Antibiotics: Handle with care

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Every five minutes a child dies due to drug-resistant bacteria in the WHO South-East Asia Region. 

Drugs that were effective in treating deadly diseases such as tuberculosis, HIV, malaria etc. are increasingly losing their impact. Misuse and overuse of antibiotics is leading to antibiotic resistance which is emerging as the greatest public health threat.

Antibiotics are often not optimally prescribed – when not needed, or with incorrect choice of medicine or incorrect dosage. Self-medication is common with antibiotics freely available without a prescription. Failure to finish a course of antibiotics or taking them for too long, lack of regulations or standards for health care workers, and misuse and overuse in animal husbandry and agriculture, are factors adding to the increasing antibiotic resistance.

WHO is strongly advocating for urgent action to reverse the growing antibiotic resistance which is threatening to outpace the ability of antibiotics to cure dangerous infections. The consequences could be catastrophic. We are heading to an era when minor cuts might become life-threatening. Common infections that were treatable for decades may once again kill.

Countries in WHO South-East Asia Region signed a declaration in Jaipur in 2011 to prioritize action against antibiotic resistance.

The World Antibiotics Awareness week aims at raising awareness and promoting best practices among the general public, health professionals and policy makers to ensure judicious use of antibiotics to avoid further emergence and spread of antibiotic resistance.

Antibiotics continue to be a precious resource. They have saved millions of lives by treating serious bacterial infections. Let us together work to stop antibiotic resistance.

Source: TimesofIndia

What doctors don’t know about the drugs they prescribe

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A very interesting session… Must watch.

When a new drug gets tested, the results of the trials should be published for the rest of the medical world — except much of the time, negative or inconclusive findings go unreported, leaving doctors and researchers in the dark. In this impassioned talk, Ben Goldacre explains why these unreported instances of negative data are especially misleading and dangerous.

Please watch the video:

https://www.ted.com/talks/ben_goldacre_what_doctors_don_t_know_about_the_drugs_they_prescribe

Source: TedMed

Are Your Supplements Screwing With Your Meds?

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Taking vitamins or other dietary supplements along with medication can be dangerous, the U.S. Food and Drug Administration warns.

Dietary supplements can alter the absorption and metabolism of prescription and over-the-counter medications, the FDA said.

“Some dietary supplements may increase the effect of your medication, and other dietary supplements may decrease it,” Robert Mozersky, a medical officer at the FDA, explained in an agency news release.

For example, the supplement St. John’s Wort can make birth control pills less effective, the FDA reported. Both the herbal supplement ginkgo biloba and vitamin E can thin blood. Mixing either supplement with the prescription blood thinner warfarin or aspirin could increase the risk of internal bleeding or stroke, the report said.

Dietary supplements are widely used in the United States. The U.S. Centers for Disease Control and Prevention’s 2005-2008 National Health and Nutrition Examination Survey found that roughly 72 million people in the United States who are on a prescription medication also took some type of dietary supplement.

Although many people take supplements to make sure they get proper nutrition, the FDA said there is no substitute for eating a healthy diet, and products labeled as “natural” or “herbal” are not necessarily harmless.

“Natural does not always mean safe,” Mozersky said. This is particularly true for children, he added.

“Parents should know that children’s metabolisms are so unique, that at different ages they metabolize substances at different rates. For kids, ingesting dietary supplements together with other medications make adverse events a real possibility,” Mozersky explained.

People planning to have surgery should inform their doctor of every medication and supplement they use. It may be necessary to stop taking supplements a few weeks before an operation to avoid potentially serious changes in heart rate, blood pressure or bleeding risk, the FDA said.

Women who are pregnant or breast-feeding should also talk to their doctor about any supplements they take.

“The bottom line is, before you take any dietary supplement or medication — over-the-counter or prescription — discuss it with your health care professional,” Mozersky said. The FDA added the following tips for consumers:

  • Every time you visit the doctor, bring a list of all the dietary supplements and medications you take. This list should include dosages and frequency.
  • Tell your doctor if your health has changed, including any recent illnesses, surgeries or other procedures. You should also tell your doctor if you are pregnant or breast-feeding.

SOURCE: U.S. Food and Drug Administration, news release, Oct. 27, 2014

Patients pay three times import price for stents

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The government has a Telecom Regulatory Authority of India (TRAI) to regulate prices of telephony, an electricity regulator to control power prices and so on. But India has no body to ensure that medical device companies do not overcharge patients. The result is loot.

