The Pharmacist

The pharmacist ... has an obligation to assure compliance with prescribed regimens through a detailed consultation

By Paul J. Munzenberger

as a Consultant to Children With Chronic Diseases

The inability or unwillingness of ambulatory

patients to accurately comply with prescribed medical regimens has been well documented. For example, in 1967 Watkins reported that seven of 34 diabetic patients measured either half or double the prescribed dose of insulin by using the wrong scale on a U40-U80 syringe. 1 In a 1969 study by Clinite and Kabat approximately 25 percent of the study patients made an error during self-administration of their prescribed drugs. 2 Further evidence of medication errors among ambulatory patients was provided by the classic study conducted by Latiolais and Berry. It revealed that approximately 43 percent of the study patients made an error . while ·self-administering prescribed medication.3 Finally, in 1970 Libow reported on a study in which 25 percent of the study patients made at least one error during the self-administration of their drugs. 4 With respect to patient compliance, Moulding's study of 122 tuberculosis patients revealed that 31 percent failed to comply with their medical regimens for one or more months. 5 A study by Willcox revealed that from 33 to 59 percent of the study patients failed to take their drugs as prescribed. 6 Additionally, Lipman's study showed that 43 percent of the study patients failed to comply by taking less than 75 percent of their prescribed medication. 7 The previously cited studies and a host of others 8- 11 clearly demonstrate the inability or unwillingness of ambulatory patients to accurately comply with prescribed medical regimens, especially those patients with a chronic disease requiring medical treatment for extended periods of time. In response to the results of the aforementioned studies, both physicians and pharmacists have published a number of additional articles related to compliance. In 1972 Blackwell attempted to review the entire problem of the drug defaulter. 12 Another article attempted to identify those factors associated with noncompliance. 13 The pharmacist's role in patient compliance was described in the Task Force Report pn the Pharmacist's Clinical Role. 14 The Report stated that pharmacists should tell patients when and how to take their medication, how

Paul J. Munzenberger

to store their medication, cautions related to the use of their medication and, where possible, when to see their physician. Further encouragement for pharmacists to provide patient consultations has been the topic of a number of recent publications. The April 197 4 issue of JAPhA was devoted almost entirely to essential hypertension and the pharmacist's role in this chronic disease. Additionally, attempts have been made to evaluate the pharmacist as a patient counselor. In 1973 McKenney reported the results of his study which showed that a pharmacist may have a positive effect on the compliance and management of hypertensive patients.15 Noncompliance and Pediatric Patients

While the majority of studies concerned with patient compliance involve adults, the pediatric literature implies that children do not always comply with prescribed medical regimens. A study by Charney and co-workers revealed that only 56 percent of their pediatric patients were taking the prescribed medication by the ninth day of therapy. 16 Another study revealed that only 18 percent of pediatric patients were still receiving their prescribed medication on the ninth day of therapy. 17 Finally, a study involving 245 pediatric patients showed that 34 percent did not complete their prescribed seven-day course of antibiotic therapy. 18

Paul J. Munzenberger, PharmD, is an associate professor of pharmacy at Wayne State University college of pharmacy and allied health professions. His major f>ractice interest is pediatric clinical pharmacy; he currently practices at Childrens Hospital of Michigan in Detroit. Munzenberger's research interests include dosing, drug disposition in the pediatric patient, pulmonary diseases affecting the pediatric patient and methods to improve the compliance of patients with their drug regimens. Memberships include APhA, ASHP, AACP and the Michigan Pharmaceutical Association. At Wayne State Munzenberger serves as the SAPhA faculty advisor.

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The problem of noncompliance among pediatric patients has become so critical that an attempt has been made to identify the characteristics of compliant and noncompliant mothers. 19 The study found that mothers who complied were relatively more concerned about the child's health in general, as well a.s about a current illness. They tended to feel that illness is a substantial threat to their child, but had confidence in the ability of physicians and medication to reduce this threat. These mothers worried about the child's health and engaged in behavior that they felt would keep the child healthy and prevent future illness. As previously stated, patients with chronic diseases requiring medical treatment for extended periods of time are especially prone to noncompliance. Although the literature describes the role of the pharmacist in the management of many of these chronic diseases, emphasis has been placed on the adult with little mention of the pediatric patient. Unfortunately the child may also suffer from a chronic disease requiring continuous medical treatment. Like their adult counterparts, these children are especially prone to noncompliance. With these cases, as with pediatric patients with acute illnesses, the pharmacist should consult with the parent, and when appropriate, the pediatric patient, concerning the need to comply with the prescribed medical regimen. The necessity to consult with these patients or their parents becomes evident when we realize the serious consequences of noncompliance. The following chronic pediatric diseases are discussed to clarify this point. Cystic fibrosis. Cystic fibrosis is a genetic disease primarily affecting Caucasians. While five percent of the general population are carriers, the incidence of this disease is one per 1,800 live births. 20 The basic lesion is not well understood but it appears to affect the exocrine structures resulting in the production of an unusually viscid, abnormally sticky mucus. The complications arising from these abnormal secretions may involve a number of organs and organ systems including the pancreas, liver, gallbladder, heart, eyes, sweat glands, genital tract and respiratory system. Frequently these complications require medical treatment. For example, the excessive loss of sodium chloride during the summer months renders the child with cystic fibrosis susceptible to heat prostration. To avoid this complication, salt supplements, two to four grams per day, are frequently prescribed. The pharmacist providing this medication should counsel the patient or

Presented in part before the APhA Academy of Pharmacy Practice at the APhA Annual Meeting, San Francisco, California, April 21, 1975.

