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).

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

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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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This is a pharmacy computer screen shot from one of the chain pharmacy’s computer systems… this is the second time this week I have heard about a chain pharmacy having 1500+ Rxs in the “waiting Que” of their computer system.  A Rx dept working with one Pharmacist and two techs should be able to fill 300-500 in 12 hrs… so this particular store is – AT THE MOMENT THIS SCREEN SHOT WAS TAKEN – up to SIX DAYS BEHIND.  Obviously, this particular pharmacy is having more Rxs sent in – mostly electronically – than they are able to fill/handle.  That does not mean, at the end of the day, there could be more/higher number of Rxs in the “waiting Que”..  Below is a quote from a FB page… the stress of working in a Rx dept at WALGREEN… apparently caused one of their employees to end up in ER and admitted to the CARDIAC UNIT.

And these are the Rx dept staffing that you are trusting your health with ?  It is human nature that when you have more to do than is really reasonable, people start using “short cuts” and short cuts… will eventually cause errors or “mis-steps” and that is when YOUR HEALTH could be put at risk… There is no better time to find yourself a independent pharmacy… who is typically better staffed… because they don’t have to support the massive corporate overhead that the chain stores do.   Where you will be dealing with the Pharmacist/owner… the person where  THE BUCK STOPS… and PROBLEMS CAN BE RESOLVED.

Here is a link to find a independent pharmacy near you by ZIP CODE https://ncpa.org/pharmacy-locator

Let keep going around!! If you are a patient, you are concerned. If you are pharmacist, technician or an ally of pharmacy, you are concerned.
The Definition of “ I don’t care about you “:
Let me tell you what you are looking at : on one picture, there are at least 517 prescriptions to fill. 517. And on the other, at least 1881.
Two major points:
1) patients care and safety. At least 517 and 1881 prescriptions behind. It will take days, weeks to recover from this. And no, this is not from power surge or anything. Just a regular day.
Forget about little Johnny and Caroline antibiotics for their ear infections. Forget about their pain medication after they got their tonsils out.
Oh did your wife just have a C section? Did you break your leg? Well too bad for you because you are not getting your pain relief?
Oh wait, you run out of your insulin? Well too bad, it will be ready in two weeks. In the meantime, you should really watch your blood sugar.
But not only that… is that medication in that bag correct? Oh oops, let me see it.
Oh you want a Covid shot? Well not today. Come back next week. Wait.. you can because your pharmacist and technicians are still expected to do all the Covid, flu vaccines while keeping you safe in this environment. And they have other “ tasks “ to do . Otherwise they will get in trouble by people who have never used a spatula.
So my question to you patients, do you feel safe? Do you feel confident that your pharmacy ( not pharmacists and technicians) actually puts your safety first? This is not the pharmacists or technicians doing. They have zero control over this .
Are you awake now?
2) Pharmacists and technicians safety. Let me tell you that one of the pharmacists working at those stores was taken to the ER and admitted on the CARDIAC floor. A perfectly healthy pharmacist. No prior history. Are we going to keep ignoring what chains pharmacies are doing to their pharmacy staff? Are we going to keep silent? How many of our pharmacists and technicians they have already pushed to the edge? Do you want to hear about the many stories of pharmacists and technicians on the floor sobbing or taken to the ER for elevated blood pressure or heart attacks?
This has to stop.

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Many many years ago … many as long ago as the Clinton Admin, some entity was hired/appointed to evaluate numerous agencies and how successful they were in meeting their goal(s)…  and I remember that the DEA GOT A SCORE OF ZERO.  I am sure that it was before the Decade of Pain Law (2001)… which was the end of the Clinton Admin.

since over the years – especially since the Decade of Pain Law expired and was not renewed in 2010…  It would seem that the DEA has stepped up their enforcement on “low hanging fruits’ … prescribers..  In 1980 the DEA estimated that the cartels were generating 12 Billion in illegal drugs and recently I have seen that estimate to be in the 100 billion range…  in FORTY YEARS the $$$ being generated by illegal drugs is up in range of EIGHT FOLD.  In 1980 our population was around 230 million and today it is around 320 million. So our population has grown 40% and illegal drug use – in $$$ – is up EIGHT FOLD ? Does this suggest how efficient the DEA has functioned in the last 40 years… or 80% of the total war on drugs years ?

