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table of Contents departments January - february 2021 5 Publisher’s Note 6 News Briefs
STAFF Publisher & Editor-in-Chief
Mike Johnston, CPhT Associate Publisher Jayne Smilie Creative Director Peter Ian Fazon Associate Editor Rhonda Chambers Production Manager Jon Mickelson Director of Education Josh Cano, CPhT Member Services Jessica Sanders
9 health-system rx 11 men’s health 12 women’s health 13 CHILDREN’S HEALTH
7 product news 8 community rx
COV I D-19 : The Role of Pharmacy Techn i c i ans i n Vacc i ne Admi n i strat i on 14 With the continued rise in COVID-19 infection rates and additional pressure being placed within health systems, the administration of the recently approved COVID-19 vaccine has never been more crucial. The purpose of this article is to provide a comprehensive view of immunizations administered by pharmacy technicians and how it has evolved, the impact that the new HHS guidance will have on the administration of COVID-19 vaccines, and how the National Pharmacy Technician Association (NPTA) is providing resources for technicians to meet HHS guidelines. Written by Mike Johnston, CPhT. Advanced Roles for Pharmacy Techn i c i ans 18 In the past, pharmacy technician roles mainly consisted of non-dispensing activities, including handling cash register operations and answering or directing phone calls from patients, providers, and insurance companies. But with recent changes and initiatives such as the creation of state pilot programs, the Pharmacy Technician Certification Board’s (PTCB) new advanced credentials, and the progressive regulatory landscape, the pharmacy technician’s role in a pharmacy team is advancing. Written by Rhea Angeles, PharmD, RPh. Assur i ng Safety 22 Well-trained pharmacy technicians are being allowed to provide vaccines in an effort to expand the services that a pharmacy team can offer and to improve access for patients seeking preventative care. A quality vaccination program, including pharmacy technicians administering vaccines, will demonstrate safety for the technicians, for the patients, for the businesses, and for the public. Written by Ally Dering-Anderson, BA, PharmD, RP, FAPhA And Kimberly Battreall, AS, LPN. ACPE UAN: 0384-0000-21-010-H06-T 2.0 contact hours Understand i ng arthr i t i s 34 Vacc i ne Admi n i strat i on : Arthritis is an inflammation of joints that causes pain and stiffness and tends to worsen with age. It is an incurable condition that can affect people of all ages, sexes, and races. The effects of arthritis and its progression can vary from person to person but range from mild to severe, debilitating the sufferer. Although the medical community has identified several types of arthritis, this article focuses on three of the major forms: osteoarthritis, rheumatoid arthritis, and juvenile arthritis. Written by Debbie Brooks, CPhT.
CONTRIBUTORS Anisha Rao
Rhea Angeles, PharmD, RPh Ally Dering-Anderson, BA, PharmD, RP, FAPhA Kimberly Battreall, AS, LPN Debbie Brooks, CPhT and the Editorial Advisory Board
CPhT CONNECT PO BOX 683148 Houston, TX 77268 888-247-8700
Opinions expressed in this publication do not necessarily reflect the official views of NPTA. No part of this publication is intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something covered in this publication. The appearance of advertising or new product information does not constitute an endorsement by NPTA of the product(s) featured. CPhT CONNECT is a bimonthly publication. All rights reserved. Jan/Feb 2021. No part of this publication may be reproduced without written consent from the publisher.
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PUBLISHER’S NOTE
mike@pharmacytechnician.org
The pharmacy industry and the scope of practice for pharmacy technicians has experienced a significant shift as a result of the Public Readiness and Emergency Preparedness Act (PREP Act) Guidance issued in October 2020. Technically, the PREP Act authorizes the Secretary of the Department of Health and Human Services to issue PREP Act declarations, which are used specifically for the purpose of providing immunity from liability. Over the past few months, we have fielded hundreds of questions regarding the PREP Act, but I wanted to provide some insight on two of the most confusing/controversial topics: My state doesn’t permit pharmacy technicians administering immunizations. The practice of pharmacy is, primarily, regulated at the state level, however federal regulations supersede state regulations, with one exception. If a state has regulations that are more permissive than a federal regulation, then the state regulation is observed. For example, qualified pharmacy technicians were already permitted to administer vaccines in certain states (like Idaho) and since they could already administer any vaccine to adult patients – the restrictions in the PREP Act Guidance does not supersede the state regulations. If, however, your state did not previously permit technicians to administer vaccines, the federal guidance from the PREP Act now (at least temporarily) supersedes the state’s policies, so long as all qualifications are met. Why are we permitted to administer non-COVID vaccines to children but not adults? This is a very interesting question – one that I actually addressed to the Deputy Secretary of HHS directly. It was explained to me that HHS knew that they were stretching the authoritative limits of the PREP Act further than they had ever been stretched due to COVID, and as a result they needed to have concrete data that justified their actions.They had data that clearly demonstrated that the immunization rates for children had significantly decreased during the pandemic and therefore, the utilization of technicians administering routine childhood vaccines could make a significant impact on this aspect of public health. Although it is suspected that non- COVID adult vaccinations are also down due to the pandemic – they did not yet have empirical data to justify inclusion into the PREP Act Guidance. It is for these reasons that HHS has authorized qualified pharmacy technicians to administer COVID-19 vaccines for all patients and additional routine vaccines for children only.
Mike Johnston, CPhT Founder & CEO, NPTA
If you have any questions, let me know.
