Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID-19), has infected an estimated 10,730,000 individuals worldwide, and approximately 2.7 million Americans. The latest COVID-19 related news centers around Gilead’s announcement on the price of remdesivir for COVID-19, and new FDA and CDC COVID-19 guidance.

Here’s a roundup of the latest coronavirus-related news:

Premature Testing More Likely to Result in False Negative for COVID-19

A Johns Hopkins team of investigators has found that testing infected individuals too early for COVID-19 may result in a false negative, even though they may test positive for the virus later.

 journal, examined 7 previously published studies that provided data on the performance of a common method called reverse transcriptase polymerase chain reaction (RT-PCR) in diagnosing COVID-19.

FDA Guidance Provides Safety, Quality Standards for COVID-19 Vaccine Development

The FDA updated its guidance for developing and evaluating vaccine candidates to protect humans from SARS-CoV-2.

Although neither the FDA nor the scientific community can predict how quickly data will be generated from vaccine clinical trials, Marks said, the FDA is committed to “thoroughly and expeditiously evaluating” all the data.

“But make no mistake: the FDA will only approve or make available a COVID-19 vaccine if we determine that it meets the high standards that people have come to expect of the agency,” Marks added.

CDC Updates List of Those With Highest Risk of Severe COVID-19 Illness

New evidence has prompted the CDC to update its list of demographics at highest risk for severe COVID-19, expanding the selection to further include various age groups and other medical condition factors.

Part 2: A Conversation on Remdesivir Trial Updates

Julie Ann Justo, infectious diseases clinical pharmacist and associate professor at the University of South Carolina College of Pharmacy, discusses the latest data from Gilead's trials for Remdesivir, a potential COVID-19 treatment.

Gilead Sets Price of Remdesivir for COVID-19 Treatment

Gilead Sciences has reached a decision on how much remdesivir should cost as a treatment for the novel coronavirus disease 2019 (COVID-19), according to an open letter by Daniel O’Day, chairman and CEO of Gilead. 1

According to O’Day, the manufacturer has set a price for governments of developed countries of $390 per vial, but for private insurance companies, it could be expected to be $520.

Articles

Here's this week's roundup of the coronavirus-related news you should know. 

Coronavirus News Roundup: Gilead Sets Price for Remdesivir, New FDA and CDC Guidance Updates

NACDS is urging the Drug Enforcement Administration (DEA) to make electronic prescriptions for controlled substances (EPCS) mandatory.

 on the reopening of the Interim Final Rule (IFR) for EPCS, NACDS described the significant benefits associated with EPCS, and offered recommendations on how best to achieve these benefits.

“For more than 20 years NACDS has collaborated with DEA on the development and implementation of policies and standards for EPCS. We remain committed to the use of electronic prescriptions for all medications, especially controlled substances,” NACDS wrote.

Further DEA action would build on a NACDS-backed federal law that requires electronic prescribing of controlled substances in Medicare Part D, starting in 2021. It also would build on NACDS-backed action by more than half of the states to require electronic prescribing of opioids, all controlled substances, or all prescriptions, NACDS wrote.

“Significant benefits of electronic prescribing include: safeguards against unauthorized changes, reproduction and diversion of controlled substance prescriptions; further reductions in medication errors; improved patient care and outcomes—including clinical decision-making at the point of care; enhanced workflow in healthcare settings; and cost savings due to improved patient outcomes,” NACDS said in a 

The effectiveness, safety, and security of mandatory e-prescribing have been apparent in New York State where—after implementing its own mandatory electronic prescribing law—the state saw a 70% reduction in the rate of lost or stolen prescription forms, NACDS wrote.

Because pharmacies have been engaged in the effective use of electronic prescribing for a long time, modifications in the rule “are necessary to reflect the advancements that pharmacies have made,” NACDS wrote.

NACDS recommends changes to the audit requirements for software applications to make them consistent with pharmacies’ current practices in ensuring the use of the latest technologies, and to prevent duplicative and unproductive audits.

“Considering the significant and substantial benefits of EPCS, further action by the DEA to make electronic prescriptions mandatory is the logical next step in helping to address this ongoing issue, and in improving patient health outcomes in every community.” said NACDS President and CEO Steven C. Anderson in the press release.

1. Letter from NACDS to The Honorable Timothy J. Shea, acting administrator, Drug Enforcement Administration. June 19, 2020. Accessed July 2, 2020. 

https://www.nacds.org/pdfs/government/2020/NACDS-EPCS-Comments-6-2020.pdf

2. NACDS urges mandatory electronic prescribing for controlled substances. Press release. NACDS; June 26, 2020. Accessed July 2, 2020. 

https://www.nacds.org/news/nacds-urges-mandatory-electronic-prescriptions-for-controlled-substances/

NACDS is urging the Drug Enforcement Administration to make electronic prescriptions for controlled substances mandatory.

