New Limitations on Chain Pharmacy Quotas in California

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Retail chain pharmacies should be aware of California’s recent passage of SB 362, signed into law by Governor Gavin Newson late last month, and the potential impact of the law on how chains evaluate their pharmacy staff and track individual productivity. At a high level, the law bars using “quota” metrics that track the number of times individual pharmacists and pharmacy technicians perform tasks or provide services while on duty. These quota systems have historically been used by various national retail pharmacy chains to track staff productivity and inform business operations. The bill cites various rationales for instituting quota prohibitions, including “overwhelming workloads” for pharmacists expected to meet certain fixed quotas and the associated negative impact on patient care. Of note, the bill noted that the Board of Pharmacy lacks the ability to determine whether to discipline non-compliant individual licensees or penalize pharmacies for created work environments that “leave little choice but noncompliance.”

The new law updates the California Business and Professions Code by adding two new Sections– 4113.7 and 4317. Section 4113.7 prohibits chain community pharmacies from establishing, utilizing, or communicating a quota. A “quota” is defined as a “fixed number or formula related to the duties for which a pharmacist or pharmacy technician license is required, against which the chain community pharmacy or its agent measures or evaluates the number of times either an individual pharmacist or pharmacy technician performs tasks or provides services while on duty related to any of the following:

• Prescriptions filled;
• Services rendered to patients;
• Programs offered to patients; and
• Revenue obtained.”

CA BUS & PROF § 4113.7(c)(1)(A-D).

Section 4317 grants the California Board of Pharmacy authority to take enforcement action against a violating pharmacy unless the pharmacy can show clear and convincing evidence that the quotas were used contrary to its policy.

Importantly, there are certain limiting factors to this quota prohibition. First, the restrictions only apply to “chain community pharmacies,” defined by California as “a chain of 75 or more stores in California under the same ownership.” CA BUS & PROF § 4001(c). Second, the following are not considered “quotas” and are therefore still permissible activities for applicable pharmacies:

• Revenue measurements for a particular pharmacy that are not calculated or measured by tasks performed/services provided by individual pharmacy staff;
• Evaluations of pharmacy staff competence, performance, or quality of care provided to patients so long as quotas are not used;
• Any performance metric required by state or federal regulators that does not use quotas; and
• Pharmacy policy and procedures that assist with assessing pharmacy staff competency and performance so long as quotas are not used.

CA BUS & PROF § 4113.7(c)(2)—(d).

In sum, large pharmacy chains may need to evaluate changes to their tracking and evaluation process for California-based pharmacy staff. However, it is important to note that SB 362 still gives California chain pharmacies room to evaluate employees and quantify productivity so long as the evaluation procedure falls in line with the delineated exceptions. Additionally, the law appears to only bar quotas used for individual pharmacy staff, meaning that pharmacy chains could arguably still use quota-type metrics to track performance on a pharmacy or entity level.

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Patients with opioid use disorder could see some of the biggest benefits of new CMS changes. The new rules would no longer require patients seeking opioid addiction treatment to appear on video. By allowing audio-only telehealth visits, patients would not feel the pressure to secure a space solely for telehealth services.

Part of assessing OUD patients is monitoring their appearance and mannerisms as a way to monitor medication adherence. Jittery patients can suggest withdrawal. With this promote individualized OUD treatment?

I made this post just yesterday 

QOL EQUITY: Homeostasis of the human body/biological systems

And the above statement showed up on a website – not CMS – and it would appear that there seems to be another divergent of the EQUITY between these two “disabled communities”.  Both of these communities rely on being prescribed CONTROLLED SUBSTANCES to help those in the community help manage their subjective diseases.

And then four days ago the DEA published this –

DEA looking for comments on their proposed opiate production quotas

Is it just me, or does it seem strange that CMS is making it EASIER for those in the substance abuse community to get appropriate treatment… including that there is no MME daily limits to the controlled substance that they can be provided…. while at the same time…  CMS & DEA is seeking ways & means to make appropriate therapy harder to get for those in the chronic pain community ?

This administration seem to promote EQUITY for every group… but… did CMS & DEA not get that memo ?

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When/if you download the 20 page proposed regulations… pay particular attention to PAGE 4 of that *.PDF… it explains the “statistical parameters” that the DEA used to come up with the “ESTIMATED DIVERSION ” of particular controlled substances.  First of all the database was on only 24% of the population – from only 17 different states PDMP databases and some “numeric numbers – like MME’s above a certain MME/day – would be a indication of diversion. Everyone – but the DEA – knows that those MME conversion programs are CRAP .. all one has to do is look at the footnotes on this MME conversion program https://globalrph.com/medcalcs/opioid-pain-management-converter-advanced/ The DEA should be ashamed to even state their “diversion numbers ” as estimates…. a more appropriate label would be “GUESSTIMATE ”  While our population typically grows abt 1% +/- in 2010 USA pop was 309 million and 2020 pop was 331 million.  Opiate Rxing peaked in 2011-2012… so while our population grew some 7%… the DEA has reduced opiate production quotas by some 50%.. New chronic pain pts are created every day from accidents to surgeries with BAD OUTCOMES.

Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2022

https://www.regulations.gov/document/DEA-2021-0014-0001

https://downloads.regulations.gov/DEA-2021-0014-0001/content.pdf

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Is the chronic pain community intentionally being left out of the current discussion on EQUITY ?  When each of us is born, NONE OF US ARE BIOLOGICALLY PERFECT. A lot of the practice of medicine focuses on using various therapies to help restore a person’s health/QOL that has deteriorated for numerous reasons.  Take places like St Jude    that focuses on curing childhood cancers and other serious – often fatal – childhood diseases.  Some of us are born with missing limbs and/or other major “defects” and places like Shriners deal with Physical therapy, Speech Therapy, Occupational therapy and orthotic/prosthetic to help kids to be able to function as normal as possible and optimize their QOL.

There is groups like Wounded Warriors    that provide all sorts of assistance to those who have come home after serving our country trying to deal with numerous physical and mental issues.

and  Tunnel to Towers       that provides a multitude of assistance for families of our first responders who have died in the line of duty, attempting to help to help the surviving family members to optimize their QOL as much as is possible.

Maybe it is time for the chronic pain community to ask our elected officials why the community is denied QOL EQUITY ? Congress has already passed at least two different law that has declared that discrimination of the disabled violates The Civil Rights Act and American with Disability Act is a civil rights violation.

Our healthcare system is so designed if one or more of a person’s biological processes goes outside of what is considered “normal” … there are therapies or medications that can hopefully restore the person’s biological function(s) to “normal” and restoring the person’s QOL.

Sometimes, the person will be required to take medications for a short period of time – like a antibiotic for a infection – or medication for – maybe – the rest of their life to restore blood pressure, blood sugar, high cholesterol etc…etc…  some times physical therapy is required and sometimes surgery is the only choice.

Here is a quote – that I like – from another Pharmacist….  who was  VP to President Johnson in the late 60’s. “The moral test of a government is how it treats those who are at the dawn of life, the children; those who are in the twilight of life, the aged; and those who are in the shadow of life, the sick and the needy, and the handicapped.” – Hubert Humphrey

This Administration is pushing EQUITY on just about anything and everywhere… why is that the chronic pain community does not deserve treatment to establish  QOL EQUITY for pts ?

Our federal bureaucracy and our healthcare system is breaking two laws on discriminating against disabled people – civil rights violations and now that the administration wants EQUITY for everyone … perhaps when pts talk to their members of Congress they should be asked to comment on why this is happening ?   Might also want to ask them why all sorts of money and resources are being thrown at those who are labeled as substance abusers/addicts… when many of those people really don’t wish to get sober.

Homeostasis

 https://courses.lumenlearning.com/nemcc-ap/chapter/1558/

 

Figure 1.10. Negative Feedback Loop

In a negative feedback loop, a stimulus—a deviation from a set point—is resisted through a physiological process that returns the body to homeostasis. (a) A negative feedback loop has four basic parts. (b) Body temperature is regulated by negative feedback.

 

In order to set the system in motion, a stimulus change an internal environment beyond its normal range (that is, beyond homeostasis). This stimulus is detected by a specific receptor.  For example, in the control of blood glucose, specific endocrine cells in the pancreas detect excess glucose (the stimulus) in the bloodstream. These pancreatic beta cells respond to the increased level of blood glucose by releasing the hormone insulin into the bloodstream. The insulin signals skeletal muscle fibers, fat cells (adipocytes), and liver cells to take up the excess glucose, removing it from the bloodstream. As glucose concentration in the bloodstream drops, the decrease in concentration—the actual negative feedback—is detected by pancreatic alpha cells, and insulin release stops. This prevents blood sugar levels from continuing to drop below the normal range.

Humans have a similar temperature regulation feedback system that works by promoting either heat loss or heat gain (Figure 1.10b). When the brain’s temperature regulation center receives data from the sensors indicating that the body’s temperature exceeds its normal range, it stimulates a cluster of brain cells referred to as the “heat-loss center.” This stimulation has three major effects:

• Blood vessels in the skin begin to dilate allowing more blood from the body core to flow to the surface of the skin allowing the heat to radiate into the environment.
• As blood flow to the skin increases, sweat glands are activated to increase their output. As the sweat evaporates from the skin surface into the surrounding air, it takes heat with it.
• The depth of respiration increases, and a person may breathe through an open mouth instead of through the nasal passageways. This further increases heat loss from the lungs.

In contrast, activation of the brain’s heat-gain center by exposure to cold reduces blood flow to the skin, and blood returning from the limbs is diverted into a network of deep veins. This arrangement traps heat closer to the body core and restricts heat loss. If heat loss is severe, the brain triggers an increase in random signals to skeletal muscles, causing them to contract and producing shivering. The muscle contractions of shivering release heat while using up ATP. The brain triggers the thyroid gland in the endocrine system to release thyroid hormone, which increases metabolic activity and heat production in cells throughout the body. The brain also signals the adrenal glands to release epinephrine (adrenaline), a hormone that causes the breakdown of glycogen into glucose, which can be used as an energy source. The breakdown of glycogen into glucose also results in increased metabolism and heat production.

