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table of Contents departments march - apr i l 2021
STAFF Publisher & Editor-in-Chief
Mike Johnston, CPhT Associate Publisher Jayne Smilie Creative Director Peter Ian Fazon Editor Edgar Galvan Associate Editor Daniel Hignett Associate Editor Rhonda Chambers Production Manager Jon Mickelson Copy Editor Susan Lankford Director of Education Josh Cano, CPhT Member Services
12 13 15 38
women’s health men’s health CHILDREN’S HEALTH Member spotlight
5 6 7 9 11
Publisher’s Note News Briefs product news community rx health-system rx
Amer i ca’ s Op i o i d Ep i demi c : Update from Netfl i x ’ s ‘ The Pharmac i st ’ 16 Netflix’s documentary The Pharmacist follows the story of a New Orleans pharmacist, Dan Schneider, whose son was murdered in a drug deal gone wrong. Coupled with the pain from his son’s death, the sudden increase in high-dosage opioid prescriptions coming into his pharmacy led Schneider to combat New Orleans’s growing opioid issue. In the documentary, Schneider tells the story of his journey. He starts with the investigation into his son’s murder, which he eventually solved. He follows up by explaining how he worked with the FBI and DEA to bring down the doctor responsible for many of the prescription pills sold on the streets. It has been nearly two decades since the events of The Pharmacist have occurred. But still, the opioid epidemic continues to grow. Written by Edgar Galvan. Spec i alty Pharmacy at a Glance 22 According to the National Association of Specialty Pharmacy (NASP), A specialty pharmacy is a state-licensed pharmacy that solely or largely provides medications for people with serious health conditions requiring complex therapies. These include conditions such as cancer, hepatitis, rheumatoid arthritis, HIV/AIDS, multiple sclerosis, cystic fibrosis, organ transplantation, human growth hormone deficiencies, hemophilia and other complex or chronic conditions. Sheila M. Arquette, RPh, the President and CEO of the National Association of Special Pharmacy, likens a specialty pharmacy to that of a primary care physician and a patient who is experiencing a specialized problem. In a similar way, a specialty pharmacy is in a setting that focuses on managing patients with specialty pharmacy conditions by providing them with specific medications to better combat those conditions. Written by Edgar Galvan. cont i nu i ng educat i on : allerg i es or not? 26 Colds, allergic rhinitis, and sinus infections are some of themost common conditions for which patients self-medicate and initiate access to the health care system. Many individuals have difficulty differentiating these conditions as they all have similar manifestations and incorporate the same symptoms. However, it is vital to be able to distinguish between these upper respiratory disorders in order to take the appropriate treatment approach. Therefore, the purpose of this continued education program is to aid health care workers in appropriately identifying key differences between colds, allergic rhinitis, and acute bacterial rhinosinusitis and appropriately managing these conditions. Written by Hayden G., PharmD. ACPE UAN: 0384-0000-21-020-H01-T 2.0 contact hours
Taylor Mearidy Jessica Sanders
CONTRIBUTORS Hayden G., PharmD
Robin Luke Anisha Rao and the Editorial Advisory Board
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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. Mar/Apr 2021. No part of this publication may be reproduced without written consent from the publisher.
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It’s official…we’ve been dealing with the COVID-19 pandemic for over a year. While there finally appears to be hope of mitigation on the horizon, the toll it has had on our well-being, especially as pharmacy technicians, will continue to be felt. As an essential worker, you are at heightened risk of work-related burnout, anxiety, depression, post-traumatic stress, and even secondary/vicarious trauma.
Do any of those resonate with you? Did you find yourself shaking your head in agreement? If so, you are not alone…
A recent study on the impact of COVID-19 found that 64% of surveyed healthcare workers, between 26 and 40 years old, had an increased risk of psychological distress and mental health problems. NPTA is committed to the well-being and resiliency of pharmacy technicians as vital members of the healthcare system. Our goal is to provide you with tools, resources, and strategies to aid in your mental health. With that being said, I am excited to announce NPTA’s Online Well- Being Resource Center. As one resource, NPTA is now offering a FREE online CE program on well- being and resiliency, called “Running on Empty: The Toll Being Essential Takes on Your Health,” from licensed therapist, Lauren Hollis, MA, CCLS, LPC, RPT.
Mike Johnston, CPhT Founder & CEO, NPTA
To access NPTA’s Online Well-Being Resource Center, go to: www.pharmacytechnician.org/wellbeing
It is important, although challenging for many of us, to recognize that self- care is not selfish. In order to best support others, including your patients and colleagues, you must be mindful of your own needs. As the saying goes, “You can’t pour from an empty cup.”
I encourage you to take some time to make sure your cup isn’t empty.
Mike Johnston, CPhT Founder & CEO, NPTA
Nunquam non paratus. Never unprepared.