Mike Johnston, CPhT Founder & CEO, NPTA
Nunquam non paratus. Never unprepared.
CPhT CONNECT www.pharmacy technician.org
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NEWS BRIEFs
AMAZONS ONL I NE PHARMACY By now you may be already aware that Amazon has moved into the drug-delivery business. Amazon, best known for its Prime service often delivering a vast array of goods in as little as two days to their members has now added drug-delivery to their services. Amazon Pharmacy has joined the U.S. online prescription ordering market, which could pick up as the COVID-19 pandemic finds more people staying at home. Amazon sees Prime customers as the perfect target opportunity and will provide these members with up to an 80% discount on generic drugs and as much as 40% off brand medications when they pay without insurance as well as 2-day delivery. Amazon Pharmacy accepts most major insurance with the ability to manage orders on its website. If members prefer in-per- son shopping over 2-day delivery, they can still enjoy the discounts on non-insurance purchases at more than 50,000 physical phar- macies, including those operated by competitors.
according to ACIP’s standard immunization schedule. • The qualified pharmacy technician or state-au - thorized pharmacy intern must complete a practical training program that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training program must include hands-on injection technique and the recognition and treatment of emergency reac- tions to vaccines. • The qualified pharmacy technician or state-au - thorized pharmacy intern must have a current certificate in basic CPR. • The qualified pharmacy technician must complete a minimum of 2 hours of ACPE- approved, immunization-related continuing pharmacy education during the relevant state licensing period. • The supervising qualified pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which they administer vaccines, including informing the patient’s primary care provider when available and submitting the required immunization information to the state or local immunization information system—for example, a vaccine registry. • The supervising qualified pharmacist is respon - sible for complying with requirements related to reporting adverse events. • The supervising qualified pharmacist must review the vaccine registry or other vaccination records prior to ordering the vaccination to be administered by the qualified pharmacy techni - cian or state-authorized pharmacy intern. • The qualified pharmacy technician and state-authorized pharmacy intern must, if the patient is 18 years of age or younger, inform the patient and the adult caregiver accompa- nying the patient of the importance of a well- child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate. • The supervising qualified pharmacist must comply with any applicable requirements or conditions of use as set forth in CDC’s COVID- 19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccines. The guidance applies to all states, even those where state and local laws prohibit or effectively prohibit pharmacists, pharmacy interns, and pharmacy technicians to administer tests and vaccines. States and local laws that permit health care provid- ers beyond pharmacists, state-licensed pharmacy interns, and qualified pharmacy technicians are not preempted. HHS guidance’s do not affect such laws.
HHS REQU I REMENTS ALLOW PHARMACY TECHN I C I ANS TO ADMI N I STER VACC I NES The U.S. Department of Health and Human Services (HHS) has released guidance that expands the immunization authorities of state-licensed pharmacy interns and “qualified” pharmacy tech - nicians during the public health emergency. Interns and techs who meet HHS conditions will not only be allowed to administer ACIP-recommended childhood vaccines (ages 3 to 18) and FDA- authorized or licensed COVID-19 vaccines and tests (ages 3 and older), including serology tests, but they will also be granted liability coverage for these duties during the public health emergency. According to the new guidance, to be deemed a “qualified person” under federal law, is someone who is authorized and granted liability coverage to administer the above-mentioned vaccines to the above-mentioned age groups. Qualified technicians and state-authorized pharmacy interns must sat- isfy and practice under the following requirements: • The pharmacy intern must be authorized by the state or board of pharmacy in the state in which the practical pharmacy internship occurs, but this authorization need not take the form of a license from, or registration with, the state board of pharmacy. • To be a “qualified pharmacy technician,” phar - macy technicians working in states with licen- sure and/or registration requirements must be licensed and/or registered in accordance with state requirements; pharmacy technicians working in states without licensure and/or reg- istration requirements must have a CPhT certi- fication from either the Pharmacy Technician Certification Board or National Healthcareer Association. • The vaccination must be ordered by the super- vising qualified pharmacist. • The supervising qualified pharmacist must be readily and immediately available to the immu- nizing qualified pharmacy technicians. • The vaccine must be FDA-authorized or FDA-licensed. • In the case of a COVID-19 vaccine, the vac- cination must be ordered and administered according to ACIP’s COVID-19 vaccine recommendations. • In the case of a childhood vaccine, the vac- cination must be ordered and administered
