Confidential Discussions Research Articles

Summary of the EMA Joint Regulators/Industry QbD workshop (London, UK; 28-29 January 2014).

This paper summarizes the discussions and insights gained from the key themes that emerged during the Quality by Design (QbD) Workshop held at the European Medicines Agency offices in London, UK, on 28-29 January 2014. Industry and regulators shared practical experiences from six case studies (five approved small-molecule products and one phase 3 biotechnological product) based on QbD submissions by five companies (AstraZeneca, GlaxoSmithKline, Novartis, NovoNordisk, and Pfizer).The case studies covered a range of different development, regulatory submission, and post-approval aspects of QbD and were developed through confidential discussions between the company representatives and regulators. Key themes that emerged from the workshop discussions were: 1. presentation of information in submissions (development story and the presentation of information in marketing authorization applications; risk assessment and criticality); 2. development aspects (design space; use of models; control strategy); and 3. post-approval aspects (lifecycle management; dossier-quality system interactions; handling of deviations). Many aspects of QbD for biotechnological products are similar to small molecules, but there are some important differences highlighted in this paper.The final section of the paper discusses some proposals for future developments to address the issues that were identified.

The Pulmonary Vascular Research Institute and its future.

The Pulmonary Vascular Research Institute and its future.

First Nations, Maori, American Indians, and Native Hawaiians as Sovereigns: EAP with Indigenous Nations Within Nations

Indigenous workforces have existed across the world since the creation of Earth. What has changed is the evolution of multicultural societies, governments, and landscapes that have become part of, or sit parallel to, sovereign Indigenous nations and their workforces. An international response to Employee Assistance Programming (EAP) and workplace health will be shared from various Indigenous groups across the globe. These societies include the Maori of New Zealand, First Nations of Canada, American Indian groups from the U.S. mainland, and Native Hawaiians. Guidelines for EAP practice include the discussion of historical trauma, communication skills, confidentiality, and environmental issues. Theoretical underpinnings for health sovereignty are shared through ancient teachings of Indigenous philosophies and their relationships to contemporary EAP development and utilization.

Architecture and acoustics … form and function—What comes 1st?

When I first studied architecture, it was expected that “form fits function” was pretty much a mantra to design. But is that the case today or has it ever been when acoustics are concerned? Numerous post occupancy studies of worker satisfaction with office IEQ indicate that things are not as they should be. And, as a matter of fact, high performance green buildings seem to fair much worse than normal office buildings when acoustic quality is considered. So what are we doing wrong—maybe the Gensler Workplace Study and other related studies could shed light on what is wrong, and how we might think differently about office design. From an acousticians viewpoint it’s all about “acoustic comfort” meaning the right amount of intelligibility, privacy, and distraction for the specific work function. Times change and work functions change, so maybe we should be looking for a new mantra … like “function drives form.” We may also want to consider that office space may need to include a “collaboration zone” where teaming takes place, a “focus zone” where concentrated thought can take place, and a “privacy zone” where confidential discussions can take place. Each of these requires different architecture and acoustic performance.

A practical overview of managing adolescent gynecologic conditions in the pediatric office.

1. Alexa Kaskowitz, MD, MPH* 2. Elisabeth Quint, MD* 1. *Department of Obstetrics-Gynecology, University of Michigan, Ann Arbor, MI * Abbreviations: BV: : bacterial vaginosis CDC: : Centers for Disease Control and Prevention HPV: : human papillomavirus HSV: : herpes simplex virus NAAT: : nucleic acid amplification test PID: : pelvic inflammatory disease STI: : sexually transmitted infections Pediatricians caring for adolescent girls should know how to screen for high-risk behaviors and sexually transmitted infections and how to diagnose and treat vaginal discharge, vulvar ulcers, pelvic pain, and simple ovarian cysts. After reading this article, readers should be able to: 1. Recognize the need for confidential discussions with teenagers as part of general health care. 2. Identify, evaluate, and manage some vulvovaginal disorders in teenagers, including vaginitis, vulvar ulcers, and condyloma. 3. Describe the screening and treatment methods of the most common sexually transmitted infections in adolescents. 4. Identify and evaluate the most common gynecologic causes of pelvic pain in a teenager, including ovarian cysts and masses. The pediatrician plays an important role in the transition of female patients through puberty and will frequently be the first health care professional an adolescent turns to for gynecologic care and guidance. This review focuses on the evaluation and management of gynecologic issues seen by pediatricians. It addresses the following common gynecologic symptoms: vulvovaginal concerns, sexually transmitted infections (STIs), pelvic pain, and adnexal masses. Abnormal bleeding, a common reason for a teen to seek health care, and screening adolescent gynecology have been addressed in previous articles in Pediatrics in Review . (1)(2) Adolescence is a transition time from childhood to adulthood and can be relatively smooth for some teens and difficult for others. During this time, the pediatrician should be open to discussing topics of adolescent development, such as risk-taking behavior and sexual issues. Usually at approximately age 11 to 12 years, the teen should be able to talk …

