Zika virus infection – India
On 15 May 2017, the Ministry of Health and Family Welfare-Government of India (MoHFW) reported three laboratory-confirmed cases of Zika virus disease in Bapunagar area, Ahmedabad District, Gujarat, State, India.
The routine laboratory surveillance detected a laboratory-confirmed case of Zika virus disease through RT-PCR test at B.J. Medical College, Ahmedabad, Gujarat. The etiology of this case has been further confirmed through a positive RT-PCR test and sequencing at the national reference laboratory, National Institute of Virology (NIV), Pune on 4 January 2017 (case 2, below). Two additional cases (case 1 and case 3), have then been identified through the Acute Febrile Illness (AFI) and the Antenatal clinic (ANC) surveillance. The cases are reported below in chronological order:
Case 1: During the Acute Febrile Illness (AFI) surveillance between 10 to 16 February 2016, a total of 93 blood samples were collected at BJ Medical College (BJMC), Ahmedabad, Gujarat State. One sample from a 64-year-old male presenting with febrile illness of 8 days’ duration (negative for dengue infection) was found to be positive for Zika virus at BJMC, Ahmedabad. This is the first Zika positive case reported through AFI surveillance at BJMC, Ahmedabad, Gujarat State.
Case 2: A 34-year-old female, delivered a clinically well baby at BJMC in Ahmedabad on 9 November 2016. During her hospital stay, she developed a low grade fever after delivery. No history of fever during pregnancy and no history of travel for the past three months was reported. A sample from the patient was referred to the Viral Research & Diagnostic Laboratory (VRDL) at the BJMC for dengue testing and thereafter found to be positive for Zika virus. She was discharged after one week (on 16 November 2016). The sample was re-confirmed as Zika virus positive by RT-PCR and sequencing at NIV, Pune.
Case 3: During the Antenatal clinic (ANC) surveillance between 6 and 12 January 2017, a total of 111 blood samples were collected at BJMC. One sample from a 22-year-old pregnant female in her 37th week of pregnancy has been tested positive for Zika virus disease.
Public health response
National Guidelines and Action Plan on Zika virus disease have been shared with the States to prevent an outbreak of Zika virus disease and containment of spread in case of any outbreak.
An Inter-Ministerial Task Force has been set up under the Chairmanship of Secretary (Health and Family Welfare) together with Secretary (Bio-Technology), and Secretary (Department of Health Research). The Joint Monitoring Group, a technical group tasked to monitor emerging and re-emerging diseases is regularly reviewing the global situation on Zika virus disease.
All the international airports and ports have displayed information for travellers on Zika virus disease.
The airport health officers along with airport organizations, National Centre for Disease Control, and the National Vector Borne Disease Control Programme are monitoring appropriate vector control measures in airport premises.
The Integrated Disease Surveillance Programme (IDSP) is tracking for clustering of acute febrile illness in the community.
In addition to National Institute of Virology, Pune, and NCDC in Delhi, 25 laboratories have also been strengthened by Indian Council of Medical Research for laboratory diagnosis. In addition, 3 entomological laboratories are conducting Zika virus testing on mosquito samples.
The Indian Council of Medical Research (ICMR) has tested 34 233 human samples and 12 647 mosquito samples for the presence of Zika virus. Among those, close to 500 mosquitos samples were collected from Bapunagar area, Ahmedabad District, in Gujarat, and were found negative for Zika.
The Rashtriya Bal Swasthya Karyakram (RBSK) is monitoring microcephaly from 55 sentinel sites. As of now, no increase in number of cases or clustering of microcephaly has been reported from centers.
Sunday, 28 May 2017
Friday, 19 May 2017
Medicine line is one where dead teach the living
Nicely written (taken directly from BD Chaurasia's Human Anatomy 6th edn.)
'Thus spoke the Cadaver
Handle me with little love and care,
As I had missed it in my life affair,
Was too poor for cremation or burial,
That is why am lying in dissection hall.
You dissect me, cut me, section me,
But your learning anatomy should be precise,
Worry not, you would not be taken to court,
As I am happy to be with the bright lot.
Couldn't dream of a fridge for cold water,
Now my body parts are kept in refrigerator,
You do students sit around me with friends,
A few dissect, rest talk, about food, family and movies,
How I enjoy the dissection periods,
Don't you? Unless you are interrogated by a teacher.
When my parts are buried post-dissection,
Bones are taken out of the skeleton,
Skeleton is the crown glory of the museum,
Now I am being looked up by great enthusiasm.
If not as skeletons as loose bones,
I am in their bags and in their hostel rooms,
At times, I am on their beds as well,
Oh, what a promotion to heaven from hell.