I made this post a a few days ago about lawsuits in Ohio against pharmacies and quoting the “large number of opiates dispensed” over several years… I did some “reverse math” and reality and “DEA math” really doesn’t “compute”  https://www.pharmaciststeve.com/i-have-heard-something-about-a-new-math-but-the-dea-apparently-has-created-their-own-math-system/

This recent lawsuit https://www.pharmaciststeve.com/7-million-awarded-to-family-of-man-who-killed-himself-after-pain-medication-denied/ stands then it may be a very serious step forward a change in how chronic pain pts are being treated/mistreated by prescribers.  What I find interesting of the decision in this lawsuit is that this clinic is in Louisville, KY  – which has all four of the major TV channels and ONLY ONE reported on the outcome of this trial.  Metro Louisville Ky encompasses some 2+ million population.   Does this represent a bias of the three local channels or a policy coming from the national HQ of these TV channels ?

It was recently reported out of the 93,000 drug OD’s ….  abt 75% involved illegal fentanyl…  It would appear that the DEA is sticking to their original concept from when they were created in 1973… opiates are HIGHLY ADDICTING…. ANY PRESCRIBING OF OPIATES WILL CAUSE ADDICTION…. ADDICTS WILL END UP USING “STREET ADDICTS AND ODing”  The fact that Opiate Rxs peaked in 2011-2012 and DEA has cut opiate production quotas by abt 50% BUT… OD’s involving illegal opiates have have increased exponentially.

The DEA’s Long Game

https://daily-remedy.com/the-deas-long-game/

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No matter the business or profession,  When the staff is expected to “run at 100%+”.. they created “short cuts” and that means that some quality control issues are sometimes skipped.  Every store has at least one tech that “never makes mistakes” – “never” is a ABSOLUTE and it is NEVER POSSIBLE.  I know that when on those rare occasions when they did make a mistake… all I had to do was ask “you want to look at this again”… because they were so proud of being such a good tech… that they would beat themselves up for letting a error get past them.

Then when I was working at a large national nursing home pharmacy, they hired a new Rx input tech that was suppose to have worked for TWO YEARS for a national chain pharmacy and after a while … when there was a documented 20%+ input errors… the pharmacists at the facility went to management and wanted her fired, but management told the pharmacists that they “had too much invested in her training to fire her”…   They eventually moved her to another position that did not involve direct involvement in taking or filling Rxs.

Understaffing at some CVS pharmacies in Virginia has put patients at risk, former employees say

http://pulse.ncpolicywatch.org/2021/10/11/virginia-report-sheds-troubling-light-on-problem-of-understaffing-at-chain-pharmacies/

[Editor’s note: Last year, in a story that referenced worrisome examples from North Carolina, the New York Times reported on how insufficient staffing has brought about big problems at American chain pharmacies that are endangering public health.

This morning, in a new report for the Virginia Mercury, reporter Kate Masters relates similarly troubling developments from our neighbor to the north at a chain pharmacy with hundreds of outlets in North Carolina.]

One location in Virginia Beach was fined $470,000 for serious dispensing errors. Pharmacists say its a systemic problem.

Over the last two years, employees at a CVS Pharmacy in Virginia Beach have raised repeated concerns over patient safety.

At one point, multiple pharmacy technicians told a state inspector that a pharmacist at the store had mistakenly given a patient a hundred extra doses of Percocet — a powerful prescription opioid. Another customer received an antibiotic despite a known history of not tolerating the drug and was taken to the emergency room after an allergic reaction.

In another instance, a patient received the right medication with the wrong instructions, according to another pharmacy tech, who said the oral cholesterol drug came with directions to insert the pills vaginally.

The root of the errors, employees said, was chronic understaffing and an unsustainable workload that made it impossible for pharmacists and technicians to focus on their jobs.

“The pharmacists cannot properly concentrate because they have so much to do,” said Kristopher Ratliff, a member of Virginia’s Board of Pharmacy, reading from a more than 600-page investigative report produced by state regulators.

