Drug Approval, Pharmacology / 04.12.2024

quality-by-design in biopharmaceutical development The biopharmaceutical industry has undergone significant transformations in recent years, particularly with the adoption of Quality by Design (QbD) principles. This innovative approach is reshaping the landscape of biopharmaceutical manufacturing by fostering a culture of quality that prioritises proactive measures over reactive solutions. This transformation not only enhances the efficiency of manufacturing processes but also ensures that patients receive safe and effective medications.

What is Quality by Design (QbD)?

Quality by Design is a strategic framework introduced to ensure that quality is built into pharmaceutical products from the outset, rather than being tested in at the end of the manufacturing process. This concept emerged from the need for a more scientific and risk-based approach to drug development, particularly in light of the complexities inherent in biopharmaceutical manufacturing. QbD is built upon several core elements, including:
  • Quality Target Product Profile (QTPP): This outlines the desired characteristics of the final product, including its intended use, dosage form, and delivery method.
  • Critical Quality Attributes (CQAs): These are the physical, chemical, and biological properties that must be controlled to ensure the product meets its QTPP.
  • Critical Process Parameters (CPPs): These are the variables that influence the CQAs during manufacturing and must be monitored to maintain product quality.
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Legal-Malpractice, Pharmacology / 21.11.2024

Running a pharmacy may be both gratifying and difficult. The healthcare sector depends heavily on chemists. Because they provide the prescription medications, advice, and support that patients need to improve their results. But these obligations also carry several serious concerns. The challenges of owning and operating a pharmacy are unique. From the possibility of drug mistakes to the physical risks of the job. This article will discuss several hazards that come with operating a pharmacy. Talk about how crucial pharmacy insurance is to effectively controlling these risks as well.

Most Significant Risks Associated with Running a Pharmacy

Let's review some of the biggest dangers that come with owning a pharmacy and how they might be lessened with pharmacy insurance.

Medication Errors and Liability

Medication errors are one of the most common risks in the pharmacy field. Mistakes in filling prescriptions and incorrect dosages can have serious consequences and provide the wrong medication which also leads to significant harm. Sometimes life-threatening consequences. Human mistakes are unavoidable, and pharmacies may be sued by impacted patients or their families despite having strict protection in place. Pharmacy liability insurance can protect in case of claims made by patients harmed by medication errors. This coverage typically includes legal defence costs and settlements. Also, other expenses are associated with the claim. It helps the pharmacy recover financially and continue operating. (more…)
Author Interviews, Pharmacology / 12.11.2024

medical medicine box You might have noticed the key details mentioned on medical medicine boxes whenever you pick them up from a pharmacy. Information, precautions, symbols, and brand details mentioned on these boxes are important for individuals who are going to consume these medicines. Custom medicine boxes thus serve as an effective means of conveying the desired insights to the exact audience who is going to benefit from the relevant medicines for curing their specific health issues. Brands make sure to keep the details mentioned on medical medicine boxes highly relevant and assure the safety of individuals at all times while keeping them informed of the right dose of the medicine they are going to consume. This post explores how important are these custom packaging solutions for your pharmaceutical brand and what are the key features of medical medicine boxes. (more…)
Author Interviews, Health Care Systems, JAMA, Pharmacology, University of Pittsburgh / 31.10.2024

MedicalResearch.com Interview with: Katie J. Suda, PharmD, M.S., FCCP Professor of medicine with tenure Associate Director, Center for Pharmaceutical Policy and Prescribing University of Pittsburgh School of Medicine MedicalResearch.com: What is the background for this study? Response: Our pharmaceutical supply chain is global where the manufacturing process for one drug may occur in multiple countries. Sometimes there are breakdowns in the pharmaceutical supply chain which may threaten access to medicines. Breakdowns in the supply chain occur for medicines manufactured in the U.S. and by international partners. While breakdowns in the supply chain occur for hundreds of drugs each year, not all result in a decrease in available supply (a “drug shortage”) because of action taken by manufacturers, pharmacies and drug regulators (e.g., the U.S. Food and Drug Administration [FDA]). Drug shortages are a critical concern to public health as pharmacies, clinicians, and patients struggle to identify safe and effective alternatives. In addition, drug shortages have been associated with adverse patient outcomes and medication safety events. Recently, drug shortages have gotten worse with shortages occurring with increasing frequency and lasting longer. There has also been a shift in the types of medicines in shortage from drugs primarily used in hospitals, such as injectables, to oral medicines frequently used to manage outpatient conditions. Countries have different regulatory authority and policy which may impact how drug supply chain breakdowns result in drug shortages. We wanted to know if there are differences between the U.S. and Canada in the frequency that national drug shortages occur after supply chain breakdowns are reported in both countries. Canada is a good comparator to the U.S. because Canada has similar drug regulatory standards and manufacturing inspections. Prescription drug coverage is also similar for the two countries where half of prescriptions are reimbursed through public insurance and half through private insurance and out-of-pocket. (more…)
Cost of Health Care, Diabetes, Pharmacology / 21.10.2024