I won't leave you, even if you pass anatomy,
Would follow you in forensic medicine and pathology,
Would be with you even in clinical teaching,
Medicine line is one where dead teach the living.
One humble request I'd make,
Be sympathetic to persons with disease,
Don't panic, you'll have enough money,
And I bet, you'd be singularly happy.'😊😊😊
'Thus spoke the Cadaver
Handle me with little love and care,
As I had missed it in my life affair,
Was too poor for cremation or burial,
That is why am lying in dissection hall.
You dissect me, cut me, section me,
But your learning anatomy should be precise,
Worry not, you would not be taken to court,
As I am happy to be with the bright lot.
Couldn't dream of a fridge for cold water,
Now my body parts are kept in refrigerator,
You do students sit around me with friends,
A few dissect, rest talk, about food, family and movies,
How I enjoy the dissection periods,
Don't you? Unless you are interrogated by a teacher.
When my parts are buried post-dissection,
Bones are taken out of the skeleton,
Skeleton is the crown glory of the museum,
Now I am being looked up by great enthusiasm.
If not as skeletons as loose bones,
I am in their bags and in their hostel rooms,
At times, I am on their beds as well,
Oh, what a promotion to heaven from hell.
I won't leave you, even if you pass anatomy,
Would follow you in forensic medicine and pathology,
Would be with you even in clinical teaching,
Medicine line is one where dead teach the living.
One humble request I'd make,
Be sympathetic to persons with disease,
Don't panic, you'll have enough money,
And I bet, you'd be singularly happy.'😊😊😊
Wednesday, 17 May 2017
50% of Indian doctors have hypertension
A study, conducted by the Indian Medical Association found that 56% of doctors suffered from irregular BP at night and 21% from masked hypertension.
More than 50% physicians have been found to have uncontrolled hypertension or high blood pressure (BP) despite taking hypertensive medicines, owing to high-stress levels, says a study.
Hypertension is one of the most common lifestyle diseases prevalent today with one in three Indian adults suffering from it and is equally widespread in the medical fraternity. However, it is often misdiagnosed given the difference in blood pressure readings at home and in a clinical setting.
The findings found that 56% of doctors suffered from irregular BP at night and 21% from masked hypertension – a condition in which a patient’s blood pressure reading is inaccurate due to specific environments.
This masked hypertension is also associated with an increased long-term risk of sustained hypertension and cardiovascular morbidity, the study said.
“Over 50% physicians had uncontrolled hypertension despite taking hypertensive medicines. While 21% of the doctors surveyed had masked hypertension or isolated ambulatory hypertension, another 56% doctors suffered from irregular BP pattern at night making them prone to future adverse cardiac events,” said Indian Medical Association (IMA) President KK Aggarwal.
More than 50% physicians have been found to have uncontrolled hypertension or high blood pressure (BP) despite taking hypertensive medicines, owing to high-stress levels, says a study.
Hypertension is one of the most common lifestyle diseases prevalent today with one in three Indian adults suffering from it and is equally widespread in the medical fraternity. However, it is often misdiagnosed given the difference in blood pressure readings at home and in a clinical setting.
The findings found that 56% of doctors suffered from irregular BP at night and 21% from masked hypertension – a condition in which a patient’s blood pressure reading is inaccurate due to specific environments.
This masked hypertension is also associated with an increased long-term risk of sustained hypertension and cardiovascular morbidity, the study said.
“Over 50% physicians had uncontrolled hypertension despite taking hypertensive medicines. While 21% of the doctors surveyed had masked hypertension or isolated ambulatory hypertension, another 56% doctors suffered from irregular BP pattern at night making them prone to future adverse cardiac events,” said Indian Medical Association (IMA) President KK Aggarwal.
Thursday, 4 May 2017
Points to remember while prescription
The recent notification of MCI making it mandatory for doctors to write generic names of drugs in the prescriptions seems to have created both apprehension and confusion among doctors regarding the prescription practices.
The MCI notification also states that and any violation would be treated as ‘misconduct’ and the violator shall be subjected to disciplinary action.
“The intent of the notification is to improve the quality of prescription, and it advises that every doctor should abide by certain rules to make it legible as well as descriptive,” said Dr Prem Aggarwal, president, National Medical Forum in a statement.
The statement advised doctors that they should make the prescription legible by writing it in capital letters and make it descriptive by writing the generic content of the drug being prescribed as well as the dose, strength, the route, and its duration.
Writing a complete and legible prescription does not prevent medical practitioners from suggesting one or two best quality manufacturers of the prescribed drug to ensure the quality of the dispensed medicine, said Aggarwal.
