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1.
AJP Rep ; 9(1): e88-e91, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31041117

RESUMO

Objectives This study was aimed to familiarize obstetricians with the legal environment surrounding Effexor lawsuits and emphasize the importance of documenting informed consent in the medical records when prescribing a medication that is being targeted for litigation. Study Design We used the LexisNexis legal search engine to review legal documents from Effexor-related cases and also used Google to search for Effexor-related lawsuits online, further researching these cases via publically available court records from district clerk offices. Finally, we conducted a year-by-year literature review from 1993 to 2017 to establish the history and evolution of scientific studies surrounding Effexor use during pregnancy. Results Litigation involving Effexor typically arises due to congenital cardiac birth defects in the neonate allegedly associated with maternal Effexor use in pregnancy. Medication manufacturers have employed a legal strategy termed the learned intermediary doctrine in an attempt to shift liability away from themselves and on to prescribing obstetricians. Manufacturers claim they adequately inform obstetricians of the risks and benefits of prescribing their product and it is the duty of the obstetrician to relay those risks and benefits to their patients. Conclusion To reduce the risk of liability exposure, obstetricians must adequately document informed consent in the medical records when prescribing medications to their pregnant patients.

2.
Int J Fertil Steril ; 10(2): 141-7, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27441045

RESUMO

The Society for Assisted Reproductive Technology (SART) method of embryo grad- ing is unique, simple, and widely practiced, and its use has been mandatory for SART membership programs since 2010. Developed by SART in 2006, the current embryo grading system categories, "good, fair, and poor," are limited because they do not describe the best 1-2 embryos in the interest of keeping pace with the shift in clinical practice to be more selective and to transfer fewer embryos. This inspired us to conduct a review on the SART embryo grading system. In this retrospective study, the literature on evaluation of human embryo quality in gen- eral, and the SART method of evaluation in particular, were reviewed for the period of 2000 to 2014. A multifaceted search pertaining to methods of embryo grading and trans- fer using a combination of relevant terms [embryo, mammalian, embryo transfer, grade, grading, morphology, biomarkers, SART, and in vitro fertilization (IVF)] was performed. The inclusion and exclusion in this review were dictated by the aim and scope of the study. Two investigators independently assessed the studies and extracted information. A total of 61 articles were reviewed. Very few studies have evaluated the efficacy of the SART embryo grading method. The present study suggests the necessity for revision of the current SART grading system. The system, as it is now, lacks criteria for describing the cohort specific best embryo and thus is of limited use in single embryo transfer. The study foresees heightened descriptive efficiency of the SART system by implementing the proposed changes. Strengths and weaknesses of the SART embryo grading were identified. Ideas for selecting the best cohort-specific embryo have been discussed, which may trigger methodological improvement in SART and other embryo grading systems.

4.
Fertil Steril ; 98(5): 1277-82, 2012 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-22901852

RESUMO

OBJECTIVE: To study legal cases against IVF facilities pertaining to preimplantation genetic diagnosis (PGD) misdiagnosis. DESIGN: Systematic case law review. SETTING: University medical center using US legal databases. PATIENT(S): The IVF recipients using PGD services. INTERVENTION(S): Lawsuits pertaining to PGD against IVF facilities. MAIN OUTCOME MEASURE(S): Lawsuits, court rulings, damage awards, and settlements pertaining to PGD after the birth of a child with a genetic defect. RESULT(S): Causes of action pertaining to PGD arise from negligence in performing the procedure as well as failure to properly inform patients of key information, such as inherent errors associated with the PGD process, a facility's minimal experience in performing PGD, and the option of obtaining PGD. Courts have sympathized with the financial burden involved in caring for children with disabilities. Monetary damage awards are based on the costs of caring for children with debilitating defects, including lifetime medical and custodial care. CONCLUSION(S): Facilities offering PGD services expose themselves to a new realm of liability in which damage awards can easily exceed the limits of a facility's insurance policy. Competent laboratory personnel and proper informed consent--with particular care to inform patients of the inherent inaccuracies of PGD--are crucial in helping deter liability.