Access to affordable insulin remains a challenge for millions of people living with diabetes around the world, particularly in middle-income countries. To bridge this gap, platforms are emerging that connect patients with high-quality insulin at reduced prices. For individuals struggling to afford their life-saving medication, these services offer a convenient and affordable solution, making a significant impact on global health.

The Global Insulin Crisis

Diabetes affects millions worldwide, and the demand for insulin continues to rise. Major insulin manufacturers, including Novo Nordisk, Eli Lilly, and Sanofi, dominate the global market, producing essential medications for managing blood sugar levels. However, in many parts of the world, including countries like India, Mexico, and the Philippines, insulin prices remain prohibitively high. This leaves a substantial portion of the population without access to the medication they need to live healthy lives. Data shows that insulin prices are often out of reach for people in middle-income countries. The situation is particularly dire in regions like Kenya, Malaysia, and Vietnam, where the cost of insulin may equal a month's salary. With nearly three major companies controlling the insulin market, competition is limited, and prices remain high. As a result, many patients with type 1 and type 2 diabetes face inconsistent access to insulin, which can put their health at significant risk. (more…)
Pharmacology / 02.10.2024

Editor's note:  Don't delay seeking advice from your health care provider with prolonger over-the-counter remedies. Some conditions, including but limited to persistent cough, gastrointestinal symptoms, headache etc may be a symptom of a more serious condition and should be evaluated by your doctor or provider. Have you ever thought about how convenient it would be if your local pharmacy was just a few clicks away? Well, with the rise of online pharmacies, that's exactly the reality for many people. These digital services have become a practical solution for managing a wide range of health conditions. Whether you need professional advice or simply want the convenience of ordering treatments from the comfort of your own home, an online pharmacy can be a reliable and efficient partner in maintaining your health.

Managing Minor Health Issues with Ease

We all deal with minor health complaints from time to time. Maybe its that cold you caught last week is still lingering. When these everyday issues arise, the last thing you want to do is wait in long queues at a pharmacy. Fortunately, online pharmacies are well-equipped to help with a wide range of over-the-counter products for common ailments. For instance, many offer treatments for sniffles, colds, and flu that can be delivered directly to your door. Pain relief options, decongestants, and throat lozenges can all be found online. Along with medications, you can also access advice about symptom management. Often, pharmacists are available for virtual consultations, offering practical advice on what you might need based on your symptoms. (more…)
Drug Approval, Pharmacology / 20.09.2024

FDA drug testing Ever thought what are the next steps after launching a product? Once a product is launched, there is much more to do about FDA approval, particularly with health and safety products. The FDA acts as a protector and safeguard of products, be they medications or medical devices, allowed to enter the U.S. market.  Here, understanding the FDA approval process will benefit you to help understand the complex world of product approval and set real expectations of your product for the market. Let’s look at the basic structure of FDA approval and its after-process.  (more…)
Pharmacology / 20.09.2024

drug safety Pharmacovigilance is the strict monitoring process in the drug industry to ensure that drugs are safe to administer. It simply ensures that public health is kept away from harmful drugs by keeping a tab on any safety concerns with the drug once it is on the market. This blog explains the fundamental characteristics of pharmacovigilance, its significance, and what process is applied. (more…)
Endocrinology, Pharmacology / 20.09.2024