“ It is a matter of concern that while the drugs are supposed to be manufactured by a strict drug quality control measures by all manufacturers, the final product in the market varies enormously in terms of its efficacy,” said Dr. Prem Aggarwal
National Medical Forum also released 10 points to be kept in mind by doctors while writing a prescription:
National Medical Forum also released 10 points to be kept in mind by doctors while writing a prescription:
It is advised that before writing any prescription, the known allergies must be ascertained and mentioned prominently.
The prescription should always be written by a qualified doctor. If a nurse is repeating the same in nursing records as a transcription, it should be again countersigned before it becomes a legible prescription.
The Patient name, the diagnosis of disease with a unique identifier, must be mentioned clearly
Medicine should be written in capital letters, clear language, should be legible and = dated, timed with the name of the doctor and his signature.
It you are writing a brand name then the generic exposition of that brand must be clearly written.
The prescription should include, generic name of medicine, route of administration, dose and frequency, time of administrate and the duration it has to be taken for.
The prescription must mention the next date of review of the prescription.
The high risk medicines must be mentioned clearly and special instructions should be specifically written.
Avoid writing rational combination of drugs.
Tuesday, 2 May 2017
How to memorize drug side effects
Study Hacks: How to Memorize Drug Side Effects
I am often asked by students how to study and retain drug information. Given the "drinking from a fire hose" environment of pharmacy school, this is understandable. Although the internet and online databases have put a lot of information at our fingertips, there's still a lot of drug information you must memorize in order to graduate and become a successful pharmacist.
When I was a student asking the same "how do I remember all of this!?" questions to my professors, the general response I got was some variation of the immersion principle (i.e. study harder). For me anyway, this worked to a point, but eventually, I started noticing diminishing returns. I experimented and came across the following process. This article will focus specifically on drug side effects, but it can be applied to just about anything. These "learning by deconstruction" techniques are what got me through pharmacy school (not to mention the NAPLEX and BCPS exams).
Learning by Deconstruction
Start by breaking down how side effects happen. What are the causes? Take the general overview of "side effects" and break it into its individual parts. We can use toxicology studies to help us with this. In general, there are 4 main "causes" of drug toxicity (and hence, side effects):1
When I was a student asking the same "how do I remember all of this!?" questions to my professors, the general response I got was some variation of the immersion principle (i.e. study harder). For me anyway, this worked to a point, but eventually, I started noticing diminishing returns. I experimented and came across the following process. This article will focus specifically on drug side effects, but it can be applied to just about anything. These "learning by deconstruction" techniques are what got me through pharmacy school (not to mention the NAPLEX and BCPS exams).
Learning by Deconstruction
Start by breaking down how side effects happen. What are the causes? Take the general overview of "side effects" and break it into its individual parts. We can use toxicology studies to help us with this. In general, there are 4 main "causes" of drug toxicity (and hence, side effects):1
1. Mechanism-Based (you'll often see these broken down into "On-Target" and "Off-Target" effects)
2. Toxic metabolites
2. Toxic metabolites
3. Immune/hypersensitivity reaction to the drug
4. Idiosyncratic reactions
With that basic framework in mind, let's look at each category separately. Afterwards, we'll explore some useful tips and tricks for memorization.
1. Mechanism-Based
The first step is to understand the pharmacology of the drug itself. For any given drug, the majority of its side effects are usually some offshoot of its mechanism of action. It might be the drug working "too well" or it might be the drug binding to the correct receptor in the wrong tissue. If you truly learn pharmacology (and the related pathophysiology), then "memorizing" side effects is easy. It almost becomes unnecessary because you can use reason to figure out most potential side effects.
Mechanism-based side effects are broken down further into "on-target" and "off-target" effects. Going a step further, on-target effects are categorized by where they occur (either the intended tissue or in an unintended tissue).
Mechanism-based side effects are broken down further into "on-target" and "off-target" effects. Going a step further, on-target effects are categorized by where they occur (either the intended tissue or in an unintended tissue).
For example, a "classic" side effect of non-selective beta blockers is asthma exacerbation. This is an on-target effect because beta receptors are being appropriately blocked but it's in an unintended tissue (the lungs instead of the heart). Another side effect of beta blockers is bradycardia, another on-target effect. This time, however, it's in the intended tissue.
For off-target effects, let's look at diphenhydramine. It's "supposed" to bind to H1 receptors, but many of its side effects stem from the fact that it also binds to (and blocks) cholinergic receptors. This leads to the classic anticholinergic effects such as dry mouth and urinary retention.