One huge advantage to Amazon Pharmacy is that it lets customers price-compare as they buy drugs on the company’s website or app. It also lets customers comparison-shop, toggling at checkout between the cost with co-pay and the non-insured price. The online store is avail- able nationwide but is not yet available in Illinois, Minnesota, Louisiana, Kentucky, and Hawaii. The move builds on the web retailer’s 2018 acquisition of PillPack, which Amazon said will remain separate for customers need- ing pre-sorted doses of multiple drugs. Over the past two years, Amazon has worked to secure more state licenses for shipping prescriptions across the country, which had been an obsta- cle to its expansion into the drug supply chain. Source: https://www.pharmacist.com/article/amazon-launches-online-pharmacy https://www.reuters.com/article/us-amazon-com-pharmacy/amazon-launches- online-pharmacy-in-new-contest-with-drug-retail-idUSKBN27X170 https://www.cnn.com/2020/11/17/business/amazon-pharmacy-launch/index. html
Source: https://www.pharmacist.com/article/pharmacy-interns-and-techs-who- meet-hhs-requirements-can-administer-childhood-covid-19
CPhT CONNECT www.pharmacy technician.org
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product news
NONPRESCR I PT I ON LOT I ON FOR HEAD L I CE The Food and Drug Administration (FDA) has approved a lotion to treat head lice for nonprescription use through a prescription- to-OTC switch. The FDA originally approved ivermectin (Sklice—Arbor Pharmaceuticals) lotion, 0.5% for the treatment of head lice infestation in individuals aged 6 months and older as a prescription drug in 2012. According to the Centers for Disease Control (CDC), an estimated 6-12 million cases of head lice infestation occur each year among U.S. children aged 3-11 years. Children more commonly experience head lice as groups of children often play closely together in areas such daycare centers, elementary schools, and their own homes. It is usually spread through direct head-to-head contact with an infected person, as the lice can only move by crawling rather than by flying or jumping. Head lice infestations can get out of hand quickly and by the time it is discovered a scalp could be completely covered. Lice can also be found on eyebrows and eyelashes. Head lice do not transmit a symptomatic disease and most individuals experience common symptoms of a sensation of something moving in the hair or a tickling feeling. Close inspection of the hair and scalp will find the nits or actual lice. If Once the lice have taken hold and reproduced the scalp becomes extremely itchy which is another tell-tale sign for parents. Excessive scratching from these symptoms may also lead to a secondary bacterial infection. Rx-to-OTC switches are generally initiated by the manufacturer of the prescription drug. For a drug to switch from prescription to nonprescription status, the data provided must demonstrate that the drug is safe and effective when used as directed in the proposed labeling. For an RX-to- OTC switch, the manufacturer must show that the average consumer could easily understand how to use the drug safely and effectively without the supervision of a healthcare professional. Once an infestation is established, a combination of nonpharmacologic and pharmacologic interventions are typically required, as none of the pediculicides are 100% ovicidal. The National Pediculosis Association recommends physical removal of the nits using an FDA-approved nit comb. You may have seen some of these as a child yourself. For example those little metal combs with the teeth very close together. When treating head lice, recommendations suggest
not to use more that the directed amount of lice medication unless instructed by a provider. Avoid medication contact with the eyes and do not treat the affected person more than two to three times with the same medication if it does not seem to be working. Additionally, some providers recommend it best not to use multiple treatment options at the same time. Sklice® is a single-use lotion with ivermectin 0.5% as the active ingredient, for the topical treatment of head lice infestations in patients 6 months of age and older. Sklice is for external use only and should only be used on the scalp and dry hair in accordance with label directions. Sklice is not approved for any other use. The product will be marketed in the United States as a nonprescription drug and will no longer be available as a prescription drug. Consumers should read and follow the Drug Facts label for the nonprescription product and are urged to talk to their healthcare professional for any questions. Home remedies for lice treatment may include wet combing, to remove active lice and nits. Essential oils, such as plant and tea tree oils, are often used to suffocate lice, while agents such as olive oil and petroleum jelly are thought to smother lice if left in the hair overnight. The effectiveness of these treatments is not well established. OTC Sklice® lice medication can help reduce the need to be seen by a provider first allowing patients to treat infestations earlier thereby increasing success. Sklice®, and its active ingredient ivermectin, have not been shown to be safe or effective for the treatment or prevention of COVID-19 and they are not FDA-approved for this use. Source: https://www.pharmacist.com/article/ fda-approves-lotion-nonprescription-use-treat-head-lice https://www.fda.gov/news-events/press-announcements/fda-approves-lotion… https://www.fda.gov/news-events/press-announcements/ fda-approves-lotion-nonprescription-use-treat-head-lice https://www.pharmacytimes.com/news/help-patients-get-rid-of-head-lice
outweigh the known and potential risks for the drug. There are no adequate, approved and avail- able alternative treatments to bamlanivimab for the authorized population. As part of the eval- uation of the EUA, the agency imposed several quality measures to protect patients. The com- pany is required to implement these quality mea- sures to manufacture this drug under the EUA.
