Could Chronic Pain Increase Risk of Cognitive Decline?

Posted on December 12, 2020 by Pharmaciststeve

Could Chronic Pain Increase Risk of Cognitive Decline?

https://www.practicalpainmanagement.com/resources/news-and-research/could-chronic-pain-increase-risk-cognitive-decline

Clinical understanding of Alzheimer’s disease in relation to pain is growing – and may soon help clinicians provide more thorough assessments and treatment plans.
By Heidi Splete

Chronic pain is common in elderly patients, including those with neurodegenerative conditions such as Alzheimer’s disease. However, recent data point to a potential link by which the presence of chronic pain actually may increase one’s risk for developing Alzheimer’s disease (AD) and similar cognitive problems in later life.

However, recent data point to a potential link by which the presence of chronic pain actually may increase one’s risk for developing Alzheimer’s disease and similar cognitive problems in later life. (Image: iStock)

Basis in Brain Biology

Data on the biologic relationship between pain and AD were recently published in the Journal of Neuroinflammation. The paper described the interaction of two processes: locus coeruleus noradrenergic system dysfunction and neuroinflammation caused by microglial pro-inflammatory activity in the brain.1

In the review, Song Cao, MD, of the Affiliated Hospital of Zunyi Medical University, Guizhou, China, and colleagues, wrote that “chronic pain is associated with increased self-rated and objective cognitive deficits,” although these deficits were not specific to a particular pain modality. His team discussed the potential mechanism behind the connection of chronic pain and AD and explained that “Chronic pain induces pathological activation of the locus coeruleus (LC)-noradrenaline (NE) system.” The resulting increase in noradrenaline in certain areas of the brain (eg, the prefrontal cortex and hippocampus) “could be one of the mechanisms of chronic pain-induced microglial pro-inflammatory activation,” they stated.

The team further hypothesized that this pro-inflammatory activation could contribute to the development of Alzheimer’s through various avenues, including accumulation of amyloid-β peptide (Aβ) aggregates, loss of synaptic function, and cytokine-induced neuron death.

However, “Whether chronic pain induces neuronal loss in the LC has not been reported yet, but it is possible, especially with long-lasting pain (defined as > 3 months),” the researchers noted, recommending: 

“Studies to examine whether chronic pain can induce or aggravate cognitive deficits as well as behavioral and psychiatric symptoms in aged and AD models would be helpful in beginning to confirm a causal relationship, and tracking AD-related biomarkers and pro-inflammatory factors released from activated microglia in brain regions related to AD pathogenesis, such as the PFC and hippocampus, would further help define pathological mechanisms.”

Clinical Data Support Pain and AD Connection

Data from a separate population-based cohort study published in the International Journal of Environmental Research and Public Health in 2020 showed an association between non-cancer chronic pain conditions (NCPC) at baseline and increased risk for incident AD and related dementias (ADRD) two years later.2 The longitudinal study included 11 pooled cohorts for the years 2001 to 2013 from the US Medicare Current Beneficiaries Survey for a total of 1,934 adults aged 65 years and older in the United States. The participants were free of ADRD at baseline, and the prevalence of NCPC was 36%.

After controlling for variables including sociodemographics, lifestyle characteristics, medications and medical history, NCPC was significantly associated with increased risk for ADRD after two years, with an adjusted odds ratio of 1.21 for any NCPC vs. no NCPC.2

Sumaira Khalid, MSPH, PharmD, of the West Virginia University School of Public Health, Morgantown, and colleagues, noted that the association increased significantly with the number of NCPCs, with an OR of 1.91 for four or more NPCs compared with zero, but was partly mediated by mood and sleep disorders. (Of note, Dr. Khalid’s study was supported by the National Institutes of Health and Alzheimer’s Research and Prevention Foundation.)

Although the researchers noted that prospective studies are needed to confirm their findings, “a growing literature suggests chronic pain can disrupt neurocognitive function and may increase risk for cognitive decline and incident dementia, whereas evidence for an inverse relationship remains sparse,” they wrote.

In a separate study published in 2019 in Osteoarthritis Cartilage, Mohammed Ikram, M.Pharm, MBA, of the West Virginia School of Pharmacy in Morgantown, and colleagues examined the possible association between pain interference from osteoarthritis and an increased risk for AD and related dementias (ADRD).3  Ikram’s team conducted a retrospective cross-sectional study of US adults aged 65 years and older. The study population included 25,009 individuals pooled from 2009-2015 Medical Expenditure Panel Survey (MEPS) data.

Overall, 27.1% of their sample had OA and 47.6% of these individuals reported pain interference, defined as frequent pain interfering with normal activities (PIA).3

After adjusting for multiple factors including demographics, socioeconomic status, behavior and lifestyle, type of insurance, chronic health conditions, medication use, region, and year, ADRD was found to be significantly more prevalent among individuals with PIA, with or without OA, compared to those with no OA (adjusted odds ratios of 1.37 and 1.86, respectively, P = 0.041) or PIA (aOR 1.44 and 1.82, respectively, P < 0.003).3

The data from this published population-based cross-sectional study of pain and ADRD in the United States reflect findings from similar studies in other countries, the researchers shared.

While mechanisms underlying the observed association of OA and PIA to ADRD remain unknown, OA and PIA may contribute to cognitive decline and subsequent development of ADRD via both direct and indirect pathways,” Ikram’s team wrote. “For example, as discussed above, pain, both in the presence and absence of OA, may lead to adverse changes in brain structure and function and in CNS activation and sensitivity that increase risk for cognitive dysfunction and ultimately, ADRD.”

Challenges of Alzheimer’s Diagnosis and Treatment in Patients with Chronic Pain

A 2019 review published in Pain Therapy examined key challenges of pain management in elderly adults with cognitive decline.4 In this population, pain is often underestimated, underreported, misdiagnosed, and undertreated, wrote Luca Cravello, MD, of Passirana di Rho Hospital, Milan, Italy, and colleagues in their paper.