How do you memorize all of this? These side effects usually extend to the entire class of drugs. So you might learn in class or in a package insert that lisinopril can cause a dry, hacking cough. By learning the mechanism of that reaction (bradykinin build up secondary to ACE inhibition), you can now reason that every ACE inhibitor can cause a dry hacking cough. This is a class-wide side effect. Another example is how all NRTIs can cause both lactic acidosis and hepatic steatosis via mitochondrial toxicity.
You can learn mechanism-based side effects "once" for one drug, and you now know it for all other drugs in the same class. You can make a note card (or similar list) of these on and off-target effects. That will help you see the forest for the trees and connect the dots of the big picture.
2. Toxic Metabolites
Another kind of side effect is due to toxic metabolites. As a point of caution, I would not necessarily include active metabolites in this categorization (active metabolites would usually fall under the mechanism-based categorization). Toxic metabolites are substances that can accumulate and cause cellular damage from the normal process of drug metabolism. An example you're likely familiar with is N-acetyl-p-benzoquinone imine (NAPQI): the toxic metabolic product of acetaminophen. As you come across toxic metabolites in your studies, keep a list of them on a notecard and review it periodically. To make it even more useful, you can also include the treatment or medical intervention for dealing with toxic metabolites (such as N-acetylcysteine for NAPQI).
3. Immune/Hypersensitivity Reactions
Another kind of side effect is due to toxic metabolites. As a point of caution, I would not necessarily include active metabolites in this categorization (active metabolites would usually fall under the mechanism-based categorization). Toxic metabolites are substances that can accumulate and cause cellular damage from the normal process of drug metabolism. An example you're likely familiar with is N-acetyl-p-benzoquinone imine (NAPQI): the toxic metabolic product of acetaminophen. As you come across toxic metabolites in your studies, keep a list of them on a notecard and review it periodically. To make it even more useful, you can also include the treatment or medical intervention for dealing with toxic metabolites (such as N-acetylcysteine for NAPQI).
3. Immune/Hypersensitivity Reactions
Immune reactions to drugs are somewhat rare, but severe when they do occur. While there is a theoretic risk of any drug causing hypersensitivity, you'll make the memorization process a lot easier on yourself if you single out the most common offending agents. Here again, it's best to take a class-wide approach. I recommend making a list of drugs (and drug classes) that commonly cause immune reactions. For example, my own list includes penicillins, sulfa drugs, taxanes, and pretty much every monoclonal antibody. Additionally, I include drugs where we might test for human leukocyte antigen (HLA). Drugs like abacavir (HLA-B*5701) and carbamazepine (HLA-B*1502) have a very high risk of an immune reaction if given to individuals positive for the respective HLA.
4. Idiosyncratic Reactions
For idiosyncratic reactions, I find (again) that the best practice is to group drugs together that can cause a certain reaction. For example, you might make a list of drugs that can prolong QTc interval (fluoroquinolones, macrolides, antipsychotics, 5-HT3 antagonists, etc...) and drugs that can cause hyperkalemia (ACE inhibitors, ARBs, aldosterone antagonists, aliskiren, heparin, SMT/TMP, etc...). These drugs don't necessarily need to be in the same class. In fact, I think it's best if you throw in any drug that applies as you come across it. This serves a few purposes. First, and most importantly, it forces you to connect the dots. We learn things in a modular format in pharmacy school.
It's tempting to "learn and dump" the information and to not realize how connected and similar medicine can be. Having a list of drugs grouped together by side effect forces you to make some of those connections (and it allows you to be mindful of synergistic drug-drug interactions). Secondly, every time you add something to one of your side effect lists, you'll naturally review the other drugs already on the list. This repetition is crucial and will help strengthen your drug info foundation.
Useful Memorization Tricks
One of my favorite "study hacks" is to memorize the exceptions to a rule. An example I like to use here is the renal dosing of antibiotics. There are only a small handful of commonly used antibiotics that don't require a renal adjustment. The "rule" here then, is to monitor kidney function for every antibiotic. Then, you can make a list of exceptions to the rule. It's much easier to memorize these few outliers than it is to try to remember the massive list every antibiotic that requires a renal adjustment. There are many examples of drugs that are exceptions to the rule that you can use when you're studying. For example
For idiosyncratic reactions, I find (again) that the best practice is to group drugs together that can cause a certain reaction. For example, you might make a list of drugs that can prolong QTc interval (fluoroquinolones, macrolides, antipsychotics, 5-HT3 antagonists, etc...) and drugs that can cause hyperkalemia (ACE inhibitors, ARBs, aldosterone antagonists, aliskiren, heparin, SMT/TMP, etc...). These drugs don't necessarily need to be in the same class. In fact, I think it's best if you throw in any drug that applies as you come across it. This serves a few purposes. First, and most importantly, it forces you to connect the dots. We learn things in a modular format in pharmacy school.
