name
Trade name
Carbamazepine Clonazepam Divalproex, valproic acid Felbamate Gabapentin Lamotrigine Levetiracetam Phenobarbital Phenytoin sodium Primidone Tiagabine Topiramate Oxocarbazepine Zonisamide
Tegretol, Carbatrol, Epitol Klonopin Depakene, Depakote ER, Depakote Sprinkles Felbatol Neurontin Lamictal Keppra Dilantin, Phenytek Mysoline Gabatril Topamax Trileptal Zonegran
Clonazepam, a benzopdiazepine, is commonly used as an AED, and was included. Diazepam was not included because it is typically administered on an as-needed basis.
under age 18). Demographic summaries of the sample are presented in Table 2. The non-adherence rate for AEDs was 5.96% for group homes, 20.00% for semi-independent settings, and 31.72% for family homes. Logistic regression was used to test and estimate adjusted odds ratios for AED non-adherence for each living arrangement while controlling for age and gender. Robust standard errors (Huber 1967) were used for inference to guard against model misspecification, and Holm’s method (Holm 1979) was used to account for multiple comparisons. Among individuals of the same age and gender, participants living in semi-independent settings had a 4.14-fold increase in the odds of prescription nonadherence (95% CI: 1.93, 8.84; P < 0.0003), and participants living in family homes had a 6.05-fold increase in the odds of prescription non-adherence compared with those living in group homes (95% CI: 3.54, 10.36; P < 0.0000). This information is summarised in Table 3. In a post hoc analysis, we investigated whether or not minor status (age < 18) affected prescription non-adherence, using age as a modifier. We failed to detect a significant effect for minor status as a modifier among participants living in family homes
© 2014 MENCAP and International Association of the Scientific Study of Intellectual and Developmental Disabilities and John Wiley & Sons Ltd
Journal of Intellectual Disability Research 4 C. L. Hom et al. • Living arrangement and medication non-adherence
Variable Age on 1/1/2000 (years) Age > 18 on 1/1/2000 Adults Gender F M Ethnicity African American Asian/Pacific Islander Caucasian Latino Native American Other Unknown
Group home (n = 554)
Semi-independent (n = 53)
Family home (n = 186)
37 (29–46)
37 (31–42)
25 (13–35)
510 (92.06%)
53 (100%)
123 (66.13%)
222 (40.07%) 332 (59.93%)
23 (43.40%) 30 (56.60%)
69 (37.10%) 117 (62.90%)
16 (2.89%) 23 (4.15%) 440 (79.42%) 53 (9.57%) 1 (0.18%) 20 (3.61%) 1 (0.18%)
1 (1.89%) 3 (5.66%) 43 (81.13%) 4 (7.55%) 0 (0.00%) 2 (3.77%) 0 (0.00%)
2 (1.08%) 47 (25.27%) 80 (43.01%) 42 (22.58%) 0 (0.00%) 13 (6.99%) 2 (1.08%)
Table 2 Demographic characteristics of the selected sample
Continuous variables are reported as mean and interquartile range, and categorical variables are reported as counts and proportions.
Semi-independent vs. group home Family home vs. group home Semi-independent vs. family home Age Male vs. female
Table 3 Medication adherence comparisons
Adjusted OR
95% CI
P
4.14 6.05 0.68 0.98 0.73
[1.93, [3.54, [0.31, [0.96, [0.47,
0.0003 0.0000 0.3368 0.0715 0.1646
8.84] 10.36] 1.49] 1.00] 1.14]
Adjusted for age and gender. OR, odds ratio; CI, confidence interval.
or group homes (P = 0.7930). Since individuals under the age of 18 do not live in semi-independent settings, a further comparison with this group was not possible.
Conclusions Our study found that living arrangement was a significant predictor of AED non-adherence. Individuals with ID living in the family home were 6 times more likely to be non-adherent than those living in group homes. Similarly, individuals in semiindependent settings were approximately 4 times more likely to be non-adherent than those living in group homes. Age and gender did not predict medication non-adherence, nor was age a modifier of the odds of non-adherence.
