Pharmacovigilance - Science topic

Dear Colleagues,

I am excited to invite you to collaborate on research projects and co-author articles. Currently, I am engaged in a research study on pharmacovigilance. If you have any suggestions or are interested in collaborating, please feel free to contact me.

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?

ORCID ID: https://orcid.org/0000-0002-6770-5916.

What are the label requirements in LATAM cocerning the biosimilars suffix, to differentiate them from the reference biologic?

In what countries is enforced to use the suffix for pharmacovigilance purposes?

Are PV reports based only on IIN ?

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

Type F ADR are due to failure of therapy like lack of efficacy of lithium, then, why there are called adverse when in reality there is no adversity related to it ?

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?

I have difficulties to differentiate between ADE vs ADR, please send me your reply. Thank you.

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.

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)

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.

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?

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?

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?

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?

Which adverse reaction type upset stomach/nausea is considered?

Had Pharmacovigilance proved to be relevant for Ayurvedic drugs yet ?

Has these cases been reported and resolved upto a significant level ??

Specifically in India ??

Can case processing (triage, causality, etc.) of published case reports on a particular drug be considered as research project?

I am looking for an answer to the question with specific examples from practical use.

Looking for any pharmacovigilance associates to answer the question.

I am interested in doing an Information Technology based Pharmacovigilance thesis ??

Would anyone like to suggest ??

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.

May you help me with resources to find Daflon adverse reactions ?

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?

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

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)

Common ones only?

So like the attached image. There should be a purpose behind mentioning rare adverse reactions, otherwise why they would mention it.

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?

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?

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?

I can collaborate, and my field of interest is Pharmacodynamics, Toxicology, and Herbal Medicine.

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

How can we use the LD50 values for calculations of PDE of particular substance ? Pl. suggest. Thanks

Patient-female,1 year 7 month old, with nephrotic syndrome, received cyclosporine,

prednisolone, claritromicine, ferrum

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?

Is there any phospho-protein amoung these proteins below ?:

Bax, Bcl-2, COX-2, NF-kappa B p65, p53. 

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?

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

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.

It would be greatly appreciated if any papers providing information about the surveillance methods and their outcomes could be added. 

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)?

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?

What would be effect of inhibition of osteoblast proliferation when Rheumatoid arthritis patient is administered with DMARD capable of inhibiting osteoblast proliferation?

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?

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.

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? 

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.

Does waterpipe smoking effect on brain weight and volume?

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?

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.

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.

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.

This question is specific to Electronic Medical Records; however I'm interested if such practice exists with the hardcopy Medical Record practice.

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?

one of the main causes of drug-induced hospitalization is upper gi bleeding due to NAIDs

We have a case with possible causality, but I'm struggling to find anything meaningful in the literature.

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.