It's tempting to "learn and dump" the information and to not realize how connected and similar medicine can be. Having a list of drugs grouped together by side effect forces you to make some of those connections (and it allows you to be mindful of synergistic drug-drug interactions). Secondly, every time you add something to one of your side effect lists, you'll naturally review the other drugs already on the list. This repetition is crucial and will help strengthen your drug info foundation.
Useful Memorization Tricks
One of my favorite "study hacks" is to memorize the exceptions to a rule. An example I like to use here is the renal dosing of antibiotics. There are only a small handful of commonly used antibiotics that don't require a renal adjustment. The "rule" here then, is to monitor kidney function for every antibiotic. Then, you can make a list of exceptions to the rule. It's much easier to memorize these few outliers than it is to try to remember the massive list every antibiotic that requires a renal adjustment. There are many examples of drugs that are exceptions to the rule that you can use when you're studying. For example
- Abacavir is the only NRTI that does not require a renal adjustment
- Ethambutol is the only drug in the RIPE regimen for tuberculosis that does not cause liver damage
- Captopril is the only ACE inhibitor dosed 3 times daily (and is the only one used in hypertensive urgencies)
You can create many such exception lists to aid you in your studying.
With those core tips out of the way, there are a couple of other memorization tricks you can explore if you're interested. I'm not even sure if I realized I was using these tricks at the time, but 2 tricks that worked for me in pharmacy school were making personal associations with drugs and placing post-it notes all over my apartment.
I later found out that there are some legit cognitive principles behind both of these (the Baker-baker paradox for making associations, and the Method of loci for my post-it notes). To give you an idea of how powerful these can be, I still remember the brand name for rifapentine (Priftin), that it is dosed weekly for latent TB infection, and that it's generally avoided for active TB, all because it was on a yellow post-it note on my refrigerator door. I have not encountered (or even thought about) rifapentine since the infectious disease test I took in a therapeutics module 5 years ago.
These studying techniques are useful for many things besides side effects. I hope they will be as useful to you as they have been to me.
References
1. Guengerich, F. Peter. Mechanisms of Drug Toxicity and Relevance to Pharmaceutical Development. Drug Metab. Pharmacokinet. 2011; 26(1): 3-14. Accessed from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4707670/
I later found out that there are some legit cognitive principles behind both of these (the Baker-baker paradox for making associations, and the Method of loci for my post-it notes). To give you an idea of how powerful these can be, I still remember the brand name for rifapentine (Priftin), that it is dosed weekly for latent TB infection, and that it's generally avoided for active TB, all because it was on a yellow post-it note on my refrigerator door. I have not encountered (or even thought about) rifapentine since the infectious disease test I took in a therapeutics module 5 years ago.
These studying techniques are useful for many things besides side effects. I hope they will be as useful to you as they have been to me.
References
1. Guengerich, F. Peter. Mechanisms of Drug Toxicity and Relevance to Pharmaceutical Development. Drug Metab. Pharmacokinet. 2011; 26(1): 3-14. Accessed from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4707670/
Saturday, 29 April 2017
Prescription Generic Medicine
The Prime Minister’s announcement that prescription of medicines by their generic names will be mandatory has set the cat among the pigeons. It is not a well-thought-out move and diverts attention from the real crisis in public health and the lack of access to quality, affordable medicines for all.
At least 90% of the Indian domestic pharmaceutical market, of ₹1,00,000 crore and more, comprises drugs sold under brand names. There simply are not enough generic name equivalents of branded medicines sold. About half the market—₹50,000 crore and more—is for fixed-dose combinations (FDCs) of drugs, a further half of them irrational. Many FDC drugs contain even eight or nine medicines. To write, and remember, the constituents of FDC drugs in generic names is impractical, considering that there would be thousands of FDC brands.
Even if the doctor manages to write a prescription in generic names for single-ingredient drugs, pharmacists will sell the brand that maximises their commission and will in all likelihood not stock the less costlier but equivalent brand or generic medicine that is as good. This defeats the basic intention of making medicines affordable for consumers. Prescription by generic names merely shifts the focus of the pharmaceutical industry’s unethical drug promotion to the pharmacist; away from the prescriber, and resulting in business as usual. Medicines will continue to account for anything from 50% to 80% of treatment costs.
The Government of India has championed setting up Jan Aushadhis, which are pharmacies selling only generic name medicines to the extent possible, giving preference to pharmaceutical public sector undertakings (PSUs) too. There are not enough Jan Aushadhis, possibly less than 3,000 against the more than eight lakh retail pharmacies in existence, with many rural areas still underserved.