NACDS: Electronic Prescriptions for Controlled Substances Should be Mandatory

The FDA granted Emergency Use Authorization for the coronavirus disease 2019 (COVID-19) Test Home Collection Kit to Kroger Health — making it the first retailer to receive an authorization for a COVID-19 test.

Kroger Health, the health care division of The Kroger Co., said in a press release that its COVID-19 Test Home Collection Kit will be immediately available to frontline associates across Kroger's Family of Companies, based on medical need.

Next, Cincinnati, Ohio-based Kroger Health plans to “rapidly expand the availability of the home collection kits to other companies and organizations in the coming weeks, with a goal of processing up to 60,000 tests per week by the end of July,” it said.

Kroger Health is partnering with Gravity Diagnostics, a full-service clinical laboratory located in Covington, Kentucky, on the home collection tests.

"Throughout the COVID-19 pandemic, the safety of our associates and our customers has remained our top priority," said Colleen Lindholz, president of Kroger Health.

"Over the past few months, Kroger Health has been providing Americans with access to COVID-19 testing through community test sites across the country; however, we've observed some individuals do not have access to transportation or live near these community testing locations. To help ease this burden and provide greater accessibility, we will be offering a home testing solution to our associates first followed by other companies and organizations,” Lindholz added.

"As our country experiences an increase in COVID-19 cases, physical distancing, wearing protective masks and testing remains paramount to flattening the curve," said Jim Kirby, senior director of Kroger Health. "We know flexible, accessible testing options like home solutions that leverage telehealth technology are critical to accelerating America's reopening and recovery.”

The Kroger Health COVID-19 Test Home Collection Kit will initially be available in Arizona, Colorado, Georgia, Indiana, Kansas, Kentucky, Michigan, Montana, Nevada, New Mexico, Ohio, Tennessee, Utah and Virginia. Additional states will be added in the coming weeks.

public drive-thru and walk-up COVID-19 testing sites

 in April. Since then, Kroger Health has administered more than 100,000 tests across 19 states.

Here is how Kroger Health's COVID-19 Test Home Collection Kit works.

The home collection is performed under the supervision of a licensed healthcare professional. The process is simple and is available at no cost to eligible patients who meet established clinical criteria for likely COVID-19 infection or exposure, Kroger Health said.

Patients are provided access to a website where they answer screening questions, input their organization's benefit code and an individual code such as an employee ID, and complete a clinical assessment.

If a patient qualifies, a health care professional will issue a prescription and the home collection kit is shipped to their home within 24 to 48 hours.

The home collection kit includes a nasal swab, transport vial, instruction sheet, prepaid shipping label, and packing materials for return shipment of the sample to the laboratory.

Upon receipt of the home collection kit, a health care professional guides the home collection process via telehealth — a 2-way video chat. “The direct observation helps to ensure the proper technique is used for sample collection,” Kroger Health said. The patient then overnight ships their sample to the laboratory for processing, which will take 24 to 48 hours, on average.

If test results are negative for an active infection, results are released to the patient's electronic medical record portal. Alternatively, patients may be called if they do not consent to use of the portal. For a patient whose test result is positive, a health care professional will contact them via phone to provide a recommended course of care.

Test results will only be accessible to the patient and only shared with their organization if the patient authorizes the release of his or her results. All results are reported to government health agencies as required by law.

Kroger Health will start offering its COVID-19 Test Home Collection Kit with the guidance of a telehealth consultation. 

Kroger Health to Start Offering COVID-19 Home Collection Test

The CDC partnered with pharmacy stakeholders to develop resources and promotional materials tailored to the needs and values of pharmacists to expand the National Diabetes Prevention Program (National DPP) in pharmacies across the country.

First implemented in 2010, the National DPP is a public-private partnership that aims to become a nationwide delivery system for an evidence-based lifestyle change program for adults with an increased risk for developing type 2 diabetes. The program uses a curriculum taught by trained lifestyle coaches, delivered in person or virtually. 

Pharmacies and pharmacists are key partners in the program, since they are uniquely positioned to care for underserved populations who are also at increased risk for prediabetes, and developing type 2 diabetes, according to the CDC. One in 3 adults in the United States has prediabetes, which leads not only to type 2 diabetes, but also heart disease and stroke.

