ASHP Guidelines on the Pharmacy and Therapeutics Committee and the Formulary System

Tyler, Linda S.; Cole, Sabrina; May, J. Russell; Millares, Mirta; Valentino, Michael; Vermeulen, Lee C.; Wilson, Andrew L.

doi:10.2146/ajhp080086

Cited by 163 publications

(125 citation statements)

References 19 publications

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“…The Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk (FOURIER) trial is assessing the effect of evolocumab on the incidence of major CV events in patients with elevated LDL-C, clinically-event CVD, and additional CV risk factors 19 . Formulary decisions are based on both clinical and economic considerations 20 . Given the robust clinical evidence on evolocumab, discussion on its access often centers on product economic value.…”

Section: Introductionmentioning

confidence: 99%

Estimated burden of cardiovascular disease and value-based price range for evolocumab in a high-risk, secondary-prevention population in the US payer context

Tóth

Danese²,

Villa

et al. 2017

Journal of Medical Economics

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Aim: To estimate real-world cardiovascular disease (CVD) burden and value-based price range of evolocumab for a US-context, high-risk, secondary-prevention population. Materials and methods: Burden of CVD was assessed using the UK-based Clinical Practice Research Datalink (CPRD) in order to capture complete CV burden including CV mortality. Patients on standard of care (SOC; high-intensity statins) in CPRD were selected based on eligibility criteria of FOURIER, a phase 3 CV outcomes trial of evolocumab, and categorized into four cohorts: high-risk prevalent atherosclerotic CVD (ASCVD) cohort (n ¼ 1448), acute coronary syndrome (ACS) (n ¼ 602), ischemic stroke (IS) (n ¼ 151), and heart failure (HF) (n ¼ 291) incident cohorts. The value-based price range for evolocumab was assessed using a previously published economic model. The model incorporated CPRD CV event rates and considered CV event reduction rate ratios per 1 mmol/L reduction in low-density lipoprotein-cholesterol (LDL-C) from a meta-analysis of statin trials by the Cholesterol Treatment Trialists Collaboration (CTTC), i.e. CTTC relationship. Results: Multiple-event rates of composite CV events (ACS, IS, or coronary revascularization) per 100 patient-years were 12.3 for the high-risk prevalent ASCVD cohort, and 25.7, 13.3, and 23.3, respectively, for incident ACS, IS, and HF cohorts. Approximately one-half (42%) of the high-risk ASCVD patients with a new CV event during follow-up had a subsequent CV event. Combining these real-world event rates and the CTTC relationship in the economic model, the value-based price range (credible interval) under a willingness-to-pay threshold of $150,000/quality-adjusted life-year gained for evolocumab was $11,990 ($9,341-$14,833) to $16,856 ($12,903-$20,678) in ASCVD patients with baseline LDL-C levels !70 mg/dL and !100 mg/dL, respectively. Conclusion: Real-world CVD burden is substantial. Using the observed CVD burden in CPRD and the CTTC relationship, the cost-effectiveness analysis showed that, accounting for uncertainties, the expected value-based price for evolocumab is higher than its current annual cost, as long as the payer discount off list price is greater than 20%. ARTICLE HISTORY

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Section: Introductionmentioning

confidence: 99%

Estimated burden of cardiovascular disease and value-based price range for evolocumab in a high-risk, secondary-prevention population in the US payer context

Tóth

Danese²,

Villa

et al. 2017

Journal of Medical Economics

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“…Usulan perbaikan dalam rangka merubah perilaku SMF, yaitu perlu dilakukan ketegasan terkait aturan dari ketua KFT dengan mengetahui Direktur, tentang batas waktu pengajuan usulan formularium disertai dengan kriterianya serta menegaskan sanksi yang tegas jika melewati batas waktu yang ditentukan. Dalam hal ini KFT bertanggungjawab dalam mengatur sistem formularium, memberikan evaluasi, pendidikan dan konsultasi kepada staf medis dan administrasi organisasi, mengawasi kebijakan dan prosedur (Tyler, et al, 2008).…”

Section: Gambar 1 Value Stream Mapping Proses Pengelolaan Obatunclassified

Analisis Proses Pengelolaan Obat Rsud Di Jawa Timur Dengan Pendekatan Lean Hospital

