Tag: CDC

Categories : Pain ManagementTags :

US CDC Pivots to a Less Rigid Approach to Opioid Prescription

On By ModernMedia
Photo by Andrea Piacquadio on Pexels

The US Centers for Disease Control have released new opioid prescribing guidelines that do not promote strict thresholds for dose and duration of pain medications. The new guidelines, which update and replace the controversial 2016 guidelines, are published in Morbidity and Mortality Weekly Report.

The previous guidelines had been interpreted as imposing strict opioid dose and duration limits and was misapplied by some organisations, leading to a clarification being released in 2019. Other organisations, such as the European Pain Federation, had stated that overly strict guidelines for their own countries were hampering effective pain management.

The 2022 recommendations are voluntary and give clinicians and patients flexibility to support individual care, said Christopher Jones, PharmD, DrPH, MPH, acting director of CDC’s National Center for Injury Prevention and Control in a press briefing. He stressed that they should not be used as a inflexible rule, or applied as a rigid standard of care, or replace clinical judgement on personalised treatment.

“Patients with pain should receive compassionate, safe, and effective pain care,” Jones stated. “We want clinicians and patients to have the information they need to weigh the benefits of different approaches to pain care, with the goal of helping people reduce their pain and improve their quality of life.”

The guidance covers four key areas: opioids initiation for pain, opioid and dosage selection, deciding prescription duration and conducting follow-up, and assessing risk and potential harms of opioids. It also suggests that clinicians work with patients to incorporate plans to mitigate risks, including offering naloxone.

The document indicates opioids should not be considered as first-line or routine therapy for subacute or chronic pain, and points out that, for many kinds of acute pain, non-opioid therapies are often better choices.

“For patients receiving opioids for 1 to 3 months (the timeframe for subacute pain), the 2022 guideline recommends that clinicians avoid continuing opioid treatment without carefully reassessing treatment goals, benefits, and risks in order to prevent unintentional initiation of long-term opioid therapy,” noted Deborah Dowell, MD, MPH and colleagues in a commentary published in the New England Journal of Medicine.

For chronic pain, clinicians should make maximal use of non-opioid therapies and consider initiating opioid therapy only if pain reduction benefits outweigh the risk, Dowell and colleagues noted. When needed, clinicians should initiate opioids at the minimum effective dose, assess risks and benefits before increasing dosage, and avoid raising dosage above levels likely to yield diminishing returns, they added.

The new guideline offers tips for tapering opioids when warranted, but is not intended to lead to rapid opioid tapering or discontinuation, Jones noted. The recommendations do not apply to sickle cell disease-related pain, cancer pain, and palliative or end-of-life care.

The 2022 document incorporated public feedback since the new version was first proposed in February, including patients discussing their experiences with pain or opioid addiction and barriers to pain care.

“The science on pain care has advanced over the past 6 years. During this time, CDC has also learned more from people living with pain, their caregivers, and their clinicians,” said Dowell in a statement. “We’ve been able to improve and expand our recommendations by incorporating new data with a better understanding of people’s lived experiences and the challenges they face when managing pain and pain care.”

Source: MedPage Today

Categories : COVIDTags :

Vaccine-related Fainting Down to Anxiety, CDC Says

On By ModernMedia

A brief bout of anxiety was likely the cause of possible COVID vaccine-linked symptoms that people experienced, said researchers with the US Centers for Disease Control and Prevention say.

Several reports emerged in early April that people in at least five different vaccination sites in the US, all in different states, experienced symptoms almost immediately after receiving a vaccination jab. 

These symptoms, all from people who received the Johnson & Johnson vaccine, were largely reported as being fainting, dizziness, lightheadedness, and rapid breathing. These incidents resulted in four of these sites being temporarily shut down, with pledges to investigate being made by both the CDC and local health officials.

The CDC investigation examined 64 cases documented across five vaccination sites between April 7 and 9, and interviewed providers who were at the sites when the events took place. Real-world safety data collected through the Vaccine Adverse Event Reporting System was also looked at.

While some people went to the hospital afterwards, none of the symptoms were deemed to be serious in severity, and most symptoms improved within 15 minutes. A total of 17 people experienced fainting, while more than half reported feeling lightheaded and dizzy and about a third experienced nausea and/or vomiting. Thirteen patients had also told staff members beforehand of past fainting due to a fear of needles or vaccines.

