refereral and prescription audit of ped neuro clinic

Study title

Referral and prescription practices at a pediatric neurology clinic in a tertiary care hospital

Name of student: Dr Kondekar Santosh, Mumbai

Name of Guide: Dr Surbhi Rathi, Professor Department of Pediatrics, Topiwala National Medical College and Nair Hospital Mumbai Central, Mumbai 400008

Study title

Referral and prescription practices at a pediatric neurology clinic in a tertiary care hospital

Introduction

Background and rationale

Neurological disorders are a major cause of morbidity, mortality, disability in pediatric population. It also affects quality of life of patient and family.

Pediatric neurology is a vast specialty of spectrum of diseases from developmental defects,disorders- disabilities and regression to various insults of central and peripheral nervous system of a developing brain ranging from infections, toxins, trauma, autoimmune, vascular, and neoplastic and diseases and syndromes of unknown etiology.

Pediatric neurological problems have varied and dynamic presentations and manifestations due to disease process and developmental process both getting affected by environmental stimulation.  This often warrants a multidisciplinary systems framework to assess an d treat them on regular and at times emergency basis.

Developmental neurology is a major division of pediatric neurology where timely intervention and referral and treatment is very crucial. Failing this early intervention, a disability may be inevitable more so in children with cerebral palsy, autism, ADHD, learning disabilities.

In a tertiary care pediatric neurology clinic, provision of effective manpower, resources and institutional structured operating  protocol is compulsory to make each child benefit from early intervention and care; emergency services, investigations, multispecialty referrals, medicines and newer/changing management policies with judicious decision making processes, revisions and re-planning the management in a given case.

Studying the current differential case load, referral pattern to various specialties, and their need will help us understand the exact requirement for each specialty resources and time management in the long run. The aim of this study is to understand whether current support of other disciplines in terms of manpower, time and resources in managing pediatric neurology cases at our institute is optimum, inadequate or in excess; in managing current referral load from pediatric neurology clinic. These supporting systems primarily involve neuroimaging & EEG services, genetic metabolic tests, therapy services under occupational therapy, speech therapy, physical therapy and vision, hearing assessments, neurosurgery and pediatric surgery references and any other consultations like dietitian, psychiatrist, orthopedic surgeon etc as needed.

Most patients though appear to have epilepsy as a main disease or comorbidity. Prevalence of epilepsy is 10% in pediatric population.  Other conditions that are often taken care of in a pediatric neurology clinic are developmental disorders, genetic syndromes, neuroregression syndromes, autoimmune, vascular, infections, demyelinating diseases, and neurological complications of other systemic diseases.

  Several drugs are often prescribed to these children. Neuropharmacology being an unexplored spectrum in pediatric research, there is likely hood of use of many drugs for which pediatric research data may not be available. Many drugs may be even over or under used. They may also be used off label and at times may be unlicensed.

This study also plans to understand the pattern of drug use and identify off label medicine use. It is assumed to be common in pediatric neurology clinics as there is no enough data from pediatric studies. This study may also help understand if hospital inventory needs to procure any drugs which may be routinely used and n ot available in hospital pharmacy. Also if any drugs are available in excess and need not be procured by hospital; aiming at optimizing the pharmacological resources. As epilepsy is commonest pediatric neurological morbidity; commonly antiepileptic drugs may be prescribed. But around 10-20 % pediatric epilepsy cases may need more than 1 drug and at times some cases may be refractory to four drugs facing a challenge in diagnosis and management for which new drugs , nutrients or diet therapies and potential agents or treatments in other discipline may be tried. This study attempts to reveal any such therapies being received by the patients presenting at pediatric neurology clinic.

Apart from epilepsy headache/migraine can also be an important morbidity which may be under and over investigated or treated. It does amount to school absenteeism. 

As limited studies are carried out in pediatric neurological disorders, it is important to know the drugs being prescribed to understand drug utilization.

Drug utilization research is defined by WHO. It states “it is the marketing, distribution,prescription, and sue of drugs in society, with special emphasis on resulting medical, social , economic consequences. The ultimate goal is to assess the rationality.”

There are countable studies done in drug utilization in epilepsies. But the research in referral utilization study is not yet published in literature.

This study is planned with the objective of evaluating resource utilization pattern in pediatric neurology clinic with respect to multi specialty referral pattern and frequency and to identify patterns of drug.

Aim of the study:

To study patterns of multispecialty referrals and drug utilization in patients attending pediatric neurology outpatients department in 0-12 year age

Objectives:

1.     To know the pattern [percentage and frequency] of referral of pediatric neurology patients referred for various reasons to OT, PT, ST, Opthal, EEG, radiology,TDM, surgical and other departments

2.     To descriptively analyze various reasons for referral for different disease groups and delay in first visit / appointments

3.     To study patterns of drug utilization [ prescription practices] for different diagnoses

4.     To descriptively analyze prescriptions having off label or unlicensed drugs

5.     To study potential for drug drug interactions

Methodology:

Study will be commenced after approval from institutional ethics Committee.

Ethical Considerations: Pediatric age group: Informed consent form will be read out to guardian/LAR. Signature of guardian or parent on consent form will be taken and if child is more than 7 years age, an assent form will be added for child’s consent. There will be no risks, no investigations or procedures. Confidentiality will be maintained.