Most patients are forced to pay anything between Rs 60,000 and Rs 1 lakh or more for cardiac drug eluting stents (DES) though the same stents cost Rs 28,000-Rs 48,000 even in rich European countries and the UK, where there is price control or a fair pricing mechanism for medical devices.

As senior doctors pointed out, almost all the over-priced stents are imported and hence the government has the bill of entry giving the price at which the stent is being imported, typically a third of the price charged to patients or even less. Yet, the government has done nothing to stop companies and hospitals from looting patients.

The Food and Drug Administration (FDA) of Maharashtra had done a detailed investigation into the overcharging of various medical devices including stents and had submitted the report to the National Pharmaceutical Pricing Authority (NPPA) over a year back, recommending that medical devices including drug eluting stents be brought under price control. The FDA’s report included pricing details of other devices too such as cochlear implant, bone cement and orthopaedic implants and pointed out that the price of most devices was hiked by over 100% at least.

The Maharashtra FDA report cites the example of drug eluting stents manufactured by Abbotts Vascular Devices Holland BV, a Holland-based firm. These stents were imported into India by Abbotts Healthcare Pvt Ltd at Rs 40,710 and sold to the distributor Sinocare at Rs 73,440 against a marked MRP of Rs 1.5 lakh. The distributor then sold it at Rs 1.1 lakh to Hinduja hospital, which in turn charged the patient Rs 1.2 lakh, a near three-fold jump over the import price.

Medical devices including drug eluting stents, orthopedic implants, disposable syringes, ocular lens and heart valves are notified as drugs under the Drugs and Cosmetics Act, 1940 but not included under the Drug Price Control Order (DPCO). Hence, their prices are neither monitored nor controlled. The multinational companies that dominate the market import the devices and mark MRP at whatever level they think the market can bear in the absence of any regulation. These devices even get customs duty concessions, the duty on cardiac stents being zero.

The NPPA has neither replied to the Maharashtra FDA after the report sent over a year ago nor has taken any action on pricing. When contacted, NPPA chairperson Injeti Srinivas told TOI that he was not aware of the FDA report as he had joined recently (in June this year) and that he would look into it.

“If the government was serious about doing something, it would have brought in price control as is done in even rich Western countries. The government knows this is happening because they can see the huge difference in cost between the import price and the price at which these devices are being sold to patients even in government hospitals. They just choose to close their eyes to this,” lamented a senior doctor in a government hospital.

 Source: Times of India

Zolpidem and Driving Impairment

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Zolpidem is the most widely used prescription drug for insomnia and one of the most commonly used drugs in the United States. Treatment of insomnia, which has important effects on patients’ quality of life, may also have larger public health benefits.  In its 2006 report, the Institute of Medicine (IOM) Committee on Sleep Medicine and Research concluded that sleep deprivation and sleep disorders represent an unaddressed public health problem that has substantial health consequences and leads to high health care costs.1 The IOM noted that one of every five serious injuries from driving accidents can be attributed to driver sleepiness. Numerous sleep drugs are available for treating insomnia and are also used to reduce next-day somnolence. But it is widely recognized that these drugs themselves can sometimes contribute to next-day somnolence, depending on such factors as drug dose, dosage form, and individual patient characteristics.

 Zolpidem was initially approved, in 1992, in an immediate-release formulation for insomnia characterized by difficulty in falling asleep. At the time of its approval, there was concern regarding morning impairment, even after a 7-to-8-hour period of sleep, particularly with regard to activities requiring full alertness, such as driving a motor vehicle. There was also some recognition that people’s risk of impairment could vary, and the drug label advised that “the dose of Zolpidem should be individualized.” Although the recommended adult dose was 10 mg, the recommended dose for the elderly (who had higher levels of the drug in their blood the next morning) and for patients with hepatic impairment (who metabolized the drug more slowly) was 5 mg. Individual differences became more apparent as new dosage forms of zolpidem were developed to address sleep maintenance and middle-of-the-night waking.

 Manufacturers of zolpidem-containing products must now make dosage recommendations that differ for women and men, to decrease the likelihood that women will have blood levels of the drug after they wake up that will impair their driving ability. Accordingly, the recommended dose of zolpidem for women has been reduced from 10 mg to 5 mg for immediate-release products and from 12.5 mg to 6.25 mg for modified-release products.