ADA 2020: Pharmacists Can Improve Diabetes Outcomes in Rural Settings

Ninety-two percent of individuals living in the United States reside within 1.6 miles of a pharmacy, and patients often visit their pharmacist more often than their primary care physician. Convenience on the basis of proximity and extended hours allow patients increased access to care, particularly for those who otherwise would have limited access.

CDC data has reported that that the National DPP can promote a 58% decreased risk for type 2 diabetes, and a 71% lowered risk for individuals 60 years or older. Another benefit of the program is its accessibility, as it is offered in settings such as hospitals and clinics, community organizations, and worksites.

The CDC identified 7 pharmacies that had already been offering the lifestyle change program and worked with the locations to evaluate the pharmacy workforce, including pharmacists, technicians, residents, community health workers, and students, in their ability to maintain and expand National DPP initiatives. The data was used to develop a pharmacy-specific resource that enables pharmacists to implement and sustain the lifestyle change program.

Data found that 5 of the 7 served rural populations; 4 focused on patients who have low incomes or who are medically underserved.

Additionally, 5 were independent pharmacies, whereas 1 was a school of pharmacy and the other was a retail chain grocery pharmacy.

The CDC analysis reported the following trends:

Pharmacists are increasingly working as providers, expanding their portfolio of patient care services.

More independent pharmacies than other pharmacy types exist in areas with a high prevalence of diabetes, although their limited resource capacity makes scalability a challenge.

National pharmacy associations are strong advocates for enabling pharmacists to offer more services and can influence pharmacist decision making.

Phase 2 of the study included testing a guide for pharmacists to help them get involved in the DPP. Results were based on establishing 3 tiers of pharmacy involvement:

Tier 1: Promote awareness of prediabetes and the National DPP. This is a simple, low-cost step to get involved with type 2 diabetes prevention efforts. The guide outlines existing promotional materials and campaigns that pharmacies can use to raise awareness of prediabetes and the National DPP.

Tier 2: Screen, test, and refer. By using a CDC-approved risk assessment or blood glucose test, pharmacies can help determine whether patients are at high risk of developing type 2 diabetes or currently have prediabetes. Pharmacy staff can then refer patients to the CDC-recognized lifestyle change program.

Tier 3: Offer the lifestyle change program. The guide describes how pharmacies can become CDC-recognized providers of the National DPP lifestyle change program.

CDC’s engagement with several diverse pharmacies revealed limitations on the basis of state-to-state scope of practice and unique barriers that limited engagement in type 2 diabetes prevention programs; however, authors stressed the success of the study in demonstrating the ways that public health and pharmacy sector partnerships are able to expand type 2 diabetes prevention.

“Pharmacists are accessible, credible, and dedicated health professionals who can play a key role in preventing type 2 diabetes and other chronic diseases while addressing health inequities in their communities,” the authors wrote.

Ross LW, Bana F, Blacher RJ, et al. Continuous Stakeholder Engagement: Expanding the Role of Pharmacists in Prevention of Type 2 Diabetes Through the National Diabetes Prevention Program. Prev Chronic Dis 2020; 17:190374. doi: 

The CDC has identified the pharmacy sector as a key partner in offering its lifestyle change-based program for patients with high risk for type 2 diabetes.

CDC: Partnerships With Pharmacists Expand Diabetes Prevention Efforts

Constipation is a common disorder that has a prevalence of approximately 20% in the general population and occurs even more frequently in the elderly.

 Constipation is generally characterized by infrequent bowel movements (BMs) over the course of a week (generally fewer than 3 BMs weekly), but patients may have a wide range of symptoms, including hard stools, a feeling of incomplete evacuation, abdominal discomfort, bloating, and distention, as well as other symptoms (eg, excessive straining and a sense of anorectal blockage during defecation).

 Constipation may be secondary to other disorders, lifestyle factors, or drug therapy, and these situations may be managed by addressing the underlying cause(s). Alternatively, an identifiable cause may not be known and in such instances, the condition is referred to as primary or idiopathic constipation.

 Regardless of the etiology, pharmacologic intervention may be necessary to manage the associated symptoms.

 Pharmacological agents used in the management of constipation fall within a variety of laxative classes, such as bulk forming agents (eg, psyllium), osmotic agents (eg, polyethylene glycol), stimulants (eg, bisacodyl, senna), lubricants (eg, mineral oil), chloride channel activator (lubiprostone), guanylate cyclase activator (linaclotide), and serotonergic agents (eg, tegaserod).

 An additional class of agents used to manage constipation includes emollient laxatives. Docusate, a commonly used member of this class, is believed to act as a stool softening agent by increasing the amount of water and lipids the stool absorbs in the gut, resulting in a softer, easier-to-pass stool.

