practice on pregnancy prevention for reproductive toxic drugs · for reproductive toxic drugs liu...

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Practice on pregnancy prevention for reproductive toxic drugs

Liu Fang, Zhang TingDepartment of pharmacy, 

Peking University third hospital2011.11.8

Corresponding to ：

Zhang Xiao-le, 010-82265743, xiaolezhang@126.com

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Outline

• Background

• Methods

• Results

• Discussion

• Conclusion

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Background

Thalidomide

Pregnancy vomiting

Thalidomide

Years later

Multiple myelomaOther indications

?Pregnancy Prevention Program

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BackgroundDrug IndicationsLeflunomide Rheumatoid arthritis

Thalidomide Multiple myeloma

Acitretin Severe Psoriasis; other keratinizing skin

Acutance Severe acne

Tretinoin Ointment

Severe Psoriasis; other keratinizing skin

Danger:

NO PPP

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Background

Drug Length of time for pregnancy prevention after treatment

Leflunomide 3 monthsThalidomide 1 monthAcitretin 2 yearsAcutance 3 months

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Case

• Patient: When can I bear child after using the drugs.

• Pharmacist: Uh…Acitretin…I’m worried that you have to wait at least two years.

• Patient: Two years! It’s too long. I’ll go back to the physician to delete the medicine from my prescription.

What will happen if the patient didn’t ask the question and is

pregnant soon after stopping using the medicine?

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Objective• Through baseline survey, learn the knowledge and practice of physicians and pharmacists in prescribing or dispensing reproductive toxic (RT) drugs .   

• According to the problems we learned from the baseline survey, intervention will be taken to improve the knowledge and practice of physicians and pharmacists.

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Methods

• Participating hospital

• Baseline survey

• Methods of intervention

• Evaluation of the improvement

• Statistics

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• Initiated and organized by Department of Pharmacy, 

Peking University Third Hospital.

• Sponsored by Beijing Pharmaceutical association.

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Participating hospitals

• 301 Hospital

• 466 Hospital

• Peking University First Hospital

• Peking University Third Hospital,

• Chuiyangliu Hospital

• United Family Hospital

• Ji Shui Tan Hospital,

• People's Hospital

• Millennium Monument Hospital

• Shougang Hospital

• Union Hospital

• Xuanwu Hospital

• Friendship Hospital

• China‐Japan Friendship Hospital

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Calendar Time Actions

Apr,2010-Jun,2010

Training investigatorsBaseline survey in patients,

pharmacists and physicians

Jul,2010-Sep,2010 Preparing the materials for intervention

Oct,2010-Mar,2011 Carrying out intervention

Apr-Jun,2011Survey after intervention in

patients, pharmacists and physicians

Jun-Jul,2011 Data processing and statistics

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Questionnaire

• For physicians• For pharmacists• For patients

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• Reference– Martindale– Drugdex– Package insert

• outline– Primary principle for safe use of RT drugs in

reproductive population– Review of the 5 kinds of RT drugs – Appendix: a list of medication with FDA

pregnancy catagory D or X

Handbook for safe use of RT drugs

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What is RT drug?

Before using RT drug

After treatment with RT drug

During treatment with RT drug

For what kind of medication, you must tell the patients to take measures to prevent pregnancy?

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Handouts for patients

Tips to stick on the package of the drugs

During and after using the drug, you must avoid pregnancy. Please find details in package insert.

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Results

• Characteristics

(physicians, pharmacists and patients)

• The knowledge of the physicians and pharmacists

• The practice of the physicians and pharmacists

• The knowledge of the patients

• Case report20

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Characteristics 

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Before(N) 

After(N) 

Total(N) 

physicians 222 166 388

pharmacists 373 389 762

Patients 503 286 789

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Characteristics 

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Personal characteristics

physicians Age, education, title ,department……

pharmacists Age, education, title……

Patients Age, gender……

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knowledge

• Physicians

• Pharmacists 

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Physicians 

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Question ScoreDo you know the FDA pregnancy category  clearly? 2Do you know which medicine is classified as X ?  2Do you know the cautions of  leflunomide?  3

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Physicians 

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3.36±1.58

3.49±1.78

（p<0.05）

Before After

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Pharmacists 

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Question ScoreDo you know the FDA pregnancy category  clearly? 2Do you know which medicine is classified as X ?  2Do you know the cautions of  leflunomide?  3Do you know how to deal with the remaining medicines? 1

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Pharmacists 

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3.55±2.47

5.65±2.48

Before After

（p<0.05）

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Practice 

• Physicians

• Pharmacists 

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Physicians 

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Question ScoreDo you tell the patients the potential riskwhen priscribing these drugs?

2

Do you ask the patient to do the pregnacytest before prescription ?

2

Do you ask the patient to show her testresult through further consultation  ?

2

Do you tell the patients when taking thesemedicines they should take method of birth‐control?

2

Do you tell the patients how to deal with theremaining medicine?

2

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Physicians 

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department of rheumatology

department of dermatology

average SD N average SD N

Before 5.61 2.8 171 6.92 3.07 76

After 6.03 2.87 70 7.03 2.81 65

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Pharmacists 

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Question ScoreDo you tell the patients the risk before dispensing?

2

How do you do the patient education? 2Do you tell the patients how to deal with the remaining medicine?

3

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Pharmacists 

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4.32±1.443.39±1.75

Before After

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Patients 

• Do you know the risk of the medicine which you will use?

• How do you know about this information?

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41.55% 78.67%

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The ways of awareness

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Before After

physicianpharmacist

introductionOthers 

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Case report

• Female 23 y

• Visited the department of dermatology

• Diagnose: Flat wart

• Prescription :

Tretinoin Cream twice a day for external use

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Case report

• The physician didn’t mention the risk about reproductive toxicity

• The patient was planning for pregnancy

• The pharmacist carried out patient education

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Discussion

• The practice maybe still not good enough, but we have already made some changes

• The continuous or periodic intervention will make sense to the patient safety

• Our objective is to discuss and try to establish a flexible mode of the pharmacovigilance

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