Introduction
During almost 50 years of its existence, pharmacovigilance has evolved from the traditional supervision of adverse reactions to medicinal products to the safety of patients. Therefore, identifying, studying, and preventing side effects and negative consequences due to irrational treatment and mistakes has become even more urgent. As emphasized by the WHO, countries’ healthcare systems must have and implement well-established mechanisms and clear rules regarding the issuance of prescriptions, dosage of medicines, and sale of drugs in pharmacies (Donaldson et al., 2017). It is also necessary, experts say, for patients to receive clear instructions on the use of drugs. Medication errors cost the global economy $42 billion annually (Donaldson et al., 2017). The most likely causes of the adverse effects of pharmacotherapy are usually related either to the pharmaceutical worker, the doctor, the patient, or the drug itself, which can cause adverse reactions due to the inappropriate quality of the medicinal product. It should be noted that the improper quality of drugs is much less often the cause of adverse effects of pharmacotherapy compared to the harm of the drug, which is determined by the pharmacodynamic and pharmacokinetic properties of the drug molecule or the individual response of the body to the administration of medications.
Definition of medication errors
To date, there is no unified terminology for characterizing, studying, and analyzing the adverse effects of pharmacotherapy. According to some scientists, the general term for the negative impact of treatment is “medical error” or “medication error.” Ferner R. and Aronson J. interpret a medication error as a failure in the medication treatment process that caused or could cause damage to the patient’s health (2017). The most vulnerable to drug errors groups of people are patients who take a large number of different drugs and patients with a history of unforeseen allergies. It is believed that a medication error is any mistake made by staff in prescribing, dispensing, or administering a medication, regardless of whether it leads to undesirable consequences for the patient’s body (Donaldson et al., 2017). However, the most widely used definition in the scientific literature is the US National Coordinating Council for Error Reporting and Prevention. According to it, a medication error is any event that could have been avoided but occurred during the use of a medication under the supervision of a healthcare professional, patient, or consumer, which may lead to inappropriate use of the medicinal product or harm the patient’s health (About Medication Errors, 2017). These phenomena may be related to professional activity, drugs, procedures, and systems, including the appointment; transfer of charges from one specialist to another; instructions for use, packaging, nomenclature; the composition of the medicinal product; vacation; distribution; management; level of knowledge; monitoring and application.
Classification of medication errors
All definitions of medication error imply that it either negatively affects or could affect the patient’s health during treatment, even at the stage of dispensing medication. However, such a mistake is not always the cause of an adverse reaction, although it could be. Therefore, a medication error is a much more common phenomenon than an adverse reaction, and only a tiny number cause such reactions’ development. According to the definition of the European Medical Agency, an adverse reaction is any unwanted negative reaction that occurs when using a medicinal product (Adverse Drug Reaction, 2017). Such a reaction is a negative consequence, the cause of which, in some cases, can be a medication error. All adverse reactions can be conditionally divided into:
- Irreversible due to the body’s individual response or the drug’s pharmacological properties.
- Reactions, the occurrence of which could be prevented.
- Potential side effects.
Potentially harmful effects are adverse reactions that could have occurred due to a medication error but did not occur due to a fortunate coincidence, or the error was corrected or eliminated. Adverse reactions, the occurrence of which could be avoided, and those whose intensity or duration could be reduced, are usually the result of medication errors. Even though the problem of studying, analyzing, and preventing such errors has been raised in the scientific literature for quite a long time, there still needs to be a unanimous approach to their classification. Thus, scientists offer a contextual approach to the variety of medication errors related to the stage of treatment at which it was committed: when prescribing the drug, dispensing it, and when it is used directly (Donaldson et al., 2017). Medication errors related to lack of knowledge can refer to general, specific, or expert acquaintance. For example, penicillin can cause adverse reactions – this is public knowledge; the patient is allergic to penicillin – this is specific; co-fluimucil contains two antibiotics of the penicillin series – this is expert knowledge. Ignorance of any of these facts can lead to a mistake due to a lack of knowledge. Errors in the sequence of actions are the so-called errors due to distraction. They usually occur when performing routine activities that a person does automatically and at the same time when he is distracted.
Institutions can collect information about medication errors in various ways, for example, by reviewing and analyzing medical histories and medication prescriptions, adverse reaction reporting databases, and patient surveys. In such countries as the USA, Canada, Great Britain, France, and several others, there is a practice of voluntary, confidential reporting of medication errors by doctors and medical personnel. However, in most cases, even in these countries, the system for reporting medication errors still needs to be sufficiently developed.
Solutions
The consequences of medication errors can be severe and even fatal. However, unfortunately, they were, are, and will be in the future because it is human nature to make mistakes. Although condoning such errors is unacceptable, the optimal solution to this problem is their identification and study, detection of a systematic error, and development of measures to reduce the frequency of its occurrence and minimize adverse consequences. Based on the global experience of identifying and analyzing drug-related errors among the total number of reports on cases of drug abuse, pharmacovigilance should be a mandatory element of the joint activity of the healthcare system to study and prevent the occurrence of drug-related errors and medical errors in the context of drug-related problems.
Ethical principles
Medication errors are an essential topic for medical ethics. If the proposed solutions are implemented, several ethical consequences will inevitably arise. Often, a systematic error that does not depend on medical personnel is difficult to distinguish from medical negligence. In the event of an incorrect definition of an error, the guilty medical officer may avoid punishment. The opposite is also true: a systematic error can be mistaken for a personal one, which is unethical and does not allow to eliminate the real problem.
Conclusion
With the help of the pharmacovigilance database, it is possible to detect, identify, analyze and classify medication errors and analyze the leading causes of their occurrence. Therefore pharmacovigilance should be a mandatory participant in the joint activities of the healthcare system to study and prevent medication errors in the context of problems related to the use of the medicinal product.
References
About Medication Errors. (2017). NCC MERP. Web.
Adverse drug reaction. (2017). European Medicines Agency. Web.
Aronson, J. K., & Ferner, R. E. (2017). Unlicensed and off‐label uses of medicines: definitions and clarification of terminology. British Journal of Clinical Pharmacology, 83(12), 2615-2625. Web.
Donaldson, L. J., Kelley, E. T., Dhingra-Kumar, N., Kieny, M. P., & Sheikh, A. (2017). Medication without harm: WHO’s third global patient safety challenge. The Lancet, 389(10080), 1680-1681. Web.