CONSTRUCTION AND VALIDITY OF AN ITEM BANK ON RISK SELF-MEDICATION

this is a methodological study carried out from May to October 2022, with two phases: 1) item bank elaboration in the light of medication literacy and Theory of Planned Behavior based on a scoping review; and 2) content validity by twenty-two health experts. The Content Validity Index, Content Validity Ratio, binomial exact test for small samples and intraclass correlation coefficient were calculated.

Results:

Risk Self-Medication construct item elaboration was based on a broad review of solidified national and international publications in the health area. The definitions were approved by judges, with their respective domains. In the first version, the bank contained 136 items. Two rounds of analysis were carried out with judges, which resulted in the removal of 87 items. The final version presented 49 items, distributed across three domains: Medication literacy; Behavioral intention; and Behavior. The total Content Validity Index was 0.89, with excellent reliability (0.964). There was significant disagreement in the attribution of scores among judges (p>0.05) in some items.

Conclusion:

the item bank has satisfactory content. It is recommended to undergo semantic analysis and subsequent structure validity.

DESCRIPTORS:
Self-medication; Validation study; Psychometrics; Health literacy; Patient safety

Latent trait definition: Risky self-medication
It is an inappropriate form of self-medication, in which several potential elements of risk to individuals’ health may occur, consisting of three non-linear and intercommunicating dimensions: medication literacy, behavioral intention and behavior11. World Health Organization. The benefits and risks of self-medication: General policy issues. WHO drug information [Internet]. 2000 [cited 2022 Jan 25];14(1):1-2. Available from: https://apps.who.int/iris/handle/10665/57617 https://apps.who.int/iris/handle/10665/5... ^-44. Ajzen I, Driver BL. Prediction of leisure participantion from behavioral, normative, and control beliefs: An application of the theory of planned behavior. Leis Sci [Internet]. 1991 [cited 2023 Jul 10];13(1):185-204. Available from: https://doi.org/10.1080/01490409109513137 https://doi.org/10.1080/0149040910951313... .
Domains/constitutive definition	Domains/constitutive definition
Medications literacy: it is the degree to which individuals can obtain, understand, communicate, calculate and process specific information about their medications to make health decisions safely and effectively regardless of the way in which the content is delivered (written, oral and visual)22. Pouliot A, Vaillancourt R, Stacey D, Suter P. Defining and identifying concepts of medication literacy: an international perspective. Res Social Adm Pharm [Internet]. 2018 [cited 2023 Jul 10];14(9):797-804. Available from: https://doi.org/10.1016/j.sapharm.2017.11.005 https://doi.org/10.1016/j.sapharm.2017.1... ^-33. Pantuzza LLN, Nascimento E, Botelho SF, Martins MAP, Veloso RCSG, Nascimento MMG, et al. Mapping the construct and measurement of medication literacy: A scoping review. Br J Clin Pharmacol [Internet]. 2020 [cited 2023 Jul 10];87(3):754-75. Available from: https://doi.org/10.1111/bcp.14490 https://doi.org/10.1111/bcp.14490... .	Access information: ability to search, find and obtain information related to medications from different sources1111. Pantuzza LLN, Nascimento E, Crepalde-Ribeiro K, Botelho SF, Martins MAP, Veloso RCSG, et al. Medication literacy: A conceptual model. Res Social Adm Pharm [Internet]. 2022 [cited 2023 Jul 11];18(4):2675-82. Available from: https://doi.org/10.1016/j.sapharm.2021.06.003 https://doi.org/10.1016/j.sapharm.2021.0... .
	Understanding: the ability to understand medication-related information obtained or received from different sources1111. Pantuzza LLN, Nascimento E, Crepalde-Ribeiro K, Botelho SF, Martins MAP, Veloso RCSG, et al. Medication literacy: A conceptual model. Res Social Adm Pharm [Internet]. 2022 [cited 2023 Jul 11];18(4):2675-82. Available from: https://doi.org/10.1016/j.sapharm.2021.06.003 https://doi.org/10.1016/j.sapharm.2021.0... .
	Assessment and processing: assessment of information on the safe and effective use of medication22. Pouliot A, Vaillancourt R, Stacey D, Suter P. Defining and identifying concepts of medication literacy: an international perspective. Res Social Adm Pharm [Internet]. 2018 [cited 2023 Jul 10];14(9):797-804. Available from: https://doi.org/10.1016/j.sapharm.2017.11.005 https://doi.org/10.1016/j.sapharm.2017.1... .
	Application/usage: use of the information obtained about their medications to make health decisions safely and effectively22. Pouliot A, Vaillancourt R, Stacey D, Suter P. Defining and identifying concepts of medication literacy: an international perspective. Res Social Adm Pharm [Internet]. 2018 [cited 2023 Jul 10];14(9):797-804. Available from: https://doi.org/10.1016/j.sapharm.2017.11.005 https://doi.org/10.1016/j.sapharm.2017.1... .
Behavioral intention: sum of a person’s decision to act and the perception of the effort they are willing to make to perform a certain behavior, involving factors such as attitudes, subjective norms and perceived behavioral control44. Ajzen I, Driver BL. Prediction of leisure participantion from behavioral, normative, and control beliefs: An application of the theory of planned behavior. Leis Sci [Internet]. 1991 [cited 2023 Jul 10];13(1):185-204. Available from: https://doi.org/10.1080/01490409109513137 https://doi.org/10.1080/0149040910951313... .	Attitudes: set of behavioral beliefs for assessing favorable or unfavorable outcomes44. Ajzen I, Driver BL. Prediction of leisure participantion from behavioral, normative, and control beliefs: An application of the theory of planned behavior. Leis Sci [Internet]. 1991 [cited 2023 Jul 10];13(1):185-204. Available from: https://doi.org/10.1080/01490409109513137 https://doi.org/10.1080/0149040910951313... .
	Subjective norms: normative beliefs about the subjective influences of references (parents, friends, family, spouse, co-workers) on medication selection and use⁴.
	Perceived behavioral control: individual belief related to the perceived power factors (difficulty or ease) in performing behavior44. Ajzen I, Driver BL. Prediction of leisure participantion from behavioral, normative, and control beliefs: An application of the theory of planned behavior. Leis Sci [Internet]. 1991 [cited 2023 Jul 10];13(1):185-204. Available from: https://doi.org/10.1080/01490409109513137 https://doi.org/10.1080/0149040910951313... .
Behavior: it is the practical function that comes from information or beliefs44. Ajzen I, Driver BL. Prediction of leisure participantion from behavioral, normative, and control beliefs: An application of the theory of planned behavior. Leis Sci [Internet]. 1991 [cited 2023 Jul 10];13(1):185-204. Available from: https://doi.org/10.1080/01490409109513137 https://doi.org/10.1080/0149040910951313... .	Risky self-medication practice: inappropriate use of medication, involving suspension of medication without medical advice, increasing medication dose, changing medication intake times and combining medications where there is an exacerbation or reduction of the effects of the medication11. World Health Organization. The benefits and risks of self-medication: General policy issues. WHO drug information [Internet]. 2000 [cited 2022 Jan 25];14(1):1-2. Available from: https://apps.who.int/iris/handle/10665/57617 https://apps.who.int/iris/handle/10665/5... .

