PHARMACIST STEVE

FDA issues the rules all other agencies must follow. No agency outranks FDA

AMA welcomes CDC’s revised view on opioids guidelines

After posting these last night and pulling the title of the posts from the article itself…  I started reviewing the “whole game” that is being played out between the DOJ/DEA, FDA, CDC  and countless other agencies and healthcare corporations and provider that are struggling with the CDC guideline.

I have stated many times before, that the one agency that is completely silent and/or missing from the conversations is the DEA .

In all of this, what has not been revised is the Controlled Substance Act (1970)  (CSA) and it appears that the DEA’s authority in using the CSA apparently remains UNCHANGED.

This is how the DEA could keep screwing with the chronic pain community:

 

 

• The DEA controls the licenses of those who produce, prescribe or dispense controlled meds.
•  The Pharmas:  the DEA still can raise/lower the annual production quotas that each pharma is allowed to produce each year. Opiate Rxs peaked in 2012 and end the ensuing years, the DEA has already decreased production quotas have been DECREASED abt 50% of what was allowed in 2012.
• Wholesalers: the BIG THREE (Amerisource, McKesson, Cardinal controls about 80%+ of the medication market in the USA. Walgreens owns part of Amerisouce – not sure if it is a minority or majority interest. Cardinal is the primary wholesaler for CVS and Mc Kesson is the primary wholesaler for Rite Aid. The wholesaler Rochester Drug Cooperative, Inc – that was recently fined by the DEA for failing to report suspicious large pharmacy orders… it was reported that they are a “major wholesaler”, but they are really part of the “secondary wholesaler market” and are really “small potatoes” in the overall wholesaler market place.  In Jan 2017, Mc Kesson paid 150 million fine ( https://www.justice.gov/opa/pr/mckesson-agrees-pay-record-150-million-settlement-failure-report-suspicious-orders ) for the same violation that Rochester Drug Cooperative, Inc was accused of and at least one of Rochester’s exec is facing 10 yrs in jail.  DEA licenses wholesalers and can fabricate charges against wholesalers, fine the crap out of them and suspend the DEA licensed to one or more distribution centers.
• Prescribers:  We have seen the DEA fabricate charges and raid prescribers offices, close their practice down, use civil asset seizure laws to confiscate all their assets and put them in the DEA’S coffer.  We have also seen the DEA use nothing but the number of Rxs and/or doses to justify a raid on a practice.
• Pharmacies: Pharmacies are licensed by the DEA, Pharmacists do not have a DEA license.  CVS was recently fined 535 million because the DEA claimed that several stores filled a total of 39 bogus C-II Rxs  https://patch.com/rhode-island/woonsocket/cvs-fined-535-000-filling-fake-opioid-prescriptions
• Pharmacy & Medical licensing boards:  These boards usually “play along” with the DEA in fining or “busting” providers.  The Medical board is mostly staffed with DEA licensed prescribers and Pharmacy boards are mostly staffed with non-practicing corporate Pharmacists – whose chains that they work for does have DEA licenses in their pharmacies.
• Then there is that part of the controlled substance act “Corresponding Responsibility”  ( https://www.deadiversion.usdoj.gov/21cfr/cfr/1306/1306_04.htm ) A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.  Because the DEA’s statutory authority only concerns the diversion of controlled substances for illegitimate uses.. they have no authority – and thus doesn’t have to care – if valid prescription does not get filled and the valid medical need of a pt is met.

So with this revision of the CDC guidelines and the FDA getting on board, the authority and the actions of the DEA against all DEA license holders and chronic pain pts could remain unchanged.

We know that the DEA abt 4 yrs ago “forced” all of the drug wholesalers to RATION controlled substances to pharmacies which is a violation of the Interstate commerce law ( https://www.britannica.com/topic/interstate-commerce-United-States-law ) but when the entity (DOJ) that is suppose to be enforcing this law is the same entity that is causing the law to be violated… who do you turn to ?

You can ask the same question about the Americans with Disability Act and the discrimination against chronic pain pts when they are denied acceptance into a practice, a Rx filled at a pharmacy or some other issue ?

Hypothetical:  FDA/CDC and other oversight agencies implement policies and procedures that legit chronic pain pts are entitled to getting adequate pain therapy, but the DEA has continued to lower the pharma’s annual quota… wholesalers don’t have to forcibly ration controls to pharmacies …there will not be enough production to cover all the needs of acute and chronic pain pts.

Previously, I have been told that some pharmacies made sure that their “regular pts” got their pain meds and others fill controlled meds on a first come … first serve basis… when they ran out of a particular med towards the end of the month… everyone of their regular pts are just OUT OF LUCK ?

We all hear routinely, that the illicit use/abuse of controlled substances has DESTROYED families, but no one talks about how the CDC opiate dosing guidelines and their implementation has destroyed families as chronic pain pts have had their pain management therapy reduced or totally taken away.  

Let’s hope that the changes that are coming out from the CDC and FDA do not end up doing more damage than the original launch of the CDC opiates dosing guidelines has caused over the past three years because of the DEA, DOJ and our politicians being entrenched in believing that opiate prescribing to treat chronic pain is the gateway to people using/abuse illicit drugs and ODing.

They are using laws and breaking laws to deny pain pts their necessary medications… and IMO… the chronic pain community is never going to get justice and their needed medications unless they get their dollars together into a legal defense fund to level the playing field by engaging law firms or lobbyists to help us do that.

Filed under: General Problems