Articles

Regulatory requirements for the registration of generic medicines and format of drug dossiers: procedures in Sri Lanka in comparison with selected regulatory authorities

The regulatory requirements for approval of generic medicines and the format of compiling drug dossiers vary among regulatory authorities. The variation is particularly wide between High-income countries (HIC)...

Authors: D. Thambavita, P. Galappatthy and R. L. Jayakody

Assessment of primary labeling of medicines manufactured by Nepalese pharmaceutical industries

Appropriate labeling of marketed medicines is necessary to fulfill the regulatory provisions and ensure patient medication safety. This study aimed to assess the primary labeling of medicines manufactured and ...

Authors: Ramesh Sharma Poudel, Shakti Shrestha, Santosh Thapa, Bhupendra Kumar Poudel and Muniraj Chhetri

Provider preferences for postoperative analgesia in obese and non-obese patients undergoing ambulatory surgery

Few guidelines exist on safe prescription of postoperative analgesia to obese patients undergoing ambulatory surgery. This study examines the preferences of providers in the standard treatment of postoperative...

Authors: Anthony H. Bui, David L. Feldman, Michael L. Brodman, Peter Shamamian, Ronald N. Kaleya, Meg A. Rosenblatt, Debra D’Angelo, Donna Somerville, Santosh Mudiraj, Patricia Kischak and I. Michael Leitman

Evaluating inter-rater reliability of indicators to assess performance of medicines management in health facilities in Uganda

To build capacity in medicines management, the Uganda Ministry of Health introduced a nationwide supervision, performance assessment and recognition strategy (SPARS) in 2012. Medicines management supervisors (...

Authors: Belinda Blick, Stella Nakabugo, Laura F. Garabedian, Morries Seru and Birna Trap

The Belgian commitment to pharmaceutical quality: a model policy to improve quality assurance of medicines available through humanitarian and development programs

Today, a combination of globalization of pharmaceutical production, lack of regulatory harmonization, and weakness of Medicines Regulatory Authorities, creates the “perfect conditions” for poor-quality medicin...

Authors: Raffaella Ravinetto, Tim Roosen and Catherine Dujardin

Weaving the health and pharmaceutical care agenda through the themes of the commonwealth heads of government meeting (CHOGM), London 2018

The biennial Commonwealth Heads of Government Meeting (CHOGM) this year is based around four key themes: prosperity, fairness, sustainability and security. This is an opportune time to consider the role of pha...

Authors: Victoria Rutter, Amy Hai Yan Chan, Chloe Tuck, Lina Bader, Zaheer-Ud-Din Babar and Ian Bates

Insights into early stage of antibiotic development in small- and medium-sized enterprises: a survey of targets, costs, and durations

Antibiotic innovation has dwindled to dangerously low levels in the past 30 years. Since resistance continues to evolve, this innovation deficit can have perilous consequences on patients. A number of new ince...

Authors: Christine Årdal, Enrico Baraldi, Ursula Theuretzbacher, Kevin Outterson, Jens Plahte, Francesco Ciabuschi and John-Arne Røttingen

A survey of knowledge, attitude, and practices of private retail pharmacies staff in tuberculosis care: study from Dera Ismail Khan City, Pakistan

In order to engage pharmacies in tuberculosis (TB) care, a survey was conducted in the Dera Ismail (DI) Khan City of the Khyber Pakhtoon Khwa province, Pakistan. The objectives were to; 1) characterize the ret...

Authors: Tehmina Mustafa, Yasir Shahzad and Ayyaz Kiani

A bibliometric analysis of the global research on biosimilars

Biosimilars could be a promising option to help decrease healthcare costs and expand access to treatment. There is no previous evidence of a global bibliometric analysis on biosimilars. Therefore, we aimed to ...