To facilitate Jan Aushadhis, the Drugs Technical Advisory Board (DTAB) in May 2016 considered amending Rule 65 (11A) of the Drugs and Cosmetics Act, 1940 so that pharmacists can dispense generic name medicines and/or equivalent brands against prescriptions in brand names. The DTAB rejected the idea citing that the bioavailability of a generic drug may not be as good as that of the prescribed brand. (Bioavailability is a measurement of the extent of a therapeutically active medicine that reaches the systemic circulation and is therefore available at the site of action; whereas bioequivalence is the comparison of the bioavailability of two medicines, say the generic drug and the branded drug.) This means that the government’s top decision-making body on medicine-related matters does not have confidence in the products manufactured by the government’s own PSUs. The DTAB, however, could have recommended biowaivers on bioavailability/bioequivalence (BA/BE) for certain classes of drugs based on their permeability and solubility, a practice followed in countries where healthcare is well regulated. BA/BE studies are essential for certain critical dose drugs and drugs of narrow therapeutic range, which are few in number.
By implication, the DTAB has doubts that generic name medicines in general can have acceptable BA/BE at all. Probably, the DTAB is not confident that India’s regulatory agencies can strictly enforce quality requirements.
The Tamil Nadu and Rajasthan governments procure generic name medicines at extremely competitive prices year after year, and crores of drugs are in use in their public health systems, thanks to the quality assurance systems in place. The success of the drug procurement system in these two states should counter the defeatist narrative that insists that generic medicines can never be good. This is not to underestimate the challenges in ensuring quality generic medicines countrywide, but the critics from the medical profession are doing the poor patient enormous disservice by swallowing the disinformation from the pharmaceutical industry about the general lack of bioavailability of generics as compared to brands.
The Medical Council of India (MCI), in an amendment to the Code of Conduct for doctors in October 2016, has recommended that every physician “should prescribe drugs with generic names legibly … and he/she shall ensure that there is a rational prescription and use of drugs.” How the MCI is going to ensure rational prescription and use, without a framework to measure the same, is anybody’s guess.
Rational use and prescription depends on the doctor, the pharmacist, the regulator, and the consumer. Some minimum prerequisites for rational use are: prescription-only medicines (Schedules G, H, H1 and X) must not be available freely over the counter; doctors and their professional bodies along with regulators must ensure there is no misuse of antibiotics and critical drugs; and the removal of all irrational/harmful/useless medicines, both FDCs and unscientific single ingredients, must be ensured. Practical guidelines for rational use and prescription audit of medicines must be developed and implemented seriously by all doctors. Branding of off-patent drugs needs to be discouraged as is the practice in well-regulated countries. The Hathi Committee Report (1975) too had recommended debranding.
Price control of an enlarged list of essential and life-saving drugs is a must as was mandated by the Supreme Court in 2003. The current market-based price mechanism of the Drug Price Control Order (DPCO) 2013 is a travesty and has resulted in ceiling prices that allow 2,000% to 3,000% (and in some cases, 10,000%) margins. This needs to be replaced by the cost-plus method of ceiling price fixation of the DPCO 1995.
The number one priority must, thus, be the replication of the Tamil Nadu/Rajasthan model of free medicines in all states, and pharmaceutical PSUs must be re-energised and reinvented instead of the government disinvesting in them.
Saturday, 18 March 2017
Glossary for Clinical research,pharmacovigilance,Clinical Trails,
1.1 Adverse Drug Reaction (ADR)
In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. The phrase responses to a medicinal product means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e. the relationship cannot be ruled out.
Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).
In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. The phrase responses to a medicinal product means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e. the relationship cannot be ruled out.
Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).
1.2 Adverse Event (AE)
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).
1.3 Amendment to the protocol
See Protocol Amendment.
See Protocol Amendment.
1.4 Applicable Regulatory Requirement(s)
Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products.
Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products.
1.5 Approval (in relation to Institutional Review Boards)
The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, Good Clinical Practice (GCP), and the applicable regulatory requirements.
The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, Good Clinical Practice (GCP), and the applicable regulatory requirements.
1.6 Audit
A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).
A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).
1.7 Audit Certificate
A declaration of confirmation by the auditor that an audit has taken place.
A declaration of confirmation by the auditor that an audit has taken place.
1.8 Audit Report
A written evaluation by the sponsor’s auditor of the results of the audit.
A written evaluation by the sponsor’s auditor of the results of the audit.
1.9 Audit Trail
Documentation that allows reconstruction of the course of events.
Documentation that allows reconstruction of the course of events.
1.10 Blinding/Masking
A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-blinding usually refers to the subject(s) being unaware, and double-blinding usually refers to the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s).
A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-blinding usually refers to the subject(s) being unaware, and double-blinding usually refers to the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s).
