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Pharmacovigilance - Science topic

Explore the latest questions and answers in Pharmacovigilance, and find Pharmacovigilance experts.
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Im currently working on the thesis project on materiovigilance of ocular medical devices and despite having good theoretical knowledge, the project is not showing any progress. Is there any other approaches for the materiovigilance on ocular medical devices except observing patients for Adverse events using ocular medical devices as Interventions
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@neil Rothman yes i have added the ISO standards and what I'm looking for is aany good approach for the methodology for materiovigilance on ocular medical devices. The most basic one i have found is the number of events by the population. As for the FDA database, I'll use it as well. Thank you for your suggestions
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This has been already more than a half of a year that COVID-19 vaccine is available (Comirnaty). There appears robust data suggesting its safety as obtained from medical event reports from vaccinated people (https://www.ema.europa.eu/en/documents/covid-19-vaccine-safety-update/covid-19-vaccine-safety-update-comirnaty-14-july-2021_en.pdf). However, majority of data is observational and this is difficult to suggest causality. Meanwhile, the randomised controlled trial (RCT) paper, that reported the initial data on Comirnaty ( ), declared a two-year follow-up safety monitoring. And RCT would be indeed an ideal research setting to investigate causality.
Is there any report of long-term safety of Comirnaty (or other) COVID-19 vaccine that is based on RCT results?
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I have difficulties to differentiate between ADE vs ADR, please send me your reply. Thank you.
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this indeed depends on the causality, so without additional information, this will likely classify as an ADR (and this is by definition also and ADE). Commonly the next step is also to assess severity (grading), not similar to seriousness.
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Hello, I am currently working on my project for my thesis in Pharmacovigilance. I found a case when a diabetic patient consumed glimepiride while at the same time he/she had Cirrhosis also CKD. I am confused about how to answer the fifth question, that is, "Are there alternative causes (other than the drug) that could on their own have caused the reaction?". Can I answer these by "Yes" because some resources stated that CKD stage 5 (kidney failure) dan Chirrhosis might cause hypoglycemia but on the other hand some sources stated CKD and Chirrosis as risk factors.
From your perspective should I answer it as a "No" or"Yes" Or "Do not Know"? Thank you, I am looking forward to your reply.
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When the amount of sugar in a person’s blood is too low to provide their body with sufficient energy, it can lead to something called hypoglycemia. Hypoglycemia is defined as a blood sugar level under 70 mg/dl (3.9 mmol/l) and can result in irritability, confusion, and even seizures and unconsciousness during extreme lows.
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I have a question related to severity assessment of ADR and that is if a patient is hospitalized due to some ADR caused by drug and has reported 6 adverse drug reactions for example, neutropenia, pancreatitis, bladder cancer, headache, rash, cough, then how would I be able to tag the ADR or classsify the ADR on the basis of Hartwig and Seigel scale or how would I be able to find that which individual ADR caused hospitalization as there are multiple ADR in practicing?
I have to put the ADR into Level 1, Level 2 and so on. (hartwig and seigel scale)
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Level 2
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As a nurse what is the exact role in pharmacovigilance because nurses are always staying with patients for caring them so how can a nurse assist in pharmacovigilance.
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Please take a look at this useful RG link.
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Is there any website that can tell me when this adverse reaction will occur? For example, will this adverse reaction occur after repeated exposure? Or can occur after first dose? Or can be delayed?
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How can I assess the medication effect on the liver? Should I check the frequency of the adverse event? And if common, go further by checking the mechanism and measures to minimize it? If so, what resource I should check SmPC and USPI or Livertox? Or you check by severity of the injury of the medication? If so, what resource do you use to assess the severity of injury caused by the medication?
For example, what will be your approach if I assigned you clindamycin? What will be your comment if my Q is, is Clindamycin entirely safe medication if the liver is the only organ in Q?
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Mostafa Elsersy The CIOMS/RUCAM scale is a tool to predict whether liver damage can be attributed to a particular medication.
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When do you go the medical literature (primary - journal articles) instead of going to well known databases like Lexicomp, PDR, etc..with regard to adverse reactions/effects?
Is it when you check OTC medications? Herbal Medications? Or what?
The data of castor oil are conflicting unfortunately! And I'm not sure if it is safe or not!! What is your recommendation?
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The medical literature may be an earlier reporting of new outcomes, positive and negative.
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If I want to gather all signals that mention hepatotoxicity of a specific medication, which database to check? Pubmed? Any other database that save reports of consumers?