“A staff pharmacist stated hours had been cut to the point where she didn’t know how the pharmacy was supposed to function,” added Mykl Egan, the board’s discipline case manager, reading from the report. “A fourth pharmacist described the pharmacy as a ‘sweatshop.’”

The findings, which covered a single CVS store, resulted in a $427,000 fine for the chain and one unannounced inspection within the next 12 months. CVS “respectfully disagree[s]” with the board’s order, according to spokesman Mike DeAngelis, and is “considering our options” for potential next steps.

But news of the investigation came as no surprise to former CVS employees in Virginia, who said working conditions were so bad that they had affected their mental and physical health. Nor were the problems contained to a single store, according to two former pharmacists, who worked in multiple locations across the state and heard similar concerns from other staff members.

“The sheer number of people who go home and cry because of the pressures they’re under — it’s unbelievable,” said Michelle Harmon, a former CVS pharmacist in the Hampton Roads region who’s still part of a Facebook group for mothers in the industry. “You’re so mentally drained you don’t have time for your family. I was just existing — going to work, coming home, doing whatever I could to hit the numbers so my patients were taken care of.”

Safety and staffing issues at national pharmacy chains have become a growing issue for state regulators both in Virginia and across the country. A 2020 investigation by The New York Times found that at least two dozen states have received multiple complaints from pharmacists and physicians worried that chain pharmacy policies are undercutting patient care.

Photo: (Joe Raedle/Getty Images)

In many cases, the errors have had significant consequences. An 85-year-old in Florida died after a Publix pharmacy dispensed a chemotherapy drug instead of the antidepressant she was prescribed. At the CVS in Virginia Beach, a state inspector reviewed 200 hardcopy prescriptions and found 74 mistakes — an error rate of roughly 37 percent. In at least two cases, pharmacists dispensed medications at multiple times over the prescribed dosage, including cyclobenzaprine, a muscle relaxant, and dexamethasone, an anti-inflammatory drug that’s been used to treat COVID-19 patients.

“Now, in my 32 years of practice in retail pharmacy, this is a classic symptom of going too fast, too distracted, to pay attention to what you’re doing,” Ratliff said during the hearing. At one point, he described the working conditions as “unacceptable,” but the board’s secretive disciplinary process makes it difficult to determine how widespread the problems are across Virginia.

Diane Powers, director of communications for the Virginia Department of Health Professions, said that board investigations are complaint-driven. However, complaints against pharmacies are considered confidential under Virginia state code, she said, making it impossible to know whether other CVS stores have experienced the same problems.

The board did release its final order in the case, but refused to provide the Mercury with a copy of the full investigative report, which was referred to repeatedly during the public hearing. Powers also said the report was exempt from disclosure under the state’s Freedom of Information Act laws.

“Investigations are confidential under law and therefore, the board can neither confirm or deny the existence of any ongoing investigations,” she added in a follow-up statement. Nearly half of the board’s disciplinary case decisions involving pharmacies over the last 90 days have been issued in response to violations by large chain locations, including CVS, Walgreens and Rite Aid. But it’s unclear if any involved complaints similar to those filed against the CVS store in Virginia Beach.

Both Harmon and another former CVS pharmacist, who requested anonymity because she feared professional repercussions, say understaffing has been a growing problem at CVS for years. It only became worse with the arrival of COVID-19, they said.

Before the pandemic, the company had steadily been reducing the number of hours that pharmacy techs, a non-salaried position, were allowed to work every week. The former pharmacist said it was clear some stores didn’t have enough staff to meet the demands of the job, but that the stress was “manageable” until cases of the virus began to spread.

“Then COVID just made things impossible,” she said. “That tipped it over the edge.” Both pharmacists worked at high-volume stores, where they’d fill anywhere between 500 and 1,000 prescriptions a day. Harmon said her pharmacy sometimes received up to 10 phone calls at a time, which employees were expected to answer by the second ring. The pharmacies also ran drive-throughs and provided in-store services, including flu vaccines and counseling patients on their medications.

When COVID-19 hit, the pharmacies also started offering testing and — eventually — vaccinations. The former pharmacist who requested anonymity said CVS sent in additional pharmacists to administer the vaccines, but billing for the shots and registering them in the state’s immunization system fell to the regular staff.

