Studi Literatur: Peran Apoteker dalam Pengawasan Keamanan Vaksin P dan M di Indonesia

Reyhan Diva Zaafira, Windy Amelia, Revita Fitri Amelia, Rosa Adelina

Abstract


Abstract: Coronavirus disease (COVID-19) has infected millions of people globally since the World Health Organization declared a pandemic on March 11, 2020. Various efforts have been made to control the COVID-19 pandemic, including the development of vaccines. Pfizer and Moderna vaccines are mRNA-based vaccines developed in Indonesia with promising safety and effectiveness. The method used in this research is a descriptive method using literature studies in journals that discuss the safety control of P and M vaccines in Indonesia, with work procedures that include literature search, literature selection, literature documentation, analysis, and drawing conclusions. The results of the literature study show that pharmacists play an important role in maintaining the safety, quality, and efficacy of vaccines starting from the selection and procurement of distribution (which includes storage) to the time of use. At the selection stage, pharmacists must be able to consider the policies of international and national organizations. Pharmacists are fully responsible for procurement by ensuring that the vaccines received meet the standards and have a certificate of release from the competent authority of the country where the vaccine was released as well as a summary protocol issued by the manufacturer. Pharmacists are also responsible for distribution by keeping the COVID-19 vaccine within the specified temperature range. In use, pharmacists play a role in ensuring that vaccines are given according to the rules and in post-vaccination Monitoring of Drug Side Effects.



Keywords


Moderna, Pfizer, the role of pharmacists in vaccination , Vaccine safety

References


Badan Pengawas Obat dan Makanan, (2019), ‘Peraturan Badan Pengawas Obat dan Makanan Nomor 9 Tahun 2019 Tentang Pedoman Teknis Cara Distribusi Obat yang Baik’.

Badan Pengawas Obat dan Makanan, (2021), ‘BPOM Izinkan Penggunaan Vaksin COVID-19 Produksi PT Bio Farma.’

Badan Pengawas Obat dan Makanan, (2021), ‘Jamin Keamanan dan Mutu, BPOM Awasi Ketat Vaksin MR.’

Badan Pengawas Obat dan Makanan, (2021), Peraturan Badan Pengawas Obat dan Makanan Nomor 10 Tahun 2021 Tentang Standar Kegiatan Usaha dan Produk pada Penyelenggaraan Perizinan Berusaha Berbasi Risiko Sektor Obat dan Makanan.

Badan Pengawas Obat dan Makanan, (2021), ‘Menguatnya sistem pengawasan Obat dan Makanan.’

Badan Pengawas Obat dan Makanan, (2021), ‘Pengawalan Keamanan, Khasiat, dan Mutu Vaksin COVID-19.’

Badan Pengawas Obat dan Makanan, (2021), ‘Tenaga kesehatan, Apoteker, dan Loka POM di Kabupaten Tangerang Bersinergi Jamin Mutu Vaksin Covid-19.’

Bio Farma, (2021), Bio Farma Sudah Produksi 90,1 Juta Dosis Vaksin Covid-19.

Centers for Disease Control and Prevention, (2021), SARS-CoV-2 Variant Classifications and Definitions, https://www.cdc.gov/coronavirus/2019-ncov/variants/variant-classifications.html.

Fauza, W. dan Rasyid, R., (2019), ‘The Analysis of Cold Chain Management of Basic Immunization Vaccine in Health Service Centers,’ 7(1), 42–50.

Herdady, M.R. dan Muchtaridi, M., (2020), ‘COVID-19: Alarm Bagi Sistem Rantai Pasok Industri Farmasi,’ Majalah Farmasetika, 5(4).

Satibi, Imam Subchi, Ning Sulistiyowati, Rosa Adelina, Zilhadia, Nur Hidayah, Ario Wicaksono, Ummi Kultsum, Rena Latifa, Wa Ode Zainab Zilullah Toresano dan Nurul Adhha, (2021), ‘Dampak Pandemi Terhadap Manajemen Obat (Termasuk Obat Covid-19 di Indonesia dan Dunia,’ Pandemi di Berbagai Perspektif, 1st edn., vol. 1, p. 65, RajaGrafindo Persada, Depok.

International Pharmaceutical Federation, (2018), Pharmacist in Supply Chain: The Role of The Medicines Expert in Ensuring Quality and Availability.

John W Cresswell, (2013), ‘Qualitative Inquiry and Research Design,’ United States of America: SAGE Publications, Inc.

Kemenkes RI, (2021), Varian Omicron Terdeteksi di Indonesia.

Kementerian Kesehatan RI, (2017), Peraturan Menteri Kesehatan Republik Indonesia no 12 Tahun 2017 tentang Penyelenggaraan Imunisasi, Jakarta.

Kementerian Kesehatan RI, (2021), ‘Petunjuk Teknis Pelaksanaan Vaksinasi dalam Rangka Penanggulangan Pandemi Coronavirus Disease 2019 (COVID-19).’

Kementerian Komunikasi dan Informatika RI, (2021), Pemerintah Amankan 370 Juta Dosis Vaksin Hingga Akhir Tahun 2021.

Mudin, N., (2018), ‘Penjaminan Mutu dalam Pendistribusian Sediaan Farmasi,’ Farmasetika.com (Online), 3(1), 1.

National Institutes of Health, (2020), Peer-reviewed report on Moderna.

Pharmacy Board Malaysia, (2017), Record of Training and Experience for Provisionally Registered Pharmacist.

Polack, F.P., Thomas, S.J., Kitchin, N., Absalon, J., Gurtman, A., Lockhart, S., Perez, J.L., Pérez Marc, G., Moreira, E.D., Zerbini, C., Bailey, R., Swanson, K.A., Roychoudhury, S., Koury, K., Li, P., Kalina, W. V., Cooper, D., Frenck, R.W., Hammitt, L.L., Türeci, Ö., Nell, H., Schaefer, A., Ünal, S., Tresnan, D.B., Mather, S., Dormitzer, P.R., Şahin, U., Jansen, K.U. dan Gruber, W.C., (2020), ‘Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine,’ New England Journal of Medicine, 383(27), 2603–2615.

Quick, J.D., Rankin, J.R., Dias dan Vimal, (2012), Inventory Management in Managing Drug Supply, 3rd edn., Management Sciences for Health, Arlington.

Rahayu, (2021), ‘Vaksin covid 19 di indonesia : analisis berita hoax,’ 2(07), 39–49.

Setiawan, A., Dian Saraswati, L., Sakundarno Adi, M., Ari Udijono, (2021), ‘Gambaran Kualitas Pengelolaan Rantai Dingin Vaksin Meningitis di Wilayah Provinsi Daerah Istimewa Yogyakarta Overview of the Meningitis Vaccine Cold Chain Management in Special Region Yogyakarta Province.’

Washington State Departemen of Health, (2021), Avoiding COVID-19 Vaccine Waste.

WHO, (2015), Module 2: The vaccine cold chain.

WHO, (2018), ‘Biosafety and Biosecurity,’ 1.

World Health Organization, (2021), WHO Director-General’s opening remarks at the media briefing on COVID-19 - 11 March 2020.

World Health Organization, (2021), COVID-19 Weekly Epidemiological Update.


Full Text: PDF

DOI: 10.15408/pbsj.v4i1.24398

Refbacks

  • There are currently no refbacks.