Tag Archives: US

Consumption of generic drugs in the US increased

In 2015, the development of generic drugs in the United States increased their consumption. proving that socialization has gone well, and prove the quality of generic drugs the same as the branded drug. Here are some facts about generic drugs:

FACT: FDA requires generic drugs to have the same quality and performance as brand name drugs.  

Generics have the same quality as brand name drugs. When a generic drug product is approved, it has met rigorous standards established by the FDA with respect to identity, strength, quality, purity, and potency. However, some variability can and does occur during manufacturing, for both brand name and generic drugs. When a drug, generic or brand name, is mass-produced, very small variations in purity, size, strength, and other parameters are permitted. FDA limits how much variability is acceptable.
Generic drugs are required to have the same active ingredient, strength, dosage form, and route of administration as the brand name product. Generic drugs do not need to contain the same inactive ingredients as the brand name product.
The generic drug manufacturer must prove its drug is the same as (bioequivalent) the brand name drug. For example, after the patient takes the generic drug, the amount of drug in the bloodstream is measured.  If the levels of the drug in the bloodstream are the same as the levels found when the brand name product is used, the generic drug will work the same.
Through review of bioequivalence data, FDA ensures that the generic product performs the same as its respective brand name product. This standard applies to all generic drugs, whether immediate or controlled release.
All generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand name drugs, and the generic products must meet the same exacting specifications as any brand name product. In fact, many generic drugs are made in the same manufacturing plants as brand name drug products.

FACT:  Research shows that generics work just as well as brand name drugs.

A study evaluated the results of 38 published clinical trials that compared cardiovascular generic drugs to their brand name counterparts. There was no evidence that brand name heart drugs worked any better than generic heart drugs.

FACT:    FDA does not allow a 45 percent difference in the effectiveness of the generic drug product.

FDA recently evaluated 2,070 human studies conducted between 1996 and 2007. These studies compared the absorption of brand name and generic drugs into a person’s body. These studies were submitted to FDA to support approval of generics. The average difference in absorption into the body between the generic and the brand name was 3.5 percent. Some generics were absorbed slightly more, some slightly less. This amount of difference would be expected and acceptable, whether for one batch of brand name drug tested against another batch of the same brand, or for a generic tested against a brand name drug. In fact, there have been studies in which brand name drugs were compared with themselves as well as with a generic. As a rule, the difference for the generic-to-brand comparison was about the same as the brand-to-brand comparison.
Any generic drug modeled after a single, brand name drug must perform approximately the same in the body as the brand name drug. There will always be a slight, but not medically important, level of natural variability – just as there is for one batch of brand name drug compared to the next batch of brand name product.

FACT: When it comes to price, there is a big difference between generic and brand name drugs. On average, the cost of a generic drug is 80 to 85 percent lower than the brand name product.

In 2010 alone, the use of FDA-approved generics saved $158 billion, an average of $3 billion every week.

FACT: Cheaper does not mean lower quality.

Generic manufacturers are able to sell their products for lower prices because they are not required to repeat the costly clinical trials of new drugs and generally do not pay for costly advertising, marketing, and promotion. In addition, multiple generic companies are often approved to market a single product; this creates competition in the market place, often resulting in lower prices.

FACT: FDA monitors adverse events reports for generic drugs.

The monitoring of adverse events for all drug products, including generic drugs, is one aspect of the overall FDA effort to evaluate the safety of drugs after approval. Many times, reports of adverse events describe a known reaction to the active drug ingredient.
Reports are monitored and investigated, when appropriate. The investigations may lead to changes in how a product (brand name and generic counterparts) is used or manufactured.

FACT:  FDA is actively engaged in making all regulated products – including generic drugs – safer.

FDA is aware that there are reports noting that some people may experience an undesired effect when switching from brand name drug to a generic formulation or from one generic drug to another generic drug. FDA wants to understand what may cause problems with certain formulations if, in fact, they are linked to specific generic products.
FDA is encouraging the generic industry to investigate whether, and under what circumstances, such problems occur. The Agency does not have the resources to perform independent clinical studies and lacks the regulatory authority to require industry to conduct such studies. FDA will continue to investigate these reports to ensure that it has all the facts about these treatment failures and will make recommendations to healthcare professionals and the public if the need arises.

Source : http://www.fda.gov

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.”