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Annals of Pharmacotherapy

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First published September 2004

Development and Validation of the Medication Regimen Complexity Index

Johnson George, Yee-Teng Phun, Michael J Bailey, David CM Kong, and Kay StewartView all authors and affiliations

Abstract

BACKGROUND:

Medication regimen attributes, such as the number of drugs, dosage frequency, administration instructions, and the prescribed dosage forms, have been shown to influence patient outcomes. No single tool for quantifying the complexity of general medication regimens has been published in the medical literature.

OBJECTIVE:

To develop and validate a tool to quantify the complexity of prescribed medication regimens.

METHODS:

Literature findings and the expertise of the authors were used for developing the tool. Eight pharmacy researchers helped in establishing the tool's face and content validity. The new tool was tested on 134 medication regimens from patients with moderate to severe chronic obstructive pulmonary disease. Six regimens with a spread of scores on the tool were presented to a 5–member expert panel that subjectively ranked these regimens to confirm the tool's criterion-related validity. The relationships between scores on the tool and various independent variables were tested to judge the tool's construct validity. Two raters scored 25 regimens using the tool to test its inter-rater and test—retest reliabilities.

RESULTS:

A 65–item Medication Regimen Complexity Index (MRCI) was developed. The expert panel had strong agreement (Kendall's W = 0.8; p = 0.001) on their individual rankings of the 6 regimens. The panel's consensus ranking had perfect correlation with the MRCI ranking. The total MRCI score had significant correlation with the number of drugs in the regimen (Spearman's Rho = 0.9; p < 0.0001), but not with the age and gender of the patients. Inter-rater and test—retest reliabilities for the total score and scores for individual sections on the MRCI were ≥0.9.

CONCLUSIONS:

The MRCI is a reliable and valid tool for quantifying drug regimen complexity with potential applications in both practice and research.

Resumen

TRASFONDO:

Se ha demostrado que características del régimen de tratamiento, tales como el número de medicamentos, la frecuencia de las dosis, las instrucciones para la administración, y las formas de dosificación prescritas, influyen en los resultados de la terapia en los pacientes. No se ha publicado en la literatura médica ningún instrumento que ayude a cuantificar la complejidad de los distintos regímenes de tratamiento.

OBJETIVO:

Desarrollar y validar un instrumento para cuantificar la complejidad de los distintos regímenes de tratamiento que se prescriben.

MÉTODOS:

El instrumento se desarrolló usando como base hallazgos publicados en la literatura científica y la experiencia de los autores. Ocho investigadores en farmacia ayudaron a establecer la validez de contenido y el aspecto. El instrumento se aplicó a 134 regímenes de tratamiento de pacientes con enfermedad pulmonar obstructiva crónica (COPD, por sus siglas en inglés) de moderada a severa. Se presentaron 6 regímenes con una dispersión de puntuaciones en el instrumento a un panel de 5 expertos, quienes los clasificaron subjetivamente para confirmar la validez de criterio. Se examinó la relación entre las puntuaciones obtenidas mediante el instrumento y varias variables independientes para determinar la validez de construcción del instrumento. Dos evaluadores utilizaron el instrumento en 25 regímenes para probar la confiabilidad entre evaluadores y la confiabilidad de prueba—reprueba.

RESULTADOS:

Se desarrolló un Índice de Complejidad del Régimen de Tratamiento de 65 pregunta (MRCI, por sus siglas en inglés). El panel de expertos concordó completamente en sus clasificaciones individuales de los 6 regímenes (W de Kendall = 0.8; p = 0.001). La clasificación por consenso del panel tuvo una correlación perfecta con la clasificación del MRCI. La puntuación total en el MRCI tuvo una correlación significativa con el número de medicamentos en el régimen (Rho de Spearman = 0.9; p < 0.0001), pero no con la edad y el género de los pacientes. La confiabilidad entre evaluadores y de prueba—reprueba para la puntuación total y las secciones individuales del MRCI fueron de 0.9 o más.

