Posts Tagged FDA
Switching from a brand name medication to an available generic medication is safe, easy and will likely save you a lot of money. Thanks to the work of the FDA, generic medications in the United States are quite safe. Patients in the US take more generics than in other countries.
When a patient starts a new brand-name drug (e.g. Lipitor) there is a risk of a side effect or allergy to the active ingredient. But, when a patient switches to a generic medication (e.g. atorvastatin) the patient already knows the active ingredient agrees with them so the chance of a reaction is as close to zero as medical science can make it.
Prescribers are well aware that some generic medications may come in different forms (tablets or capsules) and different strengths — this is not a problem, the prescription just has to be adjusted to match what the patient needs. Most care providers are quite willing to make the change to help lower the cost of treatment — patients tend to take medications they can afford!
The Wall Street Journal had a story today based on the opinion of a “pharmacist-economist” who has been a lead author on only one paper in the past 20 years and who thinks tablets and capsules of the same medication are distinct entities (yes, but it makes no practical difference). The WSJ is clearly interested how the switch to generics affects the economics for big pharma — it would not be good and the stocks could go down — such a disaster. However, if you have stock in a brand-name company you could use your stock dividends to pay for the drug.
The new bio-similar drugs and even some old drugs (like warfarin) may have a slightly different effect that depends on some minor manufacturing quirk. Prescribers are well aware of these peculiar drugs and can easily make adjustments and do tests as needed. Fortunately, small manufacturing differences for the vast majority of drugs is a distinction without a difference for the patient.
This principle needs to be considered in everyday terms. The table salt at restaurants may come from separate and distinct sources — it really makes no difference to the customer — salt is salt! Marketing departments want you the think a generic is like coal and a brand-name is like diamond — intellectual garbage.
It’s likely the actual shelf life of your medications is much longer than the date printed on the box. Medications required “as needed” often sit in the bottle for a long time — patients wonder when they should be discarded but really don’t want to pay for another expensive prescription. Heidi Mitchell of the Wall Street Journal describes this problem in her story 8/25/14 “Are Expired Medications OK to Take?”
The military has the shelf-life problem on a large scale — numerous doses of medications are stockpiled in case of an emergency. Fortunately, in 2006 the military commissioned the FDA to study the problem — just as we all suspected, most medications last much longer than the expiration date — on average 5.5 years longer.
Medications fail the shelf-life tests if there is a significant loss of potency, leakage, crumbling of pills, loss of pressure within an inhaler, mold growth or bacterial contamination. The latter two problems are mostly with liquid medications and are manifest by a cloudy or discolored appearance.
Although most medications last much longer than expected there are some cautionary notes: Don’t keep medications for emergency life-saving situations beyond the expiration date. This would include insulin, nitroglycerin and injectable epinephrine. Also, medications requiring refrigeration should not be kept beyond the expiration date. Many medications exposed to high temperatures (such as in an automobile glove compartment for several summer days) may deteriorate rapidly and are probably best discarded.
All medications, stockpiled or not, need to be kept out of the reach of children.
Medications don’t become poisonous with storage but they can become less potent. A pain pill that is 10% less potent is actually not much of a problem — most people can’t notice a 10% change.
So, if the military stockpiles medications 5 1/2 years beyond the expiration date so can you — save some money!
Elisabeth Rosenthal wrote the lead story for The New York Times today (10/13/13) “The Soaring Cost of a Simple Breath“. This is another blockbuster exposé of drug costs that are crippling US health care. Sadly, not a story about what is being done to correct the problem.
Here are some of her key points:
- The average brand name prescription has risen from 1995 at $40 to 2013 at $170
- The average generic prescription has risen from 1995 at $20 to 2013 at $45.
- A common asthma medication Pulmicort costs $175 in the US but only $20 in the UK and $25 in France.
- Drugs account for 10% of the $2.7 trillion annual health bill.
- Americans take more generic medications than people in other countries (they just can’t afford branded or new medications)
- Other countries set the wholesale price of drugs to make drugs affordable.
- US pharmaceutical companies have used the FDA to restrict manufacturing rules to favor large companies and have used the judicial system to bankrupt competitors.
- US pharmaceutical companies have paid generic companies not to sell their products in the US.
- Medicaid, paid for by taxes, pays millions of dollars to drug companies for high priced medications.
- Asthma medications have been the target of profiteering drug companies. Not a single inhaler is available as a generic. Despite the fact that inhaled medications have been available for over 30 years. The effect on people with this condition is a tremendous burden.
- Drug companies spend about 50% of funds on marketing and only about 20% on drug research. Other advanced countries prohibit marketing prescription medications directly to consumers.
- Medicare is prohibited from negotiating prices.
- Drug prescribing guidelines published by the government are prohibited from considering cost.
Rather than just be angry about the sorry state of drug costs, what can be done? Just take a lesson from other countries, this is not rocket science:
- The US government should set the prices for all drugs
- The FDA needs to loosen the rules for generic manufacturing — for goodness sake, an inhaler is an inhaler, not the space shuttle.
- Comparative effectiveness research should be required, and the results published for doctors as in the UK. Drug cost is important to all US citizens, so restricting the government from considering cost borders on insanity (perhaps giving psychiatric medications to Congress is currently too expensive).
- Finally, there is no excuse for the current drug cost problem — other countries have solved the problem, the US needs to do the same.