| As we are all aware the United States Congress
passed sweeping legislation to the Medicare drug benefit in late
2003. Beginning in 2006, Medicare beneficiaries will have access
to the standard drug benefit outlined below. The drug plan will be
provided through private prescription drug plans that contract with
the Medicare program. Although drug plan sponsors may change some of the specifics of the plan, the benefit offered must at least contain the standard benefit. Standard coverage includes:
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$5 for all other drugs, or 5% of the price,
once an enrollee’s out-ofpocket
spending reaches a limit of $3,600. Beneficiaries with limited savings and low incomes will receive a more generous benefit package. For instance, beneficiaries with limited savings and income below 135% of the federal poverty line ($12,123 for individuals and $16,362 for couples) will receive:
Discount Card Medicare beneficiaries that do not have drug coverage will be eligible for the Medicareendorsed |
Prescription Drug Discount Card, which will
begin operation sometime in June 2004 and continue until the full benefit
is implemented. The card program is estimated to save beneficiaries
between 10% and 25% on most drugs. Individuals with incomes below 135%
of poverty will be given immediate assistance through a Medicare-endorsed
prescription drug discount card with $600 annually to apply toward
purchasing their medicines The Medicare system was developed more than 40 years ago. To that end, this is the first major change to Medicare with regard to providing a drug benefit. This bill does not offer true full coverage for our seniors; however, it is a good first step. We will continue to lobby Congress to make amendments that are commensurate with what our seniors need. |
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| On January 1, 2004, United States Pharmacopeia (USP)
Chapter <797> became the standard of practice for pharmacy compounding
practices in the United States. The document, known as General Tests
and Assays Chapter 797 or “Pharmaceutical Compounding-Sterile Preparations,” is
the revision of the general information chapter 1206, “Sterile Drug
Products for Home Use” and provides procedures and requirements for
compounding sterile preparations. The chapter was moved into the General
Tests and Assays portion of USP, which has chapter numbers less than
1000. The USP is a quasi-governmental agency, chartered by Congress
to set official standards of drugs and have done so since 1906. This means that <797> can be enforced by State Board of Pharmacies and used by FDA personnel to determine whether a drug has been adulterated. According to Carmen A. Catizone, Executive Director of the National Association of Boards of Pharmacy (NABP) as interviewed in AJHP, Vol 60, Sept 15, 2003, USP chapters can be enforced by a state board of pharmacy, but only if that board stipulates so in its regulations. Chapters that become the standard of practice in pharmacy can also be enforced by a state board of pharmacy, he added. The USP does not have any enforcement authority over pharmacies or any other practice settings. Historically, attorneys have used USP chapters as the standard of practice over state board of pharmacy practice acts, especially if the regulations don’t adequately address the matter being tried. As published in the chapter’s preamble, the standards of chapter <797> apply to all practice settings (health care institutions, pharmacies, physician practice facilities and other facilities) where sterile preparations are prepared, stored and dispensed. Patient injury and deaths have been related to compounding errors. |
Although state and federal governmental
agencies may not enforce USP <797>, in the event of patient injury
and death, the standard of care that
the provider of compounded sterile preparation will judged against
USP
Chapter <797>. What should you do in order to be in compliance with USP <797>? Obtain a copy of USP 27-NF 22 by visiting USP’s website at http://store.usp.org/OA_HTML/ibeCCtpSctDspRte.jsp?a=b. Eric will present this topic in April at NJSHP Chapter meetings.
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