CONCLUSIONES:

El MRCI es un instrumento confiable y válido para cuantificar la complejidad de los regímenes de tratamiento; puede aplicarse tanto en la práctica clínica como en la investigación.

Résumé

CONTEXTE:

Il a été démontré que les caractéristiques des régimes médicamenteux telles que le nombre de médicaments, la fréquence d'administration ainsi que les formes posologiques prescrites peuvent avoir un impact sur l'issue du traitement. Aucune publication ne fait mention d'un outil pouvant aider à évaluer et quantifier la complexité d'un régime médicamenteux.

OBJECTIF:

Développer et valider un outil pour évaluer la complexité de régimes médicamenteux.

MÉTHODES:

Une recherche de la littérature de même que l'expertise des auteurs a été utilisée pour développer l'outil. Huit chercheurs en pharmacie ont collaboré à établir l'interface et la validité du contenu. Le nouvel outil a été validé à l'aide de 134 régimes médicamenteux de patients souffrant de maladie pulmonaire obstructive chronique. Six régimes ayant des différences dans leurs scores ont été présentés à un groupe de 5 membres experts qui ont subjectivement classé ces régimes afin de confirmer la validité des critères de l'outil. Les relations entre les scores et les variables indépendantes ont été évaluées afin de bâtir la validité de l'outil. Deux individus ont évalué 25 régimes en utilisant l'outil afin de mesurer sa variabilité interindividuelle et sa répétitivité.

RÉSULTATS:

L'index de complexité des régimes médicamenteux (MRCI) utilisant 65 critères a été développé. Le groupe d'experts a été fortement en accord dans la classification individuelle des 6 régimes (Kendall W = 0.8; p = 0.001). Il y a eu une corrélation parfaite entre le consensus du groupe et les scores obtenus avec le MRCI. Le score du MRCI a démontré une corrélation significative entre le nombre de médicaments (Rho Spearman: 0.9; p < 0.0001) mais non avec l'âge et le sexe des patients. La variabilité interindividuelle de même que la répétitivité des scores du MRCI étaient égales ou supérieures à 0.9.

CONCLUSIONS:

Le MRCI est un outil valide et fiable pour quantifier la complexité d'un régime médicamenteux et pourrait être utilisé en pratique comme en recherche.

