Patient experiences of their current asthma care and their views toward providing support for patients with asthma in community pharmacy: A Qualitative study.

Background: An estimated 300 million people live with asthma globally. In England, a significant percentage live with poorly controlled asthma symptoms. Community pharmacists might be able to play a role in filling gaps in asthma care as they have the expertise and are in regular contact with patients with long term conditions. This study described patients' experiences of the management of their asthma in the general physician (GP) practice and community pharmacy settings and explored patients' views on providing support for them in community pharmacy. Method: This is a descriptive qualitative study. Thirteen adult asthma patients were recruited from a GP practice in the Northwest of England. Semi-structured qualitative interviews were conducted face-to-face or by telephone. The interviews were recorded, transcribed and analysed using a thematic analysis approach. Ethics approval was obtained before the study commenced and all participants gave informed written consent to participate. Results: We identified challenges in the current asthma care provided to patients with asthma including lack of continuity of care, inability to book an appointment and other experienced differences in the quality of asthma care provided to them and/or access to annual asthma reviews across different GP practices. Additionally, there is lack of awareness of services provided in community pharmacy. These challenges along with having comorbidities alongside asthma may negatively affect asthma patients' engagement with their asthma appointments and their behaviour toward their asthma. Conclusions: Patients showed trust in community pharmacists same as other HCPs to support them with their asthma care. Patients thought that being provided with regular asthma care including reviews in community pharmacy might be a suitable approach to respond to patients' needs and preferences in terms of their asthma management because of ease of access to community pharmacy. Pharmacists could be involved in the provision of community pharmacy-based asthma interventions that involve more than inhaler technique education. Further research should focus on developing structured approaches for asthma patient education that can be implemented consistently in the context of community pharmacy in England.

The management of asthma in adult patients in the community pharmacy setting: Literature review.

BACKGROUND: Asthma poses a public health concern, with an estimated 235 million people currently living with the condition globally. The provision of evidence-based, patient-centred services for adult asthma patients in community pharmacy which involves collaboration across the multidisciplinary team could improve their asthma control. OBJECTIVES: A literature review was conducted to examine the evidence of asthma management in community pharmacy setting. METHODS: Five databases were searched to identify relevant articles published before February 2021. Screening of the potential studies was performed to remove articles that did not comply with the inclusion criteria. Relevant data from all included studies was collected using a data extraction form to ensure consistency throughout the review. RESULTS: Twenty studies were included in the review; all were conducted in community pharmacy settings in the period of 2001-2020, in different countries. The studies included randomised controlled trials, controlled trials and observational studies. Several successful community pharmacy-based services that were provided to asthma patients to improve their asthma management were highlighted in this review. These interventions consisted of one or more components and included: patient education, inhaler technique improvement, patient counselling, self-management plans, development and provision of asthma action plans and referral to other health care practitioners. None of the studies involved medication or dosage changes by community pharmacy. CONCLUSIONS: The evidence discussed in this review showed that community pharmacists are well-placed to deliver services to asthma patients and many studies were conducted in the community pharmacy to improve asthma control in adult patients. However, further research could be conducted to explore further opportunities for community pharmacy to enhance asthma patients management of their condition.

A survey of antibiotic administration practices involving patients with sepsis in UK critical care units.

Background Alternative administration methods are emerging as a key area of research to improve clinical efficacy of antibiotics and address concerns regarding multi-drug resistance. Extended intermittent infusions or continuous infusions of antibiotics exhibiting time-dependent kill characteristics may be favourable in critically ill septic patients, but more evidence is needed to determine best practice. Objective To find out whether any common practice exists for intravenous antibiotic administration in critical care units across UK NHS Trusts, and identify factors influencing the adoption of extended or continuous infusions. Setting UK hospitals. Method UK critical care pharmacists were invited to participate in a survey on behalf of all 240 critical care units via a UK Clinical Pharmacy Association message board. The survey focused on administration practices for 22 antibacterial agents. Main outcome measure Antibiotic administration method. Results Responses were received covering 64 units, a response rate of 26.2%. Common, but not uniform administration methods were apparent for 17/22 antibiotics. Four antibiotics (piperacillin/tazobactam, doripenem, meropenem and vancomycin) were more likely to be administered as continuous or extended-intermittent infusions. Choice of administration method was especially influenced by altered pk/pd properties in sepsis or severe burns patients, or by the presence of organisms requiring high minimal inhibitory concentrations. Conclusion Unlicensed alternative practices of antibiotic administration are widespread but only weak evidence exists of any patient benefit, such as reduced length of stay in critical care, and none showing improvement in mortality. Further research is needed to determine whether extended infusion methods offer clinically meaningful advantages over shorter licenced administration methods in patients in critical care units.

