Day :
- Hospital & Industrial Pharmacy, Clinical Pharmacy: Activities and Prescriptions, Healthcare & Patient safety, Healthcare Nursing.
Location: WEBINAR
Session Introduction
Dr.Steffi Jerry Mammen
Inamdar Multispeciality Hospital, Pune
Title: A study of Adverse Drug reactions in a tertiary care hospital of Pune
Biography:
Steffi Jerry Mammen had complete her B.Pharm, Pharm-D from JNUTA, India. She is a budding researcher having her expertise in Pharmacology and Pharmacotherapeutics. Currently pursuing her MHA along with clinical duties in the hospital .Interacting with other health care professionals, providing knowledge, information, patient counseling, lastly awareness, in a country where pharmacy is under-rated profession. Published research papers in various national and international journals.
Abstract:
Purpose: To study the adverse drug reactions (ADR’s) reported from wards and critical units in a tertiary care hospital of Pune. The adverse drug reactions were analyzed by Naranjo’s algorithm scale and Hartwig severity assessment scale and the outcomes were studied. Methods: This observational and interventional study was conducted for 6months from November 2016-May 2017 in an inpatient setting of a tertiary care hospital of Pune. The adverse drug reactions were checked for their causality and severity by performing the Naranjo’s algorithm scale and Hartwig’s scale respectively. Result: Total 50 ADR’s were reported from wards and critical units. 21-30 years age group was reported to have more adverse drug reactions. The most common organ affected is the Skin 32 (71.11%), followed by Respiratory system 3 (6.66%) and nervous system 3 (6.66%). Vancomycin 5 (20%) was the drug having majority of the ADR’s. The commonly reported ADR in this study was rash and itching 29 (64.44%). According to Naranjo’s algorithm scale, 23 (51.11%) suspected ADR’s were probable, 17 (37.77%) ADR’s were possible and 5(11.11%) were definite. As per Hartwig’s severity assessment scale, majority of the ADR’s were mild 21 (46.66%), followed by moderate 20 (44.44%) and severe 4 (8.88%). The outcome of the ADR’s was all recovered 38 (84.44%) during the study period. Conclusion: There is a need for more spontaneous reporting. After an ADR has occurred, patient counseling is mandatory. The active involvement of a clinical pharmacist to capture ADR’s and awareness can help change the scenario in under-reported hospitals.
Hima Bindu Gottam
Formulation Scientist II, TOLMAR Inc, Colorado, USA
Title: Understanding Q hypotheses for developing topical generic drugs
Biography:
Bindu has completed her Bachelors in Pharmacy at the age of 21 years from Acharya Nagarjuna University, India and M.S. in Chemistry (Thesis) from Western Illinois University, US. She started her career as an Associate Scientist and worked on a variety of dosage forms including oral solutions, transdermal patches, topical dosage forms and parenteral dosage forms. She worked in generic dermatology industry over 8 years and has more than 18 ANDA approvals in US within short span and 8 more products are currently under filing with the agency. She has 2 publications in reputed journals and also completed her Regulatory Affairs Certification (RAC).
Abstract:
Topical drug delivery is considered one of the safest and easiest drug delivery approaches for many reasons. Topical formulations are designed to deliver drugs to the skin to treat skin disease conditions or to alleviate symptoms. Developing a dermatology generic drug product involves many regulations and needs critical understanding of the test product as well as reference product in order to make the test formulation structurally and functionally similar to the reference product. Current regulations require conducting clinical end point trials for demonstrating bioequivalence (BE) between topical generic and refernce listed drug (RLD) products. A variety of surrogate methods have been explored but with limited success. FDA has been continuously coming up with new regulatory standards to make high quality and affordable medicines available to public and the generic industry is trying to adapt to the new requirements. Bioequivalence sudies on topical products still remained one of the challenging topics in the generic industry because of two reasons: i) due to high complexity of topical dosage forms ii) due to lack of proper design of BE studies. The new GDUFA II guidance gives a clear pathway to assist generic pharmaceutical industry with identifying the most relevant methodologies for developing drugs and generating evidence needed to support ANDA approval. To develop a therapeutically equivalent drug product to a specific reference product, it is necessary to identify the key scientific principles for consistent and efficient identification of BE methods. Availability of product quality matrices i.e. Q1 (qualitatively the same), Q2 (quantitatively the same) and Q3 (microstructure/ physical attributes of the topical dosage form) is critical to demonstrate that generic topical product is therapeutically equivalent.
Faisal Shakeel
Sarhad University of Science and Information Technology, Peshawar, Pakistan
Title: A pharmacoepidemiological approach to evaluate drug-drug interactions in a specialized stroke unit in Pakistan
Biography:
Faisal Shakeel has completed his PhD at the age of 30 years from Department of Pharmacy, University of Peshawar, Pakistan. He is one on the youngest PhD holders from the department. He also is one of the pioneers to start research in the field of pharmacy practice in Pakistan. He organized a team and made way for the establishment of the first Drug Information and Poison Control Center in the province of Khyber Pakhtunkhwa, Pakistan, which served its purpose and benefitted many health professionals as well as the general public. He also has multiple papers in reputed journals.
Abstract:
Stroke is one of the common diseases responsible for morbidity and mortality worldwide. (Mukherjee and Patil) It is a problem in both developed and developing countries despite advancements in its treatment and management through drug therapy or surgical intervention. (Murray and Lopez) Drug interactions in stroke patients present a unique challenge as the patient’s already critical condition makes concomitant drug administration risky. The main aim was to determine the prevalence of potential drug-drug interactions in stroke unit, and to identify clinically significant drug-drug interactions which have the potential to produce adverse drug events. One year cross-sectional study was carried out in a stroke unit of a tertiary care hospital. Patient medication charts were evaluated for potential drug-drug interactions and clinically significant potential drug-drug interactions using Micromedex DrugReax. Statistical analysis of the data was carried out using IBM SPSS Statistics for Windows, Version 20. A 70.8% prevalence of potential drug-drug interactions was observed in the patients of stroke unit. Furthermore, patients with cerebrovascular accident presented with a high risk of potential drug-drug interactions. Clinically significant interactions were present in 58.2% patients which was attributed to 58 drug pairs. Logistic regression analysis revealed that patients prescribed 6 or more drugs or of age 40 years or more were 6 and 4 times significantly more likely to have a drug-drug interaction respectively. A high prevalence of potential drug-drug interactions especially clinically significant interactions was present in stroke unit and could be avoided by management of a limited number of drug pairs.