Clinical Conversations About Health: The Impact of Confidentiality in Preventive Adolescent Care

PurposeTo better understand how confidentiality impacts the delivery of preventive adolescent health care by examining adolescent and parent beliefs and the relationship between confidentiality and the number and subject matter of health topics discussed at the last visit. MethodsThis study represents a secondary analysis of nationally representative online survey data collected from adolescents aged 13–17 years (N = 504) and parents of adolescents aged 13–17 years (N = 500). Descriptive statistics were conducted on confidentiality variables of interest. Analysis of variance and Scheffe post hoc tests were computed to determine whether the mean number of topics discussed varied by level of confidential consultation provided. Associations between confidential consultation and health topics discussed at the last visit were examined using multivariate logistic regression. ResultsApproximately, half of both samples reported provision of confidential consultation. Eighty-nine percent of parents believed adolescents should be able to speak with providers alone, yet 61% preferred to be in examination room for the entire visit. Nearly half of all adolescents believed parental presence impacted conversation. Mean number of topics discussed was significantly higher when a visit was partially confidential (4.11 ± 3.05; p = 0) versus when a visit was not confidential (2.76 ± 2.68; p = 0). There were significant associations between confidential consultation and discussions about 8 of 11 health topics. ConclusionsConfidential consultation significantly impacts the number and subject matter of health topics discussed. A split-visit confidentiality model for adolescent preventive care visits may result in clinical conversations that address more topics. This arrangement may also appeal to parents who have mixed feelings about confidentiality.

Cocaine abuse and confidentiality: A case of retiform purpura in an adolescent patient

A. Apologize to the patient’s mother, acknowledging her right to be present for discussion of sensitive health information about her daughter. Proceed with questioning the patient about recent drug abuse and then discuss the suspected diagnosis with the patient and her mother. B. Agree that the patient’s mother can be present, but do not specify the suspected origin of the patient’s skin condition. Instead, just call it ‘‘vasculitis’’ and discuss general aspects of management. C. Ask for the consent of the patient’s mother to have a confidential discussion with the patient. D. State that, in specific instances, adolescents maintain a legal right and ethical justification to confidentiality even from their parents and insist that the mother leave the room.

Empirical Study on Business Closures ? Who should we be Concerned About?

This article takes a closer look at entrepreneurial intentions among informants who had gone through a business closure process. Our interest was to understand better those ex-entrepreneurs who stated that they had no desire to start a business again. Business closure process is challenging at best, but it can also be a highly taxing and exhausting experience to the entrepreneur. We used bivariate analysis and logistic regression models to analyse and compare the data. Our analysis revealed that a total of 15% of entrepreneurs run a business after a genuine business closure whereas over half (51%) of interviewed entrepreneurs have business intentions and could imagine starting a business again. Those with no entrepreneurial intentions (32%) could be classified further into four groups: novice entrepreneurs operating in the service sector in rural locations who closed down their business after confidential discussions with other entrepreneurs (10% of those with negative entrepreneurial intentions), novice entrepreneurs with high basic education operating in central areas (26%, entrepreneurs with low level of education and networking activity, in manufacturing and operating in rural locations without any chance to avoid the firm clo-sure (26%), and most experienced, older entrepreneurs operating in non-rural locations (38%). Most of all, we should worry about the know-how and quality of experiences of entrepreneurs in the closure process as ideally they could be used to benefit both nascent and existing entrepreneurs. More generally, our results indicate that business closures can be associated with entrepreneurial learning, where the individual keeps the costs of learning low, while acquiring new knowledge and skills that can be utilized in new entrepreneurial action. Some policy implications also emerged.

Living with Kallmann Syndrome - Analysis of Subjective Experience Reports from Women.

Five women were questioned on their experiences with Kallmann Syndrome (KS) in thematically focused, open interviews. This investigation complements the study of the experiences of men with KS 1. The results show that the consequences and pressures of KS extend beyond the somato-medical field and that those affected are also burdened by mental and psycho-social impacts. The pressures experienced by those affected include a distorted body image resulting from the lack of physical development, which in turn leads to difficulties in developing a healthy feeling of self-worth. Furthermore, particular attention should be paid to the influence of hormone therapy on mood and libido during medical treatment. Some of the affected women reported experiencing depressive moods and low libido, and pressures in their relationship associated with this. The affected women wanted KS to be viewed as a whole in order to achieve better handling. In particular, attentive handling of issues relating to fertility was important to them. Additional relevant support included offers of confidential discussions, and offers of psychotherapy and, where required, sex education or sex therapy.

