Not only is October American Pharmacists Month, a time to recognize pharmacists for the great care they provide to communities, but October 27th is also the Drug Enforcement Agency’s (DEA) National Prescription Drug Take Back Day.
The day is designed to highlight a program that provides a safe and responsible method for patients to discard prescription medications from their homes and learn more about the risk of abuse with controlled prescription medications. The DEA website has a collection site locator, where Americans can find the exact location to discard their medications safely. The website also has a Substance Abuse and Mental Health Service (SAMHSA) Behavioral Health Treatment Services locator, it’s confidential and helps individuals find resources in their area.
Tagged with: controlled drugs, National Prescription Drug Take Back Day, opioids
The role of the Internet as a channel to obtain and misuse prescription narcotics is tiny.
A report published by the Substance Abuse and Mental Health Services Administration (SAMHSA), a division of the U.S. Centers for Disease Control and Prevention, blamed the Internet for 0.1% (one tenth of 1%) of all narcotic abuse. That data was from 2015. The latest such report, which is called the National Survey on Drug Use and Health has new data from 2017 that doesn’t even have a category for the Internet.
It’s hard to tell if the new number is lower or higher than 0.1%. While 0.1% appears to be statistically insignificant, people have died buying narcotic prescription drugs online and all channels of abuse need to be addressed.
Drug Companies Want to Hide Lower Drug Prices from Americans
On the other hand, drug companies are lobbying Congress to crackdown on Internet companies about opioids, but what they really want is for Americans to stop using the Internet to access lower prescription drug prices from Canada and other countries. In fact, drug giant Eli Lilly wants to censor the Internet by removing Canadian online pharmacies from Google search results in the U.S. Let’s address opioid sales online with a scalpel, not a sledge hammer. More importantly, let’s put resources into treatment and use law enforcement where it’s most needed.
According to the government’s survey, of the 11.1 million people who misused prescription opioids, here’s how they obtained them: 53.1% from a friend or relative; 36.6% from a doctor’s prescription; 5.7% from a drug dealer; and 4.6% some other way.
I don’t know why SAMHSA removed the Internet as a category but believe there are two possible answers:
One, the internet channel was statistically insignificant.
Two, the incredibly small percentage, 0.1%, did not fit the agenda of the pharmaceutical industry to blame the Internet for illegally obtained prescription narcotics.
The data showing that only 0.1% of Americans who abuse opioids get them online doesn’t justify the major crackdown on the Internet desired by the pharmaceutical industry.
Yes, drug companies can lobby Congress and federal agencies to have questions removed and added to research on matters that affect them. The FDA has never reported a person seriously sickened or killed by buying medicine internationally from an online pharmacy that requires a prescription. The safest international online pharmacies don’t sell opioid medicine or any controlled drugs.
What does the category “some other way” account for according to SAMHSA?
“Some other way includes write-in responses not already listed in this table or responses with insufficient information that could allow them to be placed in another category.”
That means they didn’t ask about the Internet, but people may have written it in. I’ll update this post when I find out more about it.
As drug companies continue to pressure Congress about stopping personal drug importation by censoring the Internet, it’s important for consumer advocates to stay on top of this data. As I wrote last week, if you look closely, the law, ironically, defends personal drug importation – even if it’s technically illegal.
Let’s beat the opioid crisis without stopping people from safe personal drug importation of non-opioid, non-controlled products.
Tagged with: Online Pharmacy, opioids
This week, our nation’s great senators passed a bill, the Opioid Crisis Response Act (OCRA), to fight back against the opioid epidemic. You think we’re stuck in partisan gridlock? Well, think again: the bill passed 99-1. This is how it goes down when Pharma is cool with a bill. Big Pharma can unite Congress like no other industry, organization or, certainly, president can. This bill passed unanimously (almost), because senators don’t want to vote against a bill that is seemingly dedicated to tackling opioid addiction. But some provisions, ones that may curtail access to safe personal drug importation, are unrelated to opioids and you can smell Big Pharma working behind the scenes.
There’s some easily digestible intrigue relating to this bill and personal importation, but the language itself is obscure and annoyingly technical as well.
Let’s start with the intrigue.
A bill numbered H.R. 6, passed the House in late June 2018. The bill was called: “Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act or the SUPPORT for Patients and Communities Act.” [To find it via the link provided, click the bill text, and then use the dropdown to find the version of the bill on June 28th, 2018]. That earlier H.R. 6 included the following language:
“(c) DEFINITION. – For purposes of subparagraph (B), the term ‘pattern of importing or offering for import articles of drug’ means importing or offering for import articles of drug describes in subclause (I) or (ii) of subparagraph (B)(ii) in an amount, frequency, or dosage that is inconsistent with personal or household use by the importer.”
That language applies to both the bill itself and the existing statute, which further complicates things, but the gist is simple:
The author of that language wanted to make clear that this legislation should not affect small, personal or household quantity medication imports.
