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10 pages, 554 KiB

Open AccessReview

Examining the Impact of the World Health Organization 2022 Guidelines on Evaluation of Biosimilars for Non-Local Comparators in Biosimilar Studies on Middle East and North Africa Member States

by Michael W. Strand and Jonathan H. Watanabe

Pharmacy 2024, 12(3), 94; https://doi.org/10.3390/pharmacy12030094 - 16 Jun 2024

Viewed by 1237

Abstract

Global support and standardization of regulation for biosimilars approval owes much of its legacy to the World Health Organization (WHO), since the first guidance by the organization on the matter was released in 2009. Since then, and with over a decade of research, [...] Read more.

Global support and standardization of regulation for biosimilars approval owes much of its legacy to the World Health Organization (WHO), since the first guidance by the organization on the matter was released in 2009. Since then, and with over a decade of research, the 2022 revision provides opportunities for time and financial savings to pharmaceutical manufacturers aiming to prove similarity of a potential biosimilar product to some reference product, particularly by clarifying that the use of a non-local reference product as a comparator in certain studies is permissible. This declaration has important implications, particularly in the emerging biological markets of the Middle East and North Africa region, where WHO guidelines have been integral to the regulatory framework of over a dozen countries for more than a decade. This article aims to review the impact of this revision on these countries and relevant policies on non-local comparator usage. Since 2022, this revision has been adopted only in Egypt. Many North African countries are yet to adopt a first draft of the formalized guidance. This analysis revealed that, although many of these countries reference the WHO guidelines, hesitation remains in terms of sourcing comparator products outside the US or European countries. This likely translates to slow regional development and cooperation of functioning, sustainable biosimilars markets. Future studies will be necessary to evaluate the continued development of guidance within these countries and changes in comparator sourcing norms as more time is allowed for their policies to mature and adapt to new standards. Full article

(This article belongs to the Special Issue Pharmacy Reviews in 2022)

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47 pages, 707 KiB

Open AccessReview

Uncovering the Hidden Burden of Pharmaceutical Poisoning in High-Income and Low-Middle-Income Countries: A Scoping Review

by Claire Cowans, Anya Love, Balamurugan Tangiisuran and Sabrina Anne Jacob

Pharmacy 2023, 11(6), 184; https://doi.org/10.3390/pharmacy11060184 - 24 Nov 2023

Cited by 3 | Viewed by 2747

Abstract

Pharmaceutical poisoning is a significant global public health concern, causing approximately 190,000 deaths annually. This scoping review aims to comprehensively map the available literature on pharmaceutical poisoning and compare patterns between high-income countries (HICs) and low-middle-income countries (LMICs). A systematic search was performed [...] Read more.

Pharmaceutical poisoning is a significant global public health concern, causing approximately 190,000 deaths annually. This scoping review aims to comprehensively map the available literature on pharmaceutical poisoning and compare patterns between high-income countries (HICs) and low-middle-income countries (LMICs). A systematic search was performed across the following databases: Embase, PubMed, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, and CINAHL. Studies included were from 1 January 2011 to 31 December 2020, in English, with full text available. Seventy-nine articles were included in the study; 21 were from LMICs and 58 were from HICs. Toxic exposure was largely intentional (77%) in LMICs and accidental (68%) in HICs. Drugs acting on the nervous system were responsible for 95% of toxicities worldwide with analgesics accounting for the largest subtherapeutic group in both LMICs (40%) and HICs (58%). Notable statistics were that HICs accounted for 99% of opioid overdoses, and LMICs accounted for 19% of anti-epileptic-induced toxicities. Overall, the medical outcomes due to poisonings were generally worse in LMICs. The review provides possible interventions to target specific geographic locations, based on the trends identified, to reduce the burden worldwide. Many gaps within the literature were recognised, calling for more robust analytical research. Full article

(This article belongs to the Special Issue Pharmacy Reviews in 2022)

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12 pages, 689 KiB

Open AccessReview

Application of Precision Medicine Concepts in Ambulatory Antibiotic Management of Acute Pyelonephritis

by Morgan Pizzuti, Yuwei Vivian Tsai, Hana R. Winders, Paul Brandon Bookstaver and Majdi N. Al-Hasan

Pharmacy 2023, 11(6), 169; https://doi.org/10.3390/pharmacy11060169 - 24 Oct 2023

Cited by 2 | Viewed by 2856

Abstract

Acute pyelonephritis (APN) is a relatively common community-acquired infection, particularly in women. The early appropriate antibiotic treatment of this potentially life-threatening infection is associated with improved outcomes. The international management guidelines for complicated urinary tract infections and APN recommend using oral antibiotics with [...] Read more.

