Pharmacology, particle deposition and drug administration techniques of intranasal corticosteroids for treating allergic rhinitis.

This review presents an overview of the available literature regarding intranasal corticosteroids (INCs) for the treatment of allergic rhinitis (AR). Various treatment options exist for AR including INCs, antihistamines and leucotriene antagonists. INCs are considered to be the most effective therapy for moderate-to-severe AR, as they are effective against nasal and ocular symptoms and improve quality of life. Their safety has been widely observed. INCs are effective and safe for short-term use. Local adverse events are observed but generally well-tolerated. The occurrence of (serious) systemic adverse events is unlikely but cannot be ruled out. There is a lack of long-term safety data. INC may cause serious eye complications. The risk of INCs on the hypothalamic-pituitary-adrenal axis, on bone mineral density reduction or osteoporosis and on growth in children, should be considered during treatment. Pharmacological characteristics of INCs (e.g. the mode of action and pharmacokinetics) are well known and described. We sought to gain insight into whether specific properties affect the efficacy and safety of INCs, including nasal particle deposition, which the administration technique affects. However, advances are lacking regarding the improved understanding of the effect of particle deposition on efficacy and safety and the effect of the administration technique. This review emphasizes the gaps in knowledge regarding this subject. Advances in research and health care are necessary to improve care for patients with AR.

An age-adjusted instruction video enhances the correct use of nasal corticosteroid sprays in children.

INTRODUCTION AND OBJECTIVES: Allergic rhinitis is a common disorder. Intranasal corticosteroid sprays are used to control symptoms. However, incorrect use of these sprays can decrease efficacy and lead to side effects such as nose bleeding. We studied if watching an age-adjusted instruction video is effective to improve administration technique. MATERIALS AND METHODS: We invited children who used intranasal corticosteroid sprays. We examined their administration technique before, directly after, and one month after showing them an age-adjusted instruction video. We compared their administration technique with the instructions in the patient information leaflet. We assessed whether the children performed the seventeen maneuvers mentioned in the patient information leaflet and the eight we considered essential. RESULTS: Of the 99 eligible children, 23 (15 boys, median age nine years) participated. Before watching the instruction video none of them administered according to all maneuvers in the patient information leaflet or showed all essential maneuvers. One month after seeing the instruction video, three children demonstrated correct inhalation as per the patient information leaflet. Three performed the essential maneuvers. When a 75% threshold level for carrying out all 17 maneuvers was used, still none showed 75% of all or of the essential maneuvers before watching the video. Yet, after one month 12 children showed sufficient administration technique (52%, 95% confidence interval (CI) 31%-73%, p = 0.004). Nine showed all essential manoeuvres (47%, 95%CI 24%-71%, p = 0.004). CONCLUSIONS: An age-adjusted instruction video is a useful and easy method to teach children to administer nasal intranasal corticosteroid sprays correctly.

Adverse Drug Reactions of Intranasal Corticosteroids in the Netherlands: An Analysis from the Netherlands Pharmacovigilance Center.

BACKGROUND: Intranasal corticosteroids are one of the cornerstone treatment options for allergic rhinitis and chronic sinusitis complaints. Safety information in the summary of product characteristics may not be representative for observations in daily clinical practice. The Netherlands Pharmacovigilance Center (Lareb) collects post-marketing safety information, using spontaneous reporting systems. OBJECTIVE: Our objective was to analyse reports of adverse drug reactions associated with intranasal corticosteroids reported in the Dutch spontaneous reporting database of the Netherlands Pharmacovigilance Center Lareb to obtain insight into real-world safety data. METHODS: We retrospectively examined all adverse drug reactions of intranasal corticosteroids reported to the Netherlands Pharmacovigilance Center Lareb, entered into the database from 1991 until 1 July, 2020. RESULTS: In total, 2263 adverse drug reactions after intranasal corticosteroid use were reported in 1258 individuals. Headache (n = 143), epistaxis (n = 124) and anosmia (n = 57) were reported most frequently. Nasal septum perforation (reporting odds ratio 463.2; 95% confidence interval: 186.7-1149.7) had the highest reporting odds ratio, followed by nasal mucosal disorder (reporting odds ratio 104.5; 95% confidence interval 36.3-301.3) and hyposmia (reporting odds ratio 90.8; 95% confidence interval 45.1-182.7). Moreover, 101 (4.5%) reports were classified as serious by Lareb, including reports of Cushing's syndrome, adrenal cortical hypofunction and growth retardation. CONCLUSIONS: Many side effects are consistent with the safety information in the summary of product characteristics of intranasal corticosteroids. Several serious (systemic) side effects are reported and it is important to realise that intranasal corticosteroids may contribute to the development. Healthcare providers and patients should be aware of the potential (individual) adverse drug reactions of intranasal corticosteroids. This information could help in discussing treatment options.

