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Ad hoc study of the role of hospital pharmacists in clinical trials in Bulgaria

Liliya Bogdanova, Evgeni Grigorov, Valentina Belcheva, Ilko Getov

Abstract

PURPOSE: The aim of our research is to study the role and responsibilities of the hospital pharmacists in conducting clinical trials in Bulgaria.

MATERIAL AND METHODS: A special questionnaire was developed in the Faculty of Pharmacy, MUSofia. A total number of 30 hospital pharmacies were contacted and included in the study. Three of them refused to take part in the survey. The interview was via phone and included 4 questions (3 closed and 1 open). Mainly the head hospital pharmacy manager of the participating health institutions was interviewed.

RESULTS: Analysis of the results shows that current practice in Bulgaria allowed hospital pharmacists to be involved in clinical trials but this case is not prevalent. The majority of the trials, conducted in our country that includes hospital pharmacies were with narcotic investigational products, which according to the specific local legislation can only be located at the site of the hospital pharmacy in a special metal shelf box. However there are lots of trials conducted without participation of hospital pharmacist/research pharmacist.

CONCLUSION: The participation of the hospital pharmacist can be extended - to help manage adverse events, monitor the effect of the drugs under the study and awareness for the drug-to-drug interactions. There are protocols where apart from the investigational product - there are non-drugs under the study, i.e. placed on the market which should be dispensed at the beginning of the trials during the washout period and again here is the place for the research pharmacist to control these non-investigational products.


Keywords

Bulgaria; hospital; pharmacist; role; clinical; trial

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References

Baer AR, et al. The Clinical Research Team. J Oncol Pract. 2011;7(3):188-92.

Darlenski RB, et al. Evidence-based medicine: facts and controversies. Clin Dermatol. 2010;28(5):553-77.

DMID, Pharmacy Guidelines andInstructions for DMID Clinical Trials. 2007.

Getov IN, et al. Study of obligations defined in agreements between parties involved in clinical trials of medicinal products in Bulgaria. Med Glas (Zenica). 2012;9(2):383-7.

GetovIN, et al. Clinical pharmacy - essence, progress and challenges in practice. Medical review. 2013; 49(3):30-6.

Glasgow RE, et al. Practical Clinical Trials for Translating Research to Practice: Design and Measurement Recommendations. Medical care. 2005;43(6):551-7.

Hepler CD. Clinical pharmacy, pharmaceutical care, and the quality of drug therapy. Pharmacotherapy. 2004;24(11):1491-8.

Kostov E, et al. Review of the historical aspects in the development of clinical trials. Asklepios. 2013;7(2):39-46.

Laine C, et al. Clinical Trial Registration - Looking Back and Moving Ahead. N Engl J Med. 2007;356(26):2734-6.

Lebanova HV, Getov IN, Grigorov EE. Descriptive study for look-alike and sound-alike medicines based on local language peculiarities. AJPP. 2013;6(28): 2161-5.

Rockwell K, et al. Clinical research: national survey of U.S. pharmacy-based investigational drug services - 1997. Am J Health Syst Pharm. 1999;56(4);337-44.

Sabaté E. Adherence to Long-term Therapies: Evidence for Action. Geneva: World Health Organization; 2003.

Shtereva D, Dineva-Simidchieva T, Naseva E. Opinion research methodology: observation of the opinion of the hospital management personnel on the hospital financing in Bulgaria in term of health care reform and economic crisis. J Intern Sci Publ : Economy & Business. 2013:7(1):231-40.

Stephens M. Hospital Pharmacy. Pharmaceutical Press; 2011.

Thomas KB, Tesch C. Clinical trial disclosure: the ongoing debate on public registers for clinical trials. J Euro Med Writ Assoc. 2007;16(2):67-72.




DOI: http://dx.doi.org/10.14748/ssp.v1i1.600

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About The Authors

Liliya Bogdanova
Medical University of Sofia
Bulgaria

Faculty of Pharmacy

Evgeni Grigorov
Medical University of Pleven
Bulgaria

Medical College

Valentina Belcheva
Medical University of Sofia
Bulgaria

Faculty of Public Health

Ilko Getov
Medical University of Sofia
Bulgaria

Faculty of Pharmacy

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