Stakeholder perceptions of a new model of care for medication supply at hospital discharge.

OBJECTIVES: Problems relating to patients' medication are common during hospital discharge, often resulting in unnecessary harm to patients and even hospital readmission. To overcome these issues and improve patient discharge, an evidence-based approach was used to develop an innovative model of care for the supply of medication at hospital discharge. The model increases pharmacy involvement, uses community pharmacies in the supply process and encourages patient follow-up after discharge. This study aimed to determine if the proposed new model of care was considered feasible and acceptable by the target population. METHODS: This formative evaluation involved qualitative interviews and focus groups to explore the opinions of stakeholders involved in delivery or use of the new model of care. A range of stakeholders participated, including a variety of hospital and community-based healthcare professionals as well as expert patients and carers. Thematic analysis of the data was undertaken. RESULTS: The study provided a holistic overview of stakeholder perceptions of the new model of care. Overall, stakeholders were enthusiastic about the new model. Three themes emerged during analysis, providing an informative review of the new model. Themes included: impact, resources required and ensuring safety and quality of the new model of care. Potential issues were identified within each theme along with ideas for overcoming these issues. CONCLUSIONS: The new model of care appears to be a positive step towards improving patient discharge from hospital. Future work will involve a pilot of the new model of care using the study findings to assist with implementation.

Are interprofessional healthcare teams meeting patient expectations? An exploration of the perceptions of patients and informal caregivers.

Poor teamwork skills in healthcare have been found to be a contributing cause of negative incidents in patient care, whilst effective teamwork has been linked to more positive patient outcomes. The aim of this research is to explore views of patients and informal caregivers on the key characteristics of effective healthcare teams and their experiences of healthcare teams using a qualitative approach. A focus group schedule was developed from existing literature to explore this. Topics included the purpose and value of teams in patient care, key attributes and their impact on patient care. Patients and informal caregivers were recruited via convenience sampling. Three focus groups were conducted. Thematic analysis identified a number of themes associated with effective teams. These themes included the perceived purpose of teams, perceptions about the structure of a team, team-based communication, the role of patients, delivery of care. Research participants noted the importance of key characteristics in effective teams, but felt that these were not always consistently present. Communication was considered to be the most important attribute in team working and also appeared to be the area in which the patient experience can be significantly improved. It is clear from the findings of this research that further improvements in teamwork skills in healthcare are needed to achieve effective collaborative practice, sustainable service delivery models and optimal patient care.

Cross-sectional survey of patients' need for information and support with medicines after discharge from hospital.

BACKGROUND: Most patients experience changes to prescribed medicines during a hospital stay. Ensuring they understand such changes is important for preventing adverse events post-discharge and optimising patient understanding. However, little work has explored the information that patients receive about medicines or their perceived needs for information and support after discharge. OBJECTIVES: To determine information that hospital inpatients who experience medicine changes receive about their medicines during admission and their needs and preferences for, and use of, post-discharge support. METHODS: Cross-sectional survey with adult medical inpatients experiencing medicine changes in six English hospitals, with telephone follow-up 2-3 weeks post-discharge. KEY FINDINGS: A total of 444 inpatients completed surveys, and 99 of these were followed up post-discharge. Of the 444, 44 (10%) were unaware of changes to medicines and 65 (16%) did not recall discussing them with a health professional, but 305 (77%) reported understanding the changes. Type of information provided and patients' perceived need for post-discharge support differed between hospitals. Information about changes was most frequently provided by consultant medical staff (157; 39%) with pharmacists providing information least often (71; 17%). One third of patients surveyed considered community pharmacists as potential sources of information about medicines and associated support post-discharge. Post-discharge, just 5% had spoken to a pharmacist, although 35% reported medicine-related problems. CONCLUSION: In north-west England, patient inclusion in treatment decisions could be improved, but provision of information prior to discharge is reasonable. There is scope to develop hospital and community pharmacists' role in medicine optimisation to maximise safety and effectiveness of care.

Inpatient prescribing systems used in NHS Acute Trusts across England: a managerial perspective.

