how to write a narrative review article in medicine

Guidelines for writing Review Articles

Systematic and narrative reviews.

There are two principal types of review papers: systematic and narrative reviews , each with a specific research question and rationale. In both types of reviews the objective of the review must be precisely defined and stated. A systematic review should be carried out according to a specified methodological plan in order to minimise bias and omission of relevant studies. There would be a survey of databases or other types of register for the relevant literature using specified key words and subheadings and for a specific period. There may or may not be a meta-analysis included, which means a statistical combination of data coming from independent studies with the aim of producing an overall estimation of the effect of an intervention. Note that combining data from studies, which are too different in design or methods used may be inappropriate.  For useful information and advices concerning systematic reviews a book (Advances in Rehabilitation) is available free on the internet (1). A narrative review is a review of what is considered relevant for the topic and the aim of the review, but without a specified methodological plan as for a systematic review. Journal of Rehabilitation Medicine has a restrictive policy regarding publication of narrative reviews.

Systematic Review

In reporting a systematic review or meta-analysis support will be given by guidelines of PRISMA (Preferred Items for Reporting of Systematic reviews and Meta-analysis) (2, 3). The authors are advised to follow the checklist in PRISMA. A systematic review paper should have a structured Abstract of no more than 200 words using headlines as Objective, Data Sources, Study Selection, Data Extraction, Data Synthesis and Conclusions and with at least 3 key words for indexing.

- Objective : Give precise statement of the primary objective for the review. Define if the review emphasises cause and diagnosis, prognosis, therapy and intervention, or prevention. Define if the review would be highly selective as including only randomized controlled trials (RCT) or have wider inclusion criteria.

- Data Sources : Present data sources used, including any time restriction. - Study Selection : Describe criteria to select studies for detailed review. Specify methods used, as blinded review, consensus, multiple reviewers.

- Data Extraction : Describe how extraction was made, including assessment of quality and validity.

- Data Synthesis : Present the main results of the review and state major identified sources of variation between studies.

- Conclusion : Give a clear statement of the conclusions made, its generalisability and limitations.

The Introduction of the paper could be similar to an original report, but without any longer literature survey, only reviewing shortly previous structural reviews and stating the reason and aim of the present review. The Method section may have subheadings corresponding to the Abstract ( Data Sources, Study Selection, Data Extraction ) and should include clearly defined and reported inclusion and exclusion criteria, and specification of databases and other formal register, conference proceedings, reference lists and trial authors, which are used as sources.

The full search strategy should be given so that it is easy to reproduce. If it is considered too long to be published in the article, an electronic document as an Appendix may be alternative. The stages of selection usually include several steps, each undertaken by at least two independent researchers (identified in the Methods). There will be an initial selection from titles/abstracts to select the articles to be examined in full. The full articles should be re-screened against the selection criteria. The articles fulfilling the criteria should be subjected to quality assessment. Summarize in a flow chart with the number of articles selected and reasons for rejection at each stage. The quality of the methodology should be assessed having an appropriate tool and also for outcome measures and blinding of outcome assessors. The tool that is most appropriate will depend on the extent and nature of the anticipated research evidence. Options include:

The   Result section   corresponds to Data synthesis in the Abstract and may present tables with long lists of selected articles. Extracted data from trials should, when available, include report of randomization method, study population, intervention methods and delivery, reasons to losses at follow-up, information related to treatment monitoring, post-intervention assessments and follow-up. Report the major outcomes, which were pooled, and include odds ratios or effects sizes. Use when applicable meta-analysis. Numerical values should, when possible, be accompanied with confidence intervals. State the major identified sources of variation between reported studies, as differences in treatment protocols, co-interventions, confounders, outcome measures, length of follow-up, and dropout rates. Tables and figures must be self-explanatory and have appropriate title or caption. The methods for synthesis of evidence should be pre-determined.  Sometimes it may not be possible to pool the data, but a synthesis of best evidence ought to be given.

