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Original Research (Original Article) 


Ibrahim Masoodi, 2019;3(8):699–704.

International Journal of Medicine in Developing Countries

Prescription pattern of proton pump inhibitors among adults: a drug utilization study in the western region of Saudi Arabia

Ibrahim Masoodi1*

Correspondence to: Ibrahim Masoodi

*Department of Internal Medicine, College of Medicine, Taif University, Taif, Saudi Arabia.

Email: ibrahimmasoodi [at] yahoo.co.in

Full list of author information is available at the end of the article.

Received: 09 April 2019 | Accepted: 13 April 2019


ABSTRACT

Background:

There is an increase in the indiscriminate use of PPIs during the past decades. The adverse effects of PPIs urge to control their prolonged use. This study aimed to get a clear understanding of the pattern of PPI prescriptions, assessment of the duration of administration focussing on the various predisposing conditions resulting in their prolonged use.


Methodology:

This cross-sectional descriptive study was carried out using a pre-designed questionnaire involving the adult subjects from Taif city in the western region of Saudi Arabia. The study was conducted during the period from March 2018 to August 2018 using an online proforma circulated employing social media and E-mail.


Results:

A total of 808 (506 females) subjects took part in the study. The mean age of the study subjects was 49.4 ± 12.5 years. Among the total subjects, 17% of them were found to use PPI (omeprazole, Pantoprazole, and Rabeprazole) as an over the counter medication for more than 6–8 weeks of duration. The mean duration of PPI use was found to be 103.8 days which was significantly higher (p < 0.001) than the prescribed duration of 37.3 days. The majority of the prescriptions were from internal medicine specialists (309, 46.4%) followed by general practitioners (214, 35.7%). PPI was co-prescribed for diabetes in 47 (5.8%), hypertension 36 (4.5%), cardiovascular disorders 30 (3.7%), and arthritis 23 (3%) in this study.


Conclusion:

The present study found a relatively high tendency to overuse of PPI among the adults residing in Taif city, Saudi Arabia. The prescription rates for non-gastrointestinal (GI) causes outnumbered GI cause.


Keywords:

Proton pump inhibitors, over the counter drug, gastrointestinal, omeprazole, Rabeprazole.


Introduction

In recent years, over the counter (OTC) prescription of proton pump inhibitors (PPIs) has dramatically increased. The six types of PPI approved by food and drug administration (FDA) [1] resemble in their pharmacological mechanism of action (inhibition of active parietal cell acid secretion) but differ mainly in the duration of action [2]. Although PPI use has brought a dramatic relief in the management of peptic ulcer disease (PUD), gastroesophageal reflux disease (GERD), non-variceal gastrointestinal (GI) bleeds, and Helicobacter Pylori eradication [3], their continued and prolonged use have surfaced many complications. Regarding the safety of PPI for a long duration, the studies concluded that the administration of PPI for a period longer than 1 year to be associated with various side effects [4,5]. In 2010, the FDA raised the safety concerns regarding the prolonged use of PPI as bone fractures were reported to start as early as 14 days of its use. Other adverse effects described, include increased susceptibility to pneumonia, hypomagnesemia, vitamin B12 deficiency, and acute interstitial nephritis [5,6].

Besides the side effects, indiscriminate use of PPI has been also reported to result in high financial implications to a given health care system [7,8]. The cost of PPI therapy is enormous when continued for a long term without medical advice. A longitudinal study conducted in four European countries to investigate PPI administration cost versus anti-reflux surgery (ARS) for a period of 5 years suggested that the cost of PPI treatment was significantly higher than that of ARS [9]. The above study also highlights a proper assessment of GERD patients and an early referral for ARS when indicated. Some brands of PPI are costlier than others affecting the cost of therapy yet another way. A meta-analysis compared 63 studies measuring the differences between PPI drugs, revealed no superiority for any PPI brand. The study also revealed that most of the included cases belonged to non-complicated GERD or PUD where the duration of PPI therapy could have been reduced resulting in decreased cost of prolonged treatment. Finally, it compared the six PPI drugs costs in British Colombia that varied by 10-folds [10]. Thus, prescription of PPI should be individualized to prevent unnecessary side effects of the medication and circumvent cost factors [1,3,5]. This study aimed to assess the prescription pattern of PPI with emphasis on the percentage of patients consuming PPI as an OTC drug for a long duration.


