scholarly journals A Brief History of Biomedical Products Regulation

2021 ◽  
pp. 3-7
Author(s):  
Eric D. Perakslis ◽  
Martin Stanley
Keyword(s):  
Side Effects ◽  
Medical Devices ◽  
Digital Health ◽  
Regulatory Policy ◽  
Product Regulation ◽  
Regulatory Statute ◽  
History Of ◽  
Catch Up

The history of biomedical product regulation is a history of hard-won progress. Often, only after tragedy, has regulatory statute caught up to drugs with horrid side effects or medical devices that offer no benefit but may do harm. Harmful or questionable products slip through cracks in regulatory statutes and are brought to market quickly and prolifically, while regulators play catch up and must demonstrate harms before being enabled to police or regulate them. A notable present-day example is e-cigarettes, a multi-billion-dollar industry with clearly questionable marketing practices, which arrived and grew quickly without any form of premarket regulatory obligation. Similarly, digital health tools are proliferating, and most are yet to be subject to premarket regulation. This chapter provides a brief history of biomedical-products regulation with a focus on benefit-risk determination and its impacts on regulatory policy.

scholarly journals Introducing the 10 Toxicities

2021 ◽  
pp. 87-88
Author(s):  
Eric D. Perakslis ◽  
Martin Stanley
Keyword(s):  
Side Effects ◽  
Elective Surgery ◽  
Digital Health ◽  
The Internet ◽  
Negative Effects ◽  
Credit Score ◽  
Cardiovascular Side Effects ◽  
Benefit Risk Assessment ◽  
Medical Benefits ◽  
History Of

The history of medical benefit-risk assessment shows that medical benefits tend to be far easier to demonstrate and quantify. The risks, on the other hand, tend to appear in other bodily systems than those studied for benefits—a classical example being an arthritis medicine that causes cardiovascular side effects. This principle is highly relevant for digital health and requires detailed and thoughtful study. When is a side effect of elective surgery a reduction in the credit score of the patient due to data theft? How do we quantify the negative effects of the Internet on hypochondria (cyberchondria)? Quantifying accidental and inadvertent threats can be difficult; but in examining the possible side effects of digital health, one unique characteristic is the presence of a human adversary, which truly changes the paradigm.

Probiotics in gastroenterology – from a different angle

2013 ◽  
Vol 154 (8) ◽  
pp. 294-304 ◽  
Author(s):  
György Miklós Buzás
Keyword(s):  
Side Effects ◽  
Beneficial Effect ◽  
Analytical Data ◽  
Well Being ◽  
Gastrointestinal Diseases ◽  
Convincing Evidence ◽  
Probiotic Treatment ◽  
History Of ◽  
Irritable Bowel

After a short overview of the history of probiotics, the author presents the development of human intestinal microflora based on the newest genetic data and the microbiological features of main probiotics. The indications of probiotic administration have been defined and extended in recent years. The author reviews significant results of probiotic treatment in some gastrointestinal diseases based on meta-analytical data. Probiotics are useful in preventing and treating diarrhoea caused by antibiotics and Clostridium difficile caused diarrhoea. In the treatment of Helicobacter pylori infection, preparations containing certain Lactobacillus,Bifidobacterium strains or Saccaromyces boulardii could enhance by 5–10% the rate of successful eradication and reduce the incidence and severity of the side effects. Some symptoms of irritable bowel syndrome and thus the quality of life can be improved by probiotics. Their beneficial effect in ulcerative colitis was proven, while in Crohn’s disease has not yet been defined. The use of probiotics is not included in guidelines, with the exception of the Maastricht IV/Florence consensus. For each disease it is advisable to use probiotics containing strains only with proven beneficial effect. The efficiency of preparations containing mixed strains has not yet been properly investigated. The author reviews the rare but potentially serious side effects of probiotics. In Hungary, there are many probiotic preparations available which can be purchased in pharmacies without prescription: their use is more empirical than evidence-based. The European Food Safety Authority has recently rejected claims for probiotics to be classed as medicines given the lack of convincing evidence on the effects of probiotics on human health and well-being. Clearly, further research is needed to collect evidence which could be incorporated into the international guidelines. Orv. Hetil., 2013, 154, 294–304.

