I have been working on a post covering this topic but wanted to go ahead and pose the question. Should sales representatives, marketing directors or anyone who sales or markets compounds regardless of his or her title be bound by a code of ethics? By this I mean, other professions have code of ethics--specific rules and regulations that they as a profession must adhere to or be sanctioned or removed from the profession--shouldn't these folks also have a similar set of rules and regulations, in addition to the pharmacy rules and regulations-setting forth the standards they must maintain and follow. Just as a pharmacist, doctor, and lawyer must be registered in each state, a person selling or marketing these compounds must also be licenced and registered in the state he or she is selling the compounds in. There are numerous items these ethics could include--everything from what the person can say when marketing or selling, to prohibited relationships with customers and employees. To be able to sell compounded medications, an individual would have to pass both an ethics and a knowledge based test appropriate for the type of compounds to be sold.
4 comments:
By requiring compounding sales people to be knowledgeable on all products that their company compounds, you have just moved them into the realm of manufacturers. Compounding should be the art and science of mixing medications for the specific needs of the patient at the request of a physician. There is no way a marketing rep who is marketing the service of compounding would even know what the doctor would prescribe before the patient is even seen, let alone be able to learn enough about it to take a test. That is definitely putting the cart before the horse. A manufacturer could teach it's people about a particular set of drugs they make. However, a pharmacist must actually make several new formulas per day to keep up with the demand of the physician. Compounders will never know exactly what they will be doing from one day to the next unless they have crossed the line and have become manufacturers.
As far as an ethics course, there are laws that must be followed or the whole business could be in jeopardy. This should suffice, though even the laws get muddled. On the other hand, ethics is a matter of morals. We have seen a decay in morals to the point where they have become relative. What might be seen as moral to one may not seem so to another. Until we can come to an agreement on what is moral, that is too big of a moving target. So the only thing enforceable becomes the law. Sometimes laws and morals don't even agree. Is it morally right to not treat a patient and let them suffer or die? What about when the law (or more often than not, an interpretation of the law) says that you are not allowed to treat them? Compounding itself is an example of that. Many lives are saved daily by compounded medications. This gets forgotten in the debate on how to make things safer. Yet the FDA decided in 1989 that all compounding is illegal, because to them, a compound is a new drug. They created an ethical question for all pharmacists when they decided to put forth this new interpretation of the law. I would submit that ethically we are bound to help patients even though an agency has said we can't. Even now, they hold the ax over our head and say they are "exercising regulatory discretion." So, do we want to create more gray area then we already have?
I was not suggesting that know specifics about the compounded medications per se. Instead, I was suggesting they cannot make false claims as to what the medications can do which I realize they can't and shouldn't do now, but something to make it a fairer playing field for marketing reps who are and do want to play by the rules. Ethics are morals. Lawyers follow an ethics code. Doctors follow an Ethics code. In the legal world it is irrelevant whether I think it is moral to sleep with a client--my ethics rules say it is unethical and I can be disbarred. Likewise, it should be unethical for the pharmacist to sleep with the marketing rep or the marketing rep to sleep with the client notwithstanding what morally each of those people think is right. The FDA's current position is not that all compounding is illegal as I understand it. I was not suggesting we create more grey area. In the legal world our ethics are fairly clearly defined for us. And we know the potential consequences if we violate them. The goal would not be to hard the good reps, but to get rid of the bad reps who give the good reps a bad name. Anyway, it was just a thought. I appreciate your comments.
You are right about the claims part. There shouldn't be claims. The problem comes when we try to define the definition of a claim. In my non legal way, I would think that a false claim is saying that a drug will do something that it will not do. The FDA’s definition of oa claim is anything that is outside what they have approved. Compounds are not FDA approved, so stating any possible outcome of a compound would be a claim to the FDA. The FDA has determined that even a testimonial by a patient constitutes a claim. How can a compounder tell of the successes of one doctor to other doctors so that better treatments can be spread around? As regulations get tighter and the interpretations of those get even more strict, a pharmacist or their rep will not be able to talk about any product. That is what the FDA got placed into FDAMA in 1997 (the infamous advertising clause), but was later ruled unconstitutional by the Supreme Court. What I see now are end-runs. I have been taught we can't even use studies unless they were approved by the FDA.