Subjects and Methods

This cross-sectional descriptive study was carried out using a pre-designed questionnaire involving the adult subjects from Taif city, the western region of Saudi Arabia. The study was conducted during the period from March 2018 to August 2018 using an online proforma circulated employing various social media and E-mail. The responses were excluded if they were from: (1) subjects less than 18 years of age; (2) subjects who did not understand the questionnaire; and (3) subjects who provided incomplete responses. This study was conducted in adherence to the Declaration of Helsinki of good clinical practice. The collected data were statistically described regarding frequencies (number of cases) and valid percentages for categorical variables. Mean and the standard deviation was used to describe parametric numerical variables. Paired t-test was used to compare between the prescribed and actual durations of omeprazole usage. A p value less than 0.05 was considered as significant. All statistical calculations were done using computer program IBM SPSS (Statistical Package for the Social Science; IBM Corp, Armonk, NY, USA) release 21 for Microsoft Windows.


Results

The data from 808 participants (62.6% females) were included in this study. The mean age ± SD was 49.4 ± 12.5 years. The study cohort comprised 31.3% (253) employed, 46.7% (377) students, and 22% (178) unemployed subjects. The majority of the study subjects 581 (71.9) were with a university degree, 204 (25.2%) had a secondary level degree, and 1.7% of subjects had a postgraduate degree. It was observed that 139 (17.2%) patients were taking PPI without a prescription, and 669 patients (82.8%) had been prescribed the drug. As shown in Figure 1, the maximum prescriptions were from internal medicine specialty 309 (46.2%) followed by 214 (32%) from general practitioners, gastroenterologist 6%, surgeons (3.9%), cardiologist (3%), orthopedics (3.9%), pharmacist (2.7%), and rheumatologist (1.5%). PPI was prescribed to 130 (19.4%) for abdominal pain, 244 (36.5%) for GERD. There were 9 (1.3%) participants who had been prescribed PPI for upper GI bleeding. The study subjects on PPI after bariatric surgery and for duodenal ulcer treatment comprised for 0.3% (two cases), respectively. Among the 808 study subjects, 337 (41.7%) were on analgesics for their musculoskeletal disorders and had co-administration of PPI for prolonged periods. PPI was dispensed by a community pharmacy in case of 234 subjects (35%) and 373 (46.2%) received it from the hospital pharmacy. The use of OTC, PPI for more than 6–8 weeks was found among 116 subjects. The PPI dosage varied from 20 mg once daily in 375 (56.1%) to 20 mg twice daily among136 (20.3%) subjects. A higher dose of PPI, 40 mg once daily were consumed by 135 (20.2%) and twice daily by 23 (3.4%) subjects. Among 808 study subjects, 329 (40.71%) had it for 1 month, 111 (13.73%) for 2 months, 25 (3.09%) for 3 months, 20 (2.47%) for 6 months, and 7 (0.87%) for 1 year. One patient had been consuming PPI for the last 15 years. The details are shown in Figure 2. While, 581 (71.9%) subjects had no co-morbidity, 47 subjects (5.8%) had diabetes mellitus, 37 (4.6%) had peptic ulcer, 30 (3.7%), subjects had cardiac diseases, 23 (2.8%) subjects had arthritis. Gallstones were found in 14 (1.7%) participants. Epilepsy, Bechet’s syndrome, dermatitis, hypothyroidism, renal failure, and sickle cell anemia ulcerative colitis were other disease reported. Among the 808 study subjects, there were 158 (19.6%) smokers of whom 76 (48.1%) had been smoking for more than 10 years. The association between PPI consumption and smoking was found significant. One hundred and twenty-six participants had been prescribed PPI after an endoscopic examination. It was observed that GERD was the most common finding with varying LA class of esophagitis 46 (38.3%) followed by H pylori 30 (23.8%), duodenal ulcer 31 (24.6%), and antral gastritis 19 (15.07%). The details are shown in Figure 3. People eating fast food comprised of 529 (65.5%) of the study cohort while 447 (55.3%) were eating spicy food including hot pepper, 361 (44.7%) were not consuming spicy foods. A significant association was observed between PPI consumption and fast food intake as shown in Table 1. Regarding tea consumption: the number of teacups consumed ranged from one cup a day in 243 subjects, two cups a day in 140, three cups a day in 85, and four cups a day in 40 subjects. Furthermore, 44 participants consumed five cups a day, and 24 subjects participants consumed 10 cups a day. Sixty-six subjects denied consumption of tea. A significant association was observed between PPI consumption and tea consumption as shown in Table 1. Abdominal pain was relieved in 229 (43.6%) after administration of PPI, Flatulence was relieved in 75 subjects (10.9%), and symptomatic relief was observed in 236 (34.4%) subjects with GERD (Figure 4). The prescribed duration of PPI in 617 subjects was 37.3 ± 35.46 days, and the actual PPI consumption among 538 subjects was 108.8.3 ± 429.9 days. There was a significant difference between the two (p-value ≤ 0.001).

Figure 1. Prescription pattern of PPI as per the specialty.