Assuntos
Erros de Diagnóstico/legislação & jurisprudência , Fertilização In Vitro/legislação & jurisprudência , Doenças Genéticas Inatas/diagnóstico , Testes Genéticos/legislação & jurisprudência , Seguro de Responsabilidade Civil/legislação & jurisprudência , Responsabilidade Legal , Imperícia/legislação & jurisprudência , Diagnóstico Pré-Implantação/métodos , Compensação e Reparação/legislação & jurisprudência , Erros de Diagnóstico/economia , Feminino , Fertilização In Vitro/efeitos adversos , Fertilização In Vitro/economia , Doenças Genéticas Inatas/economia , Doenças Genéticas Inatas/etiologia , Doenças Genéticas Inatas/genética , Doenças Genéticas Inatas/terapia , Testes Genéticos/economia , Custos de Cuidados de Saúde/legislação & jurisprudência , Humanos , Consentimento Livre e Esclarecido/legislação & jurisprudência , Seguro de Responsabilidade Civil/economia , Responsabilidade Legal/economia , Imperícia/economia , Valor Preditivo dos Testes , Gravidez , Diagnóstico Pré-Implantação/economia , Direito de não Nascer
5.
J Assist Reprod Genet ; 28(11): 1105-9, 2011 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-21912979

RESUMO

PURPOSE: Review of the legal and ethical basis for reproductive endocrinologists to refuse ovulation induction to patients with diminished ovarian reserve. METHODS: The Lexis-Nexis search engine was used to perform a legal review pertaining to refusal of treatment. Ethical opinions of medical organizations were also reviewed. RESULTS: Federal antidiscrimination laws provide legal recourse for patients with diminished ovarian reserve who are denied ovulation induction. However, the same laws also permit refusal of care when there is bona fide medical justification to decline services. In addition, the codes of ethics for relevant professional organizations support physicians' decisions to refuse treatment when treatment is futile. CONCLUSION: Although it is ethically and legally permissible to deny ovulation induction to patients with diminished ovarian reserve when medically justified, refusal may invite retaliatory litigation. Counseling remains a cornerstone in directing these patients to options with more potential for success, such as donor eggs and adoption.


Assuntos
Endocrinologia , Indução da Ovulação/ética , Direitos Sexuais e Reprodutivos/ética , Direitos Sexuais e Reprodutivos/legislação & jurisprudência , Adoção/legislação & jurisprudência , Endocrinologia/ética , Endocrinologia/legislação & jurisprudência , Análise Ética , Feminino , Humanos , Doadores de Tecidos/legislação & jurisprudência , Recursos Humanos
6.
Semin Reprod Med ; 28(4): 303-14, 2010 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-20683794

RESUMO

The field of fertility is rapidly evolving, bringing opportunities for improvement in our patients' quality of life as well as bringing new ethical dilemmas. As medical science continues to advance, significant numbers of the reproductive-aged population are living with chronic and/or terminal conditions but have reasonable odds of lengthy survival and wish to have children. Likewise, there are adolescents diagnosed with cancer who are increasingly expected to achieve an improved, if not normal, life expectancy after treatment. Oftentimes these children are told they must sacrifice their ability to later have genetically related offspring; however, technologies to preserve fertility are changing this prognosis. Patients with chronic infection are living longer, more normal lives and are increasingly seeking reproductive assistance. Moreover, there is an increasing number of patients' families desiring posthumous use of gametes, which also raises ethical and legal issues. This article discusses ethical principles of bioethics and then highlights specific ethical issues through four plausible cases that may be seen in a fertility practice providing medical care to patients with chronic illness or terminal disease. It concludes that prompt referral of patients to the reproductive endocrinologist, along with a multidisciplinary approach to care, provides increased chances of successful treatment of this group of patients.


Assuntos
Doença Crônica/terapia , Infertilidade/prevenção & controle , Infertilidade/terapia , Técnicas de Reprodução Assistida/ética , Doente Terminal , Adolescente , Criança , Feminino , Humanos , Infertilidade/etiologia , Masculino , Gravidez , Técnicas de Reprodução Assistida/estatística & dados numéricos , Fatores de Risco , Assistência Terminal/ética , Assistência Terminal/métodos
7.
Adv Urol ; 2010: 136898, 2010.
Artigo em Inglês | MEDLINE | ID: mdl-21234335

RESUMO

Human sperm assay (HSA) is a preferred in house quality control and proficiency test (PT) practiced in fertility laboratories. HSA is performed over varying durations, apparently without following set criteria. To better understand the assay time required for reprotoxicity testing in embryo culture media, we compared American-Association-of-Bioanalysts-(AAB-) administered HSA data to our own assay performed using PT samples obtained from AAB. Participating laboratories were required to culture sperm for 48 hours to determine media acceptability. Conclusions drawn from 48- and 24-hour observations were the same, suggesting that HSA could identify reprotoxic media in less time than required by AAB. Our assay revealed that changes in motility grade in adulterated media are significantly different from those in control media. Furthermore, grade changes can be identified earlier than differences in motility loss between samples. Analyzing motility and motility quality together provides a method for establishing an optimal time for HSA.