OBJECTIVE: The individualised patient prescription chart, either paper or electronic, is an integral part of communication between healthcare professionals. The aim of this study is to ascertain the extent to which different prescribing systems are used for inpatient care in acute hospitals in England and explore chief pharmacists' opinions and experiences with respect to electronic prescribing and medicines administration (EPMA) systems. METHOD: Audio-recorded, semistructured telephone interviews with chief pharmacists or their nominated representatives of general acute hospital trusts across England. RESULTS: Forty-five per cent (65/146) of the chief pharmacists agreed to participate. Eighteen per cent (12/65) of the participants interviewed stated that their trust had EPMA systems fully or partially implemented on inpatient wards. The most common EPMA system in place was JAC (n=5) followed by MEDITECH (n=3), iSOFT (n=2), PICS (n=1) and one in-house created system. Of the 12 trusts that had EPMA in place, 4 used EPMA on all of their inpatient wards and the remaining 8 had a mixture of paper and EPMA systems in use. Fifty six (86% 56/65) of all participants had consulted the standards for the design of inpatient prescription charts. From the 12 EPMA interviews qualitatively analysed, the regulation required to provide quality patient care is perceived by some to be enforceable with an EPMA system, but that this may affect accuracy and clinical workflow, leading to undocumented, unofficial workarounds that may be harmful. CONCLUSIONS: The majority of inpatient prescribing in hospital continues to use paper-based systems; there was significant diversity in prescribing systems in use. EPMA systems have been implemented but many trusts have retained supplementary paper drug charts, for a variety of medications. Mandatory fields may be appropriate for core prescribing information, but the expansion of their use needs careful consideration.

Hospital patient discharge process: an evaluation.

OBJECTIVES: Medication discrepancies for patients after discharge from hospital are well documented. They have been shown to cause unnecessary harm to patients and can result in hospital readmission. To improve patient discharge, the current process of discharging patients from hospital (the discharge process) needs evaluating to determine where and why medication issues occur. This study aimed to identify and evaluate the discharge process used in a range of acute National Health Service hospitals across the North West of England. METHODS: This qualitative study involved semi-structured telephone interviews with 13 chief pharmacists or an appropriately nominated member of the hospital pharmacy team. Thematic analysis of the transcribed interview data was performed. Data analysis revealed eight main themes which all impacted on the discharge process. RESULTS: The study was successful in identifying the discharge process across the range of hospitals as well as key issues and examples of good practice. The hospitals involved in the study were found to have similar discharge processes with issues common to all. One significant finding was a lack of patient involvement in the discharge process. CONCLUSIONS: To improve the patient discharge process, innovative solutions are required to overcome the current issues. In future work, the study findings will be used to develop a new model of care for patient discharge from hospital.

UK hospital patient discharge: the patient perspective.

OBJECTIVES: Hospital discharge is a complex process that can result in errors and delays for patients, particularly around the supply of medicines and communication of information. To improve patient discharge, patient perspectives of the discharge service must be explored to determine where patients feel problems arise. This study aimed to explore inpatient perceptions and experiences of the current discharge process. METHODS: This study involved questionnaires with patients at a large city-centre teaching hospital. RESULTS: A total of 104 inpatients participated, 60% (n=62) were male with an average age of 55 (age range 19-93). Participants were from a range of medical, surgical and admissions wards. The majority, 71% of respondents (n=74), took regular medicines, with 65% (n=48) taking five or more medicines daily. Most patients, 89% (n=87), were satisfied with their hospital discharge but felt that it took too long. The perceived main cause of delay was waiting for medicines. Other highlighted issues included lack of counselling by pharmacists and the need for more patient involvement throughout the discharge process. CONCLUSIONS: This study showed that certain aspects of the discharge process need improving to provide safe, quality care for patients and improve patient experience of discharge. The findings from this study will inform the development of a new model of care for patient discharge from hospital.

Emergency supply of prescription-only medicines to patients by community pharmacists: a mixed methods evaluation incorporating patient, pharmacist and GP perspectives.

