Corresponding author: Umberto M. Musazzi ( umberto.musazzi@unimi.it ) Academic editor: Guenka Petrova
© 2021 Enrico Keber, Paolo Rocco, Umberto M. Musazzi, Antonio M. Morselli-Labate, Nicolina P. Floris, Ambra Pedrazzini, Paola Minghetti, Corrado Giua.
This is an open access article distributed under the terms of the Creative Commons Attribution License (CC BY 4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Citation:
Keber E, Rocco P, Musazzi UM, Morselli-Labate AM, Floris NP, Pedrazzini A, Minghetti P, Giua C (2021) The management of upper gastrointestinal symptoms: A study on community pharmacies in Italy. Pharmacia 68(2): 401-409. https://doi.org/10.3897/pharmacia.68.e66065
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Upper gastrointestinal (GI) symptoms are usual complaints among patients presenting to Italian community pharmacies. However, information on treatment history of those patients is often lacking. This descriptive, cross-sectional study aims at exploring the medication history of individuals with upper GI tract symptoms visiting one of the 20 enrolled community pharmacies, over a period of 7 months, based on the administration of a questionnaire. Of 1,020 interviewees, 62.1% had asked for a medical consultation. The most frequent symptom was epigastric burning (31.8%), followed by acid regurgitation (14.6%) and post-prandial fullness (12.0%). Of the 1,609 therapies, proton pump inhibitors constituted the most represented therapeutic class (35.6%) followed by antacids (17.5%) and alginate-based products (17.2%). In treating symptoms, 38.1% of the patients do not seek medical advice, while 42.0% rely on non-prescription therapies. As findings suggest, support to patients with GI disorders in community pharmacies can be enhanced for a safer self-medication.
Proton pump inhibitors, Community Pharmacy, Clinical Pharmacy, Self Medication, Pharmacoepidemiology
Upper gastrointestinal (GI) disorders, despite not being life-threatening diseases (
In this regard, it is worth mentioning the overall background that encompasses the realm of possibilities available to the patient within the Italian healthcare system. Indeed, Italian community pharmacies represent an ideal setting for patients, thanks to their wide and capillary distribution throughout the country, not to mention the ease in accessibility that they offer to the entire population. This has been confirmed in the 2019 report from Federfarma (
As a matter of fact, relying on medical specialists or general practitioners (GP) can constitute sometimes an uncomfortable option from the patient’s point of view. Indeed, in the former case, usually the offered service is not free of charge, while in the latter case, substantial wait times may be required for the consultation. By contrast, community pharmacies provide fast, reliable and free of charge consultations in various areas, both clinical and drug-related, by means of trained professionals, namely, pharmacists. Pharmacists not only distribute drugs, but they also provide advice on the management of minor diseases (
Given the outlined context, the community pharmacists might play a paramount role by intercepting patients with GI symptoms more quickly than physicians: they will probably rely either on prescription and non-prescription medicines or on the advice from pharmacists on some possible natural healthcare product.
Recent therapeutic approaches demonstrated the importance of a proper patient education carried out by physicians and pharmacists (
At this point, it is paramount noting that standardized “triage” procedures for community pharmacists to support patients affected by dyspepsia or reflux symptoms are scarce in most European countries. This is also due to the lack of updated pharmacoepidemiologic data on patients. As an example, in Italy, specific guidelines are missing mainly due to a lack of real-world data on the prevalence of upper GI disorders in patients visiting the community pharmacy and on their self-management habits. To the best of our knowledge, this work is the first descriptive study that aims at exploring the medication history of patients suffering from upper GI symptoms attending community pharmacies, assuming both prescription and over-the-counter (OTC) medicinal products. A Belgian study with a similar design, published in 2009 (
The study was designed as a descriptive, cross-sectional study to explore the medication history of patients with upper GI symptoms visiting the community pharmacy and taking prescription and non-prescription medicines. In particular, the study aimed at exploring the patient’s medical history, assessing the prevalence of the main upper GI symptoms, and the therapeutic classes most used in their treatment, as well as the percentage of patients seeking medical advice or taking non-prescription drugs. Secondary outcomes were the duration of the therapy and the frequency of symptoms reappearance after therapy discontinuation for each therapeutic class.
