May 10, 2020
by PharmaReviews
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An Illogical and Specious Response of Some Stubborn Physicians Regarding the Appointment of the Highly Expert Pharmacy Professionals.

Pharmaceutical Review (Staff Reporter). The Medical superintendent police and services hospital Peshawar has assigned additional charge of Deputy medial superintendent along with their regular job to high profiled and skill pharmcy professionals. This is an official, regular and genuine act of respective officer. But unluckily, some stubborn physicians have opposed this legal and rational appointment as under,

پراونشل ڈاکٹرز اسوسیشن ایم ایس پولیس ہسپتال کی جانب سے غیر قانونی طور پر فارماسسٹ کو ڈی ایم ایس کے عہدے پر تعیناتی کو مسترد کرتے ہیں پراونشل ڈاکٹرز اسوسیشن گریڈ 18 گریڈ 19 اور گریڈ 20 کی ڈاکٹرز کی موجودگی کے باوجود ایک فارمسسٹ کو خلاف قانون انتہائی اہم عہدے پر تعیناتی ایم ایس کی نااہلی کا منہ بولتا ثبوت ہے ۔پراونشل ڈاکٹرز اسوسیشن ۔ اس غیر قانونی ارڈر کو فی الفور واپس لیا جائے اور ڈپارٹمنٹ کی بدنامی کا باعث بنے والے متعلقہ نااہل ایم ایس کے خلاف سخت سے سخت کاروائی کی جائے ۔پراونشل ڈاکٹرز اسوسیشن ۔ ایم ایس کی جانب سے فارمسسٹ کے ساتھ خلاف قانون ڈاکٹر لکھا گیا جو محکمے اور ڈاکٹرز کیمونٹی کے لئے باعث بدنامی ہے پاکستان میڈیکل اینڈ ڈینٹل کونسل نے پہلے ہی ڈاکٹر لکھنے سے منع کیا ہے ۔پراونشل ڈاکٹرز اسوسیشن ایم ایس پولیس ہسپتال کو فی الفور تبدیل کیا جائے اور میرٹ پر کسی اہل ڈاکٹر کو ایم ایس تعینات کیا جائے ۔پراونشل ڈاکٹرز اسوسیشن۔ صوبائی وزیر صحت اور سیکٹری صحت نوٹس لیں ۔پراونشل ڈاکٹرز اسوسیشن

This is not first time happened in Pakistan. There are so many illogical, ridiculous and non-sense responses noticed in miscellaneous health issue. The superiority complex of some physician is one the major obstacle to improve the health care system and standards in country.

Additionally, the current clinical and pharmaceutical systems in developing countries potentially need special attention of international health care organizations. The undermined health care facilities are hurting the overall quality of life and international health standards. So, we have to control the drug interactions, clinical errors, self/ wrong medications and therapeutical problem to achieve the Millennium Development Goals described by World Health Organization. Therefore, we have aimed this study to point out the components, potentially hurting the health care system in Pakistan. The control of irrational drug usage or poor pharmaceutical care will help to improve the indigenous health standards. Whereas, the drug jurisprudence, licensing, inventory control and supply also need a comprehensive revision and enforcement throughout the country. The channel through which the drugs supplied without appropriate examination should also be checked at each step. The quality tests, therapeutical monitoring, bio-safety and prescription review are additional safety valves to control the avoidable health hazards. Therefore the drugs experts and qualified pharmacists should be assigned their real clinical and patient oriented responsibilities instead of clerical, administrative or inventory control task. This is also noticed that the prospective bureaucracy, district health authorities and medical superintendents of public sector hospitals may intentionally work collectively to keep the real custodian of drugs (pharmacists) away from his real work. That may help them to obtain the maximum corporate, monetary and/ or political benefits. Thus, in current practice the missing roles of drug experts and omission of internationally recognized clinical pharmaceutical components lead to malpractice. We may need needs additional legal restrictions to assure the safety of patients. So, the local administration, political leadership, judiciary and civil society should work collectively to assure the safety of admitted or out patients.