 The FDA has also pointed out that the risk of impairment with modified-release formulations of zolpidem is greater than the risk with immediate-release formulations. Accordingly, the agency announced in May 2013 that patients who take modified-release formulations, either 6.25 mg or 12.5 mg, even if they then sleep for the required 8-hour period, should refrain, for the day subsequent to using the drug, from driving or engaging in any activity that requires full alertness. This recommendation reflects not only the higher zolpidem content in the modified-release formulation but also the ability of the modified-release design to prolong the period of drug exposure. A variety of new data have shown that people affected by impairment after taking zolpidem frequently do not recognize their impaired state; patient self-perception is not an adequate gauge for impairment.

Source: http://www.nejm.org/doi/full/10.1056/NEJMp1307972?query=TOC

 

Serious side effects of asthma drug!

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If your child is being treated for asthma and develops symptoms such as nightmares, hallucinations and seems agitated, do not panic.

It is quite likely that these are side effects of a relatively new asthma drug called montelukast. The drug is also combined with other medicines such as levocetirizine and bambuterol. Zafirlukast is a sister drug belonging to the same class as montelukast and can cause similar side effects.

Other reported adverse effects include insomnia, nervousness, irritability, aggressive behaviour, anxiousness, depression, disorientation, restlessness, sleepwalking, suicidal tendencies and tremors.

In addition to asthma, montelukast is also used in order to relieve symptoms of hay fever and to prevent exerciseinduced breathlessness. The European Respiratory Journal has recently published reports of nightmares in children and adults taking montelukast.

 Of the 24 patients in whom nightmares were reported, 17 were children aged 8 or younger. In 18 patients, the nightmares appeared within 1 to 7 days of exposure to montelukast. In 21 patients, the nightmares ended rapidly after discontinuing montelukast. When patients were re-exposed to montelukast, their nightmares reappeared. A study in Sweden also reported similar side effects. Of 92 cases, the most common reactions were nightmares followed by aggressiveness, sleep disorder, personality disorder, anxiety and hyperactivity. A vast majority (93%) of these reactions disappeared when the drug was stopped.

Drug-induced events can lead to unjustified psychiatric consultations and administration of more drugs with still more side effects. Unfortunately, it is not mandatory in India to provide drug information leaflets with medicines. So do check with your doctor about the possible side effects and ask for alternative medicines, if necessary.

Source: http://wonderwoman.intoday.in/story/beware-of-the-new-asthma-drug!/1/104685.html

 

Self-expiring medicine packet changes its look after the drugs have gone bad

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 Medicine packets are pretty generic looking, to say the least. Just go to your medicine cabinet and check out the blister packs and see how long it takes for you to identify which pill does what for your illness. Unless you have an efficient labeling system, you’ll have to read the complicated scientific name, remember why you have this in the first place, find the little print that says the expiration date, then decide if it’s the correct medicine to treat your conditions. Expired medicine can have side effects from either end of the spectrum – the pills can be deemed null and void, or become extremely fatal to consume.

That’s why one husband-and-wife designer and doctor team decided to come up with a new concept that reimagines medicine packaging. Gautam and Kanupriya Goel said the inspiration came to them after helping their grandparents clean out the pills cabinet. “In their frail states, with such limited vision and dexterity, they found it extremely challenging to read the expiration dates printed in these tiny five-point fonts on their medicine strips,” the Goels told Fast Co.Design. Instead, the concept packaging will contain specially-treated strips that change in appearance as the medicine expires. Rather than the fresh, clean foil that usually comes standard, the packet will show a chromatic warning that becomes so chaotic, patients won’t be able to read the details of the medicine if they tried. These special paper can change in any way pharmaceutical companies see efficient, such as a slow degradation to large X’s or turning from gray to red to denote expiration.

“Outside of the West, there is little awareness to the concept of a medicine becoming ‘expired,’” the Goels said. “We’re not even just talking about the market shelf-life of a medicine strip here. It’s alarming how little the average person understands how quickly a medicine becomes dangerous for consumption.”

In the United States, it is common for consumers to buy medicine by the box or bottle. Elsewhere, consumers can by drugs by blister packs or even by the pill, making it harder for users to locate important drug information. With the new packet concept, people can quickly identify which medicine to toss out even without reading. This is especially helpful around the world where people may not read or understand the complicated English names for various drugs.

