Adverse Drug Reaction

For the study, investigators analyzed 2001-2010 information from the UK Medicines and Healthcare products Regulatory Agency, which runs a national spontaneous reporting system to collect suspected adverse drug reaction data.
The researchers found that spontaneous reports alone are not currently generating required data, and important safety messages from the regulator do not match reporting patterns. Additional reporting strategies will be required to improve the quantity and quality of information on suspected adverse drug reactions in young children.
"The UK set up the first system in the world to report adverse drug reactions, the Yellow Card Scheme, over 50 years ago. It has helped improve the safety of drugs immensely by identifying adverse drug reactions, and continues to be valuable today," said Dr. Daniel Hawcutt, lead author British Journal of Clinical Pharmacology study. "This research shows that for newborn babies and infants, the spontaneous reporting of adverse drug reactions may not be enough, and additional systems to seek out and report adverse drug reactions are required."
Explore further: Roche probed over faulty drug-safety reporting
More information: Daniel B. Hawcutt et al. Spontaneous Adverse Drug Reaction Reports for Neonates and Infants in the UK 2001-2010: Content and Utility analysis, British Journal of Clinical Pharmacology (2016). DOI: 10.1111/bcp.13067
Journal reference: British Journal of Clinical Pharmacology

Thanks :medicalxpress

Air Pollution

Blueair says Air Pollution's deadly impact, indoors and outdoors, demands urgent action to create healthier cities and save lives :
Blueair, a World Leader in purifying indoor air to improve people's lives by removing health threatening airborne contaminants, today praised the World Bank for a new study highlighting the emergence of air pollution as the deadliest form of pollution and calling for urgent action to address the problem.

The Cost of Air Pollution: Strengthening the economic case for action, a joint study of the World Bank and the Institute for Health Metrics and Evaluation (IHME), noted how an estimated 5.5 million lives were lost in 2013 to diseases associated with outdoor and household air pollution, causing human suffering and reducing economic development.

The study estimated that the deaths due to air pollution cost the global economy about USD 225 billion in lost labor income in 2013.

"The World Bank's cost of air pollution report is both praiseworthy and scary in the way it underlines yet again how billions of people in cities around the world find it near impossible to escape breathing heavily polluted air, on the street and indoors at home and work," said Bengt Rittri, Blueair founder and CEO. He further added "City authorities and national governments need to devote more resources to improving air quality and advising individuals how to protect themselves."

"It is unacceptable that urban air is as polluted as it is. However, while individuals have little control over the air breathed outdoors, we can create safer indoor environments by using air purifiers to remove airborne contaminants in our living and working spaces," said Bengt.

The Blueair air purifier filtration process captures 99.97 percent of airborne particles down to 0.1 micron in size. Blueair's patented HEPA Silent (TM) technology unites the best in electrostatic and mechanical filtration by combining advanced filter media and an encapsulated ion particle charging chamber to ensure that a Blueair purifier delivers results far superior than either mechanical or electrostatic technology alone. A powerful Blueair Pro XL air purifier helps create safer indoor environments in larger spaces at work or home by removing airborne contaminants in rooms up to 1,180 sq. ft (110 sq. m.)

Background

The World Bank study says about 90 percent of the population in low and middle income countries are exposed to dangerous levels of ambient air pollution.

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

New Regulations for Combination Products

Combination Product Definition
Combination products are defined in 21 CFR 3.2(e). The term combination product includes:

(1) A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity;

(2) Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products;

(3) A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labeling of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose; or

(4) Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect.

