小儿退热栓剂在县域儿科岗的给药适配度应用现状述评

Fever is one of the most common clinical symptoms in children, often causing great anxiety among parents and requiring timely and effective antipyretic treatment. County-level paediatric hospitals often have a large number of patients, a shortage of medical staff and poor medical conditions; therefore, how to use antipyretics efficiently and safely has become a problem in normal work ^[1]. The active components in pediatric antipyretic suppositories are acetaminophen or ibuprofen; thus, they are different from oral medications in terms of their pharmacological mechanism. In short, a suppository is a solid form of medicine that is introduced into the rectum and then dissolves or melts at body temperature to release the drug. The main reason for the administration of this drug is that it can be absorbed in the rectum through many blood vessels in the lower part of the rectum. This path can help the active pharmaceutical ingredient not be metabolised by the liver for a while, thus increasing its systemic bioavailability and speeding up its effect. The operation of administering suppositories is relatively simple; first, adjust the position of the child, lubricate the suppository if necessary, and gently push it into the rectum above the internal anal sphincter. The mechanical simplicity of the device does not require the child to swallow properly; thus, it avoids the problem of difficulty in swallowing or vomiting that may cause aspiration. Therefore, the practical application value of paediatric antipyretic suppositories in county-level paediatrics is relatively high. In the case of frequent refusal to take oral medicine and technical difficulties and time-consuming intravenous access, the rectal route can be employed to administer the drug accurately and easily. To evaluate the administration adaptability of this dosage form, we need to consider the shape of the suppository, the release time of the drug, and the actual circumstances of the local children ^[5]. The purpose of this paper is to present the current situation of the use of suppositories in county-level hospitals, explain the basic pharmacokinetic advantages and operating procedures of these suppositories, and discuss their clinical application and safety issues.

Pediatric antipyretic suppositories are solid rectal drug preparations that melt or dissolve at body temperature to release the drug. The main active ingredients are ibuprofen, paracetamol and other known safe antipyretic components for children, and they are designed especially for children aged 0 to 12 years old who have trouble swallowing oral medications. At the county-level pediatric clinic, the connotation of administration fitness is not only about whether the drug works well pharmacologically, but also includes many other aspects, such as the matching degree of the drug's properties with the local healthcare situation. First, the stability of the suppository will be checked to determine if it can be stored in the usual way at a county-level pediatric post, which is generally limited by cold-chain facilities and other supplies. In addition, it is suitable for the general group of febrile children in the area; that is to say, delayed presentation and concomitant gastrointestinal symptoms often make oral medication contraindicated. Operability for general clinical staff with basic professional skills is another important aspect, so the insertion method and subsequent monitoring need to be simple, easy to learn and operate, and do not require special training. Besides, it should be in line with the actual medication habits and acceptance of local children's families; therefore, it needs to meet the requirements of cultural acceptance of rectal administration and convenience for home care. It is necessary to distinguish the specific connotation from the general administration fitness of antipyretic suppositories in tertiary hospital pediatric departments. Tertiary-level evaluations mainly involve precise dosage calculations, optimisation of pharmacokinetics, and the integration of multiple drugs in a rich-resource environment. On the contrary, the county-level model is more practical in operation, has less capital, and can adapt to different situations; it will serve as a research basis for the application value of the above-mentioned formulations in grassroots medical institutions.

The theoretical basis for evaluating the suitability of drug use in grassroots pediatric care is based on the actual situation of limited resources and operation of county-level pediatric posts. The first level of this framework is divided into three parts: the suitability of prescription, the suitability of clinic operation and the suitability of post-operation management. Each dimension has its own second-level indicators that combine the practical situation of grassroots medical care with the international guidelines for pediatric rectal drugs.

Prescription matching suitability is the rationality of drug selection, and the core second-level indicator is the accuracy rate of indication matching. Based on the international guidelines for paediatric antipyretic suppository use and considering the limited diagnostic resources in the county, the above is to ensure that the prescriptions of suppositories conform to clinical indications such as vomiting, oral intolerance, etc.