CPhT CONNECT www.pharmacy technician.org
NEWS BRIEFs ALLERG I C TO PF I ZER OR MODERNA? TRY THE J&J COV I D VACC I NE The FDA issued an emergency use autho- rization in late February 2021 for a third COVID-19 vaccine to be used in the United States. The Johnson and Johnson Covid- 19 vaccine has a major benefit because it is approved for people who may have aller- gic reactions to the two other approved vaccines from Pfizer and Moderna. CDC recommenda-
Affairs’ Enforcement Bureau, and the U.S. Drug Enforcement Administration’s New Jersey Tactical Diversion Squad in Newark revealed the criminal activity using prescrip- tion records, text messages between these men and a pharmacy technician. The New Jersey Prescription Monitoring Program (NJPMP) revealed suspicious activity that uncovered the criminal activity that led to these charges. Information from the Monmouth County Medical Examiner’s Office given to investi- gating agencies in September 2019 showed that oxycodone prescriptions were being filled for a deceased person for nearly a year post-death. In addition, information showed a marketed increase in controlled substance units being dispensed from this pharmacy. The four men allegedly conspired between April 2018 andOctober 2019 to illegally obtain and distribute oxycodone and promethazine by removing the controlled drug substance (CDS) from the pharmacy. New Jersey pre- scription blanks, used to remove these drugs, were taken by a pharmacy technician from St. Joseph’s UniversityMedical Center in Paterson and Holy Name Medical Center in Teaneck. Crespolini states, “Approximately 167 fal- sified oxycodone prescriptions that ranged in date from April 27, 2018 to Sept. 26, 2019 were discovered and seized.” Evidence pulled from cellphone records revealed that there was prior communication between a pharmacy technician and the other men adding to the mounting evidence. In addition to the above charges, Santiago is charged with theft by unlawful taking, and Santiago, Miller, and Vickers are charged with falsifying medical records and falsify- ing or tampering with records, officials said. Chan would eventually be asked to volun- tarily surrender her pharmacy license by the State Board of Pharmacy in February 2020, which would result in a tempo- rary suspension until further action could be taken by the Board at a later time. Actions like these are particularly frightening when thinking that those within pharmaceu- ticals could be getting their hands dirty in this way, but it is good to see that something is being done to stop these types of criminal acts before it gets completely out of hand. Source: Crespolini, Russ. “Morris County Man Charged In Oxycodone Selling Scheme.”Mendham-Chester,NJPatch, Patch, 24Feb. 2021, patch.com/new-jersey/ mendham-chester/morris-county-man-charged-oxycodone-selling-scheme.
protein. Once the adenovirus enters cells, they use that code to make spike proteins. The CDC also explains that the J&J vac- cine contains polysorbate, which is a slightly different allergic concern than the other vaccines. One of the main allergic worries for the Pfizer and Moderna shots is polyeth- ylene glycol (PEG). PEG, while structurally related to polysorbate, is absent in Johnson and Johnson’s vaccine. Many people who resist getting the vaccine at all report fear of
allergic reaction as one of the top reasons for hesitating, often wait- ing until “other people get it first” and waiting a while. The J&J vac- cine has another big advantage in that it only requires one single dose, while the others require a second dose three or four weeks after the first. Safety profiles of the Pfizer and Moderna vaccines do look good with only 4.7 cases of anaphylaxis per
tions state that people who experience a severe allergic reaction (ana- phylaxis) after getting the first shot either the Pfizer or Moderna COVID- 19 vaccine should not get the second shot. “An allergic reaction is consid- ered severe when a person needs to be treated with epinephrine or EpiPen© or if they must go to the hospital,” according to the CDC’s main website. For those who experience
an allergic reaction known as “COVID arm” where a red, itchy, swollen, or painful rash appears near the vaccination site, the CDC still recommends they receive the second shot as scheduled, perhaps in the other arm. Monitoring is recommended, as is reporting the symptoms to the vaccine provider. For itching, an antihistamine is recommended. For pain, acetaminophen or an anti-inflam- matory drug (NSAID) may provide relief. Until the J&J approval, a severe allergic reaction could leave patients without full pro- tection from COVID-19 and no other options to complete the vaccination series. The CDC has now stated that those individuals may consider the J&J vaccine for their second dose. So why can these people get the J&J vaccine when the other two cause allergic reactions? The J&J vaccine differs from the Pfizer and Moderna vaccines in that it employs DNA instead of messenger RNA (mRNA) and has an entirely different mechanism of deliver- ing the active component to cells. Isobella Harkrider, of Reform Austin points out STAT’s breakdown of these two vaccines, saying, “The Pfizer and Moderna vaccines are made using messenger RNA (mRNA), technology that delivers a bit of genetic code to cells to make the surface protein (known as spike) on the SARS-2 virus.” The J&J vaccine instructs human cells dif- ferently to make the SARS-2 spike protein, which then triggers an immune response. It is what is known as a viral vectored vac- cine. A harmless adenovirus from a large family of viruses has been engineered to carry the genetic code for the SARS-2 spike
million and 2.5 cases per million, respec- tively. However, the J&J vaccine reported even less than these numbers in clini- cal trials, but more data will come about as this vaccine is brought to the public. No vaccine is without allergy risks. Patients are still screened prior to receiv- ing the vaccine and are monitored for 15 – 30 minutes following for any reactions. Source: Harkrider, Isobella. “What Makes the Johnson & Johnson Vaccine Different?” Reform Austin, 25 Feb. 2021, www.reformaustin.org/coronavirus/ what-makes-the-johnson-johnson-vaccine-different/
OXYCODONE SELL I NG SCHEME
Panther Valley Pharmacy in Allamuchy, New Jersey was the site where four men including a registered pharmacist allegedly conspired to obtain and distribute oxycodone. The fol- lowing individuals have been arrested and charged with the crimes related to this activity. Anny Chan of Clinton, Milagros Santiago of Haledon, Jonathan Miller of Whippany, and Siraj Vickers of Tobyhanna, Pennsylvania, were all charged in relation to the crimes of con- spiracyand thedistributionof bothOxycodone and Promethazine. Of the group, Chan was formerly known as the registered pharma- cist-in-charge at Panther Valley Pharmacy. Russ Crespolini, of Patch.com, points out that more than 30,000 30 milligram oxy- codone pills, which are known as blues, were somehow diverted from the phar- macy in order to continue this scheme. An investigation by the Division of Criminal Justice Gangs & Organized Crime Bureau, the New Jersey Division of Consumer