Medical Liability for Off Label Use of Drugs in Romania

2018 ◽  
Vol 69 (3) ◽  
pp. 755-757
Author(s):  
Ionut Vida Simiti
Keyword(s):  
Side Effects ◽  
Medical Devices ◽  
Medical Liability ◽  
Criminal Offence ◽  
Off Label Use ◽  
National Agency ◽  
Off Label ◽  
Scientific Support ◽  
The Common ◽  
Label Use

Breaking the limits of the risks for the human body, health or even the life of the patient, as assumed by the pharmaceutical producers, by using a drug off label, for its side effects, in another purpose or even against the purpose for which the drug was authorized by the National Agency of Medicine and Medical Devices, is not in itself illegal if the off label use has the common consent of both the doctor and the patient for a treatment and only for a treatment which, although a spread procedure, has little or no scientific support. But if the patient is subjected to unreasonable risks, endangering his body, health or life beyond the possible benefits of the treatment, without being informed about the lack of scientific support, the doctor is liable not only for malpractice (civil medical liability) but also for a criminal offence.

Adenoid cystic carcinoma of the labium oris with rare metastasis to the pleural cavity

2021 ◽  
Vol 14 (1) ◽  
pp. e237622
Author(s):  
Osama Mosalem ◽  
Anas Alsara ◽  
Fawzi Abu Rous ◽  
Borys Hrinczenko
Keyword(s):  
Side Effects ◽  
Adenoid Cystic Carcinoma ◽  
Pleural Cavity ◽  
Epigastric Pain ◽  
Asian Woman ◽  
Upper Lip ◽  
Adenoid Cystic ◽  
History Of ◽  
The Right

A 57-year-old Southeast Asian woman with a remote history of adenoid cystic carcinoma (ACC) of the right labium superius oris (upper lip) presented to the hospital with vague epigastric pain. On workup, she was found to have multiple pleural nodules. Histopathology confirmed the diagnosis of metastatic ACC. After 8 months of active surveillance, evidence of disease progression was found and the patient was started on pembrolizumab. Follow-up after starting pembrolizumab showed stable disease with no significant side effects.

scholarly journals Lung adenocarcinoma concomitant with xeroderma pigmentosum: a case report

2021 ◽  
Vol 15 (1) ◽  
Author(s):  
Masataka Matsumoto ◽  
Kazumi Kaneshiro ◽  
Kiyonobu Takatsuki
Keyword(s):  
Epidermal Growth Factor Receptor ◽  
Growth Factor ◽  
Side Effects ◽  
Epidermal Growth Factor ◽  
Lung Adenocarcinoma ◽  
Xeroderma Pigmentosum ◽  
Growth Factor Receptor ◽  
Consanguineous Marriage ◽  
History Of ◽  
Epidermal Growth

Abstract Background Xeroderma pigmentosum is a rare, autosomal-recessive photosensitive dermatosis. Patients with xeroderma pigmentosum have an impaired ability to repair deoxyribonucleic acid damage caused by ultraviolet rays, resulting in skin cancer. Patients with xeroderma pigmentosum are more susceptible to some cancers. We herein report a case of xeroderma pigmentosum accompanied by lung cancer. Case presentation The patient was a Japanese woman in her 70s with a family history of consanguineous marriage. Her medical history included squamous cell carcinoma and basal cell carcinoma, in addition to xeroderma pigmentosum. She presented with dry skin with small, pigmented spots, which were particularly focused around the areas exposed to sunlight. Chest computed tomography was conducted to assess for any evidence of metastatic skin carcinoma, and revealed a tumor in the left upper subpleural lobe of the lung. Consequently, she was referred to our department. Finally, we diagnosed lung adenocarcinoma (pT2aN0M1b: stage IVA). She had an epidermal growth factor receptor (EGFR) mutation (p.L858R). Treatment with an epidermal growth factor receptor tyrosine kinase inhibitor (gefitinib) was initiated, and the tumor gradually regressed. No side effects were observed. However, she later died from aspiration pneumonia. Conclusions Although xeroderma pigmentosum is rare, a history of consanguineous marriage should be verified. Because of the severe side effects of cisplatin and radiotherapy in xeroderma pigmentosum patients, the risks and benefits of treatment should be considered thoroughly.

