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Article
Publication date: 6 June 2016

O. Hayden Griffin, III and Vanessa H. Woodward

One of the greatest challenges for drug regulation is valid, comprehensive surveillance of drugs after they reach the pharmaceutical market. The purpose of this paper is to…

Abstract

Purpose

One of the greatest challenges for drug regulation is valid, comprehensive surveillance of drugs after they reach the pharmaceutical market. The purpose of this paper is to propose a new method of individual and aggregate-level postmarket surveillance using data previously (and continuously) collected by drug courts, which are in operation in nearly every geographic corner of the USA.

Design/methodology/approach

To determine the feasibility of such an undertaking, data were obtained from an urban, southern county drug court. Intake data included all participants from September 2012 to November 2013. The final sample included 532 drug court participants.

Findings

Intake data were found to include various demographic variables, measures of drug use, and various sociological/criminological variables such as familial and social support, church attendance, and other pertinent variables for studying drug use and crime trends generally.

Practical implications

By using intake data from drug courts in a manner similar to Uniform Crime Report or National Incident-Based Reporting System, this could add greatly to the understanding of crime and drug use.

Social implications

The authors purport that a data management system of drug court intake data could provide a cost-efficient and generalizable representation of drug use of those within the criminal justice system.

Originality/value

Many efforts have been employed in an attempt to better ascertain where high rates of drug use occur. By using drug courts as more than just a system of treatment, postmarketing surveillance could be improved.

Details

Drugs and Alcohol Today, vol. 16 no. 2
Type: Research Article
ISSN: 1745-9265

Keywords

Article
Publication date: 6 September 2019

Marta Podemska-Mikluch

The purpose of this paper is to analyze the Parallel Review program that offers simultaneous review of the Food and Drug Administration premarket approval submissions and the…

Abstract

Purpose

The purpose of this paper is to analyze the Parallel Review program that offers simultaneous review of the Food and Drug Administration premarket approval submissions and the Centers for Medicare and Medicaid Services (CMS) national coverage determinations (NCDs) of medical devices.

Design/methodology/approach

The paper analyzes the impact of Parallel Review on medical device innovation, focusing in particular on the causes for low popularity of the program among medical device manufacturers. Program outcomes are evaluated in the light of its intended goals.

Findings

The paper identifies four reasons for the program’s limited impact. First, few devices are eligible to participate. Second, most manufacturers prefer to seek Medicare reimbursement at the local level as less risky than the CMS NCDs. Third, participation in the Parallel Review might actually delay the marketing of the device. Fourth, the program does not address numerous obstacles that device sponsors currently encounter. While giving the appearance of support for the medical device innovation, the policy falls short on its intended goals.

Originality/value

This paper elucidates the challenges to internal reform and serves as a reminder to political economists and health care researchers that to make disruptive innovation possible, we must continue to illuminate the otherwise unseen cost of marketing delays and document the ability of emergent market mechanisms to protect consumer safety.

Content available
1013

Abstract

Details

Clinical Governance: An International Journal, vol. 12 no. 4
Type: Research Article
ISSN: 1477-7274

Article
Publication date: 29 March 2013

E.M. (Mick) Kolassa, Leigh Ann Bynum and Erin Holmes

This paper seeks to clarify the use and limitations of the IMS National Disease and Therapeutic Index database, which is frequently used by scholars and courts to provide insights…

Abstract

Purpose

This paper seeks to clarify the use and limitations of the IMS National Disease and Therapeutic Index database, which is frequently used by scholars and courts to provide insights into pharmaceutical markets. Specifically, the paper aims to discuss appropriate and inappropriate uses of the data and details the limitations as a means of drawing generalizable conclusions.

Design/methodology/approach

The paper takes the form of a literature review and critical evaluation of data and its uses.

Findings

The IMS NDTI can provide useful insights into pharmaceutical markets, and also provide indications of potential trends or behaviors, but cannot be relied on for conclusive evidence of such phenomena in the marketplace. The NDTI has limitations that result from sampling and design issues, as well as the specific method by which the data are collected and coded. Although IMS is clear and forthright in addressing these limitations, many researchers have apparently chosen not to heed these cautions and have drawn unsupportable conclusions from NDTI data.

Originality/value

The implications of drawing inappropriate conclusions from the NDTI database can range from the development of a crucial misunderstanding of the market by pharmaceutical marketers, the establishment of erroneous theories or assumptions into the literature or even the miscarriage of justice when the data are used as the basis for a legal judgment or claim. Users must be cautious when drawing any conclusions from these data.

Details

International Journal of Pharmaceutical and Healthcare Marketing, vol. 7 no. 1
Type: Research Article
ISSN: 1750-6123

Keywords

Article
Publication date: 14 January 2022

Nuria Recuero-Virto and Cristina Valilla-Arróspide

In a sector that needs to satisfy a fast-increasing population, advancements like cultivated meat and bio-circular economy are basic to sustain the industry and the society. As…

Abstract

Purpose

In a sector that needs to satisfy a fast-increasing population, advancements like cultivated meat and bio-circular economy are basic to sustain the industry and the society. As innovations are key for economic and social progress, it is crucial to understand consumers' position on this matter.

Design/methodology/approach

Based on text data mining, 7,030 tweets were collected and organised into 14 different food-related topics. Of the total, 6 of these categories were positive, 5 were negative and 3 were neutral.