This cross-sectional study was conducted for 7 months in 20 community pharmacies across Italy (7 in the North, 7 in the Center, and 6 in the South and Islands) by 20 pharmacists collectively named “SIFAC Group of Community Pharmacists” (SGCP). As described in previous work (
The study has been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments. The study protocol has been reviewed and approved by the Ethical Review Board of SIFAC (Società Italiana di Farmacia Clinica). The interviews have been pursued within the community pharmacy setting. All patients gave their oral consent before such interviews.
Mean, standard deviation (SD), and range were used as descriptive statistics for scalar variables, while absolute and relative frequencies were used for reporting discrete data. The relationships between treatment/symptom characteristics and pharmacological class were evaluated using Pearson’s chi-squared test, and the log-linear models were used for comparing observed versus expected cell frequencies. The polynomial contrast was applied in the log-linear models to test the trend behavior for ordinal variables. The data were fully managed and analyzed by using the IBM SPSS Statistics package v. 23 (IBM, USA). Differences were considered significant at the p < 0.05 level.
Out of 1,064 patients who have been intercepted in the pharmacy for upper GI disorders, a total of 1,020 patients, accepted to take part in the research. More specifically, 550 patients (53.9%) were females, and the mean age was 50.2 ± 16.9 years (range 18–100 years). The body mass index (BMI = weight/height2) was stratified according to the NIH criteria (
Characteristics | No. of patients (n=1,020) |
---|---|
Gender: | |
– Female | 550 (53.9%) |
– Male | 470 (46.1%) |
Age-range (years): | |
Mean±SD (range) | 50.2±16.9 (18–100) |
– 18–25 | 65 (6.4%) |
– 26–35 | 170 (16.7%) |
– 36–49 | 264 (25.9%) |
– 50–65 | 318 (31.2%) |
– More than 65 | 203 (19.9%) |
Body mass index (BMI): | |
– Underweight (<18.5 kg/m2) | 18 (1.8%) |
– Normalweight (18.5–24.9 kg/m2) | 637 (62.5%) |
– Overweight (25.0–29.9 kg/m2) | 277 (27.2%) |
– Obese (30.0 kg/m2 and above) | 88 (8.6%) |
Daily cigarette consumption: | |
– Non smokers | 706 (69.2%) |
– Less than 10 | 173 (17.0%) |
– 10–20 | 105 (10.3%) |
– More than 20 | 36 (3.5%) |
Alcohol consumption: | |
– Never | 412 (40.4%) |
– Rarely (<1–3 times/month) | 417 (40.9%) |
– Yes (during meals only) | 168 (16.5%) |
– Often (>1–2 times/week) | 23 (2.3%) |
Main gastrointestinal symptom reported | |
– Epigastric burning | 324 (31.8%) |
– Acid regurgitation | 149 (14.6%) |
– Postprandial fullness | 122 (12.0%) |
– Burning sensation in the throat | 106 (10.4%) |
– Upper abdominal bloating | 100 (9.8%) |
– Heartburn | 76 (7.5%) |
– Epigastric pain | 71 (7.0%) |
– Chronic cough | 37 (3.6%) |
– Nausea | 35 (3.4%) |
Frequency of the main gastrointestinal symptom reported | |
– Once per month | 121 (11.9%) |
– 2 or 3 times per month | 216 (21.2%) |
– Once per week | 190 (18.6%) |
– 2 or 3 times per week | 272 (26.7%) |
– 4 or more times per week | 221 (21.7%) |
The most commonly self-reported upper GI symptoms were epigastric burning, 31.8% (n = 324); acid regurgitation, 14.6% (n = 149); and post-prandial fullness, 12.0% (n = 122). For further details on additional symptoms, see Table
On average, the frequency of reoccurrence of the main symptom was two or three times per month in 216 subjects (21.2%), two or three times per week in 272 subjects (26.7%), and four or more times per week in 221 subjects (21.7%) (Table
Frequency of the gastrointestinal symptoms reported by the 1,020 interviewed subjects.