Pharmacists’ Role in the Continued Care of Patients under Opiate Substitution Treatment

ContextIn France, over 170 000 persons benefit from opiate substitution treatment. The treatment delivery is most often assured by community pharmacies spread out throughout the territory. The aim of this study is to better know the continued care of individuals treated by methadone or high-dose buprenorphine in community pharmacies in Lille (North of France). MethodThis was a cross-sectionnal descriptive study with hand-delivered questionnaires. All pharmacies (n=65) in Lille were included. ResultsFifty-eight of pharmacies (89%) responded to the suvey and 55 of them (95%) followed patients treated by opiate substitution treatment. Addiction was considered as an illness by 53 of pharmacists (91%). Confidential discussions could only be conducted at one of every two treatment delivery work station. ConclusionPharmacists are active in the continued care of individuals treated by opiate substitution treatment. They have a privileged relationship with the general practitioner. A rearrangement of pharmacies’ premises could foster the development of therapeutic patient education within the pharmacy.

Beyond Likes and Tweets

Social networking sites are a popular way for physicians to communicate about clinical, professional, and social topics. These sites can be used for educational purposes, professional interaction, and for general discussion. There are many popular sites oriented toward health care professionals, each with their own functionality and style. We reviewed the top physician-oriented networking sites, as well as popular general social networking sites that can be used for physician communication. We also provide background on social media communication, as well as specific advice for online physician communication and a discussion of confidentiality.

The Impact of the Researcher on the Researched

The Impact of the Researcher on the Researched

Work Environment and Recent Suicidal Thoughts Among Male University Hospital Physicians in Sweden and Italy: The Health and Organization Among University Hospital Physicians in Europe (HOUPE) Study

Male and female physicians are at elevated suicide risk. The work environment has become a focus of attention as a possible contributor to this risk. The potential association between work environment and suicidal thoughts has been examined among female physicians in several countries, and significant findings have been reported. The purpose of this study was to examine the role of the work environment in relation to suicidal thoughts among male university hospital physicians in 2 European countries. Cross-sectional multivariate analysis was performed to identify significant associations between work-related factors and suicide risk among male physicians from the Health and Organization among University Hospital Physicians in Europe (HOUPE) study. The dependent variable was termed recent suicidal thoughts, which includes having thought about suicide and/or having thought about specific ways to commit suicide within the previous year. Adjusted odds ratios (ORs) and CIs are reported. Of the 456 Swedish (56%) and 241 Italian (39%) male physicians who participated, 12% of the physicians from each country reported affirmatively regarding recent suicidal thoughts. Degrading work experiences were associated with recent suicidal thoughts for the Swedish and Italian physicians (OR = 2.1; 95% CI, 1.01-4.5; OR = 3.3; 95% CI, 1.3-8.0, respectively). Role conflict was associated with recent suicidal thoughts among the Swedish physicians (OR = 1.6; 95% CI, 1.1-2.2). Support at work when difficulties arose appeared to be protective for the Swedish physicians (OR = 0.7; 95% CI, 0.5-0.96). Italian physicians with little control over working conditions had an increased risk of recent suicidal thoughts, whereas confidential discussions about work experiences appeared to be protective (OR = 0.6; 95% CI, 0.4-0.9). Attention should be paid to the work environment as it relates to suicide risk among male university hospital physicians, particularly to bolstering social support and preventing harassment.