“Before the clinic started, you’d just get pages and pages and pages,” she said. “All of that paperwork went through your pharmacy that’s filling 900 prescriptions a day.” Harmon left the company later, in July of this year, after a brain hemorrhage she said doctors attributed to stress.

“I have fully recovered and I’m thankful for that,” she said. “But as I lay in that bed, I thought to myself, ‘I’ve got to get out of this environment.’”

They aren’t the only CVS employees to report health issues traced to stressful working conditions. According to the Board of Pharmacy decision, a pharmacist at the Virginia Beach location was diagnosed with anxiety and took a medical leave of absence from the store. A technician also took stress-induced leave, and another was prescribed anti-anxiety medication “because of the stress of working” at the pharmacy.

DeAngelis, the spokesman for CVS, described many of the complaints in the report as “inaccurate or outdated” (“It should be noted that the underlying complaints from a former employee are nearly two years old and this store location has since had a change in management,” he wrote in an emailed statement).

Harmon, though, said she had experienced many of the same challenges described in the hearing as recently as July. One of the main stressors, for both her and employees at the Virginia Beach location, were the metrics that CVS set for its stores. According to Harmon, expectations were broken down into a 100-point system, from how fast it took to type a prescription into the system to how quickly it was checked by a pharmacist and delivered to a patient.

But as the company cut down technician hours, Harmon and the other pharmacist said those metrics became harder and harder to meet. With the drive-through and COVID-19 testing to run, they said there was sometimes a single pharmacist and technician left to fill hundreds of prescriptions by themselves. On some days, Harmon said it amounted to filling a prescription every minute and a half in an average 13-hour shift.

There was also what pharmacy board members described in the hearing as “busywork” — other tasks that employees were assigned and rated on. The other former pharmacist said the company expected pharmacists or technicians to call at least 100 patients a week to check if they needed a prescription refilled or wanted to switch to a larger, 90-day supply.

At first, she said CVS budgeted additional staff hours for the calls, but they eventually became part of the daily workload. Harmon said patients were also given the option to request drug delivery instead of picking up the medication in-person.

But the company expected deliveries to go out at a certain time every day, and allowed customers to order additional items from other sections of the store.

“So, I’m having to have a technician stop what she’s doing, filling prescriptions, to go package a non-prescription order,” Harmon said. At some points during the pandemic, she estimated her store received at least 20 orders a day.

Employees said the constant distractions made it impossible to meet metrics and fill prescriptions safely. At one point, one of the pharmacists worked in a store with a backlog of more than 700 orders, when that happened, they said it was up to the salaried pharmacists to work extra hours — or come in over the weekend — to get the store caught up.

The former pharmacists said the workloads made it nearly impossible for pharmacists or technicians to take a break during the day.

At the Virginia Beach location, the Board of Pharmacy found one employee was asked to sign a waiver attesting she wouldn’t take a meal break. Another “routinely” ate her lunch behind the pharmacy safe, according to the board’s order, because the store was too busy to stop working. The former pharmacist who asked for anonymity told the Mercury her pharmacy wasn’t allowed to close for lunch, and there were regularly days when she didn’t have time to use the restroom for an entire 13-hour shift.

DeAngelis noted that management had changed at the Virginia Beach location since the investigation. “In fact, our store’s lead pharmacist and its district leader both appeared at the board hearing to refute the allegations,” he wrote. New district leader Paul McCormick told the board that CVS was in the process of unrolling regularly scheduled lunch breaks at pharmacies nationwide, and that the company had reduced both the number of calls and metrics it expected employees to make and meet.

Board members, though, appeared skeptical that the personnel changes had led to a significant shift in culture. And both former pharmacists said many CVS employees weren’t waiting on improvements, with staff leaving for other jobs.

“Nobody wants to make mistakes,” Harmon added. “That’s why we didn’t take breaks. That’s why we didn’t go to the bathroom. That’s why you come in early and stay late. You basically sacrifice yourself to make sure your patients are taken care of.”

Kate Masters is a reporter for the Virginia Mercury which first published this report.

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