Docusate, formerly known as dioctyl sulfosuccinate (DSS), was approved for use in the United States in 1957 and is available in 2 different salt forms: docusate sodium (Colace and others) and docusate calcium (Surfak and others).

 Docusate is available over the counter in numerous oral dosage forms as well as a rectal enema. The usual recommended adult dose of oral docusate is 100-300 mg/day for the sodium salt and 240 mg/day for the calcium salt.

In its 2013 Position Statement on Constipation, the American Gastroenterological Association (AGA) recommends that constipation be initially managed with a gradual increase in fiber intake (through dietary means and/or via supplementation) and/or with inexpensive osmotic agents, such as milk of magnesia or polyethylene glycol. The AGA recommends that low-cost stimulant laxatives be added to the initial agents when needed, and that newer, more costly agents be reserved for patients who do not respond to less costly laxatives.

 Docusate is not included in the aforementioned recommendations, however, its use is common, with greater than 3.5 million prescriptions for docusate dispensed in the US in 2017.

 Moreover, docusate is listed on the World Health Organization’s 

the safest and most effective medicines needed in a health system

 Despite its popularity, evidence to support its use is limited.

The earliest identified data on the clinical use of docusate dates back to 1956. At that time, Cass and Frederikdescribed a study involving 74 hospitalized patients who were treated for chronic constipation.

 In this randomized, double-blind, placebo-controlled, crossover study, patients were randomized to receive docusate sodium 60 mg daily for 20 days or placebo for 10 days. The investigators reported differences in the outcomes of stool consistency (3.64 vs 4.0, respectively [with 1 = watery and 5 = extremely hard]) and frequency of BM (4.55/patient/week vs 3.5/patient/week, respectively) in the docusate group as compared with placebo group. It is unclear whether these differences were statistically significant.

A 1968 article by Hyland and Foran describes a study involving 34 geriatric hospitalized patients who were being treated for chronic constipation.

 In this placebo-controlled, crossover study, patients were randomized to receive docusate sodium 100 mg or placebo 3 times daily for 4 weeks. The investigators reported that docusate increased stool frequency by a mean of 1 BM per week compared with placebo; this difference was found to be statistically significant.

In another article, published in 1976, Goodman et al. described a study that examined the use of docusate for the prophylaxis of constipation in 34 elderly hospitalized patients.

 Patients were randomized to receive docusate sodium (100 mg twice daily) or placebo. Outcome measures included the frequency and quality of BMs; no significant between-group differences were found in the aforementioned outcome measures over the course of the study. The authors concluded that routine prophylaxis with docusate at a dose of 100 mg twice daily is not effective in altering the incidence of constipation in a hospital setting.

In a 1978 article, Fain et al. described a study that assessed the use of 2 docusate salts in 46 elderly patients with chronic constipation who were residing in a retirement center.

 Patients were randomized to 1 of 3 arms: docusate sodium 100 mg daily, docusate sodium 100 mg twice daily, or docusate calcium 240 mg daily. All patients underwent a 2-week placebo run-in period followed by 3 weeks of treatment. At the conclusion of the treatment period, a statistically significant increase in the frequency of BMs was noted in the docusate calcium arm compared with that observed at the conclusion of the placebo run-in period (2.83/week vs 1.75/week). In contrast, no such differences were noted with the 2 regimens of docusate sodium. 

A 1991 article by Castle et al. describes a randomized, double-blind, crossover study involving 15 elderly nursing home residents, all of whom were on a bowel regimen before the onset of the study.7,8 Subjects were randomized to receive docusate calcium 240 mg twice daily or placebo for 3 weeks followed by a 2-week washout period before crossing over to the other arm. Outcome measures included stool frequency, stool consistency, the need for additional laxatives, and patients’ subjective experience. The investigators reported no significant differences in any of these outcome measures.

In the largest study to date involving the use of docusate, McRorie et al. assessed the comparative efficacy of psyllium and docusate sodium in the management of chronic idiopathic constipation.10 In this multi-site, double-blind study, 170 adult patients were randomized to receive psyllium 5.1 g twice daily (along with docusate placebo) or docusate sodium 100 mg twice daily (along with psyllium placebo). The study began with a 2-week placebo phase (baseline) followed by a 2-week treatment phase. Outcome measures included BM frequency, stool weight, total stool output, dry stool weight, stool water weight, stool water content, and a combined score of the aforementioned outcome measures. The investigators reported that in treatment week 2, BM frequency was significantly greater with psyllium than with docusate (3.5/week vs 2.9/week, respectively). Increases in total stool output (359.9 g/week vs 271.9 g/week, respectively) and stool water weight (84.0 g/BM vs 71.4 g/BM, respectively) were also significantly greater with psyllium than with docusate. Likewise, when compared with baseline values, psyllium resulted in a significantly greater increase in stool water content vs. docusate (2.33% vs 0.01%, respectively). The combined score of objective measures of constipation was also significantly greater with psyllium than with docusate.

