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Yvette C. Terrie , BSPharm, RPh
After completing this continuing education article, the pharmacist should be able to: 1. Describe the various theories regarding the basic etiology and pathophysiology of autism, including risk factors, and signs and symptoms associated with autism. 2. Express the impact of autism on both patients and caregivers. 3. Counsel patients and their caregivers on the proper use of the pharmacologic agents used to manage autism, including their criteria for use. 4. Identify adverse effects associated with the use of agents in the management of autism. 5. Advise caregivers on the nonpharmacologic management of autism. 6. Analyze the latest research and clinical trials in autism. Autism, also referred to as autistic disorder, is the most prevalent form of the pervasive developmental disorders, also known as autism spectrum disorders (ASDs). Autism is a complex neurodevelopmental disorder that typically manifests itself in the first 3 years of life and is characterized by impairment in reciprocal social interaction and verbal and
ACPE Program I.D. Number: 0290-000-07-022-H01-P Pharmacy Times/Ascend Media Office of Continuing Professional Education is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This program is approved for a maximum of 2.0 hours of Continuing Education Credits (0.2 CEU) through 12/1/2010.
nonverbal communication. Other characteristics of autism may include cognitive impairment, abnormally increased or decreased response to certain stimuli, and ritualistic or compulsive behaviors. Some individuals may exhibit aggression and self-injurious behavior as well.
The hallmark feature of autism is impaired social interaction, and the degree of autism can vary from mild to severe. Two related milder ASDs are called Asperger's syndrome and "pervasive developmental disorder not otherwise specified (PDD-NOS)."2,4 Some children who are diagnosed with autism appear to develop normally and then suddenly show signs of regression between 12 and 24 months. It is estimated that 25% of affected children will experience loss of previously acquired skills.
Autism still remains a mystery to the health care profession and the large number of families that are affected by this disorder. According to the Centers for Disease Control and Prevention (CDC), autism is considered to be the fastestgrowing developmental disability in the United States. Autism is 4 times more common in boys than in girls, although the exact reason for this difference is unknown. The disorder is considered to be more prevalent than such wellknown conditions as diabetes, childhood cancer, spina bifida, and Down syndrome.
More than a decade ago, autism was thought to affect an estimated 4 to 5 of every 10,000 children. In 2007, however, results from a recent survey from the Centers for CDC reported that the incidence has increased at epidemic proportions and is significantly higher than once thought.3,7 ASDs affect 1 million to 1.5 million individuals in the United States. The most recent statistics show that a child is diagnosed with autism every 20 minutes. Additional figures released in 2007 from the CDC indicate that 1 in every 150 children has some degree of autism—up from the 1 in 166 figure reported by the CDC in January 2004.
Furthermore, the overall incidence of autism increases by about 10% to 17% annually.
It is estimated that only 50% of children
with autism are diagnosed before kindergarten. The question that arises for many is whether the number of diagnosed cases is really increasing or whether people have become more aware of the disorder due to some of the advances that have been made in recognition and diagnosis of the condition. According to the Autism Society of America, the estimated annual cost of caring for individuals with autism is $90 billion. In 10 years, the estimated cost will be $200 billion to $400 billion.9 Moreover, the society reports that the cost of lifelong care can be reduced by two thirds with early diagnosis and intervention.9 As the rate of autism continues to soar and affect so many children and their families, it is imperative that more research be done to further the understanding and management of this complex and perplexing disorder. This continuing education article will review current theories, ongoing research, and therapies available for the management of autism. It also will provide pertinent information for pharmacists that can be used when assisting patients diagnosed with autism, as well as family members and caregivers.
Autism was first diagnosed in 1943 by Leo Kanner, MD, a child psychiatrist at Johns Hopkins University Medical School. He noted the behavior of 11 children between 1938 and 1943, observing that they shared behavioral characteristics of isolation, withdrawal from human contact, and abnormal social and communication abilities. Dr. Kanner also noted that these symptoms were present early in the child's development, often right after birth.2,3,12,13 He named the condition early infantile autism.3 A year later, Hans Asperger, PhD, MD, from Vienna, Austria, first described Asperger's syndrome, which is considered to be a milder form of autism. His work was not well-known in the English language until 1981. The symptoms of Asperger's syndrome are similar to those of classic autism, because patients with the syndrome have impairments with regard to social interaction and repetitive behaviors. The biggest difference is that patients with Asperger's syndrome do not have delays in speech and cognitive skills and the ability to adapt to their surroundings. Another major difference is that some individuals with autism have some degree of mental retardation.
