Pharmacoepidemiology

• Target RWE will also be presenting at a pre-conference educational session surrounding new research approaches to pragmatic randomized clinical trials.
• Participants will gain insight into current and recent pragmatic trial case examples with regard to their ‎methods, implementation, operational challenges, and intended use as real world evidence.
• Characterizing the Distribution of Multiple Negative Control Outcome Risk Differences, Saturday, August 26, 2023, 11:30am-1:00pm.David Pritchard, PhD, Director, Data Management and Statistics, Target RWE.
• Target RWE is officially launching a suite of innovative analytical solutions called Syndicated Science™ Insights (SSI) at ICPE 2023.

• When colds, flus and allergies hit, many people automatically turn to over-the-counter medications to push through and treat their symptoms.
• Nearly 70% of adults in the U.S. use over-the-counter medications as a first-line response for treating cold and flu symptoms.
• We are a pharmacoepidemiologist and pharmacist team and we investigate adherence to medications and potential harms of medications associated with drug-drug interactions.
• Another study estimated that every year, 26,735 people went to the emergency room for adverse events related to over-the-counter cold and cough medications.

The dangers of mixing medications

• Pharmacists and physicians are typically knowledgeable about potential drug interactions, so it is very important for patients to ask their health care providers which over-the-counter medications are safe for them to use.
• It is important to read the package ingredients of over-the-counter medications closely to avoid duplication of doses.
• Cold medications are typically made up of multiple ingredients, including pain relievers, nasal decongestants and cough suppressants or expectorants.
• Combining these decongestants with monoaminooxidase inhibitors or tricyclic antidepressants could lead to very high blood pressure and heart rhythm problems.

Each person responds to drugs differently

• As we age, our bodies begin to lose the ability to efficiently clear drugs, which increases the risk of adverse events and unintentional overdoses.
• Some drugs can be dangerous for people who have particular health conditions.
• In addition, since these drugs are associated with increased blood pressure, patients with hypertension, hyperthyroidism or heart disease should be careful when using them, or avoid them altogether.

Alternatives for children

• The Food and Drug Administration and the Centers for Disease Control and Prevention do not recommend giving cold medications to children under age 4.
• Because of a variety of factors, young children have a higher risk of accidental overdose and adverse events that could lead to death.
• Research has shown that honey can be helpful for reducing cold and flu symptoms in children older than age 1.

Pregnancy best practices

• Acetaminophen is the doctor-recommended over-the-counter medication for management of pain and fever at any stage of pregnancy.
• Any other pain relievers or anti-inflammatory medicine such as ibuprofen, ketoprofen, naproxen and aspirin should not be taken during pregnancy without a doctor’s approval.
• For symptoms such as nasal congestion during pregnancy, a decongestant called oxymetazoline in its intranasal form is the drug of choice.

• mRNA COVID-19 vaccines do not increase the risk of spontaneous abortion when used in early pregnancy.
• CorEvitas sponsors the COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER), which follows pregnant vaccinated individuals from enrollment until the infant is 12 months of age.
• Using monthly online self-administered questionnaires, vaccination certificates, and medical records, the study has found that mRNA COVID-19 vaccines do not increase the risk of spontaneous abortion when used in early pregnancy, compared to the risk in the general population.
• "Pregistry is committed to being at the forefront of designing and executing regulatory-required pregnancy exposure registries, including the world's largest pregnancy registries on COVID-19 vaccines and treatments."

• In this interim analysis, no adverse safety signals were found among the study population, who overwhelmingly completed the primary series of two doses (96%).
• With study completion planned for December 2023, the safety of the vaccine will continue to be evaluated by study investigators.
• Analysis Group researchers designed the study protocol and collaborated with the VHA to identify near real-time safety signals among vaccinated individuals over the course of 30 months.
• Forty-six pre-specified safety events of interest were included in the vaccine safety surveillance program, including cerebrovascular non-hemorrhagic stroke, acute myocardial infarction, chilblain-like lesions, anaphylaxis, and acute kidney injury.