Items		n(%)	CVI*	p-value†	CVR ‡
Domain - Medication literacy			0.78
01	Before using medication on my own, I read the information in the leaflet.	09 (81.8)	0.82	0.102^a	0.636
02	Before using medication on my own, I read the information on the label.	09 (81.8)	0.82	0.102^a	0.636
03	Before using medication on my own, I look for information on the internet.	08 (72.7)	0.73	0.070^a	0.454
04	Before using medication on my own, I seek information from friends/family.	10 (90.9)	0.91	0.431^a	0.818
05	Before using medication on my own, I seek information from pharmacy clerks.	09 (81.8)	0.82	0.102^a	0.636
06	Before using medication on your own, I understand the information contained in its leaflet.	07 (63.6)	0.64	0.001^a	0.272
07	Before using medication on your own, I understand the information on its label.	07 (63.6)	0.64	0.001^a	0.272
08	Before using medication on my own, I know to check whether the information on the internet is reliable.	08 (72.7)	0.73	0.070^a	0.454
09	Before using medication on my own, I know when information from friends/family is trustworthy.	06 (54.5)	0.55	0.001^a	0.091
10	Before using medication on my own, I understand that the information from the pharmacy clerk is reliable.	08 (72.7)	0.73	0.070^a	0.454
11	Before using medication on my own, I know how to assess the possibility of an unwanted reaction.	08 (72.7)	0.73	0.070^a	0.454
12	Before using medication on my own, I know how to correctly assess the information about food interfering with the effect of a medication.	07 (63.6)	0.64	0.001^a	0.272
13	Before using medication on my own, I know that I should not take the medication with alcohol.	08 (72.7)	0.73	0.070^a	0.454
14	Before using medication on my own, I know how to assess the possibility of this medication interfering with the effect of another medication I am already using.	07 (63.6)	0.64	0.001^a	0.272
15	Before using medication on my own, I assess the appropriate amount to take.	09 (81.8)	0.82	0.102^a	0.636
16	Before using medication on my own, I check the expiration date on the label.	08 (72.7)	0.73	0.070^a	0.454
17	I take medication on my own even though I have doubts regarding the information contained in the leaflet.	10 (90.9)	0.91	0.431^a	0.818
18	When taking a medication on my own, I follow the instructions contained in the leaflet regarding the number of days to be medicated.	09 (81.8)	0.82	0.102^a	0.636
19	When taking a medication on my own, I follow my previous experience with the same medication.	10 (90.9)	0.91	0.431^a	0.818
20	When taking medication on my own, I follow previous medical appointments.	09 (81.8)	0.82	0.102^a	0.636
21	When taking medication on my own, I follow previous medical prescriptions.	10 (90.9)	0.91	0.431^a	0.818
22	When taking medication on my own, I follow information from the internet.	10 (90.9)	0.91	0.431^a	0.818
23	I take medication on my own when I use antibiotics without a prescription.	11 (100.0)	1.00	0.569	1.000
24	When I use medication on my own, I tell my healthcare professional when the problem gets worse.	07 (63.6)	0.64	0.001^a	0.272
25	When using medication on my own, in the presence of a drug reaction, I look for information on the internet.	10 (90.9)	0.91	0.431 ^a	0.818
26	When using medication on my own, in the presence of a drug reaction, I seek information from family/friends.	09 (81.8)	0.82	0.102^a	0.636
Behavioral intention domain			0.93
27	I believe that using medication(s) on my own relieves symptoms quickly	11 (100.0)	1.00	0.569	1.000
28	I believe that using medication(s) on my own has the desired effect.	10 (90.9)	0.91	0.431^a	0.818
29	I believe that I would stop using the medication prescribed by the doctor if I felt an unwanted reaction.	08 (72.7)	0.73	0.070^a	0.454
30	I believe that I would stop using the medication prescribed by the doctor when it does not have the expected effect.	10 (90.9)	0.91	0.431^a	0.818