The suitability of the operation process will be evaluated according to the administration operation standard compliance rate, and this is based on the standards for the depth and amount of rectal insertion in different countries. According to international protocols on rectal insertion depth and dosing precision, in view of the large number of patients and different professional levels at grassroots posts, this indicator will check whether the operators can operate in accordance with the standard requirements.

Post-administration management suitability is to monitor safety, and the second-level indicator is the early recognition rate of adverse events. According to the children's pharmacovigilance standard and the need for rapid triage in under-resourced grassroots clinics, this indicator can measure the ability to detect local irritation or abnormal absorption in a timely manner.

The score rules are zero to one hundred for each second-level index, and there are specific numerical standards for excellent, qualified and poor performance levels. The above is only for routine paediatric antipyretic care at county-level medical institutions. Based on the above standards, this will provide a standardised, quantified tool to support the first part of this paper's research on the current status and problems in clinical practice.

A systematic review of the peer-reviewed literature published in the last 15 years shows that there is a large difference in the global and domestic understanding of pediatric rectal antipyretic formulation use in primary care. In many low-resource primary medical settings around the world, it is accepted that antipyretic suppositories for children have therapeutic value, are non-invasive and can be used when oral intake is difficult due to vomiting or severe illness. However, there are also safety problems and operational shortcomings in these places according to the international studies. The main problems are that the depth of insertion is not correct, there is no consideration of the changes in rectal physiology in various stages of children's development, and the care-giver training is insufficient; all of these have a significant negative impact on the safety and pharmacokinetic predictability of the preparation. At home, research on the use of children's antipyretic suppositories in county-level and lower-level medical institutions is still in its infancy. Most of the current domestic literature is about the ways of giving drugs to children in large hospitals; thus, good nursing staff and a good environment for work are necessary for proper operation, and the system for monitoring is also relatively strong. There is a structural problem in research now; that is to say, the specific adaptability of the use of children in the county has been ignored. County-level hospitals face many problems, such as too many patients per doctor, lower awareness of health and illness among the general public, a lack of time for clinical observations, and so on; therefore, they have a particular working environment that is quite different from that of a large hospital. Therefore, the extrapolation of the data from the tertiary hospital to the county-level practice is not supported by evidence and may have operational risks. The innovation of this thesis is to address this specific research gap directly. Based on the data of the children's posts at the county level, the study develops a local system to evaluate how the administration can be adapted. It has closed the distance between the general pharmacological effect and the practical implementation ways needed in primary care, and has provided a basis for evidence-based operation procedures suitable for the resource and working environment of the county-level children's hospital.

To meet the demands of children with fever and other symptoms in the county-level pediatric departments, the medicine prescribed in the form of suppository should be suitable for their age, weight and fever level, and not be administered to people with allergies or other diseases. The actual situation at present is based on the public data of clinical prescriptions, the survey of paediatric medications in various places and the results of simulated prescription cases, and there are more serious non-compliance problems. There is a large proportion of situations in which the dosage of the suppository in the prescription does not meet the above clinical requirements.

The three main categories of non-compliant behaviour have been classified in an orderly manner. First, children who are underweight have been found to have taken an excessive amount of medicine; this is because doctors have relied on age-based prescription tables rather than precise weight-based adjustments according to pharmacokinetics. Second, administering repeatedly during a safe period will not only increase the possibility of liver damage but also serious adverse effects from drugs. Third, it is unnecessary to prescribe antipyretic suppositories for children with low fever below 38.5℃; first, they should be given some cold compresses to reduce the fever, and the children's condition will improve.

The reasons for these non-compliant behaviours are mainly due to two reasons. On the one hand, a large number of drug instructions have not been updated; at a busy county-level outpatient clinic, the doctor will calculate the dosage based on the age range in the table or by memory without following the instructions of the drug package insert for accurate weight calculation. On the other hand, there is a lack of timely access to reference materials for children's medication. There is no instant digital help or an updated clinical decision support system to indicate contraindications or repeated medication, so the doctor cannot check if the indication is suitable at that time. Therefore, the safety management system of suppository has been disrupted, and the role of standardised indication compliance in practice has been weakened; thus, there is more risk for children in regions with a shortage of medical resources.

