Mark P. Garofoli, PharmD, MBA, BCGP, CPE, CTTS
Clinical Assistant Professor & Clinical Pain Management Pharmacist
WVU Schools of Pharmacy/Medicine & WVU Medicine
West Virginia University Schools of Pharmacy/Medicine
Morgantown, West Virginia
Ahmed Hanif, PhD, BSPharm
Assistant Professor
WVU School of Pharmacy
Morgantown, West Virginia
Shafic Sraj, MD, MBA
Associate Professor
WVU School of Medicine and WVU Medicine
Morgantown, West Virginia
Summer Kuhn, MPH
Curriculum Research Associate
WVU Health Sciences Center
Morgantown, West Virginia
We are in the midst of a new wave of our “Opioid Crisis”, with an American dying of a drug overdose every 6 minutes, while a baby is born dependent on opioids every 30 minutes. Yet, with countless regulations on prescription and illicit opioids, and many other substances of abuse or medications, we continue to have tens of thousands of health risks with the utilization of Over-the-Counter (OTC) pain medications. Every year in our country, approximately 50,000 people visit an emergency room (ER) due to the over-the-counter (OTC) pain medication known as acetaminophen (Tylenol).
In wild and wonderful West Virginia, colloquially known as the “Ground Zero” of the “Opioid Crisis”, an interprofessional team of clinicians and researchers wanted to make a difference. Not merely a publication, nor just a poster, but an actual tangible difference in the lives of our residents. A collaboration was formed between West Virginia University (WVU) clinicians and researchers teaming up with Health Sciences and Technology Academy (HSTA) Community Research Associates to educate high school students across West Virginia, and empower them to screen the lay public for knowledge regarding OTC pain medications. Fentanyl, its analogs, and heroin dominate our current death tolls, yet OTC pain medications are readily available everywhere for anyone in pharmacies, grocery stores, convenience stores, and even hotel gift shops. This availability begs the question as to whether our society needs more education on the safe and effective utilization of OTC pain medications, and perhaps if research and development of lower risk medications is also warranted.
In this project, we had two main objectives including:
1. Assess and compare knowledge and literacy of over-the-counter (OTC) pain medications within the West Virginia general population.
2. Understand over-the-counter (OTC) pain medication perceptions within the West Virginia general population.
Methods:
The Health Sciences and Technology Academy (HSTA) Community Research Associates teamed up with an interprofessional research team from West Virginia University including PharmD, PhD, and MD clinicians. HSTA programs facilitate the active learning of high school students in the realm of health sciences and technology within a collaboration of actual healthcare professionals. This overall project received IRB approval from West Virginia University.
The first aim of this overall project concentrated on the education of HSTA students on over-the-counter (OTC) pain medications in respect to safety and efficacy. WVU researchers developed pre-and-post student surveys and seven informational lessons for HSTA students to complete with both didactic and active learning efforts to facilitate comprehensive learning.
The second aim of this overall project concentrated the screening and understanding of the lay public within West Virginia in respect to knowledge of the safety and efficacy of OTC pain medications including acetaminophen, ibuprofen, and naproxen. WVU researchers developed a community-based screening survey which included gauging questions involving knowledge and perceptions. Whenever a person completed the screening survey answering in the affirmative to questions demanding consultation with a healthcare professional, a recommendation was made to do just that.
The following were the “knowledge-based” community screening survey questions:
What is the difference between acetaminophen and Tylenol? (No Difference)
What is the difference between ibuprofen and Motrin? (No Difference)
What is the difference between naproxen and Aleve? (No Difference)
Generally speaking, over-the-counter (OTC) pain medications (compared to pain medications requiring a prescription) are: (As effective, but with certain safety concerns)
When taking a liquid over-the-counter pain medicine, one should: (measure with an oral syringe)
If you, a family member, or a friend accidentally took too many over-the-counter pain medicines, who is the most appropriate contact? (Poison Center or 911)
What is the largest amount of over-the-counter (OTC) acetaminophen extra strength 500mg tablets that anyone can swallow in one day before contacting a healthcare professional? (6)
What is the largest amount of over-the-counter (OTC) ibuprofen 200mg tablets that anyone can swallow in one day before contacting a healthcare professional? (6)
What is the largest amount of over-the-counter (OTC) naproxen 220mg tablets that anyone can swallow in one day before contacting a healthcare professional? (3)
All data was collected through HIPAA certified REDCap online data collection software. HSTA student pre/post data was analyzed to evaluate the effectiveness of the educational materials and for the specific purpose of this study, the community screening survey results were evaluated to understand the communities understanding of OTC pain medications.
Results:
In the community outreach portion of this project, a total of 1,174 community members completed the screening survey. The first portion had a “perception” theme, with one of the main questions being “Whom do you ask questions regarding any OTC pain medications?”. Responses included people stating doctor (51%), pharmacist (45%), and family (46%). Although healthcare professionals are viewed as organic sources of this information, concern can arise when people state of relying upon mere family members for this healthcare information.
