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Article ; Online: Consistent terminology for medication-related problems in pharmacogenomic cases.

Polasek, Thomas M / Mostafa, Sam / Kirkpatrick, Carl M J

Journal of psychiatry & neuroscience : JPN

2023 Volume 48, Issue 3, Page(s) E151–E152

MeSH term(s)	Humans ; Pharmacogenetics ; Terminology as Topic ; Drug-Related Side Effects and Adverse Reactions
Language	English
Publishing date	2023-05-12
Publishing country	Canada
Document type	Letter ; Comment
ZDB-ID	1077443-9
ISSN	1488-2434 ; 1180-4882
ISSN (online)	1488-2434
ISSN	1180-4882
DOI	10.1503/jpn.230022-l
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Article: An evaluation of the Australian Community Pharmacy Agreement from a public policy perspective: industry policy cloaked as health policy?

Jackson, John K / Scahill, Shane L / Mintrom, Michael / Kirkpatrick, Carl M

Journal of pharmaceutical policy and practice

2023 Volume 16, Issue 1, Page(s) 71

Abstract: Background: A series of Community Pharmacy Agreements (Agreements) between the Federal government and a pharmacy-owners' body, the Pharmacy Guild of Australia (PGA) have been influential policy in Australian community pharmacy (CP) since 1990. While ... ...

Abstract	Background: A series of Community Pharmacy Agreements (Agreements) between the Federal government and a pharmacy-owners' body, the Pharmacy Guild of Australia (PGA) have been influential policy in Australian community pharmacy (CP) since 1990. While ostensibly to support the public's access and use of medicines, the core elements of the Agreements have been remuneration for dispensing and rules that limit the establishment of new pharmacies. Criticism has focused on the self-interest of pharmacy owners, the exclusion of other pharmacy stakeholders from the Agreement negotiations, the lack of transparency, and the impact on competition. The objective of this paper is to determine the true nature of the policy by examining the evolution of the CPA from a policy theory perspective. Methods: A qualitative evaluation of all seven Agreement documents and their impact was undertaken using policy theories including a linear policy development model, Multiple Streams Framework, Incremental Theory, the Advocacy Coalition Framework, the Theory of Economic Regulation, the Punctuated Equilibrium Framework, and Elite Theory. The Agreements were evaluated using four lenses: their objectives, evidentiary base, stakeholders and beneficiaries. Results: The PGA has acted as an elite organisation with long-standing influence on the policy's development and implementation. Notable has been the failure of other pharmacy stakeholders to establish broad-based advocacy coalitions in order to influence the Agreements. The incremental changes negotiated every 5 years to the core elements of the Agreements have supported the publics' access to medication, provided stability for the government, and security for existing pharmacy owners. Their impact on the evolution of pharmacists' scope of practice and through that, on the public's safe and appropriate use of medication, has been less clear. Conclusions: The Agreements can be characterised predominantly as industry policy benefiting pharmacy owners, rather than health policy. An emerging issue is whether incremental change will continue to be an adequate policy response to the social, political, and technological changes that are affecting health care, or whether policy disruption is likely to arise.
Language	English
Publishing date	2023-06-12
Publishing country	England
Document type	Journal Article
ZDB-ID	2734772-2
ISSN	2052-3211
ISSN	2052-3211
DOI	10.1186/s40545-023-00571-y
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Article ; Online: A systematic review and meta-analysis of the impacts of germline pharmacogenomics on severe toxicity and symptom burden in adult patients with cancer.

Lingaratnam, Senthil / Shah, Mahek / Nicolazzo, Joseph / Michael, Michael / Seymour, John F / James, Paul / Lazarakis, Smaro / Loi, Sherene / Kirkpatrick, Carl M J

Clinical and translational science

2024 Volume 17, Issue 5, Page(s) e13781

Abstract: The clinical application of Pharmacogenomics (PGx) has improved patient safety. However, comprehensive PGx testing has not been widely adopted in clinical practice, and significant opportunities exist to further optimize PGx in cancer care. This ... ...

