Ensuring remote consultations are undertaken safely

2020 ◽  
Vol 30 (4) ◽  
pp. 32-33
Author(s):  
Rob Hendry

When it comes to remote consultations, the situation is fast changing. Rob Hendry has some advice for practice managers to keep abreast of current advice from the appropriate regulatory authorities

Author(s):  
Paramjeet Malik ◽  
Neelam Pawar ◽  
Kavita Bahmani

: Safety, efficacy and quality of a therapeutic product is the major concern for the pharmaceutical companies. FDA and PMDA are the main regulatory authorities in USA & JAPAN respectively that ensures the maintenance of these required parameters by forming standard guidelines and process for drug approval. These regulatory authorities’ reviews each step of a pharmaceutical drug product from its discovery phase to marketed product. Dossier plays an important role during the approval process of a drug product, as it allows both applicant and review team members to evaluate the data in an effective manner. A dossier consists of five modules containing informative data of various stages of a drug product but in a brief pattern with folders and subfolders. In the present paper, the authors focus on in-depth review of approval process for new and generic drugs in USA and Japan.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1474.1-1474
Author(s):  
L. Parker ◽  
F. Coldstream

Background:The Covid-19 pandemic has resulted in a rapid adoption of remote consultations in order to limit face to face clinical contact wherever appropriate, as recommended by the British Society for Rheumatology. The same clinic templates which existed for face-to-face encounters have been retrospectively adapted, without consideration of any potential difference in duration of consultations. Rheumatology practitioners from a variety of clinical backgrounds work alongside the rheumatology consultants, providing clinical care to patients with both inflammatory arthritis and connective tissue disease.Objectives:To record the duration of all scheduled telephone consultations carried out by advances rheumatology practitioners in a 4-week period.Methods:All scheduled telephone clinic encounters over a 4-week period were timed and the duration recorded in a spreadsheet. Data was collected in real time by all 8 rheumatology advanced practitioners working within the rheumatology department of a district general hospital, following each clinic episode.Results:Data was recorded from a total of 337 clinic appointments. Of these, 317 (94%) were booked as routine, 3 (0.9%) as urgent, 4 (1.2%) were expedited following an advice line contact, and 13 (3.9%) no data was recorded. 28 (8%) of the patients did not answer when contacted. 80 (24%) clinic appointments lasted 15 minutes or less, 186 (55%) lasted 16 - 30 minutes, 37 (11%) lasted 31 - 45 minutes, and 6 (2%) lasted 46 - 60 minutes. The average duration was 22 minutes.Conclusion:Within this department, remote consultations appear to have a similar duration when compared against the traditional clinic template for a fully face-to-face clinic, with some encounters lasting significantly longer than the planned duration. This would appear to differ to telephone consultations used in other settings, such as general practice where the duration is reportedly shorter1. This may be representative of the additional complexity and co-morbidity of a typical rheumatology patient, or due to the multi-faceted nature of a rheumatology follow-up appointment2. Although remote consultations are effective in limiting risk of exposure to Covid-19, they may not offer a quicker or more efficient service compared with the face-to-face model. Further study in this field is required to evaluate this widely adopted new pattern of working.References:[1]Pinnock H, Bawden R, Proctor S, Wolfe S, Scullion J, Price D, Sheikh A. Accessibility, acceptability, and effectiveness in primary care of routine telephone review of asthma: pragmatic, randomised controlled trial. BMJ. 2003 Mar 1;326(7387):477-9. doi: 10.1136/bmj.326.7387.477. PMID: 12609944; PMCID: PMC150181.[2]National Institute for Health and Care Excellence (NICE) (2018) rheumatoid arthritis in adults: management (NICE Guideline NG100). Available at https://www.nice.org.uk/guidance/ng100 [Accessed 05 January 2021].Disclosure of Interests:None declared


2021 ◽  
Vol 108 (Supplement_2) ◽  
Author(s):  
S Hodge ◽  
K Pattabathula ◽  
J Jenkins ◽  
M Ogg

Abstract Aim: With increasing demands on the healthcare system, a central (and currently essential) push for remote consultations, and an increasing number of co morbidities in the surgical population, the aim was to create an application that placed the focus on pre-hospital optimisation, education and autonomy – addressing these sector trends to enhance outcomes for patients and ease the burden on healthcare settings. Method After obtaining baseline data, I worked alongside students from the Queensland University of Technology to produce an application suitable for both iOS and android platforms. Results The application has four facets which mirror a patient’s journey from their initial outpatient appointment through to recovery. The application is easy to use, free to download and readily accessible. On opening the application, the user can select their planned operation and navigate along a personalised decision tree. Conclusions The application has been designed to educate and empower a patient to become an active participant in their care, leading to long-term changes in healthcare. Assessment is ongoing but early indications suggest that this will be a valuable tool in optimising outcomes for patients undergoing vascular surgery – leading to fewer post-operative complications and earlier restoration of functional status.


2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Qunying Mao ◽  
Miao Xu ◽  
Qian He ◽  
Changgui Li ◽  
Shufang Meng ◽  
...  

AbstractThe outbreak of COVID-19 has posed a huge threat to global health and economy. Countermeasures have revolutionized norms for working, socializing, learning, and travel. Importantly, vaccines have been considered as most effective tools to combat with COVID-19. As of the beginning of 2021, >200 COVID-19 vaccine candidates, covering nearly all existing technologies and platforms, are being research and development (R&D) by multiple manufacturers worldwide. This has posed a huge obstacle to the quality control and evaluation of those candidate vaccines, especially in China, where five vaccine platforms are deployed in parallel. To accelerate the R&D progress of COVID-19 vaccines, the guidances on R&D of COVID-19 vaccine have been issued by National Regulatory Authorities or organizations worldwide. The Center for Drug Evaluation and national quality control laboratory in China have played a leading role in launching the research on quality control and evaluation in collaboration with relevant laboratories involved in the vaccine R&D, which greatly supported the progression of vaccines R&D, and accelerated the approval for emergency use and conditional marketing of currently vaccine candidates. In this paper, the progress and experience gained in quality control and evaluation of COVID-19 vaccines developed in China are summarized, which might provide references for the R&D of current and next generation of COVID-19 vaccines worldwide.


Sign in / Sign up

Export Citation Format

Share Document