The operation standard of rectal administration in grassroots pediatric clinics is to strictly follow the evidence-based clinical guidelines and pharmacological principles when administering pediatric antipyretic suppositories. The basic principle is that precise drug delivery through the rectal mucosa depends on standardised procedural steps, such as the right depth of insertion, the correct position of the patient, and the retention time after administration, to guarantee consistent bioavailability and good therapeutic effects. There is a considerable operational difference in the degree of standardisation of this at the county-level paediatric posts. Due to the high number of patients and the lack of nurses, the basic procedures are often neglected. Rather than using the recommended lateral decubitus position to increase mucosal contact and reduce the risk of expulsion, children are frequently administered the suppository in a prone or sitting posture, which harms the drug absorption kinetics. Moreover, the insertion depth is often less than two to three centimetres behind the internal anal sphincter. A shallow insertion will be expelled before the suppository has dissolved, and an excessively deep insertion may bypass the middle hemorrhoidal vein, directly entering the portal vein, thus causing first-pass metabolism of the drug and weakening its antipyretic effect. Another problem is the general lack of standardised monitoring after administration. Clinical guidelines stipulate that after administration, the patient should remain for a certain period to ensure that the medicine has dissolved and been absorbed; however, grassroots clinics do not comply with this and thus lack a record of the failure of the treatment. It is very important to standardise the above operations of rectal administration. Unstable operation practices will directly lead to variable plasma drug concentrations, so there may be no improvement in fever or hepatotoxicity caused by repeated doses. Therefore, it is necessary to develop and implement standardised operating rules to narrow the gap between the theoretical pharmacokinetic benefits of antipyretic suppositories and their actual clinical performance in under-resourced paediatric areas.

The post-adverse reaction monitoring and response ability is the whole set of clinical observation records and intervention plans that will be carried out after using pediatric antipyretic suppositories in the anus. This capability is needed to verify the safety of the dosage form in real life at the county level and reduce the risks of paediatric pharmacotherapy. The basis of the rule is that a continuous circulation of experience-based observation and intervention is required to promptly detect and treat local or overall adverse reactions.

There are three consecutive stages in the monitoring process at the county-level medical institutions: first, immediate post-administration observation of mucosal irritation or unexpected expulsion; second, short-term monitoring of systemic antipyretic efficacy and excessive absorption signs; and third, delayed follow-up for possible gastrointestinal problems. But the actual effect is still not good. Because of the high patient turnover and lack of staff at the county-level paediatric posts, the time for observation cannot be standardised. The response ability is also weak; the first line of defence does not know much about the relevant regulations for handling specific adverse events of suppositories, such as rectal syndrome and local necrosis. The records of such occurrences are often incomplete and based on retrospective reports from caregivers rather than prospective clinical monitoring, making it difficult to determine the actual rate of occurrence and thus affecting the analysis of pharmacovigilance.

Therefore, to improve this ability, it is necessary to have a uniform operation path. It is necessary to stipulate the shortest post-vaccination observation period for children to be discharged and incorporate a list of adverse reactions to suppositories in the electronic child health record. Strengthen the ability to respond in a targeted manner and train the personnel at the county-level medical institutions in fast diagnosis of suppository-induced local adverse events versus systemic drug reactions; set clear referral criteria for severe complications. Strengthen the above-mentioned monitoring and response mechanisms to ensure that the convenience of rectal administration is not compromised for the safety of paediatric patients at the county-level children's posts, and truly meet the clinical and physiological needs of children.

