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Invited Review

Regulating the Use of Drugs in Diarrhea

Mittal, S. K.; Mathew, Joseph L.

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Journal of Pediatric Gastroenterology and Nutrition: October 2001 - Volume 33 - Issue - p S26-S30
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Acute diarrhea continues to be a major public health problem, especially in the developing countries. The advent of oral rehydration therapy (ORT), reassessment of nutrient absorption and feeding practices during and after acute diarrhea, and reevaluation of safety and efficacy of various antidiarrheal drugs (1) have led to the formulation of guidelines for rational management of diarrhea. However, despite complete consensus on these guidelines and strong scientific evidence to back them, these guidelines are rarely followed in actual clinical practice.

Currently available evidence suggests that commonly used antidiarrheal drugs like loperamide, diphenoxylate, various binding agents, and antimicrobials are either unsafe or ineffective in acute watery diarrhea and hence are not recommended for routine clinical use. (Table 1) (2). Their misuse increases not only the cost of therapy and exposes infants and children to potential toxic effects, but also diverts attention of both the caregivers and care providers from more rational therapies such as ORT and appropriate feeding practices.

Status of antidiarrheal drugs in children: Practice Parameters of American Academy of Pediatrics Sub Committee on Acute Gastroenteritis 1996


Various studies have highlighted the widespread use of drugs by mothers and other caregivers in treating their children with diarrhea. Mothers are concerned about decreasing the duration and amount of diarrheal losses and demand action to stop diarrhea rapidly. Apart from the fear of the supposed consequences of prolonged diarrhea, there is also concern to get back to routine daily activities. The beliefs of other family members and their image as a “good mother” who takes action to stop diarrhea further increases the mother's compulsion to use antidiarrheal drugs. Thus mothers consider antidiarrheal drugs not only desirable but also widely acceptable. This belief is frequently reinforced when mothers turn to other family members rather than to medical facilities for medical help. Thus, in rural Guatemala, more than 80% of mothers sought advice from an older woman in the family and the remainder from the nearest pharmacy/drug seller, none of whom advised or even suggested the use of oral rehydration solution (ORS) (3). Any treatment using Western drugs was considered desirable and prestigious by more than 80% of mothers. In that area, there was a tendency for mothers to visit private practitioners in preference to government facilities because the former responded to their demands. Similar tendencies seem to be prevalent in other parts of the world as well (4). Low educational status of parents may also be a reason for seeking drugs to control diarrhea rather than correction of dehydration. In Kenya, pharmacies in low socioeconomic urban and rural areas sold less oral rehydration solution (ORS) than those in middle and higher income urban areas (5).


For a variety of reasons, physicians appear to be mainly responsible for the widespread and rampant prescription of antidiarrheal drugs in children. For instance, in Chennai, India, of 48 private practitioners interviewed about their practices in treating childhood diarrhea, more than 80% prescribed antibiotics; loperamide was used in 56% cases, diphenoxylate plus atropine in nearly 20%, and absorbents in approximately one third of cases (6). Similarly in Lahore, Pakistan, of 262 general practitioners interviewed, almost two thirds prescribed ORS with some drug and 15% prescribed a drug alone. Less than one fifth of the practitioners prescribed only ORS (7). Surprisingly, attending a diarrhea-treatment training course and reading World Health Organization (WHO) guidelines for the management of childhood diarrhea had no impact on prescribing practices.

In Delhi, India, almost two thirds of practitioners prescribed a combination of antidiarrheal plus antimicrobials for diarrhea in children younger than 5 year olds. Only one in four doctors interviewed claimed to prescribe ORS. This disturbing trend was equally prevalent in the government and private sector (8). Other reports (9–11) also have pointed out the widespread misuse of drugs in childhood diarrhea. Muthuri et al. (12) have recently summarized various demographics and health surveys in this regard.

The problem of unwanted and unwarranted drug prescription in diarrhea is not restricted to developing nations or to pockets of illiteracy alone. For instance, in the Lille region of France, of 326 infants admitted to various hospitals with diarrhea, almost three fourths had already visited a physician; however, only 35% had been advised to use ORS whereas almost half were prescribed lactose-free milk. At least one drug had been prescribed in 94% children with a mean of 2.6 drugs per infant. One third of the infants received antibiotics (13). Similarly, in the United States surveys also revealed that health care providers do not follow recommended procedures for managing childhood watery diarrhea (14).