The CDC’s report on the investigation and its findings were published Friday in its Morbidity and Mortality Weekly Report (MMWR).

Fainting and similar short-term symptoms occasionally occurs following vaccination, and measures to reduce them are being investigated. In the CDC’s investigation of these cases and safety data doesn’t point to any other cause of these symptoms besides simple anxiety. In their report, the authors observed that these incidents took place before the more recent reports of a rare blood clotting condition possibly linked to the Johnson & Johnson vaccine were made known to the public. Use of the J&J vaccine has since resumed in many countries, with a warning of the risks.

Since the J&J vaccine is administered in a single dose, it’s possible that people who are more likely to be anxious about vaccines would also opt for it more often, which could then account for the higher incidence of vaccine-related fainting associated with the shot. Another possibility is that early media coverage of the first incidents on April 7 (or physically seeing someone faint) further increased people’s anxiety. However, it was widely reported that one of the first members of the public to take the Pfizer vaccine last December — a nurse — fainted right after. But the nurse pointed out at the time that she had a history of fainting.

The authors of the report summed it up in saying, “the stress of an ongoing pandemic might also increase anxiety surrounding covid-19 vaccination.”

Of course, fainting and these other symptoms can still be a scary experience, no matter the cause. And just because anxiety may be the root cause of these cases, that doesn’t mean there isn’t a real risk worth caring about. 

Since fainting is still an upsetting experience no matter the cause and the risk of it should not be dismissed, so the authors recommend that people are routinely monitored after vaccination for at least 15 minutes. This is not only the chance that fainting may occur but other rare symptoms that could appear post-vaccination, such as a strong allergic reaction.

Source: Gizmodo

Categories : COVIDTags :

FDA and CDC Justify J&J Vaccine Pause

On By ModernMedia

FDA and CDC officials recommended pausing administration of the Johnson & Johnson COVID vaccine “out of an abundance of caution,” and mainly for the benefit of clinicians to respond to associated serious events.

This comes after six cases of cerebral venous sinus thrombosis (CVST) combined with thrombocytopenia were reported in the US, all among women ages 18-48. With approximately 6.8 million doses administered in the U.S., it suggests a one-in-a-million risk. 

J&J has halted distribution of its vaccine in Europe, reportedly taking officials there by surprise. South Africa has also paused the vaccine rollout.

At a media briefing, when asked whether pausing administration of the vaccine was an “overreaction,” Acting FDA Commissioner Janet Woodcock, MD, said the aim was to provide “time for the healthcare community to learn what they needed about how to diagnose, treat, and report” such events.

FDA’s director for the Center for Biologics Evaluation and Research, Peter Marks, MD, PhD, noted that the condition involves a rare blood clot for which heparin or related anticoagulants is not the standard treatment.

“The issue with these types of blood clots is if one administered standard treatment, one can actually cause tremendous harm or the outcome can be fatal,” he said. “One needs to make sure providers are aware if they see people with low blood platelets or blood clots, to inquire about recent vaccination and act accordingly.”

The background rate of CVST is 2-14 per million in the setting of a normal platelet count, but thrombocytopenia together with abnormal clotting makes it a “pattern.” CVST symptoms also include severe headache, abdominal pain, leg pain, and shortness of breath.

Marks noted that vaccination-related headaches tend to resolve within a few days, whereas CVST symptoms could manifest over a week post-vaccination, and closer to a patient presenting to the emergency department with severe headache. No such rare events have been seen more than 3 weeks post-vaccination.

Dr Marks also said that this pause is a recommendation but does not prevent healthcare providers from providing the J&J vaccine to their patients should benefits of vaccination outweigh the risks.

“We’re not going to stop a provider from administering a vaccine,” he added. “The benefit/risk will be beneficial overall to that individual in a large majority of cases.”

Dr Marks said that while they don’t have a “definitive cause” for the adverse reactions, data from AstraZeneca on similar events in Europe, it is likely a “similar mechanism” with the J&J vaccine. An autoantibody against platelet factor 4 has recently been identified as the trigger for the reaction.
“The immune response occurs rarely after some people receive the vaccine, and that immune response leads to the activation of platelets and extremely rare blood clots,” he said.