While the concept is seemingly simple, there are plenty of regulation hurdles before the idea could ever be approved. Medicine is one of the most heavily regulated industries out there given the huge liability and all the lawyers that are ready to pounce on new products any chance they get. We can’t estimate how long it’ll take – if ever – for the Goels’ concept to come to reality, but it’s a useful one that’ll benefit all drug users young and old.
Reference: http://www.digitaltrends.com/cool-tech/self-expiring-medicine-packet-changes-its-look-after-the-drugs-have-gone-bad/#ixzz2bqRghY5Q

FDA prescribes legible writing for doctors

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While it is a given that most doctors write illegible prescriptions often seen as a ‘code’ that can be deciphered only by pharmacists, the Maharashtra Food and Drugs Administration (FDA) has decided that enough is enough. Doctors will not only have to write legibly but also a complete detailed prescription to ensure that there is no chance of wrong treatment leading to death.

In a move to lessen chances of compromise in patient safety owing to incorrectly written or interpreted prescriptions, the Maharashtra FDA recently constituted an 11-member executive committee for formulating specific guidelines for Rx or prescription of drugs.

The committee is presided over by FDA commissioner Mahesh Zagade with assistant commissioner (drugs) DR Gahane as member secretary besides representatives from Maharashtra Medical Council, Maharashtra Council of Indian Medicines, veterinary council and dental council, Indian Medical Association, State Pharmacy Council and Indian Pharmaceutical Association (IPA).

Gahane said the committee’s main agenda is to frame a set of legal requirements to highlight the way in which prescriptions should be issued by doctors in accordance with the provisions of the existing law.

“We would prepare a model prescription format. The prescription should be legible, mentioned correct dosage, strength, duration and alternatives. Most of this features are already mentioned in the Drugs and Cosmetics Act. We plan to strengthen the provisions by bringing in better clarity through guidelines,” said Gahane.

He added that if all goes according to plan, the committee plans to finalise the guidelines within three to four months.
The state drug regulator has formed the expert committee after observing an alarming rise in incidents which indicated that the prescriptions rarely comply with the rules as required leading to either inappropriate use of medications or overuse of antibiotics harming patient’s health.

Manjiri Gharat, president, community pharmacy division of IPA said frequently prescriptions are found to be incomplete, like omission of medicine strength, dosage instructions or duration of using the drug.

“Many prescriptions are illegible making it difficult to understand them. Many brands that have very similar names making interpretation for pharmacists tougher. This can lead to errors in dispensing medicines compromising patient safety. The FDA’s effort will bring uniformity in writing prescriptions across the state,” she said.

Alprazolam Information

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Alprazolam belongs to a group of drugs called benzodiazepines. It works by slowing down the movement of chemicals in the brain that may become unbalanced. This results in a reduction in nervous tension (anxiety). Alprazolam is used to treat anxiety disorders, panic disorders, and anxiety caused by depression.

 Important information about alprazolam

Do not use alprazolam if you are pregnant. It could harm the unborn baby. Do not use this medication if you are allergic to alprazolam or to other benzodiazepines, such as chlordiazepoxide , clorazepate , diazepam, lorazepam or oxazepam.

Before you take alprazolam, tell your doctor if you have asthma or other breathing problems, glaucoma, kidney or liver disease, a history of alcoholism, or a history of depression, suicidal thoughts, or addiction to drugs or alcohol

 Do not drink alcohol while taking alprazolam. This medication can increase the effects of alcohol. Alprazolam may be habit-forming and should be used only by the person for whom it was prescribed.  

Before taking alprazolam

 You should not take alprazolam if you have:

 •narrow-angle glaucoma; 

•if you are also taking itraconazole or ketoconazole 

To make sure you can safely take alprazolam, tell your doctor if you have any of these other conditions:

 •asthma, emphysema, bronchitis, chronic obstructive pulmonary disorder (COPD), or other breathing problems;

 •glaucoma;

 •kidney or liver disease (especially alcoholic liver disease);

 •a history of depression or suicidal thoughts or behavior; or

 •a history of drug or alcohol addiction. 

Do not use alprazolam if you are pregnant. It could harm the unborn baby. Alprazolam may also cause addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Use effective birth control, and tell your doctor if you become pregnant during treatment. Alprazolam can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using this medicine. The sedative effects of alprazolam may last longer in older adults. Accidental falls are common in elderly patients who take benzodiazepines. Use caution to avoid falling or accidental injury while you are taking alprazolam. Do not give this medication to anyone under 18 years old.