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The development of novel therapeutics for rare "orphan" diseases has brought a growing tension between the desire to accelerate access to these breakthrough therapies and the need to generate quality evidence regarding their safety and efficacy. Accelerating the pace of drug development and approval may facilitate the rapid delivery of benefits to patients and cost savings for research and development, which theoretically improves affordability of drugs for the health system. However, several ethical challenges arise with expedited approval, compassionate release of drugs, and subsequent study of drugs in "real-world" settings. In this article, we explore the changing landscape of drug approval and the ethical challenges expedited approval creates for patients, caregivers, clinicians, and institutions, and propose tangible strategies to maximize the benefits of "real-world" data acquisition while mitigating risks to patients, clinicians, and institutions.

Rare diseases are characterized by a wide diversity of signs and symptoms and vary not only from disease to disease but also from person to person, and living with a disease leads patients to peculiar experiences, without limits of time and space, as they extend to various environments and relationships of their lives. Therefore, the objective of this study is the theoretical interaction between value co-creation (VC) and the stakeholder theory (ST) with the shared decision-making (SDM) health care theory, to enable the analysis of the relationships between patients and their stakeholders in the co-creation of value for decision-making focused on the patient's quality of life. It is configured as a multi-paradigmatic proposal by enabling the analysis of multiple perspectives of different stakeholders in health care. Thus, co-created decision-making (CDM) emerges with emphasis on interactivity of the relationships. As previous studies have already highlighted the importance of holistic care, seeing the patient as a whole and not just the body, studies with CDM will be beneficial for analyses that go beyond the clinical office and doctor-patient relationships, extending to all environments and interactions that add value to the patient's treatment. It was concluded that the essence of this new theory proposed here is neither in patient-centered care nor in patient self-care, but in co-created relationships with and between stakeholders, including non-health care environments that are important to the patient, such as relationships with friends, family, other patients with the same disease, social media, public policies, and the practice of pleasurable activities.

Background: Community pharmacists played an essential role in the control and management of the COVID-19 pandemic; both pharmaceutical care and community pharmacists were affected, given that, patients' needs and demands increased due to the fear of lockdowns and shortage of medication throughout the pandemic.

Objectives: This study was based in Lebanon and aimed to assess the impact of the COVID-19 pandemic on (1) pharmacists, including infection rates, pay, and working hours, and (2) pharmacy practice, including medicine and personal protective equipment (PPE) shortages.

Design: A cross-sectional study involving 120 community pharmacists was carried out between August and November 2021.

Methods: Data were collected using an online survey filled out by pharmacists working in Lebanon.

Results: Most participants (71.7%) reported an increase in their income during the pandemic, and 60% reduced their working hours. A significant association was noted between being previously infected and marital status, level of education, work position, and salary of the participants. Most participants (95.8%) encountered a shortage of medications during the pandemic leading to high home storage of medication, searching for other sources of medicines, and decreased patient/pharmacist interactions.

Conclusion: The COVID-19 pandemic imposed new challenges on pharmacists and the provision of pharmaceutical care. It affected pharmacists' daily routines, putting them at risk of infection with limited availability of medicines and PPE. This study suggests that establishing effective crisis management plans to increase community pharmacists' resilience during similar outbreaks.

Background: Many people are turning to online pharmacies for medication purchases leading to a growing number of legal and illegal online pharmacies (IOPs). With a growing number of IOPs, consumers are more likely to receive substandard or falsified medications when purchasing medications online.

Objectives: This study aims to identify the number of verified, not recommended, and not verified pharmacy websites consumers see using different keywords and medications on an Internet browser based off the National Association Boards of Pharmacy's (NABP) list of verified and not recommended websites. It also aims to compare which keywords result in more not recommended pharmacy websites compared with verified pharmacy websites for consumers over time.

Design and methods: We created an Internet browser extension compatible with different Internet browsers to quickly identify which search results are verified, not recommended, and not verified based on NABP lists. We then utilized an application programming interface to automatically search different key terms and classify the search results as verified, not recommended, and not verified over a 4-week data collection period for analysis.

Results: A total of 131 key terms were used for the search. There was an average signal determining the number of verified and not recommended search results compared with not verified results of 4.3% over the 4-week data collection period. There was about a 3:1 ratio of not recommended to verified search results noted. Top signal and not recommended search result producing keywords contained words such as "shipped" and "cheap."