31	I believe I would discontinue use of the medication prescribed by the doctor if symptoms improved.	11 (100.0)	1.00	0.569	1.000
32	I believe that I would suspend the use of the medication prescribed by the doctor and use it at another time.	10 (90.9)	0.91	0.431^a	0.818
33	I would take medication on my own because I trusted the opinion of friends/neighbors.	10 (90.9)	0.91	0.431^a	0.818
34	I would take medication on my own because I value the opinion of family members.	09 (81.8)	0.82	0.102^a	0.636
35	I am able to take medication on my own because I do not need a medical appointment.	11 (100.0)	1.00	0.569	1.000
36	I am able to take medication on my own because I have it at home.	11 (100.0)	1.00	0.569	1.000
37	I am able to take medication on my own because I know how to calculate the dose.	10 (90.9)	0.91	0.431^a	0.818
38	I am able to take medication on my own because I understand the leaflet.	10 (90.9)	0.91	0.431^a	0.818
39	I am able to take medication on my own because I read the label.	10 (90.9)	0.91	0.431^a	0.818
40	I am able to take medication on my own even without knowing how to identify adverse reactions.	11 (100.0)	1.00	0.569	1.000
41	I am able to take medication on my own even without medical or nursing advice.	11 (100.0)	1.00	0.569	1.000
Behavior domain			0.96
42	How often I took medication on my own in the last three months.	11 (100.0)	1.00	0.569	1.000
43	I use medication on my own when I do not need a prescription from the pharmacy.	10 (90.9)	0.91	0.431^a	0.818
44	I use medication on my own even when prescription retention is required at the pharmacy.	11 (100.0)	1.00	0.569	1.000
45	I use medication on my own during meals.	08 (72.7)	0.73	0.070^a	0.454
46	I use medication on my own along with teas.	09 (81.8)	0.82	0.102^a	0.636
47	I use medication on my own along with alcoholic beverages.	10 (90.9)	0.91	0.431^a	0.818
48	I use medication on my own because I have previous treatment experience.	11 (100.0)	1.00	0.569	1.000
49	I use medication on my own because I have old prescriptions.	11 (100.0)	1.00	0.569	1.000
50	I use medication on my own because I have medication stored at home.	10 (90.9)	0.91	0.431^a	0.818
51	I use medication on my own even without knowing the right amount.	11 (100.0)	1.00	0.569	1.000
52	I use medication on my own even without knowing how long it will be used.	11 (100.0)	1.00	0.569	1.000
53	I use medication on my own because it is faster to solve my health problem.	11 (100.0)	1.00	0.569	1.000
54	I use medication on my own because it is recommended by friends/neighbors/family.	11 (100.0)	1.00	0.569	1.000
55	I use medication on my own because I do not need guidance from healthcare professionals.	11 (100.0)	1.00	0.569	1.000
56	I use more than one medication on my own at the same time.	11 (100.0)	1.00	0.569	1.000
57	I use medication on my own to treat symptoms of illnesses I already have (hypertension, diabetes, others).	11 (100.0)	1.00	0.569	1.000
58	I reduce the dose of the medication the doctor or nurse prescribed when symptoms improve.	11 (100.0)	1.00	0.569	1.000
59	I increase the dose of the medication the doctor or nurse prescribed when I realize that I am not improving.	11 (100.0)	1.00	0.569	1.000
60	I stop using medication on my own when I feel better.	11 (100.0)	1.00	0.569	1.000
61	I have already increased the number of days of treatment.	11 (100.0)	1.00	0.569	1.000
62	I have already reduced the number of days of treatment.	11 (100.0)	1.00	0.569	1.000
63	When I take medication on my own, I continue even if my health condition worsens.	09 (81.8)	0.82	0.102^a	0.636
64	When I take medication on my own, I continue even in the presence of unwanted reactions.	09 (81.8)	0.82	0.102^a	0.636
65	I use antibiotics on my own.	11 (100.0)	1.00	0.569	1.000
66	I use prescription medications (for anxiety, depression, pain) on my own.	11 (100.0)	1.00	0.569	1.000
Total		-	0.89	-	-
CCI (95%CI)§		0.931 (0.858-0.978)