Improved quality of reporting safety data of medication in paediatric randomised controlled trials.

OBJECTIVE: Evaluating the reporting of safety data of medication in paediatric randomised controlled trials (RCTs) in 2017-2018 compared with our earlier study. DESIGN: Literature search with a systemic appraisal of adverse drug event reporting. MAIN OUTCOME MEASURES: Quality of reporting of safety data using Consolidated Standards of Reporting Trials (CONSORT) and Ioannidis scores in paediatric drug RCTs. The CONSORT score consists of nine recommendations of the CONSORT Group issued to improve the quality of reporting adverse events. The Ioannidis score is based on these advices. We considered a CONSORT score of at least 6 and an Ioannidis score of at least 3 as sufficient. RESULTS: We reviewed 100 RCTs published in 2017 and 2018. Ninety-four (94%) articles mentioned adverse events compared with 78% in the earlier study. Fifty-seven per cent used a standardised method for reporting adverse events compared with 34% in our earlier study. In 26 of the articles, the expected adverse events were defined, and 27 articles had a preset standardised scale for adverse events. Of these, 62 articles (62%) had a CONSORT score of 6 or higher compared with 18% in 2010. In the present study, 67% had an Ioannidis score of 3 or higher, whereas in the earlier study this was 29%. Both differences are statistically significant (p<0.05). CONCLUSIONS: Reporting safety data in paediatric RCTs has improved over the past 10 years. However, there is still room for improvement and for further improvement. Authors and editors should give more attention to methods for collecting, reporting and presenting safety data of RCTs in studies and manuscripts.

Observational study of administering intranasal steroid sprays by healthcare workers.

OBJECTIVES: Patients with allergic rhinitis receive their information about administering intranasal corticosteroid sprays (INCS) from healthcare workers. Since the majority of patients does not administer these sprays correctly, we investigated whether healthcare workers know how to administer INCS. SETTINGS: We studied participants at their working place: pharmacy, outpatient clinic or general practitioner centre for emergencies. PARTICIPANTS: Pharmacist assistants, general practitioners, paediatricians and ear nose throat doctors. DESIGN: Observational study. All the participants demonstrated the administration technique with a spray device filled with water. PRIMARY OUTCOME: Number of steps of administration of INCS based on the established INCS protocol. SECONDARY OUTCOME: Number of five steps are labelled essential to obtain optimal distribution of the medication. RESULTS: Among the 75 participants, none performed all the steps correctly. The median of correctly performed steps in the protocol was 14 out of 29. A significantly better result was found among the pharmacist assistants. The essential steps were performed by 27 out of the 75 participants (36%). CONCLUSION: The majority of healthcare workers does not know how to administer INCS correctly. Patients could, therefore, receive incorrect and non-uniform instructions. The education of healthcare workers on how to administer INCS correctly may be an option for improvement.

The Quality of Instructional YouTube Videos for the Administration of Intranasal Spray: Observational Study.

BACKGROUND: Allergic rhinitis is a common disorder affecting both children and adults. Recommended treatment consists of intranasal corticosteroid spray administration, but only few patients administer the nasal spray in the correct technical manner. A wrong administration technique may result in side effects and affect the efficacy and adherence, thus making accurate administration instructions indispensable. Unfortunately, information about intranasal drug administration is generally not explained accurately, thereby leading to confusion among patients and inaccuracy in the self-administration of drugs. OBJECTIVE: In this study, we analyzed instructional videos available on YouTube for the administration of nasal sprays for allergic rhinitis. Our aim was to determine if the videos provided instructions in accordance with the standardized nationwide patient protocol in the Netherlands for intranasal spray administration. METHODS: Instructional videos for the administration of aqueous formulations of nasal spray for allergic rhinitis were found on YouTube. All videos were reviewed by 2 researchers and scored using the instructions from the Dutch standardized protocol. Correct instructions were given a score of 1, while incorrect or missing instructions were given a score of 0. The interrater reliability using Cohen ĸ was used to determine the differences in the scores between the researchers. RESULTS: We identified 33 YouTube videos made by different health care professionals and pharmaceutical companies around the world. None of the videos displayed all the steps correctly, while 5 of the 33 (15%) videos displayed over 75% of the steps correctly. The median score of the correctly displayed steps was 11 out of 19 (range 2-17, IQR 6). The interrater reliability using Cohen ĸ was statistically significant (range 0.872-1.00, P<.001). The steps "neutral position of the head," "breathing out through the mouth," and "periodically cleaning with water" scored the lowest and were incorrectly displayed in 28 (85%), 28 (85%), and 30 (91%) of the 33 videos, respectively. CONCLUSIONS: The findings of our study revealed that only few instructional videos on YouTube provided correct instructions for the administration of nasal sprays to patients. The inaccuracy of the instructions for nasal spray administration in the majority of the videos may lead to confusion in patients and incorrect use of nasal sprays. In the future, it is important to make evidence-based instructional videos that show patients the correct technique of nasal spray administration. TRIAL REGISTRATION: Not applicable.

