Impact of COVID-19 on prevalence of community pharmacies as CLIA-Waived facilities

BackgroundThe Clinical Laboratory Improvement Amendments of 1988 (CLIA) enabled greater access to low-risk tests by allowing their use in facilities with a Certificate of Waiver in the U.S. Recently, the 2019 novel coronavirus (COVID-19) pandemic has shined a spotlight on CLIA-waived diagnostic testing. To meet this increased patient demand for diagnostic testing, the U.S. Department of Health and Human Services (HHS) authorized licensed pharmacists to order and administer FDA authorized COVID-19 tests.ObjectiveThis study aims to update the previous national benching report and examine both the number of pharmacies in the United States with CLIA Certificates of Waiver before and after the SARS-CoV-2 pandemic and the state-by-state differences in the percentage of pharmacies with CLIA Certificates of Waiver.MethodsData were collected from the U.S. Centers for Disease Control and Prevention CLIA Laboratory Search website May 3rd, 2015, August 4th, 2019 and November 26th, 2020. The website allows for exportation of demographic data on all CLIA-waived facilities by state.ResultsPharmacies exhibited the largest growth both in number (4865 new locations) and by percent (45%) of CLIA-waived facilities between 2015 and 2020. The total number of pharmacies with a CLIA-waiver grew from 10,626 (17.94%) locations in 2015 to 12,157 (21.43%) locations in 2019, to 15,671 (27.63%) locations in 2020. States demonstrated considerable variability in the percentage of pharmacies with a CLIA-waiver, with a range of 2.92%–56.52%.ConclusionsPharmacies have become an increasingly important location for patients to access CLIA-waived tests in the United States, now serving as the second largest provider of CLIA-waived tests by the total number of locations. Most of this growth occurred between 2019 and 2020 due to the COVID-19 pandemic, and concentrated efforts will be necessary to sustain this momentum.     

A Retrospective Review of Digit Span-Related Effort Indicators in Probable Alzheimer's Disease Patients

There has been extensive research on the use of both stand-alone and embedded measures of effort in neuropsychological testing; however, relatively few studies have reported on their utility in the context of dementia. Previous studies that have examined the specificity of traditionally used cut-scores on embedded measures of effort with dementia samples have largely found high rates of false positive errors. The present study examined the specificity of several Digit Span derived embedded measures of effort in a large clinical sample of patients with probable Alzheimer's disease stratified by level of dementia severity. Of the measures that were examined, only the Vocabulary – Digit Span score demonstrated promising specificity through the moderate level of dementia severity. All of the remaining indices, including Reliable Digit Span, Digit Span Age-Corrected Scaled Score, and Longest Digits Forward (1 & 2 Trials), yielded unacceptable rates of false positive errors as dementia severity increased. The implications for these findings are discussed, including the limitations of importing methods of assessing effort from one sample to another.     

Physiological basis of preoperative cardiopulmonary exercise testing

The use of cardiopulmonary exercise testing (CPET) is gaining popularity as a preoperative functional assessment tool and a useful adjunct to risk stratification before surgery. Determination of the integrated response of multiple body systems (including the cardiorespiratory and peripheral oxygen delivery systems) to exercise stress, adds important prognostic value to pre-surgical assessment, shared-decision making and postoperative management of the surgical patient. Thorough CPET interpretation is complex but may be assisted by an understanding of basic exercise physiology and its application to the preoperative context.     

A proposal for a drug product Manufacturing Classification System (MCS) for oral solid dosage forms

Abstract

This paper proposes the development of a drug product Manufacturing Classification System (MCS) based on processing route. It summarizes conclusions from a dedicated APS conference and subsequent discussion within APS focus groups and the MCS working party. The MCS is intended as a tool for pharmaceutical scientists to rank the feasibility of different processing routes for the manufacture of oral solid dosage forms, based on selected properties of the API and the needs of the formulation. It has many applications in pharmaceutical development, in particular, it will provide a common understanding of risk by defining what the “right particles” are, enable the selection of the best process, and aid subsequent transfer to manufacturing. The ultimate aim is one of prediction of product developability and processability based upon previous experience.

This paper is intended to stimulate contribution from a broad range of stakeholders to develop the MCS concept further and apply it to practice. In particular, opinions are sought on what API properties are important when selecting or modifying materials to enable an efficient and robust pharmaceutical manufacturing process. Feedback can be given by replying to our dedicated e-mail address (mcs@apsgb.org); completing the survey on our LinkedIn site; or by attending one of our planned conference roundtable sessions.     

Acute cholestatic hepatitis caused by amoxicillin/ clavulanate

Amoxicillin/clavulanate is a synthetic penicillin that is currently commonly used,especially for the treatment of respiratory and cutaneous infections.In general,it is a well-tolerated oral antibiotic.However,amoxicillin/clavulanate can cause adverse effects,mainly cutaneous,gastrointestinal,hepatic and hematologic,in some cases.Presented here is a case report of a 63-yearold male patient who developed cholestatic hepatitis after recent use of amoxicillin/clavulanate.After 6 wk of prolonged use of the drug,he began to show signs of cholestatic icterus and developed severe hyperbilirubinemia(total bilirubin>300 mg/L).Diagnostic investigation was conducted by ultrasonography of the upper abdomen,serum tests for infection history,laboratory screening of autoimmune diseases,nuclear magnetic resonance(NMR)of the abdomen with bile duct-NMR and transcutaneous liver biopsy guided by ultrasound.The duration of disease was approximately 4 mo,with complete resolution of symptoms and laboratory changes at the end of that time period.Specific treatment was not instituted,only a combination of anti-emetic(metoclopramide)and cholestyramine for pruritus.     