“The complexity of patients with dementia makes it difficult not only to make a correct diagnosis of pain but also to start adequate treatment,” Dr. Cravello emphasized.To help make a correct diagnosis, the reviewers advised using validated and standardized pain assessment scales. Self-assessment scales are appropriate for those with mild to moderate cognitive impairment, while observational scales can be used for those with more severe impairment.

When it comes to treating pain in adults with cognitive impairment, “The first consideration is to use appropriate pain assessment methods and to correctly set the diagnosis in order to choose the most appropriate drug therapy and avoid the use of inappropriate, potentially harmful drugs,” Dr. Cravello said. Clinical trial data on the effectiveness of treatment strategies in this patient population are limited, so most guidance is based on clinical experience, he noted.

Effective strategies should involve “careful training of caregivers, analyzing the patient’s risk factors and comorbidities, and carefully monitoring the patient over time,” and can include both pharmacologic and nonpharmacologic elements, Dr. Cravello added.

Further Considerations and Future Directions

It is worth remembering that chronic pain can have different meanings, noted Glenn J. Treisman, MD, PhD, a professor of psychiatry and medicine at Johns Hopkins University in Baltimore, in an interview with PPM.

Chronic pain may emerge as a result of tissue that is damaged, and also from an adaptation in the nervous system, he clarified. The inflammatory system is a processor, like the brain, and exploration of the relationship between the brain and inflammatory system is “a very exciting area of medicine right now,” he added.

“We used to think that AD was purely a result of the development of sheets of protein, the amyloid plaques in the brain,” said Dr. Treisman. However, recent research suggests that there is more of a role for other cells, the microglia, and that inflammatory damage plays a role, he explained. This evolution has sparked the development of new drugs for Alzheimer’s that are directed at changing inflammation cascades, he explained.

“The studies referenced here are well done because they are stacked towards more elucidation of the relationship between the inflammation and later dementia,” he said.

When it comes to patient care, clinicians need to adopt a comprehensive approach, said Dr. Treisman. In individuals with chronic pain, treatment includes not only getting the pain and related symptoms under control but helping the person to follow a healthier diet and lifestyle to help diminish the effects of inflammation that may contribute to diseases including AD.

“When you have a new patient, you examine the whole patient,” Dr. Treisman emphasized. “Everyone should be screened for cognitive impairment, and there are some simple tests depending on how functional the patient is.”

Specifically, Dr. Treisman recommends the Mini-Mental State Examination (MMSE), which is sensitive to cognitive impairment and considered an AD screener. However, clinicians need to look at other forms of cognitive function in their patients as well, such as how well they can read or process information. Providers who are especially concerned about cognitive impairment can administer the Montreal Cognitive Assessment (MoCA), which also assesses executive functions, language, and short-term memory, he advised.

“Chronic pain itself can be a risk factor for chronic impairment,” Dr. Treisman said. “Pain makes inflammatory symptoms worse (as illustrated in the study of pain and osteoarthritis) and when you add in cognitive impairment, it makes treatment that much harder.”

Areas for additional study on the link between chronic pain and cognitive impairment, including Alzheimer’s disease, should involve interstitial medicine, the medicine between subspecialties, including work on the interaction between dementia and inflammation, he suggested. “For example, heart disease has an inflammatory component, and we are just starting to understand how some of these conditions go together to explore more options for cures.”

 

 

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Elizabeth Warren Advocates to Formalize Barriers for Pain Patients

Posted on December 11, 2020 by Pharmaciststeve

Elizabeth Warren Advocates to Formalize Barriers for Pain Patients

https://filtermag.org/elizabeth-warren-partial-refills/

Five lawmakers, including Senator Elizabeth Warren, have renewed their demands for the DEA to double down on its policy of limiting pain patients’ access to their medication

 Their position is premised on a misunderstanding of the ever-worsening overdose crisis—which is currently driven by an illicit heroin and stimulant supply adulterated by the synthetic opioid, fentanyl.

In an October 6 letter to acting DEA Administrator Timothy Shea that is almost exactly the same as one from July 2018, Sen. Warren, who has a track record of supporting harm reduction services, called on the drug-war agency to update the agency’s medication “partial fill” regulation to clarify that pharmacists can voluntarily withhold some of an opioid prescription, as advised by the patient’s prescriber. Patients can also request them.

The bipartisan Comprehensive Addiction and Recovery Act (CARA) of 2016 authorized these partial fills of Schedule II controlled substances when pharmacists are “unable to supply the full quantity.” This was an attempt, the bill states, to “address the prescription opioid abuse and heroin use crisis” by cutting patients’ access to medications. But due to the DEA’s “foot dragging,” as the five politicians describe it, part of the legislation remains unimplemented

“We can’t afford to neglect the opioid epidemic, nor the communities it is affecting the most, while we continue to combat COVID-19,” wrote Senator Warren in an op-ed published by a local Massachusetts newspaper less than a week before her latest letter to the DEA.

But her advocacy in the name of people who use opioids may have mixed results for their wellbeing. Warren’s press team did not respond to Filter‘s request for comment.

Opioid analgesics can be crucial for pain patients’ mental and physical wellbeing, and partial fills may function as a type of harm reduction support. “If someone’s having trouble controlling their medication, it’s a good thing,” pain patient advocate Anne Fuqua told Filter. The current accepted use of partial fills for when pharmacists run out of a medication is also beneficial to patients, she added. “If my pharmacy is out, I’d have to wait or forfeit [my prescription]. You’d have to get a second prescription and some doctors don’t care.”

On the flip side, for Fuqua, partial fills could make pain patients’ lives more difficult. “If the doctor writes a script for once a month but you have to pick it up every week, that would be a tremendous burden.”