HOW TO BECAME REGISTERED PHARMACISTS IN CANADA

Here is the scenario. You completed your Pharm.D/BPharm/MPharm last year, and are now undertaking your preregistration training in a community pharmacy. Having visited Canada on holiday, you would like to move there to work as a pharmacist. How do you go about it?
In general, there are seven stages to the process of gaining your registration to practise as a pharmacist in Canada. You can complete some of the earlier stages in the UK, but most of them require you to visit or move to Canada:
Evaluation of documents Registered pharmacists should send their degree certificate, proof of British registration (if applicable) and a statement of good standing from the General Pharmaceutical Council to the Pharmacy Examining Board of Canada (PEBC) (www.pebc.ca) for preliminary evaluation (ie, to check that you are eligible to proceed with the licensing process). Pharmacy students and preregistration trainees will need to include a letter written by their university or preregistration tutor to confirm that they are expected to graduate or register.
The PEBC evaluating exam The PEBC examination consists of two tests on consecutive days, each with 150 multiple choice questions on pharmaceutical science and pharmacy practice. The pass mark is 60 per cent. It can be taken in January or July, or in the UK for an additional fee (which is still cheaper than a return trip to Canada).
The PEBC qualifying exam (part 1) The PEBC qualifying exam (part 1) consists of two MCQ papers with 150 questions on consecutive days on pharmacy practice and clinical topics. It is offered in May and November every year and must be taken in Canada. The PEBC does not provide information about pass marks or pass rates for either part of the qualifying exam. Candidates cannot take papers or material into the exam.
The PEBC qualifying exam (part 2) Part 2 of the PEBC qualifying exam is an objective structured clinical examination, which should be familiar to most UK pharmacy graduates. It examines the candidate’s knowledge of pharmacy practice, plus clinical and communication skills. There are 16 stations, each lasting seven minutes. Some stations require interaction with mock patients or healthcare professionals. Appropriate reference sources are provided for each station where necessary, but candidates cannot bring in papers or other material.
English Language proficiency exam You need to pass an English language proficiency exam, such as TOEFL (see http://www.ets.org/toefl for more information). Strangely, this applies even to UK candidates who have English as their first language. If you wish to work in the Quebec province you will need to pass a French language proficiency exam instead.
Jurisprudence exam Another exam you need to pass is the jurisprudence exam for the Canadian province in which you wish to work. This tests your knowledge of Canadian pharmacy law and ethics, which varies substantially between provinces. It is generally offered several times a year in most provinces. Check the website for the provincial pharmacy organisation of your chosen province for more details.
Studentship and internship You need to undertake (usually) a studentship and an internship in your chosen province. Most provinces require you to undertake a studentship, which is a taught course, often six months in duration, at the faculty of pharmacy for the province. An internship is compulsory for all provinces, and may vary in length between three and 12 months. This is the equivalent to UK preregistration training and requires you to work under the supervision of a licensed pharmacist.
After you have completed these steps, you can then apply for your licence to practise in your chosen province.
This procedure only entitles you to practise in this one province. However, with the exception of Quebec, where the arrangements are substantially different, if you subsequently wish to move to practise in another province, you can usually do so by applying to the licensing authority for that province. In some cases, you may need to take another jurisprudence exam.

MSPC sets up Patient Counselling Centre at KEM Hospital, first of its kind in State

As a step towards realising the role of pharmacists in patient safety at the point of care in line with the Pharmacy Practice Regulations introduced by the Pharmacy Council of India (PCI) last year, KEM and Maharashtra State Pharmacy Council (MSPC) have jointly set up a patient medicine counselling centre for diabetics and patients suffering from neurological disorders like epilepsy at KEM Hospital, Mumbai.

This is the first of its kind initiative in Maharashtra to help patients get the right knowledge about rational usage of drugs with help from a dedicated pharmacist. With the coming up of the centre with pharmacists deputed from MSPC and KEM Hospital, patients will be guided on using the prescription in a practical and rationale way so that medicines are consumed properly to give the desired therapeutic effects.

Pharmacists at the centre are currently working under the guidance of Madhuri Doiphode, Superintendent of Pharmacy at KEM Hospital. The patient is guided to submit the stamped prescription from the doctor's clinic after thorough and proper investigations as guided by the physician. The pharmacist at the centre registers the patient's records and accordingly counsels him on drug usage based on the prescription with help from a Micromedex database on medicines. The centre will cater to 100 patients per day from Monday to Saturday between 9 AM to 4 PM.

Says Sheetal Chandan, Pharmacist and Co-ordinator at the centre, "Patients are generally exhausted and confused after a long arduous schedule of visiting the OPD, clinic, lab for investigations and finally to the dispensary which entails a lot of paperwork and stress. Keeping this in mind, the patient medicine counseling centre helps the patient relax and offer the patient the much needed counseling and know-how about drug use to take care of aspects like drug-drug reaction, drug-food reaction and other contraindications."

Moreover, the centre is equipped with a robust evidence based clinical reference software called Micromedex which is user-friendly and makes available evidence-based drug information and clinical answers much faster and easier. This will strengthen the process of delivering clinically important, relevant and unbiased information on medicines to pharmacist and patients.

This according to the MSPC officials will dispel a lot of misconceptions with regards to medical prescription, adverse drug reactions, drug usage, dosage and time schedule for patient safety.

Thanks : Pharmabiz

Turning Point Brochure

Hold in Your Pee...!