Further studies,

  1. https://www.consortiumpublisher.ca/index.php/cjas/article/view/464/467
  2. https://www.researchgate.net/publication/229455808_REVIEW_OF_THE_BASIC_COMPONENTS_OF_CLINICAL_PHARMACEUTICAL_CARE_IN_PAKISTAN

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Gallery of Pictures with Moral Lessons

April 8, 2020 by PharmaReviews | 0 comments

 


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March 29, 2020
by PharmaReviews
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Information for Clinicians on Therapeutic Options for COVID-19 Patients

There are no US Food and Drug Administration (FDA)-approved drugs specifically for the treatment of patients with COVID-19.  At present clinical management includes infection prevention and control measures and supportive care, including supplementary oxygen and mechanical ventilatory support when indicated.  An array of drugs approved for other indications as well as several investigational drugs are being studied in several hundred clinical trials that are underway across the globe. The purpose of this document is to provide information on two of the approved drugs (chloroquine and hydroxychloroquine) and one of the investigational agents (remdesivir) currently in use in the United States.

Remdesivir

Remdesivir is an investigational intravenous drug with broad antiviral activity that inhibits viral replication through premature termination of RNA transcription and has in-vitro activity against SARS-CoV-2 and in-vitro and in-vivo activity against related betacoronaviruses [1-3].

There are currently four options for obtaining remdesivir for treatment of hospitalized patients with COVID-19 and pneumonia in the United States:

  • A National Institutes of Health (NIH)-sponsored adaptive double-blinded, placebo-controlled trial of remdesivir versus placebo in COVID-19 patients with pneumonia and hypoxia is enrolling non-pregnant persons aged 18 years and older with oxygen saturation of ≤94% on room air or requiring supplemental oxygen or mechanical ventilation (https://clinicaltrials.gov/ct2/show/NCT04280705external icon). Exclusion criteria include alanine aminotransaminase or aspartate aminotransaminase levels >5 times the upper limit of normal, stage 4 severe chronic kidney disease or a requirement for dialysis (i.e., estimated glomerular filtration rate (eGFR) <30);
  • Two phase 3 randomized open-label trials of remdesivir (5-days versus 10-days versus standard of care) are open to enrollment in persons aged 18 years and older with COVID-19, radiographic evidence of pneumonia and oxygen saturation of ≤94% on room air (severe disease https://clinicaltrials.gov/ct2/show/NCT04292899external icon) or >94% on room air (moderate disease https://clinicaltrials.gov/ct2/show/NCT04292730external icon). Exclusion criteria include alanine aminotransaminase or aspartate aminotransaminase levels >5 times the upper limit of normal, participation in another clinical trial of an experimental treatment for COVID-19, requirement for mechanical ventilation, or creatinine clearance <50 mL/min; and
  • Finally, in areas without clinical trials, COVID-19 patients in the United States and other countries have been treated with remdesivir on an uncontrolled compassionate use basis. The manufacturer is currently transitioning the provision of emergency access to remdesivir from individual compassionate use requests to an expanded access program.  The expanded access program for the United States is under rapid development. Further information is available at: https://rdvcu.gilead.com/external icon

Hydroxychloroquine and Chloroquine

Hydroxychloroquine and chloroquine are oral prescription drugs that have been used for treatment of malaria and certain inflammatory conditions. Chloroquine has been used for malaria treatment and chemoprophylaxis, and hydroxychloroquine is used for treatment of rheumatoid arthritis, systemic lupus erythematosus and porphyria cutanea tarda. Both drugs have in-vitro activity against SARS-CoV, SARS-CoV-2, and other coronaviruses, with hydroxychloroquine having relatively higher potency against SARS-CoV-2 [1,4,5]. A study in China reported that chloroquine treatment of COVID-19 patients had clinical and virologic benefit versus a comparison group, and chloroquine was added as a recommended antiviral for treatment of COVID-19 in China [6]. Based upon limited in-vitro and anecdotal data, chloroquine or hydroxychloroquine are currently recommended for treatment of hospitalized COVID-19 patients in several countries. Both chloroquine and hydroxychloroquine have known safety profiles with the main concerns being cardiotoxicity (prolonged QT syndrome) with prolonged use in patients with hepatic or renal dysfunction and immunosuppression but have been reportedly well-tolerated in COVID-19 patients.