Water concentration in the body is critical for proper functioning. A person’s body retains very tight control on water levels without conscious control by the person. Watch this video to learn more about water concentration in the body. Which organ has primary control over the amount of water in the body?

Positive feedback intensifies a change in the body’s physiological condition rather than reversing it. A deviation from the normal range results in more change, and the system moves farther away from the normal range. Positive feedback in the body is normal only when there is a definite end point. Childbirth and the body’s response to blood loss are two examples of positive feedback loops that are normal but are activated only when needed.

Childbirth at full term is an example of a situation in which the maintenance of the existing body state is not desired. Enormous changes in the mother’s body are required to expel the baby at the end of pregnancy. And the events of childbirth, once begun, must progress rapidly to a conclusion or the life of the mother and the baby are at risk. The extreme muscular work of labor and delivery are the result of a positive feedback system (Figure 1.11).

Figure 1.11. Positive Feedback Loop

Normal childbirth is driven by a positive feedback loop. A positive feedback loop results in a change in the body’s status, rather than a return to homeostasis.

 

The first contractions of labor (the stimulus) push the baby toward the cervix (the lowest part of the uterus). The cervix contains stretch-sensitive nerve cells that monitor the degree of stretching (the sensors). These nerve cells send messages to the brain, which in turn causes the pituitary gland at the base of the brain to release the hormone oxytocin into the bloodstream. Oxytocin causes stronger contractions of the smooth muscles in of the uterus (the effectors), pushing the baby further down the birth canal. This causes even greater stretching of the cervix. The cycle of stretching, oxytocin release, and increasingly more forceful contractions stops only when the baby is born. At this point, the stretching of the cervix halts, stopping the release of oxytocin.

A second example of positive feedback centers on reversing extreme damage to the body. Following a penetrating wound, the most immediate threat is excessive blood loss. Less blood circulating means reduced blood pressure and reduced perfusion (penetration of blood) to the brain and other vital organs. If perfusion is severely reduced, vital organs will shut down and the person will die. The body responds to this potential catastrophe by releasing substances in the injured blood vessel wall that begin the process of blood clotting. As each step of clotting occurs, it stimulates the release of more clotting substances. This accelerates the processes of clotting and sealing off the damaged area. Clotting is contained in a local area based on the tightly controlled availability of clotting proteins. This is an adaptive, life-saving cascade of events.

Integrating Systems

Each organ system performs specific functions for the body, and each organ system is typically studied independently.  However, the organ systems also work together to help the body maintain homeostasis.

For example, the cardiovascular, urinary, and lymphatic systems all help the body control water balance. The cardiovascular and lymphatic systems transport fluids throughout the body and help sense both solute and water levels and regulate pressure. If the water level gets too high, the urinary system produces more dilute urine (urine with a higher water content) to help eliminate the excess water. If the water level gets too low, more concentrated urine is produced so that water is conserved. The digestive system also plays a role with variable water absorption. Water can be lost through the integumentary and respiratory systems, but that loss is not directly involved in maintaining body fluids and is usually associated with other homeostatic mechanisms.

Similarly, the cardiovascular, integumentary, respiratory, and muscular systems work together to help the body maintain a stable internal temperature. If body temperature rises, blood vessels in the skin dilate, allowing more blood to flow near the skin’s surface. This allows heat to dissipate through the skin and into the surrounding air. The skin may also produce sweat if the body gets too hot; when the sweat evaporates, it helps to cool the body. Rapid breathing can also help the body eliminate excess heat. Together, these responses to increased body temperature explain why you sweat, pant, and become red in the face when you exercise hard. (Heavy breathing during exercise is also one way the body gets more oxygen to your muscles, and gets rid of the extra carbon dioxide produced by the muscles.)

Conversely, if your body is too cold, blood vessels in the skin contract, and blood flow to the extremities (arms and legs) slows. Muscles contract and relax rapidly, which generates heat to keep you warm. The hair on your skin rises, trapping more air, which is a good insulator, near your skin. These responses to decreased body temperature explain why you shiver, get “goose bumps,” and have cold, pale extremities when you are cold.

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-688A]

Proposed Adjustments to the Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2021

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice with request for comments.

SUMMARY: The Drug Enforcement Administration proposes to adjust the 2021 aggregate production quotas for several controlled substances in schedules I and II of the Controlled Substances Act and assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.

DATES: Interested persons may file written comments on this notice in accordance with 21 CFR 1303.13(c) and 1315.13(d). Electronic comments must be submitted, and written comments must be postmarked, on or before October 4, 2021. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period.

Based on comments received in response to this notice, the Administrator may hold a public hearing on one or more issues raised. In the event the Administrator decides in her sole discretion to hold such a hearing, the Administrator will publish a notice of any such hearing in the Federal Register. After consideration of any comments or objections, or after a hearing, if one is held, the Administrator will publish in the Federal Register a final order establishing the 2021 adjusted aggregate production quotas for schedule I and II controlled substances, and an adjusted assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.