Bamlanivimab is a recombinant, neutraliz- ing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS- CoV-2. It is designed to block viral attachment and entry into human cells, thus neutraliz- ing the virus, potentially treating COVID-19. Bamlanivimab is authorized for patients ages 12 years and older who test positive for SARS- CoV-2 virus, weigh at least 40 kg (about 88 lb), and are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who adults ages 65 years or older or those who have certain chronic medical conditions. The EUA allows for bamlanivimab to be distributed and administered as a single dose intravenously by health care providers. Bamlanivimab is admin- istered as a single dose of 700 mg via IV infusion over 60 minutes. According to the EUA fact sheets potential adverse effects, and drug interactions, must be made available to health care providers and to patients and caregivers which include anaphy- laxis and infusion-related reactions, nausea, diar- rhea, dizziness, headache, itching, and vomiting. Bamlanivimab is not authorized for COVID-19 patients who are hospitalized or require oxygen ther- apy because a benefit of bamlanivimab treatment has not been shown in these patients. Monoclonal antibodies such as bamlanivimab may be associ- ated with worse clinical outcomes when adminis- tered to hospitalized patients with COVID-19 who require high-flow oxygen or mechanical ventilation. Clinical trials of bamlanivimabwere shown to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease pro- gression within 28 days after treatment when com- pared to placebo. The safety and effectiveness of this investigational therapy continues to be evaluated. Source: https://www.pharmacist.com/article/ fda-issues-eua-bamlanivimab-treat-covid-19 https://www.fda.gov/news-events/press-announcements/coronavi- rus-covid-19-update-fda-authorizes-monoclonal-antibody-treatment-covid-19
EUA I SSUED FOR BAMLAN I V IMAB
COVID treatments are being approved at rapid rates during this [pandemic as companies try to stem and treat the wave of global infections. There are more and more drugs approved each week it seems. One such drug is an FDA- EUA (emergency use authorization) to Eli Lilly for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-mod- erate COVID-19 in adult and pediatric patients. The issuance of an EUA is different than FDA approval. In determining whether to issue an EUA, the FDA evaluates the available evidence and weighs any known or potential risks with any known or potential benefits of the product for use during an emergency. Based on the FDA’s review of the total- ity of the scientific evidence available, the agency determined that it is reasonable to believe that bam- lanivimab may be effective in treating non-hospi - talized patients with mild or moderate COVID-19. And, when used to treat COVID-19 for the autho- rized population, the known and potential benefits
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COMMUNITY RX
LGBTQ AND PHARMACY We live in an increasingly multicultural society with people from different ethnicities and beliefs. Over the years we have seen an ever-growing group of people who identify as having diverse sexual orientations and gender identities. For example, one such group is the LBGTQ (lesbian, gay, bisexual, transgender, queer) community. Many members LGBTQ community report having experienced negative interactions by the health care industry. In the past, the connection between homosexuality and psychopathology was largely based on religious, legal and medical stigmas. Perhaps the literature was limiting, perhaps mem- bers of this community were shunned or perhaps this population resisted seeking medical help for fear of the stigmas. No matter the reason, times have changed, the public has become more under- standing and the need is there for pharmacy staff to obtain more information regarding the needs of LGBTQ members and their concerns so that they may receive optimum care without historical fears. There have been many studies have shown that many LGBTQ patients experience more diffi - culty obtaining care which leads to healthcare disparities and unnecessary barriers to care. For this population, many find it difficult due to the stigma associated with LGBTQ and many in the healthcare industry may not even realize their specific challenges to emotional and physical needs. It is important that people take the time to understand what is important for this group of patients and in turn realize how to help them feel more welcome during pharmacy transac- tions. Much like many people throughout the U.S.A., informal surveys support that LGBTQ patients are more comfortable approaching their pharmacists, a profession often rated as one of trust. When these patients do not feel welcomed, included or experience a negative encounter at a pharmacy, they are less likely to return, which may have impact on their future health needs. They may also tell others about their experiences which could reaffirm any belief that they would not expect to receive fair and equal treatment. To better understand the needs of this popu- lation it is important to learn about the things that make it more comfortable and inviting to receive care. Anything from the language or terminology used to specific environmental fac - tors that may not be of major concern to others. Even though there are terms to describe how one views themself, just as many people are not certain how many terms are used or how they differ from one another. Here is some basic information that may help: Sexual orientation is a person’s emotional, roman- tic, sexual attraction, or non-attraction to other people and is composed of three separate dimen- sions: behavior, identity, and desire. Sex refers to a set of biological attributes primarily related to phys- ical and physiological features. The phrase “sex assigned at birth” (SAAB) or “designated sex at birth” (DSAB) is used to describe a person’s biologi - cal sex, most often, but not exclusively, based on the external appearance of genitalia at birth. Gender identity is a person’s inner sense of their gender. For some people, their gender identity may not be congruent with the one typically expected based on
their SAAB/DSAB. They may describe themselves in a variety of ways including, but not limited to, transgender, male, female, gender fluid/gender - queer, nonbinary, agender, or as another gender. Decisions to change gender expression and/or physical appearance to be more consistent with their gender identity through medical (e.g., hor- mone replacement therapy), nonmedical (e.g., voice therapy, choosing an affirming name, etc.), and/or surgical options (e.g. gender affirmation/confirma - tion surgery) is solely determined by the individual. In order to better serve these patients, pharmacies can take positive steps by examining their patient interactions, pharmacy environments, and policies and staff training to help pharmacy staff provide an inclusive and welcoming environment. Let us take a look at some things that may help you better understand the needs of the LGBQT patient. Language Matters: Being mindful and choos- ing your words carefully are the simplest ways to create a safe space for LGBTQ patients. It is not unusual for many to have documents (i.e., license, insurance cards etc.) that do not accu- rately reflect their authentic gender identity or chosen name. Pharmacy technicians can avoid confusion and prevent mistakes by asking patients “What name and pronouns do you use?” . This may also be documented in patient profiles so that all can be aware of what the patient would like to be called when they do business with your pharmacy. Use gender-neutral pronouns such as they/them when documenting or dis- cussing relevant patient information. Replacing expressions that assume a person’s or a group of people’s gender identity such as “Hello, sir/ma’am” or “Hello, ladies/guys” with a more generalizable option such as “Hello, how may I help you today?” reflects an inclusive and culturally sensitive approach. Pharmacy Environment: LGBQT patients report that they will observe a pharmacy area for things that they feel show they are accepted. Such things as marketing/health brochures which include same-sex couples or families or displaying health education materials from local LGBQT organizations allow for an inviting environment. Restrooms: Clear signage goes a long way. Some LBGTQ members seek restrooms that match their gender identity. Many busi- nesses have designed restrooms that provide single occupancy or gender-neutral restrooms. Staff Training: Training on LGBTQ identities, terminology and health disparities, as well as on how to avoid stereotypes and assumptions about patients’ sexual orientations and gender identities help to facilitate respectful communication with LGBTQ patients. Free online training is available from the National LGBT Health Education Center. In addition to the above LBGQT patients often have many questions regarding medications and in relation to their lifestyle. For example, hormone therapy or mental health medications. Following are some medical/treatment concerns of the LGBQT patient you may need to be aware of: HIV Prevention and Care: Pharmacies can help by being familiar with and referring to community