Journal of the American Pharmaceutical Association

parent concerning the need for this drug and the correct dose. This consultation is essential because failure of the patient to follow the prescribed regimen may result in severe hyponatremia, hyperpyrexia, convulsions and circulatory collapse. The malabsorption of fats and proteins resulting from a lack of the enzymes lipase and trypsin constitutes another complication frequently observed in cystic fibrosis patients. These pancreatic enzymes are lacking in approximately 85 to 90 percent of cystic fibrosis patients resulting in their inability to absorb normal amounts of fats and proteins. Additionally, the wasting of fats may lead to the impaired absorption of the fat soluble vitamins. 21 To avoid these complications, pancreatic enzymes and fat soluble vitamin supplements usually are prescribed. Again, a consultation from the pharmacist is essential. It should emphasize the need to comply with the prescribed medical regimen and provide specific information concerning the drugs. Patients prescribed pancrelipase should be instructed to take the medication with meals and with any food eaten between meals. Problems which arise when cystic fibrosis patients fail to comply with their medical regimens include ( 1) hypoprothrombinemia, which is· observed in infants lacking sufficient amounts of vitamin K, (2) vitamin A deficiency which rarely results in night blindness, keratinization of various membranes and the formation during growth of defective bony tissue, (3) fecal masses, (4) steatorrhea from the abnormal fat digestion and (5) azotorrhea from the abnormal protein digestion. Indications of a therapeutic response to the regimen include (1) a good growth pattern, (2) a decrease in the number of bowel movements and (3) improvement in stool consistency. These indications, along with the presence or absence of the previously mentioned vitamin deficiency symptoms, may be used by the pharmacist as monitoring parameters. The complications involving the respiratory system present a formidable challenge to the patient with cystic fibrosis. The sticky mucus which lodges in the respiratory tract is difficult to remove and in many cases causes chronic pulmonary obstruction. Furthermore, the stagnant mucus fosters the growth of bacteria. Consequently, these patients are frequently prescribed oral or inhalation bronchodilating agents, expectorants and, in certain cases, antibiotics. While References 1. Watkins, J.D., eta/., "Observation of Medication Errors Made by Diabetic Patients in the Home,"' Diabetes. 16, 882

(1967) 2. Clinite, J., and Kabat, H., "Prescribed Drugs. Errors During Self-Administration," JAPhA NS9, 450 (1969) 3. Latiolais, C., and Berry, C., "Misuse of Prescription Medications by Outpatients," Drug Intel. C/in. Pharm., 3, 270

(1969) 4. Libow, L., and Mehl, B., "Self Administration of Medications by Patients in Hospitals or Extended Care Facilities," J. Am. Geriatr. Soc., 18, 81 (1970) 5. Moulding, T., eta/., "Supervision of Outpatient Drug Therapy with the Medication Monitor," Ann. Intern. Med., 73, 559

(1970) 6. Willcox, D., eta/., "Do Psychiatric Outpatients Take Their Drugs?" Br. Med. J., 2, 790 (1965) 7. Lipman, R., eta/., "Neurotics Who Fail to Take Their Drugs,"

Vol. NS 16, No. 10, October 1976

the specifics of the pharmacist's consultation depend on the medication prescribed, its necessity is demonstrated by the results of noncompliance. Cystic patients who fail to take their medication as prescribed may suffer from an increased incidence of respiratory infections associated with declining pulmonary function and possible cor pulmonale leading to an episode of cardiac decompensation. Asthma. Asthma represents another chronic disease frequently involving the pediatric patient. In fact, it is the leading cause of chronic illness in children under 17 years of age and is responsible for 25 percent of the days lost from school as a result of chronic diseases. 22 Asthma in children is a diffuse pulmonary obstructive disease usually resulting in various physiologic disturbances including abnormalities in the mechanics of breathing, changes in lung volume and the abnormal distribution of inspired air resulting in ventilation-perfusion imbalances. As the disease progresses certain anatomical changes are noted. These changes include an increase in the number of mucus-producing cells and an increase in airway smooth muscle prominence along with a thickening and hyalinization of the basement membranes. The product of these anatomical and physiological abnormalities is an asth-. matic child threatened by frequent hospitalizations and a significant mortality rate. During an acute attack, severe airway obstruction results from mucous membrane edema, increased secretions and smooth muscle spasms. Children with asthma frequently require medication either to prevent or treat acute attacks. Such drugs as cromolyn sodium, isoproterenol, corticosteroids or bronchodilators may be prescribed. While the specifics of the pharmacist's consultation depend on the drugs prescribed, just one example is necessary to demonstrate the necessity for this consultation. Cromolyn sodium may be prescribed for children with severe asthma. The pharmacist providing the consultation should tell the patient or parent to clear as much mucus as possible from the respiratory tract before inhaling this drug. This consultation is important because failure of the patient to follow this procedure may result in less than optimal penetration of the drug into the lungs. The patient or parent should also be told that occasionally the inhalation of this drug results in a mild bronchospasm. If this becomes bothersome, the Br. J. Psychiatry, 3, 1043 (1965) 8. Fox, W., "The Problem of Self-Administration of Drugs; With Particular Reference to Pulmonary Tuberculosis," Tubercle,

