By Terri A. Lewis, PhD
It’s time to call a spade a spade. Our government leaders have no idea what they are doing or why. Healthcare policy has become a massive game of SWAG. Science has slipped the bounds of earth. And it looks like it’s going to take a while to settle down.
The Center for Medicare Services (CMS) fully intends to implement CDC’s flawed opiate prescribing guidelines ( https://www.cdc.gov/drugoverdose/prescribing/guideline.html ) as policy. The citations for CMS’ Opiate Misuse Strategy 2016 is found on these link: https://www.cms.gov/Outreach-and-Education/Outreach/Partnerships/Downloads/CMS-Opioid-Misuse-Strategy-2016.pdf. They propose to issue revisions to the retrospective drug utilization review criteria used to identify potential opioid over utilizers (>90 MED/day) to better align with the CDC guideline on opioid prescribing, reduce false positives, and maintain a policy that is still manageable for drug plan sponsors; and, propose to establish the expectation for sponsors to implement hard formulary-level safety edits based on a cumulative morphine equivalent dose (MED) approach to prospectively prevent opioid overuse at point of sale at the pharmacy.
This “Big Brother” approach to fighting opioid abuse reinforces the assumption that the root cause of the opiate overdose crisis is found in Grandma’s medicine cabinet, and adopts a strategy that encourages pharmacists to become clinical gatekeepers, to report doctors who they believe may be overprescribing opioids, and to report patients who they believe may be abusing them. Information about these “potential opioid over-utilizers” is to be shared with insurance companies, which will be empowered to “prevent opioid overuse at point of sale at the pharmacy.” Nothing in this policy affords the physician or the patient due process. Disclosure, or appeal rights. They have issued an Advance Notice and Draft Call Letter for Medicare Advantage and Part D drug plans to implement the opiate prescribing policy. CMS will accept comments through this AdvanceNotice2018@cms.hhs.gov on all proposals through March 3, 2017, before publishing final versions on April 3, 2017. The link to this call letter is found here:
At the same time, in a parallel universe, other sectors of government are pushing for reduction of opiates and pharmaceutical pricing by increasing the use of compounded drugs to support epidural injection and pain pump applications. This theory of applied pain management suggests that as the distribution of opiates in pill form is reduced, the use of epidural steroid and joint injections and installation of pain pumps is expected to increase. As we speak, the Veterans Administration has issued defective solicitations for the supply of ‘FDA approved’ compounded drugs to support epidural steroid injections and IV applications. The logical problem here is that (1) FDA does not regulate or approve compounded drugs in any form, and (2) there is no such thing as a compounded drug whose sterility can be assured by any approval process associated with FDA oversight because (like the Bowling Green KY massacre) these regulatory oversight processes don’t exist within current standards.
Compounded drugs are produced in one of two types of facilities under the Drug Quality Safety Act (DQSA, 2014) – (a) a facility that produces for instate distribution purposes like a hospital or local pharmacy, or (b) a facility that is registered with FDA to produce compounded drugs in large quantities for distribution and sale across state lines in accordance with commercial rules of business practice. The first type of facility is regulated by state pharmacy boards. The second type of facility is inspected by state pharmacy boards with enforcement regulated by state pharmacy boards. The problem herein lies with the fact that the majority of state Pharmacy Boards have so far failed to enact regulations to provide adequate oversight of producing facilities of either type under the DQSA. A quick review of registered facilities and their associated deficiencies can be found here: https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm378645.htm
We have emerging evidence through both FDA inspections as captured on Fm483s, patient injuries (you know who you are) and mass casualty events such as the New England Compounding Center (NECC) disaster of 2012 that tells us that our assumptions about the safety of compounding under USP 757 should be strongly questioned. Barry Cadden, owner of NECC and investor in a sister company, Ameridose, is currently on trial for the distribution of contaminated compounded medications to 75 clinics in 21 states. Here, at least 13,500 individuals were exposed to contaminated medications, 800 were sickened, and 76 deaths were documented. Mr. Cadden, his Pharmacy Director, and 14 of his employees are charged with 25 counts of second degree murder and racketeering. Many, but not all, of the clinics involved have contributed to a nationwide bankruptcy settlement fund in order to avoid prosecution for their role in contributing to this catastrophe.