The   Discussion section   should be structured similar to an original report. The findings should be discussed with respect to the degree of consistency, variation, and generalisability. New contribution to the literature based on the review conducted and where information is insufficient must be stated. Providing the limitations of the review would be helpful. Suggest the need for new studies and future research agenda.

Length of paper:   The total length of the text should usually not be more than 5000 words (corresponding to 8-9 printed pages) and in addition tables and the reference list. The reference list should be comprehensive and will therefore often be rather long. However, in the printed version of a review paper normally not more than more than 100 references will be accepted. If needed and without an upper limit, additional references may be published only electronically with a link to such an Appendix given in the original version of the paper.

If the review is not invited, consult always the Editor-in-Chief before submitting such a manuscript to make sure that the topic is relevant for the journal, but also that it fits in a more general plan for publishing review papers and selection of specific topics. It is important for the journal to keep the time from submission to publishing as short as possible, as a review should be considered as  “fresh goods”, keeping in mind the very fast development in certain areas and that one would like to have very recently published papers included among the references.

Narrative Review

In a narrative review the selection of the papers reviewed depend more or less on the experience and attitude of the authors. If you intend to write a narrative review you must be critical to your own selection procedure. It is important that the selection criteria are defined and strictly followed. However, JRM, as many other journals, is reluctant to publish narrative reviews unless there is a compelling reason for doing so. You should therefore always consult the Editor-in-Chief before submitting such a manuscript. A particular type of narrative reviews, which is published, is educational reviews on specific topics. They are usually invited and at present JRM has a collaboration with the European Board of Physical and Rehabilitation Medicine (EBPRM) and the International Society of Physical and Rehabilitation Medicine (ISPRM) on such programs. Non-invited educational reviews may occasionally be considered, but must fall into the scheme and topics chosen for such reviews during a certain period.

A narrative (educational) review may or may not have a structured   Abstract ; often an unstructured Abstract may be most relevant and should not exceed 200 words, followed by at least 3 key words for indexing.

In the   Introduction section   a survey of relevant literature and the aim and goal for the review should be presented. The headlines in the review have to be chosen according to the need of that particular review and may be subject for discussion with the editorial office.

There is usually   no Method section .

The   Discussion section   could be structured along the lines for an original report being aware to discuss the limitation and its clinical message. Also for a narrative (educational) review paper a long reference list is accepted (see information about structured reviews). It is important by definition that an educational review has an educational approach, but at the same time to be published in a scientific journal, it should be sufficiently scientific and meant to be cited.

General information

All reviews will go through the peer review process, even in cases of invited educational reviews. In all review papers, any conflict of interest must be presented. See general information for authors.

1. Liberati A, Taricco M. How to do and report systematic reviews and meta-analysis. In Franchignoni F, editor. Research in Physical & Rehabilitation Medicine. Pavia: Maugeri Foundation Books; 2010, p. 137-164.

2. Moher D, Liberati A, Tetzlaff J, Altman DA. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann Intern Med 2009; 151: 264-269.

3. Liberati A, Altman DG, Tetzlaff J et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. Ann Intern Med 2009; 151: W-65-W-94.

4. Sign 50: A guideline developer's handbook. Edinburgh: Scottish Intercollegiate Guidelines Network; 2008.

5. van Tulder MW, Assendelft WJ, Koes BW, Bouter LM. Method guidelines for systematic reviews in the Cochrane Back Review group for Spinal Disorders. Spine 1997; 22: 2323–2330.

6. Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y, Alonso- Coello P, et al. Rating quality of evidence and strength of recommen- dations: GRADE: an emerging consensus on rating quality of evi-dence and strength of recommendations. BMJ 2008; 336: 924–926.

7. Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y, Schunemann HJ et al. GRADE: what is “quality of evidence” and why is it important to clinicians? BMJ 2008; 336: 995-998.

