UB RESEARCH PROJECT FOR CDHS CURRICULUM
DEVELOPMENT
CDHS, College Relations Group (Buffalo State College Research
Foundation) State University of New York at Buffalo, School of
Pharmacy and Pharmaceutical Sciences Partnership
Project Overview
Scott Mandel, Director of the CDHS HIV/AIDS Training Institute
HIV/AIDS Training Resource System
Meg Brin, Child Welfare Administrative Director
Michelle Barbarossa, Child Welfare Trainer
Child Welfare/Child Protective Services Outcome-Based Training
Student Names:
Melannie Cummings, Pharm.D. Student
Desiree Tomilo, Pharm.D. Student
University at Buffalo
Department of Pharmacy Practice
Primary Contact:
Linda Catanzaro, Pharm.D., Clinical Assistant Professor
University at Buffalo, Department of Pharmacy Practice
Faculty
Consultants:
Linda Catanzaro, Pharm.D., Clinical Assistant Professor
University at Buffalo, Department of Pharmacy Practice
Lori Esch, Pharm.D., Clinical Assistant Professor,
University at Buffalo, Department of Pharmacy Practice
Judianne Slish, Pharm.D., Clinical Assistant Professor
University at Buffalo, Department of Pharmacy Practice
Gene Morse, Pharm.D., FCCP, BCPS
Associate Dean, Clinical Education and Research
Professor and Chairman, Department of Pharmacy Practice
University at Buffalo
Project Site
Consultants:
Babette Sullivan, RN
PACT Clinic, Women and Children’s Hospital of Buffalo
Dawn Melancon, RN
PACT Clinic, Women and Children’s Hospital of Buffalo
Robert Welliver, MD
PACT Clinic, Women and Children’s Hospital of Buffalo
1
RESEARCH Project: Examining Adherence Barriers in Pediatric and
Adolescent HIV Patients
Overview:
Adherence to treatment is a critical component of HIV therapy for all age groups. Studies
have shown that at least 95% adherence is necessary to prevent the development of viral
resistance to currently available medications (1). Optimal medication regimens consist of
at least three antiretroviral agents (2) (3). Complex dosing schedules as well as varying
food requirements and side effect profiles present significant obstacles to achieving the
required level of adherence (4).
Previous studies in adult patients have identified several predictors of poor adherence:
depression, drug and/or alcohol use, history of non-adherence, medication side effects,
and lack of education about treatment (5) (6). While these predictors represent significant
barriers, they are not insurmountable. They can be overcome with interventions and
services provided through a multidisciplinary team approach that involves healthcare
providers, patients, and their caregivers (7) (8) (9). Medication adherence in pediatric
HIV/AIDS patients involves the additional challenge of caregiver responsibility along
with developmental changes that continue to evolve and must be addressed as the child
grows.
An HIV Pharmacotherapy Consult Service has been developed by the University at
Buffalo School of Pharmacy and Pharmaceutical Sciences to provide services in
medication management at the Women and Children’s Hospital of Buffalo. This includes
the operation of an HIV Adherence Clinic for patients at the hospital’s Parents and
Children Together (PACT) clinic for one half-day session on a bi-weekly basis. Doctor of
Pharmacy (Pharm.D.) students and residents work alongside an HIV Pharmaceutical Care
Specialist (Pharm.D.) to educate patients, caregivers, families and medical providers with
regard to optimizing drug therapy, measuring patients’ medication adherence on a routine
basis and monitoring, minimizing and/or preventing drug-related side effects and
potential drug interactions. A multidisciplinary approach is used and involves the
incorporation of nursing staff, counselors, social workers, and nutritionists along with the
pharmacists and physicians.
In addition to the on-site services, medical providers are able to request consult services
at any time by phone or via the HIV ePharmcotherapy Network at www.hiv.buffalo.edu.
The patient population includes approximately 30 children and adolescents ranging in age
from 3 months to twenty years old.
2
Rationale:
While studies have evaluated adherence barriers in adults and provided valuable
information for healthcare providers and social services personnel, there is limited data
on the impact of these barriers in the adolescent HIV patient population and even less in
pediatric patients. Conceivably, the psychosocial barriers including depression and
substance abuse, would have an indirect yet still significant effect on medication
adherence in pediatric patients when they are present in the lives of their caregivers.
Whether the HIV-status of the parent or caregiver is an independent risk factor for
predicting a child’s adherence, has yet to be formally studied as well.
A better understanding of the impact of these issues and possible interventions that can be
implemented to successfully manage them would benefit healthcare providers, social
services personnel, and caregivers of pediatric HIV/AIDS patients. The HIV Adherence
Clinic and Pharmacotherapy Consult Service that is already in operation at the PACT
Clinic in Buffalo will provide an excellent environment to evaluate this patient
population and the impact of multidisciplinary interventions that can be implemented to
help improve medication adherence and overall patient care.