Editor's note:  Consult with your medical provider beginner any form of potential hormonal regulation therapy.   The discussion below has not been FDA verified or approved and should not be construed as specific medical advice. The field of hormone regulation has evolved significantly, offering new treatments that aim to restore balance and improve overall well-being. MedicalNewsToday states that most people go through natural hormonal fluctuations at various stages of their lives. However, imbalances can emerge when the endocrine glands, which create and release hormones into the circulation, do not operate properly. These glands are distributed throughout the body, and each of them handles different organs and physical activities. As more individuals seek solutions for hormone-related issues like fatigue, weight gain, and mood swings, next-generation hormone regulation treatments are becoming increasingly popular. These innovative therapies, such as hormone pellet therapy, bioidentical hormone replacement therapy (BHRT), and peptide therapy, target specific imbalances to provide personalized solutions. These treatments offer hope for improved health, vitality, and quality of life by addressing the root causes of hormone disruptions. (more…)
Cost of Health Care, Pharmacology / 12.09.2024

When you’re at the pharmacy, it’s normal to feel a bit of confusion about whether you would like to receive generic or brand-name medication when the pharmacy technician asks you the usual question. While health professionals, from pharmacists to doctors, nurses, and students of RN to MSN programs, will understand the differences between the two, it's important that you, as a patient, know them, too. In this article, we will break down the differences between generic and brand-name medications so that you will be more aware when you visit the pharmacy.

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Pharmacology, Semaglutide / 11.08.2024

Oral Semaglutide has emerged as a significant advancement in the realm of weight loss treatments. As an alternative to traditional injectable options, oral Semaglutide offers convenience and effectiveness. This guide provides an in-depth look at oral Semaglutide, its benefits, how to access it through prescriptions, and explores compounded semaglutide online.

What is Oral Semaglutide?

Oral Semaglutide is an oral form of the medication Semaglutide, which was originally available only as an injection. It is used to manage weight loss and control blood sugar levels in individuals with obesity or type 2 diabetes.
  • Mechanism of Action: Semaglutide mimics a hormone called GLP-1, which helps regulate appetite and insulin secretion. By enhancing these processes, it can support significant weight loss and better blood sugar control.
  • Approval and Usage: The oral version is approved by the FDA for weight management and is typically prescribed as part of a comprehensive weight loss plan that includes diet and exercise.
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Pharmacology / 06.08.2024

 

In today's fast-paced world, healthcare is moving toward more personalized and patient-centric approaches. This trend is evident in the increasing popularity of compounding pharmacies. These specialized pharmacies offer customized solutions tailored to individual patient's needs, making them an essential part of modern healthcare. While healthcare services are diverse and growing, the need for personalized medication is becoming more recognized. This article will explore the top benefits of custom compounding and why it's becoming a cornerstone of personalized healthcare.

Understanding Custom Compounding

Custom compounding refers to the creation of personalized medications by pharmacists to meet the unique needs of individual patients. Unlike traditional pharmacies that dispense mass-produced medications, compounding pharmacies prepare medications from scratch. This allows for a high degree of customization, ensuring that each medication is tailored specifically to the patient's requirements. The practice of compounding dates back to the origins of pharmacy, but it has gained renewed importance in modern healthcare as patients and providers seek more targeted treatment options. (more…)
Pharmacology / 02.07.2024

A Step-by-Step Guide for Emergency Prescription Refill

Do you rely on prescription medication? Then it’s important to know how to get an emergency prescription refill, whether due to travel, misplacing, or forgetting to get one. Here is a comprehensive guide covering all the necessary actions to ensure you receive your prescription on time and without stress.

What Is an Emergency Prescription?

Emergency prescription refills are used when a patient suddenly loses access to the needed medication. Common situations requiring emergency refills include:
  • While traveling, you forget to bring your prescription medication.
  • During your trip, your medication was misplaced or broken.
  • Even with the best-laid plans, you run out of medication and forget to schedule a refill.
  • You lost your prescription, especially as you moved into a new house or you live in a busy home.
  • Your prescribing physician is unavailable because of emergencies, holidays, or vacations.
  • Unexpected changes in your health that necessitate taking your prescription more frequently or at higher dosages (if that was discussed with a healthcare provider).
  • Refills for medications may be required immediately in the event of new health difficulties or consequences.
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Author Interviews, Cost of Health Care, Pharmacology / 09.12.2023