By definition, an individual with Asperger's syndrome cannot have a "clinically significant"
cognitive delay, and the majority have an average to above-average intelligence.
The 2 disorders were not listed in the Diagnostic and Statistical Manual of Mental Disorders (DSM) until 1994. the DSM-IV as 2 of the 5 PDDs, more often referred to today as ASDs.
They are listed in
If a child has symptoms of either of these disorders but does not meet the specific criteria for either, and there is evidence of a developmental problem, the diagnosis is called PDD-NOS. Other rare, very severe disorders that are included in the category
of ASDs are Rett syndrome and childhood disintegrative disorder
Causes and Risk Factors
Autism continues to be an enigma to the world of medicine, as well as to those families affected by it. Despite a better understanding of this multifactorial disorder, the exact cause is still unknown. The etiology has been speculated on for many decades, and various research studies report that autism is caused by abnormalities in the brain's structure or function. Results from post mortem and magnetic resonance imaging (MRI) studies have demonstrated that several major brain structures may be associated. These structures include the cerebellum, cerebral cortex, basal ganglia, limbic system, corpus callosum, and brainstem. In addition, a host of studies report abnormalities of various regions of the brain that may be found in autistic individuals, including the frontal and temporal lobes and the cerebellum, as well as enlargements of the amygdala and the
hippocampus, which are common in childhood.19 Other research studies are investigating the role of neurotransmitters such as dopamine and serotonin in autism.3 Research has found that brain scans comparing children with autism and those without autism show differences in the shape and structure of the brain. In a study published in the Archives of General Psychiatry, Hazlett et al examined brain volume and head circumference in 51 children with autism (aged 18 to 35 months) and 25 children who were both developmentally delayed and normally developed in the same age group. The results showed that children with autism had significant enlargement of the cerebral cortex. Additionally, children with autism appeared to have had a normal head circumference at birth, but their head circumference grew at an increased rate, when compared with that in the other group.
In other research, published in the American Journal of Neurology, Aylward et al conducted a study to determine whether brain volume on MRI scans differs between autistic individuals and those in a control group. The results showed that brain volumes were significantly larger for autistic children 12 years and younger, when compared with those in normally developing children.22 The study reported that children with autism have abnormal brain development during the early years of life.22,23 Other theories speculate that autism may be attributed to heredity, genetics, obstetric complications, exposure to toxic agents, and prenatal, perinatal, and postnatal infections. autism.
In addition, maternal rubella is associated with significantly higher rates of
Still other theories are that environmental factors—such as viral infections, metabolic imbalances, and exposure to
chemicals—as well as food allergies may be associated with an increased risk for autism.
Some research strongly suggests that some individuals may have a genetic predisposition to autism. shown to be more likely than fraternal twins to have autism. 90%; for dizygotic twins it is less than 5%. chromosome 13.
24,26 18,28 2,3
Identical twins have been
The concordance rate of autism for monozygotic twins is 60% to
Recent studies have found the gene for at least 1 kind of familial autism on
Moreover, families with 1 autistic child have a 5% chance of having another child with autism.
Approximately 10% of children with a PDD exhibit a known medical condition.19 Autism frequently is associated with other neurologic or medical conditions including encephalitis, tuberous sclerosis, fragile X syndrome, congenital rubella syndrome, undiagnosed phenylketonuria, and underdeveloped reflexes.2,3,24,25,27 Studies also have found that an estimated 3% to 9% of individuals with autistic characteristics have chromosome aberrations, and these abnormalities occur on every chromosome.25 The most prevalent chromosomal anomaly is fragile X. Research reports that 5% of people with autism are affected by fragile X, and 10% to 15% of those with fragile X show autistic traits.2,3,25,29 In addition, autism is prevalent in patients with the genetic disorder tuberous sclerosis. Statistics show that 1% to 4% of individuals with ASD have tuberous sclerosis. In addition, a study funded in part by the National Institutes of Health (NIH) and published in the February 18, 2007, issue of Nature Genetics has associated components of the brain's glutamate chemical messenger system and a previously overlooked site on chromosome 11.