Drug Use–Chronic and Relapsing or a Treatable Condition?

It is argued that the term “chronic relapsing disorder,” which is used frequently to characterize drug use, does not capture the complexity of drug treatment evaluation findings and thereby limits an understanding and appreciation of the accomplishments of drug treatment. Specifically, it is noteworthy that a substantial minority (19%) of treated drug users have been found to maintain abstinence over a 6-year period posttreat-ment, and that the three major multisite treatment evaluations sponsored by NIDA have all found that overwhelming majorities of treated drug users do not revert to the levels of drug use (or criminal activity) shown pretreatment. Thus, the view of inevitable and continuing adoption of pretreatment behaviors, i.e., chronic relapse, gives undeserved comfort to those who deny the utility of drug treatment, and does so at a time when changes in the health care industry threaten the integrity of that treatment.     

Evidence-based guidelines for the management of lower urinary tract symptoms related to uncomplicated benign prostatic hyperplasia in Italy: updated summary

ABSTRACT

Background and scope: Despite the high prevalence and huge socio-economic impact of benign prostatic hyper­plasia (BPH) in Italy, no national guidelines have been produced so far. This is a summary of the first Italian guidelines on the diagnosis and treatment of lower urinary tract symptoms (LUTS) related to uncomplicated BPH, prepared by a multidisciplinary panel under the auspices of the Italian Association of Urologists and introduced in Italy in 2003. An update compiled by the authors is also included.

Methods: Relevant papers published from 1998 to 2003 (updated to 2006) were identified through a structured literature review and the quality of evidence presented therein was graded according to the Centre for the Evaluation of Effectiveness in Health Administration (CeVEAS) system. Recommendations were based on evidence from the literature, but also on feedback from practitioners and specialists.

Main findings/recommendations: Given the prevalence of BPH, all men aged ≥ 50 years of age should be asked about LUTS and informed about disease characteristics and therapeutic options, while sexual function should always be assessed in patients with severe and long-standing LUTS. Initial assessment should include medical history (including drug and co-morbidity history), digital rectal examination, urinalysis, International Prostate Symptom Score-Quality of Life (IPSS-QoL) and a voiding diary, while prostate-specific antigen (PSA) and measure­ment of prostate volume by suprapubic ultrasonography are indicated in fully informed patients with a life expectancy of ≥ 10 years in whom BPH progression could influence treatment choices. QoL considerations should dictate whether to start active treatment. When QoL is not affected by LUTS, watchful waiting is indicated if symptoms are mild, acceptable if they are moderate. When QoL is affected, medical therapy with α₁-blockers or 5α-reductase inhibitors (the latter indicated in patients with increased prostate volume) is appropriate. Combined therapy with α₁-blockers + 5α-reductase inhibitors should only be considered in patients at high risk for progression (prostate volume > 40?mL or PSA > 4?ng/mL), since the incremental cost of combination therapy vs. monotherapy with α₁?blockers or finasteride is prohibitive. Selection of the type of surgery should be based on the surgeon's experience, the presence of co-morbid conditions and the size of the prostate. Open prostatectomy and transurethral resection of the prostate (TURP) are recommended in patients with acute or chronic retention of urine, and acceptable in obstructed patients with moderate/severe symptoms and worsened QoL. Transurethral incision of the prostate (TUIP) is acceptable when prostate volume is ≤ 30?mL. Holmium laser enucleation of the prostate (HoLEP) may be proposed to motivated patients where expert surgeons are available. Transurethral microwave thermotherapy (TUMT) or transurethral needle ablation (TUNA) may be proposed to motivated patients who prefer to avoid surgery and/or do not respond to medical treatment. The possible effects of medical or surgical treatments on sexual function should always be discussed.

Conclusions: These guidelines are intended to provide a framework for health professionals involved in BPH management in order to facilitate decision-making in all areas and at all levels of healthcare.     

Book review of Delis-Kaplan Executive Function System. By D. C. Delis,E. Kaplan and J. H. Kramer (Texas: Psychological Corporation, 2001). [Pp. n/a]. £621.92 incl. VAT,with CD scorer; £489.18 incl. VAT,without CD scorer.

Objective: To develop and field-test a physical performance measure (MPS-PPM) for individuals with Mucopolysaccharidosis I (MPS I), a rare genetic disorder. Methods: Motor performance and endurance items were developed based on literature review, clinician feedback, feasibility, and equipment and training needs. A standardized testing protocol and scoring rules were created. The MPS-PPM includes: Arm Function (7 items), Leg Function (5 items), and Endurance (2 items). Pilot data were collected for 10 subjects (ages 5–29 years). We calculated Spearman's rho correlations between age, severity and summary z-scores on the MPS-PPM. Results: Subjects had variable presentations, as correlations among the three sub-test scores were not significant. Increasing age was related to greater severity in physical performance (r = 0.72, p<0.05) and lower scores on the Leg Function (r = ?0.67, p<0.05) and Endurance (r = ?0.65, p<0.05) sub-tests. The MPS-PPM was sensitive to detecting physical performance deficits, as six subjects could not complete the full battery of Arm Function items and eight subjects were unable to complete all Leg Function items. Subjects walked more slowly and expended more energy than typically developing peers. Conclusions: Individuals with MPS I have difficulty with arm and leg function and reduced endurance. The MPS-PPM is a clinically feasible measure that detects limitations in physical performance and may have potential to quantify changes in function following intervention.