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Milena Miljkovic (miljkovic.milena57@yahoo.com):
First, you need to have one or more case-reports with one medicine that suggests DILI that is not included in the product information (unlisted/unexpected), and presents potential signal. After that, you have to perform signal validation, using the traditional method: „analysis of similar events“, and to review all recorded similar cases (with the same medicine) in the safety database. During the signal validation and evaluation, you can perform also PubMed search of scientific literature, to investigate further whether you have sufficient evidences to confirm the potential signal (i.e. to confirm causal relationship between the medicine and liver injury). If you don’t have sufficient evidences, this potential signal can be considered as ongoing signal for re-evaluation in the next reporting period. However,if you obtain sufficient evidences this potential signal can be considered confirmed signal and newly identified risk. For further information related to signal detection, please see EMA - GVP Module IX, and other relevant docments available at EMA website).
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Which adverse reaction type upset stomach/nausea is considered?
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I fully agree with this, as stated in my first and second answers.
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Had Pharmacovigilance proved to be relevant for Ayurvedic drugs yet ?
Has these cases been reported and resolved upto a significant level ??
Specifically in India ??
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The major goals of pharmacovigilance is to improve patient care and safety in relation to drug use, and thus promote rational drug use. Commercialization of Ayurveda medicine has brought with it many challenges about safe use of ayurvedic medicines, bringing into focus the need for formal pharmacovigilance programs in the field.
And yet, the number of adverse reactions to ayurvedic drugs reported or recorded in the National Pharmacovigilance Program in India is negligible. The strong belief that ayurvedic medicines are safe contributes to a large extent to this situation. To compound this matter is the lack of knowledge about the concept and importance of pharmacovigilance in ayurveda among ayurvedic practitioners.
Few recent publications may be referred:
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Can case processing (triage, causality, etc.) of published case reports on a particular drug be considered as research project?
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Yes.
Why not?
Plz refer ..... Shang N, Xu H, Rindflesch TC, Cohen T. Identifying plausible adverse drug reactions using knowledge extracted from the literature. J Biomed Inform. 2014;52:293-310.
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I am looking for an answer to the question with specific examples from practical use.
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Looking at statistical signals are important but might not be relevant to countries with small databases. Thus, in Eritrea we do weekly case-by-case assessment of individual case safety reports. We do this in collaboration with our Volunteer Pharmacovigilance Medical Officers. Once, we identified a potential safety signal during the assessment, we assign staff to work on it.
As mentioned by Didier, we first need to check if the adverse event of ineterest is not documented, if we are working with a new ADR, by looking at the SPC of the product in the reputable webpages like USFDA, MHRA, EMA and so on. Moreover, we try to do exhaustive literature review to check labeledness. Once, we confirm that the adverse event is undocumented or incompletely documented, we do search on Vigiflow and Vigilyze (VigiBase) to see if there are similar reports. It is at this stage, where we try to see if there is a statistical signal as well (IC value). But, if you simply wait to see statistical signals, which are not a true signal, you will miss several important safety issues and/or may take you time to identify it.
We then try to export the cases to excel spread sheet and do cases series assessment using Austin Brad-Ford-Hill Criteria. For countries with small databases, we found this as a best practice we are able to identify dozens of safety signals only in the last three years. By doing this, we identified many safety signals triggered by one case report submitted to the Eritrean Pharmacovigilance Centre.
I would be very much interested to hear thoughts from other countries too.
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Looking for any pharmacovigilance associates to answer the question.
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Softwares like Argus, ArisGlobal, and PvNET are used in Pharmacovigilance. VigiFlow, VigiBase were used in post marketing surveillance
VigiBase is a WHO's global Individual Case Safety Report (ICSR) database that contains ICSRs submitted by the participating member states enrolled under WHO’s international drug monitoring programme.
Uppsala Monitoring Centre (UMC) in collaboration with ‘’Swissmedic’’ has developed ‘’VigiFlow’’, a web-based ICSR management system. VigiFlow functions as a national ICSR database management system and analysis tool, through which cases are sent to UMC.
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I am interested in doing an Information Technology based Pharmacovigilance thesis ??
Would anyone like to suggest ??
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I presume the thesis (research) topic is to pursue your masters or doctoral degree program. Duration of your studies is one of the important factor that influences your choice of topic. Also while we choose a topic for research keep in mind that the findings of the research work are applicable to the local needs and we should be able to put into practice. That means need for the study from what you derive your study objectives, should be guided by the local needs. This is very much true in any field of research.
