Category: Drugs in Nursing

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Healthcare delivery systems are undergoing constant change and reform due to an ever increasingly aging populace combined with the results of this aging populace: more debilitating diseases in conjunction with healthcare needs that are increasingly of greater complexity. The fact that people tend to move around a lot more often in modern times gives weight to the fact it is increasingly difficult to find healthcare workers such as live in nurses, at home visits and with personal support workers. In the mean time, how medicine as a field is being approached and practiced has also begun to shift vastly, as there are technological and pharmacological developments in conjunction with lesser time for patients being admitted into hospitals, where they are discharged a lot faster than they previously were before in order to do tests that were previously done while the patient was still hospitalized, now are being done on separate times, requiring the patient to commute back to the hospital for these assessments. Patients are also being increasingly pressed by healthcare providers to follow healthcare regimens at home, to execute them and evaluate themselves, without the assistance of a healthcare delivery professional.

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US Food and Drug Administration Guidelines for Drug Categories According to Level of Risk to Pregnancies

The US Food and Drug Administration has developed a categorization system that aims to classify drugs by their level of potential danger to fetuses inside pregnant women if these drugs are taken. However, if there is an off chance that the FDA has not provided us with guidelines in terms of ranking medication by pregnancy risk level, then the medication listed will have an indicator attached to it claiming the drug is “Unrated”. The categories used by the FDA in classifying fetal risk range from the letters A to X, with A signifying the least risk to fetal development and possibility of birth defects and X signifying the greatest risk to fetal development and the possibility of birth defects.

CATEGORY A: STUDIES UNDERTAKEN IN A CONTROLLED ENVIRONMENT INDICATE THERE IS NO RISK TO FETAL DEVELOPMENT

Scientifically thorough studies developed in accordance with high quality standards of testing and experimentation on pregnant woman have concluded that medications in this category pose no major risk to the health of baby fetuses, regardless of trimester.

CATEGORY B: EVIDENCE FAILS TO INDICATE RISK TO PREGNANCIES IN HUMAN BEINGS

Ethical, scientifically thorough experimentation on pregnant women did not produce any results that would indicate the arising of abnormalities in fetuses even though trials involving animals have proven otherwise, or where there is no data regarding studies on humans, the studies done on animals often showed no risk of adverse effects. There is a marginal and rare risk of an abnormality nonetheless.

CATEGORY C: A RISK EXISTS BUT CANNOT BE ACCURATELY DETERMINED

Ethical, scientifically thorough experimentation on human women are very scarce, and experimentation done on pregnant animals show the possibility of an abnormality arising, or the data and research is not in sufficient amounts to verify a claim objectively. There is some level of risk associated with administering the drug to a pregnant woman and a healthy fetal development, although the benefits can sufficiently outweigh the risk.

CATEGORY D: DATA REVEALS EVIDENCE INDICATING INCREASED CHANCE OF RISK

There is a chance of harmful effects to fetuses, from data collected during investigations as well as post-marketing. Despite this, there is also a great chance that the benefits of receiving the drug can outweigh the risks. Examples of when use of this drug is appropriate is when there is no effective alternative to a serious illness or a medical scenario in which the drug could save the woman’s life if she took it.

CATEGORY X: STUDIES SHOW GUARANTEE OF ABNORMALITY IN FETAL DEVELOPMENT

There is sufficient data to conclude that both during human and animal trials there eventually sprouted the risk of abnormalities, during both investigational as well as post-marketing phases of research. There is also an indication of higher risk than reward in terms of benefits.