Some subjects may have switched AEDs during the study period. Therefore, we calculated adherence based upon access to any AED and still found a significant difference in medication adherence between living arrangements. From the information available to us, we could not determine the reason(s) that AEDs were prescribed (i.e. for seizure or behavioural control). However, since many individuals with epilepsy have co-morbid mood disorders (Karceski 2010) a distinction between AEDs prescribed for seizure or behavioural management may not have been possible for many of the participants. This study did not measure initiation failure (prescriptions filled but not taken) or incorrect dosages taken, but it was deemed unlikely that a caregiver or participant would refill a prescription over an extended period
© 2014 MENCAP and International Association of the Scientific Study of Intellectual and Developmental Disabilities and John Wiley & Sons Ltd
Journal of Intellectual Disability Research 5 C. L. Hom et al. • Living arrangement and medication non-adherence
of time if the participant was not taking the medication, given the investment in time and money. Higher rates of AED adherence were found among those living in group homes, all of which are monitored by licensing agencies that require documentation of medication administration and errors (Department of Social Services 2008). Group homes have a highly regulated supervisory structure (Legault 1992; Velligan et al. 2009). Less restrictive living arrangements (semi-independent or family homes) do not generally provide the same degree of supervision. Paid caregivers may be more educated about the importance of medication adherence, routine or preventive healthcare, adequate nutrition and exercise than participants or their family members (Lennox & Kerr 1997; Asadi-Pooya 2005; Manjunath et al. 2009; Modi et al. 2011). Trained staff may also be more familiar with strategies that can increase patient cooperation with medication administration (Osterberg & Blaschke 2005). It is doubtful that the higher rate of medication adherence among individuals living in group homes was due to higher patient functioning or fewer behavioural issues. In fact, individuals with ID who reside in group homes typically have greater behavioural challenges and more severe levels of ID than individuals living more independently in the community (Aman et al. 2003; Bershadsky & Kane 2010). Those who live in group homes also tend to have higher psychotropic drug utilisation (Aman et al. 1995, 2003) and polypharmacy (Wood et al. 2006; Lunsky & Elserafi 2012) than individuals living in less restrictive settings. Going forward, we suggest that public health policy for individuals with ID take into consideration the relationship between living arrangement and AED non-adherence. Individuals with ID and their family members should be educated about the importance of medication adherence for chronic conditions such as epilepsy and psychiatric disorders as they may not fully understand the consequences of non-adherence (Chapieski et al. 2005). Moreover, there are ethical implications when family members, acting as proxies for individuals who lack decision-making abilities, withhold needed medical treatment (Redley et al. 2013). Our findings are likely to have implications beyond the State of California as federal standards, such as those delineated by the Centers for Medicare and Medicaid
Services (2013), also require licensed residential facilities to document, monitor, and provide access to appropriate medical and mental health treatments. International organisations such as the United Nations Development Group (2011) and the Convention on the Rights of Persons with Disabilities (2008) have also established mandates for all member countries to ensure that individuals with disabilities have access to proper health treatment and care.
Limitations The pharmacy records that we examined did not reveal whether failing to refill a prescription was in some cases associated with side effects, adverse drug interaction, or abnormal laboratory results. It seems reasonable, however, to assume that these events would be evenly distributed across individuals regardless of living arrangement. The data analysed were restricted to the years 2000–2002 as these were the only data available to us, but we have no evidence that AED prescribing practices have changed since this time in a way that would affect study outcome. A future prospective study would supply data pertinent to this point.
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© 2014 MENCAP and International Association of the Scientific Study of Intellectual and Developmental Disabilities and John Wiley & Sons Ltd
Journal of Intellectual Disability Research 6 C. L. Hom et al. • Living arrangement and medication non-adherence
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Camfield C. & Camfield P. (2007) Preventable and unpreventable causes of childhood-onset epilepsy plus mental retardation. Pediatrics 120, e52–5. Carvill S., Clarke D. & Cassidy G. (1999) The management of epilepsy in a hospital for people with a learning disability. Seizure: The Journal of the British Epilepsy Association 8, 175–80. Centers for Medicare and Medicaid Services (2013) State Operations Manual Appendix J – Guidance to Surveyors: Intermediate Care Facilities for Persons With Mental Retardation. Available at: http://www.cms.gov/Regulationsand-Guidance/Guidance/Transmittals-Items/ R94SOMA.html (retrieved 3 January 2014). Chapieski L., Brewer V., Evankovich K., Culhane-Shelburne K., Zelman K. & Alexander A. (2005) Adaptive functioning in children with seizures: impact of maternal anxiety about epilepsy. Epilepsy and Behavior: E&B 7, 246–52. Chaplin E., Paschos D., O’Hara J., McCarthy J., Holt G., Bouras N. et al. (2010) Mental ill-health and care pathways in adults with intellectual disability across different residential types. Research in Developmental Disabilities 32, 458–63. Convention on the Rights of Persons with Disabilities (2008) Including the Rights of Persons with Disabilities in United Nations Programming at Country Level (Tool 9).
