National PHARMACY Commission

Government is Silent !?

Government Is Silent !?

Advertisements are freely appearing in social media convincing gullible public on Treatment of diseases like Cardiac diseases, Diabetis, Asthama etc for which claiming of cure is Prohibited under the Drugs & Magic Remedies (Objectionable Advertisements) Act.

Dispensing Medicine

Dispensing medicine is not just a mechanical transfer of materials from one person to the other. 

It is the transfer of information with the material to ensure that the consumer adopts good technique in handling and storage and uses the medicine in the most appropriate way so that he is least harmed due to the side effects and at the same time derives optimized medication benefit that results in considerably lowered morbidity.

Corollary: 

It should Be a habit in all patients to insist on correct and authentic information on each medicine he procures from a chemist shop or a hospital, as it is he who is using the medicine.

 Chemist or hospital pharmacist cannot shirk his responsibility by telling 'Ask your doctor:.

If theChemist doesn't have an answer he should borrow time, collect the information and communicate.

At no cost and at no time the information can be refused by the dispensing professional as: 

IT IS THE BASIC RIGHT OF THE PATIENT TO KNOW ABOUT WHAT HE IS CONSUMING.

The NPW 2016 is round the corner .

Educate and create awareness in the public on the need to have full information of their medicines.

Let them demand the service from the chemist and Hosp pharmacists.

PCI & Its President

PCI & Its President.

PCI President is basically a Member of A State Council Nominated To Central Council.

He ceases to be the Member (consequently to the President ) of PCI the moment New Council Is Announced in his state.

This warrants election of New President by the General body of PCI.

Registrar cum Secretary should Mandatorily write to the Registrars of State New Council to send fresh Nomination.

PHARMACY PRACTICE

#Practice - In Pharmacy?

#DepartmentOfPharmacyPractice!?!

#Practice in professional parlance means the service delivered by a professional all through till a logical end and One who delivers such a service is called Practitioner.

Ex.  #LawPractice, #MedicalPractice, #AccountsPractice etc they serve their clients till logical end.

👉Where does the #PharmacyPractice fit in?

Or

👉Can storing, dispensing / selling drugs in a Pharmacy be called a Practice?

👉 What responsibility does a Pharmacist takes of the drug dispensed and the Patient after dispensing / sale?

👉Can every service be called a Practice?

Evidence based Medicine vs Evidence based Pharmacy

Evidence based Medicine vs Evidence based Pharmacy / Pharmaceutical Care

Evidence-based medicine (EBM) uses the scientific method to organize and apply current data to improve healthcare decisions. Thus, the best available science is combined with the healthcare professional's clinical experience and the patient's values to arrive at the best medical decision for the patient. There are 5 main steps for applying EBM to clinical practice. 

• Defining a clinically relevant question
• Searching for the best evidence
• Critically appraising the evidence
• Applying the evidence
• Evaluating the performance of EBM

EBM starts with a clinical question. The clinical question is an issue which the health-care provider addresses with the patient. After the clinical question is formulated, relevant scientific evidence is sought, which relates to the clinical question. Scientific evidence includes study outcomes and opinions. Not all data has the same strength. Recommendations from an expert are not as robust as the results of a well-conducted study, which is not as good as the results of a set of well-conducted studies. Thus in evidence-based medicine, the levels of evidence or data should be graded according to their relative strength. Stronger evidence should be given more weight when making clinical decisions.

The evidence is commonly stratified into six different levels: 

• Level IA: evidence obtained from a meta-analysis of multiple, well-conducted, and well-designed randomized trials. Randomized trials provide some of the strongest clinical evidence, and if these are repeated and the results combined in a meta-analysis, then the overall results are assumed to be even stronger.
• Level IB: evidence obtained from a single well-conducted and well-designed randomized controlled trial. The randomized controlled study, when well-designed and well-conducted, is a gold standard for clinical medicine.
• Level IIA: evidence from at least one well-designed and executed non-randomized controlled study. When randomization does not occur, there may be more bias introduced into the study. 
• Level IIB: evidence from at least one well-designed case-control or cohort study.  Not all clinical questions can be effectively or ethically studied with a randomized controlled study. 
• Level III: evidence from at least one non-experimental study.  Typically level III evidence would include case series as well as not well-designed case-control or cohort studies.   
• Level IV: expert opinions from respected authorities on the subject based on their clinical experience.