ADDRESSES: To ensure proper handling of comments, please reference “Docket No. DEA-688A” on all correspondence, including any attachments. DEA encourages that all comments be submitted electronically through the Federal eRulemaking Portal which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to http://www.regulations.gov and follow the online instructions at that site for submitting comments. Upon completion of your submission, you will receive a Comment Tracking Number for your comment. Please be aware that submitted comments are not instantaneously available for public view on Regulations.gov. If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment. Paper comments that duplicate electronic submissions are not necessary and are discouraged. Should you wish to mail a paper comment in lieu of an electronic comment, it should be sent via regular or express mail to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152.

FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting and Policy Support Section, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152, Telephone: (571) 776-2265.

SUPPLEMENTARY INFORMATION:

Posting of Public Comments

Please note that all comments received in response to this docket are considered part of the public record. They will, unless reasonable cause is given, be made available by the Drug Enforcement Administration (DEA) for public inspection online at http://www.regulations.gov. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter.

The Freedom of Information Act applies to all comments received. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be made publicly available, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all the personal identifying information you do not want made publicly available in the first paragraph of your comment and identify what information you want redacted.

If you want to submit confidential business information as part of your comment, but do not want it to be made publicly available, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also

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prominently identify confidential business information to be redacted within the comment.

Comments containing personal identifying information or confidential business information identified and located as directed above will generally be made available in redacted form. If a comment contains so much confidential business information or personal identifying information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments posted to http://www.regulations.gov may include any personal identifying information (such as name, address, and phone number) included in the text of your electronic submission that is not identified as directed above as confidential.

An electronic copy of this document is available at http://www.regulations.gov for easy reference.

Legal Authority and Background

Section 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826) requires the Attorney General to establish aggregate production quotas for each basic class of controlled substance listed in schedules I and II and for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. The Attorney General has delegated this function to the Administrator of DEA pursuant to 28 CFR 0.100.

DEA established the 2021 aggregate production quotas for substances in schedules I and II and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine on November 30, 2020 (85 FR 76604). That order stipulated that, in accordance with 21 CFR 1303.13 and 1315.13, all aggregate production quotas and assessments of annual need are subject to adjustment.

Analysis for Proposed Adjusted 2021 Aggregate Production Quotas and Assessment of Annual Needs

DEA proposes to adjust the established 2021 aggregate production quotas to be manufactured in the United States in 2021 to provide for the estimated medical, scientific, research, and industrial needs of the United States, for lawful export requirements, and for the establishment and maintenance of reserve stocks. These quotas do not include imports of controlled substances for use in industrial processes. However, DEA’s analysis does not suggest the need for adjustment of the 2021 assessment of annual needs for the List I chemicals.

Factors for Determining the Proposed Adjustments

In determining the proposed adjustments, the Administrator has taken into account the criteria in accordance with 21 CFR 1303.13 (adjustment of aggregate production quotas for controlled substances) and 21 CFR 1315.13 (adjustment of the assessment of annual needs for ephedrine, pseudoephedrine, and phenylpropanolamine). The Administrator is authorized to increase or reduce the aggregate production quota at any time. 21 CFR 1303.13(a) and 1315.13(a). DEA regulations state that there are five factors that shall be considered in determining to adjust the aggregate production quota and the assessment of annual needs. 21 CFR 1303.13(b) and 1315.13(b).

DEA determined whether to propose an adjustment of the aggregate production quotas and assessment of annual needs for 2021 by considering the factors summarized below:

(1) Changes in the demand for that class or chemical, changes in the national rate of net disposal of the class or chemical, changes in the national rate of net disposal of the class or chemical by registrants holding individual manufacturing quotas for that class or chemical, and changes in the extent of any diversion in the class of controlled substance;

(2) whether any increased demand for that class or chemical, the national and/or individual rates of net disposal of that class or chemical are temporary, short term, or long term;

(3) whether any increased demand for that class or chemical can be met through existing inventories, increased individual manufacturing quotas, or increased importation, without increasing the aggregate production quota or assessment of annual needs, taking into account production delays and the probability that other individual manufacturing quotas may be suspended pursuant to Sec. 1303.24(b) and 1315.24(b);

(4) whether any decreased demand for that class or chemical will result in excessive inventory accumulation by all persons registered to handle that class or chemical (including manufacturers, distributors, practitioners, importers, and exporters), notwithstanding the possibility that individual manufacturing quotas may be suspended pursuant to Sec. 1303.24(b) and 1315.24(b) or abandoned pursuant to Sec. 1303.27 and 1315.27; and

(5) other factors affecting medical, scientific, research, and industrial needs in the United States, lawful export requirements, and other factors affecting importation needs of listed chemicals in the United States as the Administrator finds relevant, including changes in the currently accepted medical use in treatment with the class or the substances which are manufactured from it, the economic and physical availability of raw materials for use in manufacturing and for inventory purposes, yield and stability problems, potential disruptions to production (including possible labor strikes), and recent unforeseen emergencies such as floods and fires. 21 CFR 1303.13(b) and 1315(b).

