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The German pharmaceutical education (by Hans-Rüdiger Elster)


Federal Republic of Germany:
Pharmaceutical Education: "Approbationsordnung für Apotheker (AAppO) 1989"


1. Introduction

The Federal Republic of Germany has Federal Laws for pharmacists ("Bundes-Apothekerordnung") that regulates the pharmaceutical education in Germany ("Approbationsordnung für Apotheker (AAppO) 1989").

There are 23 pharmaceutical institutes in Germany (Berlin [Freie Universität, Humboldt-Universität], Bonn, Braunschweig, Düsseldorf, Erlangen, Frankfurt/M., Freiburg, Greifswald, Halle, Hamburg, Heidelberg, Jena, Kiel, Leipzig, Mainz, Marburg, München, Münster, Regensburg, Saarbrücken, Tübingen, Würzburg).

There are 12,085 pharmaceutical students in Germany (winter term 1994/95).
All have the same lectures and the same practical education that is given by the "AAppO".
The education structure is:
- 4 years: pharmaceutical studies at university
- 8 weeks: "Famulatur" (Practice)
- 12 month: practice ("Practical Year")
- the "Pharmaceutical Exam" consisting of 3 parts:
* 1st Part: (after 2 years)
* 2nd Part: (after 4 years - if the 1st Part is passed)
* 3rd Part: (after the "Practice" - if the 2nd Part is passed).
The normal study time at university is 4 years with 3250 hours of education.
If a pharmacist has got the state licence "Approbation" he is allowed to work in community pharmacy (43,629 pharmacists in 21,290 pharmacies), hospital pharmacy (1,905 pharmacists) or pharmaceutical industry / science / administration (4,838 pharmacists).


2."Famulatur"

The student shall get an overview about the duties of a pharmacist. He shall learn more about the tasks and structure of a pharmacy. The "Famulatur" has to be done during the Holiday-time of the university before the 1st Part of the Pharmaceutical Exam starts.
Famulatur must be done for 4 weeks in a community pharmacy. The other 4 weeks can also be done (within the EU):
1) in a hospital pharmacy or pharmacy of the army "Bundeswehr"
2) in pharmaceutical industry
3) in a drug control institute.


3."Practice"
The practical education has to be done if the 2nd Part of the Pharmaceutical exam is passed.
6 month must be done in a community pharmacy.

The other 6 month can be done:
1) in a community pharmacy
2) in a hospital pharmacy or pharmacy of the army
3) in the pharmaceutical industry
4) at university
5) at a drug control institute

This has to be a full-time education, the instructor must be a pharmacist. If you choose scientific research at university it has to be lead by a professor. During this "Practical Year" the student also has to attend theoretical lectures.

4. The Pharmaceutical Exam


Table 1.The German Marks
Mark 1 - "very good knowledge" (Final Mark: from 1,0 - 1,5)
Mark 2 - "good knowledge" (Final Mark: over 1,5 - 2,5)
Mark 3 - "knowledge (average)" (Final Mark: over 2,5 - 3,5)
Mark 4 - "just enough" (Final Mark: over 3,5 - 4,0)
Mark 5 - "failed"


For every part of the Pharmaceutical Exam there is given a final mark which is the result of marks of the single exam subjects (sum of the marks of the single exam subjects divided by the number of single exam subjects), e.g. Mark "1" + Mark "2" + Mark "3" + Mark "4" = 10
10 divided by 4 subjects = Final Mark 2,5 ("good")

The final mark for the Pharmaceutical Exam is:

(Mark of the 1st Part) x 2
(Mark of the 2nd Part) x 3
(Mark of the 3rd Part) x 2
__________________________
[Sum (1Px2)+(2Px3)+(3Px2)] divided by 7.

The 1st Part is a written exam, the 2nd and 3rd Part are oral exams.

The First Part is done as a Multiple-choice-question exam. All students at all pharmaceutical universities in Germany have to answer the same questions at the same day and time, the questions are issued by an "institute for medical and pharmaceutical questions for the exam" (IMPP: Institut für Medizinische und Pharmazeutische Prüfungsfragen).

The exam for one subject is passed if the student has answered correctly 50% of the questions (minimum number) or if his performance is not more than 18% below the average result of all students (Federal Republic) who had to answer the same questions.

The student must have answered correctly the minimum number of questions to pass the exam. If he answers more than 75% of the additional questions correctly it is a "very good"/Mark 1, if he answers 50% to <75% of the additional questions correctly it is a "good"/Mark 2, if he answers 25% to <50% of the additional questions correctly it is "average"/Mark 3, if he answers more than the minimum number but below 25% of the additional questions correctly it is "just enough"/Mark 4.
The subjects of the First Part of the Pharmaceutical Exam are:

I. Inorganic and organic chemistry (100 questions, 2.5 hours)
II. Pharmaceutical Biology (100 questions, 2.5 hours)
III. Physics, Physical Chemistry (80 questions, 2 hours)
IV. Analytics (80 questions, 2 hours)

The subjects of the Second Part of the Pharmaceutical Exam are:
I. Pharmaceutical Chemistry
II. Pharmaceutical Biology
III. Galenics (Technology)
IV. Pharmacology, Toxicology
The time for each exam is between 20 and 40 minutes.