Dermal Discoloration Secondary to Triamcinolone Acetonide Injection Observed in Patients with Autoimmune Disorders

2021 ◽  
Vol 111 (4) ◽  
Author(s):  
James A. Wright ◽  
Jessica A. Wenz ◽  
Gabrielle Jackson Madrigal
Keyword(s):  
Psoriatic Arthritis ◽  
Side Effects ◽  
Autoimmune Disease ◽  
Triamcinolone Acetonide ◽  
Current Literature ◽  
Side Effect ◽  
Inflammatory Conditions ◽  
Rare Side Effect ◽  
History Of ◽  
Synthetic Glucocorticoid

Triamcinolone acetonide is a synthetic glucocorticoid used to treat numerous acute and chronic inflammatory conditions. The various side effects of this drug from parenteral administration are well documented in the literature. In this study, three patients present with a rare side effect of violaceous dermal pigmentation. To the best of the authors' knowledge, this finding is rarely presented in the current literature. The purpose of this study is to provide awareness of a less-documented, delayed side effect from triamcinolone acetonide administration. Although all patients presenting in this study had a known history of autoimmune disease (eg, lupus, psoriatic arthritis) further research is needed to suggest a possible association between dermal violaceous change and the use of triamcinolone.

scholarly journals Complications after Intrathecal Drug Delivery Due to the Underlying Malignancy in Two Patients with Intractable Cancer Pain

2013 ◽  
Vol 2;16 (2;3) ◽  
pp. E107-E111
Author(s):  
Thomas Chai
Keyword(s):  
Drug Delivery ◽  
Side Effects ◽  
Cancer Pain ◽  
Systemic Absorption ◽  
Pain Patient ◽  
Drug Side Effects ◽  
Intrathecal Drug Delivery ◽  
Underlying Malignancy ◽  
History Of ◽  
Intractable Cancer Pain

Intrathecal drug delivery is a mode of analgesic delivery that can be considered in those experiencing both refractory pain and excessive side effects from opioid and adjuvant analgesic use. Delivery of analgesic agents directly to the cerebral spinal fluid allows binding of the drug to receptors at the spinal level. Therefore, a reduced analgesic dosage can be afforded, resulting in reduction of drug side effects due to decreased systemic absorption. Drug delivery into the intrathecal space provides this benefit, yet it does not eliminate the possibility of drug side effects or risks of complications. Complications from this route of administration may be seen in the perioperative period or beyond, including infection, inflammatory mass, bleeding, and catheter or pump dysfunction, among others. This may manifest as new/worsening pain or as a neurologic deficit, such as a sensorimotor change and bladder/bowel dysfunction. Urgent evaluation with a detailed physical examination, device interrogation, and other workup including imaging is called for if symptoms suspicious for device-related problems arise. For the cancer pain patient, the underlying malignancy should also be considered as a potential cause for these new symptoms after intrathecal system implantation. We present 2 such cases of complications in the cancer pain patient after intrathecal drug delivery due to progression of the underlying malignant process rather than to surgical or device-related problems. The first patient had a history of metastatic osteosarcoma who, shortly after undergoing an intrathecal drug delivery trial with external pump, presented with new symptoms of both pain and neurologic changes. The second patient with a history of chondrosarcoma developed new symptoms of pain and sensorimotor change several days after intrathecal drug delivery system implantation. Key words: Intrathecal analgesia, intrathecal drug delivery, perioperative complications, cancer pain, malignant pain, pain pump

scholarly journals Utilization of modern contraceptives and associated factors among street women in Dire Dawa, Eastern Ethiopia: a mixed study