HIV testing sites. Keep a list of resources in your pharmacy to assist LGBQT patients who may have had difficulty finding them on their own. According to the Centers for Disease Control and Prevention (CDC), 1.2 Million Americans are likely candidates for PrEP (Pre-Exposure Prophylaxis). When taken as prescribed, PrEP has been shown to be safe and highly effective at reducing the likelihood of HIV acquisition. Work with patients on PrEP to pro- mote medication adherence and assist patients on PrEP in accessing payment assistance programs. Transgender Healthcare: Some trans- gender patients are on hormone therapy and sometimes insurance will deny medication because a drug therapy has been prescribed in a way that is not currently FDA-approved or not typi- cally addressed. Remain aware that often these patients are already leery of being treated differ - ently than others and are gauging your sensitivity to their needs. Explain the issue with the insur- ance, explain to the patient the issue itself and work towards processing to the best of your ability. Sexual Health: Studies including LGBT patients have shown they tend to be at higher risk for sex- ually transmitted infection and are may choose not receive preventive care out of fear. In addi- tion, statistics show that LGBQT people are more likely to be affected by sexual violence including rape, physical violence, or stalking from an inti- mate partner. Patients may ask their pharmacists to discuss concerns about sexual health. If a patient requests to speak to a pharmacist, be discreet as others nearby can often overhear. Remember pri - vacy and confidentiality concerns and your actions will show the patient if you are sensitive to their needs making them comfortable with discuss- ing their healthcare needs with the pharmacist. Mental Health: Some mental health disorders and conditions such depression, anxiety, psycho- logical distress, and PTSD are more prevalent in LGBTQ groups compared to the general popula- tion. These patients may experience higher rates of suicide as well. Limited data suggests transgen- der youth have a higher lifetime risk of substance abuse such as cocaine/methamphetamine. Eating disorders and unhealthy weight-control behav- iors occur more frequently among LGB youth and adults than their heterosexual peers. A vari- ety of professional organizations have already established guidelines to serve as resources for practicing professionals. A 2014 Field Guide pub- lished by the Joint Commission (https://www. jointcommission.org/lgbt/) assembled a series of health-system strategies, practice examples, and resources for patient-centered LGBT community. There are also pharmacy-specific reference mate - rials available for practicing pharmacists who seek continued education in this area. One such publication from the Human Rights Campaign (www.hrc.org) provides recommendations for establishing an inclusive environment within a pharmacy setting. The LGBT Health Education Center (www.lgbthealtheducation.org) at the Fenway Institute, in conjunction with the Institute of Medicine (IOM), provides comprehensive online resources for providers and patients alike.
Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5663655/ https://www.pharmacytoday.org/article/S1042-0991(20)30876-8/fulltext
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HEALTH-SYSTEM RX
F I NAL GU I DANCE FOR COMPOUNDERS ’ FAC I L I T I ES
I BUPROFEN SHOWS BETTER THAN ACETAMI NOPHEN I N NEW STUDY
Custom designed mounts were installed on Spot robots, essentially creating a mobile telemedicine platform. An iPad mount, with a two-way radio, allowed doctors to remotely triage patients as they approached the hospital. Dr Spot now carries a number of cameras designed to remotely mea- sure a patient’s vital signs. Since April, the team has rapidly expanded Spot’s abilities, ultimately developing what is being called VitalCam, “a robot- ic-assisted vital sign acquisition platform to facilitate contactless vital signs in hospital settings”. Some patient vital signs are easier than others to measure remotely. Body temperature, for example, can be gathered relatively simply using an infrared camera. To accommodate these variances, in this instance, the research team developed algorithms to more accurately use infrared camera data to measure body and skin temperature by incorporating factors such as ambient temperature and distance from the patient. The infrared camera can also measure a patient’s breathing rate by calculating temperature changes in their face mask. As they breathe in and out the small fluctuations in the temperature of the mask allow for breathing rate measurements to be collected. Three other monochrome cameras are incorporated into the VitalCam system. Each camera is set to filter a highly specific spectrum of light (670, 810, and 880 nanometers, respectively). Tracking these particular wavelengths allows the system to detect tiny color changes in skin blood vessels. These changes can be used to calculate a patient’s pulse and their blood oxygen saturation. The entire system is designed to be remotely oper- ated using a handheld controller. So hypothetically, patients could be triaged and monitored by Dr Spot without ever needing to come into contact with a human health care worker. The results of the latest VitalCam tests are yet to be published in a peer-re- viewed journal, however, they have been posted to a preprint journal. The system so far has only been tested in a small cohort of healthy subjects and not in hospital conditions with sick patients yet. But its measurements have been accurately confirmed on healthy subjects. The next step will be a prelimi- nary test in a hospital emergency environment with COVID-19 patients. Amongst the huge benefit uti - lizing DR. Spot with COVID patients, researchers wrote that Dr. Spot can not only help to conserve PPE but can also help curb transmission of corona- virus by keeping hospital staff and patients separate. Source: https://newatlas.com/robotics/ boston-dynamics-spot-coronavirus-patients-remote-medicine/ https://www.engadget.com/boston-dynamics-dr-spot-203745150.html
A fundamental part of the U.S. Food and Drug Administration’s (FDA) drug compounding pro- gram is to protect patients from exposure to poor quality compounded drugs. Compounded drugs are often made due to the lack of medical needs that can be met by a FDA-approved drug product. Unfortunately, compounded drugs typically have not been reviewed by the FDA for safety, effective - ness or quality. Only the individual ingredients. The FDA is constantly trying to help improve the quality of compounded drugs and reduce risk to patients. Under federal law, a drug is considered adulterated if it is prepared, packed or held under unsanitary conditions that could cause the drug to become contaminated with filth or rendered injurious to health. While some compounders work hard to meet quality standards, too often, FDA inves- tigators continue to observe poor conditions at compounding facilities such as dirt, mold, insects, unclean exhaust vents and dirty high-efficiency par - ticulateair (HEPA) filters that impact drugqualityand have the potential toharmpatients who use the drugs.