MedicalResearch.com Interview with: Joseph T. DiPiro, Pharm.D Associate Vice President, Faculty Affairs Virginia Commonwealth University Dr. DiPiro is an editor for Pharmacotherapy: A Pathophysiologic Approach MedicalResearch.com: What is the background for this study? Response: The ASHP/ASHP Foundation Pharmacy Forecast Report is constructed from a survey of health-system pharmacy leaders who were asked to rate the likelihood of events, scenarios, and trends occurring in the next five years. The purpose is for health-system pharmacists and pharmacy leaders to inform their strategic planning efforts. The Pharmacy Forecast is not intended to predict future events. Rather, the report is intended to be a provocative stimulant for the thinking, discussion, and planning that must take place in every health system. Leaders must be informed of potential developments to help position their organizations to care for patients, enhance population health, and improve medication outcomes. (more…)
Author Interviews, Cancer Research, Cost of Health Care, JAMA, Pharmacology / 17.11.2023

MedicalResearch.com Interview with: Lisa-Marie Smale, PharmD PhD Candidate Clinical Pharmacy Radboud University Medical Center Department of Pharmacy Nijmegen, the Netherlands Lisa-Marie Smale, PharmDPhD Candidate Clinical PharmacyRadboud University Medical CenterDepartment of PharmacyNijmegen, the Netherlands   MedicalResearch.com: What is the background for this study? Response: Cancer drugs are not always fully used by patients, while these drugs are mostly expensive and environmentally damaging, both in production and (waste) disposal. Therefore we investigated whether unused drugs of patients can be collected, verified of quality by a pharmacy, to be redispensed to other patients instead of being disposed of. We were interested whether such an approach ultimately leads to lower environmental impacts and costs. (more…)
Author Interviews, Cannabis, Pharmacology, Tobacco Research / 08.03.2023

MedicalResearch.com Interview with: Philip Lazarus, PhD Boeing Distinguished Professor, Pharmaceutical Sciences Professor, Dept of Pharmaceutical Sciences College of Pharmacy and Pharmaceutical Sciences Washington State University Spokane, WA 99210   MedicalResearch.com: What is the background for this study? Response: Smoking and tobacco use remains a major health issue. Smokers use cigarette over the course of the day because the levels of nicotine, the addictive agent in cigarettes and other forms of tobacco, dimmish with time in the bloodstream due to the breakdown of nicotine by enzymes in the body. By inhibiting the breakdown of nicotine in smokers, one would expect that the levels of nicotine would remain higher after smoking a single cigarette, and that these individuals may not require lighting up another cigarette so quickly, reducing the number of cigarettes smoked over the course of a day. This could have a profound effect on reducing the overall harm incurred from smoking or from using other forms of tobacco. In a single previous study, smokers who used a CBD inhaler exhibited a 40% reduction in cigarette use. In addition, while cannabis users are often smokers, previous studies have indicated that they smoke less cigarettes than non-cannabis-using cigarette smokers. In previous studies published in 2021, we found that major cannabinoids present in cannabis like THC and CBD inhibit major metabolizing enzymes in our body, including several that are important in drug metabolism. We hypothesized that CBD and its major active metabolite, 7-hydroxy (OH)-CBD, may also be inhibiting one or more of the enzymes important in the metabolism (or breakdown) of nicotine. (more…)
Author Interviews, Diabetes, JCEM, Pharmacology / 28.01.2023

This article is for informational purposes only and is not a substitute for professional medical advice, diagnosis or treatment. Contact a qualified medical professional before engaging in any physical activity, or making any changes to your diet, medication or lifestyle, MedicalResearch.com Interview with: Tingting Geng PhD Department of Nutrition and Food Hygiene Hubei Key Laboratory of Food Nutrition and Safety Ministry of Education Key Lab of Environment and Health State Key Laboratory of Environment Health (Incubating) School of Public Health, Tongji Medical College Huazhong University of Science and Technology Wuhan, China MedicalResearch.com: What is the background for this study? Response: Previous studies have suggested that proton pump inhibitors (PPIs) may lead to an increase in cardiovascular events due to the drug-drug interactions between PPIs and clopidogrel and gut microbiota dysbiosis. Patients with Type 2 Diabetes (T2D) are at more than three times higher prevalence of using PPIs, and two- to fourfold higher risk of developing cardiovascular complications and premature death than general populations. However, evidence regarding the influence of PPI use on subsequent risks of cardiovascular disease and mortality among patients with T2D is scarce. We conducted a prospective study using the UK Biobank study to examine the association of PPI use with risks of coronary artery disease, myocardial infarction, heart failure, stroke and mortality among patients with T2D. Using multivariable-adjusted Cox regression models and a propensity score-matched cohort, researchers found robust results that PPIs use was associated with a higher risk of coronary artery disease (adjusted HR=1.27), myocardial infarction (adjusted HR=1.34), heart failure (adjusted HR=1.35), and mortality (adjusted HR=1.30). (more…)
Pharmacology / 06.01.2023