They therefore risk adding one more barrier for patients who have already been harmed by other prohibitionist attempts at getting a handle on the overdose crisis. “Clinicians might universally stop prescribing opioids, even in situations in which the benefits might outweigh their risks,” the Centers for Disease Control and Prevention (CDC) wrote in a 2017 commentary. “Such actions disregard messages emphasized in the guideline that clinicians should not dismiss patients from care, which can adversely affect patient safety, could represent patient abandonment, and can result in missed opportunities to provide potentially lifesaving information and treatment.”

Politicians’ fixation on the prescription opioid supply further misses what is driving record-breaking, preventable overdose deaths—especially among poor communities and communities of color, both of whom have been made vulnerable to drug-related harms by the federal governments’ austere health policy.

Deaths involving cocaine and methamphetamine reportedly surpassed those of most opioids for the first-time in August 2019, an apparent turning point in the nature of the drug-involved deaths crisis in the United States. The latest CDC data show that, in the last month of that summer, more people’s predicted deaths involved cocaine (15,206) and/or “psychostimulants with abuse potential” (15,180)—a vague category that includes crystal meth—than those involving heroin (14,674), “natural & semi-synthetic opioids” (12,093), meaning opioid analgesics, and/or methadone (2,849) combined.

Black Americans who use cocaine are disproportionately likely to die from an overdose or overamp. According to a September 2020 study, 11 percent of reported cocaine users are non-Hispanic Black, yet more than one-quarter (27 percent) of cocaine-related fatalities involved non-Hispanic Black people. In 2018, the non-Hispanic Black cocaine-involved death rate was twice that of whites, despite past-year cocaine use prevalence being about the same between the two groups.

The synthetic opioid fentanyl is playing a large part in the current overdose crisis too. As of February 2020, it was by far the most common substance involved in the historic death toll. But its supply is mostly through illicit markets, not patient diversion, as the DEA has reported.

Warren’s recent op-ed failed to recognize these trends. Instead, she continued to characterize the issue as an “opioid crisis” and made no mention of the role of stimulants. She did mention fentanyl, but only to say that pharmaceutical companies left people who use drugs “vulnerable to developing addictions to more dangerous and illicit substances like fentanyl.” While some people have come to prefer fentanyl (which doesn’t necessarily indicate addiction), many who experience its harms don’t know about its presence in their drugs.

Warren has worked to advance laws that hold greater promise for ending the crisis. In April 2018, she and the late Representative Elijah Cummings introduced the Comprehensive Addiction Resources Emergency (CARE) Act—a bill, yet to become law, that would provide to frontline interventions what CARA failed to: money. Billions in federal funds would go to bolstering hard-hit jurisdictions’ responses; advancing public health research and surveillance; supporting treatment, prevention, recovery and harm reduction; and expanding professional and public access to naloxone, the opioid overdose reversal medication.

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Five lawmakers demands for the DEA to double down on its policy of limiting pain patients’ access to their medication.

Posted on December 11, 2020 by Pharmaciststeve

Are these FIVE LEGISLATORS proposing a bill that would cause the DEA and other agencies/entities to discriminate against all pain pts – including those with intractable chronic pain  – that would be a civil rights violation of both the American with Disability Act & Civil Rights Act ?  Does this make this proposed bill UNCONSTITUTIONAL before it even gets a vote to pass ?

Elizabeth Warren Advocates to Formalize Barriers for Pain Patients

https://filtermag.org/elizabeth-warren-partial-refills/

Five lawmakers, including Senator Elizabeth Warren, have renewed their demands for the DEA to double down on its policy of limiting pain patients’ access to their medication. Their position is premised on a misunderstanding of the ever-worsening overdose crisis—which is currently driven by an illicit heroin and stimulant supply adulterated by the synthetic opioid, fentanyl.

In an October 6 letter to acting DEA Administrator Timothy Shea that is almost exactly the same as one from July 2018, Sen. Warren, who has a track record of supporting harm reduction services, called on the drug-war agency to update the agency’s medication “partial fill” regulation to clarify that pharmacists can voluntarily withhold some of an opioid prescription, as advised by the patient’s prescriber. Patients can also request them.

The bipartisan Comprehensive Addiction and Recovery Act (CARA) of 2016 authorized these partial fills of Schedule II controlled substances when pharmacists are “unable to supply the full quantity.” This was an attempt, the bill states, to “address the prescription opioid abuse and heroin use crisis” by cutting patients’ access to medications. But due to the DEA’s “foot dragging,” as the five politicians describe it, part of the legislation remains unimplemented

“We can’t afford to neglect the opioid epidemic, nor the communities it is affecting the most, while we continue to combat COVID-19,” wrote Senator Warren in an op-ed published by a local Massachusetts newspaper less than a week before her latest letter to the DEA.

But her advocacy in the name of people who use opioids may have mixed results for their wellbeing. Warren’s press team did not respond to Filter‘s request for comment.

Opioid analgesics can be crucial for pain patients’ mental and physical wellbeing, and partial fills may function as a type of harm reduction support. “If someone’s having trouble controlling their medication, it’s a good thing,” pain patient advocate Anne Fuqua told Filter. The current accepted use of partial fills for when pharmacists run out of a medication is also beneficial to patients, she added. “If my pharmacy is out, I’d have to wait or forfeit [my prescription]. You’d have to get a second prescription and some doctors don’t care.”

On the flip side, for Fuqua, partial fills could make pain patients’ lives more difficult. “If the doctor writes a script for once a month but you have to pick it up every week, that would be a tremendous burden.”

They therefore risk adding one more barrier for patients who have already been harmed by other prohibitionist attempts at getting a handle on the overdose crisis. “Clinicians might universally stop prescribing opioids, even in situations in which the benefits might outweigh their risks,” the Centers for Disease Control and Prevention (CDC) wrote in a 2017 commentary. “Such actions disregard messages emphasized in the guideline that clinicians should not dismiss patients from care, which can adversely affect patient safety, could represent patient abandonment, and can result in missed opportunities to provide potentially lifesaving information and treatment.”

