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| Our Compounding Knowledge, Your Peace of Mind | |
| July 5, 2019 | Volume 16 | Issue 27 | |
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Question: Why must we all suffer for the actions of a few that deliberately choose to break the law? Why does it seem that when we have specific and detailed standards, regulations, and laws (SRLs) governing pharmacy, that they seem to be continually enhanced, or made stronger, whether or not there is any justification for the action. Also, when there is a significant adverse event (e.g., NECC), where the pharmacy is intentionally ignoring the standards and regulations and breaking the laws, those in governing positions tend to make the SRLs even stricter when the lawbreaker wasn't even obeying the laws that were in place at the time of the infractions! In many leaders' opinions, the previous SRLs were adequate and sufficient and had been successfully in effect for a number of years. Answer:
The USP is designed to be a "science-based" organization, and their decisions must be based on sound and documented science. These chapters are not necessarily based on science, but "opinion." If scientifically based, there should be specific scientific references for the requirements in each chapter (not just an overall listing of general references). If not, the requirement should not be there. When literally thousands of comments are received about the chapters, one should realize that something is wrong and parts of the chapters are not workable! Are there rational, scientific, and justifiable reasons for the recent major changes in USP Chapters <795> and <797>? I don?t think so. If any changes needed to be made, they would be minor and could be easily changed (as has been done in the past) without an overhaul of the chapters. Also, the introduction of an overly onerous Chapter <800> is actually causing several pharmacies to cease compounding preparations, nonsterile and/or sterile! The bottom line is that PATIENTS WILL SUFFER! Many in decision-making positions tend to forget that all patients don't live in large cities with several compounding pharmacies reasonably close by. Hundreds of thousands of patients that depend upon compounded medications live in "small town USA" or in rural communities. They will not drive 50 to 100 miles or more one way to get their prescriptions filled every "2 weeks or whatever the artificial BUD happens to be." Instead, they will do without. This makes one wonder...who will be responsible for their loss in (1) healthcare, (2) quality of life, and (3) possibly even death? Whatever happened to "Common Sense"? REMINDER: For those State Boards of Pharmacy that are not adopting the USP chapters and are preparing their own or using their own modifications of the chapters, easily-modifiable alternative versions of Chapters <795>, <797>, and <800> have been prepared and are available as a free download for use by state boards of pharmacy to modify for their individual states at the following website.
Pharmacists may wish to download and send to your state board of pharmacy for consideration.
Note:"Initial Impressions of the Recently Released Final Revision of USP <797>" by Rad Dillon is available as a free download at the same website above. | |||||
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Interesting Note....What? A national retail chain pharmacist was recently written up for violating company policy. The violation: typing in new prescriptions (this is called data entry by the chains). Evidently, only technicians are allowed to "data entry" per company policy, and the highly educated/trained pharmacist should not be doing such. (Observation: During "prescription interpretation and data entry," many errors and potential errors are found and eliminated by pharmacists. One more safety check appears to have been eliminated...all in the name of $$$). | |||||
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Did You Know ... ...that Common Sense (CS) finally gave up the will to live after a woman failed to realize that a steaming cup of coffee was hot? She spilled some on her lap and was promptly awarded a huge settlement? | |||||
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Tip of the Week CS was preceded in death by:
CS is survived by his 5 stepbrothers:
Not many attended his funeral because so few realized he was gone. | |||||
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Looking Back Sleep in a chair,
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