25 30 3,6,25
Furthermore, abnormal electroencephalogram results can be found in as many as 43% of individuals with autism, particularly in those with lower IQs. adolescence. Also, 25% to 30% of children with autism develop seizure disorders, which typically manifest themselves during
A great debate also has occurred about the link between autism and thimerosal, a mercury preservative found in vaccines, particularly the measles-mumps-rubella (MMR) vaccine. The Academy of Pediatrics and the CDC have reported no definitive link between vaccines and autism.4 The Institute of Medicine (IOM) conducted a thorough review on this link. The final report from the IOM, "Immunization Safety Review: Vaccines and Autism," released in May 2004, stated that no link was found between the MMR vaccine and autism.3,32,33 A study published in the May 16, 2007, issue of the American Journal of Medical Genetics reported that exposure to thimerosal does not increase the risk of autism. parents still have concerns about vaccinations.
Although thimerosal no longer is found in childhood vaccines, some
Two research studies conducted by the Collaborative Program of Excellence in Autism, funded by the National Institute of Child Health and Human Development, discovered that autism may involve a lack of connections and coordination in separate areas of the brain. In people with autism, the brain areas that perform complex analysis appear less likely to work together during problemsolving tasks than in people who do not have the disorder.
In the first study, published in the journal Cerebral Cortex, Just et al used functional MRI to view the brains of autistic individuals and compared them with those who did not have autism.33,34 In the second study, published in the journal Brain, Just et al studied the degree to which brain areas engaged in language work together with brain areas that process images. Results from the second study corroborated the findings of the first study and confirmed that the prefrontal and parietal regions of the cortex in individuals with autism were less likely to work at the same time. The researchers found that communications between these higher-order centers in the brains of people with autism appear to be directly related to the thickness of the anatomical connections between them.
More studies are being conducted in this area.
Signs and Symptoms
Autism is considered a spectrum disorder, meaning that the manifestations of this disorder vary in severity from 1 patient to another. Some patients are termed high-functioning because they are verbal and have above-average or normal intelligence. Others may have some degree of mental retardation, have significant speech delays, or be nonverbal. Although no 2 cases are alike, individuals tend to demonstrate certain behavioral characteristics that are commonly associated with autism. Parents usually are the first to recognize the initial signs of autism. In many cases, children appear to be developing normally until around the age of 2 years, when significant delays or regressions in their developmental progress are noticed. In some cases, children may have appeared unfocused and unresponsive to their surroundings since birth. One of the first signs that parents notice is speech delay. An estimated 40% of autistic children are nonverbal, and another 25% to 30% may speak some words between 12 and 18 months and then lose language skills, whereas some may not speak until they are older. considered to be echolalic, meaning that they repeat what is said to them.
Some individuals with autism are
Table 2 In addition to social and language delays, autism has other symptoms, such as repetitive behavior patterns. The behavior may manifest itself in the form of swaying from side to side, rocking back and forth, and flapping the arms or clapping. Autistic patients
also may exhibit the need to arrange objects in a certain way, either by sequence or quantity. These patients tend to very regimented by routine. They may be preoccupied with a single interest or object. Some may be extremely sensitive to light or sound. Others may be very finicky eaters. It has been estimated that approximately 25% to 30% of all autistic children develop seizures, usually during adolescence. autistic children who also are mentally retarded.
This manifestation is most often seen in
Typically, a diagnosis of autism occurs between the ages of 3 and 5 years, but it can occur earlier. Results from an extensive range of studies show that an estimated 2% of individuals will achieve normal function, with approximately 40% identified as having Asperger's syndrome (high-functioning autism).8 It is difficult to diagnose autism and related disabilities, such as PDD-NOS and Asperger's syndrome, especially in younger children whose language and reasoning skills are still developing. It is imperative, however, for parents who notice any signs of autism to discuss their concerns with their pediatrician, because early intervention may be beneficial to many individuals.8 Currently, no diagnostic tests for autism exist. Autistic children typically exhibit classic behavioral characteristics that often can be used as a diagnostic tool by specialists. Several other conditions may cause the same or similar symptoms as those seen in autism, however. Parents should seek the aid of the child's pediatrician to rule out other disorders, such as hearing and speech problems or mental retardation. Once autism is suspected and other probable causes have been eliminated, the pediatrician often will recommend that the child be evaluated by a specialist. It is important to note that the diagnosis of autism cannot be made until the patient has been evaluated on communication, behavior, and developmental levels. Diagnosis often is based on the specific criteria outlined in the DSM-IV. A diagnosis of autism is made when an individual exhibits 6 or more of the 12 symptoms listed in the 3 main areas of behavior, communication, and social interaction and 3).