Holm S. (1979) A simple sequentially rejective multiple test procedure. Scandinavian Journal of Statistics 6, 65–70. Huber P. (1967) The behavior of maximum likelihood estimates under nonstandard conditions. In: Proceedings of the Fifth Berkeley Symposium on Mathematical Statistics and Probability (eds L. M. Le Cam & J. Neyman), pp. 221–3. University of California Press, Berkeley, CA. Karceski S. (2010) Patient page. Epilepsy and mood. Neurology 75, e12–15. Leestma J. E., Walczak T., Hughes J. R., Kalelkar M. B. & Teas S. S. (1989) A prospective study on sudden unexpected death in epilepsy. Annals of Neurology 26, 195–203. Legault J. R. (1992) A study of the relationship of community living situation to independence and satisfaction in the lives of mentally retarded adults. Journal of Intellectual Disability Research 36, 129–41. Lennox N. G. & Kerr M. P. (1997) Primary health care and people with an intellectual disability: the evidence base. Journal of Intellectual Disability Research 41 (Pt 5), 365–72. Lunsky Y. & Elserafi J. (2012) Antipsychotic medication prescription patterns in adults with developmental disabilities who have experienced psychiatric crisis. Research in Developmental Disabilities 33, 32–8. Manjunath R., Davis K. L., Candrilli S. D. & Ettinger A. B. (2009) Association of antiepileptic drug nonadher-
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Journal of Intellectual Disability Research 7 C. L. Hom et al. • Living arrangement and medication non-adherence
ence with risk of seizures in adults with epilepsy. Epilepsy and Behavior: E&B 14, 372–8. Martinez-Leal R., Salvador-Carulla L., Linehan C., Walsh P., Weber G., Van Hove G. et al. (2011) The impact of living arrangements and deinstitutionalisation in the health status of persons with intellectual disability in Europe. Journal of Intellectual Disability Research 55, 858–72. Modi A. C., Rausch J. R. & Glauser T. A. (2011) Patterns of nonadherence to antiepileptic drug therapy in children with newly diagnosed epilepsy. JAMA: The Journal of the American Medical Association 305, 1669–76. Osterberg L. & Blaschke T. (2005) Adherence to medication. The New England Journal of Medicine 353, 487–97. Redley M., Prince E., Bateman N., Pennington M., Wood N., Croudace T. et al. (2013) The involvement of parents in healthcare decisions where adult children are at risk of lacking decision-making capacity: a qualitative study of treatment decisions in epilepsy. Journal of Intellectual Disability Research 57, 531–8. Sweileh W. M., Ihbesheh M. S., Jarar I. S., Sawalha A. F., Abu Taha A. S., Zyoud S. H. et al. (2011) Differences in medication adherence, satisfaction and clinical symptoms in schizophrenic outpatients taking different antipsychotic regimens. Current Drug Safety 6, 285–90. United Nations Development Group (2011) International standards and high-level initiatives concerning persons with disabilities 1955–2006. Including the Rights of Persons with Disabilities in United Nations Programming at Country Level.