All clinical studies or scientific evidence can be classified into one of the above categories. The clinician must then use their professional, clinical experience to extrapolate the scientific evidence as it applies to the specific patient. Most clinical studies have specific inclusion and exclusion criteria, as well as the specific population studied. More often than not, the patient being treated by the clinician will have one or more substantial differences from the population in the study. The medical provider must then use their clinical judgment to determine how the variations between the patient and the study population are important or not and how they affect applying the study results to the specific patient.

For example, a specific patient may be a 70-year-old female with a history of hyperlipidemia and a new diagnosis of hypertension, looking at hypertension treatment options. The clinician may find a good randomized controlled trial looking at medications to control hypertension, but the study's inclusion criteria were a population of 18 to 65-year-olds. Should the clinician ignore the results as the specific patient does not meet the study demographics? Should the clinician ignore the age difference between the specific patient and study population? This is where the clinical judgment helps bridge the gap between the relevant scientific evidence and the specific patient being treated.

Finally, clinicians using evidence-based medicine must put all of the information in the context of the patient's values or preferences. The patient's values or preferences may conflict with some of the possible options. Even strong evidence supporting a specific treatment may not be compatible with the patient's preferences, and thus, the clinician may not recommend the treatment to the patient. Also, the treatment might not apply to the specific patient.

As an example, a patient may have a particular form of cancer. Level IA evidence may suggest life expectancy can double from 8 to 16 months with chemotherapy. The chemotherapy has significant side effects. The patient may find those side effects not acceptable and elect not to pursue chemotherapy secondary to the specific patient's preferences and values.

Once the clinical question is formulated, relevant scientific information is evaluated, and clinical judgment is used to apply the relevant scientific evidence to the specific patient and their values, the outcome must be evaluated. The final step is a re-evaluation of the patient and clinical outcome after application of the applied information. Did the intervention help? Were the outcomes as expected? What new information is obtained? How can this information be applied to future situations and patients?

Evidenced-based medicine starts with the clinical question and returns to the clinical question at the end to see to what effect the process worked. Without continuous re-evaluation, the medical provider will not be sure if their impact is positive or negative. Evidence-based medicine is a perpetual wheel of improvement rather than a one-time linear process.

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Issues of Concern

The function of evidence-based medicine is to bring together three different entities: the patient's preferences, the healthcare professional's clinic judgment, and the best available, relevant, scientific information to provide improved medical care. [4]

There are numerous criticisms of evidence-based medicine [5][6][7][8][9]:

Publication Bias

Evidence-based medicine is based on published results, giving more weight to class I and II evidence. Many studies have shown that positive results are more likely to be published than negative results. This leads to a publication bias of positive result studies that can skew the available evidence. Additionally, studies funded by companies are more likely to get published to push for the use of the studied medication or device, which can also skew the available evidence.

Randomized, Controlled Trial Bias

Evidence-based medicine places the highest weight in randomized controlled trials. Although such randomized controlled trials may provide strong evidence, a randomized controlled trial may not always be possible or feasible. If a disease process has a very low prevalence, it may be extremely prohibitive or impossible to obtain a sufficient number of participants for a study.

For example, progeria is a rare disease with an incidence of around one in four to eight million live births and an average lifespan of 14 years.  With a global population of around 7.6 billion and an annual birth rate of 18.5 births per 1,000 people per year, there would only be around 100 to 400 total individuals with progeria in the world. It is impractical to conduct a randomized controlled trial with so few patients and produce meaningful results.

As a second example, consider the ethical implications of randomized controlled trials. In a paper by Smith et al. (2003), they argue that we take for granted that parachutes help prevent injuries and save lives after a person jumps out of an airplane. This common-sense observation has not yet been studied and proven with a randomized controlled trial. The article argues that people should accept certain common-sense ideas, and randomized, controlled trials are not always necessary. After all, can researchers easily find evidence-based medicine purists who would be willing to sign up for a randomized, cross-over, placebo-controlled trial testing the utility of parachutes to decrease injuries or death after jumping out of an airplane?

