Tag Archives: Generic Drugs

What are must be understood about generic medicines

When we buy medicine, maybe you will see two types of drugs, namely branded and generic. Its branded drug prices are much more expensive than generic medicines. Then, what about the quality of generic medicines themselves? of the articles below may help you understand what generic medicines.

Medical Author: Melissa Stoppler, M.D.
Medical Editor: Barbara K. Hecht, Ph.D.

Generic drugs are copies of brand-name drugs that have exactly the same dosage, intended use, effects, side effects, route of administration, risks, safety, and strength as the original drug. In other words, their pharmacological effects are exactly the same as those of their brand-name counterparts.

An example of a generic drug, one used for diabetes, is metformin. A brand name for metformin is Glucophage. (Brand names are usually capitalized while generic names are not.) A generic drug, one used for hypertension, is metoprolol, whereas a brand name for the same drug is Lopressor.

Many people become concerned because generic drugs are often substantially cheaper than the brand-name versions. They wonder if the quality and effectiveness have been compromised to make the less expensive products. The FDA (U.S. Food and Drug Administration) requires that generic drugs be as safe and effective as brand-name drugs.

Actually, generic drugs are only cheaper because the manufacturers have not had the expenses of developing and marketing a new drug. When a company brings a new drug onto the market, the firm has already spent substantial money on research, development, marketing and promotion of the drug. A patent is granted that gives the company that developed the drug an exclusive right to sell the drug as long as the patent is in effect.

As the patent nears expiration, manufacturers can apply to the FDA for permission to make and sell generic versions of the drug; and without the startup costs for development of the drug, other companies can afford to make and sell it more cheaply. When multiple companies begin producing and selling a drug, the competition among them can also drive the price down even further.

So there’s no truth in the myths that generic drugs are manufactured in poorer-quality facilities or are inferior in quality to brand-name drugs. The FDA applies the same standards for all drug manufacturing facilities, and many companies manufacture both brand-name and generic drugs. In fact, the FDA estimates that 50% of generic drug production is by brand-name companies.

Another common misbelief is that generic drugs take longer to work. The FDA requires that generic drugs work as fast and as effectively as the original brand-name products.

Sometimes, generic versions of a drug have different colors, flavors, or combinations of inactive ingredients than the original medications. Trademark laws in the United States do not allow the generic drugs to look exactly like the brand-name preparation, but the active ingredients must be the same in both preparations, ensuring that both have the same medicinal effects.

Reference: Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA), Generic Drugs: What you need to know. 2009.

Source : http://www.medicinenet.com

The use of generic drugs is a High Value Care way to improve health, avoid harms, and eliminate wasteful practices

In the development of the use of generic drugs, doctors should further support the use of generic drugs which are more affordable than expensive branded drugs. Generic drugs are supported by the government by the value of research and research is not cheap. With the same quality generic drugs should take precedence.

Conducted by members of the American College of Physicians’ (ACP) Clinical Guidelines Committee, the report is published in the Annals of Internal Medicine.

While the use of generic drugs has increased over time, the authors say that many health care providers continue to prescribe expensive brand-name drugs when cheaper generic alternatives are available – an issue that is likely to contributing to high health care costs; around $325 billion is spent on prescription drugs each year in the US.

By reviewing around 2,500 studies of prescription practices, the ACP assessed how often doctors prescribed brand-name drugs when generic alternatives were available.

The Committee also looked at how the prescription of generic medications affects treatment adherence, whether brand name and generic drugs produce similar clinical effects, what the barriers are to increasing use of generic medications and what can be done to overcome such barriers.

“The purpose of this article is to help guide internists and other clinicians in making high-value, cost-conscious decisions about the use of generic drugs,” the authors explain.
Generic drugs can be ‘just as effective as brand-name counterparts’

On assessing the frequency of brand-name drug prescription, the authors found that – as expected – health care providers often prescribe brand-name drugs over the generic equivalents.

They point to a 2008 study, for example, that found 23-45% of prescriptions for Medicare beneficiaries with diabetes were for branded medications that had generic equivalents.

Fast facts about prescription drug use

  1. Around 48.7% of Americans have used at least one prescription drug in the past 30 days
  2. More than 10% of Americans have used five or more prescription drugs in the past 30 days
  3. In 2010, more than 75% of doctor’s visits results in a drug prescription.

The authors estimated that for Medicare beneficiaries with diabetes alone, substituting brand-name prescription drugs for generic alternatives combined with therapeutic interchange – prescribing drugs that are chemically different but therapeutically similar – would save $1.4 billion.

The majority of peer-reviewed studies found that generic equivalents to brand-name drugs produced similar clinical outcomes, according to the authors, despite some physicians expressing concern that generic medications are less effective or cause more severe side effects.

“For example, a meta-analysis of 47 studies compared the effectiveness of generic and brand-name drugs in nine classes of cardiovascular medications and found no evidence of superiority of brand-name medication, including among anticoagulants and antiarrhythmics with narrow therapeutic windows,” they explain.

However, the ACP admit there are some situations where a brand-name drug may be more clinically appropriate than its generic alternative, or cases where prescribing an alternative is not possible.

The authors found that long-term adherence to treatment could be improved with increased prescription of generic medications, noting that prescriptions for branded medications are almost twice as likely to go uncollected after being filled than generic medications.

This is likely because brand-name drugs are significantly more costly than generic medications, though the authors note that the price of generic medications has been increasing recently.

Based on the findings of the report, ACP President Dr. Wayne J. Riley says:

 

“The use of generic drugs is a High Value Care way to improve health, avoid harms, and eliminate wasteful practices.”

 

 

 

 

 

 

Concerns about safety, efficacy of generic drugs fueling underuse

The authors cite a national survey that found, while most patients believed generic drugs were cheaper and better value than brand-name drugs, only 36% of Americans said they preferred to use them.

They believe the underuse of generic drugs is likely fueled by patient concerns about their safety and efficacy, with many believing that because they are cheaper, they will be less effective.

“Differences in the physical appearance of molecularly identical generics and between generics and their brand-name counterparts could also influence patient perceptions of efficacy or safety; such variations in pill appearance have been associated with higher rates of nonadherence,” say the authors.

Physicians are also concerned about the safety and efficacy of generic medications, according to the report, with one survey finding that around a quarter of doctors preferred that themselves and their family did not use them. Such a perception means that many doctors are unlikely to prescribe generic medications to patients.
Recommendations to increase prescribing of generic medications

Given the improved treatment adherence and cost savings associated with use of generic medications over brand-name drugs, the ACP concludes:

“Clinicians should prescribe generic medications, if possible, rather than more expensive brand-name medications.”

As such, the organization recommends a number of strategies to help increase prescription of generic drugs over brand-name drugs.

The authors suggest generic prescribing could be boosted through the uptake of electronic medical records, which will inform health care providers of the “formulary status of prescribed medications, as will be required by the ‘meaningful use’ criteria of the Affordable Care Act.”

Physician behavior could be altered through continued interactive education, such as academic detailing, according to the authors, who note that this could better inform doctors about the safety and efficacy of generic medications.

In addition, they suggest generic medications should be subject to similar public awareness and advertising campaigns as branded drugs; this may help change patient perception toward generic drugs.

Policy levers, such as tiered formularies – health plans incorporating lists of generic and brand-name drugs divided into groups based on cost and effectiveness – have proven effective for increasing use of generic medications, the authors note.

However, they point out that “current copayment differentials between generic and brand-name medications may not be sufficient to motivate generic drug use by some patients; thus, a need for further research about these behavior change tools also remains.”