However, Marks stopped short of calling it a “class effect,” meaning it was related to the viral vector vaccine itself. He said he wasn’t ready to make a “broad statement yet,” but “obviously it’s from the same general class of viral vectors.”

The AstraZeneca, J&J and Sputnik V vaccines all use adenovirus vectors to deliver antigens. The rate CVST for AstraZeneca was estimated by European officials to be about 5 per million doses. Though Sputnik V has no confirmed CVST cases, a recent report suggests a possibility.

Besides these, the Ebola vaccines are the only other ones to use adenovirus vectors.
Woodcock said that all US cases were in women of reproductive age, with one death and one hospitalisation, but Marks said it was not clear there was any association with hormonal contraception, which also carries a small thrombosis risk. The cases did not have any preexisting conditions which could have explained the events.

The American College of Obstetricians and Gynecologists (ACOG) noted there is no “clear phenotype” for women who may experience this complication.

“Until there is a better understanding of the frequency and impact of this finding, it will be important to encourage pregnant and postpartum women who wish to be vaccinated to receive the mRNA vaccines: Pfizer or Moderna,” said Christopher Zahn, MD, vice president for practice activities at ACOG, in a statement.

“If venous thrombosis is noted in the setting of thrombocytopenia, treatment includes intravenous immunoglobulin and other supportive care,” Dr Zahn added.

Source: MedPage Today

Categories : COVID General InterestTags :

CDC Director Fears ‘Impending Doom’ as COVID Cases Rise Again

On By ModernMedia

Rochelle Walensky, MD, the Centers for Disease Control (CDC) Director, says that she fears “impending doom” as COVID deaths in the US edge upwards as people increasingly ignore health restrictions and start to travel.

Beginning her usual COVID status update,  Dr Walensky spoke as she often did of “concerning trends in the data.”

Dr Walensky spoke about the country surpassing 30 million COVID cases; of a 10% increase in the 7-day average of COVID-19 cases over the past week, to slightly below 60 000 cases; and of an uptick in hospitalisations, from a 7-day average of around 4600 per day to around 4800 per day.

“And deaths, which typically lag behind cases and hospitalizations, have now started to rise,” she said, pointing to a nearly 3% increase to a 7-day average of “approximately 1000 deaths per day.”

“I’m going to pause here,” she said. “I’m going to lose the script and I’m going to reflect on the recurring feeling I have of impending doom.”  

At the start of her tenure, Walensky said she had pledged to always tell the truth even if it wasn’t something Americans wanted to hear.

“We have so much to look forward to, so much promise and potential of where we are, and so much reason for hope. But right now I’m scared,” she said.

She recalled her time caring for COVID patients, saying: “I know what it’s like as a physician to stand in that patient room, gowned, gloved, masked, shielded and to be the last person to touch someone else’s loved one because their loved one couldn’t be there.

“I know what it’s like when you’re the physician, when you’re the healthcare provider, and you’re worried that you don’t have the resources to care for the patients in front of you.” 

She also recalled “that feeling of nausea, when you read the ‘Crisis Standards of Care’ and you wonder whether there are going to be enough ventilators to go around and who’s going to make that choice.”

She emphasised that she was speaking “not only as your CDC director, but as a wife, as a mother, as a daughter, to ask you to just please hold on a little while longer.”

She sympathised, she said, with those “wanting to be done” with the pandemic.

“We are just almost there, but not quite yet. And so I’m asking you to just hold on a little longer, to get vaccinated when you can. So that all of those people that we all love will still be here when this pandemic ends.”

Dr Walensky warned that the US pandemic trajectory was looking dangerously similar to that of European countries like Germany that were still struggling to contain the virus.

“We are not powerless. We can change this trajectory of the pandemic,” she said.

“But it will take all of us recommitting to following the public health prevention strategies consistently while we work to get the American public vaccinated.”

According to the New York Times’  COVID vaccination tracker, 146 million vaccinations have been administered in the US to date, with 2.76 million doses being given daily. At this rate, 70% of the adult population will have been vaccinated by June 16.

She urged community and religious leaders, officials, and other influencers to help support the vaccination programme.

“For the health of our country, we must work together now to prevent a fourth surge.”

Source: MedPage Today