This episode this week is a call to action to all your pharmacists out there, people working in pharmacies and to all of you out there who actually care about patient safety medication use, and actually really decreasing drug costs in the United States and drug costs to pharmacies and drug costs to patients and drug costs throughout the pharmacy chain. On December 23rd, 2019 the FDA published a proposed rule, the drug importation rule from Canada.






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What you will learn

  • What is the FDA proposed Drug Importation Rule
  • How the FDA Rule would put patient Safety at Risk
  • How the Rule jeopardizes the Canadian drug supply
  • The convoluted process that will cripple pharmacy operations
  • Drug costs will not be lowered
  • The solution to high drug costs….the elephant in the room STOP THE PBM’s

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This is Michelle Sherman, president of MichRX Pharmacists consulting services, and your host for the conscious pharmacist podcast. Welcome to this week’s episode. This episode this week is a call to action to all your pharmacists out there, people working in pharmacies and to all of you out there who actually care about patient safety medication use, and actually really decreasing drug costs in the United States and drug costs to pharmacies and drug costs to patients and drug costs throughout the pharmacy chain. On December 23rd, 2019 the FDA published a proposed rule, the drug importation rule from Canada.

I’m speechless for a moment because really does the FDA think that this rule that they’ve created if implemented, is actually going to decrease drug costs in the United States? I failed to see how this is actually going to decrease drug costs. And so does the American Pharmacist Association NASBA or other pharmacy organizations out there. So this is your chance listeners to get your voices heard. Let the FDA know why this rule. It’s going to jeopardize patient safety. Gonna jeopardize the pharmacy drug chain and is actually going to disrupt pharmacy operations throughout the country. Let’s, let’s look at this rule just a little bit and see now we have to have the FDA approval rule so that we could import drugs from Canada that have to go through a whole process so that the FDA acknowledges this process, get those drugs into the supply chain and then somehow that’s going to decrease drug costs to our patients.

Is it going to decrease drug costs and improve reimbursement to the pharmacy? I fear not. We’ll go through this rule just a little bit and in the notes we, we’ve got the link to the page on the American pharmacist association page. The video of why this matters, that gray outlines this rule where you can really see that that’s not going to be a benefit at all to anybody. And it’s just going to create more mayhem in a healthcare system and a drug supply chain and a pharmacy system that is rote with me, him, instead of simplifying the process, they’ve made it more cumbersome. So we’ll go through a little bit of the process and let you know what you can do to let your voice be heard. Come on, people, I’ve talked about this before. Stand up, scream, rant and rave. Let your voice be heard.

It’s time we let our voices be heard as pharmacists so that we can take care of our patients and stop this crazy that’s going on in our healthcare system. It’s up to us. And APH J has created a letter to let the FDA know your opinion. We can let them know we’ve got to stop this rule. So first of all, importing drugs from Canada. Why would we import drugs from Canada when we have the drugs right here? Why are we focusing on decreasing the drug costs right here in the United States? First of all, importing drug costs, drug drugs from Canada. What about the Canadian population? When we see how big the U S population is versus the Canadian population, are we now going to just like completely deplete the drug supply chain in Canada for our use? That’s really not going to make a difference in the end to drug costs.

And what about the Canadian population and the needs for the drugs that are going to be imported? That seems like a self-serving, selfish attitude to deplete drug drug supplies in one country to bring them to another in a convoluted process only to have no significant changes. So how would that work? So a manufacturer in Canada would have to then link to a foreign seller who would be a wholesaler or some distributed licensed by the Canadian health system who would then have to go to an importer who would be a pharmacist or wholesaler who would then have to import the drugs into the United States and create a supply chain, which would either be the patient, the pharmacist, or the wholesaler, and they would have to implement strategies that, that match those with the FDA. So if a Canadian drug has to be comparable, a U S approved drug would then have to change the NDC number on their chain.