Finally, there are many, many more clinical questions than there are randomized controlled trials. The many suitable questions for a well-designed and well-conducted randomized controlled trial far exceed the available resources to conduct the trials. We must admit that resources are limited, and spending time on every possible clinical question or configuration of clinical importance may not be practical or advisable. Research should rather devote such resources to focusing on higher-impact clinical questions.

Lag Time

A well-designed and well-conducted randomized controlled trial take time to design, carry out, and report. There can be significant changes in the medical landscape between when the trial is designed and initiated, and when the results are published. More than once, a study has sought to examine a chemotherapy regimen for specific cancer only for that chemotherapy regimen to be antiquated and supplanted by the time the trial results are published.

Values

Although patient values are explicit to the model of evidence-based medicine, many healthcare practitioners omit or minimize patient values. It is not uncommon for the healthcare provider to recognize the medical issue, perform the review, evaluate and assimilate relevant scientific information, and implement an intervention without considering the patient's values. It is easy for providers to be swept away in trying to implement the "best evidence" or "best practices" before understanding how these either fit or contradict the patient's values.

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Clinical Significance

Evidence-based medicine provides a framework for applying the relevant scientific evidence to the patient's condition based on the patient's values using the clinician's clinical judgment to tailor the treatment for the patient. The goal of evidence-based medicine is to improve medical outcomes based on the highest quality evidence available. After the intervention is implemented, the outcome should be re-evaluated in the context of the clinical question to see what effect occurred. It can also be applied to a population to generate recommendations for the population-based on current medical evidence. Population recommendations are typically graded based on the underlying science behind the guidelines. Various grading schemes exist. These schemes rank recommendations from strong evidence (to support the guidelines) to poor or no evidence (to support the guideline with varying support levels in between).  

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Nursing, Allied Health, and Interprofessional Team Interventions

Evidence-based medicine provides a roadmap for clinicians to apply valid scientific evidence to the patient's condition based on the patient's values using the clinician's clinical judgment to tailor the treatment for the patient. The goal of evidence-based medicine is to improve medical outcomes based on the highest quality evidence available. Short term data evaluation indicates that EMB may be improving patient outcomes in certain disorders.

EVIDENCE BASED PHARMACY

Abstract

Introduction

Pharmacy is a very dynamic profession and the role of the pharmacist is improving with the expansion of the scope of services and the introduction of new subspecialties over time. Moving from being medication dispensers to outcome-oriented and patient-focused care providers; pharmacists will carry more responsibility and commitment to improve their knowledge and practice.

Being updated and evidence-based is a key tool to achieve effective pharmaceutical care services. The primary purpose of this article is to highlight the concept of “evidence based pharmaceutical care” as professional practice to improve the quality of pharmaceutical care.

Methods

Literature for relevant evidence was searched by Medline (through PubMed), Cochrane library using the keywords: pharmaceutical care, evidence-based and pharmacy practice. Also a manual search through major journals for articles referenced in those located through PubMed was done.

Results and discussion

There is strong data showing that pharmaceutical care lead to improvement in health outcomes and cost-effective therapy. More efforts, policies and qualified staff are needed to establish the “evidence-based pharmaceutical care” as new daily professional practice. Evidence to support pharmacists in their emerging role as care providers is available to improve the efficacy and quality of pharmaceutical care. Education and specialized training practicing evidence based approach are vital to prepare pharmacists to provide high quality pharmaceutical care.

Conclusion

As care providers, pharmacists are effective in providing high quality patient care and being members in multidisciplinary clinical teams is needed to give them the opportunity. Evidence based pharmaceutical care is a natural and logical emerging concept in the modern pharmacy practice to achieve high quality and more effective pharmaceutical care but still more efforts and resources are needed to promote new attitude toward more professional career.

Introduction

Personal experience or expert opinion alone is not enough to support health care decision. High quality research is the most accurate source of scientific evidence that can be used to identify and meet the patient health needs. In a recent survey of pharmacists, 90% held positive attitudes toward evidence based practice and 84% thought research findings were important to daily practice (Burkiewicz and Zgarrick, 2005). These results reflect the awareness of the pharmacists toward their profession as evidence-based practice and the desire to expand their role as researchers.