According to a new study published in JAMA Network Open, ibuprofen was associated with better fever reduction and less pain than acetamin- ophen when used to lower fever and associated pain in infants and toddlers. Nearly every parent at one time or another has sought advice for their young children who have headaches or pain. Often the advice leads to dosing of acetaminophen or ibuprofen or the alternating dosages of both. Parents often wonder which one really works best. Recently, researchers conducted a meta-analysis in which they compared acetaminophen and ibupro- fen treatment in 240,000 children younger than 2 years old. Patients included in the research came from various health care settings in seven different countries. Compared with acetaminophen, ibupro- fen resulted in reduced temperature and less pain within the first 24 hours of treatment more often. The superiority of ibuprofen as an antipyretic did not continue beyond 24 hours after treatment onset, however, and no data were available on analgesic outcomes at less than 4 hours. Equivalent safety was found for these two widely prescribed and available over the counter (OTC) medications for fever and pain in children. Acetaminophen and ibuprofen appeared to have similar serious adverse event pro- files and adverse events were uncommon. The study authors added that the evidence regarding the risk of serious bacterial infection remains inconclusive. Of note: ibuprofen is said to pose a higher risk of kidney toxic effects in younger children, which is why it is commonly avoided. But these researchers said they did not find any evidence to support this view.
Numerous compounders have voluntarily recalled drug products intended to be sterile, and also tem- porarily or permanently stopped sterile operations because of these inspectional observations. The FDA has also taken regulatory and enforcement actions when we observe these insanitary conditions. Because of concerns like these, the FDA has released a final guidance to help compound - ers identify and prevent unsanitary conditions at their facilities. This final guidance provides recent examples of unsanitary conditions at com- pounding facilities and details corrective actions that facilities should take when they identify these conditions. The guidance applies to both tradi- tional compounders and outsourcing facilities. They have also added recommendations for com- pounders to use risk management tools to develop appropriate controls toprevent unsanitary conditions at their facilities. The guidance also addresses the regulatory actions that the FDAmay take in response to insanitary conditions sometimes involv- ing their collaborative work with states and the Department of Justice remains ongoing. To download the final guidance document or for further information go to https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ insanitary-conditions-compounding-facilities-guidance-industry Source: https://www.news-medical.net/news/20201106/ FDA-releases-final-guidance-to-help-identify-and-prevent-insanitary-conditions- at-compounderse28099-facilities.aspx https://www.fda.gov/news-events/press-announcements/fda-takes-efforts-pro - tect-patients-potentially-harmful-compounded-drugs-through-finalizing
Source:https://www.pharmacist.com/article/ could-ibuprofen-fare-better-acetaminophen-kids-reducing-fever
WHO I S DR SPOT?
After more than a decade of development, a col- laborative team of researchers has turned a Boston Dynamics’ dog-like robot into a tiny mobile doctor, now able to remotely measure patients’ vital signs from a distance of over six feet making it beneficial for use with hospitalized COVID patients. Dubbed Dr Spot, the robot is currently being tested as a way to safely triage potentially contagious COVID- 19 patients. Spot robots are four legged and able to nimbly navigate areas such as hospitals where needed. They are designed to self-navigate or be remote controlled to maneuver areas that wheel robots cannot. This technology has been used to inspect building sites and work on oil rigs. But now it looks like Mr. Spot could be used during COVID to minimize exposure of healthcare workers to contagious patients. Back in April 2020 Boston Dynamics began working with staff at Brigham and Women’s Hospital in Massachusetts. Where healthcare workers had suffered a significant raft of infections. Dr. Spot was looked at as a way to help.
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WE’VE GOT ALL THE ESSENTIALS.
NPTA and PTCB have partnered to expand and simplify the process for pharmacy technicians to advance their careers through advanced education/training and PTCB’s assessment-based specialty certificate programs that count toward earning the Advanced Certified Pharmacy Technician (CPhT-Adv) credential from PTCB. NPTA continues to lead the advancement of the pharmacy technician profession by becoming the first and only organization to offer a PTCB-recognized education/ training program for every certification and certificate program offered by PTCB.
