Must Consent Be Informed? Patient rights, state authority, and the moral basis of the physician's duties of disclosure.

Legal standards of disclosure in a variety of jurisdictions require physicians to inform patients about the likely consequences of treatment, as a condition for obtaining the patient's consent. Such a duty to inform is special insofar as extensive disclosure of risks and potential benefits is not usually a condition for obtaining consent in non-medical transactions.What could morally justify the physician's special legal duty to inform? I argue that existing justifications have tried but failed to ground such special duties directly in basic and general rights, such as autonomy rights. As an alternative to such direct justifications, I develop an indirect justification of physicians' special duties from an argument in Kant's political philosophy. Kant argues that pre-legal rights to freedom are the source of a duty to form a state. The state has the authority to conclusively determine what counts as "consent" in various kinds of transactions. The Kantian account can subsequently indirectly justify at least one legal standard imposing a duty to inform, the reasonable person standard, but rules out one interpretation of a competitor, the subjective standard.

Intervention principles in pediatric health care: the difference between physicians and the state.

According to various accounts, intervention in pediatric decisions is justified either by the best interests standard or by the harm principle. While these principles have various nuances that distinguish them from each other, they are similar in the sense that both focus primarily on the features of parental decisions that justify intervention, rather than on the competency or authority of the parties that intervene. Accounts of these principles effectively suggest that intervention in pediatric decision making is warranted for both physicians and the state under precisely the same circumstances. This essay argues that there are substantial differences in the competencies and authorities of physicians and the state, and that the principles that guide their interventions should also be conceived differently. While both the best interests standard and the harm principle effectively incorporate important aspects of physicians' ethical obligations, neither adequately reflects the state's ethical obligations. In contrast to physicians, the state has major obligations of distributive justice and neutrality that should form an integral part of any proposed ethical principles guiding state intervention in pediatric decision making. The differences are illustrated by examining recent cases involving parental refusal of chemotherapy in aboriginal Canadian communities and parental refusal of blood transfusions by Jehovah's Witnesses.

Sometimes Merely as a Means: Why Kantian Philosophy Requires the Legalization of Kidney Sales.

Several commentators have tried to ground legal prohibitions of kidney sales in some form of Kant's moral arguments against such sales. This paper reconsiders this approach to justifying laws and policies in light of Kant's approach to law in his political philosophy. The author argues that Kant's political philosophy requires that kidney sales be legally permitted, although contracts for such sales must remain unenforceable. The author further argues that Kant's approach to laws, such as those governing kidney distribution, was formed in part by considering and rejecting an assumption frequently employed in the bioethics literature, namely, that legal duties can be grounded directly in moral duties. The author explains some of Kant's reasons for rejecting this assumption and concludes that arguments pertaining to the legality of kidney sales developed on the basis of Kant's moral philosophy should no longer be considered tenable.

Ethical Dilemmas in Protecting Susceptible Subpopulations From Environmental Health Risks: Liberty, Utility, Fairness, and Accountability for Reasonableness.

Various U.S. laws, such as the Clean Air Act and the Food Quality Protection Act, require additional protections for susceptible subpopulations who face greater environmental health risks. The main ethical rationale for providing these protections is to ensure that environmental health risks are distributed fairly. In this article, we (1) consider how several influential theories of justice deal with issues related to the distribution of environmental health risks; (2) show that these theories often fail to provide specific guidance concerning policy choices; and (3) argue that an approach to public decision making known as accountability for reasonableness can complement theories of justice in establishing acceptable environmental health risks for the general population and susceptible subpopulations. Since accountability for reasonableness focuses on the fairness of the decision-making process, not the outcome, it does not guarantee that susceptible subpopulations will receive a maximum level of protection, regardless of costs or other morally relevant considerations.

Knowledge, attitudes, beliefs, and behaviors of university students, faculty, and staff during a meningococcal serogroup B outbreak vaccination program.