Impact on Caregivers and Family Members
For a parent, the diagnosis of autism can be both overwhelming and challenging. The uniqueness of each case makes the experience vastly different for each family. Individual family members may experience high levels of stress, as well as emotional and physical exhaustion due to a demanding schedule when caring for an individual with autism, especially one with severe autism. Parents and caregivers should be encouraged to seek assistance from a support group and to communicate with other families with autistic children, as well as to remember to take care of themselves. Parents and caregivers also should be encouraged to learn about autism and to ask questions about the care, treatment, and management of this disorder throughout the various stages of the child's life. They should find a health care professional to assist in the care and therapy of the autistic child. Health care professionals should remind parents and caregivers about the vast resources available.
A variety of therapies are available for individuals with autism: Behavioral therapy, such as applied behavioral therapy Occupational therapy Speech-language therapy Music therapy
Sensory integration Also, certain diets, vitamins, and supplements are used. In some cases, the patients have shown an intolerance and/or allergy to certain food ingredients such as yeast or gluten (ie, wheat, oats, and barley) and also casein (a protein found in milk). The results of many studies conducted to assess whether abnormal amounts of vitamins and minerals can be found in autistic patients have been largely inconclusive. Although no scientific data support the successful use of vitamin and mineral supplementation, some physicians and parents have reported improvement in autistic patients receiving supplements such as vitamin B6, magnesium, and vitamin C. Speech therapy attempts to aid the autistic patient in communicating. A speech therapist will be consulted to determine whether the patient is verbal or nonverbal and to address other specific communication issues. Patients with verbal capabilities will be trained to have conversations. Nonverbal patients will be taught how to use picture boards, to write, or to type as a means of communication. Most nonverbal patients have difficulty being understood and typically engage in limited social interactions. Research has demonstrated that early identification and intervention may be beneficial in the management of autism. It is very important to understand that this disorder has several manifestations, so the treatments chosen for the patient always should be based on the patient's specific needs and behaviors. Most specialists believe that autistic patients benefit most from multifaceted treatment approaches that place an emphasis on education, behavior modification, and, if necessary, medications. Caregivers should be knowledgeable about all treatment options.
Some parents do not believe in treating their children with medications at all because of the side effects associated with these agents. Therefore, these parents rely solely on nonpharmacologic treatments. Some treatments have been researched and proven to be effective and others have not. Parents of autistic children always should consult with the physician or other health care professionals prior to initiating any treatments.
Managing the Symptoms of Autism
Although no pharmacologic agents are available to treat autism, sometimes the use of pharmacologic agents is necessary to successfully manage some of the symptomatic behaviors. It is very important to note that, because this disorder has several manifestations, the selected treatment should always be based on the patient's specific needs and behavior. Also, the appropriateness of the use of pharmacologic agents in pediatric patients must be considered, and the benefits must be weighed against the adverse effects. On October 6, 2006, the FDA approved risperidone for the symptomatic treatment of behaviors in autistic children and adolescents 5 to 16 years of age. This drug was the first to be approved to treat behaviors such as irritability, deliberate self-injury, and temper tantrums associated with autism. The effectiveness of risperidone with regard to symptomatic treatment of irritability associated with pediatric autism disorders was studied in two 8-week, placebo-controlled trials with 156 patients ranging in age from 5 to 16
years. An estimated 90% of the patients studied were 5 to 12 years old.18,37 The results of the study were evaluated using 2 assessment scales. They demonstrated that individuals taking risperidone achieved a significantly improved score for certain behavioral symptoms of autism, when compared with individuals on a placebo. Initial dosing of risperidone is typically 0.25 mg per day for patients weighing <20 kg and 0.5 mg per day for patients > 20 kg. Caution should be exercised with dosages for smaller children who weigh <15 kg.