Xanax (generic name is alprazolam) is a prescription medication commonly used to treat anxiety and panic disorders. It is important for those taking this or any other medication to understand how long the substance stays in their system, as this can affect the efficacy of the medication over time. Let’s take a look at how long Xanax typically remains in your system and what factors may influence its duration. The length of time that an individual's body takes to metabolize any drug depends on several different factors, such as age, weight, genetics, and overall health. Generally speaking, it takes between 4-6 hours for half of a dose of Xanax taken orally to leave the system. This means it could take up to 12 hours for the entire dose to be eliminated from your body. (more…)
Allergies, Annals Internal Medicine, Author Interviews, Pharmacology / 29.03.2022

MedicalResearch.com Interview with: Chintan V. Dave, PharmD, PhD Assistant Professor Ernest Mario School of Pharmacy Institute for Health, Health Care Policy and Aging Institute Rutgers University MedicalResearch.com:  What is the background for this study?  What are the main findings?  Response: The risks of anaphylaxis among intravenous (IV) iron products currently in use has not been assessed. Older adults have a higher risk of experiencing drug-induced anaphylaxis. Accordingly, our study objective was to elucidate the risk of anaphylaxis  among older adults receiving the five frequently used IV iron products: ferric carboxymaltose, ferumoxytol, ferric gluconate, iron dextran, and iron sucrose. (more…)
ADHD, Author Interviews, Cost of Health Care, Eating Disorders, Pharmacology / 09.01.2022

MedicalResearch.com Interview with: Sneha Vaddadi, BS Department of Medical Education Geisinger Commonwealth School of Medicine Scranton, Pennsylvania MedicalResearch.com: What is the background for this study? Response: The prescription stimulants methylphenidate, amphetamine, and lisdexamfetamine, classified as Schedule II substances, are sympathomimetic drugs with therapeutic use widely used in the US for Attention Deficit Hyperactivity Disorder. Changes in criteria for diagnosis of Attention Deficit Hyperactivity Disorder in 2013 and approval of lisdexamfetamine for binge eating disorder in 2015 may have impacted usage patterns. The goal of this study1 was to extend upon past research2 to compare the pharmacoepidemiology of these stimulants in the United States from 2010–2017, including consideration to variation within geographic regions, the Hispanic population, and the Medicaid population. (more…)
Author Interviews, Electronic Records, Pharmacology / 08.12.2021

MedicalResearch.com Interview with: Bernard Esquivel Zavala, MD, PhD, MHA GenXys Chief Medical Officer MedicalResearch.com: What is the mission of GenXys? Response: Our mission at GenXys is to tailor the right treatment for each individual patient at the right time. GenXys founders, including Professors Pieter Cullis and Martin Dawes, were heavily involved in the precision medicine field from the very beginning, and they noticed a functional gap between the expectations and the actual clinical implementation of precision medicine Particularly, when it came to, at the time, the new field of pharmacogenetics. Their solution was to provide a comprehensive, user-friendly platform that organizes all patient data relevant to prescribing to provide the safest and most appropriate personalized prescribing options. Simply put, GenXys’ solutions were made by clinicians, for clinicians. The GenXys software suite collects patient information and categorizes that information, including pharmacogenetic data, based on clinical relevance and runs it through advanced condition -based algorithms to provide real time accurate prescribing options. It makes my life as a clinician easier and safer and gives me the confidence that I am not practicing ‘trial and error’ prescribing. Ideally, every healthcare provider should be using a real time medication decision support solution like ours, and not just for pharmacogenetic test results. Pharmacogenomics is just one piece. In fact, our core product, TreatGx™ can run with or without pharmacogenomics. Let's say that you've run it without pharmacogenomics, meaning that you are using this tool to organize and rapidly identify how biophysical factors, liver function, kidney function, comorbidities, and drug-drug interactions may impact the medication you're about to prescribe to your patient. This functionality alone is incredibly helpful. In fact, the factors I just mentioned likely account for 95% of the reasons why a patient does not respond to a particular medication or might have an adverse drug reaction. But the TreatGx platform will also highlight when the evidence supports bringing pharmacogenomic information into the mix. The right approach is bringing all those relevant clinical, biochemical, and molecular factors closer to the provider which will ultimately foster personalization. We will start treating the individual instead of the disease(s). As with any new technology, there are barriers to precision prescribing. This includes educational and emotional barriers. It’s important to educate providers and keep them up to date to help them understand the power that precision prescribing can bring into their practice—and the limitations—to set the right level of expectation. The Human Genome Project was finished in 2000, and there was a lot of buzz about pharmacogenomics even back in 2003. The field got a lot of traction in 2015. So, everyone thought, "Oh, this is going to be groundbreaking and quite disruptive. From now on my prescription is going to be a hundred percent accurate and safe." But it's not quite the whole story. Pharmacogenomics has to be considered as another piece of the puzzle. It's like saying that by having an MRI, you're curing cancer. It's just another piece of the treatment puzzle. There are also emotional barriers, where ego can factor into a decision. It can be uncomfortable for a physician to say, "I don't know this. Let me check it out. Let me explore it further, review, and come back to you." It's easier to say if I don't know it, that it doesn't work or isn’t relevant, rather than exposing yourself. And so that, in terms of the emotional piece, I would say is a big component. We can tackle the emotional component that element by fostering education and bringing education closer to providers. (more…)
Alzheimer's - Dementia, Author Interviews, Memory, Pharmacology / 12.09.2019