Politicians’ fixation on the prescription opioid supply further misses what is driving record-breaking, preventable overdose deaths—especially among poor communities and communities of color, both of whom have been made vulnerable to drug-related harms by the federal governments’ austere health policy.

Deaths involving cocaine and methamphetamine reportedly surpassed those of most opioids for the first-time in August 2019, an apparent turning point in the nature of the drug-involved deaths crisis in the United States. The latest CDC data show that, in the last month of that summer, more people’s predicted deaths involved cocaine (15,206) and/or “psychostimulants with abuse potential” (15,180)—a vague category that includes crystal meth—than those involving heroin (14,674), “natural & semi-synthetic opioids” (12,093), meaning opioid analgesics, and/or methadone (2,849) combined.

Black Americans who use cocaine are disproportionately likely to die from an overdose or overamp. According to a September 2020 study, 11 percent of reported cocaine users are non-Hispanic Black, yet more than one-quarter (27 percent) of cocaine-related fatalities involved non-Hispanic Black people. In 2018, the non-Hispanic Black cocaine-involved death rate was twice that of whites, despite past-year cocaine use prevalence being about the same between the two groups.

The synthetic opioid fentanyl is playing a large part in the current overdose crisis too. As of February 2020, it was by far the most common substance involved in the historic death toll. But its supply is mostly through illicit markets, not patient diversion, as the DEA has reported.

Warren’s recent op-ed failed to recognize these trends. Instead, she continued to characterize the issue as an “opioid crisis” and made no mention of the role of stimulants. She did mention fentanyl, but only to say that pharmaceutical companies left people who use drugs “vulnerable to developing addictions to more dangerous and illicit substances like fentanyl.” While some people have come to prefer fentanyl (which doesn’t necessarily indicate addiction), many who experience its harms don’t know about its presence in their drugs.

Warren has worked to advance laws that hold greater promise for ending the crisis. In April 2018, she and the late Representative Elijah Cummings introduced the Comprehensive Addiction Resources Emergency (CARE) Act—a bill, yet to become law, that would provide to frontline interventions what CARA failed to: money. Billions in federal funds would go to bolstering hard-hit jurisdictions’ responses; advancing public health research and surveillance; supporting treatment, prevention, recovery and harm reduction; and expanding professional and public access to naloxone, the opioid overdose reversal medication.

 

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Millions receive medication by mail WITH LITTLE REGULATION for mail-order pharmacies

Posted on December 10, 2020 by Pharmaciststeve

NBC News reached out to all 50 state pharmacy boards, which oversee mail-order pharmacies, and the vast majority don’t have specific rules about how to ship medication, saying it’s up to the pharmacy to ensure it’s done safely.

There is a publication called  https://www.usp.org/ United States Pharmacopeia     that has been around for abt 200 yrs and within it is described the storage requirements for all medications, including most all OTC meds…  all Rx meds will have a exact F/C range and OTC may just state “store at room temperature”.  The Pharma, drug wholesaler, Pharmacy are legally required to meet those storage temps while the medications are in their possession.   Once the pharmacy hands a package containing medications – to a delivery service (USPS, USP, FedEx)… the legal obligation to maintain those storage temperature requirements – basically “flies out the window”..

The representative of Express Scripts – Wendy Barnes –  the President of HOME DELIVERY for Express Scripts… I will presume that she is not a Pharmacist…. so Express Scripts is putting forth a person who according to her LinkedIN page has a BS in Biochemistry and a MBA.  https://www.linkedin.com/in/wendy-barnes-6bb15639/  So saving ONE DOLLAR on the not using temp sensor in the shipping package. I just wonder how much Sophia Dean’s insurance company had to pay out for the feeding tube and tube feedings and hospitalization costs… because Express Scripts was more concern about “pinching pennies” that favored their bottom line.

The fact that they got an exception to fill Sophia’s medication at the local pharmacy – notice that they use a INDEPENDENT PHARMACY – suggests that those other costs to the insurance company for hospitalization and related tube feeding costs WERE SUBSTANTIAL.

It does not surprise me that the board of Pharmacy shirk their study and their primary charge of protecting public safety in regards medications.  I suspect that since there was nothing involving the potential of diversion of controlled substances… it is not the board of Pharmacy’s concern.

What was not addressed in the article is that Express Scripts is/was primarily a PBM ( Prescription Benefit Manager) whose primary function is to process Rx claims from community pharmacies on behalf of a insurance company, but apparently they have taken advantage of their position to expand their business plan into the mail order prescription business…. and went to the insurance company and told them they could cut a certain percent of medication cost if they could “force” their employees to use Express Scripts’ mail order facility…   What the employer didn’t understand that these PBM’s typically keep the lion’s share of what is saved by Express Scripts mail order pharmacy … goes into Express Scripts’ bottom line.

Here is just ONE OF MANY such lawsuits  https://www.washingtonpost.com/news/wonk/wp/2016/03/21/anthem-sues-express-scripts-over-prescription-drug-pricing/  and this law suit was not over just “pennies”   Anthem seeks $15 billion in damages for uncompetitive pharmacy pricing from Dec. 1, 2015 through 2020. I used this “express scripts sued by insurance company over rebates” for a web search and got PAGES of responses of many entities suing Express Scripts over them pocketing money that they were suppose to pay the entity they had a contract with.

 

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When Cops Play Doctor: How the drug war punishes pain patients

Posted on December 9, 2020 by Pharmaciststeve

The steady stream of celebrity stories about prescription drug abuse makes Americans keenly aware of the dangers of overdosing on medications like OxyContin and Vicodin. And from President Obama’s Drug Czar to California Attorney General Jerry Brown, politicians are calling for greater power to monitor doctor-patient relationships in order to fight the “epidemic” of prescription drug overdosing.