OBJECTIVE: To evaluate and inform emergency supply of prescription-only medicines by community pharmacists (CPs), including how the service could form an integral component of established healthcare provision to maximise adherence. DESIGN: Mixed methods. 4 phases: prospective audit of emergency supply requests for prescribed medicines (October-November 2012 and April 2013); interviews with CPs (February-April 2013); follow-up interviews with patients (April-May 2013); interactive feedback sessions with general practice teams (October-November 2013). SETTING: 22 community pharmacies and 6 general practices in Northwest England. PARTICIPANTS: 27 CPs with experience of dealing with requests for emergency supplies; 25 patients who received an emergency supply of a prescribed medicine; 58 staff at 6 general practices. RESULTS: Clinical audit in 22 pharmacies over two 4-week periods reported that 526 medicines were requested by 450 patients. Requests peaked over a bank holiday and around weekends. A significant number of supplies were made during practice opening hours. Most requests were for older patients and for medicines used in long-term conditions. Difficulty in renewing repeat medication (forgetting to order, or prescription delays) was the major reason for requests. The majority of medicines were 'loaned' in advance of a National Health Service (NHS) prescription. Interviews with CPs and patients indicated that continuous supply had a positive impact on medicines adherence, removing the need to access urgent care. General practice staff were surprised and concerned by the extent of emergency supply episodes. CONCLUSIONS: CPs regularly provide emergency supplies to patients who run out of their repeat medication, including during practice opening hours. This may aid adherence. There is currently no feedback loop, however, to general practice. Patient care and interprofessional communication may be better served by the introduction of a formally structured and funded NHS emergency supply service from community pharmacies, with ongoing optimisation of repeat prescribing.

Involving community pharmacists in pharmacy practice research: experiences of peer interviewing.

BACKGROUND: Translation of interest in research into active engagement of community pharmacists as research partners/co-researchers remains a challenge. Involving pharmacists in specific research techniques such as peer interviewing, however, may enhance validity of the results. OBJECTIVE: To enhance community pharmacists' involvement in pharmacy practice research through peer interview training. METHOD: A subgroup of participants in a multi-phase pharmacy practice research project trained to do peer interviews. These pharmacist interviewers attended a workshop and were mentored. Comments from their feedback forms and ongoing engagement with the Research Associate were thematically analysed. RESULTS: Positive themes from five interviewers included the importance of the topic and their wish to learn skills beyond their everyday role. The small group format of the training day helped to build confidence. Interviewers felt their shared professional background helped them to capture relevant comments and probe effectively. There were challenges, however, for interviewers to balance research activities with their daily work. Interviewers experienced difficulty in securing uninterrupted time with interviewees which sometimes affected data quality by 'rushing'. CONCLUSION: Community pharmacists can be engaged as peer interviewers to the benefit of the volunteers and research team, but must be well resourced and supported.

Inpatients' expectations and experiences of hospital pharmacy services: qualitative study.

INTRODUCTION: Hospital pharmacists' have traditionally focused on the manufacture and supply of medicines. However, the increasing complexity and range of medicines and a greater awareness of medication errors has facilitated a change towards a patient-centred role. Given this movement, it is surprising that a search of the published literature shows very little research that evaluated patients' views of hospital-based pharmacy services. OBJECTIVE: To explore inpatients' expectations and experiences of hospital-based pharmacy services. STUDY SETTING AND DESIGN: Face-to-face semi-structured interviews with inpatients admitted to acute medical wards of three NHS general hospitals. PRINCIPAL FINDINGS: Seventy-four inpatients were interviewed: 37 were male with average age 73 years (age range of 19-86 years). The predominate number of participants (62/74, 84%) being in the 65-80 years of age group. Thematic analysis of the data was driven by three themes; patients' expectations of the pharmacist's involvement in their treatment and care, the patients' experiences of any interaction that may have taken place and the patients' evaluation of their interaction with the pharmacist. CONCLUSIONS: There was a dichotomy of expectations and opinions from patients about the role of hospital pharmacists and the services being provided. As pharmacists' roles are developing towards a patient-orientated model in which pharmacists have direct contact with patients and their care, it is important to ensure that patients are aware of these developments to help them maximize the benefit they derive from their country's health-care system.

Measuring the impact of long-term medicines use from the patient perspective.

Polypharmacy is increasing, seemingly inexorably, and inevitably the associated difficulties for individual patients of coping with multiple medicines rise with it. Using medicines is one aspect of the burden associated with living with a chronic condition. It is becoming increasingly important to measure this burden particularly that relating to multiple long-term medicines. Pharmacists and other health professionals provide a myriad of services designed to optimise medicines use, ostensibly aiming to help and support patients, but in reality many such services focus on the medicines, and seek to improve adherence rather than reducing the burden for the patient. We believe that the patient perspective and experience of medicines use is fundamental to medicines optimisation and have developed an instrument which begins to quantify these experiences. The instrument, the Living with Medicines Questionnaire, was generated using qualitative findings with patients, to reflect their perspective. Further development is ongoing, involving researchers in multiple countries.

Issues potentially affecting quality of life arising from long-term medicines use: a qualitative study.

