Monitoring of safety information by pharmaceutical companies is sometimes carried out only to collect case safety reports. At the same time, special patient populations are essential for tracking the use of drugs (children, elderly, pregnant, etc.). The possible effects of the drug on the fetus should also be monitored. It helps to determine the outcome of the pregnancy and the child’s development status after birth. This is a requirement of the Good pharmacovigilance practices guideline (GVP). Here we present cases from our practice of literature monitoring and identifying the use of medicines in special patient populations in pharmacovigilance.
The collection of safety data in paediatric populations and the elderly is essential. Reports of overdose, abuse, misuse, medical errors, and occupational exposure are special situations of drug use. If adverse drug reactions (ADRs) are not detected in such cases, the data should be collected and analysed in the next periodic safety update report (PSUR). Additional submission of such reports to the regulatory authority usually is not required.
Drugs during pregnancy
Reports containing information on drug-related pregnancy anomalies are classified as serious. Therefore, they should be submitted to the regulatory body by the requirements of serious ADRs.
This applies in particular to reports on:
- congenital malformations or developmental delays in the fetus or child;
- fetal death or spontaneous abortion;
- suspected adverse reactions in newborns.
Other cases, such as termination of pregnancy without information on congenital malformations, medicines in pregnant women without consequences, or reporting the expected pregnancy outcome, should not be reported. So long as there are no data about suspected adverse reactions. However, such reports should be collected and analysed in the upcoming PSUR.
In some cases, it may be necessary to report the use of a drug during pregnancy without indicating the ADR. Such a requirement may be a condition for the marketing authorization approval or to be included in the Risk Management Plan (RMP). This is possible for drugs contraindicated during pregnancy or for which additional monitoring is required due to teratogenicity (thalidomide, isotretinoin).
Risk of Missing Information
The use of drugs in pregnant and lactating women most often refers to the missing information in the RMP list or risks. This is the type of risk when the lack of information limits the data for predicting the risk/benefit ratio. Thus, while monitoring the literature, the MAH should monitor the use of drugs in special patient populations. Even if the author does not mention any adverse reaction/event in a pregnant or breastfeeding woman, such information should be recorded and analysed in the upcoming PSUR.
The literature search for a periodic safety report should be more extensive than just a search for ICSRs. It should also include research safety data for groups of patients and other drugs with the same active ingredient. Health professionals report only cases of ADRs or lack of efficacy in patients. Such reports are spontaneous. It is necessary to conduct continuous literature monitoring to prepare the PSUR. Including identifying cases of the use of drugs in special patient populations without developing undesirable reactions.
With the DrugCard platform, the PV specialists – our clients – found a relevant article in the journal «Reproductive Endocrinology». That was about the use of a contrasting drug in breastfeeding women. It should be noted that this journal is not present in the UA CA recommended list for the MAHs to monitor safety information. Such drug use is not contraindicated by the approved Summary and is allowed by the world’s leading radiological societies. But the data from the article should be reflected in the PSUR. The RMP of gadolinium-containing contrasting agents includes use in pregnant and lactating women to risks of missing information.
Overdose and Child Suicide
The DrugCard found a vivid example of a simultaneous overdose and misuse report in the journal «Pharmacology and Drug Toxicology». The article describes a clinical case of acute poisoning caused by an overdose of acetylsalicylic acid and other drugs taken by a girl for suicide.
The problem of drug-induced suicide among adolescents is a global concern. Easily available paracetamol and acetylsalicylic acid are often the means of achieving the goal. You may know that the popular social networks spread a variety of «Challengers» among teenagers («Tylenol challenge», «Benadryl challenge»). It can provoke children to act rashly. In Ukraine in 2021, reports of poisoning schoolchildren with paracetamol and drotaverine received extraordinary publicity in the media. This was one of the reasons for the adoption of the Law of Ukraine “On Amendments to Article 21 of the Law of Ukraine “On Medicines” on Prohibition of Sale of Medicines to Children” in 2021. The Law prohibits the sale and delivery of medicines to minors (under 14 years of age). The adoption of the Law addresses the situation of rampant drug abuse by adolescents. We hope it would possibly help to reduce the number of suicides.
Special patient populations in pharmacovigilance and special cases of drug use are valuable data for understanding the drug’s safety profile. The primary source of this type of data is publications in medical journals. Therefore, we draw your attention to the product that will simplify monitoring literary sources and help find relevant safety information. This is the DrugCard pharmacovigilance platform.
Try the free demo access!