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F I RST COMPLETE REG IMEN I NJ ECT I ON FOR H I V APPROVED
TABLETS FOR OVERACT I VE BLADDER (OAB)
warning that “Cabenuva should not be used if there is a known previous hypersensitivity reaction to cabotegravir or rilpivirine, or in patients who are not virally suppressed (HIV- 1 RNA greater than 50 copies/milliliter).” This is by no means an inclusive list of side effects. Patients should receive these injections under a provider’s care and closely monitored. Source: https://www.fda.gov/news-events/press-announcements/ fda-approves-first-extended-release-injectable-drug-regimen-adults-living-hiv https://www.hiv.gov/hiv-basics/overview/data-and-trends/statistics
Health experts estimate that more than 30 million Americans suffer from overactive bladder (OAB) symptoms. Patients with OAB often experience difficultly controlling urinary symptoms such as frequent urge to urinate, frequent urination, bedwetting, bladder spasm, or leaking of urine. In addi- tion to being a major inconvenience, OAB may also be a source of embarrassment. Causes of OAB are hard to pinpoint but can include weak muscles, nerve damage, use of medications, alcohol or caffeine, infection, and being overweight. Lifestyle changes, self-care, and kegel exercises have helped many people. Additionally, some medica- tions can treat OAB as well. Most patients report tolerating these medications well with some showing some improvement in reducing symptoms, although others do not. Recently, the U.S. Food and Drug Administration (FDA) approved the New Drug Application (NDA) for the first new oral branded OAB medication since 2012. Once- daily Gentasa Gemtesa 75 mg (vibegron) is a beta-3 adrenergic receptor (β3) agonist used for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency in adults. Vibegron, a small-molecule β3 ago- nist, helps relax the detrusor bladder muscle so that the bladder can hold more urine. Furthermore, Gemtesa is the first beta 3-ago- nist available as a once-daily pill that does not require dose titration, a major benefit for patients who can more easily understand and comply with dosing instructions. In clinical trials, Gemtasa at 75mg once- daily dosing showed that it clearly treated clinical symptoms of OAB by reduc- ing urinary frequency, urge urinary incontinence, and urgency. In addition, data specifically showing a reduction in urgency episodes are included in Gemtesa’s prescribing information, which is unique among currently available OAB treatments. The most common adverse reactions to Gemtesa from a double-blind, placebo-con- trolled study in ≥2% of patients included headache, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infections. Gemtasa may also cause serious side effects such as the inabil- ity to empty the bladder. Urovant, the manufacturer of Gemtesa, plans to launch this OAB drug soon in the United States.
Statistics showed that in 2018, approximately 1.2 million people were living in the United States with HIV. Moreover, one in seven were unaware of their status and were in need of testing. In 2018 alone, 36,400 new HIV infections occurred in the United States. HIV patients in treatment may have to take pills daily, sometimes taking more than one or combination drugs to manage their condition. But now, Cabenuva (cabotegravir and rilpivirine, injectable formulation) offers another alternative. Cabenuva is the first FDA- approved injectable, complete regimen for HIV-infected adults that is administered once a month. Cabenuva is a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults that replaces current antiretroviral regimens in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. Vocabria (cabotegravir, 30 mg tablet formulation) was approved by the FDA as it is taken in unison with oral rilpovirine (Edurant) for a time period of one month prior to beginning treatment with Cabenuva in order to certify that the medications are functioning well together before shifting to an extended-release injectable formulation. Initial injections begin on the last day of oral therapy. Cabenuva (cabotegravir extend- ed-release injectable suspension; rilpivirine extended-release injectable suspension) is co- packaged for intramuscular use. The initial kit contains capotegravir 600mg/rilpirivine 900mg as this is only a one-time first dose given as gluteal intramuscular injections. Following monthly injections are for 400mg Cabenuva gluteal intra-muscular injection and a single 600 mg gluteal intramuscular injection of rilpivirine at each visit. Cabenuva was safely and efficiently administered in two randomized and controlled clinical trials, resulting in participants from both trials continuing to show signs of virologic suppression at the end of each study. The most common reactions to the Cabenuva injections were “fever (pyrexia), fatigue, headaches, musculoskeletal pain, nausea, sleep disorders, dizziness, and rashes” according to the FDA. Listed within the FDA’s new release, there is a
GENER I C SUN I T I N I B AVA I LABLE
Glenmark Pharmaceuticals Limited has received FDA approval for Sutib, a generic version of Sunitinib that is used to treat kidney cancer. Brand name Sutent, which is manufactured by Pfizer, was approved in 2006. However, all of the medicine’s patents expire in 2021, leaving the door open for generics. In 2010, Mylan submitted a generic Sutent; however, Pfizer sued, alleging patent infringement and winning exclusivity until 2021. Sunitinib is an oral multi-kinase inhibitor (MKI). It works by blocking several enzymes that promote cell growth. It is used for the treatment of certain patients with gastrointestinal stromal tumors (GIST) and advanced renal cell carcinoma. Additionally, it is approved for patients with certain types of pancreatic neuroendocrine tumors. Sunitinib may also be used for metastatic kidney cancer that has progressed after a trial of immunotherapy and has been shown to reduce the risk of kidney cancer progression by 58%. Pfizer’s Sutent has an estimated cost of $5,917 for a supply of 28 capsules at a dosage of 12.5mg, depending on the pharmacy. One major benefit of this new generic is the cost, which is about 96% lower than the Pfizer brand. For kidney cancer or a GIST, sunitinib is dosed at once a day for four weeks, followed by two weeks without the drug. This makes up a cycle of treatment that lasts for six weeks. Sutib is available as oral capsules in doses of 50 mg, 25 mg, and 12.5 mg. A sunitinib 10 mg/mL oral suspension may be prepared with capsules and a 1:1 mixture of Ora-Sweet and Ora-Plus using three sunitinib 50 mg capsules. This suspension maintains an average concentration of 96% to 106% (of the original concentration) at room temperature or refrigerated for up to 60 days in plastic, amber prescription bottles. As with any antineoplastic agent, numerous side effects can occur when taking this medication, which has a black box warning. Patients being treated with sunitinib are closely monitored with dosages, which may need to be changed at times. Capsules are stored at 20°C to 25°C (68°F to 77°F).