Pharmacy profession has improved to include the provision of cognitive services in addition to the traditional role of medication dispensing. Establishing evidence-based practice is important for pharmaceutical care services to be effective, updated and relevant to patients. Pharmacists must accept and actively participate in the research needed to establish the required evidence-base pharmaceutical care.

1.1. What is “pharmaceutical care”?

According to the definition of Hepler & Strand pharmaceutical care is “the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient’s quality of life” (Hepler and Strand, 1990). Pharmaceutical care is based on a relationship between the patient and the healthcare providers who accept responsibility to provide care to the patients. Pharmaceutical care involves the active participation of both the patient and the health care provider in drug therapy decisions.

Pharmaceutical care involves three major functions: identifying potential and actual drug related problems; resolving actual drug-related problems; and preventing drug related problems. Although there are different trends, such as clinical pharmacy services, cognitive services, medication management, medication review, they all share the same philosophy and objectives, namely “the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient’s quality of life” (Roughead et al., 1990).

Pharmaceutical care activities include medication dispensing, providing drug information, patient counseling, drug monitoring, parenteral nutrition preparation, adverse drug reaction monitoring, medication reconciliation, drug protocol/guideline development, medical rounding with the health care team, and performing admission drug histories. Practicing these activities by evidence-based approach will improve the quality of the provided services.

Pharmacists need training and support to develop and improve their practical skills to provide comprehensive pharmaceutical care (Schommer and Cable, 1996).

To be effective, pharmaceutical care needs to be adopted by majority of pharmacists in their daily work. Many barriers limit the implementation of the pharmaceutical care principles. To identify and solve these barriers well designed research is needed (Farris and Kirking, 1993a, Farris and Kirking, 1993b).

1.2. Evidence based practice

There is an increasing awareness of the need for healthcare professionals to adopt an evidence-based approach to their daily practice. Practicing pharmacy in an evidence based manner will enhance professional skills of the pharmacist with improved patient care. The concept of evidence-based pharmaceutical care requires training and education starting from undergraduate level. Pharmacy students need to be educated how to professionally apply science in patient care. Special training on research principles, literature review and evidence based approaches is very important to prepare the pharmacists to practice the evidence based pharmaceutical care efficiently.

2. Methods

A literature review was performed by searching Medline database through PubMed for relevant articles including meta-analyses, systematic reviews, review articles, randomized and non-randomized trials, as well as case reports. Search keywords were as follows: evidence-based pharmacy, patient care, pharmacist, pharmaceutical care, and pharmacy practice. Web-based searching and backward citation tracking were conducted for context and additional citations.

3. Results and discussion

3.1. Search results

There are strong data showing that pharmaceutical care is effective and led to improved patient care with more cost-effective therapy in both in- and outpatient settings. Many studies and reviews demonstrated the efficacy of the pharmaceutical care programs as described below. Research describing the term “evidence-based pharmaceutical care” is limited in the literature.

3.2. Data findings

3.2.1. Inpatient pharmaceutical care

The literature proving the beneficial role of the pharmacist in inpatient care is strong and abundant (Shekelle et al., 2013). A comprehensive systematic review of inpatient pharmacy services was conducted and summarized in a Technology Assessment report in 2013 by the Agency for Healthcare Research and Quality titled, “Making Healthcare Safer II: an Updated Critical Analysis of the Evidence for Patient Safety Practices”.

The report stated that the totality of the literature (delineated in evidence tables) shows that pharmacist-provided care enhances the patient safety and improves outcomes. Later in the report, they focus on medication reconciliation and found that pharmacists significantly decreased emergency department visits and hospitalizations within 30 days of discharge (Shekelle et al., 2013).

Services provided by pharmacists in hospitals were found to be highly cost-effective in a database analysis of 1016 hospitals (Bond et al., 2000). In all, 6 services significantly reduced costs, including drug use evaluation, drug information, adverse drug reaction monitoring, drug protocol/guideline development, medical rounding with the health care team, and performing admission drug histories. As staffing was increased for clinical pharmacists, total cost of care decreased (Bond et al, 2000)

3.2.2. Outpatient pharmaceutical care

In 2010, a comprehensive systematic review of 298 studies evaluating the impact of pharmacist-provided direct patient care in ambulatory settings found significant benefits in achieving hemoglobin A1c, LDL cholesterol, and blood pressure targets in addition to reducing adverse drug events (Chisolm-Burns et al., 2010). These intermediate health outcome benefits result from enhanced patient knowledge about medications, increased medication adherence, and improved quality of life as a result of pharmacist-provided services (Chisolm-Burns et al., 2010).

