BACKGROUND: The aim of these clinical standards is to provide guidance on 'best practice' care for the diagnosis, treatment and prevention of post-COVID-19 lung disease.METHODS: A panel of international experts representing scientific societies, associations and groups active in post-COVID-19 lung disease was identified; 45 completed a Delphi process. A 5-point Likert scale indicated level of agreement with the draft standards. The final version was approved by consensus (with 100% agreement).RESULTS: Four clinical standards were agreed for patients with a previous history of COVID-19: Standard 1, Patients with sequelae not explained by an alternative diagnosis should be evaluated for possible post-COVID-19 lung disease; Standard 2, Patients with lung function impairment, reduced exercise tolerance, reduced quality of life (QoL) or other relevant signs or ongoing symptoms ≥4 weeks after the onset of first symptoms should be evaluated for treatment and pulmonary rehabilitation (PR); Standard 3, The PR programme should be based on feasibility, effectiveness and cost-effectiveness criteria, organised according to local health services and tailored to an individual patient's needs; and Standard 4, Each patient undergoing and completing PR should be evaluated to determine its effectiveness and have access to a counselling/health education session.CONCLUSION: This is the first consensus-based set of clinical standards for the diagnosis, treatment and prevention of post-COVID-19 lung disease. Our aim is to improve patient care and QoL by guiding clinicians, programme managers and public health officers in planning and implementing a PR programme to manage post-COVID-19 lung disease. 

Clinical standards for diagnosis, treatment and prevention of post-COVID-19 lung disease

Patient safety and quality of care are a priority for hospital pharmacists all across Europe. The European Association of Hospital Pharmacists (EAHP) has manifested the importance of patient safety for hospital pharmacy practice in a dedicated section of its European Statements of Hospital Pharmacy.1 As stewards of patients’ medication safety, hospital pharmacists are the key stakeholders ensuring the safe, effective and rational use of medicines by upholding the ‘rights’ of patients. This includes improving the safety of using medications, especially high-risk medication and look-alike and sound-alike (LASA) medications, through their close surveillance as well as advising on the most appropriate use of medicines. While some prescribing, dispensing and administration may not cause harm, it may not be cost-effective or beneficial for the patient. The abovementioned phrase 'appropriate use' encompasses a multitude of situations.

Patient safety, which lies at the heart of all representations made by EAHP and its members, covers many aspects. EAHP’s position on patient safety specifically focuses on medication safety. In particular, medication errors, which occur when a medicine has been inappropriately prescribed, prepared, dispensed or administered to a patient, are a key concern for hospital pharmacists. Throughout the medication use process specific measures must be taken by healthcare professionals (figure 1). For hospital pharmacists these include improving medication safety by reducing available harm through using risk assessment procedures.



Figure 1 
The medication use process from a patient perspective.



Even before a patient is treated for a specific disease, hospital pharmacists ensure the safety of the patient throughout the care pathway. These include actions linked to the hospital formulary, such as selecting narrow-spectrum antibiotics to prevent resistance, and implementation of the decision of the Drug and Therapeutics Committee, the proper selection and procurement as well as the application of appropriate quality assurance strategies for the medication use processes to …

https://ejhp.bmj.com/content/ejhpharm/28/3/129.full.pdf

Position paper on patient safety.

BACKGROUND: The value, speed of completion and robustness of the evidence generated by TB treatment trials could be improved by implementing standards for best practice.METHODS: A global panel of experts participated in a Delphi process, using a 7-point Likert scale to score and revise draft standards until consensus was reached.RESULTS: Eleven standards were defined: Standard 1, high quality data on TB regimens are essential to inform clinical and programmatic management; Standard 2, the research questions addressed by TB trials should be relevant to affected communities, who should be included in all trial stages; Standard 3, trials should make every effort to be as inclusive as possible; Standard 4, the most efficient trial designs should be considered to improve the evidence base as quickly and cost effectively as possible, without compromising quality; Standard 5, trial governance should be in line with accepted good clinical practice; Standard 6, trials should investigate and report strategies that promote optimal engagement in care; Standard 7, where possible, TB trials should include pharmacokinetic and pharmacodynamic components; Standard 8, outcomes should include frequency of disease recurrence and post-treatment sequelae; Standard 9, TB trials should aim to harmonise key outcomes and data structures across studies; Standard 10, TB trials should include biobanking; Standard 11, treatment trials should invest in capacity strengthening of local trial and TB programme staff.CONCLUSION: These standards should improve the efficiency and effectiveness of evidence generation, as well as the translation of research into policy and practice.

Standards for clinical trials for treating TB.

Chapter 2. The 6-month regimen (2HRZ (E)/4HR) is recommended for DS-TB.However, some patients require prolonged treatment.Prolonged treatment is a burden to patients and the health care system.Early detection of patients requiring prolongated TB treatment is therefore one of the priorities of TB management.To determine risk factors associated with extended TB treatment we perform a retrospective cross-sectional study in TB patients in the Dutch outpatient setting.Chapter 3. Timely diagnosis and treatment of childhood TB is critical and remains challenging, especially in low-burden countries, in part due to small numbers of TB patients, and lack of experience of individual treatment centers.Some groups of children may have a higher risk of unsuccessful treatment outcomes.The role of these risk factors may vary by setting and population.Using data from the National TB registry we aim to identify factors associated with unfavourable TB treatment outcome in children and adolescents routinely treated in the Netherlands between 1993 and 2018.Chapter 4. It is well known that TB in the Netherlands is more common in persons who were not born in the Netherlands.In 2020 these persons accounted for almost three quarters of the reported cases.To guide improvement of TB management we evaluate treatment outcomes and predictors for poor treatment outcomes for TB among native and foreign-born adult patients with DS-TB in the Netherlands treated in the period of 2005-2015.Chapter 5. Drug-resistant tuberculosis (DR-TB) is defined as TB with M. tuberculosis isolates resistant to one or more TB-drugs.Treatment is difficult, long and costly and has a higher risk of unsuccessful treatment outcome compared to DS-TB.Preventing unsuccessful treatment outcome is therefore important.In this study we investigate the prevalence of different types of DR-TB cases and determine the patients' characteristics predicting unsuccessful treatment outcome by analyzing the treatment outcomes of drug-resistant TB in Netherlands in the last 10 years.Chapter 6. Drug resistance is acquired during inappropriate use of FQs.Further investigation of dose optimization of LFX is of interest.In this chapter, we will review the available publications concerning the in vitro activity and/or efficacy of LFX, and clinical studies on pharmacokinetic (PK) monitoring strategy and parameters of LFX in adults and children with MDR-TB, aiming to optimize the dose of LFX using pharmacokinetic and pharmacodynamic principles.Chapter 7. LFX variability in drug exposure has been associated with acquired 1 