Source: https://www.drugs.com/newdrugs/fda-approves-gemtesa-vibegron-pa- tients-overactive-bladder-oab-5415.html
Source: https://www.glenmarkpharma.com/sites/default/files/PressRelease_ Glenmark_Lanuches_SUTIB_in_India.pdf
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they stated, “We urge Gov. Newsom to remove this arbitrary limitation as an effective way to optimize the system; to increase patient access to routine vaccinations and point-of- care testing, such as COVID-19 testing; and to help pharmacy teams safely, efficiently and equitably provide COVID-19 vaccina- tions to communities throughout the state. Pharmacies, pharmacists, pharmacy techni- cians continue to serve Californians extremely well throughout the pandemic. Pharmacies have played a key role in advising the State of California, other states, and the federal government about policies needed to keep stores open and operating efficiently, to secure the safety and health of patients and staff teams, to keep patients on their medication therapies, putting patients over paperwork.”
claims include misrepresentations of opioid benefits, lobbying prescribers to increase prescribing certain opioids, failures to limit dosages, and failures to alert overprescribing to the proper authorities. In addition to many others, the retail superstore Walmart is being sued by the U.S. Justice Department, who allege that Walmart’s pharmacies have contributed to the opioid crisis. The December 2020 filing alleges that Walmart failed to properly screen their pharmacies for abusive opioid prescribing practices. Specifically, Walmart is accused of violating the Controlled Substance Abuse Act by not properly detecting and reporting suspicious prescribing activity and dispensing such prescriptions regardless of concerns. Previously in October 2020, Walmart sued the DEA and the Justice Department, alleging the government was attempting to place all the blame regarding opioid misuse on Walmart and not on other entities, especially governmental policies themselves. Claims made by the Justice Department assert that pharmacists were unable to reject prescriptions written by providers suspected of overprescribing opioids. Moreover, the staff was pressured to rapidly fill as many prescriptions as possible, hindering their ability to closely scrutinize over-prescribers and limiting their ability to share vital information between stores that would help detect over-prescribers.
Source: https://drugstorenews.com/ nacds-cra-call-increase-ratio-pharmacists-pharmacy-tech s
CAL I FORN I A ASKS FOR I NCREASE I N PHARMAC I STS TO PHARMACY TECHN I C I ANS RAT I O Steve Anderson, President and CEO of the National Association of Chain Drug Stores (NACDS), and Rachel Michelin, President and CEO of the California Retailers Association, are urging California Gov. Gavin Newsom to increase the pharmacist to phar- macy technician ratio in California. Currently, California maintains the most restrictive pharmacist to pharmacy technician ratio in the United States at 1:1. Nearly half of the other states have a greater ratio than 4:1. The COVID-19 pandemic has taken its toll on the health care community, including the pharmacy community. Pharmacy resources have been stretched thin, yet pharmacies have risen to several ever-changing chal- lenges. For example, pharmacies used every available resource to bring the COVID-19 vaccines to the public as efficiently as pos- sible. They mapped out how to receive, handle, and store the vaccine. In turn, they trained pharmacy technicians to give the vaccines to patients, increasing the number of vaccine locations in many communities. Increasing the pharmacist to pharmacy tech- nician ratio is necessary to reach patients in rural and underserved areas. Thus, an improved ratio could help bring COVID- 19 services including screening, testing, and vaccinations to communities and pop- ulations in every corner of California. In a statement by Anderson and Michelin,
WALMART SUED OVER OP I O I D CR I S I S
Source: https://www.beckershospitalreview.com/opioids/us-sues-walmart-says- its-pharmacies-fueled-opioid-crisis.html
The opioid crisis has significantly impacted both the public and pharmaceutical policies in recent history. The overuse and abuse of opioids have adversely affected many Americans. As a result, Americans increasingly feel that opioids are not being used per their original intent, leaving many patients addicted and unable to stop using these medications. The DEA (Drug Enforcement Agency) has imposed numerous new regulations, such as limiting prescribing amounts and dosages. Pain contracts, defined as a written agreement between doctor and patient determining how to go about treatment related to opioid therapy, have led to agreements with patients as to how their pain will be treated. For example, pain contracts can outline non-narcotic and non-medication treatment options for pain. For example, pain counseling has become more widely available and may help to scale back prescriptions for opioid treatment. Additionally, manufacturers, distributors, and pharmacies have been sued for their alleged part in this crisis. Defendants’
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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.