DEA considered the change in the extent of diversion of all controlled substances in proposing adjustments to the aggregate production quotas as required by 21 CFR 1303.13(b)(1). Pursuant to these factors, DEA has determined that any calculated changes from the previously determined initial calculations are slight and not statistically significant from the quantities originally calculated for the extent of diversion that were applied to the initial aggregate production quota valuations.

DEA also considered updated information obtained from 2020 year-end inventories, 2020 disposition data submitted by quota applicants, estimates of the medical needs of the United States, product development, and other information made available to DEA after the initial aggregate production quotas and assessment of annual needs had been established. Other factors the Administrator considered in calculating the aggregate production quotas, but not the assessment of annual needs, include product development requirements of both bulk and finished dosage form manufacturers, and other pertinent information.

In evaluating whether there is a need for adjustment of the 2021 assessment of annual needs for List I chemicals, DEA used the calculation methodology previously described in the 2010 and 2011 assessment of annual needs (74 FR 60294, Nov. 20, 2009, and 75 FR 79407, Dec. 20, 2010, respectively). However, DEA’s analysis does not suggest the need for adjustment of the 2021 assessment of annual needs.

Considerations Based Upon the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act

Pursuant to 21 U.S.C. 826(a)(1), “production quotas shall be established in terms of quantities of each basic class of controlled substance and not in terms of individual pharmaceutical dosage forms prepared from or containing such a controlled substance.” However, the Substance Use-Disorder Prevention that Promotes Opioid Recovery Treatment for Patients and Communities Act of 2018 (SUPPORT Act), (Pub. L. 115-271), provides an exception to that general rule by now giving DEA the authority to establish quotas in terms of pharmaceutical dosage forms if the

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agency determines that doing so will assist in avoiding the overproduction, shortages, or diversion of a controlled substance.

DEA has stated before that while there is the authority to set aggregate production quotas in terms of pharmaceutical dosage form, DEA will not be using that authority at this time. Furthermore, when DEA does utilize the authority, it will be doing so at the individual dosage-form manufacturing level, as that is where it is most appropriate to do so. As such, there are no adjustments to set any controlled substances in terms of pharmaceutical dosage forms.

Under the SUPPORT Act, when setting the aggregate production quota, DEA must estimate the amount of diversion of any substance that is considered a “covered controlled substance,” as defined by the SUPPORT Act. 21 U.S.C. 826(i)(1)(A). The covered controlled substances are fentanyl, oxycodone, hydrocodone, oxymorphone, and hydromorphone. The SUPPORT Act also requires DEA to “make appropriate quota reductions, as determined by the [Administrator],\1\ from the quota the [Administrator] would have otherwise established had such diversion not been considered.” 21 U.S.C. 826(i)(1)(C). When estimating diversion, the “[Administrator]–(i) shall consider information the [Administrator], in consultation with the Secretary of Health and Human Services, determines reliable on rates of overdose deaths and abuse and overall public health impact related to the covered controlled substance in the United States; and (ii) may take into consideration whatever other sources of information the [Administrator] determines reliable.” 21 U.S.C. 826(i)(1)(B).

—————————————————————————

\1\ All functions vested in the Attorney General by the CSA have been delegated to the Administrator of DEA. 28 CFR 0.100(b).

—————————————————————————

In February 2021, DEA sent letters to the Centers for Disease Control and Prevention (CDC), Centers for Medicare and Medicaid Services (CMS), and the states requesting overdose death and overprescribing data that could be considered for estimating diversion. DEA did not receive information from CMS. However, DEA did receive information from the CDC in June 2021 and has started to receive information from the states. DEA has begun to receive Prescription Drug Monitoring Program (PDMP) data from the states in a format that will allow the Agency to develop a more robust methodology to assist in the determination of the diversion estimate in the future. This information will be considered in determining the estimates of diversion for the five covered controlled substances in the Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2022.

To update the estimates of diversion, DEA used data from the Drug Theft and Loss Report, Statistical Management Analysis & Reporting Tools System (SMARTS), and System to Retrieve Information on Drug Evidence (STRIDE) databases to aggregate the active pharmaceutical ingredient (API) of each covered controlled substance by metric weight. From the databases, DEA gathered data involving employee theft, break-ins, armed robberies, and material lost in transit. DEA also used seizure data obtained from reports submitted by law enforcement agencies nationwide. This data was categorized by basic drug class and the amount of API in the dosage form was delineated with an appropriate metric for use in proposing the adjusted aggregate production quota values. Using the data, DEA calculated the estimates for the amount of diversion by multiplying the strength of the API listed for each finished dosage form by the total amount of units reported to estimate the metric weight in grams of the controlled substance being diverted. Below, DEA has updated the chart to include estimations of diversion for each of the covered controlled substances.

DEA considered the change in the extent of diversion of all controlled substances in proposing adjustments to the aggregate production quotas as required by 21 CFR 1303.13(b)(1). Pursuant to these factors, DEA has determined that any calculated changes from the previously determined initial calculations are slight and not statistically significant from the quantities originally calculated for the extent of diversion that were applied to the initial aggregate production quota valuations.