van Schrojenstein Lantman-de Valk H., Linehan C., Kerr M. & Noonan-Walsh P. (2007) Developing health indicators for people with intellectual disabilities. The method of the Pomona project. Journal of Intellectual Disability Research 51, 427–34. van Schrojenstein Lantman-de Valk H. M. & Walsh P. N. (2008) Managing health problems in people with intellectual disabilities. BMJ (Clinical Research Ed.) 337, a2507. Velligan D. I., Weiden P. J., Sajatovic M., Scott J., Carpenter D., Ross R. et al. (2009) The expert consensus guideline series: adherence problems in patients with serious and persistent mental illness. The Journal of Clinical Psychiatry 70 (Suppl. 4), 1–46. quiz 47–8. Welty T. E., Willis S. L. & Welty E. A. (2010) Effect of limited transportation on medication adherence in patients with epilepsy. Journal of the American Pharmaceutical Association 50, 698–703. Wood D., Hall A., Zhang J. & Hao T. (2006) Predictors of Psychoactive Medication use by Persons on the MR/DD Home and Community Based Waiver. Agency for Health Care Administration, Tallahasee, FL. Zeber J. E., Copeland L. A. & Pugh M. J. (2010) Variation in antiepileptic drug adherence among older patients with new-onset epilepsy. The Annals of Pharmacotherapy 44, 1896–904.
Accepted 24 January 2014
© 2014 MENCAP and International Association of the Scientific Study of Intellectual and Developmental Disabilities and John Wiley & Sons Ltd
Journal of Intellectual Disability Research
doi: 10.1111/jir.12123
1
Brief report
The relationship between living arrangement and adherence to antiepileptic medications among individuals with developmental disabilities C. L. Hom,1 P. Touchette,2 V. Nguyen,3 G. Fernandez,1 A. Tournay,2 L. Plon,4 P. Himber5 & I. T. Lott6 1 Department of Psychiatry and Human Behavior, University of California, Irvine, Orange, CA, USA 2 Department of Pediatrics, University of California, Irvine, Orange, CA, USA 3 Department of Statistics, University of California, Irvine, Orange, CA, USA 4 Department of Pharmaceutical Sciences, University of California, Irvine, Orange, CA, USA 5 Regional Center of Orange County, Santa Ana, CA, USA 6 Departments of Pediatrics and Neurology, University of California, Irvine, Orange, CA, USA
Abstract Background Non-adherence to antiepileptic drugs (AEDs) is associated with considerable morbidity and mortality in the general population but little is known about adherence in individuals with intellectual disability (ID). Method Using the records of a closed pharmacy billing system over a 30 month period, we examined the medication non-adherence rates for AEDs among 793 individuals with ID. We calculated the medication possession ratio (number of days each Correspondence: Professor Ira T. Lott, University of California, Irvine Medical Center, 101 City Drive, zot 4482 Orange, CA 92868, USA (e-mail: [email protected]). This research was supported in part by grants from the Department of Developmental Services, Regional Center of Orange County, and National Institutes of Health, AG 49721, HD 21912 and HD 065160.
participant was in possession of an AED), and defined non-adherence as 25% or more of the exposure days without the possession of an AED. All participants studied had filled prescriptions for AEDs spanning at least 6 months. Results Controlling for age and gender, we found non-adherence rates varied by living arrangement. Compared with those living in group homes, individuals with ID living in family homes or in semiindependent settings were significantly less adherent to AEDs (P < 0.0003). Conclusion Non-adherence to AEDs is a potential medical risk for individuals with ID that is significantly impacted by the type of community living arrangement. Keywords adherence, antiepileptic drugs, group homes, intellectual disability, living arrangement, medication possession ratio
© 2014 MENCAP and International Association of the Scientific Study of Intellectual and Developmental Disabilities and John Wiley & Sons Ltd
Journal of Intellectual Disability Research 2 C. L. Hom et al. • Living arrangement and medication non-adherence
Background Non-adherence to antiepileptic medications (AEDs) has been associated with increased morbidity (Bassili et al. 2002), sudden unexpected death (Leestma et al. 1989) and increased costs to the health care system (Davis et al. 2008; Faught et al. 2008; Ettinger & Baker 2009; Ettinger et al. 2009; Faught 2012). Additionally, poor adherence is associated with increased number of visits to the emergency department, hospitalisations and injuries as a result of uncontrolled seizures (Ettinger et al. 2009). In the general population, factors associated with medication non-adherence have included race, socioeconomic status, beliefs about medication, cognitive functioning and medication side effects (Bautista et al. 2011; Modi et al. 2011). Individual beliefs that medication may be intrinsically harmful and/or minimally beneficial have also been associated with lower adherence rates (Sweileh et al. 2011). In an elderly population, cognitive impairment is associated with non-adherence to AEDs, and certain AEDs appear to impart a differential risk of non-adherence (Zeber et al. 2010). AEDs that produce weight gain or cognitive side effects may adversely affect adherence. Complicated medication