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Appendices

Appendix I. Drug Regimens Evaluated by Expert Panel

Regimen A

albuterol MDI 100 μg 2 puffs each morning

Regimen B

albuterol MDI 100 μg 2 puffs as needed

flunitrazepam 1 mg 1/2 tablet each night

fluticasone MDI 125 μg 2 puffs twice daily

ipratropium MDI 42 μg 2 puffs 3 times daily

Regimen C

aspirin 100 mg 1 tablet daily

budesonide Turbuhaler 400 μg 2 puffs at midday

eformoterol Aerolizer 12 μg 2 puffs twice daily

ipratropium MDI 42 μg 2 puffs twice daily

simvastatin 20 mg 1 tablet each night

zolpidem 10 mg 1 tablet at night as needed

Regimen D

albuterol MDI 100 μg 1 puff as needed

albuterol nebules 2.5 mg/2.5 mL 1 each morning and afternoon

alendronate sodium 5 mg 1 tablet weekly

fluticasone MDI 125 μg 1 puff twice daily

furosemide 40 mg 1 tablet twice daily

ibuprofen 400 mg 1 tablet twice daily

ipratropium nebules 250 μg/mL 1 each morning and afternoon

perindopril 4 mg 1 tablet each morning

potassium chloride 600 mg SR 1 tablet twice daily

theophylline 300 mg SR 1 tablet twice daily

Regimen E

albuterol MDI 100 μg 1–2 puffs every 4–6 hours

albuterol nebules 2.5 mg/2.5 mL 1 twice daily

doxycycline 50 mg 1 tablet daily after food

fluticasone plus salmeterol Accuhaler 500/50 μg 1 puff twice daily

ipratropium MDI 42 μg 1–2 puffs every 4–6 hours

ipratropium nebules 500 μg/mL 1 twice daily

medroxyprogesterone 10 mg tablets, use as directed

estradiol 50 μg 1 patch each week

pantoprazole 40 mg 1 tablet daily

piroxicam 10 mg 1 capsule as needed

Regimen F

acetaminophen 500 mg 2 tablets 4 times daily

albuterol MDI 100 μg 2 puffs as needed

albuterol nebules 2.5 mg/2.5 mL 1 puff 4 times daily

alendronate sodium 70 mg 1 tablet weekly

amitriptyline 50 mg 1 tablet each night

atorvastatin 10 mg 1 tablet each night

colchicine 0.5 mg 1 tablet daily

digoxin 250 μg 1 tablet daily

doxycycline 100 mg 1 tablet each morning

ergocalciferol 25 μg 1 capsule daily

ferrous sulfate plus folic acid 1 tablet daily

fluticasone MDI 250 μg 2 puffs twice daily plus salmeterol MDI 25 μg 2 puffs twice daily (separate inhalers) or fluticasone plus salmeterol MDI 250/25 μg 2 puffs twice daily (1 inhaler)

furosemide 40 mg 2 tablets twice daily

gliclazide 80 mg 3 tablets each morning

human insulin injection 3 mL, use as directed

ipratropium MDI 42 μg 1 puff 4 times daily

ipratropium nebules 250 μg/mL 1 puff 4 times daily

levodopa plus benserazide 100/25 mg 1 tablet each morning and 2 tablets at midday

metformin 500 mg 2 tablets twice daily

pantoprazole 40 mg 1 tablet daily

prednisolone 5 mg 1 tablet twice daily

sertraline 50 mg 1 tablet each morning

spironolactone 25 mg 1 tablet at lunch

warfarin tablets, use as directed

MDI = metered-dose inhaler; SR = sustained release.

We are grateful to Associate Professor Nick Santamaria and Dr. Lisa Demos, Community and Ambulatory Services, The Alfred Hospital, Melbourne, for providing de-identified patient data from an intervention trial with COPD patients, which was funded by the Department of Veterans Affairs. We appreciate the help of all the researchers and experts involved in the validation of the Medication Regimen Complexity Index

Appendix II. Medication Regimen Complexity Index (MRCI)

MEDICATION REGIMEN COMPLEXITY INDEX

Patient ID:—–

Total no. of medications (including prn/sos medications):—–

Instructions

MRCI applies only to prescribed medications. All entries are to be made only based on information on the label or drug chart (at the time of dispensing or discharge). No assumptions are to be made based on clinical judgement.

There are three sections in the scale. Complete each section before proceeding to the next. At the end, add the scores for the three sections to give the MRCI.

If the same medication (same brand and same dosage form) is present more than once in different strengths in a regimen (e.g. Marevan 5mg, 3mg and 1 mg mdu), it is still considered as one medication.

In cases where the dosage is optional, choose the dosing instruction with the smallest dose/frequency, (e.g. Ventolin MDI 1–2 puffs, 2–3 times daily will get weightings for ‘metered dose inhalers’, ‘variable dose’ and ‘twice daily’; but not for ‘multiple units at one time’)

In certain cases the dosing frequency needs to be calculated (e.g. Ranitidine lmane and lnocte is 1 twice daily)

It is possible that with certain ‘use as directed’ instructions, the regimen will not get a score under dosing frequency (e.g. Prednisolone 5mg mdu)

If there is more than one dosing frequency direction, they should be scored for all the dosing frequency directions (e.g. Ventolin MDI 2 puffs bd and prn, will get scores for ‘metered dose inhalers’, ‘multiple units at one time’, ‘twice daily’ as well as ‘prn’)

Instances where two or more medications are mutually exclusive, they need to be scored twice or more as prn with the recommended dosing frequency (e.g. Ventolin MDI or Ventolin nebuliser twice daily will get scores for both ‘metered dose inhalers’ and ‘nebuliser’ under dosage forms, but needs to be scored two times for ‘twice daily prn’)

In cases where there is no matching option, choose the closest option (e.g. six times daily could be considered as ‘q4h’)

A) Circle the weighting corresponding to each dosage form (ONCE ONLY) present in the regimen.

