Unintended consequences of patient online access to health records: a qualitative study in UK primary care

BackgroundHealth systems around the world are seeking to harness digital tools to promote patient autonomy and increase the efficiency of care. One example of this policy in England is online patient access to full medical records in primary care. Since April 2019, all NHS England patients have had the right to access their full medical record prospectively, and full record access has been the “default position” since April 2020.AimTo identify and understand the unintended consequences of online patient access their medical record.Design and SettingQualitative interview study in 10 general practices in South West and North West England.MethodSemi-structured individual interviews with 13 patients and 16 general practice staff with experience of patient online access to health records.ResultsOnline access generated unintended consequences that negatively impacted patients’ understanding of their health care, for example patients discovering surprising information or information that was difficult to interpret. Online access impacted GPs’ documentation practices, such as when GPs pre-emptively attempted to minimise potential misunderstandings to aid patient understanding of their health care, in other cases, negatively impacting the quality of the records and patient safety when GPs avoided documenting their speculations or concerns. Contrary to assumptions that practice workload would be reduced, online access introduced extra work, such as managing and monitoring access and taking measures to prevent possible harm to patients.ConclusionThe unintended consequences described by both staff and patients show that to achieve the intended consequences set out in NHS policy additional work is necessary to prepare records for sharing and prepare patients about what to expect. It is crucial that practices are adequately supported and resourced to manage the unintended consequences of online access now that it is the default position.

Identifying the Steps Required to Effectively Implement Next-Generation Sequencing in Oncology at a National Level in Europe

Next-generation sequencing (NGS) may enable more focused and highly personalized cancer treatment, with the National Comprehensive Cancer Network and European Society for Medical Oncology guidelines now recommending NGS for daily clinical practice for several tumor types. However, NGS implementation, and therefore patient access, varies across Europe; a multi-stakeholder collaboration is needed to establish the conditions required to improve this discrepancy. In that regard, we set up European Alliance for Personalised Medicine (EAPM)-led expert panels during the first half of 2021, including key stakeholders from across 10 European countries covering medical, economic, patient, industry, and governmental expertise. We describe the outcomes of these panels in order to define and explore the necessary conditions for NGS implementation into routine clinical care to enable patient access, identify specific challenges in achieving them, and make short- and long-term recommendations. The main challenges identified relate to the demand for NGS tests (governance, clinical standardization, and awareness and education) and supply of tests (equitable reimbursement, infrastructure for conducting and validating tests, and testing access driven by evidence generation). Recommendations made to resolve each of these challenges should aid multi-stakeholder collaboration between national and European initiatives, to complement, support, and mutually reinforce efforts to improve patient care.

Current State of Regulatory Oversight of Biosimilars in India and Its Implications on the Quality of Drugs: A Comparative Assessment with EU and FDA Regulations

Biosimilars are biologic products that are highly similar to a licensed reference biologic, with no clinically meaningful differences in quality characteristics, biological activity, safety, or efficacy. Biosimilars can help to fulfill unmet medical needs due to their cost effectiveness while at the same time being as efficacious as the innovator drug. They can also improve patient access to otherwise costly innovator biologics. India has the largest number of approved biosimilars as compared to the US and Europe. However, the numbers of clinical studies that are conducted to prove the biosimilarity are lesser than the number of biosimilars approved, which is evident by the number of CTRI registrations done. Some studies have shown the quality of biosimilars approved and marketed in India to be inferior to the innovator drug. This raises concerns regarding the quality of the biosimilars. In this review, the similarities and differences in the guidelines, the approval process, and quality enforcement measures prevailing in the three regulatory regions of USA, Europe and India are discussed. Changes in the approval process and post approval monitoring of drugs and manufacturing facilities are recommended in order to ensure sustained quality standards of drugs entering the market.

Critique of the Royal Australian and New Zealand College of Psychiatrists Psychedelic Therapy Clinical Memorandum, Dated May 2020

Objective: The Royal Australian and New Zealand College of Psychiatrists (RANZCP) has positioned itself against medically controlled patient access (at this current time) to 3,4-methylenedioxymethamphetamine (MDMA) and psilocybin-assisted therapies in its Therapeutic Use of Psychedelic Substances Clinical Memorandum, May 2020. The main reason given by the RANZCP for its stance is safety concerns. Methods: Every reference in the clinical memorandum (CM) was checked against the original publications used by RANZCP to justify its position. In addition, the search engines Google Scholar, PubMed, ScienceDirect, the Multidisciplinary Association for Psychedelic Therapies (MAPS) website, the Therapeutic Goods Administration (TGA) website, relevant Australian and New Zealand legislation were searched for pertinent and up-to-date- information. Results: There is no scientific or medical evidence from the last 70 years to suggest that either psilocybin or MDMA, when administered as an adjutant to therapy in a controlled clinical setting, are linked to either mental illness or negative health outcomes. On the contrary, MDMA and psilocybin have been shown to be safe, non-toxic, non-addictive, and efficacious when administered in a medically-controlled clinical environment. All associated risks are apparent in an uncontrolled setting. Conclusion: The RANZCP’s position is based on outdated, irrelevant, misinterpreted, and misinformed evidence. With the recent positive media coverage of the efficacy of these medicines when used as an adjunct to therapy, there is an intrinsic risk of self-medication or underground therapy. This means that any medical discussion must also purvey the ethical responsibilities and social duties associated with these substances.

Improving the understanding of how patients with non-dystrophic myotonia are selected for myotonia treatment with mexiletine (NaMuscla): outcomes of treatment impact using a European Delphi panel

Background Non-dystrophic myotonias (NDMs) comprise muscle chloride and sodium channelopathies due to genetic defects of the CLCN1- and SCN4A-channels. No licensed antimyotonic treatment has been available until approval of mexiletine (NaMuscla®) for adult patients by the EMA in December 2018. This Delphi panel aimed to understand how outcomes of the pivotal phase III Mexiletine study (MYOMEX) translate to real world practice and investigate health resource use, quality of life and the natural history of NDM to support economic modelling and facilitate patient access. Methods Nine clinical experts in treating NDM took part in a two-round Delphi panel. Their knowledge of NDM and previous use of mexiletine as an off-label treatment prior to NaMuscla’s approval ensured they could provide both qualitative context and quantitative estimates to support economic modelling comparing mexiletine (NaMuscla) to best supportive care. Consensus in four key areas was sought: healthcare resource utilization (HRU), treatment with mexiletine (NaMuscla), patient quality of life (QoL), and the natural history of disease. Concept questions were also asked, considering perceptions on the feasibility of mapping the validated Individualized Neuromuscular Quality of Life (INQoL) instrument to the generic EQ-5D™, and the potential impact on caregiver QoL. Results Consensus was achieved for key questions including the average long-term dosage of mexiletine (NaMuscla) in practice, the criteria for eligibility of myotonia treatment, the clinical importance of QoL outcomes in MYOMEX, the higher proportion of patients with increased QoL, and the reduction in the need for mental health resources for patients receiving mexiletine (NaMuscla). While consensus was not achieved for other questions, the results demonstrated that most experts felt mexiletine (NaMuscla) reduced the need for HRU and was expected to improve QoL. The QoL mapping exercise suggested that it is feasible to map domains of INQoL to EQ-5D. Points of interest for future research were identified, including that mexiletine (NaMuscla) may slow the annual decrease in QoL of patients over their lifetime, and a significant negative impact on QoL for some caregivers. Conclusions This project successfully provided data from an informed group of clinical experts, complementing the currently available clinical trial data for mexiletine (NaMuscla) to support patient access decisions.