Proposed Adjustments for the 2021 Aggregate Production Quotas and Assessment of Annual Needs

DEA is proposing significant increases to the APQs of the schedule I substances psilocybin, psilocin, marihuana, and marihuana extract, which are directly related to increased interest by DEA registrants in the use of hallucinogenic controlled substances for research and clinical trial purposes. DEA firmly believes in supporting regulated research of schedule I controlled substances. Therefore, the APQ increases reflect the need to fulfill research and development requirements in the production of new drug products, and the study of marijuana effects in particular, as necessary steps toward potential Food and Drug Administration (FDA) approval of new drug products.

The DEA established the 2021 aggregate production quotas for substances in schedules I and II on November 30, 2020 (85 FR 76604). Subsequent to that publication, DEA published in the Federal Register two final rules to permanently schedule 14 specific fentanyl-related substances under the CSA (86 FR 22113, April 27, 2021, and 86 FR 23602, May 4, 2021). The specific fentanyl-related substances are 2′-fluoro 2-fluorofentanyl, 4′-Methyl acetyl fentanyl, beta-Methyl fentanyl, beta-Phenyl fentanyl, Fentanyl carbamate, ortho-Fluoroacryl fentanyl, ortho-Fluorobutyryl fentanyl, ortho-Fluoroisobutyryl fentanyl, ortho-Methyl acetylfentanyl, ortho-Methyl methoxyacetyl fentanyl, para-Fluoro furanyl fentanyl, para-Methylfentanyl, Phenyl fentanyl, and Thiofuranyl fentanyl. As a result, these substances will continue to be subject to the CSA schedule I controls and are now being assigned individual aggregate production quotas.

On March 1, 2021, DEA published a temporary scheduling order placing Brorphine in schedule I of the CSA (86 FR 11862), making all regulatory controls pertaining to schedule I controlled substances applicable to the manufacture of these substances, including the requirement to establish an aggregate production quota pursuant to 21 U.S.C. 826 and 21 CFR part 1303. This notice proposes to establish an aggregate production quota for this substance.

On May 7, 2021, DEA published an interim final rule placing serdexmethylphenidate, a component in a combination drug product recently approved by FDA for the treatment of ADHD in patients six years of age and older, in schedule IV of the CSA (86 FR 24487). Serdexmethylphenidate is manufactured from methylphenidate, a schedule II controlled substance. In order to more accurately estimate and manage the quantity of methylphenidate necessary for direct formulation into schedule II drug products versus the

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quantity of methylphenidate necessary for the manufacturing of serdexmethylphenidate or other substances, DEA has delineated methylphenidate into methylphenidate (for sale) and methylphenidate (for conversion). This notice proposes to establish an aggregate production quota for methylphenidate (for conversion).

On June 20, 2021, DEA published the final rule to place oliceridine, a medication recently approved by FDA for medical use as an intravenous drug for the management of acute pain severe enough to require an intravenous opioid analgesic and for patients for whom alternative treatments are inadequate, in schedule II of the CSA effective July 12, 2021 (86 FR 30772). The placement of oliceridine in schedule II of the CSA, makes all regulatory controls pertaining to schedule II controlled substances applicable to the manufacture of this substance, including the requirement to establish an aggregate production quota pursuant to 21 U.S.C. 826 and 21 CFR part 1303.

The Administrator, therefore, proposes to adjust the 2021 aggregate production quotas for certain schedule I and II controlled substances. The Administrator does not propose an adjustment to the assessments of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. The proposed adjusted APQs, as expressed in grams of anhydrous acid or base, are as follows:

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Now we have various state AG’s ( Attorneys) determining what medications licensed physicians can prescribe in treating COVID-19 infected people. Prescribing a FDA approved meds “off label” has been going on for as long as I can remember and I have been a licensed Pharmacists for 51 YEARS. And for all those years.. no one took issue with such prescribing.  But NOW… many attorneys have taken upon themselves to use their authority – or gave themselves authority – to “go after” prescribers that prescribe certain meds in treat pts dealing with COVID-19 …that those prescribers should have their medical license revoke, suspended or some other action by the state medical licensing board against prescribers.  It has been reported that President Biden  – who is an attorney – stated that he knew that the bureaucracy mandating people getting vaccinations was UNCONSTITUTIONAL….but… by the time that a legal challenge to that vaccination mandate made it thru out court system to be finally declared UNCONSTITUTIONAL…. millions of more people will would have “gotten the JAB”…   Isn’t it interesting that certain powerful bureaucrats can violate our constitution and/or our laws and do so without any fear of any consequences.

These groups – the American Medical Association, the American Pharmacists Association and the American Society of Health-System Pharmacists – have no legal authority and it would appear that they are active participants in the political theater surrounding the prescribing of the two meds in question off label.

Nebraska AG: Docs Can Prescribe Controversial COVID Drugs

https://www.medscape.com/viewarticle/961011

OMAHA, Neb. (AP) — Nebraska’s attorney general said Friday that he won’t seek disciplinary action against doctors who prescribe controversial, off-label drugs to treat and prevent coronavirus infections, as long as they get informed consent from patients and don’t engage in misconduct.