OBJECTIVES: During an outbreak of invasive meningococcal B disease on a university campus, we explored the knowledge, attitudes, beliefs, and behaviors of members of the university community in relation to the disease, the vaccine, and the vaccination program. DESIGN: All students, faculty and staff were invited by email to participate in a 71-item online survey, which was administered after completion of the mass clinics for the first and second doses of a meningococcal B vaccination program. RESULTS: A total of 404 individuals responded to the survey; 75.7% were students. Knowledge about meningococcal disease and vaccine was generally high; more than 70% correct responses were received on each knowledge question except for one question about the different meningococcal serogroups. Gender (female) and higher knowledge scores were significantly associated with either being immunized or intending to be immunized (p<0.05). Positive attitudes about immunization, concern about meningococccal infection, a sense of community responsibility, and trust in public health advice also correlated with being vaccinated or intending to be vaccinated (p<0.05). CONCLUSIONS: A successful mass vaccination program in a Nova Scotia university was associated with high levels of knowledge, positive attitudes toward vaccination, and positive attitudes toward public health recommendations.

Impact of pharmacists as immunizers on vaccination rates: A systematic review and meta-analysis.

BACKGROUND: Underutilization of vaccination programs remains a significant public health concern. Pharmacists serve as educators, facilitators, and in some jurisdictions, as administrators of vaccines. Though pharmacists have been involved with immunizations in various ways for many years, there has yet to be a systematic review assessing the impact of pharmacists as immunizers in these three roles. OBJECTIVE: To complete a systematic review of the literature on the impact of pharmacists as educators, facilitators, and administrators of vaccines on immunization rates. METHODS: We identified 2825 articles searching the following databases from inception until October 2015: PubMed, EMBASE, Cochrane Libraries, Cumulative Index to Nursing and Allied Health Literature, International Pharmaceutical Abstracts, Google Scholar. Grey literature was identified through use of the Canadian Agency for Drugs and Technology in Health "Grey Matters" search tool. Content from relevant journals and references of included studies were also searched. Inclusion criteria were clinical or epidemiologic studies in which pharmacists were involved in the immunization process. Studies were excluded if no comparator was reported. Two reviewers independently completed data extraction and bias assessments using standardized forms. RESULTS: Thirty-six studies were included in the review, 22 assessed the role of pharmacists as educators and/or facilitators and 14 assessed their role as administrators of vaccines. All studies reviewed found an increase in vaccine coverage when pharmacists were involved in the immunization process, regardless of role (educator, facilitator, administrator) or vaccine administered (e.g., influenza, pneumococcal), when compared to vaccine provision by traditional providers without pharmacist involvement. Limitations of the results include the large number of non-randomized trials and the heterogeneity between study designs. CONCLUSIONS: Pharmacist involvement in immunization, whether as educators, facilitators, or administrators of vaccines, resulted in increased uptake of immunizations. PROSPERO Registration: CRD42013005067.

Rapid surveillance for health events following a mass meningococcal B vaccine program in a university setting: A Canadian Immunization Research Network study.

An outbreak of Neisseria meningitidis serotype B infection occurred at a small residential university; public health announced an organizational vaccination program with the 4-component Meningococcal B (4CMenB) vaccine (Bexsero(TM), Novartis/GlaxoSmithKline Inc.) several days later. Since there were limited published data on reactogenicity of 4CMenB in persons over 17years of age, this study sought to conduct rapid surveillance of health events in vaccinees and controls using an online survey. Vaccine uptake was 84.7% for dose 1 (2967/3500) and 70% (2456/3500) for dose 2; the survey response rates were 33.0% (987/2967) and 18.7% (459/2456) in dose 1 and dose 1 recipients respectively, and 12% in unvaccinated individuals (63/533). Most students were 20-29years of age (vaccinees, 64.0%; controls, 74.0). A new health problem or worsening of an existing health problem was reported by 30.0% and 30.3% of vaccine recipients after doses 1 and 2 respectively; and by 15.9% of controls. These health problems interfered with the ability to perform normal activities in most vaccinees reporting these events (74.7% post dose 1; 62.6% post dose 2), and in 60% of controls. The health problems led to a health care provider visit (including emergency room) in 12.8% and 14.4% of vaccinees post doses 1 and 2, respectively and in 40% of controls. The most common reactions in vaccinees were injection site reactions (20.6% post dose 1, 16.1% post dose 20 and non-specific systemic complaints (22.6% post dose 1, 17.6% post dose 2). No hospitalizations were reported. An online surveillance program during an emergency meningococcal B vaccine program was successfully implemented, and detected higher rates of health events in vaccinees compared to controls, and high rates of both vaccinees and controls seeking medical attention. The types of adverse events reported by young adult vaccinees were consistent with those previously.