managed to design a system that “makes sub- cutaneous injections of high concentrated drug formulations possible by reducing the required injection force, which exceeded what is possible with manual subcutaneous injec- tions with a conventional syringe.” The system they developed; viscous fluid is to be injected surrounded by a lubricating fluid. This will allow the liquid to easily flow through the needle preventing any clogging. Using the lubricant, only one-seventh of the injection forces was needed for the high-test viscos- ity tested. These results allow for more than 100 drugs previously thought to be too vis- cous to be administered using this technology. This device that Varanasi and Jayaprakash designed contains a syringe with two bar- rels, with one located within the other, and a tube that serves the purposes of delivering the drug fluid as well as a tube that serves the purpose of delivering a thin coat of lubricant so the drug may enter the needle smoother. This design allows the viscous drug to pass with minimal shear stress, which could cause drug damage as in the case with biologicals. Therapeutic gels used in bone and joint ther- apies and time-released drug delivery could also benefit greatly through this technology making administration much easier. Varanasi hopes that to commercialize his work as he and his team continue to work on toward creating new, innovative medical technology.
patients every five minutes” in January. This was an incredible pace at the time, but this pace could not be maintained unfortunately. Deborah Simonson, vice president of pharmacy services, stated that this pace could have been maintained had the resources been readily available. This means that the supply of vaccines slowly began to dwindle as time went on, which caused a decrease in vaccination roll- out. Ochsner’s online portal stated back in February that the limited vaccine supply would be cause for worry across the nation. This led to many scheduled vaccination appointments needing to be rescheduled for a later time. MedStar Health, which operates in Maryland, managed to administer 40,000 doses through late January. 10,000 of those doses would be administered to the public, with a majority of those doses going to elderly adults and the rest to frontline staff. In Washington state, MultiCare administered 55,000 doses through mid-February with 25% of those doses going to staff and the rest to the community. MultiCare made it a prior- ity to partner with local health departments and community organizations in order to identity “at risk” and underserved individuals in the community to target for these doses. Another huge issue that these health systems needed to face was technology pieces in order to track regis- tration and tracking for these vaccinations. Bonnie Levin, of MedStar Health, said that they needed “an army of people” to get this done. This process needed to be as seamless as possible in order to easily register, track, and document for these vaccines that were being given out. Ochsner Health conducted this through a mass drive-through COVID-19 vaccination clinic in which pharmacy teams applied a bar code to each syringe, which was then scanned by the person administering the vac- cine resulting in documentation for that dose and patient. Pharmacists across the coun- try have a variety of different roles when it comes to the COVID-19 vaccine preparation, whether it is preparing the doses for others to administer or taking on lead- ership as they take part in the actual vaccination process. Levin concludes, “the pandemic has been a grueling marathon for the nation’s healthcare providers, and the availability of the vaccine marks a bright spot.”
NEW TECHNOLOGY FOR SUBCUTANEOUS V I SCOUS I NJ ECT I ONS MIT researchers have developed a new technology to administer drug formula- tions that are too viscous to be injected by conventional medical syringes. The technol- ogy is described in a paper published in the August 2020 edition of the journal Advanced Healthcare Materials. Drugs such as highly concentrated or biologics currently need to be diluted and injected intravenously. This is an extremely costly and complicated pro- cess. Injecting encapsulated drugs often clogs the needle. Diluting these medications allows them to be injected intravenously; however, this limits a patient’s ability to self-administer and therefore adds the cost of a provider visit. Instead, this new technology simplifies the pro- cess and may allow patients to self-administer such drugs at home. This technology could be especially beneficial during times such as pandemics or other situations that require people to stay home or conduct healthcare visits by virtual means. Another type of drug administration known as jet injection does not require a needle. However, limitations to this method include cost and major con- cerns about contamination from backsplash. With this new technology, regardless of how viscous a drug is, it can be made injectable. The team of researchers focused on finding a way to provide high-concentrate vaccines and biologics to developing countries, specifically remote places or those without access to medi- cal facilities. With this new technology, people previously left with no treatment options can gain access to medications that would not have been possible until now. Michael Jarvis, of MIT News, writes that Kripa Varanasi, MIT professor of mechanical engineering, and Vishnu Jayaprakash, a graduate student in MIT’s mechanical engineering department,
Source: Massachusetts Institute of Technology Journal reference:
HEALTH SYSTEMS QU I CKLY VACC I NATE COMMUN I T I ES AGA I NST COV I D-19 BUT FACE SUPPLY CONSTRA I NTS As the push to vaccinate more of the public rages on, multihospital systems have begun to maximize their efforts in vaccinating their communities. Ochsner Health in Louisiana managed to administer 39,000 COVID-19 vaccine doses members of their community in a single week and more than 150,000 doses through Feb. 22. To put this into perspective, Matthew Malachowski, system director of popula- tion health and ambulatory care pharmacy, stated that the largest clinics across the nation were vaccinating “around 100 Jayaprakash, V., Costalonga, M., Dhulipala, S., & Varanasi, K.K. (2020). Enhancing the Injectability of High Concentration Drug Formulations Using Core Annular Flows. Advanced Healthcare Materials 9(18). https://doi.org/10.1002/adhm.202001022
Source: https://www.ashp.org/news/2021/02/26/health-sys- tems-quickly-vaccinate-communities-against-covid-19-but-face -supply-constraints?loginreturnUrl=SSOCheckOnly
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BY AN I SHA RAO
exposure, obesity, having never been pregnant, alterations in the age of onset for puberty and menopause, smoking tobacco, and drinking alcohol. As with many other forms of cancer, it is not clear why some people with one or more risk factors never develop breast cancer while others with no apparent risk factors do. What Are Some Common Symptoms of Breast Cancer? There are a variety of known symptoms of breast cancer. Some of these symptoms are more familiar to the general public than others. They include: • Changes in the size, shape, or overall appearance of the breast • Changes to the skin over the breast (such as “dimpling” or “pitting”) • Newly inverted nipple •