Domain 1: Medication literacy
1	Before using medication on my own, I read the information in the leaflet.
2	Before using medication on my own, I read the information on the label.
3	Before using medication on my own, I assess the appropriate dose to be taken.
4	Before using medication on my own, I ask my questions in the leaflet.
5	Before using medication on my own, I follow the instructions contained in the leaflet regarding the number of days to use the medication.
6	Before using medication on my own, I seek information from friends/family.
7	Before using medication on my own, I seek information from pharmacy clerks.
8	Before using medication on my own, I follow my previous experience with the same medication.
9	Before using medication on my own, I follow previous medical prescriptions.
10	Before using medication on my own, I follow information from the internet.
11	When using medication on my own, in the presence of a drug reaction, I look for information on the internet.
12	When using medication on my own, in the presence of a drug reaction, I seek information from family/friends.
13	When taking medication on my own, I know how to calculate the dose.
14	When taking medication on my own, I understand the leaflet.
Domain 2: Behavioral intention
15	I intend to take medication on my own because it relieves the symptoms quickly.
16	I intend to take medication on my own because it has the desired effect.
17	I intend to take medication on my own because I trust the opinion of friends/neighbors/family.
18	I intend to take medication on my own because I do not need a medical appointment.
19	I intend to take medication on my own because I have it at home.
20	I intend to take medication on my own even without knowing how to identify adverse reactions.
21	I intend to take medication on my own even without medical, pharmacist or nurse advice.
22	I would intend to stop using the medication prescribed by the doctor if it did not have the expected effect.
23	I would intend to discontinue use of the medication prescribed by the doctor if symptoms improved.
24	I would intend to suspend the use of the medication prescribed by the doctor and use it at another time.
Domain 3: Behavior
25	I have taken medication on my own for the last three months.
26	I use medication on my own when I do not need a prescription from the pharmacy.
27	I use medication on my own even when prescription retention is required at the pharmacy.
28	I use medication on my own during meals.
29	I use medication on its own along with teas.
30	I use medication on my own along with alcoholic beverages.
31	I use medication on my own because I have previous treatment experience.
32	I use medication on my own because I have old prescriptions.
33	I use medication on my own because I have medication stored at home.
34	I use medication on my own even without knowing the right amount to take.
35	I use medication on my own even without knowing how long it will be used.
36	I use medication on my own because it is quicker to solve my health problems.
37	I use medication on my own because it is recommended by friends/neighbors/family.
38	I use medication on my own because I do not need guidance from healthcare professionals.
39	I use more than one medication on my own at the same time.
40	I use medication on my own to treat symptoms of illnesses I already have (hypertension, diabetes, others).
41	I reduce the dose of the medication the doctor or nurse prescribed when symptoms improve.
42	I increase the dose of the medication the doctor or nurse prescribed when I realize that I am not improving.
43	I stop and use medication on my own when I feel better.
44	I have already increased the number of days of treatment.
45	I have already reduced the number of days of treatment.
46	When I take medication on my own, I continue even if my health condition worsens.
47	When I take medication on my own, I continue even in the presence of unwanted reactions.
48	I use antibiotics on my own.
49	I use prescription medications (for anxiety, depression, pain) on my own.

Universidade Federal de Santa Catarina, Programa de Pós Graduação em Enfermagem Campus Universitário Trindade, 88040-970 Florianópolis - Santa Catarina - Brasil, Tel.: (55 48) 3721-4915 / (55 48) 3721-9043 - Florianópolis - SC - Brazil
E-mail: textoecontexto@contato.ufsc.br

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[1] CORRESPONDING AUTHOR
Márcio Adriano Fernandes Barreto marciofernandes@uern.br