Figure 2. Actual duration of PPI usage beyond prescription.

Figure 3. Endoscopic diagnosis and PPI usage.


Discussion

The objective of this study was to provide a comprehensive utilization of PPI in the western region of Saudi Arabia. It was observed that 9.9% of subjects were consuming PPI as a non-prescription drug and the majority of the study subjects consumed it beyond permitted duration as detailed in Figure 2. Possible reasons for this association may be the lack of awareness regarding the side effects of PPI among general population and availability of this drug as an OTC medication. While PPI was prescribed more often by internal medicine specialists, 7% of the study subjects consumed it of their own for the relief of upper abdomen pain as shown in Figure 1. A study conducted in the United States of America (USA) for measuring PPI dispensing from 2006 to 2010 found that the patients with more than one chronic condition were slightly higher in association with PPI dispensing which could explain the higher number of prescriptions from internal medicine specialty found in this study [11]. In this study, 51.2% of PPI consumers were suffering from GERD which is in cognizance with data from Iceland [12]. There was a significant association between PPI consumption and dietary habits. It was observed that participants consuming unusually high spices, excessive tea, and fast foods were significantly consuming PPI for a longer duration as shown in Table 1. While studying the effects of diet on GERD Jarosz et al. [13] in a case-controlled study observed that fatty foods, fried, sour, and spicy foods were associated with higher reflux symptoms. In another study, Chang et al. [14] in Taiwanese cohort demonstrated that the excessive consumption of tea and alcohol were positively associated with GERD. It could be postulated that emphasizing on dietary precaution could go a long way in deprescribing PPI in a given population. Studies have found that 20 mg once daily PPI for less than 2 weeks is safe but a cautious approach is warranted, especially in elderly subjects as it may mask the symptoms of adenocarcinoma [15,16]. Furthermore, the empirical use of PPI in undifferentiated GERD may be suitable for the young but prescriptions in erosive esophagitis being more common and severe in elderly warrant an endoscopic examination [5,6]. PPI was prescribed after an endoscopic examination in 126 patients in this study. Erosive and Non-erosive GERD were the most common diagnosis after an endoscopic examination, followed by H pylori, duodenal ulcer, and antral gastritis as shown in Figure 3. Short-term administration in treating frequent heartburn is recommended by laureate panels and various guidelines for only 2 weeks with 20 mg dose once daily [13] with no preference of PPI types as demonstrated by Heidelbaugh et al. [17]. Prolonged therapy is not required as the duration of healing were all recorded within 4–8 weeks for heartburn, GERD, and H. Pylori eradication by various researchers [2,4]. It may be prudent to mention that the dose of long-term PPI should be periodically re-evaluated so that the lowest effective PPI dose can be prescribed. While a majority of the patients in this study were consuming 20 mg once daily, the PPI doses varied from 40 mg once daily (20.2%) to 40 mg twice daily in 3.4% of study participants in this study. Long-term use of PPI is indicated in specific cases as prevention of re-bleeding in suspected cases, refractory GERD, Barrett’s esophagus, and Zollinger-Ellison syndrome [2,18]. None of the study participants in this study had such conditions meriting the prolonged use of PPI. PPI deprescribing policy should be adopted after 4 weeks of treatment. All attempts should focus on stopping PPI, reducing the dose or on using “on demand” dosing to prevent long-term side effects of the drug [19]. In a study conducted in Denmark to assign the criteria required for a long-term use of PPI, only 1/3 of the (124,133) population were found to have required long-term PPI [20]. In this study, the total duration of prescription was 37.3 ± 35.46 days, but the actual PPI consumption was 108.8.3 ± 429.9 days which was significantly higher (p < 0.001). This highlights the inappropriate use of PPI and questions the exact indications for each case. Increased incidence of side effects is directly proportional to the duration of administration. This study identified 29 study subjects consuming PPI for more than 5 years highlighting their increased risk of osteoporosis as acid suppression has been implicated in the impairment of calcium and Vitamin D absorption [2]. This may be particularly relevant in old people with consequences of osteoporosis. There are multiple reasons why old people are often co-prescribed PPI. First, as co-prescription with analgesics due to a higher prevalence of musculoskeletal pains and second along with anticoagulation medication as GI bleed prophylaxis. However, PPI affects metabolism and absorption of vitamin K and may cause thrombosis [2,21]. Retrospective studies have noticed an association between long-term high dose PPI and myocardial infarction, renal failure, and dementia although exact cause remains elusive [21,22]. It was observed that 3.7% of the cases had PPI co-prescription for chronic cardiac disorders, but the actual number will be quite higher as the study did not focus illiterate and old population.

Table 1. Potential factors associated with PPI prescription rate (n = 808).