Other outcomes measures were not statistically different. Notably, the focus of this study was a comparison of psyllium with docusate, and as such, the investigators did not report whether docusate resulted in significant improvements in the study’s outcomes when compared with baseline measures.

In the most recent study, Tarumi et al. assessed the efficacy of docusate sodium in hospice patients.11 In this prospective, randomized, double-blind, placebo-controlled trial, 74 patients were randomized to receive 1 to 3 sennoside tablets (8.6 mg/tablet) plus docusate sodium 200 mg twice daily or 1 to 3 sennoside tablets (8.6 mg/tablet) plus placebo for 10 days. The primary outcome measures were stool frequency, volume, and consistency. The investigators reported no significant differences between the 2 groups in regards to the primary outcome measures. The authors concluded that docusate plus sennosides was not more efficacious than sennosides alone in managing constipation in hospice patients.

In addition to the clinical studies reported above, 2 systematic reviews were identified which examined the clinical efficacy of docusate in the management of constipation. In a review of literature spanning the period of 1940-1997, Hurdon et al. identified 4 eligible prospective controlled trials which evaluated the efficacy of oral docusate in adults with chronic illness and identifiable risk factors for constipation, as well as in those with preexisting constipation.

Based on their review, the authors concluded that treatment of constipation with docusate in chronically ill and terminally ill patients is based on inadequate experimental evidence. Notably, the 4 trials included in the Hurdon review have been previously summarized in this article.

Similarly, in 2005, Ramkumar and Rao conducted a systematic review of the efficacy and safety of medical therapies for the management of chronic constipation.

 In this review, the authors searched for randomized studies published between 1966 and 2003 that included adult patients. The search yielded 4 studies that examined the efficacy of docusate, all of which have been summarized in the current review. Based on the evidence, Ramkumar and Rao concluded that “[t]he efficacy of docusate in the treatment of constipation is modest at best”.

Although the use of docusate remains common, evidence to support its use is based on a small number of clinical trials which often carried significant limitations. Pharmacists should be mindful of the lack of robust evidence to support the use of docusate for the management of constipation. Considering its OTC status, pharmacists can and must play an active role in guiding patients on the selection of laxatives which are supported by sound evidence. Likewise, such guidance should be provided to other health care practitioners caring for patients who require the use of laxatives.

At the time of writing, Dr Chattah was a student at The Arnold & Marie Schwartz College of Pharmacy and Health Sciences, Long Island University. 

Dr Grossman is a drug information specialist at the International Drug Information Center and adjunct assistant professor at Arnold & Marie Schwartz College of Pharmacy and Health Sciences, Long Island University. 

Dr Nathan is the director at the International Drug Information Center and associate professor at Arnold & Marie Schwartz College of Pharmacy and Health Sciences, Long Island University.

1. Vazquez Roque M, Bouras EP. Epidemiology and management of chronic constipation in elderly patients. 

 2015;10:919-930. doi:10.2147/CIA.S54304.

2. Bharucha AE, Dorn SD, Lembo A, Pressman A. American Gastroenterological Association medical position statement on constipation. 

 2013;144(1):211-217. doi:10.1053/j.gastro.2012.10.029.

3. Fabel PH, Shealy KM. Diarrhea, Constipation, and Irritable Bowel Syndrome. In: DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey L. eds. 

Pharmacotherapy: A Pathophysiologic Approach,

 10e New York, NY: McGraw-Hill. Accessed April 28, 2020.

 [database online]. Elsevier Inc. Accessed April 28, 2020.

5. Medical Expenditure Panel Survey summary tables – Prescribed drugs. Agency for Healthcare Research and Quality. U.S. Department of Health and Human Services. Accessed April 28, 2020.https://meps.ahrq.gov/mepstrends/hc_pmed/.

6. Model List of Essential Medicines. 21st List 2019. World Health Organization. Accessed April 28, 2020. https://apps.who.int/iris/bitstream/handle/10665/325771/WHO-MVP-EMP-IAU-2019.06-eng.pdf?ua=1.

7. Hurdon V, Viola R, Schroder C. How useful is docusate in patients at risk for constipation? A systematic review of the evidence in the chronically ill. 