In a systematic review of 15 randomized controlled trials in 9111 outpatients with diabetes published in 2012, the use of pharmacist medication management, educational interventions, feedback to providers, and patient reminders had a significant effect on systolic blood pressure, diastolic blood pressure, total cholesterol, LDL cholesterol, and body mass index versus standard of care (Santschi et al., 2012).

Similar benefits were seen in a systematic review of hyperlipidemia patients treated by pharmacists, where markers of lipid control were markedly improved (Charrois et al., 2012). In July 2013, the impact of pharmacists, specifically on geriatric care, was assessed in a meta-analysis of 20 studies (Lee et al., 2013). Pharmacist-provided care resulted in significant improvements in hospitalizations, medication adherence, combined therapeutic outcomes (blood pressure, INRs, etc), and combined safety end points (falls, adverse events, and number of unnecessary drugs being used) (Lee et al., 2013).

3.2.3. Evidence-based pharmaceutical care

The concept “evidence-based pharmaceutical care” has been mentioned as a term in 2008 (Gaebelein and Gleason, 2008) and it has been defined in 2009 as ‘‘the responsible provision of evidence-based medication-related care for the purpose of achieving definite outcomes that improve patients’ quality of life” (Aburuz, 2015). EBPC evolves the application of the current best up to date pharmacy research to provide effective pharmaceutical services to patients. Like other health care disciplines, implementation of EBPC mainly involves four sequential steps (Weng et al., 2013): first, framing a clear question based on a clinical problem; second, searching for relevant evidence in the literature; third, critically appraising the validity of contemporary research; and fourth, applying the findings to clinical decision-making.

4. Discussion

From the literature review results it is clear that pharmaceutical care achieves a brilliant and innovative step in improving the pharmacy practice to be more professional and effective health care service. Changing practice from dispensing to care providing system requires major changes in education and training of the pharmacists that should be started early from undergraduate level and continues throughout their carrier.

Commitment and dedication of the pharmacists toward self improvement and professionalism should be enforced and encouraged since this will build up the future of the pharmacy practice.

As any other health care discipline to be effective, pharmaceutical care needs to be evidence-based practice that is systemic, well organized and updated. Being systemic implies input, process and output. This flow will also be subjected to continuous corrections and modifications through feedback step (pharmacists need to measure and monitor their contribution to health care for the ultimate benefit of the patient). In order to ensure standards of practice, pharmacists must be willing to assess their knowledge and audit their practice to determine the effectiveness of their interventions.

Evidence-based pharmaceutical care is a dynamic daily practice that is updated according to new and emerging evidence of high quality research and this represents the feedback loop in this system.

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To simplify the concept; pharmaceutical care services can be subdivided into direct services that are provided directly to the patient (ex. patient counseling) and indirect services like any other pharmacy service that eventually will help the patient (ex. therapeutic drug monitoring).

4.1. Example

In the anti-coagulation clinic the pharmacist is in direct contact with the patients who are treated with warfarin. Pharmacists are using written brochures to counsel the patients about the proper use of warfarin but during the routine patient satisfaction survey it had been noticed that some patients still do not understand the basic information regarding warfarin use.

Now we have identified the problem, the root cause analysis would be a good option or we can use the PICO method. The next step is to review the literature to figure out the best evidence based approach to be applied in order to achieve effective and convenient patient counseling. By literature search it was found that there is evidence suggesting that weekly scheduled phone consultations increased awareness regarding warfarin use and this resulted in decreased risk of hospitalization for an adverse event associated with anticoagulation (Ibrahim and Saber-Ayad, 2013). Consequently the pharmacy team decided to apply the weekly phone consultations as warfarin counseling tool in addition to the conventional written (warfarin booklet) educational brochures, and to follow the effect of the new counseling program on the proper usage and understanding of warfarin using patient satisfaction measurement tool. In this example evidence-based approach is used to provide pharmaceutical care to patient on warfarin.