*"சிறுநீரை அடக்க வேண்டாம்..*"

ஒரு உண்மை சம்பவம்...

15 வயது சிறுமிக்கு காய்ச்சல் என்று சில நாட்கள் முன்னதாக அந்த மருத்துவமனைக்கு சிகிச்சைக்காக வந்திருந்தனர்.

அன்று மருத்துவரின் அறிவுரைப்படி அச்சிறுமிக்கு இரத்தப் பரிசோதனை மேற்கொண்டுள்ளனர்.

அன்று தான் ஒரு அதிர்ச்சிகரமான விஷயத்தை மருத்துவரும் அச்சிறுமியின் பெற்றோரும் அறிய வந்தனர்.

என்னவெனில் அச்சிறுமியின் இரண்டு சிறுநீரகங்களும் செயலிழந்து விட்டது என்பது.

அச்சிறுமியின் பெற்றோர் கலங்கி விட்டனர்.

எவ்வாறு இந்த பெரிய சங்கடம் உருவானது என்று மருத்துவர் அறிய அச்சிறுமியிடம் விசாரித்தபோது தான் தெரிந்தது அச்சிறுமி பள்ளி செல்லும் பொதெல்லாம் சிறுநீரை கழிக்கவே மாட்டாராம்.

ஏனெனில் சிறுநீர் கழிக்க அச்சிறுமிக்கு இருந்த தயக்கமும் அப்பள்ளியில் அதற்கான வசதி வாய்ப்புகள் குறைவாக இருந்ததுமே இதற்கு முக்கிய காரணமாக இருந்துள்ளது.

இந்த சிறுநீரை அடக்கும் பழக்கத்தால் அச்சிறுமியின் சிறுநீர்ப்பாதையில் தொற்று ஏற்பட்டு இறுதியில் சிறுநீரகமே செயலிழந்து போனது தான் கொடூரத்தின் உச்சம்.

அதைவிட கொடூரம் என்னவெனில் நான் சந்தித்த இரண்டாவது நாள் அச்சிறுமி மரணத்தையும் தழுவி விட்டாள் என்பது மிகுந்த மன வேதனைக்குள்ளாக்கி விட்டது.

பல கல்லூரிகள் மற்றும் பள்ளிகளில் மாணாக்கர்களுக்கு ஒதுக்கப்பட்டுள்ள கழிவறைகளை கண்டீர்களானால் நம் வயிற்றுக்குள் உணவு செல்லாது.

அவ்வளவு கொடூரமாக இருக்கிறது கழிவறைகள்.

அது மட்டுமில்லாமல் பல அரசு மற்றும் தனியார் பள்ளிகள் சிறுநீர் கழிக்கும் இடைவெளியை வெறும் 10 நிமிடத்திற்கு ஒதுக்கி 400 மாணாக்கர்களை அங்கு தள்ளுகின்றனர்.

இதனால் பல மாணாக்கர்கள் கூச்சப்பட்டுக்கொண்டு இயற்கை உபாதைகளை கழிக்காமலே அடக்கிக் கொள்கின்றனர்.

இதனால் குழந்தைகள் சிறுநீர் தொற்றிற்கு உள்ளாகி உயிரை இழக்கும் அபாயத்திற்கு தள்ளப்படுகின்றனர்.

அன்பர்களே தயவு செய்து இந்த பதிவை முடிந்த அளவு உங்கள் நண்பர்கள் மற்றும் குழுக்களுக்கு பகிர்ந்து பெற்றோர்களுக்கு விழிப்புணர்வை ஏற்படுத்த உதவுங்கள்.

மேலும் அரசிற்கும், பள்ளி கல்வித்துறைக்கும், அனைத்து பள்ளிகளுக்கும் மற்றும் பெற்றோர்களுக்கும் மாணாக்கர்களுக்கும் இப்பதிவின் மூலம் கோரும் வேண்டுகோள் என்னவெனில்

1. ஒவ்வொரு 2 மணி நேரத்திற்கும் மாணாக்கர்கள் சிறுநீர் கழிப்பதை முறையாக கொண்டுள்ளனரா என்பதை அக்கறையுடன் வினவ வேண்டும்.

2. ஆசிரியர்கள் தங்கள் மாணாக்கர்களை தங்கள் குழந்தை போல் பாவித்து இம்மாதிரியான அபாயத்திற்குள் சென்றுவிடாமல் பாதுகாக்க முனைய வேண்டும்.