BACKGROUND: Polypharmacy is increasing and managing large number of medicines may create a burden for patients. Many patients have negative views of medicines and their use can adversely affect quality of life. No studies have specifically explored the impact of general long-term medicines use on quality of life. OBJECTIVE: To determine the issues which patients taking long-term medicines consider affect their day-to-day lives, including quality of life. SETTING: Four primary care general practices in North West England. METHODS: Face-to-face interviews with adults living at home, prescribed four or more regular medicines for at least 1 year. Interviewees were identified from primary care medical records and purposively selected to ensure different types of medicines use. Interviews were recorded, transcribed and analysed thematically. RESULTS: Twenty-one interviews were conducted and analysed. Patients used an average of 7.8 medicines, 51 % were preventive, 40 % for symptom relief and 9 % treatment. Eight themes emerged: relationships with health professionals, practicalities, information, efficacy, side effects, attitudes, impact and control. Ability to discuss medicines with health professionals varied and many views were coloured by negative experiences, mainly with doctors. All interviewees had developed routines for using multiple medicines, some requiring considerable effort. Few felt able to exert control over medicines routines specified by health professionals. Over half sought additional information about medicines whereas others avoided this, trusting in doctors to guide their medicines use. Patients recognised their inability to assess efficacy for many medicines, notably those used for prophylaxis. All were concerned about possible side effects and some had poor experiences of discussing concerns with doctors. Medicines led to restrictions on social activities and personal life to the extent that, for some, life can revolve around medicines. CONCLUSION: There is a multiplicity and complexity of issues surrounding medicines use, which impact on day-to-day lives for patients with long-term conditions. While most patients adapt to long-term medicines use, others did so at some cost to their quality of life.

Transformation in the pharmaceutical industry--a systematic analysis of operational evidence.

Through systematic collection and trending of pharmaceutical data, operational evidence to verify existence of 14 factors affecting the ongoing pharmaceutical transformation has been compiled. These 14 factors are termed transformation triggers. The theoretical evidence in support of these triggers is carried forward from a systematic review of the literature that was conducted previously. Trends in operational evidence and the associated theoretical evidence were compared to identify areas of similarity and contrast. Areas of strong correlation between theoretical evidence and operational evidence included four transformation triggers: a fully integrated pharma network, personalized medicine, translational research, and pervasive computing. Key areas of contrast included three transformation triggers-namely, healthcare management focus, adaptive trials, and regulatory enforcement-for which the operational evidence was stronger than the theoretical evidence. LAY ABSTRACT: The intent of this paper is to provide proof to demonstrate if there is any operational evidence that supports the 14 transformation triggers previously identified during the theoretical part of this research. The theoretical evidence for these triggers was carried forward to this paper for study from an operational perspective. The practical evidence established in this paper was compared with the corresponding theoretical evidence to identify areas of similarity and difference. This resulted in four triggers that had strong relationship between operational and theoretical evidence; they are a fully integrated pharma network, personalized medicine, translational research, and pervasive computing. The areas of difference included three transformation triggers for which the operational evidence was stronger than the theoretical evidence. These were healthcare management focus, adaptive trials, and regulatory enforcement.

Characterization of the evolution of the pharmaceutical regulatory environment.

This paper is part of a research study that is intended to identify pharmaceutical quality risks induced by the ongoing transformation in the industry. This study establishes the current regulatory context by characterizing the development of the pharmaceutical regulatory environment. The regulatory environment is one of the most important external factors that affects a company's organization, processes, and technological strategy. This is especially the case with the pharmaceutical industry, where its products affect the quality of life of the consumers. The quantitative analysis of regulatory events since 1813 and review of the associated literature resulted in identification of six factors influencing the regulatory environment, namely public health protection, public health promotion, crisis management, harmonization, innovation, and modernization. From 1813 to the 1970s the focus of regulators was centered on crisis management and public health protection-a basic mission that has remained consistent over the years. Since the 1980s a gradual move in the regulatory environment towards a greater focus on public health promotion, international harmonization, innovation, and agency modernization may be seen. LAY ABSTRACT: The pharmaceutical industry is currently going through changes that affect the way it performs its research, manufacturing, and regulatory activities. The impact of these changes on the approaches to quality risk management requires more understanding. The authors are engaged in research to identify elements of the changes that influence pharmaceutical quality. As quality requirements are an integral part of the pharmaceutical regulations, a comprehensive understanding of these regulations is seen as the first step. The results of this study show that (i) public health protection, public health promotion, crisis management, harmonization, innovation, and modernization are factors that affect regulations in the pharmaceutical industry; (ii) the regulators' main mission of public health protection has remained a constant feature over the years; and (iii) since the 1970s other factors such as public health promotion, international harmonization, innovation, and agency modernization are playing more important role in regulatory agency thinking and actions.