The most common adverse effects include
fatigue, weight gain, somnolence, tachycardia, increase in saliva, and constipation.
Physicians may prescribe several other pharmacologic agents to manage other behavioral symptoms. For example, agents such as the antipsychotic medication olanzapine is used off label for the treatment of aggression and other serious disturbances in children. In addition, selective serotonin reuptake inhibitors (SSRIs) are used for anxiety, depression, and obsessive-compulsive disorder (OCD). Fluoxetine is the only approved SSRI that has been approved for both OCD and depression in children. It is approved for depression in children > 8 years. Fluoxetine and sertraline are approved for children 7 years and older with OCD. In 2007, the FDA extended the black box warning on all antidepressants to include young adults up to 25 years of age. Individuals, especially children, should be routinely monitored while receiving these agents, especially during the first few weeks of therapy.
3 3,39 3 3
In some children receiving these agents for treatment, a decreased frequency of repetitive behaviors and compulsive rituals as well as improvements in eye contact were experienced.3 Other pharmacologic agents that are sometimes prescribed to treat certain behavioral symptoms of autism include antidepressants, antipsychotics, anticonvulsants, stimulants, and alpha adrenergic agonists (Table 4).3,19,24,39,40
Autism is a complex condition that presents itself in varying degrees, and the management of autism may be overwhelming and challenging at times. Unfortunately, children diagnosed with autism do not outgrow this disorder, but with an increased awareness and early intervention, more options can aid in its management. The disorder is still quite complex, but experts do know that early diagnosis and intervention can be very beneficial. In October 2007, the American Academy of Pediatrics (AAP) released 2 reports on the identification/evaluation and management of children with autism spectrum disorders. The AAP now recommends that pediatricians screen all children for autism spectrum disorders twice by the age of 2.41,42 More information on these reports can be found at the AAP's official Web site, www.aap.org. Pharmacists can aid both patients and caregivers through comprehensive reviews of patients' medication profile, ensuring that appropriate drug counseling is conducted, and continually reviewing patients' reactions to the medications prescribed, as well as screening for potential drug interactions and possible contraindications. It is imperative for pharmacists to keep abreast of developments in research and in pharmacologic therapies regarding the disorder.
1. Miller-Keane Encyclopedia and Dictionary of Medicine, Nursing and Allied Health. 7th ed. Philadelphia, Pa: Saunders; 2005. 2. Autism Spectrum Disorders. Merck Manual Online. Available at: www.merck.com~ch299c.html. Accessed May 24, 2007. 3. Autism Spectrum Disorders (Pervasive Developmental Disorders). National Institute of Mental Health Web site. Available at:
www.nimh.nih.gov/publicat/autism.cfm. Accessed May 22, 2007. 4. Autism. Medline Plus,A Service of the US National Library of Medicine and National Institutes of Health Web site.Available at: www.nlm.nih.gov/medlineplus. 5. Overview of Autism. Neurology Channel Web site. Available at: www.neurologychannel.com/autism/index.shtml. Accessed June 5, 2007. 6. The Crisis of Autism. National Foundation for Autism Research Web site. Available at: www.nfar.org/page.aspx?page_id=18. Accessed May 23, 2007. 7. Autism Development Disabilities Monitor Network. Centers for Disease Control and Prevention Web site. Available at: www.cdc.gov/ncbddd~AutismCommunityReport.pdf. Accessed May 22, 2007. 8. Diagnosing Autism. Available at: www.autism-pdd.net/diagnosing-autism.html. Accessed May 21, 2007. 9. Autism Facts and Statistics. Autism Society of America Web site.Available at: www.autismsociety.org~about_whatis_factsstats. Accessed May 21, 2007. 10. Prevalence of Autism Now 1 in 150, According to CDC Report. Cure Autism Now Web site. Available at: www.cureautismnow.org/site/apps/nl/content2.asp. Accessed May 23, 2007. 