But maybe the real epidemic is underdosing. Countless Americans suffer with severe chronic pain because doctors are afraid to treat them properly.

Michael Jackson’s death unleashed a flurry of media stories about all aspects of the pop star’s life, including his alleged prescription drug abuse. On the same day countless millions watched Jackson’s star-studded memorial service, reason.tv interviewed another musician.

Seán Clarke-Redmond, a man who enjoyed an active live before the neurodegenerative disease ALS, often referred to as Lou Gerig’s disease, rendered him nearly immobile—he can no longer even play the piano.

The disease also left him in almost constant pain. Redmond is prescribed some medication, but not nearly enough to keep his pain under control. Dr. Frank Fisher says Redmond’s case is an appallingly common one.

“Chronic pain in America is an enormously under treated disease,” says Fisher, a Harvard-trained physician. “It’s a public health disaster.”

Pain specialists like Fisher and patients’ groups like the Pain Relief Network battle law enforcement officials who are forever on the lookout for “pill mills” and patients who misuse pain medicine. Fisher notes that the same medications so often associated with celebrity addiction are the same medications that combat pain most effectively.

Fisher has treated his patients with high doses of opioids-that is, until a swat team raided his clinic and threw him behind bars.

“They were trying to give me 256 years to life,” says Fisher who argues that fear of prosecution often prevents doctors from treating chronic pain patients effectively.

What allows doctors’ medical decisions to be overruled by police?

“What we’re dealing with is a mass insanity,” says Fisher. “We call it the war on drugs.”

“When Cops Play Doctor” is written and produced by Ted Balaker and hosted by Nick Gillespie. Director of Photography is Alex Manning, Associate Producers are Hawk Jensen and Paul Detrick.

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The RETURN of the SWAMP ?

Posted on December 9, 2020 by Pharmaciststeve

Michigan rep Cynthia A Johnson making threats against Trump Supporters 12-8 MI

BUT don’t worry … she has been PUNISHED…. she lost all her committee assignments thru 12/31/2020

according to the Congressional calendar  https://www.nab.org/documents/advocacy/2020CongressionalCalendar.pdf   … the House leaves for Christmas break on Thursday Dec 10,2020 — which is TOMORROW !!

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COVID-19: Allergic Reaction Warning for Pfizer/BioNTech Vaccine

Posted on December 9, 2020 by Pharmaciststeve

COVID-19: Allergic Reaction Warning for Pfizer/BioNTech Vaccine

https://www.medscape.com/viewarticle/942285

UK regulators have issued a warning that people who have a history of significant allergic reactions should not currently receive the Pfizer/BioNTech vaccine.

The incidents relate to two healthcare workers who suffered allergic reactions after having the vaccine yesterday but who have since recovered.

MHRA Chief Executive Dr June Raine told MPs on the Commons Health and Science Committee: “Last evening, we were looking at two case reports of allergic reactions. We know from the very extensive clinical trials that this wasn’t a feature. But if we need to strengthen our advice now that we’ve had this experience in the vulnerable populations, the groups who’ve been selected as a priority, we get that advice to the field immediately.”

Pfizer UK said in a statement: “We have been advised by MHRA of two yellow card reports that may be associated with allergic reaction due to administration of the COVID-19 BNT162b2 vaccine.

“As a precautionary measure, the MHRA has issued temporary guidance to the NHS while it conducts an investigation in order to fully understand each case and its causes. Pfizer and BioNTech are supporting the MHRA in the investigation.

“In the pivotal phase 3 clinical trial, this vaccine was generally well tolerated with no serious safety concerns reported by the independent Data Monitoring Committee. The trial has enrolled over 44,000 participants to date, over 42,000 of whom have received a second vaccination.”

Trial Data

Data released by the US FDA show a small number of allergic reactions reported in both the vaccine and placebo trial groups (0.63% and 0.51%).

Commenting via the Science Media Centre, Professor Peter Openshaw, past-president of the British Society for Immunology, Imperial College London, said: “The fact that we know so soon about these two allergic reactions and that the regulator has acted on this to issue precautionary advice shows that this monitoring system is working well.”

Dr Raine also told MPs “data packages for the AstraZeneca/Oxford vaccine have been arriving”. She didn’t commit to a date for a decision but said “work is proceeding intensively, and with great scientific rigour”.

She was asked about the half dose, full dose approach that gave better results than two full doses. “Clearly we have a great interest into the possible reasons for the different doses having a different efficacy effectiveness readout. But the position is we will look at every piece of evidence.”

She added: “We will be reaching a position on the basis of all completed studies and analyses. And of course, part of that will be to examine with great rigour the basis for the appropriate dosage regimen for UK people.”

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COVID-19 Vaccine Has Potential Side Effects, Nurse Volunteer Says

Posted on December 8, 2020 by Pharmaciststeve

COVID-19 Vaccine Has Potential Side Effects, Nurse Volunteer Says

https://www.medscape.com/viewarticle/942133

Nurse researcher Kristen Choi, PhD, RN, experienced first-hand a “worst-case scenario” of potential side effects after receiving an experimental COVID-19 vaccine in a phase 3 trial. She says clinicians should be prepared to reassure patients if reports of similar experiences spread when vaccine rollouts begin.

“This was the highest fever I can ever remember having, and it scared me,” said Choi, with the School of Nursing at the University of California, Los Angeles.

Choi volunteered to participate in Pfizer’s COVID-19 vaccine trial in August. When she came back for the second dose in September she began to experience distressing symptoms.

The symptoms, she writes in a perspective piece published online today in JAMA Internal Medicine, started with immediate pain at the injection site. By nightfall, she felt “felt light-headed, chilled, nauseous, and had a splitting headache” and went to bed.