Conclusion: The Internet browser extension will aid in making it easier to identify which search results are safe and which are not safe when searching to purchase medications online. This study has set the premise on expanding how to use an Internet pharmacy extension to combat IOPs, improve patient safety, and increase safe access to medications.

Background: Pharmacists' knowledge of the differences in the characteristics between generic drugs and biosimilars is essential to ensure good practice and lower pharmaceutical bills.

Objectives: This study aimed to evaluate community pharmacists' knowledge and perception of using and substituting biosimilars and generic drugs.

Design: A pilot cross-sectional study was performed over 2 months (August-September 2022) targeting community pharmacists in their work site.

Method: Data were collected using a uniform survey given to 75 pharmacists. Afterward, a knowledge score was generated by summing several individual scores of statements regarding generic drugs and biosimilars.

Results: Overall, pharmacists had moderate to low knowledge scores, namely, with the statements tackling biosimilars. No significance was reported between these scores and their general characteristics. As regards their substitution, most pharmacists agreed to substitute generic drugs if the brand was not available, while the doctor's approval was crucial for biosimilar switching. Most participants perceived equal effectiveness of generic drugs but similar to a lower one for biosimilars compared to the reference medication. Pharmacists highlighted the need to include generic drugs and biosimilars in the continuing education program and workshops.

Conclusion: To promote their use, improving pharmacists' knowledge can help overcome misconceptions about generic drugs and biosimilars. It is recommended that health care stakeholders focus on fostering good understanding among pharmacists to enhance access to medication.

Background: Healthcare professionals can experience problems regarding mental health and emotional well-being (e.g. burnout) at a higher degree compared to their non-physician counterparts. Fear of stigma is often a barrier to seeking treatment among physicians. However, there is a shortage of studies related to mental health and treatment seeking among trainees and medical students.

Objectives: This study sought to examine mental health in U.S. medical students, factors contributing to mental health symptoms, and obstacles to seeking treatment.

Design and methods: This cross-sectional study was conducted through a confidential survey sent out in fall 2021, with 510 U.S. medical student participants. This survey included scales to assess depression (the Patient Health Questionnaire-8), anxiety (Generalized Anxiety Disorder-7), past year symptoms of hazardous drinking (Alcohol Use Disorder Identification Test), and past 30-day binge drinking days. The survey also included free-response questions about their reasons for seeking mental health care if they did (facilitators) and any barriers that kept them from seeking treatment.

Results: About one-quarter of participants met criteria for possible depressive (24%) or anxiety disorders (24%); 9% of the sample drank at hazardous drinking levels. Between 47% and 60% of those who screened positive for depression, anxiety, or hazardous drinking reported an unmet need for mental health services. Anxiety and depression were cited as the most common reasons to seek treatment; concerns about stigma from peers and professional retaliation were notable for being barriers to treatment.

Conclusion: Our sample of medical students reported notable prevalence of probable depression or anxiety disorder, while also reporting needing more support to improve their mental health. Despite this, barriers exist that may discourage medical students from seeking needed treatments. Findings from this study aim to encourage discussion and positive change in the healthcare community regarding perception and attitudes toward mental health and substance use treatment.

Background and objective: In low- and middle-income countries, pharmaceutical compounding is vital to provide high-quality healthcare service. Accordingly, this study aimed to investigate the extent status of practice and barriers to compounding services in hospital and community pharmacies of Southwest Ethiopia.

Methods: A healthcare institution-based cross-sectional study was conducted from 15 September 2021 to 25 January 2022. Data were collected from 104 pharmacists using a self-administered questionnaire. The responding pharmacists were selected by purposive sampling technique. Finally, descriptive statistical methods were used for data analysis with the help of IBM SPSS Statistics V21.0.

Results: A total of 104 pharmacists (27 hospital pharmacists and 77 community pharmacists) responded (response rate: 0.945). Besides providing other routine essential pharmacy services, around 93.3% of contacted pharmacies have a history of practicing compounding services. The most common practices were granule or powder reconstitution to suspensions or solutions (98.97%) and crushing tablets into smaller forms (92.8%). Commonly, compounding was requested and practiced for preparing pediatrics (97.9%) and geriatrics (96.9%) doses from adult doses, unavailable dosage forms (88.7%), and solving therapeutic gaps (86.6%). All compounding pharmacies participated in compounding antimicrobial medications. They often cited lacking skills or training (76.3%) and insufficient equipment and supplies needed for compounding (99%) as the main barriers.

