scholarly journals Possible Causes of and Measures to Minimise Risks of Abscesses Following DTP Vaccination

2021 ◽  
Vol 9 (1) ◽  
pp. 3-14
Author(s):  
N. V. Tereshkina ◽  
I. I. Snegireva ◽  
M. A. Darmostukova
Keyword(s):  
Side Effects ◽  
Patient Information ◽  
Objective Assessment ◽  
Vaccine Safety ◽  
Patient Information Leaflet ◽  
Cold Chain ◽  
Healthcare Personnel ◽  
Information Leaflet ◽  
Healthcare Facilities ◽  
Lack Of Information

Registration and analysis of adverse events following immunisation (AEFIs) allow for objective assessment and systematisation of AEFI causes, and promotion of vaccination safety. Development of abscesses after DTP vaccination is a fairly common AEFI, however, they are not included in the “Side effects” part of the patient information leaflet of the vaccine. The aim of the study was to analyse reasons for abscess development after DTP vaccination and to elaborate recommendations on enhancing the vaccine safety. The review of literature data, solicited reports on AEFIs, and AEFI investigation reports submitted to the Scientific Centre for Expert Evaluation of Medicinal Products during 2014–2018 suggests that abscesses associated with DTP vaccination may be caused by the vaccine reactogenicity, quality defects arising during production or distribution, and vaccine administration errors by healthcare personnel. Lack of information in the documents submitted by medical institutions does not allow to rule out any of the identified reasons. The minimisation of risks of abscesses requires quality control of DTP vaccines, maintenance of the cold chain during transportation and storage, and compliance with aseptic regulations during administration. Additional pharmacovigilance measures will also help enhance vaccination safety: improvement and standardisation of data collection during investigation of abscess development in the post-vaccination period, obligatory inclusion of data on the thickness of children’s subcutaneous adipose tissue (weight, body mass index) and the length of the needle used for vaccination in AEFI investigation reports. It is advisable to add information on abscess risk in the “Side effects” part of the patient information leaflet of the DTP vaccine, and to update the “Dosage regimen and administration route” and “Precautions” parts in order to minimise the risk. Personnel of healthcare facilities performing vaccination should be made aware of the importance of providing detailed data on AEFIs for subsequent objective analysis.

A comparative analysis of the lay-friendliness of Danish EU patient information leaflets from 2000 to 2012

2014 ◽  
Vol 11 (3) ◽  
Author(s):  
Inger Askehave ◽  
Karen Korning Zethsen
Keyword(s):  
Comparative Analysis ◽  
Patient Information ◽  
Patient Information Leaflet ◽  
General Interest ◽  
Information Leaflet ◽  
Empirical Results ◽  
Patient Information Leaflets ◽  
Information Leaflets ◽  
The Subject ◽  
The Eu

Since becoming mandatory in the EU in 1992, the patient information leaflet (PIL) has been the subject of an on-going discussion regarding its ability to provide easily understandable information. This study examines whether the lay-friendliness of Danish PILs has improved from 2000 to 2012 according to the Danish consumers. A reproduction of a questionnaire study from 2000 was carried out. The responses of the 2012 survey were compared to those of the 2000 survey and the analysis showed that Danes are less inclined to read the PIL in 2012 compared to 2000 and that the general interest in PILs has decreased. The number of respondents who deem the PIL easy to read has gone down. According to Danish consumers, the lay-friendliness of PILs has not improved from 2000 to 2012 and a very likely explanation could be that the PIL as a genre has become far too regulated and complex to live up to its original intentions. On the basis of the empirical results the article furthermore offers suggestions for practice changes.

The role of clinical pharmacist in enhancing the health-related quality of life in patients with pulmonary tuberculosis

2020 ◽  
Vol 10 (4) ◽  
Author(s):  
Eldhose Varghese ◽  
Irrin Poulose ◽  
Chaitanya Sagar G ◽  
Jennifer Ann Jose ◽  
Mintu Mathew Ms
Keyword(s):  
Quality Of Life ◽  
Pulmonary Tuberculosis ◽  
Patient Information ◽  
Patient Information Leaflet ◽  
Information Leaflet ◽  
Patient Counselling ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related

Tuberculosis (TB) is potentially airborne severe infectious disease which requires long term treatment. It considerably affects the physical and mental health quality of the patient’s life. Appropriate patient counselling with the help of Patient Information Leaflet will help to improve the patient’s quality of life and overall treatment outcome. To enhance the health related quality of life in pulmonary tuberculosis patients by providing patient counselling with the aid of patient information leaflet. An interventional study was carried out for six months in 80 patients diagnosed with pulmonary tuberculosis from the OP & IP of Tuberculosis and Chest Department of a medical college hospital. The HRQoL was assessed using the SF-36 questionnaire. Appropriate patient counselling was provided with the help of Patient Information Leaflet. In our study, a total of 80 patients were enrolled, out of which 49[61%] were Out-patients, and 31[39%] were In-patients. All the 8 sub domains of the SF-36 survey show statistical significance with improvement in 2nd Visit (after counselling) when compared with the baseline visit. The demographic variables like smoking, low socioeconomic status, allergies, family history show statistically significant association with overall HRQoL. The HRQOL of the pulmonary tuberculosis patients were initially low before the start of Anti-TB therapy, after providing proper patient counselling using patient information leaflet the HRQoL scores were found to be increased on the subsequent re-visits, which implies the need of proper patient counselling and follow-up in PTB for the better quality of life.

Dizziness, driving, and the Driver and Vehicle Licensing Agency: audit of advice given to patients, and design of a patient information leaflet

2019 ◽  
Vol 133 (09) ◽  
pp. 822-824
Author(s):  
J D Sinnott ◽  
H Mahoney ◽  
A S Wilkinson ◽  
S J Broomfield
Keyword(s):  
Patient Information ◽  
Closed Loop ◽  
Significant Proportion ◽  
Patient Information Leaflet ◽  
Information Leaflet ◽  
Referral Centre ◽  
Tertiary Referral ◽  
Tertiary Referral Centre ◽  
Clinical Notes ◽  
Individual Interpretation

AbstractBackgroundEvidence from the literature shows that clinicians’ knowledge of rules and legislation surrounding driving can often be poor. A closed-loop audit was conducted to gauge the level of driving advice given to patients with dizziness.MethodsThe clinical notes of 100 patients referred to the vertigo clinic at a tertiary referral centre were retrospectively searched for evidence of driving advice. Education sessions were undertaken and a patient information leaflet was developed before a second cycle of the audit.Results and conclusionThe proportion of patients having documented evidence of receiving driving advice increased from 6.3 per cent to 10.4 per cent. It is therefore clear that, despite this improvement, a significant proportion of patients’ notes did not contain documentation about driving. This is likely because of many reasons, including individual interpretation by clinicians. This paper provides a reminder of the rules, and discusses their interpretation and implementation in an increasingly medicolegal environment.

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