She woke up at midnight and the symptoms had intensified and she could hardly move her arm from injection-site pain. Choi slept fitfully and when she woke up at 5:30 AM her thermometer read 104.9 °F (40.5 °C).

By the next morning all symptoms had disappeared except for a sore bump at the injection site.

Because the trial was blinded, Choi wasn’t told whether she received the vaccine or placebo, but the symptoms left her with little doubt.

She told Medscape Medical News her reason for writing the article was to let anyone who will be administering a COVID-19 vaccine know that when a rollout begins some patients may experience the same side effects.  Disclosure forms are not enough to make sure people understand that what they may experience is normal, she said.

After all, even Choi, who administers vaccines and whose career centers on research, began to fear something was wrong when symptoms flared even though she was thoroughly briefed on potential side effects. She says rational thought for her went out the window when her fever spiked.

Experts Say Her Symptom Combination Is Unusual

Two vaccine experts told Medscape Medical News that Choi’s symptoms were the extreme case and the vast majority of people will not experience her level of discomfort.

But they both agree Choi’s message is an important reminder that healthcare professionals need to be prepared to answer questions when the rollouts begin.

Her story may also point out the need for creating a hotline for 24/7 access so that if patients do experience severe symptoms they can get answers right away, they said.

William J. Moss, MD, MPH, executive director of the International Vaccine Access Center at Johns Hopkins’ Bloomberg School of Public Health in Baltimore, Maryland, told Medscape Medical News that spotlights on individual cases of extreme side effects should be paired with spotlights on the experience of a patient with COVID-19 in an intensive care unit to give proper context.

“The type of side effects we’re seeing with the Pfizer and Moderna vaccines are typical of any vaccine, though there is a spectrum,” Moss said.

“The numbers I’ve seen range from maybe 2% to 10% ­­— maybe up to 15% — of people having these kinds of really noticeable side effects. Again all transient. But some people have more severe [reactions] than others.” Moss continued. He notes that any inflammatory response — or reactogenicity — is normal.

“What we don’t want is for people to be surprised by that,” he said.

An important point, Moss says, is that “these are always transient, lasting 12-36 hours, maybe 48 hours.”

Moss said people getting the vaccines should leave the vaccination location knowing a phone number to call if they experience severe symptoms so that they can talk directly with a healthcare professional at any time of day or night.

“I Would Do it Again in a Heartbeat”

Choi wants to be clear that her message is not meant to warn against the vaccine itself: “I would do it again in a heartbeat even if I knew I was going to have the same reaction,” she said.

Her message, rather, is that clinicians may be underestimating the effort it will take to be ready to correct misinformation; they should reassure patients that the symptoms come because the body is training itself to fight the virus.

Albert Rizzo, MD, chief medical officer for the American Lung Association, told Medscape Medical News that the side effects Choi experienced — especially all at once — are uncommon with the Pfizer vaccine as well as with the other two frontrunners by Moderna and Oxford/AstraZeneca.

“People should not expect to get that many side effects,” he said.

However, milder side effects, such as soreness at the injection site, are common, he said.

Part of the message to patients should include the risk–benefit balance: an emphasis should be placed on weighing the deadly risk of COVID-19 as well as the benefit of helping protect society at large against potential vaccine side effects, he said.

Healthcare professionals should partner with other trusted influencers within cultures, particularly among people of color, where trust of vaccines is particularly low, Rizzo said. Leaders who understand both the hesitancy and the need for the vaccine can help reinforce the clinical message.

The American Lung Association, for instance, is partnering in the Black community with church pastors and community health center clinicians.

“We can’t just from on high say this is an important thing to do,” he said.

Choi reports grants from the Agency for Healthcare Research and Quality outside the submitted work. Rizzo and Moss have disclosed no relevant financial relationships.

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Amazon Pharmacy Boasts Big Discounts for Prescription Meds, but Probably Isn’t the Best Deal

Posted on December 8, 2020 by Pharmaciststeve

Amazon Pharmacy Boasts Big Discounts for Prescription Meds, but Probably Isn’t the Best Deal

https://www.healthline.com/health-news/amazon-pharmacy-boasts-big-discounts-for-prescription-meds-but-probably-isnt-the-best-deal#Amazon-Pharmacy-has-potential,-but-likely-wont-be-a-game-changer-for-prescription-drug-prices

  • Amazon launched Amazon Pharmacy, a delivery service for prescription medications.
  • The service allows customers to purchase prescription medications with or without insurance.
  • It boasts that Amazon Prime members can save up to “80 percent off generic and 40 percent off brand name medications when paying without insurance.”
  • Experts say Amazon Pharmacy has the potential to improve drug pricing in the United States, but it likely won’t be a game-changer since it will work within the same system as other online pharmacies.
  • Despite its boasting, Amazon Pharmacy pricing doesn’t really offer much of a discount.

Amazon’s blue delivery vans have quickly become ubiquitous around the nation, delivering everything to people’s doors, from essential daily items to live insects.

Now, the world’s largest online retailer run by the world’s richest man is getting even further into the U.S. healthcare market by offering to send prescription drugs to its customers’ doors.

In announcing the new venture on Nov. 17, Amazon said in a statement that customers can purchase prescription medications with or without insurance.

It boasts savings for its 100 million Prime members of up to “80 percent off generic and 40 percent off brand name medications when paying without insurance.”

That membership also includes unlimited, free 2-day delivery.

“We designed Amazon Pharmacy to put customers first — bringing Amazon’s customer obsession to an industry that can be inconvenient and confusing,” TJ Parker, vice president of Amazon Pharmacy, said in a statement.

On the site, Amazon users can compare the cost of drugs to see what’s covered by their insurance, while also giving the option of paying entirely out of pocket — sometimes the cheaper route, especially if coupons are available from the drug’s manufacturer.

Amazon does say it won’t be delivering any drugs listed under the Drug Enforcement Administration’s Schedule II controlled substances, which includes opioid pain meds.