The subjects of the Third Part of the Pharmaceutical Exam are:
I. Pharmaceutical Practice
II. Pharmaceutical Law
The time for the exam is between 30 and 60 minutes.


5. "Approbation"

The Pharmaceutical Exam is a State Exam and if someone wants to work as a "Pharmacist" he needs a state licence, called "Approbation".

For the application are necessary:
1. curriculum vitae
2. birth certificate
3. Document of Nationality (German or EU)
4. Police certificate of good conduct
5. Declaration that there is no investigation or trial against the applicant
6. Health certificate
7. Certificate of the Pharmaceutical exam

So it is guaranteed that only a reliable person can work as a pharmacist in Germany. This licence is valid for all pharmaceutical tasks in community pharmacy, hospital pharmacy or industry.


6. "Diploma" thesis

A special possibility could be (re-)established at eastern German universities: the "Diploma" thesis.
In the past all students in Eastern Germany had to do a research project for one year, to write a thesis about it and to pass an exam. After the introduction of the western German AAppO it was not longer necessary because there is only the state exam that is relevant for the profession of the pharmacist.
But according to the good experiences and a high level of acceptance among the students the "Diploma thesis" (comparable with the "Masters" degree) could be re-established at some universities. Now the official time for the research project is 6 month during the "Practical Year" because the other 6 month must be done in a community pharmacy. The degree "Diplom--Pharmazeut (Dipl.Pharm.)" is now only an academic degree which has nothing to do with the "Approbation". It has to be mentioned that studies without a state exam, e.g. "Biology" or "Chemistry" finish with a "Diploma" degree.
But for a student who is interested in doing Ph.D. studies the "Diploma" is an unique opportunity to learn more about scientific research.

It is the first time at all during the pharmaceutical education that the student has the chance to do an own research project to learn the methods.

For the research at university it is very useful to have "Diploma" research. Very often a sub-topic of a Ph.D. research project is given to a "Diploma" student. So the student learns to co-operate with researchers and very often the result is a good input for the research topic. Many diploma students have got a basic knowledge in a special field that they can use for their future Ph.D. studies.

7. Reform of the Education

Due to the fact that the pharmaceutical education is regulated by law it is necessary to change the law whenever a change in the system of education should be made. This is a long lasting process.
Recently the government has asked representatives of all involved organisations, e.g. pharmaceutical students, professors, pharmacists what they think about the AAppO. The result is that the present curriculum does not meet the needs of a pharmacist. The German system has a lot of chemistry and a lot of practice in the laboratory. The average in Europe is much lower. Especially the hours for pharmacology should be extended because this subject is relevant for the community pharmacy.
The German education is good for a student who wants to work in the pharmaceutical industry. But there is nothing to prepare students for the work in community pharmacy. They don't hear anything about new topics like Pharmaceutical Care, compliance and patient counselling at university.
So there is a demand for the subject "Social Pharmacy"/"Pharmacoepidemiology and Pharmacoecono-mics" - a subject that is established in many countries and that was part of the East German curriculum in the past.
So the Bundesapothekerkammer (BAK: Federal Pharmacists' Chamber) has issued a thesis about a reform of the pharmaceutical education in 1993: The education at university should include a separate lecture that is dealing with pharmaceutical law, economical and social aspects of drugs. The student shall learn that a drug is not only a research object in natural science. A drug is a special good. There are special laws, there is the role of drugs within the society, there are pharmacoepidemiology and - at least - economic aspects. The name for the new lecture should be "Pharmacoepidemiology and Pharmacoeconomics".

The aim of "Pharmacoepidemiology and Pharmacoeconomics in the pharmaceutical education" was defined as:
"Pharmacoepidemiology and Pharmacoeconomics" is a discipline of the pharmaceutical sciences that is related to the "classical" natural sciences and that includes elements of the medical and behavioural sciences. This subject investigates the relations between physician, pharmacist, patient and drug and shows social, economical and health-political causation.
The drug is the central topic of all pharmaceutical subjects, the basis is natural science and pharmacoepidemiology and pharmacoeconomics are investigating the different periods of the drug: research, production, distribution and use. More and more important are the intention and the needs of the patient. So pharmacoepidemiology and pharmacoeconomics are important for drug safety if statistical investigations and questionnaires are used to improve the situation.

It is necessary that the pharmaceutical education still remains the same unique education for all pharmacists - so that a pharmacist can work in community pharmacy, hospital pharmacy or industry without any limitation.
But a reformed education should offer the possibility to choose between some elective courses so that the student can get some special knowledge in his fields of interest. Due to the fact that nearly 80% of the students will work in a community pharmacy in the future topics like patient counselling must be introduced into the curriculum.


