Dear all,
JNTUA, Ananthapuramu has
released Guidelines to Conduct Examinations in view of
COVID-19. You can download the
document by clicking through this link.
Sunday, July 19, 2020
Friday, July 17, 2020
How to choose top notch research work in 5th Pharm D
As far as my knowledge concern, Pharm D 5th year is one such critical stage where the students are supposed to do a project work on areas related to pharmacoepidemeology, Pharmacotherapeutics, Pharmacokietics, Clinical Pharmacy etc.,
The project can be of any type but the key factors to be noted are :
1.Would that be useful for us in building up our resume?
2. Can we learn skills like statistical analysis, result determination, thesis writing?
3. Is our project really show a change in the topic of our interest. If not at least can it cause a change in our level of knowledge?
The title you choose should satisfy all of the above qualities.
Coming to the topics of project, we can do something related to :
1. Comparative studies like between drugs/diseases/Age Vs disease etc.
2. Prescription analysis example compile N number of prescriptions related to your interested variable and start analyzing the results about QOL, Quality of therapy, outcome of treatment etc)
3. Pharmacokinetic studies like You are supposed to tie up with a CRO and collect data of drug trial on patients and analyse the results.
4.Survey based study ( simplest one, prepare a questionnaire of your topic interested and collect responses from patients/Health care providers and analyse the results)
5. Prevalence and incidence studies( choose topic of your interest and collect data from hospitals/community and perform the prevalence of the disease and possible factors)
6. Multi centered studies ( choose more than two hospitals and collect data for the same topic of your choice and analyse the results and determine the reasons behind differences in disease Incidence Rate and therapy outcome)
We have many more to do upon your interest and abilities.
Feel free to comment here for any specific research in case of further clarifications needed.
Defined daily dose
The DDD is the assumed average daily maintenance dose for a drug for its main indication in adults.
Expressed as DDDs per 1000 inhabitants per day, for chronically used drugs
It can be interpreted as the proportion of the population that may receive treatment with a particular medicine on any given day.
For use in hospital settings, the unit is expressed as DDDs per 100 bed-days (adjusted for occupancy rate); it suggests the proportion of inpatients that may receive a DDD.
For medicines that are used for short-term periods, such as antimicrobials, the unit is expressed as DDDs per inhabitant per year; this provides an estimate of the number of days for which each person is treated with a particular medication in a year.
The defined daily dose (DDD) methodology was developed in response to the need to convert and standardize readily available volume data from sales statistics or pharmacy inventory data into medically meaningful units, to make crude estimates of the number of persons exposed to a particular medicine or class of medicines.
The DDD methodology is useful for working with readily available gross drug statistics and is relatively easy and inexpensive to use. However, the DDD methodology should
be used and interpreted with caution. The DDD is not a recommended or a prescribed dose, but a technical unit of comparison; it is usually the result of literature review and available information on use in various countries.
Prescribed daily dose
The prescribed daily dose (PDD) is another unit, developed as a means to validate the DDDs. The PDD is the average daily dose prescribed, as obtained from a representative sample of prescriptions.
Not useful to estimate incidence and prevalence of drug use or to quantify or identify patients who receive doses lower or higher than those considered effective and safe.
Tuesday, July 14, 2020
Job Alert Pharmacovigilance Associate
Job Description
Rewarding career opportunity with one of the fastest growing organization, APCER Life Sciences.
Job Description:
Data Entry of ICSRs in APCER (ArisG, Argus etc.)/client's pharmacovigilance database duplicate check, entering source data in the database, MedDRA coding, narrative(s) writing, labelling of events, report scheduling (if applicable) & attachment of source document in database
Screening, evaluation and review of literature articles for identification of valid/potential ICSRs for processing
Receipt and evaluation of safety data exchange agreements (If applicable) for sharing and other obligations
Execution of organization's standard operating procedures
Management of compliance with the organization's standard operating procedures and regulatory requirements
Liaise effectively and maintain excellent relationship with the internal contacts
Maintain awareness of changes to/new regulations affecting pharmacovigilance activities
Communicate new or changed regulations to relevant members of the department in order to initiate any change in processes
Builds and maintains good relationships across functional units and company affiliates
Escalate critical calls to concerned managers/clients Remain up-to-date with the latest information on the assigned product(s)
To carry out necessary administrative duties required for the job
Other duties as assigned by management
Trains and mentors new employees in PVG (if required)
Generation and review of SOPs and WIs (if required)
Complies with applicable ISMS related procedures & policies
Key Competencies:
Self motivated
Good competence with therapeutic and medical terminology
Meticulous attention to detail client focused approach
Ability to follow instruction and deliver assigned tasks within agreed timelines
Aptitude to learn new skills and enhance pharmacovigilance knowledge
Key Skills:
Knowledge of European and ROW (if applicable) regulatory requirements
Good time and management skills
Strong interpersonal & communication skills
Basic knowledge of Microsoft Office/Applicable software
Qualification :
A graduate/post graduate degree in Pharmaceutical sciences/Life Sciences
Submit your CV today to be considered for role within our organization.