8. Atkins D, Briss PA, Eccles M. et al. Systems for grading the quality of evidence and the strength of recommendations II: a pilot study of a new system. BMC Health Serv Res 2005; 5: 25.

9. Department of Health Long-term Conditions NSF Team. The National Service Framework for Long–term Conditions. Annex 2 Research and Evidence. UK: Department of Health; 2005, p. 88.

10. Turner-Stokes L, Harding R, Sergeant J, Lupton C, McPherson K. Generating the evidence base for the National Framework for long term conditions: a new research typology. Clin Med 2006; 6: 91-97.

how to write a narrative review article in medicine

Scholarly article on topic 'Forces influencing generic drug development in the United States: a narrative review'

Forces influencing generic drug development in the United States: a narrative review Academic research paper on " Clinical medicine "

Similar topics of scientific paper in Clinical medicine , author of scholarly article — Chia-Ying Lee, Xiaohan Chen, Robert J. Romanelli, Jodi B. Segal

Academic research paper on topic "Forces influencing generic drug development in the United States: a narrative review"

Lee et al. Journal of Pharmaceutical Policy and Practice (2016) 9:26 DOI 10.1186/s40545-016-0079-1

Journal of Pharmaceutical Policy and Practice

REVIEW Open Access

Forces influencing generic drug development in the United States: a narrative review

Chia-Ying Lee1*, Xiaohan Chen1, Robert J. Romanelli2 and Jodi B. Segal1,3

Background: The United States (U.S.) Food and Drug Administration, as protectors of public health, encourages generic drug development and use so that patients can access affordable medications. The FDA, however, has limited mechanisms to encourage generic drug manufacturing.

Main results: Generic drug manufacturers make decisions regarding development of products based on expected profitability, influenced by market forces, features of the reference listed drug, and manufacturing capabilities, as well as regulatory restrictions. Barriers to the development of generic drugs include the challenge of demonstrating bioequivalence of some products, particularly those that are considered to be complex generics.

Conclusions: We present here a focused review describing the influences on generic manufacturers who are prioritizing drugs for generic development. We also review proposed strategies that regulators may use to incentivize generic drug development.

Keywords: Generic drug, Incentives, U.S. Food and Drug Administration

The use of generic drugs products typically yields lower costs to insurers and patients than use of branded products. Efforts to increase generic drug utilization have proven helpful in reducing healthcare spending in the United States (U.S.) [1]. According to the most recent report from the Generic Pharmaceutical Association, generic drugs accounted for 88 % of all dispensed retail prescriptions in the U.S in 2014, while consuming only 28 % of total drug spending [2]. The use of generics, where available, is estimated to have saved the U.S. healthcare system $1.68 trillion between 2005 and 2014, with $254 billion saved in 2014 alone [2]. Patent expiration for a number of blockbuster drugs from 2010 to 2014, followed by the launch of generic equivalents, has played an important role in healthcare cost savings.

Despite evidence that generic drugs bring value to the healthcare system, these products are not uniformly

* Correspondence: [email protected]

Johns Hopkins University Bloomberg Schoolof Public Health, Center for Drug Safety and Effectiveness, 624 N. Broadway, Room 644, Baltimore, MD 21205, USA

Fulllist of author information is available at the end of the article

valuable to their manufacturers. Manufacturers are appropriately deliberate about investing in the development of generic products. The United States (U.S.) Food and Drug Administration, as protectors of public health, encourages generic drug development and use so that patients can access affordable medications; however, the FDA has few mechanisms to incentivize generic manufacturing. Herein, we present a review aimed at exploring the forces that limit the development and production of generics in the U.S. and the ways in which the FDA could conceivably reduce barriers to the development of generic drugs. Our objective was to review the influences on manufacturers, which are the parties responsible for prioritizing drugs for generic development, as well as the strategies that regulators may use to incentivize generic drug development in the U.S.