1.11 Case Report Form (CRF)
A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject.
A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject.
1.12 Clinical Trial/Study
Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous.
Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous.
1.13 Clinical Trial/Study Report
A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report (see the ICH Guideline for Structure and Content of Clinical Study Reports).
1.14 Comparator (Product)
An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial.
A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report (see the ICH Guideline for Structure and Content of Clinical Study Reports).
1.14 Comparator (Product)
An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial.
1.15 Compliance (in relation to trials)
Adherence to all the trial-related requirements, Good Clinical Practice (GCP) requirements, and the applicable regulatory requirements.
Adherence to all the trial-related requirements, Good Clinical Practice (GCP) requirements, and the applicable regulatory requirements.
1.16 Confidentiality
Prevention of disclosure, to other than authorized individuals, of a sponsor’s proprietary information or of a subject’s identity.
Prevention of disclosure, to other than authorized individuals, of a sponsor’s proprietary information or of a subject’s identity.
1.17 Contract
A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters. The protocol may serve as the basis of a
contract.
A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters. The protocol may serve as the basis of a
contract.
1.18 Coordinating Committee
A committee that a sponsor may organize to coordinate the conduct of a multicentre trial.
A committee that a sponsor may organize to coordinate the conduct of a multicentre trial.
1.19 Coordinating Investigator
An investigator assigned the responsibility for the coordination of investigators at different centres participating in a multicentre trial.
An investigator assigned the responsibility for the coordination of investigators at different centres participating in a multicentre trial.
1.20 Contract Research Organization (CRO)
A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor’s trial-related duties and functions.
A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor’s trial-related duties and functions.
1.21 Direct Access
Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. Any party (e.g., domestic and foreign regulatory authorities, sponsor’s monitors and auditors) with direct access should
take all reasonable precautions within the constraints of the applicable regulatory requirement(s) to maintain the confidentiality of subjects’ identities and sponsor’s proprietary information.
Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. Any party (e.g., domestic and foreign regulatory authorities, sponsor’s monitors and auditors) with direct access should
take all reasonable precautions within the constraints of the applicable regulatory requirement(s) to maintain the confidentiality of subjects’ identities and sponsor’s proprietary information.
1.22 Documentation
All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the
actions taken.
All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the
actions taken.
1.23 Essential Documents
Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced (see 8. Essential Documents for the Conduct of a Clinical Trial).
Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced (see 8. Essential Documents for the Conduct of a Clinical Trial).
1.24 Good Clinical Practice (GCP)
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
Monitoring Board, Monitoring Committee, Data Monitoring Committee) An independent data-monitoring committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial.
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
Monitoring Board, Monitoring Committee, Data Monitoring Committee) An independent data-monitoring committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial.
1.26 Impartial Witness
A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject’s legally acceptable representative cannot read, and who reads the informed
consent form and any other written information supplied to the subject.
A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject’s legally acceptable representative cannot read, and who reads the informed
consent form and any other written information supplied to the subject.
1.27 Independent Ethics Committee (IEC)
An independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical professionals and non-medical members, whose responsibility it is to ensure the protection of the rights, safety and well-being
of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving / providing favourableopinion on, the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects.
The legal status, composition, function, operations and regulatory requirements pertaining to Independent Ethics Committees may differ among countries, but should allow the Independent Ethics Committee to act in agreement with GCP as described in this guideline.
An independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical professionals and non-medical members, whose responsibility it is to ensure the protection of the rights, safety and well-being
of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving / providing favourableopinion on, the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects.
The legal status, composition, function, operations and regulatory requirements pertaining to Independent Ethics Committees may differ among countries, but should allow the Independent Ethics Committee to act in agreement with GCP as described in this guideline.
1.28 Informed Consent
A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed consent is documented by
means of a written, signed and dated informed consent form.
A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed consent is documented by
means of a written, signed and dated informed consent form.
1.29 Inspection
The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor’s and/or contract research organization’s (CRO’s) facilities, or at other establishments deemed appropriate by the regulatory authority(ies).
The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor’s and/or contract research organization’s (CRO’s) facilities, or at other establishments deemed appropriate by the regulatory authority(ies).
1.30 Institution (medical)
Any public or private entity or agency or medical or dental facility where clinical
trials are conducted.
Any public or private entity or agency or medical or dental facility where clinical
trials are conducted.
1.31 Institutional Review Board (IRB)
An independent body constituted of medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and
providing continuing review of trial protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.
An independent body constituted of medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and
providing continuing review of trial protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.
1.32 Interim Clinical Trial/Study Report
A report of intermediate results and their evaluation based on analyses performed during the course of a trial.