regimens also increase the risk for AED nonadherence (Asadi-Pooya 2005) as adherence rates are usually correlated with the number of times per day that an individual has to take a medication (Garnett 2000). Poor medication adherence has been reported among home-based individuals who do not have access to consistent pharmacy transportation (Welty et al. 2010). Little is known about AED adherence in individuals with intellectual disabilities (ID) despite a seizure prevalence of up to 27% (Airaksinen et al. 2000; Camfield & Camfield 2007; Berg et al. 2008) in this population. AEDs for seizure control are the most frequently prescribed medications in individuals with ID even with the exclusion of AEDs prescribed for mood control or behavioural problems (Carvill et al. 1999; van Blarikom et al. 2006). One of the variables that may affect AED nonadherence is the type of community residential living arrangement. While not studied with respect to AED adherence, certain types of living arrangement for community-based individuals with ID have been associated with unmet health care needs
(Martinez-Leal et al. 2011), misdiagnosis (Ali & Hassiotis 2008) and failure to treat both common and severe medical conditions (Baxter et al. 2006; van Schrojenstein Lantman-de Valk et al. 2007; van Schrojenstein Lantman-de Valk & Walsh 2008). Living arrangements have also been shown to affect several mental health characteristics in individuals with ID (Chaplin et al. 2010). For adults with ID, clinical decision-making regarding medication adherence has been viewed as a 3-way relationship between a parent-proxy, the adult lacking decisionmaking capacity, and a clinician (Redley et al. 2013). Within this context, we questioned whether living arrangements might be related to AED compliance – i.e. whether those living in a more structured supervisory setting would have better compliance than those living in a family home or a semi-independent arrangement. Access to pharmacy records for a large cohort of community-based individuals with ID allowed us to explore this relationship.
Method Materials and procedure Data from two separate sources were combined. The first data set consisted of Medicaid pharmacy billing records for individuals in the community between the years 2000–2002. The second set was Regional Center of Orange County client data, which contained demographic and living arrangement information. Regional Centers are non-profit private corporations contracted with the Department of Developmental Services to coordinate services for individuals who have ID or conditions that require treatment and services similar to an individual with ID such as autistic spectrum disorder. By matching social security numbers, we extracted a subset of pharmacy records for Medicaid individuals who are also clients of the Regional Center of Orange County. Personal identifiers were eliminated from the database prior to analysis. Data from participants living in one of three types of living arrangements were included: (1) group home, (2) semi-independent setting, or (3) family home. Group homes are community care facilities licensed to provide 24-hour residential care (State Of California, Health and Human Services Agency,
© 2014 MENCAP and International Association of the Scientific Study of Intellectual and Developmental Disabilities and John Wiley & Sons Ltd
Journal of Intellectual Disability Research 3 C. L. Hom et al. • Living arrangement and medication non-adherence
Department of Social Services 2008). Semiindependent settings consist of individuals living in their own apartment or house while receiving supported living services from an agency, ranging from daily to weekly staff assistance. Family homes are defined as any home in which the participant’s primary caregiver is a relative. We considered AEDs collectively as a class and identified participants who had AED prescription fills that spanned at least 6 months. This allowed us to define a meaningful endpoint even in the presence of two potential confounds. First, physicians may have changed a participant’s prescription from one AED to another for various reasons including lack of efficacy or side effects. Second, physicians may have prescribed multiple AEDs to treat a chronic condition. Thus, our calculation of the medication possession ratio (MPR), a widely accepted and well-documented method for measuring adherence (Andrade et al. 2006), is based on access to any AED during the study period. We calculated the number of days each participant had access to an AED (exposure period E) by using the first and last prescription fill dates. Nonadherence (called N) was defined as the number of days in which a participant did not have access to any AED during the exposure period. The MPR was then calculated as (E-N)/E, and the medication non-possession ratio (MNPR) as 1 – MPR (a higher ratio corresponded to more days that a participant did not refill any AED prescription). We classified each participant as non-adherent if the MNPR was greater than 0.25 (i.e. had 25% or more of their exposure days without access to any AED). The list of AEDs utilised by the participants in our study is presented in Table 1. The study was approved by the Institutional Review Board at the University of California, Irvine.