The problem this gag causes is that if doctor x finds something good, the only people that hear about it are those he tells. Our little pharmacy has two examples where we could save people millions and reduce suffering for many people, but I can’t tell the doctors without making an illegal claim. The FDA has not approved these. I don’t have the millions to get approval, because contrary to popular belief, we actually take home less money that we would at a regular chain drug store
How do I share about a vitamin compound that has literally restored the sight for some people with diabetic retinopathy or have been repairing nerves, as seen in MRI's, and has helped with neuropathy? We are spending billions a year to treat these problems as a society, yet because of an FDA interpretation of a rule I can't share the good news? Or how about a new way of administering amino acids that reduces or relieves craving and withdrawal symptoms of alcohol and amphetamine addiction in about 10 minutes according to the addicts? If I were to actually say that to others, and associate that to a drug, I have made a claim. Sure it is anectodtal and has not been approved by the FDA. Does that mean the doctors should not be able to even hear about it? Do we believe they are so stupid that because I said we have seen good results they will act like a zombie and prescribe it? What happened to building relationships with colleagues for the purpose of learning more? Are we going to stop all progress until the FDA has determined it to be worth looking into? Those are just two of the things that our pharmacy has found that can help mankind. Yet I cannot tell the people who can make a difference.
I guess you can see my frustration. How do the good guys continue to help when our hands are tied and our mouths are gagged? I know there are bad players. But some of the rules smack more of a power grab than a move for public safety. I just watched an addict die who asked for this new treatment 2 years ago, but I couldn't tell the doctor about it in a way that made sense because I am the marketer. How has that helped the public?
P.S. I would love to read your 101 series, but don't have access. How do I get the access?
Also, please keep up the good work. Education is the key. There are bad players on both sides of the issue, but I believe that the majority will make the right decisions if they know the facts and the ramifications. I have been involved with our State to formulate regulations for compounding over the last 12 years. They gave me your website two weeks ago. I just believe that knowledge and access to good compounding pharmacies is a key to public health. Anything that restricts that access, does the public more harm than good. Since the NECC tragedy, we have save more lives (both animal and human) at our little pharmacy than has been lost total so far from NECC. Imagine if that number was multiplied across the entire US. I just don't want the baby thrown out with the bathwater.
I do see your frustration. And I know there are good people out there trying to do the right thing and help the right people. Thank you for your words of encouragement about the blog. The purpose of this blog has been to educate. I, myself, learn something new everyday about compounding and the benefits of it.
My 101 series and other articles I have published are hyperlinked on the left hand side of the blog if you have a computer. If you are using a mobile app they are also scattered throughout the blog and can be found by searching for 101. Here is a list--
101 Series on this Blog
Change 101: & Update on Change 101: What Are the Pros and Cons of the FDA Regulating Some or All of Compounding?
Credibility 101: A Compounding Pharmacy, Pharmacist, its Sales or Marketing Representative and a Checklist
Damage Control 101: What Does the Compounding Industry Need to Do?
Education and Enforcement 101: Do Pharmacist Really Need More Laws, Regulations, and Rules to Comply With or Is What They Really Need Is Enforcement of the Laws, Regulations, and Rules on the Books and Training of the Inspectors to Enforce Those Laws, Regulations, and Rules?
Enforcement 101 Revisted: What the FDA and The State Boards of Pharmacy Are Missing In the Veterinary Compounding World
Marketing 101: Where Have All the Good Guys and Girls Gone in the Compounding Pharmacy World
Notice 101: When Will Someone, Anyone, State or Federal Notice All the Veterinary Compounding Pharmacies That Are Violating The Law?
Passion 101: Our Work Is Not Done in the Compounding Legal World
Price 101 : Why the Cost of Compounded Medications Should Not and Cannot Be A Factor in Deciding Whether to Purchase from a Particular Company
Purging 101: Like in Life to make room for the good things and people, we purge the bad and unhealthy ones ....SO To Make Room for all the Great Compounders Don't We Need to Get Rid of the Bad, Unhealthy Ones
Author, Joint Defense Agreements: Could It Help Your Client, Oklahoma Bar Journal, March 1998
Author, King for a Day, An Overview of Qui Tam Litigation Under State and Federal Law, Oklahoma Bar Journal, May 1999
Author, The Fifth Amendment Privilege Against Self-Incrimination: Walking the Tight Rope in Parallel Civil and Criminal Proceedings, Oklahoma Bar Association, October 2002
I couldn't get the hyperlinks to copy and paste into the comments but if you email me at stuckrichmond@gmail.com I will try to send the article to you that way if it would be easier for you to read them.
Sue
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