Findings

In total, 6 categories related to food technologies were positively perceived by Twitter users, such as innovative solutions and sustainable agriculture, while 5 like the virtual dimensions of the industry or crisis-related scenarios were negatively perceived. It is remarkable that 3 categories had a neutral sentiment, which gives ground to improvement before consumers have a negative opinion and consequently will be more complicated to change their minds.

Originality/value

Technological innovations are becoming predominant in the food industry. The SARS-CoV-2 pandemic has made the sector improve even faster. Traditional methods needed to be substituted and technologies such as robots, artificial intelligence, blockchain and genetics are here to stay.

Details

British Food Journal, vol. 124 no. 12
Type: Research Article
ISSN: 0007-070X

Keywords

Open Access
Article
Publication date: 12 February 2018

Kerry Wilbur, Arwa Sahal and Dina Elgaily

Patient safety is gaining prominence in health professional curricula. Patient safety must be complemented by teaching and skill development in practice settings. The purpose of…

Abstract

Purpose

Patient safety is gaining prominence in health professional curricula. Patient safety must be complemented by teaching and skill development in practice settings. The purpose of this paper is to explore how experienced pharmacists identify, prioritize and communicate adverse drug effects to patients.

Design/methodology/approach

A focus group discussion was conducted with cardiology pharmacy specialists working in a Doha hospital, Qatar. The topic guide sought to explore participants’ views, experiences and approaches to educating patients regarding specific cardiovascular therapy safety and tolerability. Discussions were audio-recorded and transcribed verbatim. Data were coded and organized around identified themes and sub-themes. Working theories were developed by the three authors based on relevant topic characteristics associated with the means in which pharmacists prioritize and choose adverse effect information to communicate to patients.

Findings

Nine pharmacists participated in the discussion. The specific adverse effects prioritized were consistent with the reported highest prevalence. Concepts and connections to three main themes described how pharmacists further tailored patient counseling: potential adverse effects and their perceived importance; patient encounter; and cultural factors. Pharmacists relied on initial patient dialogue to judge an individual’s needs and capabilities to digest safety information, and drew heavily upon experience with other counseling encounters to further prioritize this information, processes dependent upon development and accessing exemplar cases.

Originality/value

The findings underscore practical experience as a critical instructional element of undergraduate health professional patient safety curricula and for developing associated clinical reasoning.

Details

International Journal of Health Care Quality Assurance, vol. 31 no. 1
Type: Research Article
ISSN: 0952-6862

Keywords

Article
Publication date: 14 October 2013

James Ducharme

– The purpose of this paper is to define best practice, while identifying the impediments to its implementation.

548

Abstract

Purpose

The purpose of this paper is to define best practice, while identifying the impediments to its implementation.

Design/methodology/approach

The paper takes the form of a commentary.

Findings

There is as of yet no accepted definition of best practice that has both face and construct validity.

Practical implications

Defining what best practice means for health systems around the world will require a collaborative approach, adapting recommendations to local culture and resources. Avoiding a silo approach that could result in unintended consequences and conflicting recommendations can only be achieved with a patient-centric approach. Holistic patient care with consideration of varying societies' needs as a whole is the only way to truly offer best practice recommendations. Emergency medicine needs to be a leader in stepping away from the silo approach and establishing what truly is best in patient care.

Originality/value

Practical application of concepts of best practice will be difficult. Of necessity they will vary from country to country and from one level of care to another.

Details

Clinical Governance: An International Journal, vol. 18 no. 4
Type: Research Article
ISSN: 1477-7274

Keywords

Content available
Article
Publication date: 1 February 2005

Ronald E. McGaughey

86

Abstract

Details

Benchmarking: An International Journal, vol. 12 no. 1
Type: Research Article
ISSN: 1463-5771

Open Access
Article
Publication date: 11 September 2017

Michel van Eeten

The issue of cybersecurity has been cast as the focal point of a fight between two conflicting governance models: the nation-state model of national security and the global…

5195

Abstract

Purpose

The issue of cybersecurity has been cast as the focal point of a fight between two conflicting governance models: the nation-state model of national security and the global governance model of multi-stakeholder collaboration, as seen in forums like IGF, IETF, ICANN, etc. There is a strange disconnect, however, between this supposed fight and the actual control over cybersecurity “on the ground”. This paper aims to reconnect discourse and control via a property rights approach, where control is located first and foremost in ownership.

Design/methodology/approach

This paper first conceptualizes current governance mechanisms through ownership and property rights. These concepts locate control over internet resources. They also help us understand ongoing shifts in control. Such shifts in governance are actually happening, security governance is being patched left and right, but these arrangements bear little resemblance to either the national security model of states or the global model of multi-stakeholder collaboration. With the conceptualization in hand, the paper then presents case studies of governance that have emerged around specific security externalities.

Findings

While not all mechanisms are equally effective, in each of the studied areas, the author found evidence of private actors partially internalizing the externalities, mostly on a voluntary basis and through network governance mechanisms. No one thinks that this is enough, but it is a starting point. Future research is needed to identify how these mechanisms can be extended or supplemented to further improve the governance of cybersecurity.

Originality/value

This paper bridges together the disconnected research communities on governance and (technical) cybersecurity.

Details

Digital Policy, Regulation and Governance, vol. 19 no. 6
Type: Research Article
ISSN: 2398-5038

Keywords

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