8.
J Assist Reprod Genet ; 27(2-3): 83-6, 2010 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-20012683

RESUMO

PURPOSE: To investigate the prevalence of spontaneously developed tail swellings (SDTS) in human sperm samples that are commonly encountered in the laboratory, and their influence on the hypo-osmotic swelling test (HOS-test). METHODS: Ejaculated, epididymal, and testicular sperm were evaluated for SDTS. Further, HOS-test scores were compared with those of vital stains using column washed sperm maintained in the laboratory. RESULTS: SDTS, at <10%, was present in all types of sperm samples. The highest and lowest occurrences of SDTS were found in cryopreserved sperm, and column-washed sperm respectively. SDTS can inflate the HOS-test score, and so lower the accuracy of the HOS-test. However, the HOS-test efficiency can be improved by assessing SDTS in the sample. CONCLUSION: HOS-test and vital stain cannot be used interchangeably in all circumstances for sperm viability determination. The accuracy of the HOS-test can be enhanced by incorporating SDTS as a correction factor.


Assuntos
Análise do Sêmen/métodos , Cauda do Espermatozoide/ultraestrutura , Adulto , Permeabilidade da Membrana Celular/efeitos dos fármacos , Sobrevivência Celular/efeitos dos fármacos , Criopreservação , Humanos , Soluções Hipotônicas/farmacologia , Masculino , Pressão Osmótica , Preservação do Sêmen , Motilidade Espermática/efeitos dos fármacos , Recuperação Espermática , Espermatozoides/efeitos dos fármacos , Espermatozoides/fisiologia
9.
Fertil Steril ; 89(1): 237-9, 2008 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-17482167

RESUMO

Spermatozoa were cultured in vitro to monitor time-dependent changes in motility, viability, morphology, and membrane integrity. The degree of preservation of these clinically relevant sperm parameters over time was satisfactory. Extended culture probably can be used as a transient storage for sperm to compensate for a male's inability to produce sperm to synchronize oocyte retrieval in assisted reproduction.


Assuntos
Técnicas de Cultura de Células , Técnicas de Reprodução Assistida , Preservação do Sêmen/métodos , Espermatozoides/fisiologia , Membrana Celular/fisiologia , Forma Celular , Sobrevivência Celular , Células Cultivadas , Feminino , Humanos , Masculino , Motilidade Espermática , Fatores de Tempo
10.
Pak J Pharm Sci ; 20(4): 327-32, 2007 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-17604258

RESUMO

The samples of secondary packaging items (cartons, labels and package inserts) of 45 essential drug products used at Union health and family welfare center and Thana health complex level, that included 23 solid (tablet and capsule), 34 liquid (syrup, suspension, and injectables) and 4 semisolid (ointment and cream) preparations either manufactured in Bangladesh or imported by local distributing agencies, were thoroughly examined from April 30, 2005 to March 31, 2006 on the basis of 32 parameters which are usually regarded important for the labeling of any pharmaceutical preparation including essential drug products. Many of the products were available simultaneously as solid, liquid and topical (total 74 different) dosage forms and all dosage forms have been considered in this study. The secondary packaging items of a total of 58 pharmaceutical companies for 45 generics of essential drug products have been collected, sorted/arranged and meticulously studied, and packaging parameters were accumulated for analysis. It has been observed that many of the important packaging information were either completely missing or not properly described. This study was aimed at examining the extent of the packaging information provided in the secondary packaging items.


Assuntos
Rotulagem de Medicamentos/normas , Embalagem de Medicamentos/normas , Preparações Farmacêuticas , Bangladesh , Centros Comunitários de Saúde , Indústria Farmacêutica/normas , Serviços de Informação sobre Medicamentos , Humanos , Legislação de Medicamentos , Controle de Qualidade
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