Transformation in the pharmaceutical industry: transformation-induced quality risks--a survey.

This paper is the fourth in a series that explores ongoing transformation in the pharmaceutical industry and its impact on pharmaceutical quality from the perspective of risk identification. The aim of this paper is to validate proposed quality risks through elicitation of expert opinion and define the resultant quality risk model. Expert opinion was obtained using a questionnaire-based survey with participants with recognized expertise in pharmaceutical regulation, product lifecycle, or technology. The results of the survey validate the theoretical and operational evidence in support of the four main pharmaceutical transformation triggers previously identified. The quality risk model resulting from the survey indicated a firm relationship between the pharmaceutical quality risks and regulatory compliance outcomes during the marketing approval and post-marketing phases of the product lifecycle and a weaker relationship during the pre-market evaluation phase. LAY ABSTRACT: In this paper through conduct of an expert opinion survey the proposed quality risks carried forward from an earlier part of the research are validated and resultant quality risk model is defined. The survey results validate the theoretical and operational evidence previously identified. The quality risk model indicates that transformation-related risks have a larger regulatory compliance impact during product approval, manufacturing, distribution, and commercial use than during the development phase.

Patients' use of information about medicine side effects in relation to experiences of suspected adverse drug reactions: a cross-sectional survey in medical in-patients.

BACKGROUND: Adverse drug reactions (ADRs) are common, and information about medicines is increasingly widely available to the public. However, relatively little work has explored how people use medicines information to help them assess symptoms that may be suspected ADRs. OBJECTIVE: Our objective was to determine how patients use patient information leaflets (PILs) or other medicines information sources and whether information use differs depending on experiences of suspected ADRs. METHOD: This was a cross-sectional survey conducted in six National Health Service (NHS) hospitals in North West England involving medical in-patients taking at least two regular medicines prior to admission. The survey was administered via a questionnaire and covered use of the PIL and other medicines information sources, perceived knowledge about medicines risks/ADRs, experiences of suspected ADRs, plus demographic information. RESULTS: Of the 1,218 respondents to the survey, 18.8 % never read the PIL, whilst 6.5 % only do so if something unexpected happens. Educational level was related to perceived knowledge about medicines risks, but not to reading the PIL or seeking further information about medicines risks. Over half the respondents (56.0 %) never sought more information about possible side effects of medicines. A total of 57.2 % claimed they had experienced a suspected ADR. Of these 85.9 % were either very sure or fairly sure this was a reaction to a medicine. Over half of those experiencing a suspected ADR (53.8 %) had read the PIL, of whom 36.2 % did so before the suspected ADR occurred, the remainder afterwards. Reading the PIL helped 84.8 % of these respondents to decide they had experienced an ADR. Educational level, general knowledge of medicines risks and number of regular medicines used all increased the likelihood of experiencing an ADR. CONCLUSION: More patients should be encouraged to read the PIL supplied with medicines. The results support the view that most patients feel knowledgeable about medicines risks and suspected ADRs and value information about side effects, but that reading about side effects in PILs or other medicines information sources does not lead to experiences of suspected ADRs.

Transformation in the pharmaceutical industry--a systematic review of the literature.

The evolutionary development of pharmaceutical transformation was studied through systematic review of the literature. Fourteen triggers were identified that will affect the pharmaceutical business, regulatory science, and enabling technologies in future years. The relative importance ranking of the transformation triggers was computed based on their prevalence within the articles studied. The four main triggers with the strongest literature evidence were Fully Integrated Pharma Network, Personalized Medicine, Translational Research, and Pervasive Computing. The theoretical quality risks for each of the four main transformation triggers are examined, and the remaining ten triggers are described. LAY ABSTRACT: The pharmaceutical industry is currently going through changes that affect the way it performs its research, manufacturing, and regulatory activities (this is termed pharmaceutical transformation). The impact of these changes on the approaches to quality risk management requires more understanding. In this paper, a comprehensive review of the academic, regulatory, and industry literature were used to identify 14 triggers that influence pharmaceutical transformation. The four main triggers, namely Fully Integrated Pharma Network, Personalized Medicine, Translational Research, and Pervasive Computing, were selected as the most important based on the strength of the evidence found during the literature review activity described in this paper. Theoretical quality risks for each of the four main transformation triggers are examined, and the remaining ten triggers are described.