Abstract	The clinical application of Pharmacogenomics (PGx) has improved patient safety. However, comprehensive PGx testing has not been widely adopted in clinical practice, and significant opportunities exist to further optimize PGx in cancer care. This systematic review and meta-analysis aim to evaluate the safety outcomes of reported PGx-guided strategies (Analysis 1) and identify well-studied emerging pharmacogenomic variants that predict severe toxicity and symptom burden (Analysis 2) in patients with cancer. We searched MEDLINE, EMBASE, CENTRAL, clinicaltrials.gov, and International Clinical Trials Registry Platform from inception to January 2023 for clinical trials or comparative studies evaluating PGx strategies or unconfirmed pharmacogenomic variants. The primary outcomes were severe adverse events (SAE; ≥ grade 3) or symptom burden with pain and vomiting as defined by trial protocols and assessed by trial investigators. We calculated pooled overall relative risk (RR) and 95% confidence interval (95%CI) using random effects models. PROSPERO, registration number CRD42023421277. Of 6811 records screened, six studies were included for Analysis 1, 55 studies for Analysis 2. Meta-analysis 1 (five trials, 1892 participants) showed a lower absolute incidence of SAEs with PGx-guided strategies compared to usual therapy, 16.1% versus 34.0% (RR = 0.72, 95%CI 0.57-0.91, p = 0.006, I
MeSH term(s)	Humans ; Neoplasms/drug therapy ; Neoplasms/genetics ; Pharmacogenetics ; Pharmacogenomic Variants ; Antineoplastic Agents/adverse effects ; Antineoplastic Agents/administration & dosage ; Adult ; Germ-Line Mutation ; Pharmacogenomic Testing ; Symptom Burden
Chemical Substances	Antineoplastic Agents
Language	English
Publishing date	2024-05-03
Publishing country	United States
Document type	Journal Article ; Systematic Review ; Meta-Analysis ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	2433157-0
ISSN	1752-8062 ; 1752-8054
ISSN (online)	1752-8062
ISSN	1752-8054
DOI	10.1111/cts.13781
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Article ; Online: A Qualitative Evaluation of the Australian Community Pharmacy Agreement.

Jackson, John K / Chaar, Betty B / Kirkpatrick, Carl M / Scahill, Shane L / Mintrom, Michael

Pharmacy (Basel, Switzerland)

2023 Volume 11, Issue 6

Abstract: The Australian Federal Government's Community Pharmacy Agreement (Agreement), initiated in 1990 and renegotiated every five years with a pharmacy owners' organisation, is the dominant policy directing community pharmacy. We studied the experience with ... ...

Abstract	The Australian Federal Government's Community Pharmacy Agreement (Agreement), initiated in 1990 and renegotiated every five years with a pharmacy owners' organisation, is the dominant policy directing community pharmacy. We studied the experience with the Agreements of 38 purposively selected individual pharmacists and others of diverse backgrounds, using in-depth, semi-structured interviews. Although perceived to lack transparency in negotiation and operation, as well as paucity of outcome measures, the Agreements have generally supported the viability of community pharmacies and on balance, contributed positively to the public's access to medicines. There were, however, contradictory opinions regarding the impact of the policy's regulation of pharmacy locations, including the suggestion that they provide existing owners with an undue commercial advantage. A reported shortcoming of the Agreements was their impact on pharmacists' abilities to expand their scopes of practice and assist patients to make better use of medicines, in part due to the funding being almost totally focused on supply-related functions. The support for programs such as medication management services was perceived to be limited, and opportunities for diversification in pharmacy practice appeared constrained. Future pharmacy policy developed by the government could be more inclusive of a diverse range of stakeholders, seek to better utilise pharmacists' expertise, and have a greater focus on health outcomes.
Language	English
Publishing date	2023-12-18
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2737194-3
ISSN	2226-4787 ; 2226-4787
ISSN (online)	2226-4787
ISSN	2226-4787
DOI	10.3390/pharmacy11060188
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Article ; Online: New Horizons in the impact of frailty on pharmacokinetics: latest developments.

Hilmer, Sarah N / Kirkpatrick, Carl M J

Age and ageing

2021 Volume 50, Issue 4, Page(s) 1054–1063

Abstract: Frail older people have a high prevalence of drug use and are susceptible to adverse drug reactions. The physiological changes of frailty are likely to affect pharmacokinetics and pharmacodynamics. We reviewed the methods and findings of published ... ...