Results Our sample consisted of 793 participants: 107 children (13.49%), 479 males (60.40%) and 563 Caucasian (71%). The majority resided in group homes (69.86%), followed by family homes (23.46%), lastly semi-independent settings (6.68%). Most adults lived in group homes (74.3%), but most children lived in family homes (58.8% of participants
Table 1 Antiepileptic drugs (AED) prescription fills
Generic name
Trade name
Carbamazepine Clonazepam Divalproex, valproic acid Felbamate Gabapentin Lamotrigine Levetiracetam Phenobarbital Phenytoin sodium Primidone Tiagabine Topiramate Oxocarbazepine Zonisamide
Tegretol, Carbatrol, Epitol Klonopin Depakene, Depakote ER, Depakote Sprinkles Felbatol Neurontin Lamictal Keppra Dilantin, Phenytek Mysoline Gabatril Topamax Trileptal Zonegran
Clonazepam, a benzopdiazepine, is commonly used as an AED, and was included. Diazepam was not included because it is typically administered on an as-needed basis.
under age 18). Demographic summaries of the sample are presented in Table 2. The non-adherence rate for AEDs was 5.96% for group homes, 20.00% for semi-independent settings, and 31.72% for family homes. Logistic regression was used to test and estimate adjusted odds ratios for AED non-adherence for each living arrangement while controlling for age and gender. Robust standard errors (Huber 1967) were used for inference to guard against model misspecification, and Holm’s method (Holm 1979) was used to account for multiple comparisons. Among individuals of the same age and gender, participants living in semi-independent settings had a 4.14-fold increase in the odds of prescription nonadherence (95% CI: 1.93, 8.84; P < 0.0003), and participants living in family homes had a 6.05-fold increase in the odds of prescription non-adherence compared with those living in group homes (95% CI: 3.54, 10.36; P < 0.0000). This information is summarised in Table 3. In a post hoc analysis, we investigated whether or not minor status (age < 18) affected prescription non-adherence, using age as a modifier. We failed to detect a significant effect for minor status as a modifier among participants living in family homes
© 2014 MENCAP and International Association of the Scientific Study of Intellectual and Developmental Disabilities and John Wiley & Sons Ltd
Journal of Intellectual Disability Research 4 C. L. Hom et al. • Living arrangement and medication non-adherence
Variable Age on 1/1/2000 (years) Age > 18 on 1/1/2000 Adults Gender F M Ethnicity African American Asian/Pacific Islander Caucasian Latino Native American Other Unknown
Group home (n = 554)
Semi-independent (n = 53)
Family home (n = 186)
37 (29–46)
37 (31–42)
25 (13–35)
510 (92.06%)
53 (100%)
123 (66.13%)
222 (40.07%) 332 (59.93%)
23 (43.40%) 30 (56.60%)
69 (37.10%) 117 (62.90%)
16 (2.89%) 23 (4.15%) 440 (79.42%) 53 (9.57%) 1 (0.18%) 20 (3.61%) 1 (0.18%)
1 (1.89%) 3 (5.66%) 43 (81.13%) 4 (7.55%) 0 (0.00%) 2 (3.77%) 0 (0.00%)
2 (1.08%) 47 (25.27%) 80 (43.01%) 42 (22.58%) 0 (0.00%) 13 (6.99%) 2 (1.08%)
Table 2 Demographic characteristics of the selected sample
Continuous variables are reported as mean and interquartile range, and categorical variables are reported as counts and proportions.
Semi-independent vs. group home Family home vs. group home Semi-independent vs. family home Age Male vs. female
Table 3 Medication adherence comparisons
Adjusted OR
95% CI
P
4.14 6.05 0.68 0.98 0.73
[1.93, [3.54, [0.31, [0.96, [0.47,
0.0003 0.0000 0.3368 0.0715 0.1646
8.84] 10.36] 1.49] 1.00] 1.14]
Adjusted for age and gender. OR, odds ratio; CI, confidence interval.
or group homes (P = 0.7930). Since individuals under the age of 18 do not live in semi-independent settings, a further comparison with this group was not possible.