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Alemu Guta ◽  
Bezhabh Amsalu ◽  
Tadesse Weldamanuel ◽  
Alekaw Sema ◽  
Legesse Abera ◽  
...  
Keyword(s):  
Side Effects ◽  
Health Facility ◽  
Health Professionals ◽  
Associated Factors ◽  
Qualitative Data ◽  
Sexual Partners ◽  
Modern Contraceptive ◽  
Eastern Ethiopia ◽  
Modern Contraceptives ◽  
History Of

Abstract Introduction Unwanted pregnancy and sexually transmitted diseases are the major problems in street women because of the non-utilization of modern contraceptives. To the best of our knowledge, no studies have assessed the utilization of modern contraceptives and associated factors among street women in the study area. Therefore, this study aimed to determine the utilization of modern contraceptives and its associated factors among street women. Methods A community-based cross-sectional study using mixed methods was conducted from February 16th to April 10, 2021, among all censuses and 615 reproductive-aged street women. Face-to-face and in-depth interviews were employed to generate quantitative and qualitative data, respectively. Binary logistic regression was used to analyze the association between modern contraceptive utilization and independent variables with statistical significance set at p < 0.05. Qualitative data were analyzed using a thematic approach. Results Approximately half 279 (50.3%) (95% CI: 46.3%, 54.4%) street women currently used modern contraceptives. Factors significantly associated were women aged 25–34 years [AOR = 5.5, 95% CI: 1.2–24], distance from a nearby health facility within 30 min [AOR = 9.2, 95% CI: 1.6–51], getting advice from health professionals [AOR = 14.3; 95% CI = 5.3–38.4], discussed with their sexual partners about the utilization of modern contraceptives [AOR = 6.2, 95% CI: 2.4–16.5], a history of pregnancy [AOR = 2.7, 95% CI: 1.2–6], the desire to have a child after two years [AOR = 2.2, 95% CI: 1.1–4.7], and women who faced rape in street life [AOR = 5.4; 95% CI = 1.9–15.3]. Fear of side effects, misperceptions, and the desire to have a child are the main identified themes for the key barriers to using modern contraceptives. Conclusion The proportion of street women currently using modern contraceptives was low. Age, distance from the health facility, discussion with health professionals, discussion with sexual partners, history of pregnancy, desire time to have a child in the future, and history of rape were factors significantly associated with the use of modern contraceptives. Most of the participants’ reasons for the lack of use of modern contraceptives were fear of its side effects.

scholarly journals University of Nebraska-Lincoln Fundamentals of Geoscience in the Field and Methods in Geoscience Field Instruction

2012 ◽  
Vol 35 ◽  
pp. 168-169
Author(s):  
David Harwood ◽  
Kyle Thompson
Keyword(s):  
Undergraduate Teaching ◽  
Education Majors ◽  
Geoscience Education ◽  
Field Instruction ◽  
History Of ◽  
Catch Up ◽  
Teton Range ◽  
University Of Nebraska Lincoln ◽  
K 12 ◽  
The University

This field course offers in-service teachers and pre-service science education majors an opportunity to discover the geological history of the Rocky Mountains and experience inquiry-based geoscience education during a 2-week journey across Wyoming, South Dakota and Nebraska. In 2012 this course utilized the UW-NPS facilities for 3 days in mid-June. The group built upon their growing geological knowledge to investigate the geological evolution of the Teton Range. The 2012 course included six in-service teacher participants (all from Nebraska), two pre-service graduate education majors, and one Geoscience Education Research professor who observed the process. The staff included two instructors and one geology undergraduate teaching assistant. This course is offered through the University of Nebraska-Lincoln’s Nebraska Math and Science Summer Institute (NMSSI) Program. This course improves educators' ability to teach inquiry-based science, gain knowledge and understanding of geoscience, and to demonstrate effective teaching methods that can integrate geoscience into K-12 learning environments. The UW-NPS facilities provide an excellent opportunity for participants to discover the natural history of the Teton Range and catch up on fieldbook notes while sitting at a real table - - a welcome change from our normal campground setting.

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