Narrowing down to research in PV, if you are a healthcare professional or would like to do research in a healthcare set up the topics you choose should be healthcare focussed. It is also possible to do data mining if you have access to a large dataset to answer the questions raised by Rimple. In this way you are helping to convert the data to information, Information to knowledge and this knowledge should be applied in daily practice for better patient care. The ultimate goal of PV is to promote safe use of medicines.
You could also explore how we can use information technology to improve ADR reporting by healthcare professionals and patients. Communication in PV is a challenging area. How information technology can be used to address this issue may be of interest to all working in this area.
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I am a fresh graduate in MD Clinical Pharmacology from Nepal, working in one of the medical colleges here.
Our department is interested in starting PVP in this college but we are uncertain about how to start. Some of our ideas are:
1. Do a baseline study to see how many reports can we generate in one year period.
2. Develop a SOP for ADR report collection
3. How to report the information to UMC. Here we have 2 options: obtain a Vigiflow account, OR be a part of the National PV reporting system.
So it would be really appreciable if you could share the experiences of your department for the same.
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The biggest challenge with pvp centres in to get adrs from clinicians... there are two reasons for reluctance of clinicians to re adr:
1. Misconception that adr reporting can harm them .. they could be held responsible for occurrence of adr
2. They are busy and they dont think adr reporting is important
both these issues can be addressed by having frequent adr reporting sensitisation sessions.
other important thing that can help is to have good social repo witt clinicians
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May you help me with resources to find Daflon adverse reactions ?
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I am to some extent related with the topic. My personal idea is that scientific research in that aspect is not sufficient.
I suppose that there may be no such facility to check ADR of so called natural products.
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I'd like to know how far should I go with regard to the effect? For example, we know that bisoprolol reduce the heart rate, so, lets assume this is the only known effect that has been shown through studies. So, based on this piece of info, should I conclude other parameters to assume safety of this medication, like I may conclude it will affect the blood pressure, etc..? Or only this piece of info, along with adverse reactions sufficient for safety? I'm interested to know this, because natural products aren't subjected to many studies, so the only available data are just few pieces of info. So, when considering safety for any natural product, will I have to conclude other facts based on the known effect? or the only known piece of info.along with the adverse reactions are sufficient for safety?
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Yes, they are requested for the pre-clinical trials.
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I'm not sure why d they mention rare adverse reactions? Any idea, of what purpose does this serve? Like here in the case of Cetirizine
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When a side effect is listed as “common,” what does that mean? What are the odds of a “rare” side effect happening to me? It was news to me that these terms are actually very specific. The World Health Organization (WHO) defines categories as:
  • Very common means 1 in 10 — 1 out of every 10 people (or more) taking that medicine will experience that side effect.
  • Common means more than 1 in 100 — between one in 10 and one in 100 people are affected
  • Uncommon means more than 1 in 1,000 — between one in 100 and one in 1,000 people are affected
  • Rare means more than 1 in 10,000 — between one in 1,000 and one in 10,000 people are affected
  • Very Rare means more than 1 in 10,000+ — fewer than one in 10,000 people are affected
I found these definitions to be comforting. After all, a rare effect that happens to 1 in 1,000 to 10,000 seems safe. Then I pulled out my calculator. As an example, Crestor is one of the most prescribed drugs in America, through June 2015. It “rarely” causes liver damage (among other things). 21 million prescriptions for Crestor were written from July 2014-June 2015. Doing the math reveals that it’s possible that between 2,100 and 21,000 people in the US suffered new onsets of liver damage from taking Crestor each year.
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We know that natural products aren't regulated by the FDA, so when checking the safety of natural products/Herbs, should I check for adverse reactions and toxic dose only? Or should I also check for carcinogenic capability? Or carcinogenic capability will be listed as a default under adverse reactions? (I mean whether this product is carcinogenic or not)
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Natural products are a very important class of medicinal drugs. Roughly 25% of all drugs are derived from natural sources. For your particular product, a good starting point would be the products history. If people have been taking this product for many centuries (eons?), then the risk of adverse effects is very low. However, standard toxicity tests and carcinogen tests should be performed. Beyond this, I would recommend testing for heavy metals and persistent environmental toxins (pcbs, etc.). Also, there are requirements in the US for vitamins (not sure how much supplements apply). These are listed in the DSHEA standards.
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Common ones only?