 2000;19(2):130-136. doi:10.1016/s0885-3924(99)00157-8.

8. Ramkumar D, Rao SS. Efficacy and safety of traditional medical therapies for chronic constipation: systematic review. 

 2005;100(4):936-971. doi:10.1111/j.1572-0241.2005.40925.x.

9. American College of Gastroenterology Chronic Constipation Task Force. An evidence-based approach to the management of chronic constipation in North America. 

 2005;100 Suppl 1:S1-4. DOI:10.1111/j.1572-0241.2005.50613_1.x.

10. McRorie JW, Daggy BP, Morel JG, Diersing PS, Miner PB, Robinson M. Psyllium is superior to docusate sodium for treatment of chronic constipation. 

 1998;12(5):491-497. doi:10.1046/j.1365-2036.1998.00336.x.

11. Tarumi Y, Wilson MP, Szafran O, Spooner GR. Randomized, double-blind, placebo-controlled trial of oral docusate in the management of constipation in hospice patients. 

 2013;45(1):2-13. doi:10.1016/j.jpainsymman.

Pharmacists can and must play an active role in guiding patients on the selection of laxatives which are supported by sound evidence. 

Reevaluating the Use of Docusate in the Management of Constipation

vaccine.png

The American Pharmacists Association (APhA) has announced its plans to collaborate with the Pharmacy Technician Certification Board (PTCB) to offer an immunization delivery credential program for pharmacy technicians enrolled in the APhA/Washington State University Pharmacy-Based Immunization Administration by Pharmacy Technicians program.

“This very exciting collaboration builds on APhA’s decades of experience in delivering pharmacy-based immunization training,” said Daniel Zlott, PharmD, BCOP, vice president of professional education resources for APhA.

“The program will ensure that pharmacy technicians who complete the training are well-positioned to support immunization-related services within pharmacies, while the US identifies solutions to meet the increased demand for vaccine services that we anticipate in the face of the upcoming flu season, provision of routine vaccines, and the release of a COVID-19 vaccine,” he said.

The program, developed by APhA and Washington State University, will aid PTCB Certified Pharmacy Technicians (CPhTs) in attaining their Assessment-Based Certificate.

Pharmacy technicians in states such as Idaho, Rhode Island, and Utah, are allowed to provide immunizations to their patients, whereas many other states are currently considering legislative changes that would authorize pharmacy technicians to administer immunizations.

Additionally, pharmacy technicians in all states hold key roles related to providing immunizations, such as helping patients complete vaccine administration record forms, as well as accessing vaccination histories, managing inventory, inputting data, and being responsible for billing.

Other new specialty certificate programs, including those related to billing and reimbursement and hazardous drug management, will roll out sometime this summer. Later this year, the new Controlled Substances Diversion Prevent Program will launch as well. These new programs, including the Immunization Program, comprise 6 new certificate programs that have been launched since last year.

Pharmacy technicians interested in completing APhA Education programs can learn more at 

; technicians ready to apply to the new certificate programs can do so at 

“Pharmacy technicians are an integral component of optimal pharmacy practice,” said Scott Knoer, MS, PharmD, FASHP, chairman of the PTCB Board of Governors, and APhA chief executive officer and executive vice president. “Offering this credential will support the expanding role of pharmacy technicians as important members of the pharmacy care team focusing on improving the health of their communities.”

Pharmacy Technician Certification Board Collaborates with American Pharmacists Association To Develop Immunization Credential Program for Pharmacy Technicians. News Release. APhA; June 29, 2020. Accessed June 30, 2020. 

https://www.pharmacist.com/press-release/pharmacy-technician-certification-board-collaborates-american-pharmacists-association

A collaboration between APhA and PTCB will help provide pharmacy technician credentialing in immunization delivery. 

APhA Connects with Pharmacy Technician Certification Board To Provide Immunization Training

A research team led by the University of Bristol recently published findings in 

 that determined a clear correlation between changes in human DNA and the existence and amount of certain gut-pertaining bacteria.

David Hughes, BSc, MSc, PhD, senior research associate in applied genetic epidemiology, and lead author of the paper, said that the findings could pose a huge breakthrough in understanding how gut bacteria are affected by changes in human genotype. “It marks major progress in our ability to know whether changes in our gut bacteria actually cause, or are a consequence of, human disease,” he stated in a press release about the findings.

The study was prompted by the fact that the human body is made up of numerous microecosystems that are populated by equally numerous microorganisms. The millions of bacteria that habituate the gut are responsible for digesting food and producing life-sustaining molecules; due to such a large encompassing responsibility, previous researchers wondered if these bacteria were also responsible for aspects of human health and disease.