Abstract	Frail older people have a high prevalence of drug use and are susceptible to adverse drug reactions. The physiological changes of frailty are likely to affect pharmacokinetics and pharmacodynamics. We reviewed the methods and findings of published studies of pharmacokinetics in frailty. Nine studies describing pharmacokinetics and an additional three of pharmacokinetic pathways in frail older people were identified. Most pharmacokinetic studies investigated a single administration of a medication, dose or formulation, in small populations, often with limited representation of males or females, and applied variable definitions of frailty. Pharmacokinetic sampling designs generally utilised saturated sampling followed by analysis based on the trapezoidal rule for area under the curve, with more recent studies using sparser sampling and more sophisticated modelling to obtain individual and population values of all pharmacokinetic parameters. Overall, the pharmacokinetic studies reported only small changes in some parameters for some drugs with frailty, with the most consistent change reduced hepatic clearance in frail older people. Recommendations for future studies of pharmacokinetics in frailty include (i) standard objective definitions of frailty; (ii) larger studies including people with mild, moderate and severe frailty; (iii) population pharmacokinetic modelling to allow sparser sampling and consideration of multiple influences on pharmacokinetics; (iv) physiologically based modelling as the physiology of frailty emerges and (v) longitudinal pharmacokinetic studies of chronic drug therapy from middle to old age and from robust to pre-frail to frail, including pre-clinical studies. These data, accompanied by pharmacodynamics data in frailty, will inform safe, effective prescribing for frail older people.
MeSH term(s)	Aged ; Drug-Related Side Effects and Adverse Reactions ; Female ; Frail Elderly ; Frailty/diagnosis ; Frailty/drug therapy ; Frailty/epidemiology ; Humans ; Male ; Prevalence
Language	English
Publishing date	2021-03-09
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	186788-x
ISSN	1468-2834 ; 0002-0729
ISSN (online)	1468-2834
ISSN	0002-0729
DOI	10.1093/ageing/afab003
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Article ; Online: Science fiction has become reality: Best practice for future viral pandemics.

Wright, Daniel F B / Kirkpatrick, Carl M J

British journal of clinical pharmacology

2021 Volume 87, Issue 9, Page(s) 3385–3387

MeSH term(s)	Humans ; Pandemics/prevention & control
Language	English
Publishing date	2021-08-02
Publishing country	England
Document type	Editorial
ZDB-ID	188974-6
ISSN	1365-2125 ; 0306-5251 ; 0264-3774
ISSN (online)	1365-2125
ISSN	0306-5251 ; 0264-3774
DOI	10.1111/bcp.14997
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Article ; Online: A meta-analysis of palifermin efficacy for the management of oral mucositis in patients with solid tumours and haematological malignancy.

Coutsouvelis, John / Corallo, Carmela / Spencer, Andrew / Avery, Sharon / Dooley, Michael / Kirkpatrick, Carl M

Critical reviews in oncology/hematology

2022 Volume 172, Page(s) 103606

Abstract: Background: Palifermin, a recombinant keratinocyte growth factor promotes thickening of the mucosa, minimising severity of mucositis caused by chemotherapy and radiotherapy.: Objective: To synthesise published literature on palifermin for the ... ...

Abstract	Background: Palifermin, a recombinant keratinocyte growth factor promotes thickening of the mucosa, minimising severity of mucositis caused by chemotherapy and radiotherapy. Objective: To synthesise published literature on palifermin for the management of oral mucositis, in patients receiving chemotherapy and/or radiotherapy, aiming to ascertain recommendations for practice. Methods: Databases searched were Medline, Embase, IPA and CIANHL. A meta-analysis included randomised controlled trials (RCT) for palifermin compared to placebo or no palifermin, with the key data extracted being number of events of severe mucositis (defined by WHO criteria grade 3 or 4). Results: The meta-analysis included 10 RCT. Patients were treated for solid and haematological malignancy. Analysis suggested benefit of palifermin decreasing the incidence of severe mucositis in solid tumours RR0.76 [95%CI 0.63-0.92;p = 0.004], haematological malignancy RR0.63 [95 %CI 0.48-0.82;p = 0.0007] and overall RR0.69 [95 %CI 0.59-0.81;p < 0.0001]. Conclusion: Palifermin reduces the incidence of severe mucositis up to 30 % in patients receiving treatment with chemotherapy and/or radiotherapy.
MeSH term(s)	Fibroblast Growth Factor 7/therapeutic use ; Hematologic Neoplasms/complications ; Hematologic Neoplasms/drug therapy ; Humans ; Mucositis/complications ; Mucositis/etiology ; Neoplasms/complications ; Stomatitis/drug therapy ; Stomatitis/etiology
Chemical Substances	Fibroblast Growth Factor 7 (126469-10-1)
Language	English
Publishing date	2022-01-31
Publishing country	Netherlands
Document type	Journal Article ; Meta-Analysis ; Review
ZDB-ID	605680-5
ISSN	1879-0461 ; 0737-9587 ; 1040-8428
ISSN (online)	1879-0461
ISSN	0737-9587 ; 1040-8428
DOI	10.1016/j.critrevonc.2022.103606
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Article ; Online: Palifermin, administered for three doses only, reduces mucositis in patients undergoing HSCT and receiving chemoradiotherapy conditioning.