The fitness of the administration of pediatric antipyretic suppositories at the county level is not up to standard because of the large gap between the standard operating procedures and actual practice. International and domestic guidelines for children's rectal medication have set up unified steps, such as strict hand hygiene before surgery, sufficient lubrication of the suppository, proper depth of insertion in the rectum, etc. The children are then to lie laterally or prone for a certain period of time to prevent them from being expelled. However, it is found that non-standard operation links still exist in the county-level paediatric workstations. Staff often do not lubricate the suppository sufficiently before administering it, so the suppository is prone to frictional resistance and cannot be inserted smoothly. Incorrect insertion depth, usually too shallow, can easily cause the medicine to fall out and fail to treat the disease. In addition, children are often not kept in bed after taking medicine for long enough, and there is also a lack of standard hand washing before the operation; thus, the basics of infection control are not met. In addition to the above reasons, the operation standards of various county-level medical institutions are not uniform. County general hospitals have more staff and regular training, so they are relatively good at following procedures; however, township health centres often have poor standardisation and largely rely on experience rather than rules. The effects of these non-standard operations on the fitness of administration are serious. Insufficient depth of insertion and changes in posture too soon can result in rapid excretion of the drug and thus delay the reduction of fever. At the same time, insufficient lubrication and improper insertion mechanics will lead to unnecessary mechanical trauma and further aggravate local rectal irritation, causing immediate distress to children and resistance from caregivers to rectal preparations, thus perpetuating a vicious cycle of poor medication use in resource-poor areas.

There is still a lack of good monitoring and response capacity for adverse events after administration at the county-level pediatric clinic, which would directly affect the safety of children taking antipyretics in this region. Common mild adverse reactions after taking the above medicine are local irritation at the site of injection, mild diarrhoea and low body temperature. Although they occur quite often, many county-level paediatric institutions have not yet begun to carry out special monitoring for these adverse events. Routine pharmacovigilance is usually general, without specific standards for rectal administration, so these localised reactions are often not reported and not recorded. In addition, the grassroots paediatric staff do not know how to quickly identify rare and severe adverse reactions, such as drug rash and abnormal blood pressure. There is no ready-to-use standardised reaction process, and thus the diagnosis is delayed. In the case of an adverse event, clinicians often rely on fragmented clinical experience rather than a systematic protocol; thus, they may delay or improperly intervene. Therefore, medical staff often do not provide accurate reports of adverse events due to the cumbersome documentation process and lack of standardised operational guidelines for the primary care environment. Systemic problems in post-administration management can cause serious clinical risks. Without active monitoring, mild rectal irritation will develop into mucosal injury, and unchecked abnormal blood pressure or severe drug rash may be life-threatening. The lack of collection and analysis of adverse event data also results in a lack of knowledge about local pharmacovigilance for all drugs, so it is difficult to improve the suitability of suppository administration. To solve this problem, a unified monitoring and response system should be built at the grassroots level, and grassroots staff need to be trained in quickly identifying, systematically managing and accurately reporting adverse events to protect children's medication safety and improve the overall adaptability of suppository therapy in the county.

In short, the flexibility of administration for pediatric antipyretic suppositories in county-level hospitals is a combination of pharmacy preparation technology and grassroots care. Fundamentally, the main purpose of the above suppositories is to achieve antipyretic effects through rectal absorption; thus, they can bypass the first-pass effect and address the problem of children not wanting to take oral drugs. County-level hospitals often have many children with high fever and vomiting or who cannot take oral medications; therefore, the traditional way of giving them orally is inconvenient or even impossible.

In order to have good adaptability to all people, the degree of insertion needs to be appropriately controlled; besides, the amount to be given should be based on the child's weight rather than age; moreover, the child should be placed in a suitable position to avoid the early removal of the medicine. But there are many problems in the current path of implementation at the county level. Caregivers are often not trained in the correct insertion method and due to a large number of patients, medical staff may not offer sufficient guidance for drug administration. Moreover, if the size of the suppository is not in line with the age of children of different ages, it will be hard to be absorbed and may cause local irritation of the mucous membrane.

Improving the adaptability of this application will be of great benefit. By regulating the operating procedures, one can obtain the expected pharmacokinetic data and prevent subtherapeutic dosing or inadvertent toxicity. In resource-poor areas of county-level hospitals, the reliable effect of antipyretic suppositories can reduce the incidence of fever-induced seizures and lower the need for intravenous administration, which is more expensive and risky. Therefore, improving the adaptability of pediatric antipyretic suppositories in terms of administration is not only an issue of pharmaceutical preparation but also a crucial demand in clinical practice ^[4]. A strict operational guide and targeted caregiver education should be formulated to address the gap between the theoretical advantages of rectal drug administration and its actual therapeutic effects in grass-roots pediatric care. Finally, guaranteeing the accuracy of administration will directly protect the safety of children's medications and improve the quality of basic health services.

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