Study design:                      Prospective Cross Sectional Study

Study setting:                     Pediatric Neurology Clinic at BYL Nair Ch Hospital on Monday 1-3 pm 

Study population: All the children 0-12 year attending pediatric neurology clinic will be enrolled, only after appropriate written informed consent/ assent form from guardian-LAR/child as applicable.

Source population:Patients presenting to pediatric neurology OPD

Selection criteria: Following criteria should match for enrollment and guardian-LAR/child as applicable should be willing for written consent for the clinical research.

Inclusion criteria:  1. Age: 0-12 years

2. Child must register for pediatric neurology outpatient department [OPD]

Exclusion criteria: 1. Patients with neurological problems presenting to general OPD and emergency department or wards

                                    2. Patients not having registered for pediatric neurology OPD

Sampling and sample size:

                                    Being a time bound and institution based project; study data will be collected over 3 months after approval of ethics committee from Dec 2019 to Feb 2019

                                    As monthly on an average 15 patients present per OPD day, we expect a max of 180 patients to be enrolled over 12 weeks.

Study duration:      As this is a time bound study for project for university course to be completed in short span. Study duration will be less than 8 months.

Study tools- Statstics:

            Data collection:     Being a time bound and institution based project; study data will be collected over 3 months after approval of ethics committee from Dec 2019 to Feb 2019

Variables:

Data management and analysis:

1. Differential demography of diseases and co morbidities

2. Referral and prescription patterns in two different groups 0-6 year and 6-12 years

3. Referral and prescription pattern in various disease groups, depending on their prevalence

4. Descriptive analysis of referrals per patient, multi disciplinary referrals and frequency of referrals, first appointment delay across various disciplines

5. Prevalence comorbidities and monotherapy versus polytherapy across disease and age groups

6. Average number of drugs/ nutrients per prescription and potential drug drug interaction pDDI

7. Prevalence of off label use of drug and nutrients

8. Student T test will be used for statistical significance of use of montherapy versus polytherapy, drugs/ versus drugs and nutrients across groups by age and developmental delay.

REFERENCES:

1.      Bhatt KM, Malhotra SD,Patel KP, Patel VJ. Drug utilization in pediatric neurology out patient department: A prospective study at a tertiary care teaching hospital. J Basic Clin Pharma 2014:5 68-73

2.      Raj T, H. D., S. A., C. S., and N. P. “A PROSPECTIVE STUDY OF DRUG UTILIZATION PATTERN OF ANTI-EPILEPTIC DRUGS AND THEIR ADVERSE EFFECTS IN A TERTIARY CARE HOSPITAL”. International Journal of Current Pharmaceutical Research, Vol. 9, no. 6, Nov. 2017, pp. 42-45, doi:10.22159/ijcpr.2017v9i6.23427.

3.       Thiruthopu NS, Mateti UV, Bairi R, Sivva D, Martha S. Drug utilization pattern in South Indian pediatric population: A prospective study. Perspect Clin Res 2014;5:178-83.

4.      Zheng Z, Yang M, Wu J. Ethical off-label drug-use: Need for a rethink?. Indian pediatrics. 2017 Jun 1;54(6):447-5

5.      Henry Daniel Raj T, Sylvia A, Chidambaranathan S, nirmala P. Monotherapy and polytherapy in Paediatric seizures: A prospective, observational study in a tertiary care teaching hospital. IAIM, 2017; 4(10): 97-104.

6.      Hubermann L, Boychuck Z, Shevell M, Majnemer A. Age at referral of children for initial diagnosis of cerebral palsy and rehabilitation: current practices. Journal of child neurology. 2016 Mar;31(3):364-9.

7.      Utilization of Antiepileptic Drugs in Hong Kong Children Author links open overlay panelKaren L.KwongMD^aKwing W.TsuiMD^bShun P.WuMD^cAdaYungMD^dEricYauMD^e FungEvaMD^fChe K.MaMD^gSharonCherkMD^hKam T.LiuMD

8.      Gor KA, Shah KN, Joshi PB, Joshi HM, Rana DA, Malhotra SD. Off-label drugs use in neurology outpatient department: A prospective study at a tertiary care teaching hospital. Perspect Clin Res [Epub ahead of print] [cited 2019 Oct 28]. Available from: http://www.picronline.org/preprintarticle.asp?id=257225

9.      Webb DW, Coleman H, Fielder A, et al An audit of paediatric epilepsy care Archives of Disease in Childhood 1998;79:145-148.

10.  Uddin MS, Al Mamun A, Asaduzzaman M, Hosn F, Sufian MA, Takeda S, Herrera-Calderon O, Abdel-Daim MM, Uddin GS, Noor MA, Begum MM. Spectrum of disease and prescription pattern for outpatients with neurological disorders: an empirical pilot study in Bangladesh. Annals of neurosciences. 2018;25(1):25-37.

11.  Dayal P, Chang CH, Benko WS, et al. Hospital Utilization Among Rural Children Served by Pediatric Neurology Telemedicine Clinics. JAMA Netw Open. Published online August 16, 20192(8):e199364. doi:10.1001/jamanetworkopen.2019.9364