In order to further standardize the clinical application of proton pump inhibitors and provide reference for the review of prescription suitability, the pharmaceutical affairs management professional committee of Chongqing Hospital Association launched the "Proton Pump Inhibitor Review Rule Formulation Project" in accordance with the "Guidelines for the Clinical Use of Proton Pump Inhibitors" promulgated by the General Office of the National Health Commission. Led by the First Affiliated Hospital of the Army Military Medical University, the project was led by clinical experts, pharmacy experts and evidence-based experts from many medical institutions in the United Nations, and discussed the key review contents of proton pump inhibitors, dosage, medication for special populations and drug interactions, and finally formed this consensus. The main content of the consensus includes the basic trial rules of omeprazole, esomeprazole, pantoprazole, rabeprazole, lansoprazole and eprazole (all including injections and oral preparations, according to the common name), and on this basis, 12 trial recommendations have been formed for some clinical applications not covered by the basic trial rules, in order to provide reference for medical institutions at all levels.
Expert consensus on proton pump inhibitor review rules
Pharmaceutical Affairs Management Professional Committee of Chongqing Hospital Association
Body content
Proton pump inhibitors (protonpumpinhibitors, PPIs), also known as gastric hydrogen-potassium pump (hydrogen-potassium adenosine triphosphatase) inhibitors, can block the common and final link of gastric wall cell acid secretion caused by various reasons by inhibiting hydrogen-potassium adenosine triphosphatase on gastric wall cells, thereby effectively and lastingly inhibiting gastric acid secretion. PPIs are currently one of the most acid-suppressing drugs and are widely used in the clinical treatment and prevention of acid-related diseases such as peptic ulcer, gastroesophageal reflux disease, upper gastrointestinal bleeding, and Dro-Ai syndrome (also known as "gastrinoma") and stress ulcers [1].
In recent years, the global use of PPIs has been increasing, with an increasing number of cases of hyper-indications, over-dosing, over-courses, and inappropriate combinations, which has greatly increased the risk and economic burden of medication in patients [2-4]. In order to further standardize the clinical application of PPIs and promote rational drug use, the General Office of the National Health Commission issued the Guiding Principles for the Clinical Application of Proton Pump Inhibitors (2020 Edition) (hereinafter referred to as the "Guiding Principles")[5], which put forward normative and principled opinions on the rational application of PPIs, and pointed out the direction for medical institutions to form unified and clear adjudication rules.
In order to better implement the Guiding Principles and make the manual and/or information-based review of PPIs prescriptions in medical institutions more operable, the Pharmaceutical Affairs Management Professional Committee of Chongqing Hospital Association launched the "Proton Pump Inhibitor Review Rule Formulation Project" in June 2021. The project was led by the First Affiliated Hospital of the Army Military Medical University, and clinical experts, pharmacists and evidence-based experts from many medical institutions in the United Nations discussed the key review contents of PPIs, such as indications, dosage, medication for special populations and drug interactions, and finally reached the following consensus: (1) Based on the drug instructions and the Guiding Principles, omeprazole, pantoprazole, rabeprazole, lansoprazole and eparazole (all including injections and oral preparations, According to the common name), the basic trial rules, and the clinical application beyond the trial rules stipulates four warning levels of "prohibition", "not recommended", "caution" and "concern", and corresponding interventions. (2) For some clinical applications not covered by the basic trial rules, 12 review party recommendations were formed based on evidence-based medical evidence. The grading criteria for the quality of evidence and the strength of recommendations are graded (gradingofrecommendationsassessment, developmentandevaluation), in which the quality of evidence is divided into four grades: "high", "medium", "low" and "very low", which are expressed in A, B, C, and D (Table 1); the recommended strength is based on the quality of evidence, the balance of pros and cons, the patient's values and wishes, As well as factors such as resource consumption, it is comprehensively determined and divided into two levels: "strong recommendation" and "weak recommendation", which are represented by "1" and "2".
1 PPIs basic review rules, warning levels beyond the trial rules, and interventions
The specific content of this section includes three parts: the basic trial rules, the warning level beyond the trial rules, and the intervention measures. PPIs that establish basic prescription rules include injections and oral preparations of omeprazole, esomeprazole, pantoprazole, rabeprazole, lansoprazole and eparazole, and the content of the rules of review include indications, dosage, medications for special populations and special pathological states, contraindications, drug interactions, etc. For the clinical application of the content beyond the "PPIs Basic Review Rules", this consensus stipulates four warning levels, from high to low, which are "disabled", "not recommended", "cautious use" and "concern", as detailed in Table 2. After the doctor issues the prescription, the prescription is reviewed by the pharmacist or the information-based prescription review system. Prescriptions that exceed the different warning levels of the trial rules correspond to different interventions, as detailed in Table 3. The basic review rules of each PPIs and the warning levels beyond the review rules are detailed in Table 4 to Table 15.
2PPIs reviewer recommendations
In view of some clinical application situations not covered by the basic review rules of PPIs under "1", on the basis of referring to the existing relevant guidelines and expert consensus, the problem-oriented, grade evaluation method is adopted, and clinical experts, pharmacy experts and evidence-based experts from many medical institutions in the United Nations hold project kick-off meetings, problem seminars and expert seminars, etc., and conduct two rounds of expert opinion consultation and modification, and finally form 12 review party recommendations, as detailed in Table 16.
3 Conclusions
This consensus is initiated by the Pharmaceutical Affairs Management Committee of Chongqing Hospital Association and invited domestic clinical and pharmaceutical experts to jointly participate in the formulation of the expert consensus to guide the rational use of PPIs by medical institutions, which is an expert consensus led by the association after the General Office of the National Health Commission issued the Guiding Principles, so that the "Guiding Principles" are landed, and the reviewers are more operable, hoping to provide an important reference for medical institutions to carry out MANUAL prescription review of PPIs and the setting and review of pre-trial party rules, and provide an important reference for the follow-up continuous development of anticoagulants. The construction of prescription rules for anti-tumor drugs and endocrine drugs provides a valuable reference.
References (abbreviated)
Source: China Pharmacy, Vol. 33, No. 8, 2022
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