Pathways to generic drug development

The Drug Price Competition and Patent Term Restoration Act of 1984, often referred to as the Hatch-Waxman Act, amended the Federal Food, Drug, and Cosmetic Act to create an abbreviated pathway for the approval of new drugs that are therapeutically equivalent to a branded drug [1].

O© 2016 The Author(s). Open Access This article is distributed under the terms of the Creative Commons Attribution 4.C Central International License (, which permits unrestricted use, distribution, anc

reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( applies to the data made available in this article, unless otherwise stated.

Under this Act, a manufacturer needs only to demonstrate the bioequivalence of a generic product to a reference listed drug through an abbreviated new drug application (ANDA), rather than repeating the costly and time consuming safety and efficacy studies required of innovative, new chemical entities [3-5]. The FDA considers a generic drug to be bioequivalent to the reference listed drug if the rate and extent of absorption of the generic drug do not show a significant difference from the rate and extent of absorption of the listed drug when administered at the same molar dose of the therapeutic ingredient under similar experimental conditions in either a single dose or multiple doses [3]. Pharmaceutically equivalent drugs are products with the same active ingredients, dosage form, strength, and route of administration. Of these, those proven to be bioequivalent are consequently considered therapeutically equivalent or substitutable - with the expectation that they have the same safety and efficacy profile. Once the FDA approves the ANDA and the branded version is no longer protected by patent or market exclusivity, the generic product can be brought to market.

When identifying a new development target, generic manufacturers first seek an informed perspective on the competitive landscape about potential generic competitors before prioritizing resources and making a decision to proceed [6]. Strategies for generics development have evolved rapidly, responding to market dynamics [7]. Between 1984 and 2012, generic manufacturers focused largely on the production of "simple" to formulate small molecules, and won the market via mass production. The years between 2012 and 2017 have been called the "patent cliff', when many drugs considered to have been "blockbuster drugs' lost, or will soon lose, their patent protection. This opened important opportunities for generic manufacturers, who commonly apply one or more strategies. The first is the "portfolio-centric approach". Generic manufacturers include re-innovation design (i.e., the process of producing the next generation of generics with revised and refined features of successfully-launched products) in their portfolio ostensibly to provide personalized, cost-effective generic products that meet the demand of healthcare systems, policymakers, and patients [8]. One way is through what is called re-innovation or sometimes called the production of "super generics". The products have modifications beyond the originator generic; these often require a submission to FDA of a new drug application rather than an ANDA. An example is the generic drug, abraxane, which the manufacturer expected to gain market share over paclitaxel. The active ingredient, pacli-taxel, is unchanged but abraxane has the molecule coated in albumin, allowing the company to claim fewer adverse reactions for the patient [9, 10]. The second is the "therapeutic area dominance". With this approach, generic manufacturers compete within a specialized area of generic

drugs such as cardiovascular, oncology, or rheumatology drugs [11]. For example, Relax Pharmaceuticals (an Indian generic manufacture) specializes in the manufacturing of generic antibiotics and gastrointestinal products. Finally, market experts have predicted that after 2017, when many branded drugs have lost their patent protection, generic manufacturers will shift resources to the production of complex generics such as drug/device combinations and sterile injectables, or may move into the marketplace for biosimilar products [5,12].

Manufacturing considerations

When generic manufacturers are selecting products for development, the expectation of an adequate return on investment is the foremost consideration. This can be forecast, to some extent, by knowing the demand for the product and the requirements for production.

Market forces

Generic manufacturers understandably focus on drugs with a potential for high profit. Companies are often interested in developing a generic if the branded medication has a high average wholesale price, which is expected to translate into a profitable generic. Similarly, chronic diseases, with a larger population health burden, are also often targeted areas for generic manufacturers. For example, cardiovascular and central nervous system diseases are the two largest market segments, composing nearly 38 % of the global generic pharmaceutical market together [13, 14]. Generic manufacturers may also choose to avoid densely populated therapeutic classes, when deciding whether to join the competition.