Potential factors for PPIs prescription Percentage of patients who were prescribed PPIs prescription (%) p-value
Smoking habits Yes
No
93.7
80.2
<0.001
Analgesic usage Yes
No
92.3
76.0
<0.001
Chronic diseases Cardiac disorders
Diabetes Mellitus
Arthritis
Gallstones
Hypertension
No
100
100
95.7
92.9
91.7
78.0
<0.001
Spicy food intake Yes
No
87.9
76.5
<0.001
Fast food intake Yes
No
87.0
74.9
<0.001
Tea consumption Yes
No
87.1
70.8
<0.001

Figure 4. Relief of symptoms after PPI usage.


Conclusion

Based on the discussed results it may be concluded that PPI use for more than 6–8 weeks is significantly common among the adults in the Taif city, Saudi Arabia. Continuous medical education programs are needed to raise the awareness of healthcare providers and the public about the various side effects of long-term use of PPIs. The study also highlights the restriction of PPI as OTC drug.


Acknowledgment

The author would like to thank the data collectors of this study viz. Khairiah Yaqoub Alqashqari, Abdullah Hussain Alfaifi, Samar Musarri Alkhaldi, Ghaida Turki Alrbaiai, Mohammed Abdullah Alsuwat, and Afrah Muhaisen Allehabi Mohammed Abdullah Alzahrani who helped in explaining the study goals and collected data meticulously for this study.


List of Abbreviations

ARS Anti-reflux surgery
FDA Food and drug administration
GERD Gastroesophageal reflux disease
GI Gastrointestinal
OTC Over the counter
PPI Proton-pump inhibitors
PUD Peptic ulcer disease
SPSS Statistical Package for the Social Science

Conflict of interest

The author declares that there is no conflict of interest regarding the publication of this article.

Funding

None.


Consent for publication

Informed consent was obtained from all the participants.


Ethical approval

The study was conducted online without any medical or surgical intervention and required no ethical approval. This study was conducted in adherence to the Declaration of Helsinki of good clinical practice.


Author details

Ibrahim Masoodi1

  1. Department of Internal Medicine, College of Medicine, Taif University, Taif, Saudi Arabia

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How to Cite this Article
Pubmed Style

Ibrahim Masoodi. Prescription pattern of proton pump inhibitors among adults: A drug utilization study in the western region of Saudi Arabia.. IJMDC. 2019; 3(8): 699-704. doi:10.24911/IJMDC.51-1552663163


Web Style

Ibrahim Masoodi. Prescription pattern of proton pump inhibitors among adults: A drug utilization study in the western region of Saudi Arabia.. http://www.ijmdc.com/?mno=37359 [Access: September 23, 2019]. doi:10.24911/IJMDC.51-1552663163


AMA (American Medical Association) Style

Ibrahim Masoodi. Prescription pattern of proton pump inhibitors among adults: A drug utilization study in the western region of Saudi Arabia.. IJMDC. 2019; 3(8): 699-704. doi:10.24911/IJMDC.51-1552663163



Vancouver/ICMJE Style

Ibrahim Masoodi. Prescription pattern of proton pump inhibitors among adults: A drug utilization study in the western region of Saudi Arabia.. IJMDC. (2019), [cited September 23, 2019]; 3(8): 699-704. doi:10.24911/IJMDC.51-1552663163



Harvard Style

Ibrahim Masoodi (2019) Prescription pattern of proton pump inhibitors among adults: A drug utilization study in the western region of Saudi Arabia.. IJMDC, 3 (8), 699-704. doi:10.24911/IJMDC.51-1552663163



Turabian Style

Ibrahim Masoodi. 2019. Prescription pattern of proton pump inhibitors among adults: A drug utilization study in the western region of Saudi Arabia.. International Journal of Medicine in Developing Countries, 3 (8), 699-704. doi:10.24911/IJMDC.51-1552663163



Chicago Style

Ibrahim Masoodi. "Prescription pattern of proton pump inhibitors among adults: A drug utilization study in the western region of Saudi Arabia.." International Journal of Medicine in Developing Countries 3 (2019), 699-704. doi:10.24911/IJMDC.51-1552663163



MLA (The Modern Language Association) Style

Ibrahim Masoodi. "Prescription pattern of proton pump inhibitors among adults: A drug utilization study in the western region of Saudi Arabia.." International Journal of Medicine in Developing Countries 3.8 (2019), 699-704. Print. doi:10.24911/IJMDC.51-1552663163



APA (American Psychological Association) Style

Ibrahim Masoodi (2019) Prescription pattern of proton pump inhibitors among adults: A drug utilization study in the western region of Saudi Arabia.. International Journal of Medicine in Developing Countries, 3 (8), 699-704. doi:10.24911/IJMDC.51-1552663163