It also only sells 30-day supplies, while other online pharmacies allow for 90-day supplies.

But outside Amazon’s own distribution structure and size as a company, many familiar with the way Americans get their prescription drugs say it has the potential to create meaningful contributions to lowering drug costs.

But, so far, it’s essentially another mail-order prescription drug delivery service and not tackling larger issues in the United States’ notoriously high-priced drug market.

Amazon Pharmacy has potential, but likely won’t be a game-changer for prescription drug prices

“The larger issue is much more complicated,” Eric Levin, CEO of Scripta Insights, a service that analyzes data and identifies savings on prescriptions, told Healthline.

“Drug pricing is one of the most secret prices of them all in America. Just because Amazon has it, it doesn’t mean it’s going to be the best price or best for you,” he said.

Pharmacy isn’t Amazon’s first venture into prescription medications.

Amazon bought PillPack in 2018. That service is aimed at helping people manage their chronic conditions by receiving their multiple medications in presorted packages delivered directly to their doors.

Even then, as CNBC reported, pharmacy benefit managers (PBMs) — the middlemen between patients and insurance companies — were worried about Amazon entering the prescription drug market “because it’s really the only company that could conceivably break up their control if it were to jump into the distribution market and pressure drug manufacturers to lower prices.”

While lowering drug prices is often a bipartisan campaign promise, spending on prescription medications in the United States continues to grow.

According to a 2019 report by the IQVIA Institute, which tracks spending on medications, net medication spending in the United States will increase from $344 billion in 2018 to $420 billion in 2023.

But those familiar with the prescription drug market say Amazon won’t be a gigantic game-changer in what people pay for their prescription medications.

Levin said Amazon is merely “putting a Band-Aid on the enormous problem of prescription drug pricing” and will only “feed the beast and contribute to the drug pricing problem in this country rather than disrupting it.”

“While consumers will enjoy lower prices on their drugs, the discounts are still paid for by the same PBMs responsible for the exorbitant cost of drugs to begin with,” Levin said. “Ultimately, this service won’t do anything to reduce costs in our broken healthcare system.”

Part of that broken system is the public’s ability to fully understand all the forces behind what goes into drug pricing.

That’s due in part because PBMs, whose prices they negotiate for things like private insurance plans and Medicare Part D, aren’t transparent in what the true cost is for the drugs they buy for these plans.

They’re also highly criticized for needlessly increasing the price of those prescription medications.

“They make it harder to understand,” Levin said.

And since Amazon is using the PBM model, many skeptics argue it’s not bringing much new to the game in terms of revolutionizing the way people — whether they have insurance or not — get their prescription medications.

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Millions of Americans receive drugs by mail. But are they safe?

Posted on December 8, 2020 by Pharmaciststeve

Millions of Americans receive drugs by mail. But are they safe?

https://www.nbcnews.com/specials/millions-of-americans-receive-drugs-by-mail-but-are-they-safe/index.html

One evening in mid-June, Megan Becker stepped outside of her Las Vegas home and scooped up a package containing her medication, a monthly injection to prevent debilitating migraines. 

It was a sweltering night – the temperature hovered just below 95 degrees. When Becker opened up the package, which arrived a day late, she found that the ice packs were melted and the medicine, which is supposed to be refrigerated, was warm to the touch.

“They literally just dump the box on my front stoop, regardless of the weather,” Becker, an English professor at the University of Nevada, Las Vegas, said. “It’s just such expensive medication and it seems like such a careless way to deliver it.”

A shipment of Megan Becker’s migraine medication left at her door in late August. (Megan Becker)

Shortly after the drug, Aimovig, hit the market, Becker began picking it up from a nearby pharmacy. But last year, her health insurance confronted her with a choice: switch to the Express Scripts mail-order pharmacy and get it for roughly $50 per month, or pay out of pocket for the more than $600-per-dose medication. 

Becker fought to keep picking it up locally, but said she gave up after two months of what she described as maddening calls with Express Scripts. 

“I really, really, really did not want to get it this way and I was not given an option,” she said.

Millions of Americans receive their medications by mail but many, like Becker, find themselves forced to do so by their insurance plans or face the prospect of paying exorbitant amounts for the same drugs. 

An NBC News investigation found the growth of mail-order pharmacies has caused many people to feel trapped in a system that has left them with crushed pills, damaged vials and lifesaving drugs exposed to extreme weather.

A delivered package of refrigerated medication in Millerton, N.Y. (Kim Yarnell)

Interviews with more than 65 mail-order pharmacy customers across the nation revealed deep worries over how their medication is delivered — and no affordable alternatives. Many reported receiving drugs in flimsy packaging without temperature indicators, which can cost as little as a dollar per package. Others have had to plead with pharmacies to send them replacement drugs after receiving medication they thought arrived too warm or cold.

The industry is massive, generating billions in annual sales, but it occupies a gray area with little regulation and even less enforcement, NBC News found. 

“It’s a quagmire,” said Georgia state Rep. Ron Stephens, a pharmacist, who has sponsored multiple bills to increase patient choice when it comes to pharmacies. “If they’re sending it without a temperature strip, and you’re the recipient of insulin or a lifesaving drug, you’re taking your life into your hands,” the Republican said.

Extreme temperatures can degrade medications, potentially rendering them unsafe or ineffective for patients. Industry guidelines make clear that pharmacies should package and ship medications in accordance with their recommended temperature range. But many mail-order pharmacy customers have no way of knowing whether their medicine has gone too far outside that range for too long. 

“[Patients] just might think that they’re getting sicker or that it might be their fault,” said Erin Fox, director of drug information at University of Utah Health, who researches drug quality and shortages. “But it’s important to think about, ‘Could it be my medicine that is maybe not of high quality or potentially got ruined with high temperatures?”