Tests and procedures used to stage breast cancer include: • Blood tests • Follow-up mammography procedures • Breast MRI • Bone Scans • PET (positron emission tomography) scans • CT (computerized tomography) scans Breast cancer stages range from 0 to IV. A stage 0 cancer indicates the cancer is noninvasive or contained within the milk ducts. Stage IV, also referred to as metastatic breast cancer, indi- cates the cancer has spread to other areas of the body. Cancer staging must also consider the can- cer’s grade (or the presence of tumor markers). Breast Cancer Treatment and Outcomes Treatment options and prognosis are largely based on the type of breast cancer, its stage, grade, tumor size, and whether the cancer cells are sensitive to hormones. Other essential considerations include the patient’s overall health and preferences. Most women choose to undergo surgery and will also receive additional treatment after surgery, such as chemotherapy, hormone therapy, radiation, or a combination of the three. Today, the range of tra- ditional and alternative treatment options is highly varied. It often helps to discuss each in detail with a medical provider to determine which will be the most effective. According to the American Cancer Society, the mortality rate from cancer dropped over 40% between 1989 and 2017. Generally, the earlier cancer is detected, the more positive prog- nosis indicators are. The most positive prognosis are those cancers that are stage 0 or 1; however, survival rates, regardless of stage, continue to improve. The National Cancer Institute reports as many as 90% of women diagnosed with cancer (regardless of stage) survive five years or more after diagnosis, and 99% of those with localized (stage 1 or 0) cancers survive five years or longer. The current 10-year survival rate ranges from 81-89%, and the 30-year rate is approximately 80%. Improving Breast Cancer and Breast Cancer Awareness Regular preventative screening for breast cancer can help detect changes to the breast in its earliest stages. Most medical providers recommend mam- mography on an annual basis beginning at age 45 or sooner if there is a family history or other increased risk factors. It is important to remem- ber that survival rates and prognosis details are only general indicators. They often do not reflect the fact that the methods used to diagnose and treat breast cancer are improving daily. Every patient is different, and each person’s outlook will be their own. Continued research and ongo- ing developments in breast cancer treatment will continue to improve the outlook on breast cancer. Sources: https://cebp.aacrjournals.org/content/26/6/809 https://seer.cancer.gov/about/ https://www.cdc.gov/cancer/breast/statistics/index.htm the Outlook of
Although medical researchers have identified mul- tiple types and forms of cancer, some are much more well-known among the public than others. Unfortunately, this also means these types of cancers are more common in the population. Breast cancer is one such type. According to data provided by The American Cancer Society, one in eight women will develop invasive breast cancer in her lifetime. That accounts for approximately 13% of the female population in the United States. Although breast cancer is indeed more common in women, men can be diagnosed with breast cancer, as well. Despite years of progress, researchers still have not been able to eradicate this and other forms of cancer. However, with adequate screening, diag- nosis, and treatment, the mortality rate of breast cancer has been declining. Still, it remains higher than those of any other cancer besides lung cancer.
A lump or thickening of the breast tissue that feels different than the surrounding area Redness or pitting of the skin over the breast tissue (such as the skin of a lemon or orange) Peeling, scaling, flaking, etc., of the areola or breast skin
Is Breast Cancer Preventable? Like many cancers (or other disease processes), breast cancer is likely not 100% preventable; how- ever, there are likely ways to reduce overall risk. Specific lifestyle changes may contribute to risk reduction in some instances. For example: • Consume no more than one alcoholic beverage per day at the most • Attempt to exercise for at least 30 minutes every day • Be sure to “know your breasts.” This way,
if changes occur or lumps appear, the differences will be identifiable sooner Participate in annual screenings. Early and effective detection through mammography is a key factor in the ability to implement early and effective treatments Maintain a healthy weight and diet
What Causes Breast Cancer? Breast cancer occurs when the cells in the breast tissue begin to grow abnormally. These abnormal cells divide more rapidly than healthy cells and accumulate faster, resulting in the development of a lump or mass within the breast or armpit. When left undetected and/or untreated, cancer cells may metastasize (spread outside) the breast to the lymph nodes or other parts of the body. Breast cancer commonly begins in the milk-producing ducts (invasive ductal carcinoma) or in the glandular tissue called lobules (invasive lobular carcinoma). However, it can be first detected in other areas of the breast as well. A spe- cific cause of breast cancer is difficult to pinpoint; hormonal, lifestyle, and environmental factors may all contribute to an increased risk of breast cancer. Various inherited risk factors also increase one’s risk for developing breast cancer. It is estimated that as many as ten percent of breast cancers are linked to genetic mutations passed down from gen- eration to generation. Several inherited mutated genes have been discovered that significantly increase the risk of both breast and ovarian can- cers. Other risk factors include biological gender (specifically being biologically female), natural aging, personal or family history, genetics, radiation
Other preventative options such as preventive medi- cations and preventative surgery are also possible for women who are at a significantly elevated risk (based on family history or other genetic predispositions). How is Breast Cancer Diagnosed? Several tests and procedures are used to diagnose breast cancer. The most common include breast exams and mammograms. A breast exam is a digital exam whereby a medical provider feels for lumps and abnormalities in the breast tissue. Mammography takes a digital image of the breast to screen for abnormalities in the tissue. If an abnormality is detected, further screening may be recommended. If a cancer diagnosis is made, the cancer is iden- tified by stages. Understanding the stage to which the cancer has developed can help deter- mine treatment options and possible prognosis.