Industry : Pharma / Biotech / Clinical Research
Functional Area : Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role : Documentation/Medical Writing
Keyskills : PSUR, Periodic Safety Update Report, Pader, PBRER, Periodic Benefit Risk Evaluation Report, Periodic Adverse Drug Experience Report, Aggregate Report, PSR, Periodic Safety Report, ACO, DSUR
Education Qualification
UG : B.Sc-Any Specialization,BAMS-Any Specialization,BDS-Dentistry,B.Pharma-Pharmacy,BHMS-Any Specialization
PG : MDS-Any Specialization,MS/M.Sc(Science)-Any Specialization,M.Pharma-Pharmacy
Company Profile
APCER Life Sciences provides comprehensive drug safety/pharmacovigilance, medical information, medical writing, regulatory services, quality assurance and risk management programs to pharmaceutical and biotech companies globally.
We bring medicinal / scientific expertise through our healthcare professionals & physicians and address full pharmacovigilance requirements for North America, UK & Europe markets. Our clients benefit from our vast experience in regulatory submissions across 100+ countries and consultative approach towards audit /inspection readiness.
Our focus towards Patient safety and Risk profile management makes us the preferred choice for pharma companies who are looking for pre /post marketing compliance & reporting solutions.
We have scalable operations across five global offices which house more than 750 employees: Princeton, NJ, USA; London, UK; Germany, Wan Chai, Hong Kong, New Delhi and Ahmedabad
APCER Life Sciences is an equal opportunity employer that is committed to diversity and inclusion. At APCER Life Sciences, employment decisions are made regardless of race, colour, national or ethnic origin, religion, gender, sexual orientation, gender identity or expression, age, marital status, disability or other characteristics protected by law and selected candidates will be offered appropriate designation / CTC in line with overall selection criteria & individual competence required for the role
Monday, July 13, 2020
INDIAN CONGRESS OF PHARMACY PRACTICE 2020 & 4TH IACP CONVENTION
Indian Congress of Pharmacy Practice 2020 and the 4th IACP convention’ is scheduled as an ONLINE CONFERENCE on Saturday 1st and Sunday 2nd August 2020 with the theme ‘Pharmacy Practice and Beyond’.
The Indian Congress of Pharmacy Practice 2020 & 4th IACP Convention aims at advancing pharmacy practice & education and look ‘Beyond’ the traditional approaches and create new opportunities and pathways that will pave way for an ‘Action Plan’ that is dedicated to four domains of action
Pharmacoacademics - Strengthening academic and Institutional capacity
Careers and beyond - Employment embedded education
The emergence of a specialist pharmacists - Education & Competencies
Strategic Plan - A vision for pharmacy practice profession and education
Fees: 1000 Rupees ( Including GST)
The Indian Congress of Pharmacy Practice 2020 & 4th IACP Convention aims at advancing pharmacy practice & education and look ‘Beyond’ the traditional approaches and create new opportunities and pathways that will pave way for an ‘Action Plan’ that is dedicated to four domains of action
Pharmacoacademics - Strengthening academic and Institutional capacity
Careers and beyond - Employment embedded education
The emergence of a specialist pharmacists - Education & Competencies
Strategic Plan - A vision for pharmacy practice profession and education
Fees: 1000 Rupees ( Including GST)
DRUG UTILIZATION REVIEW
Drug
utilization review (DUR) programs have been defined as “structured, ongoing
initiatives that interpret patterns of drug use in relation to predetermined
criteria, and attempt to prevent or minimize inappropriate prescribing.”
DUR
programs differ from drug utilization studies, which are time-limited
investigations that measure drug use, but do not necessarily assess
appropriateness or attempt to change practice.
Recently,
the use of clinical decision support within computerized prescriber order entry
(CPOE) programs has risen dramatically. The use of such programs to improve
prescribing can be considered a form of prospective DUR in which prescribers
are the targets of interventions
Generally,
the DUR process involves comparing actual behavior to explicit, prospectively
established standards, referred to as criteria. For example, a commonly
used criterion is that patients should not receive more than one non steroidal
anti-inflammatory agent at any one time. Criteria have been developed to identify
the following types of problems: drug–drug interactions, drug–disease
interactions, drug–age interactions, drug–allergy interactions, use of too high
or too low a dose, duplication of therapeutic class, excessive duration of
therapy, obtaining prescription refills sooner or later than should be needed,
failure to prescribe a known effective agent in patients with certain
conditions, abuse of psychoactive medications, and use of a more costly agent
when a less costly agent is available. After developing criteria, the next step
in the DUR process is to measure adherence to explicit criteria by examining individual-level
data. Instances in which medication use does not agree with criteria are called
exceptions.