Pakistan's Counterterrorism Strategy: Separating Friends from Enemies

Click to increase image sizeClick to decrease image size Notes 1. Correspondent for the British daily The Independent, discussion with author, Islamabad, August 2, 2010. 2. Kamran Yousaf, “Pakistan, U.S. at odds over definition,” The Express Tribune, October 30, 2010, http://tribune.com.pk/story/69816/pakistan-us-at-odds-over-definition/. 3. Mohammad Aamir Rana, discussion with author, Islamabad, July 30, 2010. 4. Yahya Mujahid and Syed Saleem Shehzad, discussion with author, Islamabad, October 10, 2010. 5. “India Supporting Militancy in Balochistan: Musharraf,” The Express Tribune, October 10, 2010, http://tribune.com.pk/story/60862/india-supporting-militancy-in-balochistan-musharraf/. 6. Yahya Mujahid, interview with author, Islamabad, October 10, 2010. 7. Karachi-based journalist, confidential discussion with author, October 7, 2010. 8. Bob Woodword, Obama's Wars (New York: Simon and Schuster, 2010), p. 116. 9. Major General Athar Abbas, discussion with author, Rawalpindi, November 2009. 10. This was part of Pasha's statement to a select group of media soon after the Mumbai attacks. 11. Susanne Koelbl, “Pakistan's New Intelligence Chief: ‘Terror Is Our Enemy, Not India’,” Der Spiegel, January 6, 2009, http://www.spiegel.de/international/world/0,1518,599724,00.html. 12. Dexter Filkins, “Pakistanis Tell of Motive in Taliban Leader's Arrest,” The New York Times, August 22, 2010, http://www.nytimes.com/2010/08/23/world/asia/23taliban.html. 13. U.S. diplomats from the political section of the U.S. Embassy in Islamabad, discussions with author, October 12, 2010. 14. Safiya Aftab, “Poverty and Underdevelopment,” The Friday Times, April 9, 2010, http://waseb.wordpress.com/2010/04/19/poverty-and-underdevelopment-by-safiya-aftab/. 15. Ayesha Siddiqa, “Terror's Training Ground,” Newsline, September 9, 2009, http://www.newslinemagazine.com/2009/09/terror's-training-ground/. 16. Vali Nasr, Forces of Fortune: The Rise of the New Muslim Middle Class and What It Will Mean for Our World (Free Press, 2009). 17. See Ayesha Siddiqa, “The Conservatively Hip,” Newsline, August 31, 2010, http://www.newslinemagazine.com/2010/08/the-conservatively-hip/. 18. Shahzada Irfan Ahmed and Ayesha Siddiqa, “Religious Mission or Political Ambition?,” Newsline, September 30, 2010, http://www.newslinemagazine.com/2010/09/religious-mission-or-political-ambition/. 19. Javed Ahmed Ghamdi, discussion with author, Islamabad, October 8, 2010. 20. Jamal Hoti, “Moderate scholar Dr. Farooq killed in Mardan,” Dawn, October 3, 2010, http://news.dawn.com/wps/wcm/connect/dawn-content-library/dawn/news/pakistan/44-swat-universitys-vice-chancellor-dr-farooq-assasinated-fa-03. 21. Angel Rabasa, Cheryl Benard, Lowell H. Schwartz, and Peter Sickle, “Building Moderate Muslim Networks,” RAND Corporation Monograph Series (Santa Monica, CA: RAND Corporation, 2007), pp. 102-103, http://www.rand.org/pubs/monographs/2007/RAND_MG574.pdf. 22. Sumit Ganguly and S. Paul Kapur, “The Sorcerer's Apprentice: Islamist Militancy in South Asia,” The Washington Quarterly 33, no. 1 (January 2010), pp. 47-59, http://www.twq.com/10january/docs/10jan_GangulyKapur.pdf. Additional informationNotes on contributorsAyesha SiddiqaAyesha Siddiqa is the first Pakistan scholar at the Woodrow Wilson International Center for Scholars and the author of Military Inc.: Inside Pakistan's Military Economy (Pluto Press, 2007)

Confidentiality: a core feature of general practice.

In the medical press in July 2010, Professors Pattison and Marshall ask Is Confidentiality a Con? 1 and repeatedly state that confidentiality of medical information is now ‘a delusion'. The text makes it clear that Professor Pattison is a Professor of Religion, Ethics and Practice and a member of the RCGP Ethics Committee, and that Martin Marshall is Chairman of the Ethics Committee of the RCGP. It includes a disclaimer ‘that this article does not represent the views of the College or of the Ethics Committee but is intended to provoke discussion'. In view of the high importance of the subject, the danger of patients being misled, and the request for discussion, a response is needed. This article makes no reference to the law, which provides the framework for medical practice in the UK and which is the starting point for discussion of confidentiality in the modern world. There are many legal aspects. The Data Protection Act2 which covers England, Scotland, and Wales, requires all those handling personal information to do so ‘fairly and lawfully'. All general practices need to register under this Act, as the data which practices handle fall within the definition of this Act. ‘Lawfully’ includes acting within the Common Law. It is necessary to distinguish corporate and professional confidentiality. The common law duty of confidentiality3 applies in all parts of the UK. This provides protection for patients against disclosure of information given to their doctors and nurses. This position is important to all patients and all practising doctors. Patients have rights and while it is obviously for patients to decide how much to tell the doctor, anything that they do decide to say within a medical …

