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Identification and prevention of deleterious effects of supplementary health products on medical therapy

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Aknowledgements: This work was supported by the grant SROP-4.2.2/B-10/1-2010-0029 Supporting Scientific Training of Talented Youth at the University of Pécs.

PATIENT

OTC medicines from other sources aside

from pharmacies (e.g. gas station) Rx medicines

prescribed by a doctor

food supplements, herbs

internet

multi-level marketing advice of relatives,

friends

salesmen, direct selling

OTC medicines and other products

available in pharmacies

The project was realised through the assistance of the European Union,

with the co-financing of the European Social Fund.

INTRODUCTION

In the last decade it has become a challenging problem for the pharmaceutical profession that alongside their prescribed drug treatment patients take supplementary products (OTC, herbal remedies, food supplements, “panacea” etc.) without consulting their physician or pharmacist.

Our pilot exploratory study aims at exploring and analyzing interactions between drugs and additional remedies among inpatients and outpatients at departments of internal medicine.

Identification and prevention of deleterious effects of supplementary health products on medical therapy:

A challenge for clinical pharmacists

Anna Végh

1

, Erzsébet Lankó

2

, András Fittler

1

, Lajos Botz

1

1

Department of Pharmaceutics and Central Clinical Pharmacy, University of Pécs Medical School, Pécs, Hungary

2

First Department of Internal Medicine, University of Pécs Medical School, Pécs, Hungary

Figure 2. Blue area represents products taken by the patient which healthcare professionals have information about.

Active ingredient „A” Active ingredient „B”

Selected international literature and drug information databases Official Hungarian

summary of product characteristics

Information on the CYP450 enzyme system

Figure 1. The general scheme of drug interaction evaluation.

Difficulties associated with

supplementary health products:

 No comprehensive database exists

 Uncertain ingredients in products

 No marketing authorization required

 Unclear ingredient nomenclature

 Many interaction evaluation systems do not contain these products

 Patients do not tell their

doctor/pharmacist about taking supplementary products

(including OTC)

MATERIALS AND METHODS: PATIENT CHARACTERISTICS AND STUDY DESIGN

The patient interviews and the review of the medical records were performed by clinical pharmacists. We have gained information regarding current medication and additional remedies, past medical history, immunization status and known allergies with the aid of a medication history worksheet (see the extended worksheet attached).

Collected data was analyzed by an interaction evaluation software and database developed by our department in collaboration with HC Pointer Ltd.

This database contains all the authorized or notified paramedicines and food supplements which have noteworthy market in Hungary. In the study of interactions we looked at products taken in the previous two weeks.

total number of

surveyed patients 152

age 56.7±14.97 (16-85)

gender 65 male, 87 female (male to female ratio: 0.75)

smoking 35 smoker, 112 nonsmoker place of medical

treatment

(for details see Figure 3)

University of Pécs Medical School, 1st

Department of Internal Medicine

number of prescribed medicines

according to patient interviews 5.1±3.59 (0-16) according to medical records 7.3±4.60 (0-20)

number of supplementary products (including OTC medicines)

according to patient interviews 2.5±2.00 (0-11) according to medical records 0.4±0.65 (0-2)

Figure 3. Interviewed patients categorized on basis of their place of treatment

14 9

40

11 22 26

17

16 6

General Internal Medicine inpatient care General Internal Medicine outpatient care Endocrinology inpatient care

Endocrinology outpatient care

Gastroenterology and Hepatology inpatient care Haematology one-day-attendance

Haematology inpatient care Haematology outpatient care Cardiology inpatient care

Cardiology outpatient care inpatients: 74

outpatients: 78

RESULTS, CONCLUSION

As for the prescribed medicines coumarin anticoagulants, beta-blockers, diuretics, NSAIDs and antidiabetic agents were most often involved in interactions.

Our results show that inpatients and outpatients both take supplementary health products extensively, and that many of the known interactions are occuring among these patients. Gathering detailed information about the use of these products should be included in extended medical histories in clinical pharmaceutical practice. It is essential we explore the potential impact of these products on patients as well.

Special software and databases are of great help because of the complexity of possible interactions.

153 interviewed patients

130 reported supplementary

product use (85.5%)

25 clinically relevant interactions

(13.8%)

67 potential interactions

identified (27.0%)

60 187

24 10 41

pharmacy

herb shop, drugstore

self-produced or gathered (herbs) grocery store or supermarket

other source (internet, multi-level marketing, direct selling etc.)

Figure 4. Types and procurement sources of supplementary products taken by the interviewed patient

Components of supplementary products which were most commonly involved in interactions (numbers in the brackets show numbers of interactions)

potential interactions

ascorbic acid (9), magnesium (7), ibuprofen (5), St John's wort (4), ginseng (4), chamomile (4), vitamine E (4), cranberry (3), ginkgo (3), phenylephrine (3)

clinically relevant interactions

St John's wort (3), chamomile (3), cranberry (3), ibuprofen (3), ginkgo (2), garlic (2), magnesium (2), chondroitin (2),

phenylephrine (2)

5 47

52

37 84 104

669 8 27

OTC herbal medicines

OTC medicines containing vitamins or minerals other OTC medicines

herbs

herbal food supplements

non-medicinal vitamin and mineral products cartilage strengthening food supplements

food supplements containing fish oil

products containing "medicinal mushrooms"

homeopathic remedies other products

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