A report of intermediate results and their evaluation based on analyses performed during the course of a trial.
1.33 Investigational Product
A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.
A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.
1.34 Investigator
A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator. See also Subinvestigator.
A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator. See also Subinvestigator.
1.35 Investigator / Institution
An expression meaning “the investigator and/or institution, where required by the applicable regulatory requirements”.
An expression meaning “the investigator and/or institution, where required by the applicable regulatory requirements”.
1.36 Investigator’s Brochure
A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human subjects (see 7. Investigator’s Brochure).
A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human subjects (see 7. Investigator’s Brochure).
1.37 Legally Acceptable Representative
An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject’s participation in the clinical trial.
An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject’s participation in the clinical trial.
1.38 Monitoring
The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).
The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).
1.39 Monitoring Report
A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor’s SOPs.
A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor’s SOPs.
1.40 Multicentre Trial
A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator.
A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator.
1.41 Nonclinical Study
Biomedical studies not performed on human subjects.
Biomedical studies not performed on human subjects.
1.42 Opinion (in relation to Independent Ethics Committee)
The judgement and/or the advice provided by an Independent Ethics Committee (IEC).
The judgement and/or the advice provided by an Independent Ethics Committee (IEC).
1.43 Original Medical Record
See Source Documents.
See Source Documents.
1.44 Protocol
A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. Throughout the ICH GCP Guideline the term protocol refers to protocol and protocol amendments.
A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. Throughout the ICH GCP Guideline the term protocol refers to protocol and protocol amendments.
1.45 Protocol Amendment
A written description of a change(s) to or formal clarification of a protocol.
A written description of a change(s) to or formal clarification of a protocol.
1.46 Quality Assurance (QA)
All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s).
All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s).
1.47 Quality Control (QC)
The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled.
The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled.
1.48 Randomization
The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias.
The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias.
1.49 Regulatory Authorities
Bodies having the power to regulate. In the ICH GCP guideline the expression Regulatory Authorities includes the authorities that review submitted clinical data and those that conduct inspections (see 1.29). These bodies are sometimes referred to as competent authorities.
Bodies having the power to regulate. In the ICH GCP guideline the expression Regulatory Authorities includes the authorities that review submitted clinical data and those that conduct inspections (see 1.29). These bodies are sometimes referred to as competent authorities.
1.50 Serious Adverse Event (SAE) or Serious Adverse Drug Reaction
(Serious ADR)
Any untoward medical occurrence that at any dose:
- results in death,
- is life-threatening,
- requires inpatient hospitalization or prolongation of existing hospitalization,
- results in persistent or significant disability/incapacity,
or
- is a congenital anomaly/birth defect
(see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).
(Serious ADR)
Any untoward medical occurrence that at any dose:
- results in death,
- is life-threatening,
- requires inpatient hospitalization or prolongation of existing hospitalization,
- results in persistent or significant disability/incapacity,
or
- is a congenital anomaly/birth defect
(see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).
1.51 Source Data
All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies).
All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies).
1.52 Source Documents
Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or
transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial).
Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or
transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial).
1.53 Sponsor
An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial.
An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial.
1.54 Sponsor-Investigator
An individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. The term does not include any person other than
an individual (e.g., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator.
An individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. The term does not include any person other than
an individual (e.g., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator.
1.55 Standard Operating Procedures (SOPs)
Detailed, written instructions to achieve uniformity of the performance of a specific function.
Detailed, written instructions to achieve uniformity of the performance of a specific function.
1.56 Subinvestigator
Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows). See also
Investigator.
Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows). See also
Investigator.
1.57 Subject/Trial Subject
An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control.
An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control.
1.58 Subject Identification Code
A unique identifier assigned by the investigator to each trial subject to protect the subject’s identity and used in lieu of the subject’s name when the investigator reports adverse events and/or other trial related data.
A unique identifier assigned by the investigator to each trial subject to protect the subject’s identity and used in lieu of the subject’s name when the investigator reports adverse events and/or other trial related data.
1.59 Trial Site
The location(s) where trial-related activities are actually conducted.
The location(s) where trial-related activities are actually conducted.
1.60 Unexpected Adverse Drug Reaction
An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator’s Brochure for an unapproved investigational product or package insert/summary of product characteristics for an approved product) (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).
An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator’s Brochure for an unapproved investigational product or package insert/summary of product characteristics for an approved product) (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).
1.61 Vulnerable Subjects
Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.
Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.
1.62 Well-being (of the trial subjects)
The physical and mental integrity of the subjects participating in a clinical trial.
The physical and mental integrity of the subjects participating in a clinical trial.
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