Gastrointestinal symptoms | Frequency of symptoms | P-value (+/-)1 | ||||
Once per month | 2–3 times per month | Once per week | 2–3 times per week | 4 or more times per week | ||
Epigastric burning | 47 (14.5%) | 76 (23.5%) | 70 (21.6%) | 86 (26.5%) | 45 (13.9%) | <0.001 (-) |
Acid regurgitation | 10 (6.7%) | 22 (14.8%) | 21 (14.1%) | 56 (37.6%) | 40 (26.8%) | 0.025 (+) |
Postprandial fullness | 11 (9.0%) | 33 (27.0%) | 27 (22.1%) | 33 (27.0%) | 18 (14.8%) | 0.175 (-) |
Burning sensation in the throat | 12 (11.3%) | 30 (28.3%) | 20 (18.9%) | 22 (20.8%) | 22 (20.8%) | 0.131 (-) |
Upper abdominal bloating | 18 (18.0%) | 15 (15.0%) | 18 (18.0%) | 17 (17.0%) | 32 (32.0%) | 0.274 (-) |
Heartburn | 8 (10.5%) | 13 (17.1%) | 12 (15.8%) | 24 (31.6%) | 19 (25.0%) | 0.758 (+) |
Epigastric pain | 9 (12.7%) | 20 (28.2%) | 10 (14.1%) | 18 (25.4%) | 14 (19.7%) | 0.143 (-) |
Chronic cough | 1 (2.7%) | 3 (8.1%) | 5 (13.5%) | 8 (21.6%) | 20 (54.1%) | 0.011 (+) |
Nausea | 5 (14.3%) | 4 (11.4%) | 7 (20.0%) | 8 (22.9%) | 11 (31.4%) | 0.916 (+) |
Overall | 121 (11.9%) | 216 (21.2%) | 190 (18.6%) | 272 (26.7%) | 221 (21.7%) | - |
At the time of the survey, a total of 633 (62.1%) of the interviewed patients had previously consulted a physician for the management of the symptoms. Nonetheless, a significant time gap between the onset of symptoms and medical consultation was reported by 89.6% of the subjects (n = 567): 56.1% of them (n = 318) sought medical advice within 15 days of the onset of symptoms; 17.1% (n = 97) between 15 days and one month; 21.3% (n = 121) between one and six months, and the remaining 5.5% (n = 31) after six months or more.
Focusing on the pharmacological treatments, 1,018 patients had taken between 1 to 3 different drugs (mean 1.58 treatments per patient) for upper GI symptoms: 1 medicine for 518 (50.9%) patients, 2 medicines for 409 (40.2%) patients and 3 medicines for 91 (8.9%) patients, for a total of 1,609 treatments. The most common therapeutic class used was PPIs (n = 572 treatments, 35.6%), followed by antacids (n = 281, 17.5%) and alginates (n = 276, 17.2%) (Table
Summary of the 1,609 treatments reported by the 1,020 interviewed subjects.
Characteristics | PPI§ (n = 572, 35.6%) | H2 blockers (n = 52, 3.2%) | Alginate (n = 276, 17.2%) | Antacids (n = 281, 17.5%) | Prokinetic agents (n = 116, 7.2%) | MP‡ (n = 157, 9.8%) | Herbal supplement (n = 83, 5.2%) | Others (n = 72, 4.5%) | Total (n = 1,609) |
---|---|---|---|---|---|---|---|---|---|
A) Treatment recommendation (P<0.001*) | |||||||||
- Self-medication | 33 (5.8%) c | 10 (19.2%) | 42 (15.2%) b | 138 (49.1%) c | 16 (13.8%) | 11 (7.0%) | 20 (24.1%) b | 14 (19.4%) | 284 (17.7%) |
- Pharmacist | 33 (5.8%) c | 13 (25.0%) | 57 (20.7%) c | 48 (17.1%) c | 12 (10.3%) c | 138 (87.9%) c | 58 (69.9%) c | 32 (44.4%) | 391 (24.3%) |
- General practitioner | 323 (56.5%) c | 17 (32.7%) | 110 (39.9%) | 76 (27.0%) | 59 (50.9%) c | 6 (3.8%) b | 5 (6.0%) | 19 (26.4%) | 615 (38.2%) |
- Medical specialist | 183 (32.0%) c | 12 (23.1%) a | 67 (24.3%) c | 19 (6.8%) | 29 (25.0%) c | 2 (1.3%) a | 0 a | 7 (9.7%) | 319 (19.8%) |
B) Symptoms (P<0.001*) | |||||||||
- Epigastric burning | 155 (27.1%) | 18 (34.6%) | 86 (31.2%) b | 117 (41.6%) c | 16 (13.8%) a | 72 (45.9%) c | 11 (13.3%) | 5 (6.9%) c | 480 (29.8%) |