This aberrant prescribing behavior is not limited to the treatment of acute diarrhea, but is often seen in the other common childhood conditions, such as acute respiratory infection and fever (15). Studies in Lima, Peru, also revealed that knowledge (or the lack of it) was not the reason for physicians prescribing behavior (16).

Physicians' Reasons for Prescribing Drugs in Diarrhea

Although in many instances physicians are aware of appropriate treatment guidelines, they seem to be caught in a dilemma between scientifically appropriate therapy and socially desirable treatment (7,8,17–19). It is not surprising that those working in communities, and dependent on them for their livelihood, tend to respond to their felt social need for action to stop diarrhea. Table 2 highlights some of the quoted reasons for prescription of antidiarrheal drugs or failure to advise ORS. Mothers' desire to have drugs and physicians' willingness to prescribe constitute a self-perpetuating cycle.

Why physicians prescribe drugs in diarrhea

Adult Treatment Practices

Unfortunately, the child is often regarded as a small adult; hence, therapeutic regimes deemed successful and actually recommended in adults (Table 3) (20) are indiscriminately used in children as well. This practice is a natural tendency among physicians, particularly when the nature of childhood diarrhea seems no different from that of the adult disease and the consequences are known to be much worse. Thus there is anxiety to treat it fast.

Adult recommendations: Practice Parameters of the American College of Gastroenterology (indications and recommendations)

In addition, most general practitioners have had little or no experience or training in managing pediatric patients. Hence, they tend to extrapolate adult regimes to children, evidenced by the different prescribing practices of general practitioners and pediatricians in the same patient population (13,21). Availability of a large number of unqualified practitioners or practitioners of alternate systems of medicines in the community, among whom prescribing antidiarrheal drug is almost universal, further increases the pressure on modern practitioners to prescribe these irrational drugs.

Accessibility and Availability of Antidiarrheal Drugs

Easy availability of antidiarrheal drugs is an important factor in perpetuation of their misuse. Most of the antidiarrheal drugs are easily available at pharmacies. Even though, in most countries, law mandates their sale only with proper prescriptions and even though many have been descheduled and banned, the reality in practice is quite different. For instance, in Chennai, India, of 56 pharmacists interviewed, more than three fourths dispensed loperamide. More than 50% sold diphenoxylate, and almost one in five sold binding agents like kaolin or pectin—all without prescription. Further, more than 50% of them sold antibacterial drugs when approached for medication to treat diarrhea (6).

Similarly, in several African nations, in which drugs are generally advised and sold by pharmacies, and advise of the sellers is essential for appropriate therapy, most sold unwanted and unwarranted antidiarrheal drugs—often even toxic ones (5,22,23). In Thailand, ORS was sold by barely one third of pharmacists and drug sellers, whereas almost all freely dispensed antidiarrheal drugs and antibiotics (24).

In Nepal, as in several other countries, the law mandates that antidiarrheal drugs are sold by valid prescription. However, in an assessment of 100 drug-dispensing sources, all sellers dispensed unnecessary antibiotics whereas only half suggested ORT. In an exercise involving a mock patient with acute watery diarrhea, only 3% recommended consulting a doctor whereas all engaged in diagnostic and therapeutic activities beyond their scope (25).

Merely descheduling or banning a drug does not seem to retard its use, as noted in several countries worldwide. In the United States, for example, approximately 100 compounds are available as over-the-counter drugs for treatment (26) of diarrhea. In 1962, the authority of the Federal Drug Administration was widened to look into the sale of such drugs. Despite the Federal Drug Administration's (FDA) three-phase over-the-counter drug review process, after which only three compounds fulfilled the stringent criteria laid down, several continue to be sold over the counter (26), because a majority of dugs were sanctioned for use before 1962 and were not subject to revision powers of the FDA. Similarly banning various antidiarrheal preparations for use in children by the drug controller of India has decreased the misuse of these drugs in clinical practice but at the same time has probably increased the misuse of antimicrobial suspensions, particularly those available in combination with antiamoebic drugs. Bangladesh also allows only essential drugs, according to WHO recommendations, for use in the country. However, the impact of this legislation on prescribing patterns remains unclear.

Another loophole, legislation does not cover practitioners of the complementary/alternate system of medicine who continue to use the banned drugs under the guise of herbal and other mixtures.