Features of reference listed drug

The Hatch-Waxman Act defined single-dose pharmacokinetic studies as the method of establishing bioequivalence for systemically acting drug products. However, there are formulations or routes of administration where systemic blood levels cannot be used to determine bioequivalence, such as when the product is not intended to be systemic-ally active. Therefore, drugs that are used topically in the eye; or dosage forms intended to act within the gastrointestinal tract lumen without absorption, do not have clear paths for demonstrating bioequivalence, which is a major deterrent to their production. The FDA has made significant progress in defining bioequivalence methodologies for many of these non-systemically active drug products; [15] however, a number of products remain without clearly defined methodology, including inhaled drug products and transdermal preparations. This impacts the production of generics for inhaled corticosteroids, such as for asthma treatment, and transdermal testosterone for hormone replacement, as examples. In the absence of product-specific guidance, drug developers may ask the

FDA development questions via the controlled correspondence process or request to meet with FDA scientists in pre-ANDA meetings. Sponsors also may develop their own analytical tools and study protocols through which they can demonstrate bioequivalence, and then work with the FDA for approval of their plan [2].

Manufacturing capabilities of complex drugs

Generic manufacturers also consider their technical ability to manufacture generic versions of branded products. They evaluate the complexity of the manufacturing that is needed to produce a generic equivalent, the cost of manufacturing, and their own research and development capabilities. For example, small molecule pharmaceutical products are simpler to create and therefore are more likely to be developed generically than complex large molecules. Dosage form also may play a role in generic drug development; solid oral forms (e.g., tablets, capsules) and parenteral solutions have a higher likelihood of being easily developed than more complex drug delivery systems (again, inhaled products, topical products). These differences are due to technological barriers and manufacturers' capabilities. For example, the drug delivery system development process is particularly complicated for inhaled products with manufacturers needing to work around the bans on ozone-depleting propellants and the multiple patents on hydrofluorocarbon-free devices. Generic manufacturers need sufficient research and development resources to manufacture these technically challenging generic products.

Innovative products have become increasingly complex and, necessarily, so have their generic equivalents [16]. Each complex generic is "complex" in its own way [17, 18] (Table 1). The development of complex generics requires substantial commitment from the manufacturer, which may lower the benefit to cost ratio for its production. The manufacturer may be asked to repeat clinical studies due to the challenges of demonstrating bioequivalence for these products or do additional physiochemical characterization testing [11]. Furthermore, for complex generics the pathway to drug approval may differ substantially from one product to another product; [13] the FDA's Office of Generic Drugs (OGD) manages each submission on a case-by-case basis. Complex generics are expected to eventually become a significant percentage of the generic market, but the approval challenges first must be overcome.

Table 1 Complex generics examples [11]

Complex Active Ingredients Peptides, complex mixtures, naturalsource products

Complex Formulations Liposomes and iron colloids

Complex Route of Delivery Locally acting drugs

Complex Drug-Device Metered dose inhaled products and

Combinations transdermalsystems

Materials challenges

Some generic products are challenging to develop because of inadequate source raw materials, although this is not unique to generics. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use guidelines are the main instructions for sourcing qualified raw materials for any drug manufacturing [19]. Drugs with car-cinogenicity or toxicities may require suitable handling conditions in clinical practice and during development, which may be a deterrent to production, particularly if the return on investment cannot be assured [20, 21].

Regulatory considerations 180-day exclusivity period

The Hatch-Waxman Act gave additional protection to the inventors of innovative, new drugs by lengthening patent terms and by providing guaranteed periods of data exclusivity (5 years for a new chemical entity). The Act, in return, offers the first generic manufacturer to file an ANDA a 180-day period of market exclusivity. An effect of this regulation, however, is that the exclusivity period prevents other generic manufacturers from bringing their generic product to market during this time. This is typically not advantageous for consumers because it is not until roughly six generic products are available that the full cost savings of generics are typically realized; although the largest price decrease occurs with the entry of the second product [22].