The office of Attorney General Doug Peterson released a legal opinion saying it didn’t see data to justify legal action against health care professionals who prescribe ivermectin, a decades-old parasite treatment, or hydroxychloroquine, a malaria drug that former President Donald Trump took to try to prevent a COVID-19 infection.

“Based on the evidence that currently exists, the mere fact of prescribing ivermectin or hydroxychloroquine for COVID-19 will not result in our office filing disciplinary actions,” the Republican attorney general said in the opinion.

Many health experts and leading medical groups have been trying to stop  the use of both drugs, arguing that they can cause harmful side effects and there’s little evidence that they help. It’s also unclear whether many doctors are actually prescribing them in Nebraska or elsewhere, although a few isolated cases have emerged nationally.

In a joint statement last month, the American Medical Association, the American Pharmacists Association and the American Society of Health-System Pharmacists said they strongly oppose the use of ivermectin as a COVID-19 drug outside of a clinical trial.

“We are alarmed by reports that outpatient prescribing for and dispensing of ivermectin have increased 24-fold since before the pandemic and increased exponentially over the past few months,” the groups said.

Ivermectin has been promoted by Republican lawmakers, conservative talk show hosts and some doctors, amplified via social media to millions of Americans who don’t want to get vaccinated. It has also been widely used in other countries, including India and Brazil.

Hydroxychloroquine has been boosted in a similar manner, despite American Medical Association warnings that the drug is an unproven and potentially dangerous treatment for the virus.

In Arkansas, a state medical board is investigating reports that a doctor prescribed ivermectin to county jail inmates, including several who said they didn’t know what they were being given.

Kansas U.S. Sen. Roger Marshall, a Republican and a doctor, has acknowledged that he took hydroxychloroquine throughout his 2020 campaign, along with his parents, siblings and wife, but he hasn’t said how they obtained their prescriptions.

In Nebraska, the attorney general’s office said it wasn’t recommending specific treatments for the virus and would still prosecute doctors who fail to get informed patient consent, prescribe excessively large doses or neglect to check what other drugs a patient is taking. The opinion only applies to doctors prescribing the drugs as a preventative measure and an early treatment for outpatients.

“Allowing physicians to consider these early treatments will free them to evaluate additional tools that could save lives, keep patients out of the hospital, and provide relief for our already strained health care system,” the opinion said.

The opinion came in response to a request from the Nebraska Department of Health and Human Services, which licenses and disciplines doctors. The attorney general’s office files complaints on the public’s behalf against health care providers who violate state regulations and put their patients at risk, and the department has the power to suspend or revoke their licenses or take other action.

Nebraska Department of Health and Human Services CEO Dannette Smith said in her request letter that consumers and doctors have been inundated with information about COVID-19 treatments, and “it may become difficult to discern the quality or validity of the information,” raising questions about what doctors can legally prescribe.

Peterson was first elected attorney general in 2014 and won re-election unopposed in 2018. He hasn’t said publicly whether he plans to run again next year.

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Walgreens says vaccine mix-ups are rare after Indiana family claims kids received COVID, not flu shots

https://www.foxbusiness.com/lifestyle/walgreens-vaccine-mixups-rare-covid-flu

Walgreens says vaccine mix-ups are rare after an Indiana family claimed that their children were given coronavirus shots rather than flu shots.

The family told WFIE in an exclusive interview that their two children, who are 4 and 5 years old, were mistakenly given full adult doses of the Pfizer vaccine rather than flu shots at a Walgreens in Evansville.

The mix-up allegedly occurred on Oct. 4.

Due to privacy laws, Walgreens told FOX Business that it isn’t allowed to comment on specific patient events but that patient safety is its “top priority” for the company and it takes such matters very seriously.

“Generally speaking, such instances are rare, and Walgreens takes these matters very seriously,” Walgreens said in a statement. “In the event of any error, our first concern is always our patients’ well-being.”

Vials of Pfizer-BioNTech COVID-19 vaccines are ready to be injected to medical staff at the Ichilov Hospital in Tel Aviv, Israel, Sunday, Dec. 20, 2020. (AP Photo/Ariel Schalit / AP Newsroom)

Walgreens says it has a multi-step vaccination procedure that “includes several safety checks to minimize the chance of human error.” The company also noted that it has reviewed the multi-step vaccination procedure with its pharmacy staff as a means to prevent these incidents from occurring.

The Price family didn’t find out about the mix-up until after a Walgreens employee called them admitting that they made a mistake, according to WFIE.

“Walgreens called me to say there was a mix-up, we did not receive the flu shot,” Alexandra Price said.After finding out that the kids were given a coronavirus shot instead, Price recalled thinking, “I was like, well what does this mean for my kids…?”The Price family’s attorney, David Tuley, told the outlet that the children were taken to the doctor and are showing signs of heart issues.GET FOX BUSINESS ON THE GO BY CLICKING HERE To date, Pfizer and BioNTech’s vaccine hasn’t been approved for children just yet. Earlier this month, however, the companies offered parents a sign of hope after asking the U.S. government to authorize its COVID-19 vaccine for youngsters ages 5 to 11.If regulators give the go-ahead, a reduced dose of the shot could be doled out within a matter of weeks. The companies said their research shows younger children should get one-third of the dose now given to everyone else.