Authors: Akram Hernández-Vásquez, Christoper A. Alarcon-Ruiz, Guido Bendezu-Quispe, Daniel Comandé and Diego Rosselli

Pharmaceutical company spending on research and development and promotion in Canada, 2013-2016: a cohort analysis

Competing claims are made about the amount of money that pharmaceutical companies spend on research and development (R&D) versus promotion. This study investigates this question in the Canadian context.

Authors: Joel Lexchin

A real world example of coverage with evidence development in Australia - ipilimumab for the treatment of metastatic melanoma

Australian Government subsidisation of ipilimumab for the treatment of patients with metastatic melanoma was conditional on the sponsor entering a ‘managed entry scheme’ to assess the 2-year overall survival r...

Authors: Hansoo Kim, Samantha Comey, Karl Hausler and Greg Cook

Health care for all: effective, community supported, healthcare with innovative use of telemedicine technology

Almost half of the world’s total population reside in rural and remote areas and a large number of these people remain deprived of most basic facilities like healthcare and education. It is deemed impossible f...

Authors: Tariq Kazim Shah, Tasneem Tariq, Roger Phillips, Steve Davison, Adam Hoare, Syed Shahzad Hasan and Zaheer-Ud-Din Babar

Barriers and facilitators to hospital pharmacists’ engagement in medication safety activities: a qualitative study using the theoretical domains framework

Hospital pharmacists play a central role in medication safety activities. However, in Ethiopia, this role has been launched recently and little is known regarding the current status of this extended service. U...

Authors: Alemayehu B. Mekonnen, Andrew J. McLachlan, Jo-anne E. Brien, Desalew Mekonnen and Zenahebezu Abay

Analysis of changes in trends in the consumption rates of benzodiazepines and benzodiazepine-related drugs

To analyse trends in the rates of consumption of benzodiazepine (BZD) anxiolytics, BZD hypnotics and non-BZD hypnotics and the association with contextual factors.

Authors: Miguel Angel Fernández García, Antonio Olry de Labry Lima, Ingrid Ferrer Lopez and Clara Bermúdez-Tamayo

Exploring the extended role of the community pharmacist in improving blood pressure control among hypertensive patients in a developing setting

In most developing countries including Ghana, there is scant literature on the involvement of the community pharmacist in the care of patients with chronic conditions such as hypertension and blood pressure co...

Authors: Afia Frimpomaa Asare Marfo and Frances Thelma Owusu-Daaku

Evaluation of the National Return of unwanted medicines (RUM) program in Australia: a study protocol

The National Return of Unwanted Medicines (NatRUM) program in Australia is one of the few nationally coordinated, free-to-consumer schemes to dispose of unwanted medicines globally. This scheme has been in ope...

Authors: Amanda J. Wheeler, Jean Spinks, Emilie Bettington and Fiona Kelly

To what extent do prescribing practices for hypertension in the private sector in Zimbabwe follow the national treatment guidelines? An analysis of insurance medical claims

Hypertension is the most prevalent cardiovascular disease in Zimbabwe. The prevalence of Hypertension in the country is above 30% regardless of the cut off used. Currently, majority of patients in Zimbabwe see...

Authors: Victor Basopo and Paschal N. Mujasi

Evaluating treatment outcomes and durations among cases of smear-positive pulmonary tuberculosis in Yemen: a prospective follow-up study

Evaluating outcomes after tuberculosis (TB) treatment can help identify the primary reasons for treatment success or failure. However, Yemen has a treatment success rate that remains below the World Health Org...

Authors: Ammar Ali Saleh Jaber, Amer Hayat Khan and Syed Azhar Syed Sulaiman

Availability, prices and affordability of UN Commission’s lifesaving medicines for reproductive and maternal health in Uganda

Uganda was one of seven countries in which the United Nations Commission on Life Saving Commodities (UNCoLSC) initiative was implemented starting from 2013. A nationwide survey was conducted in 2015 to determi...