Pay for delay

The 180-day exclusivity advantage provided to generic manufactures under the Hatch-Waxman Act encourages generic manufacturers to challenge the existing patents of brand manufacturers ("the Paragraph IV challenges"). It has, however, also encouraged generic drug manufacturers to settle and accept compensations from brand manufacturers for their delaying entry into the market [16]. This is counter to forces that encourage generic development and introduction to the market. Kesselheim describes studies measuring the impact of the Hatch-Waxman act; he notes that there are no well-controlled studies of the economic impact of Paragraph IV challenges and the effect of settlements on generic drug availability and public health outcomes [23].

These settlements have taken the form of a cash payment (so called "pay for delay") to reimburse some or all of a generic manufacturer's legal fees, or non-cash deals where the brand manufacturer agrees to purchase their product's active ingredients from the generic manufacturer or not to market their own generic version of the product (i.e., an authorized generic) for a period of time [21]. In one notable case of cash payments, Cephalon made reverse payments totaling $300 million dollars to

four generic drug manufacturers to drop patent challenges and suspend marketing of generic versions of Cephalon's drug Provigil for six years. During that time, Cephalon earned an additional $4 billion dollars in sales for Provigil [24]. This was later found to be unlawful by the Federal Trade Commission (FTC) on the basis of these settlements being anticompetitive.

Pay for delay has posed a threat to the timely development of generic drugs and a substantial cost to the U.S. healthcare system. According to an FTC study, these deals cost consumers and taxpayers $3.5 billion in higher drug costs each year [25]. In 2013, there were more than 100 settlements reached between brand and generic manufacturers. In a suit filed by the FTC against the pharmaceutical company, Actavis, the U.S. Supreme Court ruled in 2013 that reverse payments are subject to U.S. antitrust laws [26]. Larger penalties to brand manufacturers, as well as generic manufacturers who accept such payments, may be needed to dissuade settlements that delay the availability of generic products. Hemphill and Lemley described a strategy called earning exclusivity that they proposed would improve the effect of the Hatch-Waxman Act on encouraging generic drug development [27]. They suggested that under the strategy of earning exclusivity, generic manufacturers would have to earn the 180-day exclusivity offered by FDA by successfully defeating the weak or bad patents on the branded products, without settlements. This would be done by demonstrating that the patent was invalid or by demonstrating that the generic product does not infringe upon the existing patent. Barr won an exclusive marketing rights challenge against Lilly for the production of a generic version of Prozac in 2000, which was 2 years before the patent was expected to expire [28].

Access to the branded reference products

Manufacturers, necessarily, must have access to the reference listed reference drug to perform the bioequiva-lence testing that the FDA requires of a generic product under an ANDA [29]. There have been instances, however, of brand manufacturers preventing generic manufacturers from accessing their product [23]. Some brand manufacturers have used the restrictions in their Risk Evaluation and Mitigation Strategies (REMS), and other restricted access programs, to prevent generic manufacturers from accessing brand drug samples for testing. These manufacturers have argued that they cannot provide generic manufacturers with samples of such REMS-covered products because doing so would be outside the FDA-sanctioned, restricted distribution pathway [30].

The Fair Access for Safe and Timely (FAST) Generics Act, first proposed in Congress in September 2014, was considered a solution to this REMS barrier [31]. The FAST Generics Act would create a pathway for generic

manufacturers to secure a branded drug from its maker, wholesaler, or specialty distributor regardless of whether the product was subject to REMS, and impose stiff penalties for non-compliance. Ultimately, the branded drugs and their generic equivalents would then share a single REMS. At the time of writing, neither the House nor Senate has passed the FAST Generics Act [32].

