Monthly Archives: January 2018

Why is Healthcare Regulation so Complex?

Regulatory Writing

Healthcare systems are driven by regulations which ensure patient’s access to safe, effective, and high-quality products. Regulations are basically rules which are framed by the government or the regulatory authority of the respective region so that risk associated with public health is under scanner. Regulations help in improving the quality and affordability of healthcare. These regulations are implemented by all levels of government including federal, state, local, and private organizations. However, many a times there is lack of coordination between them which results in complexity of the healthcare regulations.

What Makes Regulation Complex?
Healthcare sector is currently the largest and fastest growing industry which is making the regulations more diverse and complex to provide safe and quality service to every individual who accesses the healthcare system. The reason behind complexity of healthcare regulation is a series of historical tragedies like thalidomide and sulfanilamide tragedy. Thalidomide tragedy took place in early 1960s where the drug was prescribed as sedative and later was used for nausea in pregnant women. The drug got marketed in Germany without passing rigorous drug approval and monitoring system. This led to the birth of infants with phocomelia (congenital deformity which leads to development of abnormally short limbs). Similarly, sulfanilamide disaster took place in 1937, where the drug which was used for Streptococcal infections was responsible for deaths of more than 100 people in 15 states. These incidences later gave a lesson to drug safety and regulatory authorities leading the regulatory bodies to structure strict rules and regulations.

What is the Role of Healthcare Regulatory Bodies?
The pharmaceutical industry is considered as one of the most highly regulated industries worldwide where the regulatory bodies are responsible to enforce rules and regulations and issue guidelines for regulating drug development process, manufacturing, and marketing of any given pharmaceutical product. The European Medicines Agency (EMA) of Europe, Ministry of Health, Labour & Welfare (MHLW) of Japan, and Food and Drug Administration (FDA) of the United States came together for scientific and technical discussion and make some common standards on quality, safety, and efficacy of pharmaceutical products by the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The main aim of ICH is to harmonize technical regulatory standards in different countries in order to avoid duplicative testing in pharmaceutical development.
In conclusion, healthcare sector has flourished over the past hundred years irrespective of the complicated nature of healthcare regulations which has shown that the complexity has served to support and nurture the overall enterprise. However, regulatory bodies keep changing their laws constantly for betterment of the public health.
Turacoz healthcare solutions (THS) aims you keep you updated about the recent trends related to healthcare regulations and guide you through the fine technicalities of the same. We provide end-to-end regulatory writing support for clinical trials which includes Investigator Brochures (IBs), Protocols, Clinical Study Reports (CSRs) and Common Technical Documents (CTDs).

Evidence-Based Practice

Medical Writing

Evidence-based practice (EBP) is defined asthe conscientious, explicit and judicious use of current best evidence in making correct, prompt and individualistic patient care decisions. (Sackett D, 1996)
EBP integrates the clinician’sown expertise, the best available scientific evidence, and the patient values and preferences (Figure 1).

Figure 1: Elements of Evidence-Based Practice (EBP)
Inability of current medical practice to cape pace with the available evidences generated interest in the use of evidence-based practice while a varied number of steps have been defined to be applied for the use of EBP (Figure 2).

Figure 2:Steps Involved in Evidence-Based Practice (EBP)
1. Problem definition: Clinician formulates an answerable clinical question based on the most updated and relevant data to solve individual patient problem. Defining the problem may provide answers to certain areas ofdisease prevention, diagnosis, prognosis, therapy, causation, cost-effectiveness, etc.
A defined PICO (Population, Intervention, Comparison, Outcome) approach which directly focuses on the clinical question may ensures that it will be helpful in finding the relevant evidences to bridge the prevailing clinical gap.
2. Search for information sources:
After formulating the clinical question, search for appropriate scientific evidences in various databases including PubMed, EMBASE etc. must be done. Firstly, a search for the relevant evidence-based guidelines is done and if it is not available, scientific evidences including systematic reviews or individual studies are referred too.
3. Appraise the information for validity and applicability:
After literature search,each review/study needs to be critically appraisedfor relevance, reliability, validity, and applicability to the persisting clinical question. A clinician can rapidly appraise the study by assessing three important aspects which are:
Validity of study results: It should include assessment of research methods (randomization or non-randomization), characteristics of patients prior to intervention, and instruments used to measure outcomes.
Results and their importance: It should include effectiveness of the intervention, its impact on outcomes, and probability of getting similar results in the clinicians’ own practice settings.
Applicability of the results in patent care: Clinical considerations of the study results such as similarity between study subjects and one’s own patients, benefits/risks ratio, and patient values and preferences, and feasibility and cost-effectiveness needs to be incorporated.
4.Integration of the evidence with one’s clinical expertise and patient preferences and values:
As discussed above, EBM is not solely based on appraising scientific evidences. In the integration step, the relevant scientific evidences are combined with clinical expertise andalso the patient’s perspective. This step requires answering to several questions on: similarity between study patients and one’s own patient; availability of the treatment; alternative treatments available; side effects of the treatment, outweighing risks and appropriateness of the patient outcomes.
5. Evaluating the effectiveness of EBP for individual patients
The last and the final step in EBP is to assess the effectiveness of evidence-based approach when applied to a specific patient. It assesses the clinical improvement of the patient achieved with the evidence and whether it is comparable and as found in the research study.
Level of Evidence
The Level-of-Evidence pyramid represents the types of studies which represents their research quality and risk of biasness. As we move up in the pyramid, the research quality increases while risk of biasness decreases.Studies are assigned to specific hierarchy in the pyramid based on their methodological design quality, results validity, and applicability to patient care. Levels of evidence for different subjects including therapy, diagnosis, prognosis etc. can be viewed at the Oxford Centre for Evidence-based Medicine website (http://www.cebm.net/blog/2009/06/11/oxford-centre-evidence-based-medicine-levels-evidence-march-2009/) Researchers practicing EBP should have an understanding of level of evidences to prioritize all the information collected. EBP holds a strong ground in the top-order of the pyramid as shown in Figure 3.
Current Status of EBP Application
Presently, the implementation of EBP is not sufficient in making healthcare decision. A recent survey assessed the factors which facilitates or hinders the application of EBP in the clinical context. Respondents stated that in clinical healthcare currently EBP is underused and explained this shortcoming with several practical and structural barriers, which they felt can be better monitored by individual organization and directors. In the survey, only 11% of the respondents used EBP and 20% stated that they worked ‘in the way they always had’.
It was also highlighted that increased awareness about EBP and implementation systems for the same in future will be useful in providing evidence-based, best quality and cost-effective healthcare to individual patients.

Figure 3: Level-of-Evidence Pyramid
Evidence based practice is central to providing high-quality care and decreasing unwarranted variation in practice. Turacoz Healthcare Solutions aims to spread awareness about the latest offerings of evidence based practice so that we are able to do our bit and contribute more towards patient healthcare.