Dosage Forms		Weighting
ORAL	Capsules/Tablets	1
	Gargles/Mouthwashes	2
	Gums/Lozenges	2
	Liquids	2
	Powders/Granules	2
	Sublingual sprays/tabs	2
TOPICAL	Creams/Gels/Ointments	2
	Dressings	3
	Paints/Solutions	2
	Pastes	3
	Patches	2
	Sprays	1
EAR, EYE & NOSE	Ear drops/creams/ointments	3
	Eye drops	3
	Eye gels/ointments	3
	Nasal drops/cream/ointment	3
	Nasal spray	2
INHALATION	Accuhalers	3
	Aerolizers	3
	Metered dose inhalers	4
	Nebuliser	5
	Oxygen/Concentrator	3
	Turbuhalers	3
	Other DPIs	3
OTHERS	Dialysate	5
	Enemas	2
	Injections: Prefilled	3
	Ampoules/Vials	4
	Pessaries	3
	Patient controlled analgesia	2
	Suppositories	2
	Vaginal creams	2
	Total for Section A

DPI = dry-powder inhaler; MDI = metered-dose inhaler.

B) For each medication in the regimen tick a box [√] corresponding to the dosing frequency. Then, add the no. of [√] in each category and multiply by the assigned weighting. In cases where there is no exact option, choose the best option.

Dosing Frequency	Medications	Total	Weighting	Weighting × No. of medications
Once daily			1
Once daily prn			0.5
Twice daily			2
Twice daily prn			1
Three times daily			3
Three times daily prn			1.5
Four times daily			4
Four times daily prn			2
q 12h			2.5
q 12h prn			1.5
q 8h			3.5
q 8h prn			2
q 6h			4.5
q 6h prn			2.5
q 4h			6.5
q 4h prn			3.5
q 2h			12.5
q 2h prn			6.5
prn/sos			0.5
On alternate days or less frequently			2
Oxygen prn			1
Oxygen <15hrs			2
Oxygen >15hrs			3
Total for Section B

C) Tick a box [√] corresponding to the additional directions, if present in the regimen. Then, add the no. of [√] in each category and multiply by the assigned weighting.

Additional Directions	Medications	Total	Weighting	Weighting × No. of medications
Break or crush tablet			1
Dissolve tablet/powder			1
Multiple units at one time (e.g. 2 tabs, 2 puffs)			1
Variable dose (e.g. 1–2 caps, 2–3 puffs)			1
Take/use at specified time/s (e.g. mane, nocte, 8 AM)			1
Relation to food (e.g. pc, ac, with food)			1
Take with specific fluid			1
Take/use as directed			2
Tapering/increasing dose			2
Alternating dose (e.g. one mane & two nocte, one/ two on alternate days)			2
Total for Section C

DPI = dry-powder inhaler; MDI = metered-dose inhaler.

Medication Regimen Complexity = Total (A) + Total (B) + Total (C)=

References

1Billups SJ, Malone DC, Carter BL. The relationship between drug therapy noncompliance and patient characteristics, health-related quality of life, and health care costs. Pharmacotherapy 2000;20:941–9.

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Abstract

Abstract

BACKGROUND:

OBJECTIVE:

METHODS:

RESULTS:

CONCLUSIONS:

Resumen

TRASFONDO:

OBJETIVO:

MÉTODOS:

RESULTADOS:

CONCLUSIONES:

Résumé

CONTEXTE:

OBJECTIF:

MÉTHODES:

RÉSULTATS:

CONCLUSIONS:

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Appendices

MEDICATION REGIMEN COMPLEXITY INDEX

References

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