Generic Medications: Safe and Cost Effective

April 5, 2011

Generic Medications: Safe and Cost Effective

As a physician my duty is to help the patients with their problems and work to not only give them a diagnosis, but to also determine an appropriate treatment.  For me that treatment must have 2 criteria.  First it must be effective and show clinical evidence of this effectiveness.  That is why the drug companies spend billions of dollars on studies and trials.  They want to show me that their new drug is better than their or someone else’s old drug.  This is good practice but this all adds to the cost of the drug to manufacture.  That brings me to my second criteria, cost.  It does no good to prescribe the latest and greatest medication to a patient if they can’t or can barely afford it.  Often patients will skip doses of cut these pills in half because they are expensive and they are trying to make due.  Doing this makes the treatment less effective so in turn they end up spending more for a less effective response while on these meds.

One of my greatest accomplishments of my medical career came while in residency.  I had a new patient who transferred to me from her old doctor because he no longer would accept Medicare.  This is happening more often than most would think.  When I reviewed her medication list she was on a number of the latest and greatest that the pharmaceutical industry had to offer.  However, one of her concerns was that she could not afford all of her medications so she was picking and choosing which ones to buy in a particular month.  Needless to say, none of the medical problems she was being treated for were under control and many were getting worse.

She and I sat together and review her entire list and I compared it to the Wal-Mart $4 drug list (which at that time was the only $4 drug list available).  I adjusted her medications and changed her monthly drug expense from $480+ to about $82 a month.  All by switching her fancy new once daily medications to the tried and true twice daily generics.  This ended up saving her a ton of money but also got her medical issues under good control.  She was shocked that her prior doctor didn’t take the time or bother to ask if she could afford all that he had written for her.  Unfortunately some physicians don’t think about these issues, but that needs to change.

Generics have gotten a bad rep in the past but that seems to be changing.  According to the Food and Drug Administration (FDA), a generic drug is identical or bioequivalent to its brand-name counterpart in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. The current FDA criterion for bioequivalence for both branded and generic drugs is a 0.8 to 1.2 confidence interval. Tighter confidence intervals would result in many branded and generic products not being bioequivalent to themselves.
The question remains are generic and branded drugs interchangeable in the case of narrow-therapeutic-ratio (NTR) drugs? These drugs (such as warfarin, quinidine, procainamide, theophylline, lithium, phenytoin, carbamazepine and valproic acid and thyroid medications) are used in clinical situations where small variations in tissue levels might result in sub-therapeutic or toxic clinical outcomes. The FDA makes no distinctions between standard and NTR drugs when it comes to interchangeability. NTR drugs do require frequent adjustments and careful patient monitoring, regardless of whether a brand-name or generic product is being used. However, the FDA does not recommend that physicians perform additional testing when switching NTR drugs or any other drugs, whether from branded to generic, generic to branded, or generic to generic.

When a patent on a drug expires, the FDA generally grants a single generic-drug manufacturer the exclusive right to produce the generic drug for six months. This generic typically costs 20 percent to 25 percent less than the brand-name drug. (Recently, when Prozac became available as generic fluoxetine, the retail price fell from $85 to $68 per month.) After six months, multiple generic manufacturers often enter the market and costs plummet 50 percent to 80 percent.

Generic products are less expensive because they do not require lengthy clinical trials to prove their safety and effectiveness and because they are infrequently marketed to physicians and consumers. Generics are allowed into the market as a means of encouraging competition, lower prices and innovation within the industry.  Not to mention that all of these generics were the latest and greatest new medication at some time in the past.  This means they still are effective and safe due to their extensive track record.�

My bottom line is your bottom line.  I will always start a patient on a generic medication first and if necessary will change to a new brand name if we have exhausted all generic alternatives.  The majority of the time I am able to keep my patients on the generic formulation of their medications.  The best thing a patient can do to help their pocket book is to bring in their insurance formulary which will list the preferred generic as well as branded medications that will be covered.  These are sent out every year with one’s insurance premium updates and information.  That way you can help me help you.

One Comment
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    Bob G

    Great perspective on generic medications, Dr. Isherwood! I have always found it particularly troubling when a pharmaceutical company launches and patents a "branded" product that is a slight variation of a tried and true medication and charges as much as 20 times the price of the generic. As a pharmacist, I have always felt that my role is not only to ensure that prescriptions are filled accurately, but also appropriately as well. To my thinking, appropriate therapy encompasses many different criteria including safety and effectiveness of the medication, appropriate dosing, timing and duration, drug /drug interactions, drug / food interactions, and patient specific concerns (including cost). Pharmacists are trained to understand all aspects of medication therapy and also have the resources to best identify the most cost effective solutions for an individual patient. With the increasing demands on physicians, it makes sense to utilize the expertise of the pharmacist to help manage the complexities of patient's medication therapy. I have always felt that this is one of the differentiation for the Alegent Health Pharmacies. There is much outcome based research that supports the value of pharmacist Medication Therapy Management (MTM) programs. These have shown to not only decrease cost for the patient but also improve compliance and adherence to medication therapy. Informed patients tend to take their medications more consistently and correctly. This leads to improved therapeutic outcomes and reductions in overall healthcare costs which translates into a healthier population.

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