Standardization of Prescribing and Using Oral Liquid Dosage Forms (OLDFs)

1. Standardization of Prescribing and Using Oral Liquid Dosage Forms (OLDFs) Moslem Movahed Department of Medical Management of Province of Qom Social Security Organization, Iran, Islamic Republic of

2. Standardization of Prescribing and Using Oral Liquid Dosage Forms (OLDFs) Moslem Movahed Department of Medical Management of Province of Qom, social security organization, Iran, Islamic Republic of Background:Various factors affect the correct dosing and measuring of OLDFs, excluding drops, thereby leading to adverse effects or preventing the desired results to be obtained in treatment. Aims and Settings: This study aims to evaluate the current situation in dosing OLDFs in Qom, Iran and includes all oral liquid products manufactured in Iran; 20 physicians (16 GPs and 4 pediatricians), 2000 OLDF prescriptions, 20 community pharmacists, and 60 literate mothers Results:(1) Only 60% of the oral liquid products (including antibiotics, even those presented as powder for suspension) are offered with a measure; 8 kinds of medicine (33 products) come with varying measures, of which some are a spoon with a capacity of 5 mL and others are in a cylindrical shape, with 4 capacities ranging from 5 to 20 mL. (2) Many physicians and pharmacists are not aware of the current diversity in measures whereas nearly all the physicians and pharmacists conventionally and practically presume a 5 mL measure. (3) In the group of mothers, 50% fill 10 mL measures completely and 10% fill 20 mL measures up to 15 mL when they are advised to use 1 measure of the drug; 5 mL measures pose no problems. (4) Although 5 sizes of domestic spoons are used by patients, prescribers ignore this diversity by reducing it to 3 sizes only. (5) Although pediatricians have a good knowledge of domestic spoon capacities, many GPs and most of the pharmacists overestimate them, leading to underdosage for adults, especially in cough preparations with low drug content. (6) Less than 10% of adults‘ prescriptions come with precisely specified dosages in mL whereas 90% have unclear volume. For children, 27% of the dosages are clear and 73% remain unclear. Conclusion: A number of dosing problems in manufacturing, prescribing, and using OLDFs cause overdosing or underdosing which can lead to adverse effects or treatment failure. In children; for example, if the intended prescription is 5 mL 3 times a day (but written as "3 measures a day") and the consumer is given a 20 mL measure. In addition, treatment fails in many cases due to underdosing of cough preparations and acetaminophen elixirs. To improve the current situation and prevent problems, it is suggested that (1) OLDFs be offered with a syringe (the best choice), or uniform and/or unisize (preferably 5 mL) measures, or even no measure at all; (2) physicians be advised to prescribe the OLDFs in exact volumes (mL or cc) and avoid prescribing in terms of ―measure‖ or domestic spoons (this should be included in physicians‘ and pharmacists‘ education); (3) cough preparations be produced in higher concentration and volume for adults; and (4) parents be advised to use appropriate syringes (without a needle) instead of spoons or other measures.

3. Background: • In order to take the exact desired dose of the oral liquid drugs (OLDs) the consumer needs to know the exact volume (i.e. cc or mL) specified by the physician and to have a calibrated device. • Writing the dose of OLDs in terms of “measure” by physicians and assuming the measure to contain 5 ml, while in fact there is a diversity of measures (both in size and shape) offered with OLDs, could lead to overdosing and even intoxication. • Physicians’ writing the dose of OLDs in terms of “spoon,” when they assume a spoon to contain a volume which is usually more than the actual volume of domestic spoons, along with the diversity of spoons, could mostly lead to treatment failure.

4. Settings: • All oral liquid products (including antibiotics offered as powder for suspension), excluding drops, manufactured in Iran And • 20 physicians (16 GPs and 4 pediatricians) • 2000 OLDs prescriptions • 20 community pharmacists • 60 literate mothers In the Province of Qom, Iran

5. Objectives: This descriptive study aims to evaluate the current situation of factors relevant to dosing OLDs including: • Different kinds of measures coming with the drugs • Physicians and pharmacists’ behavior in writing the desired dose • Different kinds of domestic spoons used to take liquid drugs • Consumers’ behavior in measuring and taking the liquid drugs

6. Results (1): • Only 60% of the oral liquid products (including antibiotics, even those presented as powder for suspension) are offered with a measure; 8 kinds of medicine (33products) come with varying measures, of which some are a spoon with a capacity of 5 mL and others are in a cylindrical shape, with 4 different capacities ranging from 5 to 20 mL.

7. Results (2): • Many physicians and pharmacists are not aware of the current diversity in measures whereas nearly all the physicians and pharmacists conventionally and practically presume a 5 mL measure. • In the group of mothers, 50% fill 10 mL measures completely and 10% fill 20 mL measures up to 15 mL when they are advised to use one measure of the drug; 5 mL measures pose no problems.

8. Results (3): • Although patients make use of 5 sizes of domestic spoons, physicians and pharmacists ignore this diversity by reducing it to 3 sizes only. • While pediatricians have a good knowledge of domestic spoon capacities, many GPs and most of the pharmacists overestimate them, leading to under-dosage for adults, especially in cough preparations with low drug content.

9. Results (4) : • Less than 10% of adults‘ prescriptions come with precisely specified dosages in mL whereas 90% have unclear volume. For children, 27% of the dosages are clear and 73% remain unclear.

10. Conclusion (1): Oral liquid drugs are offered with measures of sizes varying from 5 to 20 ml. Physicians and pharmacists usually write the doses in terms of “measure” when they assume the measure to accommodate 5 ml. This frequently causes overdosing the drug, which can lead to adverse effects. For example, if the intended dosage is 5 ml 3 times a day (but written as "3 measures a day") and the consumer is given a measure with a capacity up to 10 or 20 mL, the patient might take 2-4 times the desired dose.

11. Conclusion (2): Prescribing the oral liquid drugs in terms of “spoon,” when the domestic spoons are available in 5 sizes without any calibration and when physicians and pharmacists usually ignore their diversity and overestimate their capacities, can cause treatment failure in many cases of cough preparations and acetaminophen elixirs.

12. Suggested Interventions (1): • OLDs had better be offered with a syringe (the best choice), or uniform and/or unisize (preferably 5 mL) measures, or even no measure at all. • Physicians should be advised to prescribe the OLDs in exact volumes (mL or cc) and avoid prescribing in terms of measures or spoons. This point should be included in physicians‘ and pharmacists‘ education.

13. Suggested Interventions (2): • Parents should be advised to use appropriate syringes (without a needle) instead of spoons or other measures • Cough preparations should be produced in higher concentration and volume for adults