Treatment outcomes and medication management of tuberculosis

BACKGROUNDIn Pakistan, 84% of healthcare is provided by the private sector. We conducted an epidemiological and programme review for TB to document progress and guide further efforts.METHODSSurveillance
 and data systems were assessed before analysing epidemiological data. We reviewed the programme at federal, provincial and peripheral levels and compiled national data along with WHO estimates to describe the evolution of epidemiological and programme indicators.RESULTSIn
 2021, of the estimated number of TB cases, 55% of overall cases and 18% of drug-resistant cases were diagnosed and treated respectively. The contribution of the private sector in case detection increased from 30% in 2017 to 40% by 2021. For newly diagnosed pulmonary TB cases, the overall proportion
 of confirmed cases was 52%. In 2021, testing for rifampicin resistance among confirmed cases was 66% for new and 84% for previously treated patients. The treatment success rate exceeded 90% for drug susceptible TB. The main challenges identified were a funding gap (60% in 2021–2023),
 fragmented electronic systems for data collection and suboptimal coordination among provinces.CONCLUSIONSThe main challenges prevent further progress in controlling TB. By addressing these, Pakistan could improve coverage of interventions,
 including diagnosis and treatment. Bacteriological confirmation using recommended diagnostics also requires further optimisation.

2022 TB programme review in Pakistan: strengthening governance, with better patient diagnosis and treatment

BACKGROUND: Adverse effects (AE) to TB treatment cause morbidity, mortality and treatment interruption. The aim of these clinical standards is to encourage best practise for the diagnosis and management of AE. METHODS: 65/81 invited experts participated in a Delphi process using a 5-point Likert scale to score draft standards. RESULTS: We identified eight clinical standards. Each person commencing treatment for TB should: Standard 1, be counselled regarding AE before and during treatment; Standard 2, be evaluated for factors that might increase AE risk with regular review to actively identify and manage these; Standard 3, when AE occur, carefully assessed and possible allergic or hypersensitivity reactions considered; Standard 4, receive appropriate care to minimise morbidity and mortality associated with AE; Standard 5, be restarted on TB drugs after a serious AE according to a standardised protocol that includes active drug safety monitoring. In addition: Standard 6, healthcare workers should be trained on AE including how to counsel people undertaking TB treatment, as well as active AE monitoring and management; Standard 7, there should be active AE monitoring and reporting for all new TB drugs and regimens; and Standard 8, knowledge gaps identified from active AE monitoring should be systematically addressed through clinical research. CONCLUSION: These standards provide a person-centred, consensus-based approach to minimise the impact of AE during TB treatment.

Clinical standards for the management of adverse effects during treatment for TB

Background Medication errors are a major problem for patient safety all over Europe. To avoid medication errors, a better knowledge of the respective risk factors as well as the type of errors and causes are necessary. Purpose With documentation of medication errors and later identification of risk factors, we invented the PEPPAS to detect major risk, learn from other countries and share strategies to avoid medication errors. Material and methods We invented the German medication error reporting system DokuPIK in Iceland, Estonia and Hungary. In these critical incident reporting system reports could be submitted online. Apart from a standalone use in a single hospital, it can also be used nationwide as well as internationally to detect major risk. These records were inputted into the database by pharmacists and pharmaceutical technicians. They were free to put in all errors they thought were worth reporting. Data were exported into MS Excel and screened independently by a hospital pharmacist. Entries were categorised for frequency of type of error, cause of error and degree of severity caused by the medication error. Results The present pilot study is based on analysis of 1522 records stored in the DokuPIK (November 2014 to February 2015). The analysis revealed the following rank order of types of error: (wrong) dose (250), clear indication but no drug prescribed (155) and interactions (140). The most common causes were identified as: lack of knowledge (737), organisation (380) and workload (361). Most of the errors were classified as “an error occurred, reached the patient but did not cause patient harm”. Conclusion Based on our present data, we are already able to identify a number of risk factors that most likely cause medication errors. There is only a small bias in the system, caused by the reporting colleagues. They have to decide which errors to report. With this information we have a means of developing specific strategies to avoid medication errors while keeping human and financial resources at an optimum by sharing knowledge all over Europe. The database should be enrolled in more European countries in the future to gain more data. No conflict of interest.

https://ejhp.bmj.com/content/ejhpharm/23/Suppl_1/A214.3.full.pdf

PS-001 Identification of risk factors frequently associated with medication errors – pan-european project for patient safety (peppas)

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Clinical standards for the management of adverse effects during treatment for TB

PS-001 Identification of risk factors frequently associated with medication errors – pan-european project for patient safety (peppas)