Acute pyelonephritis (APN) is a relatively common community-acquired infection, particularly in women. The early appropriate antibiotic treatment of this potentially life-threatening infection is associated with improved outcomes. The international management guidelines for complicated urinary tract infections and APN recommend using oral antibiotics with <10% resistance among urinary pathogens. However, increasing antibiotic resistance rates among Escherichia coli and other Enterobacterales to fluoroquinolones, trimethoprim-sulfamethoxazole (TMP-SMX), and beta-lactams has left patients without reliable oral antibiotic treatment options for APN. This narrative review proposes using precision medicine concepts to improve empirical antibiotic therapy for APN in ambulatory settings. Whereas resistance rates to a particular antibiotic class may exceed 10% at the population-based level, the predicted antibiotic resistance rates based on patient-specific risk factors fall under 10% in many patients with APN on the individual level. The utilization of clinical tools for the prediction of fluoroquinolones, TMP-SMX, and third-generation cephalosporin resistance improves the ambulatory antibiotic management of APN. It may also reduce the need to switch antibiotic therapy later based on the in vitro antibiotic susceptibility testing results of bacterial isolates in urinary cultures. This approach may mitigate the burden of increasing antibiotic resistance in the community by ensuring that the initial antibiotic prescribed has the highest likelihood of treating APN appropriately. Full article

(This article belongs to the Special Issue Pharmacy Reviews in 2022)

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13 pages, 1023 KiB

Open AccessReview

Medication Reviews and Clinical Outcomes in Persons with Dementia: A Scoping Review

by Rishabh Sharma, Neil Mahajan, Sarah Abu Fadaleh, Hawa Patel, Jessica Ivo, Sadaf Faisal, Feng Chang, Linda Lee and Tejal Patel

Pharmacy 2023, 11(5), 168; https://doi.org/10.3390/pharmacy11050168 - 20 Oct 2023

Viewed by 2509

Abstract

Persons diagnosed with dementia are often faced with challenges related to polypharmacy and inappropriate medication use and could benefit from regular medication reviews. However, the benefit of such reviews has not been examined in this population. Therefore, the current scoping review was designed [...] Read more.

Persons diagnosed with dementia are often faced with challenges related to polypharmacy and inappropriate medication use and could benefit from regular medication reviews. However, the benefit of such reviews has not been examined in this population. Therefore, the current scoping review was designed to identify the gaps in the current knowledge regarding the impact of medication reviews on the clinical outcomes in older adults with dementia. Relevant studies were identified by searching three databases (Ovid MEDLINE, Ovid EMBASE, and Scopus) from inception to January 2022 with a combination of keywords and medical subject headings. After the removal of duplicates and ineligible articles, 22 publications of the initial 8346 were included in this review. A total of 57 outcomes were identified, including those pertaining to the evaluation of medication use (n = 17), drug-related interventions (n = 11), drug-related problems (n = 10), dementia-related behavioral symptoms (n = 8), cost-effectiveness (n = 2), drug-related hospital admissions (n = 1), as well as outcomes classified as other (n = 7). Gaps identified through this scoping review included the paucity of studies measuring the impact of medication reviews on the medication management capacity and medication adherence, quality of life, and mortality. Full article

(This article belongs to the Special Issue Pharmacy Reviews in 2022)

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15 pages, 663 KiB

Open AccessReview

Adult Patients with Difficulty Swallowing Oral Dosage Forms: A Systematic Review of the Quantitative Literature

by Anne Harnett, Stephen Byrne, Jennifer O’Connor, Declan Lyons and Laura J. Sahm

Pharmacy 2023, 11(5), 167; https://doi.org/10.3390/pharmacy11050167 - 19 Oct 2023

Cited by 5 | Viewed by 3782

Abstract

The aim of this systematic review was to identify and critically appraise the available evidence regarding solid oral dosage forms (SODFs), e.g., tablets, and challenges regarding the oral administration of medicine to inpatients in a variety of healthcare settings such as (1) hospitals, [...] Read more.