3. அரசு இவ்விஷயத்தில் உடனடியாக தலையிட்டு பள்ளிக் கல்வித்துறை மூலம் அனைத்து பள்ளிகளுக்கும் சுற்றறிக்கை விட்டு கழிப்பறை இல்லாத பள்ளிகளின் கல்லூரிகளின் மீது உரிய நடவடிக்கை எடுக்க ஆவண செய்ய வேண்டும்.

மேலும் இயற்கை உபாதைகளை கழிக்க வேண்டிய நேரத்தை மாணாக்கர்களின் எண்ணிக்கை அடிப்படையில் ஒதுக்கவும் ஆணையிட வேண்டும்.

4, பெற்றோர்கள் தவறாது குழந்தைகள் இயற்கை உபாதைகளை சரியான நேரத்தில் கழிக்கின்றனரா என்பதை தீர ஆராய வேண்டும்.

5. பெற்றோர்கள் இவ்விஷயத்தை பற்றி பள்ளிகளிடமும் கலந்து ஆலோசிக்க வேண்டும்.

நமது நாடு மற்றம் வீட்டின் வருங்காலத் தூண்களை சிறுநீரகமற்ற தூண்களாக மாற்றி வளரும் பயிர்களை முளையிலேயே கருகவிட்டு விடாதீர்கள்.

*"சிறுநீர் மட்டுமல்லாமல் இயற்கை உபாதைகள் (மலம், தும்மல், இருமல், தாகம், பசி, விக்கல், அபான வாயு...) எதையும் அடக்க கூடாது."*

தயவுசெய்து நண்பர்களே இப்பதிவை சாதாரண பதிவாக எண்ணிவிடாமல் அனைவரும் முக்கியத்துவத்துடன் பகிருமாறும் நம் குழந்தைகளையும் தீர கவனிக்குமாறும் பணிவன்புடன் கேட்டுக்கொள்கிறேன்.

what about bathroom procrastination?

 You know, when you put off peeing until your legs are crossed and you can barely hobble to finally park yourself on the porcelain throne. Whether it's because you're powering through work e-mails at your desk or you'd rather avoid the horrors of a public restroom, sometimes peeing just lands at the bottom of your to-do list. But can that actually be dangerous? We consulted Benjamin Brucker, M.D., assistant professor of urology at NYU Langone Medical Center, to find out.

How Long Is It Okay to Hold It?
Your body's physical capacity to keep in urine is based on a few things: "Most of the time women can hold urine for three to six hours, but this will vary," says Brucker. "It really depends on the amount of urine that someone makes, which is determined by hydration status and fluid intake, and also functional bladder capacity, which is a combination of the actual size of the bladder and bladder sensitivity." But ultimately, there's not a ton of research on the subject. "The truth of the matter is normal urination in women across the lifespan is not as well understood as it should be," says Brucker.

Should You Pee at Every Pang?
As you know, that "I gotta go" sensation ranges from small pangs to a feeling that almost hurts. "You don't want to give in to every slight sensation to urinate, but you also don't want to hold it in to the point where it is painful," says Brucker. "Ultimately, you want to have healthy voiding habits." That translates into finding a middle ground that doesn't have you running to the bathroom every time you take a sip of water but also doesn't result in you bent over with cramp-like sensations.

What's the Worst-Case Scenario?
"There aren't any specific complications you can get from holding in your urine, although it may put you at a bit more of a likelihood of developing urinary tract infections, which can be treated with antibiotics," says Brucker. Having a UTI can also make you feel like you have to go more often than normal, as can conditions like overactive bladder and painful bladder syndrome. If all of a sudden you feel the need to pee way more than usual, head to a doctor to get checked out. Kegels and medication can improve an overactive bladder, while physical therapy and medication can help treat painful bladder syndrome.

Can You Train Your Body to Pee Less?
You know it's important to stay hydrated, but guzzling water can have the annoying side effect of needing to pee every few minutes. So it is possible to get your body used to holding out? "Some people's bladders are quite sensitive, and they will have the sensation to void even with the smallest amount of urine in the bladder. It's okay to try to distract yourself and not give in to every slight urge," says Brucker. This could potentially stretch your bladder a bit in a healthy way, though you shouldn't expect any major changes. "There is a small study out there that shows nurses, who may not have the opportunity to frequent the facilities, have slightly larger bladder capacities than age-matched controls," says Brucker. The bottom line is that you probably aren't going to do any real damage to yourself by holding it in, but just for comfort's sake, you should hit the bathroom when it starts to feel annoying. After all, not very many other things can bring on quite the same sense of relief!