Anabolic androgenic steroid induced necrotising myopathy

We describe the case of a 23-year-old gentleman who developed a severe generalised necrotising myopathy. Initially presenting with features of a virus-induced polymyositis, both symptomatic and biochemical improvements were initially achieved with glucocorticoid-based immunosuppression. Subsequently he represented with evidence of severe generalised rhabdomyolysis (creatinine kinase peaking at 210,000 U/L). Rendered anuric from the myogloburic assault, he required intensive care support from the development of multi-organ failure. Subsequent investigations failed to demonstrate an infective, inflammatory, metabolic or inherited aetiology. Muscle biopsy demonstrated severe generalised necrotising myopathy in the notable absence of inflammation. Confidential discussion with the patient and relatives confirmed a suspicion of anabolic androgenic steroid (AAS) abuse. There is limited literature as to the toxic effect of AAS compounds on muscle tissue, and these tend to focus on localised disease. Indeed, AAS have consistently been shown in animal models to produce a generalised myotrophic state. Apart from the social uses of such compounds, the scope for their supervised use in various medical conditions has been established since the 1960s.

Issues in monitoring medication effects in the classroom

AbstractThe task of medication monitoring in the schools has increased for school psychologists, yet there is little research specific to pediatric psychoactive medication. The current article reviews issues pertinent to school‐based medication monitoring. Feasibility, acceptability, and perception of effectiveness are reviewed as fundamental considerations before implementing a medication‐monitoring plan in the schools. The importance of individualization, ecological implementation, and development of socially valid objectives is stressed along with the need for additional research, tools, and measures in this area. Practical considerations for school psychologists include discussion of parental consent and confidentiality, multilevel assessment and monitoring, data recording, and determining clinical significance. © 2009 Wiley Periodicals, Inc.

Confidentiality, consent, and caring for the adolescent patient

This study reviews the healthcare-related rationale for providing confidential care to adolescents, as well as the legal framework for the provision of such care. Physician assurances of confidentiality increase adolescents' willingness to disclose sensitive health information, but these assurances are rarely given. Physicians may not be aware of legal minor consent guidelines or may be concerned about parental reaction to such confidential discussions. Fortunately, many parents and teens understand the importance of confidential healthcare. Adolescent consent and confidentiality laws vary from state to state, but there are federal guidelines and common law concepts that are applicable throughout the United States. The Health Insurance Portability and Accountability Act Privacy Rule also provides guidelines for confidential care to minors. Future challenges for adolescent confidentiality include ease of access to electronic medical records as well as patient (and/or parent)-controlled health records. Confidentiality for adolescents has important implications for the quality provision of healthcare for this vulnerable population. Physicians and other healthcare providers must be aware of these health implications, as well as federal policies, common law, and their individual state's laws pertaining to this important topic.

What Are The Ethical Considerations Surrounding a Minor's Request for Confidentiality?

What Are The Ethical Considerations Surrounding a Minor's Request for Confidentiality?

Physician suicide: Unnecessary losses

Male and female physicians are at elevated suicide risk. The work environment has become a focus of attention as a possible contributor to this risk. The potential association between work environment and suicidal thoughts has been examined among female physicians in several countries, and significant findings have been reported.The purpose of this study was to examine the role of the work environment in relation to suicidal thoughts among male university hospital physicians in 2 European countries.Cross-sectional multivariate analysis was performed to identify significant associations between work-related factors and suicide risk among male physicians from the Health and Organization among University Hospital Physicians in Europe (HOUPE) study. The dependent variable was termed recent suicidal thoughts, which includes having thought about suicide and/or having thought about specific ways to commit suicide within the previous year. Adjusted odds ratios (ORs) and CIs are reported.Of the 456 Swedish (56%) and 241 Italian (39%) male physicians who participated, 12% of the physicians from each country reported affirmatively regarding recent suicidal thoughts. Degrading work experiences were associated with recent suicidal thoughts for the Swedish and Italian physicians (OR = 2.1; 95% CI, 1.01–4.5; OR = 3.3; 95% CI, 1.3–8.0, respectively). Role conflict was associated with recent suicidal thoughts among the Swedish physicians (OR = 1.6; 95% CI, 1.1–2.2). Support at work when difficulties arose appeared to be protective for the Swedish physicians (OR = 0.7; 95% CI, 0.5–0.96). Italian physicians with little control over working conditions had an increased risk of recent suicidal thoughts, whereas confidential discussions about work experiences appeared to be protective (OR = 0.6; 95% CI, 0.4–0.9).Attention should be paid to the work environment as it relates to suicide risk among male university hospital physicians, particularly to bolstering social support and preventing harassment.