MedicalResearch.com Interview with: James O’Donnell, PhD Dean and professor Pharmacy and Pharmaceutical Sciences University at Buffalo School of Pharmacy Ying Xu, MD, PhD Research associate professor University at Buffalo School of Pharmacy and Pharmaceutical SciencesYing Xu, MD, PhD Research associate professor University at Buffalo School of Pharmacy and Pharmaceutical Sciences     MedicalResearch.com: What is the background for this study? Response: We have been studying cyclic nucleotide phosphodiesterase (PDE), an enzyme, for quite a while as a potential target for neuropsychiatric disease.  One aspect involves the effects of PDE inhibitors on memory.  This was prompted by our earlier finding that one form of the enzyme, PDE4, is in the NMDA receptor signaling pathway in neurons; this pathway has been implicated in memory.  (more…)
Author Interviews, Pharmacology / 17.07.2019

MedicalResearch.com Interview with: Craig A. Pedersen, RPh, PhD, FAPhA Manager, Sterile Compounding and Investigational Drug Service, Pharmacy Clinical Professor University of Washington MedicalResearch.com: What is the background for this study? Response: The ASHP national survey of pharmacy practice in hospitals originated with the Mirror to Hospital pharmacy, the first comprehensive, national audit of pharmaceutical services in hospitals, published in 1964.  Since that time, ASHP has conducted national surveys to document practices and technologies for managing the improving the medication-use system and the role that pharmacist play in that effort.  Beginning in 1998, the national survey became an annual project by ASHP.  This survey provides important information to pharmacists, managers, and external stakeholders to document the current state of pharmacy practice. (more…)
Author Interviews, Melatonin, Pharmacology, Sleep Disorders / 23.06.2019

MedicalResearch.com Interview with: David C. Brodner, M.D. Founder and Principle Physician The Center for Sinus, Allergy, and Sleep Wellness Double Board-Certified in Otolaryngology (Head and Neck Surgery) and Sleep Medicine Assistant Clinical Professor Florida Atlantic University College of Medicine Medical Director, Good Samaritan Hospital Sleep Laboratory Senior Medical Advisor, Physician’s Seal, LLC® MedicalResearch.com: What is the background for this study? Response: Chronic disorders of sleep and wakefulness affect an estimated 50-70 million adults in the United States. The cumulative long-term effects of sleep loss have been associated with a wide range of damaging health consequences, including obesity, diabetes, impaired glucose tolerance, cardiovascular disease, hypertension, anxiety and depression. In terms of preventing health consequences, sleeping 6-8 hours per night consistently may provide optimal health outcomes. Comprehensive data from two recently completed patient-reported outcomes (PRO) studies provide further evidence of the observed hypnotic effects of REMfresh, demonstrating statistically significant improvements in sleep onset, sleep duration, sleep maintenance and sleep quality. PRO studies of this kind, which more closely address real-world patient experience, are increasingly being recognized by regulatory authorities and academia in evaluating new therapies. In addition to the traditional randomized, placebo-controlled trial studies, regulatory authorities are now incorporating the patient perspective in their decision making, including PRO studies. A PRO study is a measurement based on a report that comes directly from the patient about the status or change in their health condition and without amendment or interpretation of the patient's response by health-care intermediaries. PRO measures can be used to capture a patient's everyday experience outside of the clinician's office, and the effects of a treatment on the patient's activities of daily living. Together, clinical measures and PRO measures can provide a fuller picture of patient benefit. REMfresh, the first and only continuous release and absorption melatonin (CRA-melatonin) formulation, is designed to give patients up to 7 hours of sleep support. It is a clinically studied, drug-free, nonprescription, #1 sleep doctor-recommended melatonin sleep brand. (more…)
Author Interviews, Hepatitis - Liver Disease, JAMA, Kaiser Permanente, Pharmacology / 10.06.2019