parent or patient should be instructed to consult with the physician as to whether or not to use a bronchodilator prior to the use of cromolyn. This consultation is important because the bronchospasm may actually initiate an acute asthmatic attack. Finally, along with information concerning the proper use and maintenance of the inhaler, the patient should be instructed to take the medication regularly. Failure to comply with the prescribed medical regimen most certainly will result in a therapeutic failure manifested by an increased incidence of acute asthmatic attacks. Cystic fibrosis and asthma are two chronic diseases frequently observed in. children. Certainly juvenile rheumatoid arthritis which may require the chronic administration of aspirin, corticosteroids, gold or hydroxychloroquine represents another example. Rheumatic fever, which may require the chronic administration of antimicrobials such as oral penicillin or sulfadiazine, and convulsive disorders, which frequently require continuous anticonvulsants such as phenytoin, phenobarbital or mephenytoin could also be cited as chronic pediatric diseases. Conclusion The pharmacist providing medication for pediatric patients with chronic diseases has an obligation to assure compliance with prescribed regimens through a detailed consultation. For maximum effect, the consultation should include but not be limited to a review of the physician's instructions. Regardless of content, the consultation should be given with the complete knowledge of the prescriber in order to avoid any confusing or conflicting statements. This will necessitate continuous communication between the pharmacist and the patient's physician. Occasionally, a patient will not comply with a prescribed regimen even though both physician and pharmacist have provided detailed consultations. When this occurs, we are reminded of (1) the complicated relationship between members of the health care team and the patient, (2) the patient's relation to disease, and (3) the fact that we are dealing with a human being. With these patients, the phq.rmacist and physician must provide the additional counseling necessary to assure compliance and attempt to understand the causes of noncompliance. •

lation XLVIII, 1104 (1973) 16. Charney, E., eta/., "How Well Do Patients Take Oral Penicillin? A Collaborative Study in Private Practice," Pediatrics,

40, 188 (1967)

39, 269 (1958) 9. Pitman, E., eta/., "Clinic Experience With Urine PAS Test," Dis. Chest, 36, 1 (1959) 10. Renton, C., eta/., "A Follow-up of Schizophrenia Patients in Edinburgh," Acta Psychiatr. Schand., 39, 548 (1963) 11. Dixon, W., eta/., "Outpatient PAS Therapy," Lancet, 2, 871

(1957) 12. Blackwell, B., "Commentary the Drug Defaulter," Clin. Pharmacal. Ther .. 13,841 (1972) 13. Blackwell, B., "Patient Compliance," N. Engl. J. Med., 289, 249 (1973) 14. Task Force on the Pharmacist's Clinical Role," Report of Task Force on the Pharmacist's Clinical Role," JAPhA,

NS11, 482 (1971) 15. McKenney, J., eta/., "The Effect of Clinical Pharmacy Services on Patients With Essential Hypertension," Circu-

17. Bergman, A., and Werner, R., "Failure of Children to Receive Penicillin by Mouth," N. Engl. J. Med., 268, 1334

(1963) 18. Mohler. D., et a/., "Studies in the Home Treatment of Streptococcal Disease I. Failure of Patients to Take Penicillin by Mouth as Prescribed," N. Engl. J. Med., 252, 1116

(1955) 19. Becker. M., eta/., "Predicting Mother's Compliance With Pediatric Medical Regimens," J. Pediatr., 81, 843 (1972) 20. Crozier, D.N., "Cystic Fibrosis a Not-so-Fatal Disease," Pediatr. Clin. North Am., 21, 935 (1974) 21. DiSantagnese, P.A., "Cystic Fibrosis (Mucoviscidosis)," Am. Fam. Physician, 7, 102 (1973)

22. Barnett, H.L., Pediatrics, Appleton-Century-Crofts, New York, 464 (1972)

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The pharmacist as a consultant to children with chronic diseases.

The Pharmacist The pharmacist ... has an obligation to assure compliance with prescribed regimens through a detailed consultation By Paul J. Munzenb...
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