Purpose:
HIV Pharmaceutical Care Specialist, physician, nursing staff, and social workers will
have a more thorough understanding of the specific adherence barriers that are most
prevalent in their pediatric/adolescent patient population as well as specific interventions
that can be most effective in overcoming them. Patient caregivers will, in turn, be
provided with more specific education on how to manage these issues in their role.
Application:
The findings from this project will be applied to three of the Children with HIV/AIDS
Training Project’s courses/curricula:
An Overview of HIV/AIDS,
HIV/AIDS Training for Foster/Adoptive Parents and Respite Care Providers,
HIV Case Planning for Children and Adolescents in Foster Care.
CC02:
Child Welfare/Child Protective Services Outcome-Based Training
3
Objectives:
1. Gather demographic data for all current PACT Clinic patients, including the
nature of the relationship between the parent(s)/caregiver(s) and the
child(ren)/adolescents (i.e. biological, foster care, kinship foster care or adoption).
2. Review social history of each patient, including any substance use.
3. Review medical history of each patient with regard to depression status.
4. Review medication adherence history of each patient.
5. Determine most common adherence barriers in this population.
6. Track interventions (adherence counseling and tools, home visits, psychological
consults, etc.)
7. Investigate which barriers and which interventions have the biggest impact on
adherence.
8. Evaluate, when possible, substance abuse and depression in the caregiver as
potential adherence barriers.
9. Explore the impact of HIV+ vs. HIV- status of parent/caregiver on adherence.
Research Product Deliverables:
Fall 2003
1. Data collection form outlining parameters being evaluated as described in
objectives.
2. Interim report containing tabulation of subjects enrolled to date along with
baseline data collected
Spring 2004
1. Written report outlining methodology and results of this adherence evaluation
along with potential application to broader population of pediatric HIV patients
and their caregivers.
2. PowerPoint Presentation for use in caregiver and/or staff training.
4
References:
1.
Paterson D, Swindells S, Mohr J, et al. Adherence to protease inhibitor therapy and outcomes in patients with
HIV infections. Ann Intern Med 2000; 133:21-30.
2.
Department of Health and Human Services Guidelines for the Use of Antiretroviral Agents in HIV-infected
Adults and Adolescents, February 4, 2002.
3.
National Institutes of Health Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection, June
25, 2003.
4.
Gallant J, Block D. Adherence to antiretroviral regimens in HIV-infected patients: results of a survey among
physicians and patients. J Int Assoc Physicians AIDS Care 1998; 4:32-5.
5.
Kleeberger CA, Phair JP, Strathdee SA, Detels R, Kingsley L, Jacobson LP. Determinants of heterogeneous
adherence to HIV-antiretroviral therapies in the multicenter AIDS cohort study. J Acquir Immune Defic
Syndr 2001; 26:82-92.
6.
Gordillo V, del Amo J, Soriano V, Gonzalez-Lahoz J. Sociodemographic and psychological variables
influencing adherence to antiretroviral therapy. AIDS 1999; 13:1763-9.
7.
Ickovics JR, Meade CS. Adherence to antiretroviral therapy among patients with HIV: a critical link between
behavioral and biomedical sciences. JAIDS 2002; 31:98-102.
8.
Tuldra A, Wu AW. Interventions to improve adherence to antiretroviral therapy. JAIDS 2002; 31:S154-7.
9.
Esch LD, Klem K, Kuhmann L, Hewitt RG, Morse GD. Intensive Adherence Interventions Improve
Virologic Response to Antiretroviral Therapy (ART) in Treatment Naïve Patients. Presented at the 14th
International AIDS Conference, Barcelona, Spain, July 7-12, 2002 (Poster MoPeB3301).
5
Authorized Work Plan Signatures:
_______________________________________________
Linda Catanzaro, Pharm.D., Clinical Assistant Professor
University at Buffalo, Department of Pharmacy Practice
______________
Date
_______________________________________________
Lori Esch, Pharm.D., Clinical Assistant Professor,
University at Buffalo, Department of Pharmacy Practice
______________
Date
____________________________________________
Melannie Cummings, Pharm.D. Student,
Department of Pharmacy Practice
______________
Date
____________________________________________
Desiree Tomilo, Pharm.D. Student
Department of Pharmacy Practice
______________
Date
____________________________________________
Scott Mandel, Director of the CDHS HIV/AIDS Training
Institute
______________
Date
____________________________________________
Angelo Conorozzo, Director, College Relations
______________
Date
6