Conclusions Our study found that living arrangement was a significant predictor of AED non-adherence. Individuals with ID living in the family home were 6 times more likely to be non-adherent than those living in group homes. Similarly, individuals in semiindependent settings were approximately 4 times more likely to be non-adherent than those living in group homes. Age and gender did not predict medication non-adherence, nor was age a modifier of the odds of non-adherence.
Some subjects may have switched AEDs during the study period. Therefore, we calculated adherence based upon access to any AED and still found a significant difference in medication adherence between living arrangements. From the information available to us, we could not determine the reason(s) that AEDs were prescribed (i.e. for seizure or behavioural control). However, since many individuals with epilepsy have co-morbid mood disorders (Karceski 2010) a distinction between AEDs prescribed for seizure or behavioural management may not have been possible for many of the participants. This study did not measure initiation failure (prescriptions filled but not taken) or incorrect dosages taken, but it was deemed unlikely that a caregiver or participant would refill a prescription over an extended period
© 2014 MENCAP and International Association of the Scientific Study of Intellectual and Developmental Disabilities and John Wiley & Sons Ltd
Journal of Intellectual Disability Research 5 C. L. Hom et al. • Living arrangement and medication non-adherence
of time if the participant was not taking the medication, given the investment in time and money. Higher rates of AED adherence were found among those living in group homes, all of which are monitored by licensing agencies that require documentation of medication administration and errors (Department of Social Services 2008). Group homes have a highly regulated supervisory structure (Legault 1992; Velligan et al. 2009). Less restrictive living arrangements (semi-independent or family homes) do not generally provide the same degree of supervision. Paid caregivers may be more educated about the importance of medication adherence, routine or preventive healthcare, adequate nutrition and exercise than participants or their family members (Lennox & Kerr 1997; Asadi-Pooya 2005; Manjunath et al. 2009; Modi et al. 2011). Trained staff may also be more familiar with strategies that can increase patient cooperation with medication administration (Osterberg & Blaschke 2005). It is doubtful that the higher rate of medication adherence among individuals living in group homes was due to higher patient functioning or fewer behavioural issues. In fact, individuals with ID who reside in group homes typically have greater behavioural challenges and more severe levels of ID than individuals living more independently in the community (Aman et al. 2003; Bershadsky & Kane 2010). Those who live in group homes also tend to have higher psychotropic drug utilisation (Aman et al. 1995, 2003) and polypharmacy (Wood et al. 2006; Lunsky & Elserafi 2012) than individuals living in less restrictive settings. Going forward, we suggest that public health policy for individuals with ID take into consideration the relationship between living arrangement and AED non-adherence. Individuals with ID and their family members should be educated about the importance of medication adherence for chronic conditions such as epilepsy and psychiatric disorders as they may not fully understand the consequences of non-adherence (Chapieski et al. 2005). Moreover, there are ethical implications when family members, acting as proxies for individuals who lack decision-making abilities, withhold needed medical treatment (Redley et al. 2013). Our findings are likely to have implications beyond the State of California as federal standards, such as those delineated by the Centers for Medicare and Medicaid
Services (2013), also require licensed residential facilities to document, monitor, and provide access to appropriate medical and mental health treatments. International organisations such as the United Nations Development Group (2011) and the Convention on the Rights of Persons with Disabilities (2008) have also established mandates for all member countries to ensure that individuals with disabilities have access to proper health treatment and care.
Limitations The pharmacy records that we examined did not reveal whether failing to refill a prescription was in some cases associated with side effects, adverse drug interaction, or abnormal laboratory results. It seems reasonable, however, to assume that these events would be evenly distributed across individuals regardless of living arrangement. The data analysed were restricted to the years 2000–2002 as these were the only data available to us, but we have no evidence that AED prescribing practices have changed since this time in a way that would affect study outcome. A future prospective study would supply data pertinent to this point.
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Accepted 24 January 2014
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