Drugs undergo several tests before they are approved for use by the Food and Drug Administration (FDA). Some of the requirements during this assessment include establishing whether the warnings and risks that may arise when the drug is used are clearly indicated. However, there has been a rising concern as to whether drug manufacturing companies should strive and focus on meeting the bare minimum legal standards set by FDA or whether they should go the extra mile to ensure users’ safety.
Some of the ethical issues from the case of Wyeth v. Levine include the fact that the drug manufacturer did not explicitly warn against administering the drug using an IV push. Despite mentioning that there was a significant risk if the injection was mistakenly inserted in an artery, this risk should have been explicitly mentioned. It is an ethical issue because omission of this information might have been done intentionally to reduce the overall risk profile of the drug. Another ethical issue is that while the manufacturer complied with the FDA guidelines in labeling the drug, he did not go beyond the FDA to ensure that the product was safe enough for use by patients, thereby posing a risk to the users.
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Through introspection, I feel that proper labeling is a vital method of communicating the information regarding the medication. However, in most cases, such labels are usually not easily comprehensible for patients who may not have background knowledge in medicine, since complex terms and explanations are used. Apart from that, some of the warnings are written in small fonts, which may be easily be missed while reading product information. Therefore, it may be beneficial if pharmacists take the initiative of reading through this information and explain it to patients in a more straightforward manner.
The information in product labels is often not exhaustive. A study conducted by Alshammari et al. (2017) compared the labeling in similar drugs being sold in three countries, the United States, the United Kingdom, and Canada. Findings from the study revealed that the total contraindications and safety information varied in terms of content and volume among the three countries despite being the same drug from the same company. Such non-standardization is an indication that other countries may receive even significantly less information.
Depending on how the possible side effects are stated, a pharmaceutical company may or may not be absolved of liability associated with the drug use. If a drug has been manufactured by strict adherence to the set standards and accompanied by sufficient warnings of the risks and side effects arising from the use of the drug, there may not be a substantive basis for a lawsuit ( Karlin & Owermohle, 2019 ). It is noteworthy that it is the manufacturer’s duty to warn of any side effects expected or those which are known to occur. However, they cannot be reasonably expected to warn of unknown dangers.
Most people do not read through the information that accompanies the drug. Some possible reasons why this is the case include the fact that during an illness, most patients’ focus is likely to be inclined towards recovery, and not the potential risks associated with a drug. Apart from that, most drugs have labels containing a lot of information, some of which may be written using languages that may not be easily comprehensible for individuals without a background in medicine.
Based on the above, it is evident that drug labeling is an ethical issue that can have fatal consequences. Therefore, drug manufacturers should strive to go beyond the standards set by the FDA in ensuring the safety of drug users. On the same note, drug users should take their time to read through drug labels.
References
Alshammari, T. M., Devadasu, V. R., & Rathnam, R. P. (2017). Comparison of the safety information on drug labels in three developed countries: the USA, UK, and Canada. Saudi pharmaceutical journal , 25 (8), 1103-1107.
Karlin, S., and Owermohle, S., 2019. When Can Drugmakers Be Sued Over Failure To Warn? . [online] POLITICO. Available at: <https://www.politico.com/newsletters/prescription-pulse/2019/01/07/when-can-drugmakers-be-sued-over-failure-to-warn-470608> [Accessed 7 September 2020].
Shiyanbola, O. O., Meyer, B. A., Locke, M. R., & Wettergreen, S. (2014). Perceptions of prescription warning labels within an underserved population. Pharmacy Practice , 12 (1).
