Wednesday, December 3, 2014

Thank you to all the readers who are sharing comments. Here are some recent ones.



5 comments:


Anonymous said...
The pharmacy I have been going to compounds, My problem with that is that last month about half my script was not medication but all buffering agent. I complained and the owner/Pharmacist said that that is IMPOSSIBLE !! It is a fact, why on earth would I lie. My hand to god I came home from the pharmacy after being told they had to make more and they wouldn't be able to fill until the following day. OK NO PROBLEM !
I get back home and they call and say they have half ready, and I can pick up the remainder in the am. So I go pick it up and get home I take one and an hour later no relief, I take another, still no relief......Hmmmmmmm...so I opened one of the capsules up and low and behold its all buffering agent. If you know opiates you can tell by the taste....NO MEDICATION ONLY BUFFER !!!!!
about half my script was no good.....Then she puts in the computer no compound on my profile, which basically means no meds. They claim to never have the tablets, but I know other people who go there and they get the tablets every month, personally I think they save the tablets for specific people, people who the owner/ Pharmacist is friends or friendly with. The owner from day one has not liked me for whatever reason.....If she liked me I would have no problem getting the tablets each and every month. Another thing is that the tablets and the compound are the same price. They make up this compound and they decide how much actual medication goes into them VS Buffering agent...I know other people who go there and I have heard that some of the employees are on pain meds with no prescription.....How do you think that works....they give me and others capsules with all buffer and they keep the actual medication for themselves. I don't know how they get away with what they do there. I am scared to even go to my appointment this month because if I am unable to fill there now, I go out of county to a doctor. No doctor here in Brevard county will see me because I have liver disease. So I basically have to go out of county, then there is only that one pharmacy that wil fill out of county prescriptions.
I have one more doctor that I plan to try and get into see this month if he refuses to write my pain meds, I don't have any other options left. There is one other pharmacy that I have been trying to get into for over a year, he fill out of county but has told me each month that he is waiting for an allotment increase which never happens. He has a specific amount of patients that he fills for and until a spot opens up, I am S*** out of luck.....The kicker is that he is the ex husband of the owner/pharmacist that I have mentioned earlier in my post. CRAZY RIGHT !!!!!!!
What am I supposed to do ????? Die in pain and suffer while I wait to die. How unfair is that.
They want a heroin nation....they are going to get what they want....I sure hope not !!!
Anonymous said...
"is this real life?"
Anonymous said...
Anytime a filler is used with solid powders, there is a risk that the person preparing the compound may not achieve content uniformity before finishing the dosage form--this means that some capsules may be sub-potent (too little active ingredient), with little active ingredient. Perhaps more worrisome, other capsules in the same prescription may be super potent (too much active ingredient).

Pharmacists may not realize how difficult it is to achieve content uniformity with blended powders. Think about powders with different physical-chemical properties--some ingredients might be light and fluffy, like baking soda, some like dense crystalline sugar. What happens when you try to mix these ingredients with flour? In the old days, pharmacists added a color dye to powders in zip-lock bags using a method casually referred to as "shake and bake"--once the powder mixture looked relatively uniform in color, content uniformity was assumed to be achieved. This is sketchy, however, because the properties of the dye and interactions of the dye with ingredients are unknown. Depending on the properties of the container in which the powders are mixed, some ingredients may flow freely while others appear to stick to the walls of the container. In drug manufacturing, content uniformity is one of the most difficult hurdles to overcome for mixtures, in particular multi-active-ingredient formulations.

Information asymmetries between drug formulation scientists and drug compounders; information asymmetries between drug compounders/marketers and prescribers, information asymmetries between drug compounders and patients, and finally, information asymmetries between sellers of chemicals and formulas and pharmacists may give rise to indirect, hidden risks for patients.

See FDA limited survey of compounded drugs, including figure 1, showing content uniformity http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm204237.htm
Anonymous said...
The information asymmetries may be a hairline crack in a sidewalk, posing little if any risk, or they may be wide uneven cracks that create a tripping hazard, or they may be chasms, posing a significant risk of injury and harm. But unlike cracks and chasms--you will not see the information asymmetries and may be unable to protect yourself (if you are a patient) or your patients (if you are a doctor or pharmacist).

Drugs that meet conditions for exemptions to new drug, certain misbranding and GMP provisions of the FFDCA under section 503A are not required to carry disclosures, but, states will be surveyed on benefit-risk communication in an upcoming GAO study.

How can that be, a well-known patient advocate once said, when even strands of holiday lights have multiple warning stickers? The purchasing of holiday lights does not generally require a learned intermediary--the use of dangerous drugs does. Then who is responsible for identifying and addressing the information asymmetries when unapproved drugs are prescribed, compounded and dispensed/administered?

Stay tuned!

Question of the Day December 3, 2014 If it cost 2.6 Billion to bring a new drug to market (leaving aside the issue of how much illegal compounding of drugs have driven up the cost on that) what is the incentive to go that route instead of just mass producing compounded medications from formulas bought from compounding organizations much as some are doing now? Why not just move to a market where all drugs are compounded with little oversight and regulations? Why or why not? Is that where we are headed with the compounding pharmacies becoming mega compounders bought up by corporations? Then compounding pharmacies would no longer have big pharma or anyone else to blame for some of the very issues they have brought on themselves. Everyone could also keep the personalized medications they want and shop around for the compounder who will make them at the cheapest prices? In other words go back to pre-FDa, pre-manufactured drug days? Good idea, bad idea? Why or why not?

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