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You do not specify any particular drug, which is understandable given the number of drugs to consider, so I would offer this general advice. You should inform the patient about possible harmful or dangerous side effects, anything that would affect the efficacy of the medication, and either inform or question about circumstances that would increase the likelihood of an adverse event or lessened medication effectiveness.
For instance, you should inform the patient about side effects that can be harmful (drowsiness, seizures, rash and/or allergic or anaphylaxis, tachycardia, fainting, nausea, etc.).
Also, the best regimens... take with food or on an empty stomach, finish all of the medication, what to do if you miss a dose, etc.
Finally, anything that affects the above. For instance, don't take an antidepressant with certain cold medications (with antihistamines, alcohol as a solvent, etc.). Also, check previous prescriptions for interactions and tell them, even if the prescription is old. (Some patients keep old meds around for a rainy day.) even if you think the patient does not have another med around, verify and/or warn the patient to be careful.
Also, when informing about side effects, tell the patient the symptoms and/or warning signs that he/she should recognize as a possible problem, and what to do. (Call the pharmacist, MD, go to the emergency room for certain symptoms, etc.)
These are all patient, profile and drug specific of course. The role of the pharmacist is to look for potential problems and educate the patient on how to avoid problems, how to react to them, and how to best use the medication for maximum safety and effects.
Hope this helps!
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So like the attached image. There should be a purpose behind mentioning rare adverse reactions, otherwise why they would mention it.
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The frequency (whether rare or very rare) speaks to how likely the adverse effect is to be a problem. If an adverse event is rare/very rare, then the benefits of the drug is likely going to outweigh the risk. This is especially when the disease condition is serious.
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In other words, which websites list the adverse reactions of the drugs instead of listing the adverse events (no causality established)? I know of https://www.medicines.org.uk/emc/ which lists SmPC, any other websites?
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LexiComp is the as it give an up to date information and I find very handy and user friendly.
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Reference that can list side effects according to cause & effect relationship, so I can know with certainty that this drug will be the cause of the side effect. Do you use Meyler's Side Effects of Drugs as your reference?
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Micromedex®
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Why most websites report frequency of adverse reactions of drugs(In terms of common, rare, etc..)? Does this indicate causal relationship? Like common adverse reactions is established to be induced by the drug and not as an adverse event? Like here in the case of cetirizine or reporting the frequency serves another purpose?
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CIOMS generally gives this classification :
  • Very common ADR occurs in more than 1/10 patients who take the drug
  • Common (frequent) > = 1/100 and < 1/10
  • Uncommon (infrequent) >= 1/1000 and < 1/100
  • Rare >= 1/10000 and < 1/1000
  • Very rare < 1/10000
The frequency of ADR is often determined during the clinical trials, although clinical trials are more designed to assess efficiency than to detect side effects (as clinical trials do not include more than 3000, it is for example impossible to see very rare ADR).
During those clinical trials ADR are assessed with an imputability method, as it is done in real life with pharmacovigilance.
When a patient has a symptom, those data helps health professionals to see if it could be or not an ADR, and if so stop or not the drugs if needed (and ask an expertise).
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I can collaborate, and my field of interest is Pharmacodynamics, Toxicology, and Herbal Medicine.
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Hi Kim, I don't have much info. in this field, but I can collaborate with you on this project. You can assign me the points needed, and I'll work on it.
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Discuss the suitability of current regulations for biotechnology medicinal products globally under the following four topics:
(i) Fitness for purpose
(ii) Impact on, and response to innovation
(iii) Impact on the access of medicines to patients
(iv) Any other suitable topic(s)
You should provide, where relevant, examples and identify the regulations
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Thanks Bruce :)
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Patient-female,1 year 7 month old, with nephrotic syndrome, received cyclosporine,
prednisolone, claritromicine, ferrum
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Both of edema and inflammation should be decreased by corticosteroids. I suppose the local iritation of mucosa and diarrhoea caused by iron and clarythromicine.
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I have an issue in analyzing the graph to determine the IC50 for drug A and C which are categorized as a mitotic inhibitor and B is HDACi. I know the possible reason is could be mitotic slipage but I have no idea how to determine the IC50. I have repeated the experiment to make sure it was not caused by technical mistake. Graphpad has the function to calculate the EC50 for biphasic model but I do not really understand the output of the results because when I calculate the log EC50 given by graphpad, somehow it did not make sense. This was because the adjusted/trendline/best fit line did not show a clear cut of IC50. Is this correct for biphasic or any other way to go about calculating the IC50. The mitotic inhibitor has been found to be biphasic on a few papers I have read. But no mention of IC50. They only mentioned that there are 2 range of inhibition/ stimulation. Should I split the graph for each mitotic inhibitor and calculate IC50 manually? Low and high range IC50. Or did I get it wrong using biphasic model?