11. The Silent Epidemic. National Foundation for Autism Research Web site. Available at: www.nfar.org/Epidemic.aspx. 12. Yazbak FE. Autism in the United States: a perspective. Journal of American Physicians and Surgeons, Winter 2003, Volume 8, Number 4. Available at: Journal of American Physicians and Surgeons(Formerly The Medical Sentinel) Web site at: www.jpands.org/jpands0804.htm. Accessed June 1, 2007. 13. Pervasive Developmental Disorders. Gale Encyclopedia of Genetic Disorders. Farmington Hills, Mich: Gale; 2005:1007-1010. 14. Asperger's Disorder. Autism Society of America Web site. Available at: www.autismsociety.org/site~about_whatis_asperger. Accessed May 22, 2007. 15. Diagnostic and Statistical Manual of Mental Disorders. 4th ed.Washington, DC: American Psychiatric Association; 1994. 16. 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Aylward E, Minshaw N, Field K, Sparks BF, Singh N. Effects of age on brain volume and head circumference in autism. Neurology. 2002;59:175-183. 23. Researchers Shed Light on Early Brain Growth and Autism. Science Daily Web site.Available at: www.sciencedaily.com/releases/2002/07/020724080815.htm . 24. Medical Encyclopedia Info on Autism. Autism Overview. Medicine Online Web site. Available at: www.medicineonline.com/reference/Society/info/Autism.htm . 25. Hilt RJ, Metz WP. Autism Spectrum Disorders. EMedicine Web site. Available at: www.emedicine.com/med/topic3202.htm . 26. Autism. MedicineNet Web site. Available at: http://www.medicinenet.com/autism/page3.htm. Accessed May 21, 2007. 27. Autism Fact Sheet. National Institute of Neurological Disorders and Stroke Web site. Available at: www.ninds.nih.gov/disorders/autism/detail_autism.htm . 28. Biomedical and Dietary Approaches. Autism Society Web site. Available at: www.autism-society.org/site /PageServer?pagename=about_treatment_biomedical . Accessed June 3, 2007. 29. Autism Awareness. MedicineNet Web site. Available at: www.medicinenet.com/script/main/art.asp?articlekey=80625 . 30. Largest-Ever Search for Autism Genes Reveals New Clues. National Institute of Child Health and Human Development Web site. Available at: www.nichd.nih.gov/news/releases/autism_gene_reveals_clues.cfm?from=autism . 31. Autism Spectrum Disorders Overview. Centers for Disease Control and Prevention Web site. Available at: www.cdc.gov/ncbddd/autism/overview.htm#causes . 32. Thimerosal in vaccines has no link to autism. Medline Plus Web site. Available at: www.nim.nih.gov/medlineplus/newsstory /fullstory_49399.html . 33. Researchers Gain Insight into Why Brain Areas Fail to Work Together in Autism. National Institute of Child Health and Human Development Web site. Available at: www.nichd.nih.gov/news/releases/autism_brain_structure.cfm . 34. Just MA, Cherkassky VL, Keller TA, Kana RK, Minshaw NJ. Functional and Anatomical Cortical Underconnectivity in Autism: Evidence from an fMRI Study of an Executive Function Task and Corpus Callosum Morphometry. Cerebral Cortex. Advance access published online June 13,2006. Available at: cercor.oxfordjournals.org/cgi/content/full/17/4/951 . 35. Autism Symptom Checklist. Autism and PDD Support Network Web site. Available at: www.autism-pdd.net/checklist.html . 36. Diagnosis and Consultation. Autism Society of America Web site. Available at: www.autism-society.org/site /PageServer?pagename=about_whatis_diagnosis#Screening . Accessed June 1, 2007. 37. Autism Information Center. Centers for Disease Control and Prevention Web site. Available at: www.cdc.gov/ncbddd/autism /treatment.htm#Medications . 38. Risperdal Package Insert. Available at: www.risperdal.com . 39. Prozac Package Insert. Available at: www.prozac.com. 40. Lewis MH, Lazoritz M. Psychopharmacology of Autism Spectrum Disorders. Psychiatric Times, May 2005, Volume 22, Issue 6. Available online at: www.psychiatrictimes.com/showArticle.jhtml?articleId=164303316. 41. Autism Speaks Applauds New American Academy of Pediatrics Guidelines for Autism, Autism Speaks Web site.Available at:
www.autismspeaks.org/press/autism_speaks_aap.php . 42. American Academy of Pediatrics Releases Autism Reports, Autism Society of America Web site. Available at: www.autismsociety.org . Yvette C. Terrie, BSPharm, RPh is a Clinical Pharmacy Writer, Haymarket,Va
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