The aim of this systematic review was to identify and critically appraise the available evidence regarding solid oral dosage forms (SODFs), e.g., tablets, and challenges regarding the oral administration of medicine to inpatients in a variety of healthcare settings such as (1) hospitals, (2) nursing homes and (3) long-term stay units (LTSUs). A literature search was undertaken in September 2021 and repeated in June 2023 in the following databases: PubMed, EMBASE, CINAHL, Scopus, Web of Science, The Cochrane Library, PsycINFO and ProQuest. A Microsoft Excel^® spreadsheet was devised to collate the following data from each eligible study: study author and year, country, number of participants, title, duration (follow-up period), study design, inclusion and exclusion criteria, method and data collection, relevant outcomes, and key findings. A total of 3023 records were identified, with 12 articles being included in the final systematic review. Seven of the twelve studies reported on the prevalence of difficulties swallowing SODFs, which varied from 10–34.2%. Nine of the twelve studies reported the methods used to manipulate SODFs, with the most reported method being tablet crushing. Given the prevalence of swallowing difficulties and the subsequent crushing of medicines in response to this, it is evident that concerns should be raised regarding the potential for a medication administration error to occur. Full article

(This article belongs to the Special Issue Pharmacy Reviews in 2022)

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8 pages, 215 KiB

Open AccessReview

Considering the Intercultural Development Inventory (IDI) to Assess Intercultural Competence at U.S. Pharmacy Schools

by Diana Tamer, Yifei Liu and Jennifer Santee

Pharmacy 2023, 11(1), 39; https://doi.org/10.3390/pharmacy11010039 - 19 Feb 2023

Cited by 3 | Viewed by 2391

Abstract

Background: U.S. pharmacy schools need to engage in improving intercultural competence among administrators, faculty, staff, and students. The Intercultural Development Inventory (IDI) can be a possible tool to determine the level of intercultural competence. U.S. pharmacy schools need to examine the validity of [...] Read more.

Background: U.S. pharmacy schools need to engage in improving intercultural competence among administrators, faculty, staff, and students. The Intercultural Development Inventory (IDI) can be a possible tool to determine the level of intercultural competence. U.S. pharmacy schools need to examine the validity of the IDI within the context of health professional education prior to using this tool. Objectives: To describe the relationship between the IDI and its underlying theory, identify whether the validity of the IDI has been established within two specific contexts, and discuss the practical issues and implications of using the IDI. Methods: Medline, Embase, and selected health professional education journal websites were searched to identify fully published studies utilizing the IDI within health professional education. Eligibility of articles was determined with a standardized approach. Results: Ten studies were identified by full-text reviews, but none investigated the validity of the IDI. Conclusions: The IDI has been shown to be valid in certain contexts, but its validity has yet to be confirmed within health professional education. U.S. pharmacy schools need to examine practical issues and implications when deciding if the resources required to administer, analyze, and report IDI results are reasonable. Full article

(This article belongs to the Special Issue Pharmacy Reviews in 2022)

16 pages, 911 KiB

Open AccessReview

Revisiting the Therapeutic Effects of Essential Oils on the Oral Microbiome

by Casandra-Maria Radu, Carmen Corina Radu, Sergiu-Alin Bochiș, Emil Marian Arbănași, Alexandra Ioana Lucan, Viorela Romina Murvai and Dana Carmen Zaha

Pharmacy 2023, 11(1), 33; https://doi.org/10.3390/pharmacy11010033 - 10 Feb 2023

Cited by 10 | Viewed by 5288

Abstract

The extensive use of antibiotics has resulted in the development of drug-resistant bacteria, leading to a decline in the efficacy of traditional antibiotic treatments. Essential oils (EOs) are phytopharmaceuticals, or plant-derived compounds, that possess beneficial properties such as anti-inflammatory, antibacterial, antimicrobial, antiviral, bacteriostatic, [...] Read more.

