Stakeholders in Pharmaceutical Policy Development

Pharmaceutical policy development is a linear and step-wise process that moves from problem statement or agenda setting, to planning and analysis, to definitions and objectives, to policy formulation and statutory approval, to implementation and monitoring, to policy review and evaluation and finally to improvisation. In the process of developing and implementing such a policy framework several stakeholders including national and multi-national drug manufacturers, state and central governments (including all ministries like health, commerce, trade, industry), regulatory authorities, patients, doctors, pharmacists, pharmaceutical traders, insurance agencies, academia, professional associations, NGOs, civil society and consumer groups assume primary importance without whose active involvement the whole process would be inadequate and sometimes even inappropriate leaving huge gaps in their comprehensiveness, inclusiveness and acceptability. This chapter defines the role and describes the importance of these very stakeholders in the process of pharmaceutical policy development and implementation in any settings across the world

Insulin Resistance and Polycystic ovary Syndrome: A Review

Polycystic Ovary Syndrome (PCOS) is the most common, yet complex, endocrine disorder affecting women in their reproductive years and is a leading cause of infertility. This disease appears to be multifactorial and polygenic in nature involving multisystem dysfunction, namely reproduction, endocrine and metabolic. Hyperandrogenism and insulin resistance appear to be central cause to the pathophysiology of the disease. The glucose and insulin metabolism pathways have been studied and debated to understand whether Insulin Resistance is due to a defect in insulin action or a primary defect in β-cell function or decreased hepatic clearance of insulin, or a combination of all these factors. Numerous studies have demonstrated that obese, normal weight and thin women with PCOS have a form of insulin resistance that is unique and intrinsic to the disorder. Moreover obese women with PCOS possess an additional burden of insulin resistance resulting from their excess adiposity. Hyperinsulinemia leads to increase in androgen production directly by acting as a co-gonadotropin, augmenting Luteinizing Hormone activity within the ovary, and indirectly by increasing serum LH pulse amplitude. Whereas Androgens may in turn contribute at least partially to the insulin resistance state linked with PCOS.  In this review, we will briefly study the role of insulin resistance in polycystic ovary syndrome. Keywords: Polycystic ovary syndrome, insulin resistance, Hyperandrogenism

Drug safety and Pharmacovigilance: An overview

Adverse drug reactions (ADRs) have a major impact on public health, reducing patient’s quality of life and imposing a considerable financial burden on the health care systems at a time when many health care systems are under considerable financial strain. All healthcare providers have roles to play in maintaining a balance between a medicine's benefits and risks. Once a drug is available to the public, making a determination about its safety is the shared responsibility of all who are part of the prescribing process, including patients. The role of healthcare professionals is vital in recording and reporting suspected ADRs in order that regulatory agencies are alerted of emerging safety concerns and thereby facilitating timely and appropriate action. Pharmacovigilance is an important exercise for monitoring of drug related issues after marketed in “real world setting”. Pharmacovigilance and all drug related issues are important for everyone whose life is being impacted any way by medical interventions. The evolution of Pharmacovigilance in recent years has growing importance as a science critical to effective clinical practice and public health science. The national Pharmacovigilance centers have become a significant influence on the drug regulatory authorities, at a time when drug safety concerns have become increasingly important in public health and clinical practice. This paper unfolds the basics of drug safety and other important aspects of Pharmacovigilance. Keywords: Adverse drug reactions, Pharmacovigilance, Drug regulation

Connecting Pharmacists and Other Health Care Providers (HCPs) towards Drug Therapy Optimization: A Pharmaceutical Care Approach

