Proton pump inhibitors have long been cornerstones for treating gastroesophageal reflux disease, a malady caused by excessive stomach acid escaping into the esophagus. Treatment is not limited to GERD but also extends into the realm of management in Barrett’s esophagus, peptic ulcers-most often drug-induced due to the overuse of nonsteroidal anti-inflammatory drugs, Helicobacter pylori infections (alongside antibiotics), and Zollinger-Ellison syndrome, to name a few.
Common prescription PPIs in the U.S., currently, include the likes of pantoprazole, omeprazole, lansoprazole, esomeprazole, rabeprazole, and dexlansoprazole. Of these, omeprazole, esomeprazole, and lansoprazole are also available OTC in the United States. The FDA approval of omeprazole in the United States was the first step in what became an. As a result, large numbers of people take PPIs too often and for much longer than necessary. Moreover, following over-the-counter availability beginning in 2003, many without a legitimate medical need started using PPIs without oversight or medical guidance.
In the late ’90s, 4% of the population in America received prescriptions for PPIs. Contrarily, since the approval of OTC variants, prescription PPIs have increased fourfold. This is closely related to the increase in the number of prescriptions for PPIs and the growing number of research concerned with the harmful effects of PPI overuse. In present times, at any given time, 7% to 15% of the population of the U.S. is consuming PPIs regardless of age and gender. For instance, a review of the results of an estimated 6.8 billion outpatient visits from 2009 to 2015 revealed that some 600 million individuals or 8.8 percent of the study group were on prescription PPIs. What was the astonishing part, though-the fact that probably two-thirds of them were taking PPIs without clear-cut therapeutic goals or for longer than that was necessary. Finally, about one-quarter of older Americans take prescription PPIs for more than a year, usually in addition to OTC versions.
This inadvertent overuse of OTC PPIs is partly explained by the limited familiarity of the general public with medical knowledge and terminology. The majority of the users of OTC PPIs are unaware of the fact that these drugs do not act immediately to alleviate acidity or heartburn; it may take as long as 1 to 4 days before the noted therapeutic effect of these drugs is observed, thus defeating the expectation of rapid symptom alleviation.
The prescription of PPIs should be reserved, similarly, for people who have heartburn twice a week. The general misunderstanding of how to use PTCs frequently results in therapeutic duplication whereby patients unknowingly combine prescription and over-the-counter PPIs. The host of adverse events associated with prolonged administration led many studies, systematic reviews, and FDA warnings to raise long-term PPI use as being associated with kidney problems, bone fractures-particularly of the hip, wrist, and spine-chronic kidney disease, infection, especially related to antibiotic-resistant Clostridium difficile, and cardiovascular disease. In light of such risks, OTC PPIs must be the drug of last resort-resorted to only when antacid classes such as aluminum-, calcium-, and magnesium-based antacids as well as H2 receptor antagonists like famotidine and ranitidine have already failed.
This is where pharmacists and interns can intercede as the much-needed line of defense by simply asking pointed, open-ended questions of anyone who requests an OTC PPI. Other currently taken medications, patient’s age, gender, symptoms, and previously administered therapies are very useful in raising suspicion for potentially inappropriate/ harmful use of PPIs. There is an increasing body of evidence that most patients on long-term PPI therapy have one or more chronic diseases, and the increasing adverse evidence on long-term therapy requires re-evaluation of such therapy. The relative few studies address the possible disparities in PPI overuse concerning age, gender, or socioeconomic status. Such studies also identify that the use of PPIs among infants is of questionable efficacy and safety; thus, there is almost a complete absence of any therapeutic benefit while adverse effects may be more easily produced.
Current Gaps
There are continuing gaps in current knowledge of PPI overuse- the overuse because of the uninadvertent combination of prescription and OTC variants. A fair share of the risks associated with PPI could be modulated by the addressing of these gaps. Whereas in the use of controlled or scheduled drugs, there is no tracking system that would be quite invaluable to pharmacists monitoring patient use to prevent duplications of unnecessary therapy. Adding the PPI use data in the medication management platforms would offer pharmacists the capability of reconciling the therapies, thereby minimizing the risk of such duplications.
Another strategy for the prevention of inappropriate PPI practice may be achieved by pharmacy-based computerized systems, allowing the choice for the pharmacy staff to reject the automatic renewal of a PPI. These systems should also always prompt special approval and justification to confirm the indication of long-term PPI therapy. The growing trend of mid-level practitioners given prescribing privileges, coupled with a complete absence of deep knowledge related to PPI pharmacology, may constitute an additional cause of overprescription. These exacerbating factors include prescribing for unnecessarily long durations, ordering excessive quantities, or ignorance of a patient’s OTC PPI use.
In a nutshell, OTC PPIs can be a godsend for patients-provided they are used judiciously with the help of a team of pharmacists, prescribers, and pharmacy managers who ensure that use is clinically justified, minimizing the risks of duplicative therapy.
This article was originally published on pharmacytimes. Read the original article.
Frequently Asked Questions
- Can OTC PPIs be taken long-term?
no It is not advisable to take OTC PPIs for a long period without being medically supervised, as this may result in side effects and dependencies. You should consult a health provider for a personalized treatment plan.
- What are the safest alternatives to PPIs?
Lifestyle changes, dietary adjustments, and natural remedies may be more effective than medicating. H2 blockers and antacids will also work as the symptoms are tamed without the associated long-term side effects of PPIs.
- How can I avoid PPI dependence?
Take PPI only when prescribed and for the shortest period possible. Gradual withdrawal under a doctor’s supervision can help the body get off the habit of relying on these medicines.
- Are over-the-counter PPIs safe to take during pregnancy?
OTC PPIs have not been able to establish their safety in pregnant women. A healthcare provider should be consulted by a pregnant woman before taking such medications to ensure they are free from risk for the mother and baby.
- What should I do if my heartburn does not improve with a PPI?
If you have not experienced an improvement in your heartburn with just a PPI, you should speak to a healthcare professional. Continued symptoms may suggest an underlying disorder requiring medical intervention.