The extensive use of antibiotics has resulted in the development of drug-resistant bacteria, leading to a decline in the efficacy of traditional antibiotic treatments. Essential oils (EOs) are phytopharmaceuticals, or plant-derived compounds, that possess beneficial properties such as anti-inflammatory, antibacterial, antimicrobial, antiviral, bacteriostatic, and bactericidal effects. In this review, we present scientific findings on the activity of EOs as an alternative therapy for common oral diseases. This narrative review provides a deeper understanding of the medicinal properties of EOs and their application in dentistry. It not only evaluates the effectiveness of these oils as antibacterial agents against common oral bacteria but also covers general information such as composition, methods of extraction, and potential toxicity. Further nonclinical and clinical studies must be conducted to determine their potential use and safety for treating oral diseases. Full article

(This article belongs to the Special Issue Pharmacy Reviews in 2022)

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25 pages, 352 KiB

Open AccessReview

Pharmacy Workplace Wellbeing and Resilience: Themes Identified from a Hermeneutic Phenomenological Analysis with Future Recommendations

by Jon C. Schommer, Caroline A. Gaither, Nancy A. Alvarez, SuHak Lee, April M. Shaughnessy, Vibhuti Arya, Lourdes G. Planas, Olajide Fadare and Matthew J. Witry

Pharmacy 2022, 10(6), 158; https://doi.org/10.3390/pharmacy10060158 - 23 Nov 2022

Cited by 12 | Viewed by 4033

Abstract

This study applied a hermeneutic phenomenological approach to better understand pharmacy workplace wellbeing and resilience using respondents’ written comments along with a blend of the researchers’ understanding of the phenomenon and the published literature. Our goal was to apply this understanding to recommendations [...] Read more.

This study applied a hermeneutic phenomenological approach to better understand pharmacy workplace wellbeing and resilience using respondents’ written comments along with a blend of the researchers’ understanding of the phenomenon and the published literature. Our goal was to apply this understanding to recommendations for the pharmacy workforce and corresponding future research. Data were obtained from the 2021 APhA/NASPA National State-Based Pharmacy Workplace Survey, launched in the United States in April 2021. Promotion of the online survey to pharmacy personnel was accomplished through social media, email, and online periodicals. Responses continued to be received through the end of 2021. A data file containing 6973 responses was downloaded on 7 January 2022 for analysis. Usable responses were from those who wrote an in-depth comment detailing stories and experiences related to pharmacy workplace and resilience. There were 614 respondents who wrote such comments. The findings revealed that business models driven by mechanized assembly line processes, business metrics that supersede patient outcomes, and reduction of pharmacy personnel’s professional judgement have contributed to the decline in the experience of providing patient care in today’s health systems. The portrait of respondents’ lived experiences regarding pharmacy workplace wellbeing and resilience was beyond the individual level and revealed the need for systems change. We propose several areas for expanded inquiry in this domain: (1) shared trauma, (2) professional responsibility and autonomy, (3) learned subjection, (4) moral injury and moral distress, (5) sociocultural effects, and (6) health systems change. Full article

(This article belongs to the Special Issue Pharmacy Reviews in 2022)

12 pages, 284 KiB

Open AccessReview

Advances in Pharmacy Practice: A Look towards the Future

by Jeffrey Atkinson

Pharmacy 2022, 10(5), 125; https://doi.org/10.3390/pharmacy10050125 - 30 Sep 2022

Cited by 6 | Viewed by 5610

Abstract

This review looks at the factors that may influence practice in the future. Transformation could occur at 3 levels. Firstly, the traditional profession of the pharmacist as a dispenser of medicines is expanding. Secondly, the pharmacist’s activities are progressing into new healthcare fields. [...] Read more.