MedicalResearch.com Interview with: Elizabeth A. McGlynn, PhD Vice President for Kaiser Permanente Research Executive Director Kaiser Permanente Center for Effectiveness and Safety  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: A report from the Institute for Safe Medication Practices based on FDA data and observations from a Kaiser Permanente physician leader raised questions about whether direct acting antiviral medications for the treatment of Hepatitis C posed any significant safety risks for patients. Since the decision to take medications requires making tradeoffs between benefits (which had been clearly established in clinical trials) and risks (which are often harder to ascertain until drugs are in widespread use in the real world) we decided this was an important question to pursue.  We found no evidence of increased risks of significant side effects associated with taking these drugs.  In this cohort study of 33,808 patients in three large health systems we found lower adjusted odds of experiencing the following adverse events:  death, multiple organ failure, hepatic decompensation, acute-on-chronic liver event, and arrhythmia.  (more…)
Author Interviews, Gastrointestinal Disease, Heart Disease, Pharmacology / 31.05.2019

MedicalResearch.com Interview with: Ziyad Al-Aly, MD, FASN Assistant Professor of Medicine Director of the Clinical Epidemiology Center Chief of Research and Education Department of Veterans Affairs Health Care System Saint Louis  MedicalResearch.com: What is the background for this study?   Response: In 2017, we published a paper showing increased risk of death associated with Proton-pump inhibitors (PPI) use. Following the publication of that 2017 paper, several key stakeholders including patients, doctors, research scientists, medical media folks, mainstream media folks, and others asked us: what do these people die from? Did you study causes of death attributable to PPI use? In the study published today, we developed a causal inference framework to answer this question. (more…)
Author Interviews, Brigham & Women's - Harvard, Cancer Research, FDA, JAMA, Pharmacology / 29.05.2019

MedicalResearch.com Interview with: Bishal Gyawali  MD PhD
  • Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts
  • Department of Oncology, Department of Public Health Sciences, and Division of Cancer Care and Epidemiology, Queen’s University, Kingston, Ontario, Canada
MedicalResearch.com: What is the background for this study? What are the main findings? Response: Accelerated approval pathway from the FDA allows cancer drugs to come to market sooner by showing improvement in surrogate measures such as change in tumor size. Surrogate measures do not reflect clinical benefit in terms of living longer or feeling better. So, when a drug receives accelerated approval, the drug is required to undergo a confirmatory trial to confirm that true clinical benefit from the drug actually exists. Last year, a paper from the FDA argued that accelerated approval pathway is working effectively because 55% of such drugs confirmed clinical benefit. However, we saw that most of those drugs were actually improving only a surrogate measure even in confirmatory trials. So the confirmatory trials were not confirming clinical benefit but actually confirming benefit in a surrogate endpoint. We investigate that issue in our study using updated results from the confirmatory trials that were ongoing at the time of FDA review. Our main finding is that only one-fifth of cancer drugs that received accelerated approval actually improved overall survival later in confirmatory trials. For, 20% of other drugs, the confirmatory trials tested the same surrogate endpoint as did the preapproval trial. For another 21%, the confirmatory trial showed benefit in a surrogate endpoint different from the one used in preapproval trial. Furthermore, when drugs fail to confirm clinical benefits in confirmatory trials, they still continue to remain on market.  (more…)