Strategies for promoting generic drug utilization and development

In order to encourage generic drug development, two strategies have been frequently proposed by researchers and policymakers: implementing initiatives or reforms to increase generic utilization (thereby stimulating the generic economy by inducing demand) and offering aids or incentives for generic drug innovations [9, 33].

Godman and his colleagues proposed a 4 "E" methodology (Education, Engineering, Economics and Enforcement) for developing initiatives to increase generic drug utilization in Europe [8] (Table 2). Initiatives focusing on "Education" are usually programs that influence generic prescribing by disseminating educational materials. Initiatives that focus on organizational interventions ("Engineering") include agreements on price and volume of existing drugs or disease management programs. Financial incentives ("Economics") are for increasing generic drug utilization through the use of positive and negative incentives for physicians and patients. Finally, regulatory or law enforcement ("Enforcement") methods may include mandatory generic substitution laws to which pharmacists must adhere. Some of these initiatives can benefit generic utilization in the U.S., while others may face unique challenges in the U.S. marketplace.

Indeed, the U.S. healthcare system has mechanisms that promote generic usage. For example, most insurance companies incentivize patients to use generic drugs by requiring less cost-sharing for generic versus branded products. In addition, 14 states currently have mandatory generic substitution laws for pharmacists and the remainder, except Oklahoma, have laws permitting substitution by pharmacists [34]. However, it is unlikely that federal laws promoting generic substitution will be enacted due to the organization of the U.S. legal system, and "engineering"

Table 2 Strategies for increasing generics development and utilization: the four "E" method [8]

Education Educationalmaterials: treatment guidance and

educationaloutreach visit

Engineering Organizationalinterventions: agreements on price and

volume of existing drugs

Economics Financialincentives: positive and negative incentives for

Enforcement Regulatory or law enforcement: mandatory generic

substitution laws

initiatives may be challenging given the fragmented nature of the U.S. healthcare system. Evidence is needed about the effects on generic development and utilization of those initiatives already in place, and future research should assess the potential impact of supplemental initiatives such as those involving education of patients and health care providers.

The above activities are promising but all hinge upon the production of new generic products. With more complicated branded products losing their patent protection, bioequivalence methodologies for complex drugs or dosage forms need to be developed. Guidance documents with updated standards or reference documents from the FDA may encourage generic manufacturers to proceed with the development of new products [8, 35]. Regular engagement with OGD may help drug manufacturers contain costs and decrease time-to-market delays. The OGD now has provisions to grant pre-ANDA meetings for complex generics [36].


We have described in this review select U.S. federal policies, and described the regulatory environment and market forces influencing generic developers. Generic drug developers choose candidate drugs based on the market forces, features of the reference listed drug, and manufacturing capabilities, as well as regulatory restrictions. With suitable policy and regulatory incentives to increase generic utilization or facilitate the generic drug development process, as described, generic manufacturers may be encouraged to develop new generic drugs that will help increase access to medications, improve population health, and contain healthcare spending.


ANDA: Abbreviated new drug application; FAST: Fair Access for Safe and Timely; FDA: Food and Drug Administration; FTC: Federal Trade Commission; OGD: Office of Generic Drugs; REMS: Risk evaluation and mitigation strategy


We have no additional contributors to acknowledge in this manuscript. Funding

Dr. Jodi Segal, Dr. Robert Romanelli, and Ms. Lee were funded by the Food and Drug Administration through grant UC1FDCC5267. Ms. Chen was not funded for her work on this project.

Availability of data and materials

Not applicable.

Authors' contributions

CYL - Prepared a first draft of the manuscript. XC - Provided additional background research and drafted sections of the manuscript. RR - Provided critical suggestions and edited the final manuscript. JS - Conceived of the manuscript, drafted sections, and did the final editing. All authors read and approved the final manuscript.

Competing interests

The authors declare that they have no competing interests.