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Hi Reagen,
Can't offer too much help about the assays, but biphasic will not work for your data (biphasic needs the drugs at similar effects at both curves, e.g. 100% to 50%, then 50% to 10%), as your drugs appear to have opposing functions at various concentrations (e.g. drug A at high nM conc appears to offset its own effect at low nM conc). A possible better model will be bell curve (http://www.graphpad.com/guides/prism/7/curve-fitting/index.htm?reg_bellshaped_dose_response.htm), which will give you EC50 1 and 2.
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Is there any phospho-protein amoung these proteins below ?:
Bax, Bcl-2, COX-2, NF-kappa B p65, p53. 
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Thank you Mr.Solano.
Regards,
Mustafa
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Actually as per BCS classification system acyclovir 200 mg tablet consider as BCS class III and 800 mg tablet Class IV , is there any paper proved as 800 mg tablet is has less solubility?
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Since the oral bioavailability of drug is only 10-20% anyway, the FDA is just saying that you have maxxed out the intestinal uptake with 200 mg. Since sodium acyclovir is soluble to 50 mg/ml in water (IV stock solution preparation), obviously it's not a solubility issue per se (i.e., if you don't dissolve all 800 mg in your medium, it won't matter in terms of amount absorbed in vivo).
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Hi everyone, I am trying to find out if there some sort of correlation between LD50 and LOEL of a certain compound. Is there a rationale behind the thumb rule that the 10% of LD50 can be considered as a LOEL? If yes, could you please indicate the references? Thank you in advance
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I think the rationale is pretty simple - if you don't have the data for the LOEL, you can make a very rough calculation of it using the LD50 as above, but this is just an estimate. As such, this doesn't imply any correlation between the LOEL and LD50 - it's just using the LD50 as a substitute in the calculation, because the LD50 is easier and cheaper to determine. In reality, this calculation is often going to be very different from what you would determine if you quantified the LOEL experimentally. Because drugs can often bind to multiple receptors/enzymes in the body, the receptor which is responsible for the LD50 can be completely different to that which is responsible for the LOEL. A good example is thalidomide, where the sedative effect which is responsible for the LD50 is mediated through an entirely different mechanism than the teratogenicity (birth defects).
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How can we use the LD50 values for calculations of PDE of particular substance ? Pl. suggest. Thanks
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Nothing I can cite, no. But I haven't found a contradiction yet, although it may exist. I learned it from a professor in grad school as a good place to start if no experimental data existed. There are compounds where the safe acute dose is much higher fractions. That could be an interesting survey to do over different classes of materials and worth a publication. If there is an exception, I would hazard a guess it might be found in some venom components perhaps.
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The sample size for the BE is directly poportional with power. However, the proposed/accepted power ingeneral is 80-90%. Consideration of power more than 90 % may end up the issue of ' 'Forced Bioequivalence' by regulatory.
Can any one please explain clearly the term 'Forced Bioequivalence' associated with larger larger sample size due to high power consideration?
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I am currently undertaking my PhD on drug combination against nasopharyngeal carcinoma, NPC. I am screening various targeted therapies and chemotherapies with aim to come out with the best synergism activity. I have found possible drug combination that synergized but what about drugs that antagonized each other? I would like to know if antagonized combinations are worth to be looked into? It may help to further understand the mechanisms of NPC other than just focusing solely on synergism.
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 Thanks for the paper suggestion Ali. I have more than 10 drugs (targeted therapies n chemodrugs) with top 3 drugs selected as core drug in combination with the rest of the drugs based on their selectivity index. I tested on 2 NPCs cell lines so far. Narrowing down the best combination with high synergism on both cell lines. It's just that I feel it would be such a waste of months hardwork if i just ignore the antagonize combination although my study aims to determine best combination. The only thing that I can think of for now is antagonized combination also provide in depth information on NPCs survival/resistance mechanism. Negative results are still results.
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It would be greatly appreciated if any papers providing information about the surveillance methods and their outcomes could be added. 
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Pharmacovigilance is a series of actions and activities that are part of patient safety, it is one of the main tasks of the World Health Organization (WHO) in the care of patients when drugs are used that cause adverse reactions that can endanger the lives of people.