Azizah

Ciptono

Satibi

2017

J. Manaj. dan Pelayanan Farm.

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ABSTRAKProses pelayanan yang efisien erat kaitannya dengan proses pengelolaan obat yang efisien. Tujuan dari penelitian ini untuk mengidentifikasi aktivitas serta menganalisis akar penyebab masalah dari waste kritis dengan menggunakan pendekatan lean hospital pada proses pengelolaan obat di sebuah Rumah Sakit Umum Daerah di Jawa Timur. Penelitian ini bersifat deskriptif kualitatif yaitu melalui observasi, wawancara dan penelusuran dokumen pada bulan November-Desember 2016 dan Januari 2017, untuk mendapatkan identifikasi aktivitas seleksi, pengadaan dan distribusi. Waste kritis diperoleh melalui kuesioner pembobotan waste dari penilaian seluruh petugas yang terlibat dalam proses, untuk dilakukan analisis lebih lanjut. Future state mapping dibuat dengan menghilangkan unsur waste dari proses pengelolaan obat. Hasil penelitian: Value stream mapping menunjukkan waste di setiap tahapan proses pengelolaan obat yaitu waste of defect, waste of waiting, waste of inventory, waste of transportation, waste of motion, waste of overprocessing, waste of overproduction, dan waste of human potential. Kesimpulan: Sebagian besar tahapan dalam proses pengelolaan obat memiliki value added activity kurang dari 50%. Analisis akar penyebab masalah dari waste kritis yaitu kesibukan dokter dalam pelayanan menyebabkan penundaan dalam pengisian formulir usulan dan tidak semua SMF memiliki sekretaris, perencanaan belum terfasilitasi oleh SIM, sistem yang memaksa input SPPH pada saat penyusunan PO e-purchasing, adanya perubahan harga obat yang mendadak, tidak adanya tenaga kasir di UPF, tidak ada pemisah resep di awal pelayanan, bentuk ruangan UPF 1 memanfaatkan fasilitas lama, CPO belum difasilitasi oleh SIM, mesin etiket hanya 1 unit dan belum optimal. Kata kunci: Lean Hospital, Waste kritis, Pengelolaan Obat, Fishbone diagram ABSTRACTEfficient service processes are closely related to efficient drug management processes. The purpose of this research is to identify every activity and analyze the root cause of critical waste using lean hospital approach at public hospital in east java. This research is descriptive qualitative, through observation, interview, and document tracing on november-desember 2016 until januari 2017, to identify every activity of selection, procurement and distribution. Critical waste obtained through 'waste weighting questionnaire' from the assessment of all officers involved in the process, for further analysis. Future state mapping is made by eliminating waste element from drug management process. Results: value stream mapping shows that many wastes in every stage of drug management process, including waste of defect, waste of waiting, waste of inventory, waste of transportation, waste of motion, waste of overprocessing, waste of overproduction, and waste of human potential. Conclusions: most of the stages at drug management process have value added activity less than 50%. The root cause analysis of the critical waste problem is doctor's busyness in their service causes a delay in completing the proposal form and no...

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“…14 Generic substitution occurs when a pharmacist selects and dispenses a drug product that is identical to the branded product in terms of active ingredient, strength, concentration, dosage form, and administration route. State pharmacy practice laws give pharmacists the authority to make this substitution within reason, and the ASHP guidelines state that the use of generic products deemed by the FDA to be bioequivalent to branded products does not need review by an institution's pharmacy and therapeutics (P&T) committee.…”

Section: ■■ Substitution Versus Interchangementioning

confidence: 99%

Pharmacist Substitution of Biological Products: Issues and Considerations

Ramanan²,

Green³

2015

JMCP

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SUMMARYBiosimilars are biological products that are highly similar to their biological reference products, notwithstanding minor differences in clinically inactive components. However, unlike generics of small-molecule drugs, biosimilars are not identical to their reference products, since each manufacturer uses unique cell lines and processes, and these lead to slight structural differences between products. Because these structural variations can lead to differences in clinical response, clinical studies demonstrating biosimilarity are required before and robust pharmacovigilance after approval. Although the FDA has not yet issued formal guidance on interchangeable biosimilars, higher standards of similarity will be required in order to achieve an interchangeable designation. In this commentary, we review the differences between generics and biosimilars, describe their respective regulatory approval pathways, discuss interchangeability and substitution, and review substitution of interchangeable biosimilars, focusing on key professional considerations for pharmacists.

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ASHP Guidelines on the Pharmacy and Therapeutics Committee and the Formulary System

Cited by 163 publications

References 19 publications

Estimated burden of cardiovascular disease and value-based price range for evolocumab in a high-risk, secondary-prevention population in the US payer context

Estimated burden of cardiovascular disease and value-based price range for evolocumab in a high-risk, secondary-prevention population in the US payer context

Analisis Proses Pengelolaan Obat Rsud Di Jawa Timur Dengan Pendekatan Lean Hospital

Pharmacist Substitution of Biological Products: Issues and Considerations

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