- Acid regurgitation | 108 (18.9%) a | 7 (13.5%) | 60 (21.7%) c | 43 (15.3%) | 11 (9.5%) | 18 (11.5%) | 5 (6.0%) | 4 (5.6%) a | 256 (15.9%) |
- Postprandial fullness | 43 (7.5%) c | 6 (11.5%) | 13 (4.7%) c | 30 (10.7%) | 44 (37.9%) c | 11 (7.0%) | 19 (22.9%) c | 12 (16.7%) | 178 (11.1%) |
- Burning sensation in the throat | 72 (12.6%) | 5 (9.6%) | 40 (14.5%) c | 26 (9.3%) | 5 (4.3%) | 20 (12.7%) a | 3 (3.6%) | 3 (4.2%) | 174 (10.8%) |
- Upper abdominal bloating | 52 (9.1%) | 3 (5.8%) | 20 (7.2%) | 23 (8.2%) | 7 (6.0%) | 9 (5.7%) | 38 (45.8%) c | 20 (27.8%) c | 172 (10.7%) |
- Hearthburn | 61 (10.7%) b | 6 (11.5%) | 32 (11.6%) c | 14 (5.0%) | 3 (2.6%) | 7 (4.5%) | 1 (1.2%) | 2 (2.8%) | 126 (7.8%) |
- Epigastric pain | 46 (8.0%) | 3 (5.8%) | 4 (1.4%) b | 16 (5.7%) | 5 (4.3%) | 12 (7.6%) | 3 (3.6%) | 12 (16.7%) b | 101 (6.3%) |
- Cronic cough | 19 (3.3%) a | 4 (7.7%) | 18 (6.5%) | 4 (1.4%) b | 7 (6.0%) | 5 (3.2%) | 3 (3.6%) | 9 (12.5%) a | 69 (4.3%) |
- Nausea | 16 (2.8%) | 0 | 3 (1.1%) | 8 (2.8%) | 18 (15.5%) c | 3 (1.9%) | 0 | 5 (6.9%) a | 53 (3.3%) |
C) Duration of therapy (P<0.001*) | |||||||||
- When the need arises | 32 (5.9%) c | 14 (28.6%) | 106 (43.4%) | 212 (80.6%) c | 45 (42.1%) | 107 (72.3%) c | 25 (32.5%) | 18 (26.9%) | 559 (37.4%) |
- Until 2 weeks | 97 (18.0%) c | 13 (26.5%) | 46 (18.9%) | 22 (8.4%) | 23 (21.5%) | 19 (12.8%) | 27 (35.1%) a | 32 (47.8%) b | 279 (18.7%) |
- From more than 2 weeks to 1 month | 82 (15.2%) c | 1 (2.0%) | 26 (10.7%) | 6 (2.3%) | 13 (12.1%) | 7 (4.7%) | 2 (2.6%) | 3 (4.5%) | 140 (9.4%) |
- From more than 1 month to 6 months | 218 (40.4%) c | 14 (28.6%) | 45 (18.4%) | 19 (7.2%) | 19 (17.8%) | 10 (6.8%) b | 22 (28.6%) a | 13 (19.4%) | 360 (24.1%) |
- More than 6 months | 101 (18.7%) c | 6 (12.2%) | 19 (7.8%) | 4 (1.5%) | 5 (4.7%) | 4 (2.7%) | 1 (1.3%) | 1 (1.5%) | 141 (9.4%) |
- Cyclical | 9 (1.7%) | 1 (2.0%) | 2 (0.8%) | 0 | 2 (1.9%) | 1 (0.7%) | 0 | 0 | 15 (1.0%) |
- Not reported# | n = 33 (5.8%) | n = 3 (5.8%) | n = 32 (11.6%) | n = 18 (6.4%) | n = 9 (7.8%) | n = 9 (5.7%) | n = 6 (7.2%) | n = 5 (6.9%) | n = 115 (7.1%) |
D) Reappearance of symptoms (P<0.001*†) | |||||||||
- Yes | 229 (40.2%) | 22 (43.1%) | 112 (43.8%) a | 147 (54.9%) b | 49 (44.5%) | 43 (28.3%) a | 21 (30.0%) b | 19 (27.9%) | 642 (41.6%) |
- No | 116 (20.4%) | 8 (15.7%) | 46 (18.0%) a | 58 (21.6%) b | 29 (26.4%) | 42 (27.6%) a | 27 (38.6%) b | 20 (29.4%) | 346 (22.4%) |
- Ongoing therapy | 224 (39.4%) | 21 (41.2%) | 98 (38.3%) | 63 (23.5%) c | 32 (29.1%) | 67 (44.1%) a | 22 (31.4%) | 29 (42.6%) | 556 (36.0%) |
- Not reported# | n = 3 (0.5%) | n = 1 (1.9%) | n = 20 (7.2%) | n = 13 (4.6%) | n = 6 (5.2%) | n = 5 (3.2%) | n = 13 (15.7%) | n = 4 (5.6%) | n = 65 (4.0%) |
However, it should be noted that a physician may prescribe even non-prescription medicinal products. Indeed, of the total 1,609 treatments, only 391 (24.3%) were recommended by a pharmacist, and 284 (17.7%) have been chosen by patients in self-medication regimen (Table
PPIs were prescribed by GPs in 323 cases (56.5%; P<0.001), by the medical specialist in 183 cases (32.0%; P<0.001) and were recommended by the pharmacist in 33 cases (5.8%; P < 0.001). They were generally used to treat epigastric burning in 155 cases (27.1%; P = 0.800), acid regurgitation in 108 cases (18.9%; P = 0.016), and heartburn in 61 cases (10.7%; P = 0.003).