Pharmacovigilance started in Mexico in 1995 when the Ministry of Health (Health Authority) implemented the Permanent Program of Pharmacovigilance, which is responsible for collecting, investigating and assessing information on the effect of drugs, biological products, herbal remedies and medical devices, in order to identify new adverse information, to know the frequency and prevent possible damage to the population that uses them. This worldwide program had already begun since the sixties years of the last century with the "Thalidomide Disaster".
From this background to the present, it has come a long way on the road to the ideal goal. There are a lot of reports in the medical literature, own and shared with many countries of the world experiences and strategies, methods and instruments that have implemented the various ministries of health at the international level to fulfill the mandate of WHO in the safety of patients using drugs to prevent, cure or control diseases that afflict the world's population.
In the attached file documents published on the subject, with detailed information on strategies, methods and tools related to pharmacovigilance, of which perhaps the most important instruments is to know or recognize their achievements, strengths and limitations in order to make proposals to improve if the case.
Cheers
Sincerely
Dr. Jose Luis Garcia Vigil
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I have  a cross sectional study with two time point (two patient visit) BP measures and other related variables.Can you suggest me analytical method to see association between hypertension(controlled yes/no; SBP and DBP) and predictor variables (categorical or continuous)? Can I use logistic regression? For the continuous predictor variables? would be nice to use linear regression instead of logistic regression(as far as they fulfill the assumptions)?
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Thank Jones.
Your approach is indeed better than mine. As you said, my approach would make loose information in some way.
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I have examined a paper put out by ISPOR for a general overview. For specifics, I have searched through the FDA databases without making much headway on what types of methodologies were employed in evaluating the safety/efficacy/benefit/risk of a drug for approval. I'd like to look at both approved and failed drugs at each stage of the clinical process. Is such information available on any database? I would greatly appreciate your advice.
Thank you
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Hello,
In 2013 the FDA published the following draft plan "Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making "http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM329758.pdf
I am not sure of the progress they have made since but it may be worth filing an FOI or contacting the authors.
Best Regards
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The UMC provide a Guidelines for setting up and running a pharmacovigilance centre, is it enough in resource-limited country hospital setting? Are there others considerations? I am looking for your opinion about it and documented experience if it is possible?
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The policy makers ( central authorities) should principally agree or be convinced that implementation of PV system will not only include ADR monitoring but also  prescription monitoring, medication errors, promote rational use of medicines, implement and adhere to standard treatment guidelines.
This all will result into cost saving and improve health care services with optimal use of country's resources.
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What would be effect of inhibition of osteoblast proliferation when Rheumatoid arthritis patient is administered with DMARD capable of inhibiting osteoblast proliferation?
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In Rheumatoid arthritis, the inflammatory cytokines (TNF alpha, IL1, IL17 etc)  inhibit osteoblast proliferation and promote osteoclast differentiation. This causes bone erosions & periarticular osteopenia locally and generalised osteoporosis at distant sites.
The effect of inflammation in negatively affecting bone loss is very high. Almost all DMARDs have a salutatory effect on bone health by reducing this inflammation. Though invitro studies show that there is some deleterious effect on osteoblast proliferation, this effect is very small compared to the deleterious effects of inflammation itself. Thus, in clinical terms, the net effect is positive by stopping the bone loss or at least reducing the rate significantly.
The newer Biologic DMARDs like the TNF inhibitors (Infliximab, etanercept etc) have even shown reversal of bone erosions in a few studies (by MRI imaging) and possibly have a more positive effect on bone health than the non Biologic DMARDs like methotrexate. 
Hope this helps
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In case of adverse drug reaction study, there is no control group and only the patients use the drug. After using the drug, some patients show some adverse drug reactions and others do not show these. We have now he genotyping data, patient subgroups depending on the different adverse drug reactions and odds ratio. Due to the division of the patients in different subgroups, the number of patients in each group is not very large. Now how can I prove that my sample size meets the 80% statistical power? Is there any special method of power calculation for the Pharmacogenomics adverse drug reaction?
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You can estimate the sample size according to your information about the population which the sample will be taken from it :
Sample size from finite population can be estimate by :
n= N / ( 1+ N * e^2 ) 
and from infinite population by :
n= ( Z^2 * S^2) / E^2
where : Z  ( 1.96 for 0.05 and 2.58 for 0.01 )
S = standard deviation from previous studies or pilot  study
E = significant level 
Also, you can use software to calculate sample size ( SPSS , Minitab , Gpower )
The key component to estimate sample size ( when we fixed the other ) is variance of the trait , when the study include many traits , we depend on the trait of higher variance which give us estimation sufficient sample size suitable for other traits.