Inadequate quality of administration of intranasal corticosteroid sprays.

PURPOSE: Considering the fact that many mistakes are still being made by asthmatic patients when inhaling lung medication, it is important to gain insight into current techniques used to administer intranasal corticosteroid sprays (INCS) in allergic rhinitis patients. In this study, we aimed to get insight into daily use of INCS and to determine if improvement of the technique is required. PATIENTS AND METHODS: A checklist, based on available patient information leaflets (PILs) and literature, was used to determine the participants' application of the techniques used to administer INCS. These applied techniques were compared with steps described in PILs and recommended essential steps. RESULTS: In the overall population (64 participants) four participants (6%) carried out all steps as described in the PIL and seven participants (11%) carried out all recommended essential steps. CONCLUSION: The technique used to administer INCS is inadequate. Uniform and generally applicable instructions are needed and patients using INCS should be guided better.

Evaluation of instructions in patient information leaflets for the use of intranasal corticosteroid sprays: an observational study.

OBJECTIVES: In this study, we analysed patient information leaflets (PILs) of intranasal corticosteroid sprays (INCS) of different manufacturers in the UK to determine if instructions for the use of INCS are complete and uniform. SETTING: PILs of all INCS of all manufacturers, available for patients in the UK, were collected from the British National Formulary website and the Medicines and Healthcare products Regulatory Agency website. All instructions in these PILs were analysed. PARTICIPANTS: We identified PILs of INCS from 21 different manufacturers, available for patients in the UK. RESULTS: We analysed the instructions for the use of INCS in 21 different PILs and there is large variation in the PIL instructions for the technique of using INCS across PILs. CONCLUSION: Complete and uniform instructions for the use of INCS are lacking in PILs for registered preparations in the UK. Structured and standardised instructions to be used by both professionals and patients are essential in order to optimise daily use of INCS.

An age-adjusted instruction video enhances the correct use of nasal corticosteroid sprays in children

INTRODUCTION AND OBJECTIVES: Allergic rhinitis is a common disorder. Intranasal corticosteroid sprays are used to control symptoms. However, incorrect use of these sprays can decrease efficacy and lead to side effects such as nose bleeding. We studied if watching an age-adjusted instruction video is effective to improve administration technique. MATERIALS AND METHODS: We invited children who used intranasal corticosteroid sprays. We examined their administration technique before, directly after, and one month after showing them an age-adjusted instruction video. We compared their administration technique with the instructions in the patient information leaflet. We assessed whether the children performed the seventeen maneuvers mentioned in the patient information leaflet and the eight we considered essential. RESULTS: Of the 99 eligible children, 23 (15 boys, median age nine years) participated. Before watching the instruction video none of them administered according to all maneuvers in the patient information leaflet or showed all essential maneuvers. One month after seeing the instruction video, three children demonstrated correct inhalation as per the patient information leaflet. Three performed the essential maneuvers. When a 75% threshold level for carrying out all 17 maneuvers was used, still none showed 75% of all or of the essential maneuvers before watching the video. Yet, after one month 12 children showed sufficient administration technique (52%, 95% confidence interval (CI) 31%-73%, p = 0.004). Nine showed all essential manoeuvres (47%, 95%CI 24%-71%, p = 0.004). CONCLUSIONS: An age-adjusted instruction video is a useful and easy method to teach children to administer nasal intranasal corticosteroid sprays correctly

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