The United States has the drug supply chain security act. The DAC is a, or the track and trace rule with a drug has to be tracked from each specific bottle, from the manufacturer through the entire convolution of the supply Trek chain till it eventually ends up on the pharmacy shelf. So those pieces in some form would have to be put in place, not to undermine the DAC. Say, look at all these touchpoints. If our healthcare system is not complicated enough with way many ti with way too many cooks with a broth that’s already rotten. Now we’re going to import drugs from Canada and create worst convolution. How I asked you are costs going to go down? Why are we doing this? So this undermining of DACs if this convolution of all the touch points that have to go be put into place before the ends up on the pharmacy shelf and then when it does end up eventually on the pharmacy shelf, the pharmacy has to keep us brands.

It has to keep the Canadian brands. It’s going to cause complete mayhem and disruption in a pharmacy workflow and pharmacy operation that’s already stretched way too thin because pharmacy reimbursements are like ludicrous right now. How is this going to work? It’s not. And at the end of the day, what cost savings is the patient going to achieve? What cost savings is the pharmacy going to benefit from? Really none. This is a convoluted process that’s going cause may him in the drug supply chain that is already completely paralyzed and crippled that needs improvement not more convolution. Why would we want to import drugs from another country to lower drug costs here when the solution people is steering us right in the face, it’s a three letter solution. It’s a P B M solution prescription benefit manager. If we input port drugs from Canada, do you really think that the PBMs are going to lower drug costs and lower day food?

You learned criminal thieving tactics, never. They still going to be taking all the money dictating the reimbursements to the pharmacy dictating drugs that patients can take. There is no way that PBMs are going to lower drug costs just because of drugs imported by Canada. Let’s just think about that for a second. If you go around any pharmacy shelves and look at generic brands and look with those generics are manufactured. Many of those are manufactured in countries other than the United States. So many of our generics are manufactured in India and other places and then imported into the United States already. We’ve already seen in previously that the FDA clearly has no adequate oversight of these manufacturing plants in other countries. We’ve seen problems in the manufacturing supplies in the manufacturing practices in these, in these places, and we’ve had drugs recalled because of this. So the FDA is already doing a very bad job monitoring the facilities that they have in other countries for importing drugs that have clearly not shown clearly these generics have not shown decreases in drug cost to the patient, to the pharmacy, and anywhere in the supply chain in any way to this absolutely criminal healthcare system that we have absolutely none.

So why in heaven’s name do we think that importing drugs from Canada is really gonna make a difference when again, it’s a three letter solution PBN. If we regulate or just completely get rid of the PBMs and we stop having all these touch points between the manufacturer and the actual production of a drug to the provision of the drug at the end to the patient from the pharmacy. And we eliminate all these middlemen, especially PBMs, literally raping and pillaging a healthcare system, destroying lives by increasing costs to patients, to pharmacists, decreasing reimbursements. That’s where we’re going to decrease drug costs and save the life. Put the pedals on the life and the chest of our healthcare system is to get rid of the PBMs or regulate the PBMs in such a way that they stop making hundreds of billions of dollars in profit. That’s where the crippling effect comes to in our healthcare system, not by importing drugs from another country.

It’s going to make zero difference whatsoever. Create more re red tape and convolution to an already crippled system. Let’s act now to all the pharmacists out there listening to the show. Heck, now you can do that. Always, as I say, become advocates in your community support and join your local, state and national organizations. This is a chance for you to download the APH a letter that’s in the show notes here. Also on the link to the APH, a post regarding this FDA rule. Please act. Please write your letter, putting your comments, send it to the FDA so that they can hear from us how bad this rule is and how importing drugs from Canada is not going to improve drug costs. In fact, it’s going to be a detriment to patient safety in the United States. Not only in the United States, but a detriment to patient safety in Canada as well.

Let’s think about people in Canada not getting access to their own drug supply chain because those drugs are being sent to the United States where people like PBMs are profiting on, that patients are not getting served, patients are not getting the drugs they need in Canada or in the United States at a reasonable cost and people will die. So let your voice be heard that the FDA know about this rule. Do it today, do it this week. Those those letters have to be submitted to the FDA by March 9th let your voice be heard. It’s your time to act now. So we don’t jeopardize the supply chain. We don’t jeopardize patient safety. And most of all, we take action against PBMs and they the FDA know that this rule, the way it’s written is not going to work. And importing drugs is not going to decrease drug drug costs. Remember, it’s up to you people, until next time, be the change.