Background. Pharmaceutical care services offered by pharmacists rationalize drug therapy, improve patient quality of life, and save patients’ lives. This study was designed to optimize patient drug therapy through pharmaceutical care services offered by a pharmacist in consultation with other health care providers (HCPs) at a tertiary care hospital. Methods. This descriptive study was conducted to assess the role and effectiveness of pharmacists in optimizing drug therapy outcomes. The study was carried out at an internal and pulmonary medicine unit of a tertiary care hospital in Srinagar, Jammu and Kashmir, India, with a total of 50 health care providers (HCPs) (24 doctors, 16 nurses, and 10 pharmacists). A total of 182 patients (males and females) of all age groups were recruited into the study over a period of nine months. Patient-specific pharmaceutical care plans initiated by the pharmacist based on drug therapy-related needs and problems were used to address and optimize drug therapy outcomes in consultation with other HCPs. Results. A total of 388 drug-related problems (DRPs) with an average of 2.29 DRPs per patient were identified, for which 258 pharmaceutical care plans as interventions were proposed, out of which 233 (90.31%) were accepted and implemented. Preassessment and postassessment by HCPs on services rendered by the pharmacist showed a positive change in attitude among HCPs with respect to their endorsement and acceptance of the pharmacist’s services in providing direct patient care. Conclusions. Pharmaceutical care services offered by pharmacists helped in optimizing drug therapy and patient care

DEVELOPMENT OF AN INDICATOR BASED TOOL FOR THE ASSESSMENT OF MEDICINES SELECTION PRACTICES IN VARIOUS PUBLIC SECTOR HOSPITALS

Objective: To develop and validate an indicator based assessment tool for carrying out an in-depth assessment of drug selection practices prevalent at various public health facilities.Methods: The study was designed across the different levels of healthcare settings. One super specialty children's tertiary care hospital (CH), one government medical college hospital (MCH), one district hospital (DH), one sub-district hospital (SDH) and one primary health center (PHC) was selected for the study. A set of 29 qualitative and 7 quantitative indicators was developed and validated to evaluate and assess drug selection practices in these public healthcare facilities.Results: All the surveyed healthcare facilities managed and stored essential medicines except solid oral dosage forms, contraceptives, antiretrovirals and anti-tubercular drugs. The selection process for medicines was not carried out at SDH and PHC level. National List of Essential Medicines (NLEM), manufacturer's information, and expert faculty opinion were used as basic tools for carrying out a selection of drugs. None of the facilities were found to have Drugs and Therapeutics Committee (DTC) in place or its own Hospital Formulary (HF). Insufficient and irregular disbursement of funds was found to be the main constraint in selecting drugs for procurement. None of the facilities had any policy and procedural manual or standard operating procedures for governing their drug selection and quantification processes. Quantitative assessments showed that disbursement of the budget was fragmented. On the basis of NLEM children's hospital was found to have highest medicines percentage availability of eighty percent (80%) with the lowest at SDH and PHC of twenty percent each (20%). Facility wise percentage adherence to various indicators for policies and procedures was found to be 50% in MCH, CH, and DH respectively and 66.6% adherence for NLEM indicator was recorded in MCH, CH and DH respectively.Conclusion: Drug selection process for public health facilities is a highly technical and professional activity that can only be achieved efficiently by having a well-defined document containing Standard Operating Procedures (SOPs) and comprehensive policy framework for drug selection, quantification, procurement, storage, distribution, and use besides having suitably qualified, adequately trained, sufficiently skilled manpower both at managerial and ground level

Hypotensive Potential of Aqueous Extract of Emblica Officinalis

Effect of aqeuous extract of dried fruits of Emblica officinalis (AE) on the mean arterial blood pressure (MABP) , heart rate (HR) and respiratory rate (RR) of the anaesthetized male dogs when given alone and in combination with various agonists as well as antagonists was studied. AE showed a biphasic response on MABP with a slight initial increase of short duration, followed by a prominent decrease of longer duration. An increase in the rate and depth of respiration was also seen. HR was decreased. Response due to carotid occlusion (C.O) was not altered but the response due to vagal stimulation (V.S) was enhanced by AE. AE potentiated the effects of histamine and acetylcholine. Initial increase in MABP was not blocked by Prazocin, neither was the subsequent decrease blocked by propranolol. However both pheniramine and atropine reduced the magnitude of decrease in MABP due to AE to some extent. Observations suggest a synergistic cholinergic as well as histaminergic effect of AE on MABP and HR of anaesthetized dogs thus revealing its hypotensive potential. JK