APPENDIX

Germany: Pharmaceutical Education - Year 1 and 2
Lectures:
Inorganic chemistry
Inorganic analytics
Organic chemistry
Organic analytics
Instrumental analytics
Pharmaceutical chemistry
Biology for pharmacists
System of medical plants
Microorganisms/ Virus
Anatomy of plants
Microbiology / Hygiene
Galenics (Technology)
Physics for pharmacists
Physical Chemistry
History of Natural Science, especially pharmacy

Duty to attend these lectures:
Stereo-chemistry
Chemical nomenclature
Mathematics for pharmacists
Pharmaceutical/Medical terminology (Latin)

Germany: Pharmaceutical Education - Year 3 and 4
Lectures:
Pharmaceutical chemistry
Pharmaceutical Biology
Biotechnology
Galenics (Technology)
Anatomy, Physiology
Pathophysiology
Pharmacology/Toxicology
Clinical Chemistry
Nutrition Theory
Pharmaceutical Law

Duty to attend these lectures:
Standards of the pharmacopoea for the production of drugs
Technological and biopharmaceutical analytical methods
Drugs on the market (Trade name products)


Germany: Practice in the Laboratory
Year 1 and 2:
208 h qualitative chemical analysis
130 h quantitative chemical analysis
169 h instrumental analysis
195 h Pharmaceutical Chemistry (organics: synthesis)
78 h Galenics
52 h Biology (anatomy of plants)
26 h Biology: zytology, histochemistry
26 h Classification of medical plants
26 h Physical experiments
26 h Physical chemistry: experiments
39 h Microbiology

Year 3 and 4:
182 h Pharmaceutical Chemistry
Analytical methods of the pharmacopoea
208 h Pharmaceutical Chemistry
Toxicology, Analytics of drugs
39 h Pharmaceutical Biology
Analytics of medical plants
104 h Pharmaceutical Biology
Analytical methods of the pharmacopoea
247 h Galenics
143 h Biochemistry / Clinical chemistry
26 h Physiology
104 h Demonstration: Pharmacology, Toxicology


Germany: Educational topics for the "Practical Year"
Compounding / Galenics
Prescriptions of the physician
Organisation and control of drug production
Economic storage of drugs in a pharmacy
Storage problems (stability)
Drug information
Drug data bases
Misuse and addiction
Patient counselling
Baby nutrition
Diet products
Patient care products
Medical instruments
Drugs for animals
National and international drug market
First Aid
Protection against radiation
Health education and prevention
Law in general
Pharmaceutical Law
Health care authorities
Social insurance
Pharmacist in pharmacy, industry, science, administration
Pharmaceutical organisations
Historical background of development of the pharmacy system
Economics for pharmacists


Country__________________Hours of education_________Law/"Social Pharmacy"
=========================================================================

Belgium ______________________3.080__________________1 %
Denmark _____________________2.256_________________14 %
Germany AAppO 1989___________3.250__________________2 %
Germany Suggested by BAK 1993__3.268__________________2 %
Spain_________________________2.825__________________5 %
France________________________2.010__________________3 %
Greece________________________2.067__________________2 %
The Netherlands________________3.420__________________7 %
Ireland________________________2.102__________________4 %
Italy__________________________2.630__________________3 %
Portugal_______________________4.227__________________5 %
Scotland_______________________1.893_________________16 %

(BAK 1993: Thesen zu Berufsbild und Ausbildung des Apothekers)


Pharmacoepidemiology and Pharmacoeconomics in the pharmaceutical curriculum (Topics)
I. The drug
- trends in drug development
- the drug as a special good
- registered drugs
- registration of drugs
- drug safety
- drug evaluation
- drugs and therapeutical progress
- cost-benefit-analysis
- drug information
- the patient's understanding of drugs

II. The drug market and special conditions
- international trends and the EU market
- the social political environment for the drug market
- costs in the health care system / health economics
- special conditions for the production of drugs
- the pharmaceutical industry
- drug research and drug development
- drug distribution
- drug utilisation studies

III. Management of a pharmacy
- economics for pharmacists
- wholesaler and pharmacy
- health insurance companies - drug regulations
- computer in pharmacy
- organisation and staff management in a pharmacy
- marketing
- future trends
- leadership skills
- hospital pharmacy

IV. Safe drug use
- health and disease, the role of the drug
- Co-operation with physicians
- safe drug use
- self-medication
- drug addiction and misuse
- sociological and psychological aspects of drug use
- patient counselling and health education


References

"Bundesrepublik Deutschland: Approbationsordnung für Apotheker." Pharmazeutenkalender WS 95/96. Stuttgart: Deutscher Apotheker Verlag, 1995: 8-32

Bericht der ABDA - Bundesvereinigung Deutscher Apothekerverbände, der Bundesapothekerkammer - Arbeitsgemeinschaft Deutscher Apothekerkammern und des Deutschen Apothekerverbandes e.V. sowie weiterer Institutionen der Apotheker für den Zeitraum 1.Juli 1996 bis 30.Juni 1997. Pharmazeuti-sche Zeitung 142 (1996) 38

Thesen zu Berufsbild und Ausbildung des Apothekers. Bundesapothekerkammer, 1993

N.N.:Arzneimittelepidemiologie und -ökonomie in der universitären Ausbildung von Pharmazeuten

Email: elster@pharmazie.uni-halle.de