Consent for publication

Ethics approval and consent to participate

Author details

1Johns Hopkins University Bloomberg School of Public Health, Center for

Drug Safety and Effectiveness, 624 N. Broadway, Room 644, Baltimore, MD

21205, USA. 2Palo Alto Medical Foundation Research Institute, Palo Alto, CA,

USA. 3Division of General Internal Medicine, Johns Hopkins University School

of Medicine, 624 N. Broadway, Room 644, Baltimore, MD 21205, USA.

Received: 20 May 2016 Accepted: 10 September 2016 Published online: 22 September 2016

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E-learning Challenges in Nursing Education during COVID-19 Pandemic-A Narrative Review.

Background: The COVID-19 pandemic has alarmed an urgent change in all spectra on the lives of people including education sector. Objective: This narrative review summarizes the challenges of online education in nursing and explores the possible opportunities to improve or maintain the standards of nursing education. Methods: A comprehensive literature search was done to identify the challenges of online education in nursing. Seven primary studies meeting the inclusion criteria, published from the onset of COVID-19 until 5th September 2020 were included in this narrative review. Results: The available literature shows that, students are missing the practical aspects of nursing care, the real essence of nursing education during e-learning, cancellation of international training, loss of job opportunities due to lack of confidence in their skill are bothersome for students and educators. Success of e-learning is also affected by internet connectivity issues, problem with electricity and lack of computer literacy. At the same time, it is found that online education delivery is substituting theory learning to a great extent, however practical training remains indispensable for nursing education. Conclusion: Continuous engagement and motivation from the part of both the students and nurse educators is very essential in meeting the educational needs during this crisis.

Author Biographies

Lecturer, College of Nursing, Sultan Qaboos University, Sultanate of Oman

Associate Professor, Department of Psychiatric (Mental Health) Nursing, Manipal College of Nursing, Manipal Academy of Higher Education, Manipal, India

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Types, Purposes And Simulation Of Contributions In Vocational Training In Health: Narrative Review

Objective:  To identify the types, purposes and the contributions of simulation in training in health.

Method:  This is a narrative review of the literature in its construction were used studies surveyed in databases Latin American and Caribbean Health Sciences (LILACS) and Scopus, and other data sources.

Results:  The types of simulations and simulators are characterized by the degree of organization of landscape and simulator technology: low, medium and high fidelity. These degrees of fidelity enable the development of skills and abilities in students in the context of health education.

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  Descriptors:  Education. Simulation. Health. Education. Formative feedback.

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how to write a narrative review article in medicine

Can literary reading and writing improve pharmacists’ medication counselling? A feasibility study of pharmacists’ efforts to achieve competence in narrative medicine

Background: Narrative medicine is an innovative approach where empathetic skills are nurtured through close reading of literary texts and creative writing. The aim of this study was to evaluate the feasibility of a course in narrative medicine for pharmacists. 

Methods: A 2-day course of narrative medicine was offered to community and hospital pharmacists. Feasibility was assessed using focus group interviews, participant observation, and a questionnaire. Pharmacists’ self-reported level of empathy was also assessed.    

Results: Eight pharmacists participated in the course. They found participation acceptable, even though some of the sessions required a personal investment far from their routines. The pharmacists were generally satisfied with the course and found it helpful in their daily patient communication. There was no significant change in the pharmacists’ level of empathy.   

Conclusion: A course in narrative medicine has the potential to improve pharmacist communication with patients but needs further testing, including patient-reported outcomes.

Author Biographies

Trine graabæk, university of southern denmark, odense, denmark.

Clinical Pharmacology, Pharmacy, and Environmental Medicine, Department of Public Health

Anders Juhl Rasmussen, University of Southern Denmark, Odense, Denmark

Department for the Study of Culture

Anne-Marie Mai, University of Southern Denmark, Odense, Denmark

Charlotte rossing, danish college of pharmacy practice, hillerød, denmark.

Department of Research and Development, Pharmakon

Ulla Hedegaard, University of Southern Denmark, Odense, Denmark

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