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Men’s health ANDROPAUSE
When people think of menopause, they may ini- tially think that menopause affects women as they age. It usually comes as a significant sur - prise to learn that “male menopause” is a real condition. Andropause is the medical term used to describe age-related changes in male hor- mone levels. Unlike menopause (the female counterpart to andropause), not all men will expe- rience andropause, which could explain why so many people are unfamiliar with the condition. What is andropause? What are the symptoms? How long does it last? And maybe the ques- tion that comes to mind first- can it be treated? • BY AN I SHA RAO
to hormonal changes, others for whom testoster- one production declines rapidly are more likely to experience discomfort and unpleasant symptoms. Treating Andropause: It is important to note that a certain amount of age-related decline in testosterone production is considered normal. However, “normal” does not mean you have to indefinitely deal with unpleasant symptoms. Just as many women choose to utilize hormone replace- ment therapy to mitigate discomfort related to menopause, men can also benefit from hormone treatments to reduce the effects and health risks associated with andropause. Using hormone ther- apy may help restore your libido, increase energy, improve mood, and build muscle tone. Testosterone replacements are available in a variety of prepa- rations, including patches, gels, injections, and capsules. Your primary care provider can work with you to determine which treatment is best.
Reduced muscle mass and feelings of physical weakness • Development of breasts • Decreased bone density • Erectile dysfunction and reduced libido • Infertility Some men may also experience other less common symptoms such as swollen or tender breast tissue, decreased testicle size, hot flashes, or body hair loss. In some cases, reduced testosterone levels associated with andropause have been linked to osteoporosis. These symptoms are far less common than those listed above and typically affect men at the same age as women entering menopause. A Little About Testosterone: Men are not born with excessive amounts of testosterone. As men grow and age, levels of testosterone in the body increase. Before males reach puberty, testosterone levels are low, but they continue to increase as men reach sexual maturity. Testosterone is the male hormone that is responsible for changes that take place in the male body during puberty, including: • Increased muscle mass • Growth of body hair and facial hair • Vocal changes including deepening of the voice • Changes in sexual functioning As men age, testosterone levels again begin to drop. According to data provided by the Mayo Clinic, testosterone levels typically decline at a rate of 1% each year after men turn 30. Some medical conditions can cause earlier or more sig- nificant declines in testosterone levels. By the time most men reach age 70 (or sometimes 80), it is common for testosterone levels to have reached half of the peak levels they achieved in their 20s. Diagnosing Male Menopause: It is not uncom- mon for men to feel timid about reaching out to their primary care provider for concerns related to sexual dysfunction. To determine if your symptoms are indeed andropause, your primary care provider will ask a series of questions about your symptoms to see if your physical and psychological symptoms match those of individuals with low testosterone. Next, a blood test is performed to check the level of testosterone in your blood. Because there are other medical conditions associated with low tes- tosterone, your primary care provider will likely conduct additional tests to rule out other medical conditions before making an official diagnosis. When Does Andropause Start? And When Will It End? In rare situations, men in their 30s can experience symptoms pertaining to andro- pause; however, it is significantly more common in men between the ages of 40 and 60. The dura- tion of male menopause is difficult to predict. According to some data, symptoms of male meno- pause can last between 15 and 20 years as the body slowly adjusts to lower testosterone production. While some men may not notice symptoms related
What is Andropause? Andropause occurs when testosterone production decreases in men over age 50. It often coincides with hypo- gonadism (diminished function in the testes), which may result in reduced hormone produc- tion. For men, testosterone is produced in the testes. Therefore, when the gland’s functional- ity changes, it can impact sex drive as well as mental energy, physical energy, and muscle mass. Although andropause and menopause often arrive at approximately the same age, the two conditions differ in a few ways. First, not all men will expe - rience symptoms related to andropause, while all women will experience menopause to some degree. Also, andropause does not result in a com- plete shutdown of the male sexual organs; it just changes the level to which they produce specific sex hormones. This, however, can result in sexual complications due to altered hormone levels. What Are the Common Symptoms of Andropause? Approximately 30% of men over the age of 50 will experience symptoms related to andropause. Andropause can cause several physical, emotional, and sexual dif- ficulties. Generally, these symptoms worsen with age, and andropause goes untreated. Some of the most common symptoms include: • Reduced energy levels • Depression or unexplained sadness • Lack of motivation • Reduced self-confidence • Difficulties with concentration • Changes in sleep patterns • Increased body fat
In addition to hormone replacement treatments, your provider may also recommend lifestyle changes that can naturally increase hormone levels, such as eating a balanced and clean diet, reduc- ing stress, and participating in regular exercise. If you are concerned about andropause symptoms, it is essential that you speak to your primary care provider before adding dietary supplements or altering your current medication regimen in any way. It is also important that your medical pro- vider understand the complex challenges related to hormonal changes in men. Although reduced testosterone is common for older men, it does not mean you have to deal with unpleasant symptoms for years to come. Reach out to your primary care provider today to learn more about andropause and what treatment options may be right for you. Sources: Mayo Clinic. (2020, June 20). Male menopause: Myth or reality? Mayo Clinic Healthy Lifestyle. https://www.mayoclinic.org/healthy-lifestyle/mens-health/in-depth/male- menopause/art-20048056?pg=1 Andropause. (n.d.). MedBroadcast. https://medbroadcast.com/condition/getcondition/andropause Krans, B. (2018, September 16). What Is Male Menopause? Healthline. https://www.healthline.com/health/menopause/male#diagnosis-and-treatment
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Women’s health
MENOPAUSE
BY AN I SHA RAO