The evidence available for review by the Department of Justice offers us rare insight into the workings of compounding organizations under existing state and federal requirements. We can observe clearly the gaps in regulatory oversight. From this evidence we are able to infer that current inspection systems under USP 797 (https://www.usp.org/sites/default/files/usp_pdf/EN/USPNF/usp-gc-797-proposed-revisions-sep-2015.pdf) are inadequate to protect the health and safety of individuals who rely on sterile compounded drugs produced in large quantities. Products produced by these organizations rely on a process of self-certification as to their conformance with a standard of identity, performance efficacy and safety. FDA does not regulate or oversee compounded products produced for sterile applications and product verification is not part of the inspection protocol utilized under this standard. As we see in the evidence submitted in the NECC trial, products sold into the commercial trade by this large supplier were frequently out of date (past their shelf life), subpotent (missing or not enough of the active ingredient), super potent (too much of one or more of the active ingredients), or contaminated by bacteria and fungi. The source of supplies incorporated into these medications can be derived from any domestic or foreign source without disclosure to the customer – their conditions of production and verification of their performance is neither assured or verified. When physicians purchase compounded drugs, they frequently lack the business practices to protect patients from the purchase of impaired supplies or the knowledge about the performance of these supplies to properly counsel patients as to risks, benefits, safety or efficacy. This makes informed consent nothing more than a farce.
So what’s a person to do when seated at the Mad Hatter’s Tea Party?
First, understand the context in which your medications are prescribed. Under the proposed CMS rules, you’re going to have to do some homework with your insurance company. Call them and find out how they plan to implement and how your medications will be affected. Identify their procedures for appeal and provide them to your physician. Begin now to document the needs that you have for continued care. Make sure you have a dedicated pharmacy and that your needs are a matter of record.
Second, if you are pushed to accept the use of injections or pumps that rely on compounded drugs, and you and your physician together decide that this represents a reasonable alternative, make sure of the following:
(a) Know your source and do not accept any medications from a compounding pharmacy with open issues as documented by a Form483.
(b) Medications are developed for single use applications only – you should be provided with a label that contains your name, the product name, the lot code, the expiry date, the ingredients, and a certificate of analysis (COA) that provides assurance that finished drug is exactly what they claim it to be at the time it was sold. You should be provided with a copy of this information and it should be entered into your medical records for recall purposes.
(c) Make an appoint with your physician to review their business practices – ask them to inform you about their ordering practices, their inspection and receipt verification (which should include production information placed into their order entry system), their inventory management and stock rotation to insure shelf life expiry dates are managed, and how they can assure you that you are receiving medication that is designed for your use. Ask them to provide you with their procedures for patient followup in case of an adverse event, potential recall of medications and reporting of critical information to the manufacturer. Compounded drugs are not regulated by FDA. Adverse events must be provided to the compounder, whose customer service complaint log is reviewed by regulators. Regulators however cannot direct the compounder to take a specific action on behalf of customers unless there is a documented violation of USP.
Third, if you haven’t already started this process, know your role as a consumer, your rights, and the responsibilities of various parties to the health care transaction. It’s getting more complicated by the day. Enlist the help of your friends and family. Form a learning community with a method that works for you – meetings, social media, clubs. Put your key health care partners on speed dial. Attend community meetings held by your elected representatives. Above all, don’t be silent.
Many pain patients are losing their health care providers entirely within this climate of care or are threatened with the loss of their providers due to changes of regulation and insuror coverage. That is also especially troubling as many consumers pay fees monthly for access to care. If this happens to you, file a complaint with your state Department of Health (https://www.apha.org/policies-and-advocacy/public-health-policy-statements/policy-database/2014/07/21/09/50/the-state-health-department ), the Center for Medicare Services r (https://www.medicare.gov/claims-and-appeals/file-a-complaint/complaint.html), and your insurer. Ask for an investigation and remediation of this situation within 30 days.
Fourth, if you are a Medicare insurance program user, each state has an advocacy organization that helps locate the best plans for your use and investigates fraud, waste and consumer abuse by plan providers. This link ( https://www.seniorsresourceguide.com/directories/National/SHIP/ ) will help you locate resources in your state. Make an appointment with them to make sure you are in the right plan for your needs as changes develop in coverage.
Fifth, if you are dumped or are locked out of care, make a polite nuisance of yourself. Know who is on your state legislative health committees and make an appointment with them. Identify your needs clearly and what you have done to secure the care your need. If necessary, invite them into your home or make an appointment with them and inform them of how you have been negatively affected – be prepared to elaborate exactly what you have done to act on your own behalf.
If you are a family member, friend or someone in an advocacy position who is available to act, steel yourself for this work. Use all your resources and prepare to go the distance. Don’t try to go it alone.
It is not the work of heroes. It work of people like you and me.
Terri A. Lewis, PhD, is a regular contributor to National Pain Report and is involved with the Rally Against Pain meeting that is occurring this today in Washington D.C. National Pain Report ran an article about this rally, to which she submitted the following update in the “comments” section, which we believe warrants its own article.