Lack of standardization related to compounded drug preparations, especially in the transition of ... more Lack of standardization related to compounded drug preparations, especially in the transition of care situations, threatens patient safety by facilitating medication error. This paper outlines progress to-date from the United States Pharmacopeia (USP) Expert Panel on the Exchange of Compounded Drug Preparation Information in Health IT Systems. The work plan developed for the group is focused on proposing a set of encoding rules that would govern how compounded nonsterile drug preparations (CNSPs) are digitized and exchanged, including patient electronic health records (EHR), pharmacy systems, e-prescribing (eRx), and other Health IT (HIT) systems to ensure a seamless compounding process tailored to the needs of an individual patient. Included in this work are identifying authorized compounding monographs, surveying provider and end-user groups for information about data specificity during e-prescribing, and generating guidelines for the development of a compatible data model for cli...
Drugs administered to children in the United States fall into two broad categories: (1) those tha... more Drugs administered to children in the United States fall into two broad categories: (1) those that have followed the US Food and Drug Administration (US-FDA) pediatric drug approval process and are marketed as finished dosage forms with pediatric labeling; and (2) all others, many of which are used “off-label”. The use of most drug products in pediatrics is still off label, often requiring special preparation, packaging, and, in some cases, compounding into preparations. The latter category includes compounded preparations that incorporate either a US-FDA approved finished dosage form (e.g., a sterile solution, sterile powder, nonsterile capsules, oral solution, crushed tablets, etc.), or rely on bulk active pharmaceutical ingredients (APIs). Compounded preparations are prepared for individual patients in 503A pharmacies, or on a larger scale and not just for specific patients, in licensed 503B establishments. Critical gaps in the current drug approval process for finished dosage fo...
The perspectives of the Compounded Drug Preparation Information Exchange Expert Panel of the Unit... more The perspectives of the Compounded Drug Preparation Information Exchange Expert Panel of the United States Pharmacopeia (CDPIE-EP) on the urgent need to create and maintain data standards to support the electronic transmission of an interoperable dataset for compounded nonsterile preparations (CNSPs) for children and the elderly is presented. The CDPIE-EP encourages all stakeholders associated with the generation, transmission, and preparation of CNSPs, including standards-setting and informatics organizations, to discern the critical importance of accurate transmission of prescription to dispensing the final product and an urgent need to create and adopt a seamless, transparent, interoperable, digitally integrated prescribing and dispensing system benefiting of all patients that need CNSPs, especially for children with special healthcare needs and medical complexity (CSHCN-CMC) and for adults with swallowing difficulties. Lay summary: Current electronic prescription processing stan...
The influence of pharmacotherapy regimens on surgical patient outcomes is increasingly appreciate... more The influence of pharmacotherapy regimens on surgical patient outcomes is increasingly appreciated in the era of enhanced recovery protocols and institutional focus on reducing postoperative complications. Specifics related to medication selection, dosing, frequency of administration, and duration of therapy are evolving to optimize pharmacotherapeutic regimens for many enhanced recovery protocolized elements. This review provides a summary of recent pharmacotherapeutic strategies, including those configured within electronic health record (EHR) applications and functionalities, that are associated with the minimization of the frequency and severity of postoperative complications (POCs), shortened hospital length of stay (LOS), reduced readmission rates, and cost or revenue impacts. Further, it will highlight preventive pharmacotherapy regimens that are correlated with improved patient preparation, especially those related to surgical site infection (SSI), venous thromboembolism (VT...
The purpose of this work was to evaluate the suitability of recently US Food and Drug Administrat... more The purpose of this work was to evaluate the suitability of recently US Food and Drug Administration (US-FDA) approved and marketed oral liquid, powder, or granule products for children in North America, to identify the next group of Active Pharmaceutical Ingredients (APIs) that have high potential for development as commercially available FDA-approved finished liquid dosage forms , and to propose lists of compounded nonsterile preparations (CNSPs) that should developed as commercially available FDA-approved finished liquid dosage forms as well as those that pharmacists should continue to compound extemporaneously. Through this identification and categorization process, the pharmaceutical industry, government, and the professions are encouraged to continue to work together to improve the likelihood that patients will receive high quality standardized extemporaneous CNSPs and US-FDA-approved products.