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Men’s health PROSTATE CANCER
BY AN I SHA RAO
treatment. While the idea of finding any and all cancers early to ensure successful treatment sounds logical, some prostate cancers grow so slowly that they would never result in medical problems during the lifetime of the patient. Because of early test- ing and screening, some men who never would have known or been impacted by prostate cancer may undergo invasive and harmful procedures that are unnecessary based on their unique situation. Treatment and Prognosis Depending on the specific circumstances of each case, treatment for prostate cancer can range from observation to targeted therapies such as chemo- therapy and immunotherapy. Again, the type and intensity of the specific treatment depend on the patient. For most men, treatment (if necessary) can remove or destroy the cancer. Prostate cancer is the most common cancer for men, second to skin cancer. Most of the cases (approximately 60%) are in men over the age of 65, and most cases are found when before the cancer has spread outside of the prostate (regional stage). The five-year survival rate is nearly 100% for regional stage prostate cancer, but once the cancer spreads, the five-year survival rate declines drastically. Although prostate cancer remains the second leading cause of death in men in the United States, the death rate has declined by more than 50% in the last decade due to advance- ments in screening, diagnosis, and treatment. Sources: https://www.cancer.net/cancer-types/prostate-cancer/statistics https://www.cancer.org/cancer/prostate-cancer.html
Pre-Cancerous Prostate Concerns According to data from the American Cancer Society, some prostate cancer may start as one of a few pre-cancerous conditions, although research is still required to confirm if there is a possible connection. In some cases, these conditions are found during a prostate biopsy to look for or defin- itively diagnose prostate cancer. Some conditions that are believed to be possible pre-cancerous conditions include prostatic intraepithelial neo- plasia and proliferative inflammatory atrophy. Prostatic intraepithelial neoplasia (PIN) When a man has a PIN, there are changes to how the cells of the prostate gland look when they are examined under a microscope. However, unlike cancer cells, these cells do not appear to spread to other parts of the prostate. PIN is classified as either low-grade or high grade, depending on the level of abnormality observed in the cell structure. Low-grade PIN is not thought to be connected to an elevated risk of prostate cancer, but high-grade PIN is believed to be a precursor of prostate cancer. PIN can develop in the prostates of men as early as their 20’s, but it is important to note that many men with PIN will never develop prostate cancer. Proliferative inflammatory atrophy (PIA) In men with PIA, the prostate appears smaller than normal, and there are indicators of inflam- mation in the surrounding area. PIA is not a form of cancer, although a certain amount of research indicates that PIA may lead to high-grade PIN or perhaps to prostate cancer. Screening for and Diagnosing Prostate Cancer As with many forms of cancer, early detection is vital for successful treatment and positive prog- nosis outcomes. However, early detection is not always easy. Fortunately, there are early detec- tion tests for prostate cancer that, when utilized properly, can lead to early detection. Prostate cancer can often be detected in the early stages through PSA (prostate-specific antigen) testing. A PSA test looks for levels of prostate-specific antigens in the blood. Another way to detect early changes and potential cancers in the pros- tate is through a DRE or digital rectal exam. Although early screening would seem like an essential process for most men, there are concerns regarding early detection screening procedures. However, it is crucial to note that in many cases, the benefits of early detection far outweigh the risks. One concern is the possibility of inaccurate or unclear test results. Neither PSA nor DRE tests are 100% accurate. These tests can sometimes produce false-positive or false-negative results. Unclear or inaccurate test results can indeed lead to a host of problems for the patient. Another concern is overdi- agnosis and overtreatment. Even if cancer is found through one of the above testing models, it can be difficult to tell if the cancer is dangerous and needs
Despite a reduction in mortality rates for most can- cers, prostate cancer saw some of the highest fatality numbers in two decades as 2020 came to a close. Each year, the American Cancer Society estimates the number of people who will be newly diagnosed with cancer or lose their battle with cancer in a calendar year. In January of 2020, the American Cancer Society estimated that 191,930 men would be diagnosed with prostate cancer. Although con- firmed statistics are not available yet, this would signify a five percent increase over 2019 data.
