Rajashri Ojha and Shivanand P. Puthli
Accepted Abstracts: Pharmaceut Reg Affairs
At the outset, this paper aims to present how the changes in regulations pertaining to pharmacists, particularly in India, will be useful in order to downsize disintegration in the bounds of the healthcare system, to make the management of medication effective, to upgrade the persistent patient care and patient user-friendliness towards the medication. Furthermore, in the context of this conceptual paper, the regulatory changes stand for the prescribing rights for the registered pharmacists.There is a general favorable reception of ?prescription by pharmacist? in the international pharmacy literature. Interestingly, in India we can implement this system to lessen the workload on physicians. Nevertheless, it goes without saying that this system would have its own pros and cons. All the same, it has some advantage in patients point of view. There can be some replicas which we can put into practice and are described in the paper. Firstly, ?Pharmacist prescribing by contingent practice? which would be a written guideline, a specific comprehensive set of documents that delineate the actions that are to be performed by pharmacists in the prescriptive authority. Secondly, in ?complimentary prescribing? doctors would embark on the initial assessment and the ancillary prescriber [the pharmacist] can thereafter prescribe working on the basis of care management policy settled by the physician. Here, the role of complimentary prescriber will significantly donate to clinical supervision plan and monitoring along with change of medicine, if any, and eventually referring to the doctors. Thirdly, ?collaborative prescribing? replicas embraces a mutual practice association sandwiched between a pharmacist and a physician additionally with authorized permission for medicine prescription. Moreover and importantly, the ?Role of government? is to check the competence of registered pharmacist. Government can set the exams that will examine their competency to prescribe the medication. To sum up, the establishment of above suggested models will be the apposite opening phase towards the aim of this paper.
Mrs. Survase-Ojha has completed her B.Pharm from Bombay College of Pharmacy with post graduate Diplomas in IPR, ADPQAM, CTD-eCTD and pursuing PhD from JJT University, Rajasthan. She is a Director and Founder of Raaj Global Pharma Regulatory Affairs Consultants, Thane- Mumbai(India). She has published more than 6 Articles and papers in reputed journals. She is a competent Regulatory Affair professional with 20 years of work experience in the pharmaceutical industry like Novartis-OTC, Glenmark , GSK-TCS, Sandoz Pvt. Ltd, Famycare, local FDA and Unichem laboratories since 1991. Significant experience in Registration of pharmaceutical product & Regulatory Approvals; inclusive of IND/NDA/ ANDA/ANDs submission to different national & International Health Authorities. Faced Regulatory Audits for USFDA, UK-MHRA, EdQM, WHO and other local Audits.
Pharmaceutical Regulatory Affairs: Open Access received 533 citations as per Google Scholar report