Aside from menstruation changes that signal their arrival, perimenopause, menopause, and postmenopause are generally quite similar. The most common symptoms of perimenopause are: • Less frequent or highly irregular menstruation • Heavier or lighter periods (in relation to what was usually experienced before perimenopause) • Vasomotor symptoms, including hot flashes, night sweats, and flushing
take place during this time as well. One of the most notable is the loss of active ovarian follicles. These structures within the ovaries are responsible for pro- ducing and releasing eggs, allowing for menstruation and fertility. As perimenopause and menopause progress, the ovarian follicles become significantly less active, and therefore menstruation ceases for a period. Most women first notice their cycles become less consistent and their flows become heavier and longer. This typically occurs at some point in the mid- to late-40s; however, by the age of 52, most women have started or completed menopause. For some women, menopause is induced or caused by injury or surgical removal of the ovaries and related reproductive organs. This is most common when women undergo a hysterectomy at an early age. Known as induced menopause, this process can be caused by pelvic surgery that damages or destroys the ovaries, pelvic radiation (as would be used to treat ovarian or uterine cancer), hormone therapies that shut down a variant function, or removal of the ovaries through a hysterectomy. Diagnosing and Treating Menopause: If you are experiencing symptoms that you believe may be related to menopause (especially if you are younger than the age of 45), it may be worth talking to your OBGYN or your primary health care provider. Several new means of testing can determine if a woman has entered menopause, including a new blood test recently approved by the Federal Food and Drug Administration. This test may help those who show symptoms of early menopause, especially those with associated higher risks of osteoporosis or other chronic health con- ditions that can be exacerbated by menopause. These tests, combined with other menopausal symptoms, are typically significant enough to diag - nose menopause. Depending on your symptoms and your health history, your medical provider may also order additional tests to help rule out other underlying medical conditions that could contrib- ute to your symptoms yet be completely unrelated to menopause. Depending on the severity of your symptoms, available treatments can help reduce symptomatic impacts and improve your qual- ity of life. Hormone therapy has shown to be an effective treatment for women under the age of 60. It can help reduce hot flashes, flushing, night sweats, and the risk of osteoporosis. Other med- ications are available to treat specific symptoms, including vaginal dryness, sleeping difficulties, fre - quent urinary tract infections, and hair loss. Your provider may also recommend lifestyle changes, including exercise, dietary changes, weight manage- ment, and quitting smoking (if you are a smoker). While menopause is unavoidable, it is manageable if you understand the symptoms and how to manage them best. If you are experiencing symptoms of menopause, whether early-onset or otherwise, talk to your primary care provider to see what options are available for symptom management.
As many women begin to approach their late 40s and 50s, they begin to consider the arrival of menopause. For most women, menopause starts between the ages of 45 and 55; however, cer- tain circumstances can result in its development well before or years after this typical age range. Menopause is something every woman will experience to some extent. For some, it brings about a host of unpleasant symptoms. But for others, it comes and goes relatively unnoticed. For many women, treatment is not necessary; how- ever, treatments are available for those with severe or unmanageable symptoms to help reduce symp- tomatic effects throughout the menopausal process. When Women Can Expect Menopause to Come and Go? Many women will begin to develop menopause symptoms approximately 4 years before they stop menstruating (or have their last period). These symptoms will often remain for 4 to 5 years, depending on the individual. A minimal number of women experience meno- pause symptoms for up to 10 years before menopause (the actual cessation of a monthly period) occurs. Approximately one out of every ten women will experience menopause symp- toms for 10 to 12 years after their last period. The onset of menopause and the symptoms each woman will experience are unique to the indi- vidual. Many factors, including race, genetics, and reproductive health, will determine when women begin menopause. The first stage of menopause is called perimenopause. This starts well before menopause when hormones start to change in preparation for the onset of menopause. Perimenopause can last anywhere froma fewmonths to several years, again, depending on various factors. Some women may even skip perimenopause and suddenly enter menopause as they reach their mid- 40s. A small percentage of women (approximately 1%) who will naturally (menopause that occurs unrelated to surgical intervention or disease process) begin menopause before the age of 40. This is often referred to as premature menopause or primary ovarian insufficiency. Another 5% of women will naturally go throughmenopause between the ages of 40 and 45, which is referred to as early menopause. What Are the Symptoms of Menopause? As each woman is unique, so are her menopause symptoms. Inmost cases, awomanwill experience the most severe symptoms when her menopause comes on suddenly or lasts for a brief time. Certain medical conditions, including ovarian health problems like cancer, surgical procedures such as hysterectomy, and lifestyle choices such as smoking, often increase the severity and duration of menopausal symptoms.
Hot flashes are the most common symptom associated with menopause. An estimated 75% of women experience hot flashes through - out menopause. Other symptoms of menopause that may or may not occur include: • Changes in sleeping patterns including insomnia • Vaginal dryness and reduced libido • Sore or tender breast tissue • Frequent urinary tract infections and increased urination • Reduced bone mass and increased risk for osteoporosis • Thinning hair or hair loss While this list is not exhaustive, it provides insight into some of the more common symptoms women may expect to experience between the onset of perimenopause and through postmenopause. • Weight gain • Depression • Anxiety • Memory and concentration difficulties Why Does Menopause Occur? Menopause is a naturally occurring process as women’s ovaries age and consequently produce less reproductive hor- mones. This happens as the reproductive system and associated hormones prepare the body to no longer carry children. As the body begins to undergo changes in response to lower hormone levels, including estrogen, progesterone, testosterone, and other hormones pertinent to the reproductive pro- cess, symptoms pertaining to menopause typically begin. Specific changes to the reproductive organs
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