I hope that be useful for you 
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I would like to know what is the best approach between prevented number of cases for every 1000 vaccinated individuals and the decreasing lethality of cholera in the vaccinated region when it comes to assess the Oral Cholera Vaccine Efficacy during a mass vaccination campaign in Sub Saharan Africa.
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It might be a ''before-after" study. Incidence rate of cholera using person-time determined before (risk in exposed) and after (risk in unexposed) vaccination campaign can be compared. The number of preventable cases is calculated as follows : number of person-time in exposed group * risk difference.  The etiologic fraction in exposed to assess the vaccine efficacy is : (RR-1)/RR = (number of preventable cases)/(number of cases in exposed group = (risk difference)/(risk in exposed).
NB : RR = risk ratio.
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Lot of practitioners use alternate day statins in patients unable to tolerate daily statins. I feel there is no pharmacological or physiologic basis for the same.However lot of patients complain of weakness and myalgia with regular statin use and inability to tolerate in-spite of compelling indications.I would like to know if there is any scientific basis for alternate day statin use? 
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I would like to see larger scale trials (and comparative graphs) before forming an opinion, but alternate day dosing does look like a possibility, based on the limited AJM data, and an extended secondary phase pharmacologic profile. Actually, I am already conducting a personal trial, as I experience myalgia occasionally on 20 mg/day simvastatin, and have reduced it to alternate days. Great question, Anil. 
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Although community pharmacy and dispensing pharmacy are basic role of pharmacists but the training and implementation of community pharmacy at institutional level is not well considered. I would like to know what may be the reasons behind for not having such things in the college, students often referred to local community pharmacies to get trained, but a institution has their own community pharmacy shop this can help the students to train and also can generate a trustful revenue to the institution.
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the role of a pharmacist in India is not very clear. Dispensing any drug was done at a time when there was formulations but not now.
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Does waterpipe smoking effect on brain weight and volume?
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Thanks Halboob for your elaboration. I'm indeed aware of the effect of smoking on cognitive function, however the growth restriction hypothesis seems to be in the case of pregnant women smoking and the effect here would be encountered on the intrauterine fetal growth in general and the brain in particular. On the other hand, most of literature show that the brain is not fully matured until around the age of 25, so smokers might still be affected, yet more research needed to establish this association in humans. 
My question to you is, why would you think smoking by different method might affect the brain differently (frequency, patterns, chemical components) and how is that significant for smoking cessation efforts and public health?
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ADR reporting may become a redundant, monotonous and boring activity for faithful reporters if pharmacovigilance centers do not constantly stimulate reporters’ interest. How can PV centers best achieve this?
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Try the followings for healthcare professionals:
- Create a newsletter/formal professional publication in which you include the reported ADR.
- Split the national center into regional centers and delegate all the activities to the regional centers and hence you have a direct or better communication terms.
- Update your frequent reporter(s) with the ADR documented/reported globally by reliable organization.
- Educate reports on ADR terminology and other related issues.
- I’m sure it’s more difficult for public, but yet try to provide feedback on their specific disease, but it’s really difficult.
- Take a glance on the book described by UMC,
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There is no pharmacovigilance centre in my state, which is a malaria endemic zone. I want to get one on board. I would need to develop some hands-on training, as well as learn how to relate with and manage the personnel that are involved in the hospital setting.
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Do not use the pharmacovigilance tools available in the countries where malaria is prevalent. Mostly in such places they do not need such tools. Anyway, I would recommend the one supplied or certified by WHO centres in other parts og the world.
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I am intending to do a postmarket surveillance of the Combined Oral Contraceptive pill which contains ethinylestradiol and levonorgestrel. a common brand being the Bayer Microgynon. I will be collecting samples from the Nyeri Town of Kenya. The samples will be analyzed for uniformity of weight, assay and dissolution at the National Quality Control Laboratory here in Kenya. In that regard, i would like access to papers on such postmarket surveillance activities carried out in the past. Thanks.
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You are talking about Phase IV clinical research of the drug which is a research component in the field of pharmacovigilance or safety surveillance. You can use some key words (for example: pharmacovigilance + drug name, Phase IV clinical study+drug name, safety surveillance+drug name etc...) and do some search in PubMed database or in Google Scholar.