After the bill passed, 396-14, it went to the Senate, specifically the Senate Committee on Health, Education, Labor and Pensions (HELP), led by the chair, Senator Lamar Alexander (R-TN) and ranking member, Senator Pat Murray (D-WA). In HELP, I believe that Senator Alexander crossed out H.R. 6 and added a whole new bill in the form of a substitute amendment. That substitute amendment, without vote or a committee conference report, removed the language above that was protective of personal imports.
Go to the bill H.R. 6. [After clicking the link, you’ll see “AMENDMENT” – “Strike all after the enacting clause and insert the following.” That’s what I mean by replacing the entire bill with a new one; one that contains new language and omits other language.]
This backroom editing and revising of bills often undermine the democratic process but is sadly commonplace in Congress. Large industry trade associations know how to play the game to make sure those revisions and edits work in their favor. There is no better player than the Pharmaceutical Researchers and Manufacturers of America (PhRMA) and their allies.
But what the hell does that definition above mean and pertain to anyway?
It relates to something called debarment. Under federal law, specifically Section 301 (cc) of the Food, Drug and Cosmetics Act, Title 21 U.S. Code 331, a person who is debarred cannot be involved in certain work relating to FDA-regulated industries.
There is mandatory and permissive debarment. We’re just concerned with permissive debarment here. Current law mostly calls for debarment of individuals who have committed felonies and misdemeanors – crimes. HR 6 amends this language by adding to that list:
“[a] person [who] has engaged in a pattern of importing or offering for import…adulterated or misbranded drugs”
And by adding the bolded text as you see below to define a Prohibited Act:”
“The importing or offering for import into the United States of an article of food or a drug by, with the assistance of, or at the direction of, a person debarred under section 335a(b)(3) of this title”
Let’s say you buy your cholesterol and asthma medication from Canada on a regular basis.
That’s a pattern. Under federal law, because of the Canadian label, the medications are misbranded, even if they are the exact same drug as the one sold here. In theory, this patient and/or a person who has helped that patient can be debarred from doing so.
There you have it. Now you see why that original language was in there to protect such people who import medications that are consistent with personal or household use by the importer – not resale.
Synthetic Trafficking and Overdose Prevention Act (STOP)
Another part of this bill that threatens importation are the provisions taken from the Synthetic Trafficking and Overdose Prevention Act (STOP Act). The STOP Act’s stated goal is to stop illegal imports of fentanyl and other drugs. The STOP Act is focused on making changes to our system of regulating international mail shipments. Small import packages come through international mail facilities without tracking in the way that FedEx, UPS, DHL packages are required by law to be tracked. If you order a drug from a Canadian pharmacy, the U.S. Postal Service delivers it to you. When Chinese fentanyl ingredient traders want to get stuff into the U.S., it also goes through the USPS via international mail facilities. So, the STOP Act creates new rules for the USPS to know what’s coming in with the goal of stopping illegal drugs.
The STOP Act can be great because it will be harder for opioid dealers in the U.S. to import the ingredients or finished opioid drugs that wreak havoc on our people. It’s potentially bad because the FDA very well might use this to stop “other drugs,” such as personal imports of lower-cost medicines, because it will be easier to do with the advanced data about incoming mail packages required under the new regulations. It’s certainly concerning because the drug companies and their allies have invested time and money to highlight, as a negative, that Americans receive their lower-cost medications via USPS.
Creating and Restoring Equal Access To Equivalent Samples Act (CREATES) vs. Higher Medicare Drug Prices
Now that different versions of the bill H.R. 6 have passed the House and Senate, the two chambers meet in conferences to create one version for the president to sign. To add insult to injury, behind the scenes, Pharma is trying to add language that would erase new discounts in Medicare Part D slated for 2019. On the other hand, drug price advocates are trying to get language in there to push through the provisions of the CREATES Act (Creating and Restoring Equal Access To Equivalent Samples Act).
Simply put, now, brand drug companies sometimes make it hard for generic drug companies to acquire the pharmaceutical samples they need to create a lower-cost generic. If CREATES goes through, generic drug companies could more easily obtain these samples. That would facilitate faster generic availability and save patients and taxpayers money: about $3-4 billion. The just outcome is Pharma losing its pitch to ditch the Medicare savings and then CREATES makes it in the bill! I’ve heard talk about horse trade.
What does this bill do to curtail the opioid epidemic? It will help, but it’s not even close to what is needed. I’m not going there at the moment, but here’s Politico’s take. Since there’s some good stuff in there, Congress feels obligated to go for it; so here we are. As I’ve shown you, Pharma’s many allies in Congress have used this bill to sneak in stuff that is unrelated to opioid addiction that Pharma wants – including taking a jab at importation and lower drug prices in other countries.
Tagged with: Opioid Crisis Reduction Act, opioids, politics, Synthetics Trafficking and Opioid Prevention Act