बुधवार, 7 मई 2014

Are you taking the right pills?

A little knowledge about the drug you are using can ensure 

that you don't fall prey to medication errors.

Are you taking the right pills?

I believe that the doctor who orders, the pharmacist who dispenses, the nurse who administers or the patient who accepts the drug should be held responsible for medication errors leading to complications

A medication error is any preventable event that may cause or lead to inappropriate medication use or harm patients while the medication is in control of the healthcare professional, patient or consumer. According to the National Co-ordinating Council of Medication Error Reporting and Prevention, this may also involve ordering, prescribing, distributing, labeling, administrating, monitoring and using. One must differentiate between adverse drug reactions, drug interactions, and prescription errors.

So a little knowledge about what a drug does goes a long way. It is wise for patients to determine the generic name of a drug that has been prescribed to him -- for what it is being used, what side effect are possible, and what the recommended dose is and for how long it is to be taken. It may be also important to ask what you should do if you miss a dose and will it interfere with any medication you are taking. An estimated 1 million medication errors occur every year that contribute to 7000 deaths.

A colleague of mine was once perplexed because his patient had become semi-comatose. It was later found out that instead of a digestive tablet, he was given an anti-diabetic drug of similar sounding name. Hence his sugar level had become extremely low and he had become semi-comatose. This, in my opinion, was a drastic error. It left one lesson in my mind that when I find a patient not doing well, I pick up and examine the medication that he has with him to ensure that he is taking the right medicines. Unfortunately in this city there are no pharmacists in chemist shops and the shops manned by people with little education. Many of them pass of similarsounding drugs as the same drug, a drastic and even fatal mistake at times.

Many hospitals have used computerised physician order entry. Such system reduces medication errors by 85%. In such instances when a physician orders medication, the computer checks the safety and appropriateness of the order and it is electronically sent to the pharmacy. This curbs the need of the pharmacist. It is also helpful because doctors who write prescriptions usually have horrible handwriting. For example, I myself get at least 2 calls a week from chemists, who are unable to read my handwriting.

I had once asked them whether they face this problem on a daily basis, or is my handwriting the worst - absolutely illegible -- they said that this is a perennial problem that they deal with.

A study done in 2010 and published in the prestigious New England Journal of Medicine said that 25% of patients are harmed by medical care. Another study published in Health Affairs in 2011 stated that the standards hospitals used to detect medical errors fail over 90% of the time. Approximately, 1.3 million people are injured annually in the United States following medication errors.

People above 60 years are mostly affected by fatal medication errors. This is not surprising because they take multiple medications. In 2006, a study by Institute of Medicine Study stated that medication errors are among the most common medical mistakes.

According to this study, 4,00,000 preventable drug-related injuries occur each year in hospitals; 8,00,000 in long term care and roughly 5,30,000 among medicare recipients in out-patient clinics. In a single year, the extra medical costs by preventable drug-related injuries, is approximately $887 million.

I believe that the doctor who orders, the pharmacist who dispenses, the nurse who administers or the patient who accepts the drug should be held responsible for medication errors leading to complications. A little care from everyone will help prevent drug related disasters.

Generic Drugs: Questions and Answers

What are generic drugs?
A generic drug is identical -- or bioequivalent -- to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price. According to the Congressional Budget Office, generic drugs save consumers an estimated $8 to $10 billion a year at retail pharmacies. Even more billions are saved when hospitals use generics.
Is there a generic equivalent for my brand-name drug?
To find out if there is a generic equivalent for your brand-name drug, use Drugs@FDA, a catalog of FDA-approved drug products, as well as drug labeling.
You can also search for generic equivalents by using the "Electronic Orange Book." Search by proprietary "brand" name," then search again by using the active ingredient name. If other manufacturers are listed besides the "brand name" manufacturer when searching by the "active ingredient," they are the generic product manufacturers.
Since there is a lag time after generic products are approved and they appear in the "Orange Book," you should also consult the most recent monthly approvals for "First Generics".
Are generic drugs as effective as brand-name drugs?
Yes. A generic drug is the same as a brand-name drug in dosage, safety, strength, quality, the way it works, the way it is taken and the way it should be used.
FDA requires generic drugs have the same high quality, strength, purity and stability as brand-name drugs.
Not every brand-name drug has a generic drug. When new drugs are first made they have drug patents. Most drug patents are protected for 20 years. The patent, which protects the company that made the drug first, doesn't allow anyone else to make and sell the drug. When the patent expires, other drug companies can start selling a generic version of the drug. But, first, they must test the drug and the FDA must approve it.
Creating a drug costs lots of money. Since generic drug makers do not develop a drug from scratch, the costs to bring the drug to market are less; therefore, generic drugs are usually less expensive than brand-name drugs. But, generic drug makers must show that their product performs in the same way as the brand-name drug.
How are generic drugs approved?
Drug companies must submit an abbreviated new drug application (ANDA) for approval to market a generic product. The Drug Price Competition and Patent Term Restoration Act of 1984, more commonly known as the Hatch-Waxman Act, made ANDAs possible by creating a compromise in the drug industry. Generic drug companies gained greater access to the market for prescription drugs, and innovator companies gained restoration of patent life of their products lost during FDA's approval process.
New drugs, like other new products, are developed under patent protection. The patent protects the investment in the drug's development by giving the company the sole right to sell the drug while the patent is in effect. When patents or other periods of exclusivity expire, manufacturers can apply to the FDA to sell generic versions.
The ANDA process does not require the drug sponsor to repeat costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness. This applies to drugs first marketed after 1962.
What standards do generic drugs have to meet?
Health professionals and consumers can be assured that FDA approved generic drugs have met the same rigid standards as the innovator drug. To gain FDA approval, a generic drug must:
  • contain the same active ingredients as the innovator drug(inactive ingredients may vary)
  • be identical in strength, dosage form, and route of administration
  • have the same use indications
  • be bioequivalent
  • meet the same batch requirements for identity, strength, purity, and quality
  • be manufactured under the same strict standards of FDA's good manufacturing practice regulations required for innovator products

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