Authors: Denis Kibira, Freddy Eric Kitutu, Gemma Buckland Merrett and Aukje K. Mantel-Teeuwisse

Expanding HIV/AIDS care service sites: a cross sectional survey of community pharmacists’ views in South-East, Nigeria

Community pharmacists are very accessible to most patients yet; they have been underutilized in the aspect of providing HIV care and services. The World Health Organisation recently recommended expanding commu...

Authors: Nnenna Ajagu, Maureen Ugonwa Anetoh and Sunday Odunke Nduka

Competency in supportive supervision: a study of public sector medicines management supervisors in Uganda

Supportive supervision has been found to be more effective than corrective fault-oriented inspections. Uganda’s Ministry of Health in 2012 implemented a comprehensive strategy (SPARS) to build medicines manage...

Authors: Rachael Henry, Lynda Nantongo, Anita Katharina Wagner, Martha Embrey and Birna Trap

Evaluating the impact of Brexit on the pharmaceutical industry

The UK Pharmaceutical Industry is arguably one of the most important industries to consider in the negotiations following the Brexit vote. Providing tens of thousands of jobs and billions in tax revenue and re...

Authors: Fawz Kazzazi, Cleo Pollard, Paul Tern, Alejandro Ayuso-Garcia, Jack Gillespie and Inesa Thomsen

Branded prescription drug spending: a framework to evaluate policy options

High drug spending is a concern for policy makers due to limits on access for patients. Numerous policies have been proposed to address high drug spending. The existence of multifarious proposals makes it diff...

Authors: Jeromie Ballreich, G. Caleb Alexander, Mariana Socal, Taruja Karmarkar and Gerard Anderson

Does access to credit services influence availability of essential child medicines and licensing status among private medicine retail outlets in Uganda?

Despite making great progress in reducing under five mortality in the last three decades. Uganda still ranks high among countries with the highest under five mortality rates. More than a third (36%) of these d...

Authors: Lorraine Nabbanja Kabunga and Paschal Mujasi

Controlled Substance Agreements for Opioids in a Primary Care Practice

Opioids are widely prescribed for chronic non cancer pain (CNCP). Controlled substance agreements (CSAs) are intended to increase adherence and mitigate risk with opioid prescribing. We evaluated the demograp...

Authors: Lindsey M. Philpot, Priya Ramar, Muhamad Y. Elrashidi, Raphael Mwangi, Frederick North and Jon O. Ebbert

Hypnotics use in children 0–18 months: moderate agreement between mother-reported survey data and prescription registry data

Different methods in pharmacoepidemiology can be used to study hypnotic use in children. But neither questionnaire-based data nor prescription records can be considered a “gold standard”. This study aimed to i...

Authors: Ingvild Holdø, Jørgen G. Bramness, Marte Handal, Leila Torgersen, Ted Reichborn-Kjennerud, Eivind Ystrøm, Hedvig Nordeng and Svetlana Skurtveit

Antimicrobial resistance in India

Authors: Isha Patel, Rabia Hussain, Anam Khan, Akram Ahmad, Muhammad Umair Khan and Mohamed Azmi Ahmed Hassalai

Evaluation of a guided continuous quality improvement program in community pharmacies

The importance of creating and sustaining a strong culture of patient safety has been recognized as a critical component of safe medication use. This study aims to assess changes in attitudes toward patient sa...

Authors: Chanadda Chinthammit, Michael T. Rupp, Edward P. Armstrong, Tara Modisett, Rebecca P. Snead and Terri L. Warholak

Evaluating insulin information provided on discharge summaries in a secondary care hospital in the United Kingdom

Prescribing errors at the time of hospital discharge are common and could potentially lead to avoidable patient harm, especially when they involve insulin, a high-risk medicine widely used for the treatment of...

Authors: Amie Bain, Lois Nettleship, Sallianne Kavanagh and Zaheer-Ud-Din Babar

Antibiotic use during pregnancy: a retrospective study of prescription patterns and birth outcomes at an antenatal clinic in rural Ghana

Babies are increasingly being exposed to antibiotics intrapartum in the bid to reduce neonatal and maternal deaths. Intrapartum antibiotic exposure, including even those considered safe in pregnancy, have been...