Analyzing data from 3890 individuals selected from 3 different population studies, the Bristol research team was able to identify 13 DNA changes that related to changes in the appearance and number of gut bacteria. Individuals’ DNA was measured for known changes, and the team also sampled individuals’ feces to register gut bacteria.

 on chromosome 9. Another association was found between 

 on chromosome 1. A third reflected another team’s previous observation of an association between whether a person could digest lactose and the prevalence of 

However, the team contends that the absence of clear microbiome-driven effects means the associations should be cautiously accepted, as without knowing the exact origin of these associations, future attempts at understanding the relationship will be complicated.

Nonetheless, the findings were exciting. “Now comes the great challenge of confirming our observations with other studies and dissecting how exactly these DNA changes might impact bacterial composition,” said Dr Hughes.

Kaitlin Wade, BSc, PhD, lecturer in epidemiology at the University of Bristol and co-author of the study, expressed just how much impact the findings could have on future approaches to medicine. “The implications for our understanding of human health and our approach to medicine are far-reaching and potentially game changing,” she said.

Hughes, DA, Bacigalupe R, Wang J, et al. Genome-wide associations of human gut microbiome variation and implications for causal inference analyses. 

https://doi.org/10.1038/s41564-020-0743- 8

University of Bristol. Pioneering research reveals certain human genes relate to gut bacteria. ScienceDaily. June 22, 2020. Accessed June 25, 2020. 

https://www.sciencedaily.com/releases/2020/06/200622133018.htm

Though the relationship between genetics and gut-dwelling bacteria is still a realm of mystery, new research has begun a new step towards better understanding how one affects the other.

Research Shows Human DNA Affects Gut Bacteria

A Johns Hopkins team of investigators has found that testing infected individuals too early for the novel coronavirus disease 2019 (COVID-19) may result in a false negative, even though they may test positive for the virus later.

RT-PCR function tests function by copying and detecting a virus’s genetic material when a group of infected cells are swabbed. Though capable of rapidly generating results, these tests have a history of producing negative results, such as when cells are missed, or if virus levels are too low during the earliest stages of an infection.

The 7 selected studies covered a total of 1330 upper respiratory swab samples collected from both inpatients and outpatients using the RT-PCR method. From them, the researchers calculated the probability that someone who later tested positive for COVID-19 tested negative initially. False negatives were estimated at a daily rate since exposure and the first appearance of symptoms.

Over the course of 4 days, the team estimated that the probability of getting a false-negative decreased from 100% on day 1 to 67% on day 4. The day that symptoms started appearing, day 5, the median rate for false-negative testing was 38% and decreased to just 20% on day 8. The rate increased to 21% on day 9 and to 66% on day 21.

Lauren Kucirka, MD, PhD, MSc, obstetrics and gynecology resident at Johns Hopkins Medicine, explained that this demonstrates that the later a person suspected to have contracted COVID-19 is tested, the less likely they are to result in a false-positive. “A negative test, whether or not a person has symptoms, doesn’t guarantee that they aren’t infected by the virus,” she said, arguing that individuals who have high-risk exposure should still be treated as if they are infected, especially if they exhibit symptoms consistent with the virus. The RT-PCR tests and their shortcomings should also be conveyed to these individuals.

The study investigators also noted that its estimates in probability were imprecise due to the diverse pool of patients on which the results of the 7 chosen studies were based.

The investigators concluded that care must be taken when interpreting any test for COVID-19, especially when using results as reason for removing precautions that are intended to prevent further transmission. New and improved tests are needed to diagnose patients accurately and quickly, which will allow for better control of the virus’s spread, the investigators said.

Kucirka LM, Lauer SA, Laeyendecker O, Boon D, Lessler J. Variation in False-Negative Rate of Reverse Transcriptase Polymerase Chain Reaction-Based SARS-CoV-2 Tests by Time Since Exposure. 

Johns Hopkins Medicine. COVID-19 false negative test results if used too early. ScienceDaily. June 10, 2020. Accessed June 25, 2020. 

https://www.sciencedaily.com/releases/2020/06/200610094112.htm

A Johns Hopkins research team has determined that tests are more likely to result in false negatives for the COVID-19 virus if taken too early in the course of infection.

Vaccine candidates for COVID-19 are progressing through clinical trials at record rates. 

Moderna's mRNA-1273 is currently in late-stage development, and the company remains on track to deliver approximately 500 million doses per year, starting in 2021.