The second portion included nine (9) knowledge-based questions regarding the safety and efficacy of OTC pain medications including acetaminophen, ibuprofen, and naproxen. The overall median of knowledge-based survey questions answered correctly of the nine total was five, with a standard deviation of two. Only 2 of 1,174 people answered all nine questions correctly, while 12% answered every single question incorrectly. Overall, 85% answered 2/3rds of the questions incorrectly, while 71% answered more than half of all questions incorrectly. All results had a p-value of < 0.001 correlating to strong statistical significance.
Further analysis was conducted in respect to the demographics of sex, race, age, education level, and income level. Female respondents fared better with a mean of 3.6 correct responses compared to male respondents with 2.3 mean correct responses. In respect to race, Caucasian respondents had the most correct answers with a mean of 3.2, followed by Black (2.5), Latino (2.3), Asian (1.9), and ‘other” (1.9). In respect to age, the most correct responses belonged to the 26yo to 45yo age group with a mean of 5.1 correct answers, followed by 46yo to 64yo (4.6), at least 65yo (3.3), 18yo to 25yo (2.9), less than 18yo (2.2), and “prefer not to answer” (1.5). In respect to education level, the most correct responses belonged to those with a Bachelor’s degree (Mean 5.1), followed by Master’s degree (5), high school graduate (4.4), Doctorate degree (4.3), in high school (2.4, “prefer not to answer” (1.6), and some high school (1.8). In respect to income level, the most correct responses belonged to those with an income of $40,001 to $80,000 (mean 4.3), followed by $80,001 to $100,000 (4.1), $20,000 to $40,000 (3.9), greater than $100,000 (3.6), less than $20,000 (2.5), and “prefer not to answer” (2.2). There was great diversity observed in these demographic results, including unexpected results (e.g., a higher education level or a higher income level, resulting in lower knowledge-based question scores).
Conclusion:
This statistically significant study data protrudes the absolute need for widespread OTC pain medication safety and efficacy education. Even though these medications are available without a prescription, or in other words, without any mandated healthcare professional guidance or recommendations, each year there continues to be approximately 50,000 acetaminophen-related emergency room (ER) visits annually in the United States. Considering that this study also involved other OTC pain medications known as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) including ibuprofen and naproxen, one can easily understand the need for more education, or perhaps even novel OTC pain medications with lower risk profiles. Considering the observed increase in OTC self-care medication use during the COVID-19 pandemic due to the lockdown of most healthcare systems, the need for more education and perhaps lower risk OTC pain medications is promulgated now more than ever, especially as more and more people are recommended or prescribed/dispensed non-opioid pain management medications. Based on the results of this study, the authors agree that future more geographically and demographically diverse studies are needed in order to understand the national, or even international, understanding of perceptions and knowledge of OTC pain medications in respect to safety and efficacy.
References: 1. https://www.getreliefresponsibly.com/
2. Kelly T, Conn KM, Zak M. Evaluation of Over-the-Counter Medication Knowledge and Literacy in Adolescent Students. Acad Pediatr. 2018;18(5):556-562. doi:10.1016/j.acap.2018.02.012.
3. Chambers CT, Reid GJ, McGrath PJ, Finley GA. Self-administration of over-the-counter medication for pain among adolescents. Arch Pediatr Adolesc Med. 1997;151(5):449-455. http://www.ncbi.nlm.nih.gov/pubmed/9158435.
4. Abel C, Johnson K, Waller D, Abdalla M, Goldsmith C-AW. Nonprescription medication use and literacy among New Hampshire eighth graders. J Am Pharm Assoc. 2012;52(6):777-782. doi:10.1331/JAPhA.2012.11158.
5. Gummin DD, Mowry JB, Spyker DA, Brooks DE, Osterthaler KM, Banner W. 2017 Annual Report of the American Association of Poison Control Centers’ National Poison Data System (NPDS): 35th Annual Report. Clin Toxicol (Phila). December 2018:1-203. doi:10.1080/15563650.2018.1533727.
6. Shehnaz SI, Agarwal AK, Khan N. A systematic review of self-medication practices among adolescents. J Adolesc Health. 2014;55(4):467-483. doi:10.1016/j.jadohealth.2014.07.001.
7. Wilson KM, Singh P, Blumkin AK, Dallas L, Klein JD. Knowledge Gaps and Misconceptions About Over-the-Counter Analgesics Among Adolescents Attending a Hospital-Based Clinic. Acad Pediatr. 2010;10(4):228-232. doi:10.1016/j.acap.2010.04.002.
8. Shone LP, King JP, Doane C, Wilson KM, Wolf MS. Misunderstanding and Potential Unintended Misuse of Acetaminophen Among Adolescents and Young Adults. J Health Commun. 2011;16(sup3):256-267. doi:10.1080/10810730.2011.604384.
9. Huott MA, Storrow AB. A survey of adolescents’ knowledge regarding toxicity of over-the-counter medications. Acad Emerg Med. 1997;4(3):214-218. http://www.ncbi.nlm.nih.gov/pubmed/9063550.
10. Myers WC, Otto TA, Harris E, Diaco D, Moreno A. Acetaminophen overdose as a suicidal gesture: a survey of adolescents’ knowledge of its potential for toxicity. J Am Acad Child Adolesc Psychiatry. 1992;31(4):686-690. doi:10.1097/00004583-199207000-00016.