Routine immunization of adults by pharmacists: Attitudes and beliefs of the Canadian public and health care providers.

Vaccine coverage among adults for recommended vaccines is generally low. In Canada and the US, pharmacists are increasingly becoming involved in the administration of vaccines to adults. This study measured the knowledge, attitudes, beliefs, and behaviors of Canadian adults and health care providers regarding pharmacists as immunizers. Geographically representative samples of Canadian adults (n = 4023) and health care providers (n = 1167) were surveyed, and 8 focus groups each were conducted nationwide with adults and health care providers. Provision of vaccines by pharmacists was supported by 64.6% of the public, 82.3% of pharmacists, 57.4% of nurses, and 38.9% of physicians; 45.7% of physicians opposed pharmacist-delivered vaccination. Pharmacists were considered a trusted source of vaccination information by 75.0% of the public, exceeding public health officials (68.3%) and exceeded only by doctors and nurses (89.2%). Public concerns about vaccination in pharmacies centered on safety (management of adverse events), record keeping (ensuring their family physician was informed), and cost (should be no more expensive than vaccination at public health or physicians' offices). Concerns about the logistics of vaccination delivery were expressed more frequently in regions where pharmacists were not yet immunizing than in jurisdictions with existing pharmacist vaccination programs. These results suggest that the expansion of pharmacists' scope of practice to include delivery of adult vaccinations is generally accepted by Canadian health care providers and the public. Acceptance of this expanded scope of pharmacist practice may contribute to improvements in vaccine coverage rates by improving vaccine accessibility.

The challenge of vaccinating adults: attitudes and beliefs of the Canadian public and healthcare providers.

OBJECTIVES: Vaccine coverage for recommended vaccines is low among adults. The objective of this study was to assess the knowledge, attitudes, beliefs and behaviours of adults and healthcare providers related to four vaccine-preventable diseases and vaccines (diphtheria-tetanus-pertussis, zoster, pneumococcus and influenza). DESIGN: We undertook a survey and focus groups of Canadian adults and healthcare providers (doctors, nurses, pharmacists). A total of 4023 adults completed the survey and 62 participated in the focus groups; 1167 providers completed the survey and 45 participated in the focus groups. RESULTS: Only 46.3% of adults thought they were up-to-date on their vaccines; 30% did not know. In contrast, 75.6% of providers reported being up-to-date. Only 57.5% of adults thought it was important to receive all recommended vaccines (compared to 87.1-91.5% of providers). Positive attitudes towards vaccines paralleled concern about the burden of illness and confidence in the vaccines, with providers being more aware of disease burden and confident in vaccine effectiveness than the public. Between 55.0% and 59.7% of adults reported willingness to be vaccinated if recommended by their healthcare provider. However, such recommendations were variable; while 77.4% of the public reported being offered and 52.8% reported being recommended the influenza vaccine by their provider, only 10.8% were offered and 5.6% recommended pertussis vaccine. Barriers and facilitators to improved vaccine coverage in adults, such as trust-mistrust of health authorities, pharmaceutical companies and national recommendations, autonomy versus the public good and logistical issues (such as insufficient time and lack of vaccination status tracking), were identified by both the public and providers. CONCLUSIONS: Despite guidelines for adult vaccination, there are substantial gaps in knowledge and attitudes and beliefs among both the public and healthcare providers that lead to low vaccine coverage. A systematic approach that involves education, elimination of barriers and establishing and improving infrastructure for adult immunisation is required.

Universal tetanus, diphtheria, acellular pertussis (Tdap) vaccination of adults: What the Canadian public knows and wants to know.