This review looks at the factors that may influence practice in the future. Transformation could occur at 3 levels. Firstly, the traditional profession of the pharmacist as a dispenser of medicines is expanding. Secondly, the pharmacist’s activities are progressing into new healthcare fields. Thirdly, other changes are stimulated by global developments. This review may be helpful for pharmacy and healthcare leaders looking at the future configuration and aims of their pharmacy services. Full article

(This article belongs to the Special Issue Pharmacy Reviews in 2022)

13 pages, 491 KiB

Open AccessReview

The Potential of Methocinnamox as a Future Treatment for Opioid Use Disorder: A Narrative Review

by Colleen G. Jordan, Amy L. Kennalley, Alivia L. Roberts, Kaitlyn M. Nemes, Tenzing Dolma and Brian J. Piper

Pharmacy 2022, 10(3), 48; https://doi.org/10.3390/pharmacy10030048 - 19 Apr 2022

Cited by 3 | Viewed by 4807

Abstract

The opioid epidemic is an ongoing public health crisis, and the United States health system is overwhelmed with increasing numbers of opioid-related overdoses. Methocinnamox (MCAM) is a novel mu opioid receptor antagonist with an extended duration of action. MCAM has potential to reduce [...] Read more.

The opioid epidemic is an ongoing public health crisis, and the United States health system is overwhelmed with increasing numbers of opioid-related overdoses. Methocinnamox (MCAM) is a novel mu opioid receptor antagonist with an extended duration of action. MCAM has potential to reduce the burden of the opioid epidemic by being used as an overdose rescue treatment and a long-term treatment for opioid use disorder (OUD). The currently available treatments for OUD include naloxone, naltrexone, and methadone. These treatments have certain limitations, which include short duration of action, patient non-compliance, and diversion. A narrative review was conducted using PubMed and Google Scholar databases covering the history of the opioid epidemic, pain receptors, current OUD treatments and the novel drug MCAM. MCAM could potentially be used as both a rescue and long-term treatment for opioid misuse. This is due to its pseudo-irreversible antagonism of the mu opioid receptor, abnormally long duration of action of nearly two weeks, and the possibility of using kappa or delta opioid receptor agonists for pain management during OUD treatment. MCAM’s novel pharmacokinetic and pharmacodynamic properties open a new avenue for treating opioid misuse. Full article

(This article belongs to the Special Issue Pharmacy Reviews in 2022)

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16 pages, 1104 KiB

Open AccessSystematic Review

Guidance on the Conduct of Clinical Research within OECD Countries during the Early Stages of the COVID-19 Pandemic: A Systematic Review

by Renu Bhutkar, Jack C. Collins, Claire L. O’Reilly and Sarira El-Den

Pharmacy 2023, 11(1), 15; https://doi.org/10.3390/pharmacy11010015 - 12 Jan 2023

Cited by 1 | Viewed by 2067

Abstract

Background: In response to the COVID-19 pandemic, member countries of the Organisation for Economic Co-operation and Development (OECD) rapidly published guidance regarding the conduct of clinical research. A systematic review was conducted to explore the recommendations issued in relation to the commencement, continuation [...] Read more.

Background: In response to the COVID-19 pandemic, member countries of the Organisation for Economic Co-operation and Development (OECD) rapidly published guidance regarding the conduct of clinical research. A systematic review was conducted to explore the recommendations issued in relation to the commencement, continuation and termination of clinical research during the early phases of the pandemic. Methods: Searches consisting of the terms “COVID-19”, “clinical research”, and “guidance”, were conducted in PubMed, Embase, MEDLINE, Trip, Guidelines International Network, and Google in April–May 2021 (up to 4 May 2021). Data were extracted from guidance published from OECD member countries and mapped to inductively-developed categories. Results: 9419 references were systematically screened, resulting in the inclusion of 46 publications from 27 OECD countries. Thirty-three sources made recommendations regarding monitoring, risk-benefit assessments and information technology. There was limited specific recommendations made in relation to personal protective equipment (PPE) in the included guidance. Findings demonstrate that guidance differed by publication date demonstrating the rapidly evolving environment within which research was conducted. Importantly, many organisations opted to endorse existing guidance published by the United States’ Food and Drug Administration and the European Medicines Agency rather than develop their own recommendations. Conclusions: Given the rapidly evolving nature of the pandemic, particularly in the early stages, findings demonstrate the global response in relation to clinical research conduct, thereby providing important insights for future public health emergencies. Full article

(This article belongs to the Special Issue Pharmacy Reviews in 2022)

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