This commentary summarizes a collection of key references published within the last ten years, an... more This commentary summarizes a collection of key references published within the last ten years, and identifies pharmacologic research directions to improve treatment access and success through greater biosimilar or “follow-on” biologic utilization combined with other targeted small molecule agents that possess unique pathophysiologic mechanisms for inflammatory bowel diseases (IBD) in adult and pediatric patients. Since they are not identical to the originator or reference biologic agent, all biosimilars are not generically equivalent. However, in the US and other countries, they are considered therapeutically interchangeable if the manufacturer has demonstrated no clinically meaningful differences from the reference product. Comparisons of different clinical initiation and switching scenarios are discussed with reference to interchangeability, immunogenicity, nocebo effect, cost effectiveness, and time courses for discontinuation rates.
Cohn's work fills a void in the perioperative care literature by providing a concise, compreh... more Cohn's work fills a void in the perioperative care literature by providing a concise, comprehensive, practical, and authoritative guide to the medical management of common periprocedural issues and scenarios [...].
Surgical organizations dedicated to the improvement of patient outcomes have led to a worldwide p... more Surgical organizations dedicated to the improvement of patient outcomes have led to a worldwide paradigm shift in perioperative patient care. Since 2012, the Enhanced Recovery After Surgery (ERAS®) Society has published guidelines pertaining to perioperative care in numerous disciplines including elective colorectal and gynecologic/oncology surgery patients. The ERAS® and ERAS-USA® Societies use standardized methodology for collecting and assessing various surgical parameters in real-time during the operative process. These multi-disciplinary groups have constructed a bundled framework of perioperative care that entails 22 specific components of clinical interventions, which are logged in a central database, allowing a system of audit and feedback. Of these 22 recommendations, nine of them specifically involve the use of medications or pharmacotherapy. This retrospective comparative pharmacotherapy project will address the potential need to (1) collect more specific pharmacotherapy ...
Children with special health care needs (CSHCN) use relatively high quantities of healthcare reso... more Children with special health care needs (CSHCN) use relatively high quantities of healthcare resources and have overall higher morbidity than the general pediatric population. Embedding clinical pharmacists into the Patient-Centered Medical Home (PCMH) to provide comprehensive medication management (CMM) through collaborative practice agreements (CPAs) for children, especially for CSHCN, can improve outcomes, enhance the experience of care for families, and reduce the cost of care. Potential network infrastructures for collaborative practice focused on CSHCN populations, common language and terminology for CMM, and clinical pharmacist workforce estimates are provided. Applying the results from the CMM in Primary Care grant, this paper outlines the following: (1) setting up collaborative practices for CMM between clinical pharmacists and pediatricians (primary care pediatricians and sub-specialties, such as pediatric clinical pharmacology); (2) proposing various models, organizationa...
Cancellations or delays in surgical care for pediatric patients that present to the operating roo... more Cancellations or delays in surgical care for pediatric patients that present to the operating room create a great obstacle for both the physician and the patient. Perioperative outpatient management begins prior to the patient entering the hospital for the day of surgery, and many organizations practice using the perioperative surgical home (PSH), incorporating enhanced recovery concepts. This paper describes changes in standard operating procedures caused by the COVID-19 pandemic, and proposes the expansion of PSH, as a means of improving perioperative quality of care in pediatric populations.
Almost 30 million babies worldwide are born prematurely or become ill annually and need specializ... more Almost 30 million babies worldwide are born prematurely or become ill annually and need specialized care to survive. Formalized collaborative practice agreements (CPA) between clinical pharmacists and physicians have been put forward as a means for improving the overall medicating experience in many patient populations, including children. This report briefly describes opportunities for collaboration using examples from countries on each continent where CPA is established in professional governance documents and standards. It also provides resources in the form of a toolkit for countries and pharmacist–physician collaborators to authorize and form CPAs to provide comprehensive medication management (CMM) for children and youth with special health care needs (CSHCN).