Products based on alginate were prescribed by the GP in 110 cases (39.9%; P = 0.067), by the medical specialist in 67 cases (24.3%; P < 0.001) and were recommended by the pharmacist in 57 cases (20.7%; P<0.001). Alginates were used mainly to control the epigastric burning (n = 86, 31.2%; P = 0.009), and acid regurgitation (n = 60, 21.7%; P < 0.001). Antacids were chosen without a medical prescription in 186 cases (66.2%; P<0.001) to control mainly the epigastric burning (n = 117, 41.6%; P < 0.001). The pharmacist recommended mucopolysaccharides in 138 cases (87.9%; P < 0.001) and herbal treatments in 58 cases (69.9%; P < 0.001) (Table
The duration of the therapy with PPIs was significantly longer than the one of the other therapies, lasting from more than one month to six months in 218 cases (40.4%; P < 0.001) and over six months in 101 cases (18.7%; P < 0.001). Antacids and mucopolysaccharides were only used when needed in 212 cases (80.6%; P < 0.001) and 107 cases (72.3%; P < 0.001), respectively (Table
This study provides real-world evidence data about the medication history of 1,020 individuals suffering from upper GI symptoms visiting a community pharmacy, and represents one of the most significant studies, in terms of sample size, performed in the Italian or European community pharmacies in this fild (
According to the results, two-thirds (67%) of the enrolled patients reported a frequency of symptoms higher than 1 episode per week (Table
As far as the most used therapeutics is concerned, results showed that the most common was PPIs (35.6%) (Table
Our study showed that more than one-third of eligible patients (37.9%) did not seek medical advice and about 42% of all medicines were assumed by patients based on self-medication (17.7%) or following pharmacists’ advice (24.4%). These trends agree with data available in the literature (
The monitoring of real-world usage of OTC medicinal products by community pharmacists would be useful to set up appropriate guidelines on the management and triage of patients suffering from upper GI symptoms, to improve pharmacovigilance, and the establishment of proper counseling on such medicinal products. Considering that patients expect high-quality counseling on self-medication (
In conclusion, this work represents, to the best of our knowledge, the first descriptive study conducted in the Italian community pharmacy setting, aiming at exploring the history of patients with upper GI symptoms, assessing their prevalence, and the pharmacological treatments used to manage them. The study’s findings confirmed the importance of the role of community pharmacists in supporting patients since about 40% of them had not seen a physician before entering the pharmacy. Data obtained from the present study may be a reliable support for the development of guidelines addressed to community pharmacists, fostering an evidence-based approach to the management of patients suffering from upper GI symptoms. Training and standardization of the pharmacist’s approach to professional advice may improve patients’ compliance and quality of life, as well as the pharmacovigilance of non-prescription medicines.
The authors are grateful to Matteo Alberto Baio, Giulia Contemori, Giulia Costa, Clementina Nucci e Stefania Paolazzi for the coordination of the SIFAC Group of Community Pharmacists (SGCP) and the other members of the SGCP: Caterina Accardi, Pasqualina Accogli, Valeria Armand, Maria Bono, Aurelia Capuani, Matteo Cattaneo, Maria Luisa Coppo, Valentina Dal Pos, Angela Di Cello, Laura Di Palma, Elisabetta Ferrara, Marzia Franzoni, Laura Gambino, Maria Gargano, Anna Rita Maggio, Giorgio Nenna, Gianluigi Petito, Viviana Romano, Giorgio Stancati, and Sara Zonta for data collection. The authors thank Chiara Deiana for editing and correcting the English of the manuscript.