ABSTRACT
Today, drug safety data collection in India is both manual and electronic with reporting of potential overlapping and duplicate data, which is likely incomplete for further review and analysis. Furthermore, standardized data collection and timelines are not aligned with international standards. Complete coverage of safety data from all sources throughout the life of the drug cannot be ensured. There is no requirement to submit periodic safety data in clinical trials to regulatory authority. There is clearly a lack of emphasis on deriving meaningful safety data insights for ensuring patient safety. Efforts toward the early detection of drug safety issues are minimal. There is no mandate to publicly disclose drug safety findings. Benefit-risk evaluation of investigational and marketed products cannot be assured merely through annual status reports and periodic safety update reports, respectively. Focused initiatives involving stakeholders from regulatory, health-care, and pharmaceutical industries are required to change the current situation and enable derivation of meaningful insights from safety data. Equal emphasis on assessing real-time safety of the drugs and protection of patients' rights, safety, and well-being is required. Periodic safety data reporting in clinical trials, proactive safety data collection related to potential safety concerns, electronic medical records, electronic expedited reporting, collection of targeted data from stakeholders, and standardized and harmonized data collection aligned to the International Council for Harmonization guidelines are required. The Central Drugs Standard Control Organization should implement requirements to submit Development Safety Update Reports, Periodic Benefit-Risk Evaluation Reports, and Risk Management Plans. Access to clinical trials and postmarketing safety data through central repository would enable researchers to explore the data for application in clinical practice.
ABSTRACT
Bilateral superficial cervical plexus block may help in reduction of postthyroidectomy pain. The aim of this study was to evaluate the influence of bilateral superficial cervical plexus block (BSCB) given either presurgically or postsurgically on analgesia in postthyroidectomy patients. Sixty adult euthyroid patients were randomly allocated to one of the three groups, to receive BSCB either presurgically (group A) or postsurgically (group B). Both of the above groups were compared with parenteral analgesics (group C). Thyroid surgery was performed according to a standardised procedure. Postoperative pain was assessed by visual analog scale (VAS), with 10 being the worst pain and 0 being no pain, when patient was fully awake and extubated (0) and after 1, 2, 4, 8, 12, 18, 24, 36 and 48 h. VAS was assessed at four phases: at rest, neck movements, vocalisation and swallowing. Total use of intraoperative fentanyl was noted. The time for first rescue analgesic was also noted. There was no significant statistical difference amongst three groups as regards demographic data and duration of surgery. Patients given BSCBs (either presurgically or postsurgically) had significant lower VAS at all four phases of pain assessment as compared to group C. The time for first rescue analgesia was the earliest in group C. We concluded that BSCB whether given presurgically or postsurgically significantly reduce pain intensity and opioids requirement in postoperative period after thyroid surgery.