Preventing Unwanted and Unwarranted Use of Antidiarrheal Drugs

From the foregoing, it is obvious that to regulate therapy for children with acute watery diarrhea and to prevent misuse and abuse of drugs for diarrhea, we must adopt a multiprong and a more comprehensive approach. Table 4 briefly outlines some of the options.

Possible options to prevent use/misuse of antidiarrheal drugs

Decrease Demand

Obviously, the key strategy will be to make antidiarrheal agents unacceptable to caregivers and physicians through appropriate education and training. Caregivers and physicians must realize that such drugs not only are unnecessary but are potentially harmful as well. Simultaneously, confidence in ORS needs to be boosted. One of the main reasons that ORS fails to meet the demand of parents and doctors is that they are looking for something to decrease volume and duration of diarrhea, whereas ORS helps in preventing and treating dehydration and has no impact on volume or duration of diarrhea. Unfortunately, it has often been promoted as the only drug for “diarrhea” (rather than for “dehydration”), which also may have led to dissatisfaction with its use among parents and primary care physicians. In Lima (19), an intensive educational campaign was launched to decrease the misuse of antidiarrheal drug. It was a community-based program and targeted caregivers, doctors, and the community in general. Mass media as well as personal communication methods were used. Data collected before and after the campaign regarding use of antidiarrheal agents were compared. Use of antidiarrheal drugs in that community significantly decreased. Simultaneously, physicians in the locality were reoriented to the appropriate management of diarrhea by an appropriate educational package that included personal meetings and booklets.

For an educational program of this nature (i.e., breaking accepted beliefs and perceptions and modifying practices) to be successful, it must be a community-based approach. Therefore local leaders, influential persons, and existing organizations need to be tapped and used as channels. Further, the messages used have to he socially, culturally, and religiously acceptable as well. An effective approach would include personal communication combined with use of media. It is very important to stratify the community and deliver the same message in different forms to parents, physicians, and other influential persons of the community. Some of the key messages to be disseminated are included in Table 5.

Health education compaign for AWD: suggested key messages

An important message to convey in such community-based programs may be that diarrhea is actually an attempt by the intestines to wash away (flush out) toxins. Stopping diarrhea will only interfere with this flushing action and may not be desirable. However, action must be taken to “refill the tank” by appropriate use of ORS. This may not only help to prevent misuse of drugs but even help to promote the use of ORS.

Reorienting physician practices in the treatment of adult diarrhea is an important to prevent extrapolating such therapy to children. It must be emphasized that a child is not a smaller version of an adult. Therefore, as noted previously, it would be dangerous to prescribe adult therapy for children. It may also be worthwhile to study whether pediatric practice can be extrapolated to adults with acute watery diarrhea, and thus induce a change in adult treatment practices.

Decrease Availability

Along with decreasing acceptability of antidiarrheal drugs, other strategies would include limiting access to them by appropriate legislation to deschedule/ban their production and sale. In most cases, legislation already exists but is not effective, especially in developing countries. Pharmaceutical companies should prominently display the harmful effects of these drugs and should be brought under the purview of the law to withdraw the agents should they prove dangerous.

In this regard, manufacturing firms often do not disclose and sometimes even misrepresent information to sell their products. For instance, the four firms that manufacture and distribute six antidiarrheal drugs in Canada were asked to supply the best possible evidence they had to substantiate claims in their product monographs. None were able to show placebo-controlled studies that proved efficacy of their products. The drug safety information included was below par in two of the four companies' literature (27).

Promote Use of Safe Drugs?

Despite all the methods suggested above, mothers may continue to demand treatment for diarrhea and there will be physicians quite willing to oblige. Therefore, an effective but unconventional, yet innovative, move might be to allow use of “safe” agents such as a binding agents or even lactobacillus to address caretakers perceptions and meet demands. Thus, although there is no risk to children with these agents, their use may help to promote other rational practices in diarrhea management, such as ORS use and proper feeding, by meeting expectations of caregivers and physicians in terms of prescribable drugs. The ethical aspects of such a course must be considered in detail before initiating such a move.


Despite appropriate information and guidelines for managing acute watery diarrhea in children, several unscientific and irrational practices continue. One of these is the unwanted and unwarranted use of antidiarrheal drugs, which are often dangerous. This article has attempted to analyze the reasons for misuse of these agents while suggesting practical measures to tackle the problem.


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© 2001 Lippincott Williams & Wilkins, Inc.