Conclusion and recommendation: With many facilitators, challenges, and limitations, medication compounding services remain one of the core healthcare services. Areas needing improvement include strengthening comprehensive and continuous professional development for pharmacists on compounding standards.

Technology is instrumental in delivering health services, especially telehealth during the COVID-19 pandemic. This article aimed to explore the role of telehealth as a public health approach to support responses to address the COVID-19 pandemic in Pakistan. We developed this article by mapping existing telehealth initiatives developed and implemented during the COVID-19 pandemic in Pakistan. The initiatives were identified searching online portals such as Google Scholar, PubMed, and websites of various governmental and non-governmental agencies. The services are categorized into teleconsultation and follow-ups, online vaccine registration, information dissemination, high-risk subset tracking, virtual Health Care Worker (HCW) and medical student training, and tele-psychological counseling. The teleconsultation category offers online registration and follow-ups. Information dissemination services include federal helpline, SMS alerts, and social media campaigns. The high-risk subset tracking services include app-based COVID-19 checks and online surveys. Virtual HCW and medical student training services include tele-ICU support, COVID-19 critical care courses, and COVID management courses. The tele-psychological counseling services offer helplines for emotional support, proactive counseling for COVID-19 patients, and mental health support and psychiatry services. Telehealth interventions provided novel solutions amid health and social crises such as the COVID-19 pandemic. Health care systems need to expand telehealth services and ensure that health care organizations deliver effective and safe medical care. However, future research should focus on assessing the impact of telehealth on population health.

Background: Pharmaceutical drug recall is a relentless issue that is composed of multidimensional criteria. The distinct criteria that contributed to drug recalls have been identified in previous literature; however, there is limited information regarding the causal relationships between each criterion. Highlighting key influential aspects and criteria of pharmaceutical drug recall is critical in addressing this ongoing issue and promoting patient safety.

Objective: The objective of this study is as follows: (1) identify critical criteria of pharmaceutical drug recalls for improvements, (2) determine the interrelationships among the criteria, and (3) define the causal relationships of pharmaceutical drug recall and provide theoretical insights and practice recommendations to minimize risks associated with pharmaceutical recalls and maximize patient safety.

Design: This study proposes five aspects and 42 criteria to identify the impact of pharmaceutical drug recalls on patient safety by evaluating the interrelationships between the criteria by employing the fuzzy decision-making trial and evaluation laboratory method.

Methods: A group of 11 professionals across the pharmaceutical industry, hospitals, ambulatory care, regulatory authority, and community care settings were selected for interviews.

Results: Risk control is the influencing aspect of pharmaceutical drug recalls that has the most substantial impact on risk assessment and risk review; it generates medium effects on risk communication and technology. Risk assessment, risk communication, and risk review demonstrated comparative weak interrelationships, while risk communication exhibits a weak unidirectional effect on risk review. Finally, risk assessment exerts a weak influence on technology application and development. Product contamination, product subpotent or superpotent, injury to patients, product not sterile or impure, and system detectability of hazards have the strongest influence in the causal group of pharmaceutical drug recalls.

Conclusion: The study shows that risk control drives risk assessment and risk review in the pharmaceutical industry manufacturing process. To achieve patient safety, this study suggests focusing on risk control strategies, as this aspect displays the most substantial effect on influencing other critical risk management aspects such as risk assessment and risk review.

Background: Mental health walk-in clinics (MHWCs) are a model of service delivery that has gained increasing interest and traction. The aim of the study was to better understand how MHWC use is related to use of other services provided by agencies.

Objectives: (1) Explore if and how MHWCs are used alongside other services, including the different time points (e.g. MHWCs used exclusively, MHWCs used before other agency services); (2) identify correlates of MHWC use alongside other agency services.

Design: Administrative data from two child and youth mental health agencies in Ontario were extracted, including demographics, visit data, and presenting concerns.

Methods: In this exploratory, descriptive study, analyses of administrative data were conducted to identify patterns and correlates of MHWC use before other agency services, compared with MHWC use exclusively.

Results: More than half of families used MHWCs and other agency services before or concurrently with other agency services. Child age, guardianship, and disposition at discharge emerged as correlates of MHWC use before other agency services.

Conclusions: MHWCs are sufficient for some families, easing the pressure on other agency services. For the remaining families, MHWCs can help support them at the beginning of their service use journey.