This paper is a continuation of the first paper on drug formularies. It details the various types... more This paper is a continuation of the first paper on drug formularies. It details the various types of formularies, and speculates on the future of formularies as an instrument for improving rational drug therapy.
This editorial describes the purposes and content of the Special Issue for the development of a n... more This editorial describes the purposes and content of the Special Issue for the development of a national pediatric pharmacotherapy collaborative practice network. A collaborative practice network from a population health perspective is needed to better manage the medication-related needs of children with special health care needs and medical complexity (CSHCN-CMC). Over the last 25 years, the pharmacy profession has been engaged in organized efforts both to elevate practice and educational standards for pediatric pharmacy practice and to design medication management systems that benefit children and their families and caregivers. Moreover, alignment with pediatric clinical pharmacologists will aid in the development of new practice-based research paradigms that can be applied in the clinical setting. Formalized multi-disciplinary collaboration (CPAs) with new approaches to specialized electronic medication systems and comprehensive medication management (CMM) is necessary to improve...
American journal of medical genetics. Part A, 2018
Nephronophthisis is a progressive disease that affects development of the renal tubules and leads... more Nephronophthisis is a progressive disease that affects development of the renal tubules and leads to end stage renal disease. Many affected children have isolated renal disease; however, there can be additional manifestations including heart defects, liver fibrosis, brain malformations, and situs inversus. There is no way to slow or modify the disease. We describe a patient who presented at birth with cholestatic jaundice and decreased kidney function, found by exome sequencing to have two NPHP3 variants. Her clinical status deteriorated rapidly, and two disease-modifying agents were given in hopes of slowing disease progression, the arginine vasopressin type II receptor antagonist tolvaptan to stabilize her renal function and isosorbide dinitrate to manage her poorly controlled hypertension. Tolvaptan therapy initiated at 82 days of life had limited effect on the rate of decline in renal function and was insufficient to abrogate the need for dialysis; however, isosorbide dinitrate ...
Lack of standardization related to compounded drug preparations, especially in the transition of ... more Lack of standardization related to compounded drug preparations, especially in the transition of care situations, threatens patient safety by facilitating medication error. This paper outlines progress to-date from the United States Pharmacopeia (USP) Expert Panel on the Exchange of Compounded Drug Preparation Information in Health IT Systems. The work plan developed for the group is focused on proposing a set of encoding rules that would govern how compounded nonsterile drug preparations (CNSPs) are digitized and exchanged, including patient electronic health records (EHR), pharmacy systems, e-prescribing (eRx), and other Health IT (HIT) systems to ensure a seamless compounding process tailored to the needs of an individual patient. Included in this work are identifying authorized compounding monographs, surveying provider and end-user groups for information about data specificity during e-prescribing, and generating guidelines for the development of a compatible data model for cli...
Drugs administered to children in the United States fall into two broad categories: (1) those tha... more Drugs administered to children in the United States fall into two broad categories: (1) those that have followed the US Food and Drug Administration (US-FDA) pediatric drug approval process and are marketed as finished dosage forms with pediatric labeling; and (2) all others, many of which are used “off-label”. The use of most drug products in pediatrics is still off label, often requiring special preparation, packaging, and, in some cases, compounding into preparations. The latter category includes compounded preparations that incorporate either a US-FDA approved finished dosage form (e.g., a sterile solution, sterile powder, nonsterile capsules, oral solution, crushed tablets, etc.), or rely on bulk active pharmaceutical ingredients (APIs). Compounded preparations are prepared for individual patients in 503A pharmacies, or on a larger scale and not just for specific patients, in licensed 503B establishments. Critical gaps in the current drug approval process for finished dosage fo...
