By the standards of “good journalism”, the lack of balance, the lack of interest in even talking with pro-compounding prescribers or pharmacists, is appalling.
You’re thinking: “This ain’t a new problem. What set you off?”
Well, I’ll tell you. It was this sentence in a health.com piece this week on FDA’s recent warning about compounded ketamine nasal spray:
The drug [Spravato] is the only FDA-approved ketamine-based nasal spray, but compounding pharmacies are creating their own, unregulated versions of ketamine nasal spray and selling them to people who can use them without the requirement of going to an approved healthcare provider.
A licensed prescriber — almost certainly one with expertise in treating psychological disorders – makes the judgment that an FDA-approved therapy is not right for his or her patient — perhaps after the patient has been through the litany of FDA-approved therapies already — and so he or she writes a prescription for compounded ketamine – there’s obviously some research suggesting it may help the patient when nothing else has, even though it’s off-label — and sends it to a licensed pharmacy where a licensed pharmacist with expertise in prescription drugs collaborates on dosing, and then operating within state and federal law and rigid USP standards, dispenses the medication to the patient with the understanding that the physician-patient relationship is such that monitoring of administration of the drug and follow-up is being provided by that physician.
What is unregulated about any of that?!
Pardon the rant. It’s just the final straw in a year in which I’ve seen otherwise intelligent reporters refer to compounded medications as “knock-offs” or “concoctions” or worse; or lump compounding in with sketchy non-pharmacy direct-to-consumer providers of research-grade API; or simply swallow what opponents of compounding tell them without bothering to dig a little – you know, just in case there may be another side to the story.
The point is, words matter. Precision matters. Compounded drugs are not knock-offs. Compounded drugs are not unregulated. Far from it. But you wouldn’t know that from what you read in the news.
As with Tom and Jerry, the mouse never gets a fair shake, does he?
Scott Brunner, CAE is APC’s ranter-in-chief. Contact him at email@example.com.