Authors: Kwesi Boadu Mensah, Kwame Opoku-Agyeman and Charles Ansah

Drug utilization patterns among elderly hospitalized patients on poly-pharmacy in Punjab, Pakistan

Reports from drug utilization reviews are important tools employed in the assessment of healthcare practices. The objective of this study was to evaluate drug utilization patterns among elderly hospitalized pa...

Authors: Muhammad Rehan Sarwar, Muhammad Atif, Shane Scahill, Anum Saqib, Muhammad Qamar-uz-Zaman and Zaheer Babar

Taking the lead from our colleagues in medical education: the use of images of the in-vivo setting in teaching concepts of pharmaceutical science

Despite pharmaceutical sciences being a core component of pharmacy curricula, few published studies have focussed on innovative methodologies to teach the content. This commentary identifies imaging techniques...

Authors: Louise E. Curley, Julia Kennedy, Jordan Hinton, Ali Mirjalili and Darren Svirskis

Exploring the status of retail private drug shops in Bangladesh and action points for developing an accredited drug shop model: a facility based cross-sectional study

The private retail drug shops market in Bangladesh is largely unregulated and unaccountable, giving rise to irrational use of drugs and high Out-of-pocket expenditure on health. These shops are served by sales...

Authors: Syed Masud Ahmed, Nahitun Naher, Tarek Hossain and Lal Bahadur Rawal

The effectiveness of naltrexone combined with current smoking cessation medication to attenuate post smoking cessation weight gain: a literature review

Smoking is the number one cause of preventable morbidity and mortality globally and although many countries have invested heavily in smoking cessation programs, 21% of the global population still smoke. Post c...

Authors: Raewyn Rees and Ali Seyfoddin

Data exclusivity exceptions and compulsory licensing to promote generic medicines in the European Union: A proposal for greater coherence in European pharmaceutical legislation

The challenge of providing access to high-priced patented medicines is a global problem affecting all countries. A decade and a half ago the use of flexibilities contained in the World Trade Organization Agree...

Authors: Ellen F. M. ‘t Hoen, Pascale Boulet and Brook K. Baker

Promoting transparency, accountability, and access through a multi-stakeholder initiative: lessons from the medicines transparency alliance

Barriers to expanding access to medicines include weak pharmaceutical sector governance, lack of transparency and accountability, inadequate attention to social services on the political agenda, and financing ...

Authors: Taryn Vian, Jillian C. Kohler, Gilles Forte and Deirdre Dimancesco

Comparison of medicines management strategies in insurance schemes in middle-income countries: four case studies

Many middle-income countries are scaling up health insurance schemes to provide financial protection and access to affordable medicines to poor and uninsured populations. Although there is a wealth of evidence...

Authors: Warren A. Kaplan, Paul G. Ashigbie, Mohamad I. Brooks and Veronika J. Wirtz

Individual capacity-building approaches in a global pharmaceutical systems strengthening program: a selected review

Medicines use related challenges such as inadequate adherence, high levels of antimicrobial resistance and preventable adverse drug reactions have underscored the need to incorporate pharmaceutical services to...

Authors: Niranjan Konduri, Megan Rauscher, Shiou-Chu Judy Wang and Tanya Malpica-Llanos

Two years post affordable medicines facility for malaria program: availability and prices of anti-malarial drugs in central Ghana

The Affordable Medicines Facility for malaria (AMFm) Program was a subsidy aimed at artemisinin-based combination therapies (ACTs) in order to increase availability, affordability, and market share of ACTs in ...