The perspectives of the Compounded Drug Preparation Information Exchange Expert Panel of the Unit... more The perspectives of the Compounded Drug Preparation Information Exchange Expert Panel of the United States Pharmacopeia (CDPIE-EP) on the urgent need to create and maintain data standards to support the electronic transmission of an interoperable dataset for compounded nonsterile preparations (CNSPs) for children and the elderly is presented. The CDPIE-EP encourages all stakeholders associated with the generation, transmission, and preparation of CNSPs, including standards-setting and informatics organizations, to discern the critical importance of accurate transmission of prescription to dispensing the final product and an urgent need to create and adopt a seamless, transparent, interoperable, digitally integrated prescribing and dispensing system benefiting of all patients that need CNSPs, especially for children with special healthcare needs and medical complexity (CSHCN-CMC) and for adults with swallowing difficulties. Lay summary: Current electronic prescription processing stan...
The influence of pharmacotherapy regimens on surgical patient outcomes is increasingly appreciate... more The influence of pharmacotherapy regimens on surgical patient outcomes is increasingly appreciated in the era of enhanced recovery protocols and institutional focus on reducing postoperative complications. Specifics related to medication selection, dosing, frequency of administration, and duration of therapy are evolving to optimize pharmacotherapeutic regimens for many enhanced recovery protocolized elements. This review provides a summary of recent pharmacotherapeutic strategies, including those configured within electronic health record (EHR) applications and functionalities, that are associated with the minimization of the frequency and severity of postoperative complications (POCs), shortened hospital length of stay (LOS), reduced readmission rates, and cost or revenue impacts. Further, it will highlight preventive pharmacotherapy regimens that are correlated with improved patient preparation, especially those related to surgical site infection (SSI), venous thromboembolism (VT...
The purpose of this work was to evaluate the suitability of recently US Food and Drug Administrat... more The purpose of this work was to evaluate the suitability of recently US Food and Drug Administration (US-FDA) approved and marketed oral liquid, powder, or granule products for children in North America, to identify the next group of Active Pharmaceutical Ingredients (APIs) that have high potential for development as commercially available FDA-approved finished liquid dosage forms , and to propose lists of compounded nonsterile preparations (CNSPs) that should developed as commercially available FDA-approved finished liquid dosage forms as well as those that pharmacists should continue to compound extemporaneously. Through this identification and categorization process, the pharmaceutical industry, government, and the professions are encouraged to continue to work together to improve the likelihood that patients will receive high quality standardized extemporaneous CNSPs and US-FDA-approved products.
This commentary summarizes a collection of key references published within the last ten years, an... more This commentary summarizes a collection of key references published within the last ten years, and identifies pharmacologic research directions to improve treatment access and success through greater biosimilar or “follow-on” biologic utilization combined with other targeted small molecule agents that possess unique pathophysiologic mechanisms for inflammatory bowel diseases (IBD) in adult and pediatric patients. Since they are not identical to the originator or reference biologic agent, all biosimilars are not generically equivalent. However, in the US and other countries, they are considered therapeutically interchangeable if the manufacturer has demonstrated no clinically meaningful differences from the reference product. Comparisons of different clinical initiation and switching scenarios are discussed with reference to interchangeability, immunogenicity, nocebo effect, cost effectiveness, and time courses for discontinuation rates.
Cohn's work fills a void in the perioperative care literature by providing a concise, compreh... more Cohn's work fills a void in the perioperative care literature by providing a concise, comprehensive, practical, and authoritative guide to the medical management of common periprocedural issues and scenarios [...].
Surgical organizations dedicated to the improvement of patient outcomes have led to a worldwide p... more Surgical organizations dedicated to the improvement of patient outcomes have led to a worldwide paradigm shift in perioperative patient care. Since 2012, the Enhanced Recovery After Surgery (ERAS®) Society has published guidelines pertaining to perioperative care in numerous disciplines including elective colorectal and gynecologic/oncology surgery patients. The ERAS® and ERAS-USA® Societies use standardized methodology for collecting and assessing various surgical parameters in real-time during the operative process. These multi-disciplinary groups have constructed a bundled framework of perioperative care that entails 22 specific components of clinical interventions, which are logged in a central database, allowing a system of audit and feedback. Of these 22 recommendations, nine of them specifically involve the use of medications or pharmacotherapy. This retrospective comparative pharmacotherapy project will address the potential need to (1) collect more specific pharmacotherapy ...