Implementation of EBPC can improve the quality of the pharmaceutical care services and encourage the pharmacists to be involved in the health care systems as both practitionersc107 and researchers. Barriers to the implementation of the use of evidence in clinical decision-making can generally be summarized as problems in identifying, assessing, interpreting, and applying best evidence to practice.

Some potential barriers may hinder the implementation of an evidence base approach; these barriers can be categorized as personal or environmental factors. Personal factors include: Attitude and perception toward EBPC, time (due to a heavy clinical load), basic knowledge, skills in critical appraisal, skills in literature searching, clinical incorporation. Environmental factors are those barriers related to system adopted by the health institution like lack of support and reward, inadequate library and evidence based resources and lack of specialized training courses (Weng et al., 2013).

5. Conclusion

Health care interventions can no longer be based on opinion or individual experience alone. Scientific evidence, built up from good quality research, is used as a guide, and adapted to each individual patient’s circumstances. As a new innovative concept evidence-based pharmaceutical care seems promising practice to improve the quality of the pharmaceutical care. We encourage all health system pharmacists to adapt, disseminate and promote this new concept to improve the pharmacy profession. More focused studies are needed to establish and market this concept as a daily pharmacy practice.

I think this should be done" A bridge course for connecting Pharm D and MBBS". (SARCASM) Pharmacist A HealthCare professional? If so why pharmacy course is not?. Has the Pharmacy education been got included in National Health Education Manual?

I think this should be done : " A bridge course for connecting Pharm D and MBBS". This shall allow to produce talents and experts who have amalgamated, comprehensive  knowledge of  all the 3 most important aspects of healthcare which are medicine( for diagnosis of disease), pharmacy( for authentic knowledge of medications for prescription writing) and surgery (of course for operations). This has to definitely improve  and enhance quality of patient-care manyfolds . Why we shall always follow USA or western setups of education and service systems? They are good no doubt, as they are rich countries with large budgets for healthcare; but sometimes we must take initiatives and become leaders and provide path-breaking or a new-path setting grounds for others to follow.
Therefore I wrote a mail to secretory of MCI (secretary@mciindia.org), requesting for the same. It goes as follows:

Respected Sir/Madam,

I am currently pursuing 2nd year of PharmD (Post baccalaureate), which is a relatively a new curriculum started by PCI since 2008 and which is clinically oriented pharmacy. Up till now pharmacy in India was industry oriented i.e. pharmacist was more into manufacturing,sales,research of discovery of novel molecules and invention of formulations etc.But now with the advent of PharmD, it has become clinically oriented i.e. now a pharmacist is given an opportunity, allowed and equipped to play a role in direct patient care, giving pharmaceutical care. 
Madam, PharmD syllabus framed by PCI contains many pharmacy related subjects along with the subjects which are present in common in both MBBS and PharmD curriculum, i.e. subjects like anatomy and physiology (a lot lesser of it is there in PharmD), Pathophysiology, Biochemistry, Microbiology, Pharmacology, Biopharmaceutics (a lot more of it is there in PharmD). 
Madam, I have a great respect for MBBS course and for physicians and surgeons. And I am currently 29 year old man. This is to ask you whether its feasible/ possible that a new course/curriculum may be framed and started by MCI within two to three years, which can bridge this gap between PharmD and MBBS.That is, a bridge-course(of 3years duration) which shall allow a PharmD graduate to be certified as MBBS,upon successfully completion of such a course. This may bring a new input, perspective and vision in patient care, to MBBS/physician as well as provide an opportunity, encourage, help fulfil dreams and strong aspirations of human beings like me, who wish to study such a curriculum, get a medical license, be a physician and earnestly want to play that very role in the healthcare system, at this stage and age of our lives.  
May all this come into effect for the 2014-2015 session.

Hoping for an encouraging, enlightening and positive reply on this request from you.

Yours truly,

Samrat Paul

Pharmacist A HealthCare professional? If so why pharmacy course is not?.

Has the Pharmacy education been got included in National Health Education Manual?