What is Prostate Cancer? All forms of cancer begin when cells in the body start to grow in abnormal ways. Often, they grow too quickly and begin to accumu- late in specific organs or tissues, forming a mass. Cells in almost any part of the body can become cancer cells and can spread to other areas of the body if left untreated or undiagnosed. Prostate cancer begins when cells within the pros- tate begin to grow uncontrollably. The prostate is an organ found only in males. Located below the bladder and in front of the rectum, it is respon- sible for producing some of the fluid that forms semen. The urethra travels through the center of the prostate. As a man ages, the size of the prostate can change. In younger men, a healthy prostate is typically no larger than a walnut; how- ever, as males age, the prostate can swell, resulting in difficulties with urination and sexual dysfunction. Types of Prostate Cancer Like other types of cancer, there is more than one type of prostate cancer. Some types grow and spread quickly, but most grow slowly. In many cases, men will not realize they have prostate cancer until they have had it for many years. According to stud- ies by the American Cancer Society, some autopsy results performed on individuals who passed from causes unattributed to cancer also had prostate cancer that never affected them during their lives. Most prostate cancers are adenocarcino- mas. These cancers develop from the gland cells within the prostate that are responsible for making prostate fluid. The prostate fluid is one of the fluids added to semen. Other types of prostate cancer are very rare and include: • Sarcomas • Transitional cell carcinomas • Small cell carcinomas • Neuroendocrine tumors other than small cell carcinomas
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CHILDREN’s health PED I ATR I C MED I CAT I ON FLAVOR I NG
BY AN I SHA RAO
Unfortunately, many medications are plant-de- rived and are therefore bitter-tasting. Some even have unpleasant smells, which can further increase the unpleasantness of the medicine. For teens and adults, the bitter factor can be miti- gated to some degree by formulating medications in pill form. When taken correctly, their taste is never an issue, but they remain equally as effec- tive. For infants and young children, this is not an option. Thus, the advent of medication fla- voring. While including flavorings in medication is not a guarantee that all of the bitter flavors are removed, it can help reduce the intensity of the bitterness, making the mediation more pal- atable for younger children’s flavor preferences. What Medications Can be Flavored? Medication flavoring is a pharmaceutical pro- cess that helps mask the bitter, unpleasant flavors naturally found in many common medications. The goal of flavoring is to trick a child or infant’s taste buds into believing they are consuming something sweet. The process introduces famil- iar, desirable flavors such as orange, grape, raspberry, strawberry, tutti frutti, bubblegum, or even chocolate chips (among others) into the med- ication as the time of mixing in the pharmacy. As previously mentioned, children’s taste buds are naturally geared toward sweet things. When they are sick, their sense of taste is often more sensitive. The idea of having to regularly take something that tastes terrible only worsens their already fragile emotional state. Unfortunately, most of the most commonly prescribed medications for frequently occurring childhood ailments are naturally bitter and unpleasant tasting. This makes getting a tod- dler to swallow essential medications to alleviate strep throat, an ear infection, or any other ailment nearly impossible. Fortunately, many common med- icines used to treat these illnesses and many others are frequently enhanced with flavorings. Some of the most commonly flavored medications include:
When children are sick, it can be emotionally trying not only for the child but also for their parent or caretaker. One of the most significant challenges related to pediatric illness is often the struggle that accompanies getting them to take their med- ication. Ask any parent about how successful or unsuccessful their most recent experiences were, and they will likely speak of the frustration and exasperation of getting their infant or toddler to willingly swallow something they are not interested in taking. Worse and often even more concerning is the aftermath that occurs when a child spits up or spits out their medication. Now, parents are stuck wondering how much, if any, of the med- icine their child consumed and whether they should change or stick to the same dosing schedule. Unfortunately, medications only work when taken correctly and at the correct doses. When the med- ication a parent is trying to give their child tastes bitter, chalky, or worse, the chances they will take it willingly and easily are limited at best. Young patients are significantly more likely to take the full recommended dose with less pushback or refusal when the flavor is appealing or pleasing.
The Risks of Flavored Medication As with many good things, flavored medications are not without risks. Misuse or abuse of sweet or candy-flavored medications does occur, and the effects can range widely. Some highly flavored cough and cold medications are used as “gate- way” drugs for teens looking to experiment with the impact of certain over-the-counter medicines. In most cases, the effects of these medications are harmless in the short-term. Still, in some instances, abuse or misuse of medication in this manner can evolve into something more troubling. However, on the other end of the age spectrum, there is a gen- uine risk of younger children ingesting too much of a medication when a parent or caretaker is not looking. Children’s medications, either over-the- counter (such as Tylenol or Motrin) or prescriptions that are flavored in sweet or appealing ways, can be dangerous to children who are not equipped to understand anything more about the medication other than the simple fact that it tastes like candy. The idea of making medication taste better has been an underlying mission in the pharmaceuti- cal industry almost as long as medications have been prescribed to treat illness. Due to the obvious benefits related to pediatric flavored medications, it has become nearly impossible to find a med- ication geared toward infants and children that is not flavored to some degree. In addition, flavored medications clearly benefit both patients and par- ents by ensuring the successful completion of an entire medication regimen. Although medica- tion flavorings are common, parents need to note the risk factors associated with candy-flavored and appealing medications. As with any medi- cation, flavored medications are not necessarily suitable for all circumstances and situations, and individual consultation with a pediatrician is always recommended before taking any formof medication. Sources: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2744307/ https://www.acs.org/content/acs/en/pressroom/newsreleases/2008/august/ helping-the-medicine-go-down.html https://www.fda.gov/industry/structured-product-labeling-resources/flavor
Why Medication Flavoring Helps Studies have shown that flavoring medications do not adversely impact the effectiveness of the medication. For this reason, pediatric medica- tion flavorings have become a “go-to” for many frustrated parents seeking a means for convinc- ing their unwilling little ones to take a full dose of their prescription. But why are children so averse to taking medications without flavoring? Children are born with a much stronger pref- erence for things that taste sweet over those that taste bitter. This is one of the factors that attract newborn infants to their mother’s milk. In most cases, by late adolescence, the significant preference towards sweeter flavors begins to wane. However, during childhood, taste buds tend to be much more sensitive to bitter flavors. It is also important to consider the number of taste buds humans have in their mouths. Overall, we have very few receptors for sweet flavors but around 30 for bitterness, helping humans avoid things that may be toxic. Bitter tastes are often affiliated with substances that are dangerous or inedible.
• Erythromycin Suspension • Robitussin • Claritin Syrup • Bactrim Suspension • Griseofulvin Suspension • Augmentin Suspension • Iron supplements • Vitamins
Are Medication Flavorings Safe? The practice of flavoring medications is not new to the medical or pharmaceutical communi- ties. The flavor substances used for medications require rigorous and comprehensive screening and approval by the Food and Drug Administration before they are integrated into pharmaceutical and compounding services. The flavor options provided as part of a prescription are a safe and effective way to increase pediatric medication adherence rates while reducing parental frustration.
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