Due to higher in-vitro activity against SARS-CoV-2 and its wider availability in the United States compared with chloroquine, hydroxychloroquine has been administered to hospitalized COVID-19 patients on an uncontrolled basis in multiple countries, including in the United States. One small study reported that hydroxychloroquine alone or in combination with azithromycin reduced detection of SARS-CoV-2 RNA in upper respiratory tract specimens compared with a non-randomized control group but did not assess clinical benefit [7]. Hydroxychloroquine and azithromycin are associated with QT prolongation and caution is advised when considering these drugs in patients with chronic medical conditions (e.g. renal failure, hepatic disease) or who are receiving medications that might interact to cause arrythmias.

Hydroxychloroquine is currently under investigation in clinical trials for pre-exposure or post-exposure prophylaxis of SARS-CoV-2 infection, and treatment of patients with mild, moderate, and severe COVID-19. In the United States, several clinical trials of hydroxychloroquine for prophylaxis or treatment of SARS-CoV-2 infection are planned or will be enrolling soon.  More information on trials can be found at:  https://clinicaltrials.gov/external icon.

There are no currently available data from Randomized Clinical Trials (RCTs) to inform clinical guidance on the use, dosing, or duration of hydroxychloroquine for prophylaxis or treatment of SARS-CoV-2 infection.  Although optimal dosing and duration of hydroxychloroquine for treatment of COVID-19 are unknown, some U.S. clinicians have reported anecdotally different hydroxychloroquine dosing such as: 400mg BID on day one, then daily for 5 days; 400 mg BID on day one, then 200mg BID for 4 days; 600 mg BID on day one, then 400mg daily on days 2-5.

Other Drugs

Lopinavir-ritonavir did not show promise for treatment of hospitalized COVID-19 patients with pneumonia in a recent clinical trial in China [8].  This trial was underpowered, and lopinavir-ritonavir is under investigation in a World Health Organization study.

Several other drugs are under investigation in clinical trials or are being considered for clinical trials of prophylaxis or treatment of COVID-19 in the United States and worldwide. Information on registered clinical trials for COVID-19 in the United States is available at: https://clinicaltrials.gov/external icon.