Tetanus, diphtheria, and acellular pertussis vaccine (Tdap) is recommended for all adults in Canada but uptake is low. This study measured the knowledge, attitudes, beliefs, and behaviors of Canadian adults to identify potential barriers and facilitators to Tdap uptake. A survey was undertaken on a geographically representative sample of Canadian adults (n=4023) and 8 focus groups (62 participants) were conducted nationwide. The survey revealed that knowledge about pertussis and Tdap was low (38.3% correct answers). Only 36.0% of respondents reported being aware that all adults were recommended to receive Tdap and only 10.7% reported being immunized; 36.7% did not know whether they had received Tdap. Respondents who were aware of the immunization recommendations were twice as likely to be immunized (16.6% vs. 8.3%; p<0.001). Only 9.3% believed that their health care provider thought that Tdap was important for adults. The focus group data supported the survey results. Participants wanted information about pertussis and Tdap communicated through multiple modalities, but a recommendation by their family physician was most important to their decision to be immunized or not. This study demonstrates that current recommendations for universal adult vaccination with Tdap are not reaching the general public in Canada and an alternative strategy will be required to improve Tdap vaccine uptake.

Universal tetanus, diphtheria, acellular pertussis (Tdap) vaccination of adults: What Canadian health care providers know and need to know.

The tetanus, diphtheria, and acellular pertussis vaccine (Tdap) is recommended for all adults in both Canada and the United States. There are few data on the proportion of Canadian adults vaccinated with Tdap; however, anecdotal reports indicate that uptake is low. This study aimed to explore the knowledge, attitudes, beliefs, and behaviors of Canadian health care providers (HCPs) in an attempt to identify potential barriers and facilitators to Tdap uptake. HCPs were surveyed and a geographic and practice representative sample was obtained (N =1,167). In addition, 8 focus groups and 4 interviews were conducted nationwide. Results from the survey indicate that less than half (47.5%) of all respondents reported being immunized with Tdap themselves, while 58.5% routinely offer Tdap to their adult patients. Knowledge scores were relatively low (63.2% correct answers). The best predictor of following the adult Tdap immunization guidelines was awareness of and agreement with those recommendations. Respondents who were aware of the recommendations were more likely to think that Tdap is safe and effective, that their patients are at significant risk of getting pertussis, and to feel that they have sufficient information (p < 0.0001 for each statement). Focus group data supported the survey results and indicated that there are substantial gaps in knowledge of pertussis and Tdap among Canadian HCPs. Lack of public knowledge about adult immunization, lack of immunization registries, a costing differential between Td and Tdap, workload required to deliver the vaccine, and vaccine hesitancy were identified as barriers to compliance with the national recommendations for universal adult immunization, and suggestions were provided to better translate recommendations to front-line practitioners.

Whistleblowing: Don't Encourage It, Prevent It Comment on "Cultures of Silence and Cultures of Voice: The Role of Whistleblowing in Healthcare Organisations".

In a recent article, Mannion and Davies argue that there are a multitude of ways in which organizations (such as the National Health Service [NHS]) can deal with wrongdoing or ethical problems, including the formation of policies that encourage and protect would-be whistleblowers. However, it is important to distinguish internal reporting about wrongdoing from whistleblowing proper, because the two are morally quite different and should not be dealt with in the same way. This article argues that we should not understand the authors' conclusions to apply to "whistleblowing" proper, because their recommended approach would be both unfeasible and undesirable for addressing whistleblowing defined in this way.

Whistleblowing and the bioethicist's public obligations.

Bioethicists are sometimes thought to have heightened obligations by virtue of the fact that their professional role addresses ethics or morals. For this reason it has been argued that bioethicists ought to "whistleblow"--that is, publicly expose the wrongful or potentially harmful activities of their employer--more often than do other kinds of employees. This article argues that bioethicists do indeed have a heightened obligation to whistleblow, but not because bioethicists have heightened moral obligations in general. Rather, the special duties of bioethicists to act as whistleblowers are best understood by examining the nature of the ethical dilemma typically encountered by private employees and showing why bioethicists do not encounter this dilemma in the same way. Whistleblowing is usually understood as a moral dilemma involving conflicting duties to two parties: the public and a private employer. However, this article argues that this way of understanding whistleblowing has the implication that professions whose members identify their employer as the public-such as government employees or public servants--cannot consider whistleblowing a moral dilemma, because obligations are ultimately owed to only one party: the public. The article contends that bioethicists--even when privately employed--are similar to government employees in the sense that they do not have obligations to defer to the judgments of those with private interests. Consequently, bioethicists may be considered to have a special duty to whistleblow, although for different reasons than those usually cited.