Children with special health care needs (CSHCN) use relatively high quantities of healthcare reso... more Children with special health care needs (CSHCN) use relatively high quantities of healthcare resources and have overall higher morbidity than the general pediatric population. Embedding clinical pharmacists into the Patient-Centered Medical Home (PCMH) to provide comprehensive medication management (CMM) through collaborative practice agreements (CPAs) for children, especially for CSHCN, can improve outcomes, enhance the experience of care for families, and reduce the cost of care. Potential network infrastructures for collaborative practice focused on CSHCN populations, common language and terminology for CMM, and clinical pharmacist workforce estimates are provided. Applying the results from the CMM in Primary Care grant, this paper outlines the following: (1) setting up collaborative practices for CMM between clinical pharmacists and pediatricians (primary care pediatricians and sub-specialties, such as pediatric clinical pharmacology); (2) proposing various models, organizationa...
Cancellations or delays in surgical care for pediatric patients that present to the operating roo... more Cancellations or delays in surgical care for pediatric patients that present to the operating room create a great obstacle for both the physician and the patient. Perioperative outpatient management begins prior to the patient entering the hospital for the day of surgery, and many organizations practice using the perioperative surgical home (PSH), incorporating enhanced recovery concepts. This paper describes changes in standard operating procedures caused by the COVID-19 pandemic, and proposes the expansion of PSH, as a means of improving perioperative quality of care in pediatric populations.
Almost 30 million babies worldwide are born prematurely or become ill annually and need specializ... more Almost 30 million babies worldwide are born prematurely or become ill annually and need specialized care to survive. Formalized collaborative practice agreements (CPA) between clinical pharmacists and physicians have been put forward as a means for improving the overall medicating experience in many patient populations, including children. This report briefly describes opportunities for collaboration using examples from countries on each continent where CPA is established in professional governance documents and standards. It also provides resources in the form of a toolkit for countries and pharmacist–physician collaborators to authorize and form CPAs to provide comprehensive medication management (CMM) for children and youth with special health care needs (CSHCN).
This paper is a continuation of the first paper on drug formularies. It details the various types... more This paper is a continuation of the first paper on drug formularies. It details the various types of formularies, and speculates on the future of formularies as an instrument for improving rational drug therapy.
This editorial describes the purposes and content of the Special Issue for the development of a n... more This editorial describes the purposes and content of the Special Issue for the development of a national pediatric pharmacotherapy collaborative practice network. A collaborative practice network from a population health perspective is needed to better manage the medication-related needs of children with special health care needs and medical complexity (CSHCN-CMC). Over the last 25 years, the pharmacy profession has been engaged in organized efforts both to elevate practice and educational standards for pediatric pharmacy practice and to design medication management systems that benefit children and their families and caregivers. Moreover, alignment with pediatric clinical pharmacologists will aid in the development of new practice-based research paradigms that can be applied in the clinical setting. Formalized multi-disciplinary collaboration (CPAs) with new approaches to specialized electronic medication systems and comprehensive medication management (CMM) is necessary to improve...
American journal of medical genetics. Part A, 2018
Nephronophthisis is a progressive disease that affects development of the renal tubules and leads... more Nephronophthisis is a progressive disease that affects development of the renal tubules and leads to end stage renal disease. Many affected children have isolated renal disease; however, there can be additional manifestations including heart defects, liver fibrosis, brain malformations, and situs inversus. There is no way to slow or modify the disease. We describe a patient who presented at birth with cholestatic jaundice and decreased kidney function, found by exome sequencing to have two NPHP3 variants. Her clinical status deteriorated rapidly, and two disease-modifying agents were given in hopes of slowing disease progression, the arginine vasopressin type II receptor antagonist tolvaptan to stabilize her renal function and isosorbide dinitrate to manage her poorly controlled hypertension. Tolvaptan therapy initiated at 82 days of life had limited effect on the rate of decline in renal function and was insufficient to abrogate the need for dialysis; however, isosorbide dinitrate ...
Uploads
Papers by Richard Parrish