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This is a email that I got this week… I have put it in the order received and my answer to her. It would appear that CVS has put a “do not fill” lock on invermectin in their pharmacy computer system.  There is a lot of “political theater” around the use of ivermectin in treating COVID-19. I am STUNNED that the pharmacist stated that “didn’t know what the med was for”… If I don’t know something about a med – a new one or one not used much… I used this UTILITY called the internet to look up the information and do a “quick read” on the med.  Once again, one of the basics of the practice of medicine is the starting, changing, stopping a pt’s therapy.  So is the fact that CVS has a “do not fill” lock on Ivermectin in their pharmacy computer system or the fact that the pharmacist “destroyed” the pt’s prescription… which one – OR BOTH – is attempting to practice medicine without a license ?  Because

Hello,

A doctor prescribed 3 medications for me.  The pharmacy refused to fill one but filled the others?  They said they had a policy not to fill but referred me to the CDC for the information?  I did not find a policy denying the medication.   I left a message for the District Manager to call me but hasn’t.

What is the best way to proceed?  I feel my civil rights have been violated, and that the pharmacist over stepped her authority by practicing medicine?  The drug in question is not a controlled substance.

I suspect that pharmacy was a CVS or Walgreens and the med was for COVID-19 med…  maybe ivermectin…  One of the basics of the practice of medicine is the starting, changing, stopping a pt’s therapy… did she give you the Rx back or was it sent electronically ? either way… she has imposed you from getting that med ANYWHERE… she has basically confiscated your Rx…  which is your property…  until it is filled…  if it was anything but a C-II and it was electronically – she is able to transfer it to another pharmacy…  But is not unusual for these chains to establish corporate edict as to how their employee pharmacist practice pharmacy – which is also against the law.

Here is a link to find a independent pharmacy by zip code  https://ncpa.org/pharmacy-locator  where you will be dealing with the Pharmacist/Owner and they tend to be much less judgemental and don’t have some “big shots” at the corporate HQ telling them how to practice pharmacy and/or tell them to break the law and practice medicine without a license…

Take all your meds to them… the pharmacy that refused to honor your prescriber’s orders…does not deserve your patronage nor your money.

Yes you are correct.  It was CVS and Ivermectin.  The thing is they really did not know that the drug was for, although they were inferring it was and practicing medicine.  I asked for the prescription back but  I believe, they deleted the prescription sent electronically because the clerk said something that led me to think that, although he was able to retrieve the “Prescription Inspect” but don’t know if I can take it elsewhere?  The pharmacist was rude to me, and when I asked her where I could get a copy of the “policy” she told me to go to the CDC and gave me the phone number to the CVS District Manager who has no name or any message on his phone so I don’t even know who I am calling?  I’ve left 2 messages now and he won’t call.

I am thinking of filing a complaint with the Pharmacy Board.  But  don’t want to if it won’t make any difference.  Can you advise on that? And thank you so much for responding to my complaint.

You can file a complaint with the pharmacy board  but suggest that you read this first  https://abcnews.go.com/Business/story?id=6552337&page=1   The BOP’s are political animals and the “inaccurate info” about invermectin is part of our political theater.. Japan has been using it as part of treating COVID-19 and reportedly they have used tens or hundred of million of doses. suggest that you watch this video  https://rumble.com/embed/vjypfn/?pub=4  person testifying before a senate committee with “tons” of info about clinical trials successfully using invermectin to treat COVID-19.  IF you do call the board of pharmacy… I would complain about them confiscating and destroying your prescription…  that is like taking a check to a bank to cash or deposit and they refuse and shred it …

Steven R. Ariens, P.D. R.Ph.

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Find a 2022 Medicare plan

https://www.medicare.gov/plan-compare/

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Recently I made this post  Could better chronic pain management – prevent thousands of OD’s (suicides) EACH YEAR ?     It is well known – or should be – that under/untreated pain can cause complications to a pt’s comorbidity issues resulting in premature deaths and/or suicides.  But I am not aware of any statistics that are tracked on these issues.  Complications of comorbidity issues just adds demands on our healthcare systems that could otherwise be avoided.  How often do we see much about chronic pain pts committing suicide because of under/untreated pain ?  Here is a recently court case – and the first one that I have seen – $7 million awarded to family of man who killed himself after pain medication denied

Could it be that a certain part of our bureaucracy has an agenda that having those  deaths prevented would be counter productive to THEIR AGENDA but PUSHING VACCINATIONS and coming up with a hypothetical deaths that could have been prevented because more people got vaccinated sooner – IS JUST ANOTHER/DIFFERENT BUREAUCRATIC AGENDA ?

Vaccination could have prevented 90,000 deaths over four months, study says

https://www.washingtonpost.com/nation/2021/10/14/covid-delta-variant-live-updates/#link-JFMJWL3LZVEBVIMSPXF5JBVZVI

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