Saturday, June 28, 2008

Safety takes priority over savings with generics

From the in Florida:

Mary Ellen Ross • My View • June 28, 2008

Times are tough. The cost of living is up, and finances are tight. So it's no surprise that everyone is looking for ways to save money.

One of the biggest targets for cost-cutting is health care. This is evident in Florida's Pharmacy Practice Act, which requires pharmacists to substitute medications prescribed by physicians for lower-cost generic drugs, if available.

This policy may offer immediate savings, but allowing critical treatment decisions to be made without a physician's approval is extremely risky — especially for organ transplant recipients.

Many post-transplant anti-rejection medications require complicated dosing based on specific patient characteristics, such as age, weight, ethnicity and many other factors. Because of these dynamics, consistent blood-level monitoring by a physician is needed to ensure that proper drug absorption is achieved for each patient. When drug substitutions are made, active physician and pharmacist communication is vital to ensure patient safety and treatment success.

Some argue that generic substitutions are chemically equivalent to both innovator (aka, "brand name") drugs and to each other; however, testing to determine chemical equivalence of generic substitutes focuses largely on active ingredients. There are other ingredients in many post-transplant anti-rejection medications that may affect patient response and lead to severe side effects — including infection and organ rejection — which can lead to costly emergency care and hospitalization.

We also must consider that testing for chemical equivalence in generic substitutes is conducted among healthy subjects, so there is no guarantee of therapeutic value because unique patient characteristics and conditions — such as age, weight, ethnicity and other illnesses and medications — can alter a drug's effectiveness.

Physician involvement is vital not only for innovator-to-generic substitutions, but for generic-to-generic substitutions as well. Studies show that ingredients other than the active ingredient in variant formulas of the same medication can impact absorption and alter the patient's blood drug level, requiring close blood-level monitoring.

Consider, for example, the different octane levels of gasoline. Depending on its make, model and year, a car may experience an increase in performance when running on high-octane gasoline. The smallest difference in octane can cause changes in performance and even potentially expensive complications. Consumers who understand these dynamics willingly spend more money for increased performance.

The same understanding must be applied to post-transplant anti-rejection medications. Regular and frequent drug substitutions — done purely to save money — will cost patients and coverage providers more in increased office visits and lab tests. Organ transplant recipients expect and deserve to have their physicians make the final choice on medications and treatment — and physicians' medical judgments and treatment directives should be respected.

A provision of Florida's 2008-09 state budget calls for a study — to be conducted by the Florida Department of Health — to determine whether the Pharmacy Practice Act requirements for drug substitution properly allow for patient safety, physician input and treatment success. The study does not seek to end mandatory generic drug substitutions; rather, it seeks to conduct an evaluation on the effect this measure truly has on safety and savings. It will show how best to meet the needs of all patients, including organ transplant recipients.

Gov. Charlie Crist should be commended for his vision, for his understanding of a complex medical issue and for putting patient safety above financial concerns by signing the state budget with the provision for this study left intact.

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