Liberalism, authority, and bioethics commissions.

Bioethicists working on national ethics commissions frequently think of themselves as advisors to the government, but distance themselves from any claims to actual authority. Governments however may find it beneficial to appear to defer to the authority of these commissions when designing laws and policies, and might appoint such commissions for exactly this reason. Where does the authority for setting laws and policies come from? This question is best answered from within a normative political philosophy. This paper explains the locus of moral authority as understood within one family of normative political theories--liberal political theories--and argues that most major "liberal" commentators have understood both the source and scope of ethics commissions' authority in a manner at odds with liberalism, rightly interpreted. The author argues that reexamining the implications of liberalism for bioethics commissions would mean changing what are considered valid criticisms of such commissions and also changing the content of national bioethics commission mandates. The author concludes that bioethicists who participate in such commissions ought to carefully examine their own views about the normative limits of governmental authority because such limits have important implications for the contribution that bioethicists can legitimately make to government commissions.

Physicians' strikes and the competing bases of physicians' moral obligations.

Many authors have addressed the morality of physicians' strikes on the assumption that medical practice is morally different from other kinds of occupations. This article analyzes three prominent theoretical accounts that attempt to ground such special moral obligations for physicians--practice-based accounts, utilitarian accounts, and social contract accounts--and assesses their applicability to the problem of the morality of strikes. After critiquing these views, it offers a fourth view grounding special moral obligations in voluntary commitments, and explains why this is a preferable basis for understanding physicians' moral obligations in general and especially as pertaining to strikes.

Kinetics of the antibody response to tetanus-diphtheria-acellular pertussis vaccine in women of childbearing age and postpartum women.

BACKGROUND: Because adolescents and adults act as a primary source of pertussis infection for infants, vaccination of mothers immediately postpartum is a potential strategy to reduce transmission (cocoon strategy). For this to be effective, high levels of antibodies must be achieved rapidly after vaccination. We sought to determine whether the antibody response to tetanus-diphtheria-acellular pertussis vaccine (Tdap) is sufficiently rapid to support the cocoon strategy. METHODS: Two sequential studies were performed. The first was a nonrandomized, open study of a 5-pertussis-component Tdap vaccine (tetanus toxoid, diphtheria toxoid, pertussis toxoid [PT], filamentous hemagglutinin [FHA], fimbriae types 2 and 3 [FIM], and pertactin [PRN]) given to women of childbearing age; the second was a randomized, open study of Tdap or no vaccine in postpartum women. Serum levels of immunoglobin (Ig) G and IgA against pertussis antigens, serum levels of IgG against diphtheria and tetanus, and breast milk levels of IgA against pertussis antigens were measured at various times after vaccination. RESULTS: In both studies, the antibody response was relatively rapid, with serum IgG and IgA levels beginning to increase noticeably by days 5-7 and approaching peak levels by day 14. Greater than 68% and 84.4% of IgG and IgA responders, respectively, achieved ≥ 90% of their maximum titer by day 14. The diphtheria and tetanus antibody kinetics followed a similar time course. Breast milk levels of IgA against PT, FHA, and FIM were first detectable at day 7, peaked by day 10, and then slowly decreased through day 28. Antibodies against PRN showed a similar response, although the peak occurred at day 14. There were no significant antibody responses in the control group. CONCLUSIONS: Although the antibody response to a dose of Tdap in healthy nonpregnant women of child-bearing age and postpartum women occurs by day 14 and is suggestive of an anamnestic immune response, it may not be sufficiently rapid to protect infants in the first weeks of life.

Rawls and the refusal of medical treatment to children.

That Jehovah's Witnesses cannot refuse life-saving blood transfusions on behalf of their children has acquired the status of virtual "consensus" among bioethicists. However strong the consensus may be on this matter, this article explores whether this view can be plausibly defended on liberal principles by examining it in light of one particularly well worked-out liberal political theory, that of Rawls. It concludes that because of the extremely high priority Rawls attributes to "freedom of conscience," and the implication from the original position that parents must act paternalistically toward their children as their protectors, Jehovah's Witnesses cannot legitimately be barred from making decisions on behalf of their children, even when the consequences of such decisions are serious and irremediable.