The University of Oxford's vaccine candidate, ChAdOx1 nCoV-19, recently entered phase 2/3 trials.

Anthony Fauci, MD, director of the National Institutes of Allergy and Infectious Disease, has said that, if everything goes right, a vaccine could be available by late this year. 

Seeking to assure those who are concerned that an 

expedited coronavirus disease 2019 (COVID-19) vaccine

 may not be safe and effective, the FDA updated its guidance for developing and evaluating vaccine candidates to protect humans from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

“In this particular crisis in which there is so much at stake, we need to help expedite vaccine development as much as we can without sacrificing our standards for quality, safety, and efficacy,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a 

 “We firmly believe that transparency regarding the FDA’s current thinking about the scientific data needed to support approval of safe and effective COVID-19 vaccines will help build public confidence in the FDA’s evaluation process, which will be critical in ensuring their use.”

Development and Licensure of Vaccines to Prevent COVID-19

,” states these important requirements:

1. The agency “strongly encourages the inclusion of diverse populations in all phases of clinical development, including populations most affected by COVID-19, specifically racial and ethnic minorities.”

2. Late phase trials should include adequate representation of elderly individuals and those with medical comorbidities. Older adult participants aged 55 and older may be enrolled in FIH and other early phase studies so long as they do not have medical comorbidities associated with an increased risk of severe COVID-19, FDA said.

3. Sponsors are encouraged to include studies in their development plans that would provide data to support use during pregnancy, as well as plan for pediatric assessments of safety and effectiveness. “Use of COVID-19 preventive vaccines in pregnancy and in women of childbearing potential will be an important consideration for vaccination programs. Therefore, FDA recommends that prior to enrolling pregnant women and women of childbearing potential who are not actively avoiding pregnancy in clinical trials, sponsors conduct developmental and reproductive toxicity (DART) studies with their respective COVID-19 vaccine candidate,” the agency said.

4. The sizes of clinical trials must be large enough to demonstrate the safety and effectiveness of a vaccine. “The FDA would expect that a COVID-19 vaccine would prevent disease or decrease its severity in at least 50% of people who are vaccinated,” the agency said. Late phase clinical trials will likely need to enroll many thousands of participants, including many with medical comorbidities for trials seeking to assess protection against severe COVID-19, according to the guidance.

1. Coronavirus (COVID-19) update: FDA takes action to help facilitate timely development of safe, effective COVID-19 vaccines. Press release. FDA; June 30, 2020. Accessed June 30, 2020. 

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-action-help-facilitate-timely-development-safe-effective-covid?utm_campaign=063020_PR_FDA%20Helps%20Facilitate%20Development%20of%20Safe%2C%20Effective%20COVID-19%20Vaccines&utm_medium=email&utm_source=Eloqua

2. FDA. Development and licensure of vaccines to prevent COVID-19: Guidance for industry. Published June 30, 2020. Accessed June 30, 2020. 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/development-and-licensure-vaccines-prevent-covid-19

In a new guidance, the FDA provides recommendations for those developing COVID-19 vaccines to ensure safety and efficacy.  

FDA Guidance Provides Safety, Quality Standards for COVID-19 Vaccine Development 

Researchers from Harvard Medical School and the Novartis Institutes for BioMedical Research announced the creation of an open-source machine learning tool capable of predicting drug adverse effects (AEs).

, examined 2 databases: 1 that reported adverse drug reactions and another with 184 proteins that specific drugs are known to interact with. Investigators constructed a computer algorithm to develop associations between the drug reactions and the 184 individual proteins.

The algorithm discovered 221 associations, some known and some new. These associations indicated which proteins contribute to certain AEs and which may not.

Adverse reactions to drugs contribute to 2 million US hospitalizations each year, according to the Department of Health and Human Services, and occur during 10% to 20% of hospitalizations, according to the Merck manuals. As such, researchers have attempted numerous tactics to minimize the numbers, but because an individual drug can affect several proteins at once, it is difficult to predict what side effects, adverse or otherwise, may occur. The difficulty extends to identifying the protein responsible.

The new algorithm could help predict these AEs before the drug goes to human clinical trials, as well as before and after it enters the market.

The research team supplied the algorithm with 2 large data sets. The first, provided by Novartis, gave information about the proteins that each of the 2000 drugs interacted with. The second, from the FDA, provided 600,000 physician reports of AEs in patients.

Aside from generating information about the relation between individual proteins and adverse reactions, the algorithm also supported previous observations, such as how a drug binding to the protein hERG could cause cardiac arrhythmias.

A new computer algorithm might be the next step toward accurate prediction of adverse drug reactions.

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