Best of luck!
Regards.
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What are the evidences to be attached while reporting a case, and how it differs from normal case studies? Please justify
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Yes, case reporting is part of pharmacovigilance. Apart from describing an adverse drug reaction observed, you can go further to investigate the effect on other organs or corresponding markers in the blood or urine. Case reports will also give details on how the reaction was managed i.e withdrawal of the suspected drug and prompt normalization of blood and urine parameters.
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In my daily practice, I have seen many people reporting ADR's without a causality assessment and even few were reported without clinically observing the patient. Is this appropriate? How do we overcome these obstacles for better results? Please help the reporters in overcoming such barriers with your suggestions.
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Just a quick point of vocabulary: adverse events (AEs) are reported, and these AEs are then assessed to identify ADRs. Not all AEs are ADRs. The same goes for most published studies, whereby the authors lists all events and then assess their causality.
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Some distress related to administration of Azithromycin.
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Hi,
There are many cases I came across...
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Efavirenz is known to cause CNS effects. Symptoms resolve within 3 to 6 months but in some patients may persist until efavirenz is substituted for nevirapine.
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Interesting question. It goes hand in hand with the fact that Interferon alpha given treat people with hepatitis C makes around 40% of them develop a full blown major depressive episode. These are people who never had psychiatric problems in their lives. We believe it is a clinical model for inflammation-induced depressive symptoms a theory we work a lot in my lab.
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This question is specific to Electronic Medical Records; however I'm interested if such practice exists with the hardcopy Medical Record practice.
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I inform my patients when I am changing interventions based on evidence-based reasoning. I sometimes read aloud (with vernacular English translations) the relevant research to increase their engagement in their healing process. I record the citations in my chart notes. I don't use electronic reporting. However, I am also not a physician!
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Drugs have unwanted effects, which may be as small as a headache, but these effects often go unreported. Why is this the case? Is it time/money/ease of reporting/unawareness?
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In my setting the most common reason for not reporting ADRs is lack of time or incentive to fill out the forms. Generally no feed back is given after reporting and health workers lose incentive.
See attached article that outlines some of the most common barriers to reporting of adverse drug reactions.
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one of the main causes of drug-induced hospitalization is upper gi bleeding due to NAIDs
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OTC drugs fill in a void in developing countries where the patient may be unable to have access to a doctor.Going to a doctor for a headache or menstrual cramps may not be possible for patients at all hours. It goes without saying that the regulatory enforcement regarding the prescription only drugs should be very strict, though. As regards paracetamol, it is sold as an OTC drug in most countries. It has been found however, that it is one of the commonest causes of liver toxicity. Moreover, paracetamol overdose can be more dangerous in alcoholics. Limiting the pack size has been seen to reduce the incidence of overdose.
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We have a case with possible causality, but I'm struggling to find anything meaningful in the literature.
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Perhaps this will be of relevance to your case. http://www.ncbi.nlm.nih.gov/pubmed/17116619
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As the Doctor of Pharmacy is the emerging profession in branch of Pharmacy. I wish to know where exactly the Pharm.D can fit. As many people say many words of carrier... But eager to know what a Pharm.D graduate can do the best as specific to his professional skills exclusive to the Pharm.D
As in India, there are many P.G branches available as M.Pharmaeutics, M.Pharmacology, M.Pharmacy Practice, M.Clinical Pharmacy and M.Clinical Research etc. Every speciality has their own role to play in Patient care and Industry too. But what exactly the role of Pharm.D can be different from that of these speciality branches.
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I feel the 'Doctor of Pharmacy' is an appropriate professional degree in pharmacy which is started with a long delay in India. It can be bright career option in the field of Hospital Pharmacy, Clinical Research, Pharmaceutical and Drug Administration, Pharma-Academia, Rural Healthcare,and Pharmaceutical Care Research and Consultancy. But This could be possible only if Pharmacy Council of India dare to take some strict steps in active coordination with CDSCO and Ministry of Health and Family Welfare. Recently MCI announced to introduce B.Sc in Community Health programme which may cause great decline in interest to Pharm.D. programme as the said B.Sc. degree holders are suppose to practice in rural healthcare units, PHCs, and CHCs -- why not our pharmacy council take and active step to demonstrate the suitability of Pharm.D. course which hasalready been started in several Universities, to be a substitute of B.Sc - Community Health Proposed. By doing this lacks of jobs can be created exclusively for Pharm.d. and Pharm.D. (PB).