References

  1. Wang M, Cao R, Zhang L, Yang X, Liu J, Xu M, Shi Z, Hu Z, Zhong W, Xiao G. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res. 2020 Mar;30(3):269-271.
  2. Sheahan TP, Sims AC, Leist SR, Schäfer A, Won J, Brown AJ, Montgomery SA, Hogg A, Babusis D, Clarke MO, Spahn JE, Bauer L, Sellers S, Porter D, Feng JY, Cihlar T, Jordan R, Denison MR, Baric RS. Comparative therapeutic efficacy of remdesivir and combination lopinavir, ritonavir, and interferon beta against MERS-CoV. Nat Commun. 2020 Jan 10;11(1):222.
  3. Sheahan TP, Sims AC, Graham RL, Menachery VD, Gralinski LE, Case JB, Leist SR, Pyrc K, Feng JY, Trantcheva I, Bannister R, Park Y, Babusis D, Clarke MO, Mackman RL, Spahn JE, Palmiotti CA, Siegel D, Ray AS, Cihlar T, Jordan R, Denison MR, Baric RS. Broad-spectrum antiviral GS-5734 inhibits both epidemic and zoonotic coronaviruses. Sci Transl Med. 2017 Jun 28;9(396).
  4. Colson P, Rolain JM, Lagier JC, Brouqui P, Raoult D. Chloroquine and hydroxychloroquine as available weapons to fight COVID-19. Int J Antimicrob Agents. 2020 Mar 4:105932. doi: 10.1016/j.ijantimicag.2020.105932. [Epub ahead of print]
  5. Yao X, Ye F, Zhang M, Cui C, Huang B, Niu P, Liu X, Zhao L, Dong E, Song C, Zhan S, Lu R, Li H, Tan W, Liu D. In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Clin Infect Dis. 2020 Mar 9. pii: ciaa237. doi: 10.1093/cid/ciaa237. [Epub ahead of print]
  6. Gao J, Tian Z, Yang X. Breakthrough: Chloroquine phosphate has shown apparent efficacy in treatment of COVID-19 associated pneumonia in clinical studies. Biosci Trends. 2020 Mar 16;14(1):72-73
  7. Gautret P, Lagier J, Parola P, Hoang V, Meddeb L, Mailhe M, et al. Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. International Journal of Antimicrobial Agents. In Press.
  8. Cao B, Wang Y, Wen D, Liu W, Wang J, Fan G, Ruan L, Song B, Cai Y, Wei M, Li X, Xia J, Chen N, Xiang J, Yu T, Bai T, Xie X, Zhang L, Li C, Yuan Y, Chen H, Li H, Huang H, Tu S, Gong F, Liu Y, Wei Y, Dong C, Zhou F, Gu X, Xu J, Liu Z, Zhang Y, Li H, Shang L, Wang K, Li K, Zhou X, Dong X, Qu Z, Lu S, Hu X, Ruan S, Luo S, Wu J, Peng L, Cheng F, Pan L, Zou J, Jia C, Wang J, Liu X, Wang S, Wu X, Ge Q, He J, Zhan H, Qiu F, Guo L, Huang C, Jaki T, Hayden FG, Horby PW, Zhang D, Wang C. A Trial of Lopinavir-Ritonavir in Adults Hospitalized with Severe Covid-19. N Engl J Med. 2020 Mar 18. doi: 10.1056/NEJMoa2001282. [Epub ahead of print]

Source: https://www.cdc.gov/coronavirus/2019-ncov/hcp/therapeutic-options.html

Noval Corona Viral Disease – 19 (nCOVID-19)

March 29, 2020 by PharmaReviews | 0 comments


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March 21, 2020
by PharmaReviews
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Public Health Resources Regarding CoViD-19

Public health resources available to obtian the most current and authentic information about COVID-19

More resources for clinicians

Novel Coronavirus Information Center

Elsevier’s free health and medical research on novel coronavirus (COVID-19)

For Clinicians
Under the Clinical information tab, you will find evidence-based skill guides and care plans for treatment, safety and patient education, along with emergency prepared webinars by the CDC.

For Patients
In the Patient resources section, you can find our 3D4Medical coronavirus video, resources from the CDC and WHO, and information about Elsevier’s Patient Access Program for research.

Articles in Elsevier journals

A selection of articles curated by our Clinical Solutions team

Below are a selection of articles curated by our Clinical Solutions team and directly relevant to Novel Coronavirus (COVID-19).

In addition, Elsevier has made nearly 20,000 coronavirus-related articles freely available for six months, commencing in February 2020. You can find those articles here.

We are updating this section continually, with newly created categories to make this section easier to browse.

Virology

More published research

Research in JAMA, BMJ, NEJM and more

Book chapters

Early-stage research

Preprints on SSRN

Emerging and rapidly evolving healthcare emergencies necessitate the quick dissemination of research. The growing role of preprints, or early-stage research, was acknowledged in the Ebola and Zika virus outbreaks as a way of “accelerating the dissemination of scientific findings to support responses to infectious disease outbreaks.

SSRN, Elsevier’s world-leading platform devoted to the rapid worldwide dissemination of early-stage research, is committed to making authors’ coronavirus related research available immediately. Research on SSRN is free to download and upload. It is important to note that these papers have not benefited from the pivotal role of the peer-review process, which validates and improves the quality of final published journal articles.