Editorial: HEADLINE: Prescription Drugs Unavailable!
*80% of toys in the United States come from China (USA Today, Oct. 5, 2007)
*Over 60% of crude oil is imported into the United States (http://www.gravmag.com/oil.html)
*Most electronics are imported into the United States
*Imported automobiles reaching new records
*Most drug substances are imported into the United States for manufacturing and compounding
It seems like we are becoming a "consumer nation" instead of a "producer nation." What kind of a situation are we getting ourselves into? With most drug substances for pharmaceutical companies and for compounding pharmacies coming primarily from China and India, what might happen in the future? What are the possibilities of the following?
Drug shortages may increase due to the difficulty in getting quality drugs imported through U.S. Customs for meeting the demand in the U.S.
- The U.S. is already dependent upon importing drug substances from other countries.
- If political relations deteriorate, the U.S. can be held "hostage" if the drug substances are held back until demands are met. Imagine the U.S. without antibiotics, hormones, cardiovascular drugs, and others.
- As with the oil industry, the cost of drug substances will increase, resulting in an increase in the cost of the final pharmaceutical product to pharmacies and to consumers.
- We have outsourced chemical synthesis of drug substances (partly due to rigid OSHA and EPA requirements), and pharmaceutical companies have taken the "economic" way out by outsourcing to countries where it can be done cheaper without all the environmental regulations.
The downside to participating in a global economy is being a consumer nation, rather than a producer nation, because we are no longer independent. In summary, it is quite possible that the desire for short-term profits by outsourcing to other countries is going to result in a catastrophic event in the supply of needed medications in the U.S.
Think about it!
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
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U.S. Representative Jim Cooper, D-Tennessee, who is seeking a new commission to tackle the pending crisis in entitlement programs, stated that means testing is going to be a necessary part of all our entitlement programs. We simply cannot afford the promises we've made.
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Just a reminder...
Testing requirements for potency testing are different than beyond-use dating (BUD) or stability testing.
Potency testing provides you with concentration information. This information can be used to check your compounding processes.
Stability or BUD testing should be conducted using a high-performance liquid chromatographic stability-indicating method. This is a method which has demonstrated chromatographic separation of drug ingredient from its degradant product.
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