Authors: Alexander Freeman, Anthony Kwarteng, Lawrence Gyabaa Febir, Seeba Amenga-Etego, Seth Owusu-Agyei and Kwaku Poku Asante

Ethiopian patients’ perceptions of anti-diabetic medications: implications for diabetes education

The purpose of this study is to explore medication-related perceptions of adult patients with type 2 diabetes attending treatment in public hospitals of urban centers in central Ethiopia.

Authors: Bruck Messele Habte, Tedla Kebede, Teferi Gedif Fenta and Heather Boon

Antibiotic knowledge, attitudes and behaviours of Albanian health care professionals and patients – a qualitative interview study

The inappropriate use of antimicrobials is a problem worldwide. To target future interventions, a thorough understanding of the reasons behind this current behaviour is needed. Within the EU, the culture of an...

Authors: Susanne Kaae, Admir Malaj and Iris Hoxha

Comparison of hydroxyethyl starch regulatory summaries from the Food and Drug Administration and the European Medicines Agency

This article aims to highlight the positions of the Food and Drug Administration and the European Medicines Agency regarding use and marketing of hydroxyethyl starch (HES) products, and how these have changed ...

Authors: Christian J. Wiedermann and Klaus Eisendle

Drug pricing and reimbursement decision making systems in Mongolia

It is essential to allocate available resources equitably in order to ensure accessibility and affordability of essential medicines, especially in less fortunate nations with limited health funding. Currently,...

Authors: Gereltuya Dorj, Bruce Sunderland, Tsetsegmaa Sanjjav, Gantuya Dorj and Byambatsogt Gendenragchaa

The changing landscape of expanded access to investigational drugs for patients with unmet medical needs: ethical implications

When patients are told that standard medical treatment options have been exhausted, their treating physicians may start looking for promising new drugs that are not yet approved, and still under investigation....

Authors: Eline M. Bunnik, Nikkie Aarts and Suzanne van de Vathorst

Capacity for ethical and regulatory review of herbal trials in developing countries: a case study of Moringa oleifera research in HIV-infected patients

Lack of regulatory capacity limits the conduct of ethical and rigorous trials of herbal medicines in developing countries. Sharing ethical and regulatory experiences of successful herbal trials may accelerate ...

Authors: Tsitsi G. Monera-Penduka, Charles C. Maponga, Gene D. Morse and Charles F. B. Nhachi

Structured pharmaceutical care improves the health-related quality of life of patients with asthma

Asthma as a chronic health condition can be controlled when in addition to clinical care, adequate education and support is provided to enhance self-management. Like many other chronic health conditions improv...

Authors: Philip O. Anum, Berko P. Anto and Audrey G. Forson

Engagement of the private pharmaceutical sector for TB control: rhetoric or reality?

Private-sector retail drug outlets are often the first point of contact for common health ailments, including tuberculosis (TB). Systematic reviews on public-private mix (PPM) interventions for TB did not perf...

Authors: Niranjan Konduri, Emily Delmotte and Edmund Rutta

Prices and availability of locally produced and imported medicines in Ethiopia and Tanzania

To assess the effect of policies supporting local medicine production to improve access to medicines.

Authors: M. Ewen, W. Kaplan, T. Gedif, M. Justin-Temu, C. Vialle-Valentin, Z. Mirza, B. Regeer, M. Zweekhorst and R. Laing

Civil society engagement in multi-stakeholder dialogue: a qualitative study exploring the opinions and perceptions of MeTA members

The Medicines Transparency Alliance (MeTA) is an initiative that brings together all stakeholders in the medicines market to create a multi-stakeholder dialogue and improve access, availability and affordabili...

Authors: Gemma L. Buckland-Merrett, Catherine Kilkenny and Tim Reed

Approval status and evidence for WHO essential medicines for children in the United States, United Kingdom, and Japan: a cross-sectional study

The WHO Model List of Essential Medicines for Children (EMLc) covers medicines for globally high-burden diseases. Regulatory approval in high-income countries ensures evidence and dosage form but usually focus...

Authors: Rumiko Shimazawa and Masayuki Ikeda