Coutsouvelis, John / Dooley, Michael / Kirkpatrick, Carl M / Avery, Sharon / Hopkins, Ria / Spencer, Andrew

Bone marrow transplantation

2022 Volume 57, Issue 8, Page(s) 1329–1331

MeSH term(s)	Chemoradiotherapy/adverse effects ; Fibroblast Growth Factor 7/therapeutic use ; Hematopoietic Stem Cell Transplantation/adverse effects ; Humans ; Mucositis/etiology ; Mucositis/prevention & control ; Stomatitis/etiology ; Stomatitis/prevention & control
Chemical Substances	Fibroblast Growth Factor 7 (126469-10-1)
Language	English
Publishing date	2022-05-19
Publishing country	England
Document type	Letter
ZDB-ID	632854-4
ISSN	1476-5365 ; 0268-3369 ; 0951-3078
ISSN (online)	1476-5365
ISSN	0268-3369 ; 0951-3078
DOI	10.1038/s41409-022-01714-6
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Article ; Online: Drug repurposing using real-world data.

Tan, George S Q / Sloan, Erica K / Lambert, Pete / Kirkpatrick, Carl M J / Ilomäki, Jenni

Drug discovery today

2022 Volume 28, Issue 1, Page(s) 103422

Abstract: The use of real-world data in drug repurposing has emerged due to well-established advantages of drug repurposing in supplementing de novo drug discovery and incentives in incorporating real-world evidence in regulatory approvals. We conducted a scoping ... ...

Abstract	The use of real-world data in drug repurposing has emerged due to well-established advantages of drug repurposing in supplementing de novo drug discovery and incentives in incorporating real-world evidence in regulatory approvals. We conducted a scoping review to characterize repurposing studies using real-world data and discuss their potential challenges and solutions. A total of 250 studies met the inclusion criteria, of which 36 were original studies on hypothesis generation, 101 on hypothesis validation, and seven on safety assessment. Key challenges that should be addressed for future progress in using real-world data for repurposing include isolated data sources with poor clinical granularity, false-positive signals from data mining, the sensitivity of hypothesis validation to bias and confounding, and the lack of clear regulatory guidance.
MeSH term(s)	Drug Repositioning ; Drug Discovery ; Data Mining
Language	English
Publishing date	2022-10-28
Publishing country	England
Document type	Journal Article ; Review ; Research Support, Non-U.S. Gov't
ZDB-ID	1324988-5
ISSN	1878-5832 ; 1359-6446
ISSN (online)	1878-5832
ISSN	1359-6446
DOI	10.1016/j.drudis.2022.103422
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Article ; Online: Virtual twins for model-informed precision dosing of clozapine in patients with treatment-resistant schizophrenia.

Mostafa, Sam / Rafizadeh, Reza / Polasek, Thomas M / Bousman, Chad A / Rostami-Hodjegan, Amin / Stowe, Robert / Carrion, Prescilla / Sheffield, Leslie J / Kirkpatrick, Carl M J

CPT: pharmacometrics & systems pharmacology

2024 Volume 13, Issue 3, Page(s) 424–436

Abstract: Model-informed precision dosing using virtual twins (MIPD-VTs) is an emerging strategy to predict target drug concentrations in clinical practice. Using a high virtualization MIPD-VT approach (Simcyp version 21), we predicted the steady-state clozapine ... ...

Abstract	Model-informed precision dosing using virtual twins (MIPD-VTs) is an emerging strategy to predict target drug concentrations in clinical practice. Using a high virtualization MIPD-VT approach (Simcyp version 21), we predicted the steady-state clozapine concentration and clozapine dosage range to achieve a target concentration of 350 to 600 ng/mL in hospitalized patients with treatment-resistant schizophrenia (N = 11). We confirmed that high virtualization MIPD-VT can reasonably predict clozapine concentrations in individual patients with a coefficient of determination (R
MeSH term(s)	Humans ; Clozapine/pharmacokinetics ; Clozapine/therapeutic use ; Antipsychotic Agents/pharmacokinetics ; Schizophrenia/drug therapy ; Fluvoxamine ; Schizophrenia, Treatment-Resistant
Chemical Substances	Clozapine (J60AR2IKIC) ; Antipsychotic Agents ; Fluvoxamine (O4L1XPO44W)
Language	English
Publishing date	2024-01-19
Publishing country	United States
Document type	Journal Article
ZDB-ID	2697010-7
ISSN	2163-8306 ; 2163-8306
ISSN (online)	2163-8306
ISSN	2163-8306
DOI	10.1002/psp4.13093
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