After receiving organ transplant medication that felt hot, a mail-order pharmacy customer posted a photo to social media of a home thermometer reading inside the pill bottle. (Obtained by NBC News)

Proving that a drug had become ineffective or made someone sicker because it was exposed to extreme temperatures is nearly impossible, experts say. By the time such a possibility is considered, the medication itself would likely have already been consumed or thrown away, preventing it from ever being tested. Plus, experts say, without temperature tracking during shipment, there’s no way to know how the medication may have been affected by the conditions inside a delivery truck or the temperature outside someone’s home.

But some people believe they or their loved ones have experienced a decline in health after receiving medications through the mail, including the family of a young girl from North Carolina. 

‘You’re not a pharmacist, ma’am.’ 

Shortly after she was born, Sophie Dean was diagnosed with cystic fibrosis.

She was two weeks old when doctors put her on a lifesaving pancreatic enzyme to help her digest food and absorb nutrients. The medication worked, allowing Sophie to gain weight and grow.

But in 2015, when she was eight, her parents’ health insurance started requiring that they receive her medication through Express Scripts mail-order pharmacy rather than the specialty pharmacy that had been sending it to them previously.

Instead of receiving the medication in an insulated box with a device that indicated if it was exposed to potentially harmful temperatures, as her family had done previously, Express Scripts sent it without any kind of temperature indicator in a cardboard box or often just a thin, gray plastic bag, Erica Dean, Sophie’s mother, said.

And because the mail-order pharmacy didn’t notify them when the package arrived or provide them with a tracking number, the package would sometimes sit on the family’s porch for hours, baking under the North Carolina sun.

Sophie began suffering from debilitating stomach aches. Her appetite evaporated, her mother said, and her body mass index plummeted.

Sophie Dean, 13, has taken pancreatic enzymes with meals since she was two weeks old. (Kenzi Abou-Sabe / NBC News)

“I started to think, ‘OK, wait a minute.’ We were told when she was two weeks old, ‘Don’t even keep the enzymes in the car because it’s not safe. They won’t be as effective,’” Dean said.

She called the pharmacy asking them to ship it a different way, but she said an Express Scripts representative told her, “You’re not a pharmacist, ma’am.” 

Dean said she called again and again. “It was a script, every time. I knew exactly what they were gonna say every time I called,” she said. 

“My option was either fill it like they tell me to, or sell my house and my kids and my organs,” Dean said, “That’s just one medication she’s on, and not the most expensive one.”

And then something strange happened. When Sophie landed back in the hospital with severe lung inflammation in 2017, she regained her appetite.

“The doctor is baffled,” Dean recalled. “And he comes in and he says, ‘Ms. Dean, I don’t understand. Enlighten me. What’s going on?’” 

Dean explained that after Sophie was placed on the hospital’s supply of enzymes, her discomfort during mealtimes had all but disappeared. 

“At that time, my take was the enzyme source needed to be reviewed,” Dr. Patrick Sobande, Sophie’s then-doctor, said in an email. 

Soon after, Sophie’s family secured an exception allowing them to fill the prescription at a local pharmacy. She continued gaining weight, and in the last three years, her mother says she hasn’t had the same digestive issues.

A bottle of Sophie Dean’s pancreatic enzymes, which she takes to help treat cystic fibrosis. (Kenzi Abou-Sabe / NBC News)

Definitively linking Sophie’s digestive problems with how her medication was delivered would be nearly impossible, multiple pharmacological experts said. The medication is gone — ingested by Sophie long ago — and can’t be tested for changes in potency before and after transit. And there are other potential explanations for her discomfort that aren’t easily disproved. 

Cystic fibrosis specialists have long warned families about pancreatic enzymes’ sensitivity to heat. 

“Even before mail-order pharmacies, when it came to enzymes, we very explicitly told families never to leave them in their cars, never to leave them in a hot spot in the house,” said Dr. Greg Sawicki, an associate professor of pediatrics at Harvard Medical School who runs the Cystic Fibrosis Center at Boston Children’s Hospital. “It could have very much been that the enzymes were denatured or not working effectively because they were not being stored or shipped properly.”

When asked about Dean’s and Becker’s cases, a representative for Express Scripts Pharmacy said that when patient issues arise, “our team works quickly to resolve them, just as we did with these patients.” 

In an interview, Wendy Barnes, Express Scripts’ head of home delivery, said all medications are shipped with tracking information and if a patient’s drug is damaged during transit, the company will expedite a replacement to them, which is what happened with Becker’s warm migraine medication.

“Everything we do is to serve our patients. We want nothing more than for them to have the medication that they need in a timely and efficacious manner,” she said.

“While we are getting it right the majority of the time, any time we’re not, we absolutely need to do better,” she added. 

As for Dean’s and Becker’s inability to fill their prescriptions locally without paying out of pocket, Barnes said Express Scripts is not the one imposing the requirement to fill long-term medications by mail. “Those decisions are ones that are often made by someone’s employer or their health plan,” she said.

In a statement, Express Scripts said that only about six percent of its patients are in plans like Dean’s where patients have to use mail service for maintenance medications or pay out of pocket. The rest can choose to fill prescriptions at a local pharmacy, Express Scripts said, but it will likely cost about 30 percent more than doing so by mail.

‘Sorry for the inconvenience’

Sending drugs by mail is not new. The Department of Veterans Affairs has been shipping prescriptions since the 1970s. But in the last 20 years, the number of users nationwide has roughly doubled, with federal data showing an estimated 26 million people receiving their medication by mail.

Much of how prescriptions work in the U.S. is now determined by companies like Express Scripts — called pharmacy benefit managers — which work with insurers and employers to negotiate drug prices, and often operate their own mail-order pharmacies. Many patients are effectively forced onto their services, particularly those with long-term prescriptions for chronic conditions, either by financial incentives to fill those prescriptions by mail or because coverage is withheld if they don’t.

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