Next,
interventions are implemented where appropriate, often following an implicit
review. Although the general model for DUR does not require that practitioners
be made aware of individual exceptions occurring in their patients (that is,
interventions can be made based on aggregate rather than individual findings),
this step usually involves alerting the physician and/or pharmacy of record as
to the occurrence of the specific exception.
There
are different settings in which the DUR model is applied.
computerized
administrative data (i.e., pharmacy and medical claims data maintained for
billing and other administrative purposes) to identify exceptions that are then
reviewed by a physician or pharmacist, or by a committee of health
professionals, and result in an intervention (e.g., a mailed alert letter to
the physician). The alert letter typically describes the DUR program and the
criterion, and provides literature references supporting the criterion and a
patient profile demonstrating that the criterion was violated.
Meta Ananlysis
Meta –analysis is a method which can
be used to combine the results of two or more studies. The first Meta –analysis
performed by karlpearson in 1904
Meta –analysis may conveniently be defined
as a quantitative method of pooling information from independent studies
concerning a single theme in order to draw conclusion.
Meta –analysis does not simply involve averaging the results of the individual studies, but requires a statistical method which combines the result whilst taking into account the size of the studies. Thus Meta –analysis is the statistical analysis of a large collection of analysis results for the purpose of integrating the findings.
Meta –analysis can provide researchers with single pooled results to answer whether treatment A is more beneficial than treatment B. This pooled result is usually more precise than the result from the individual studies. The precision with each of these studies calculates the treatment effect depends on many factors including the number of people in the study. Generally as the number of people increases in a study the precision of the treatment effect will increase.
Therefore by statistical combining the all the sample size together from the individual studies, the precision of our pooled result for the treatment effect can be improved.
Meta – analysis increases power. By combining the results from the smaller studies using Meta– analysis we can increase the overall power of the analysis. Therefore, the results from a Meta – analysis will usually have more power than the results from the individual studies.
STEPS TO PERFORM META – ANALYSIS
The theoretical relationship of interest
Collect the population of studies
that provide data on the relationship.
Code the studies and compute the
effect sizes
Examine the distribution of effect
sizes and analyze the impact of moderating variables
Interpret and report the results.
SUMMARY
Meta – analysis leads to a shift of emphasis
from single studies to multiple studies. It is performed with assistance of
computer data bases (Microsoft access, paradox) and statistical software
(DSTAT, SAS). The most common use of Meta – analysis has been in quantitative
literature review. A valid meta – analysis however, require careful planning in
the protocol stage as for any other research.
PHARMACOEPIDEMIOLOGIC STUDY DESIGNS
Pharmacoepidemiology
Ø Pharmacoepidemiology
applies the methods of epidemiology to the content area of clinical
pharmacology.
EPIDEMIOLOGIC STUDY DESIGNS:
CASE REPORTS
Case reports are simply
reports of events observed in single patients. As used in Pharmacoepidemiology,
a case report describes a single patient who was exposed to a drug and
experiences a particular, usually adverse, outcome.
For example, one
might see a published case report about a young woman who was taking oral
contraceptives and who suffered a pulmonary embolism.
Case reports are
useful for raising hypotheses about drug effects, to be tested with more
rigorous study designs. However, in a case report one cannot know if the
patient reported is either typical of those with the exposure or typical of
those with the disease.
Certainly, one cannot usually determine
whether the adverse outcome was due to the drug exposure or would have happened
anyway. As such, it is very rare that a case report can be used to make a
statement about causation.
One exception to this would be when the outcome
is so rare and so characteristic of the exposure that one knows that it was
likely to be due to the exposure, even if the history of exposure were unclear.
An example of this is clear cell vaginal
adenocarcinoma occurring in young women exposed inutero to
diethylstilbestrol. Another exception would be when the disease course is very
predictable and the treatment causes a clearly apparent change in this disease
course.An example would be the ability of penicillin to cure
streptococcal endocarditis, a disease that is nearly uniformly fatal in the
absence of treatment. Case reports can be particularly useful to document
causation when the treatment causes a change in disease course which is
reversible, such that the patient returns to his or her untreated state when the
exposure is withdrawn, can be treated again, and when the change returns upon
repeat treatment. Consider a patient who is suffering from an overdose of
methadone (a long-acting narcotic) and is comatose. If this patient is then
treated with naloxone (a narcotic antagonist) and immediately awakens,this would
be very suggestive that the drug indeed is efficacious as a narcotic antagonist.
As the naloxone wears off the patient would become comatose again, and then if
he or she were given another dose of naloxone the patient would awaken again.
This, especially if repeated a few times,would represent strong evidence that
the drug is indeed
effective as a
narcotic antagonist. This type of challenge–re challenge situation is relatively
uncommon, however, as physicians generally will avoid exposing a patient to
a drug if the patient experienced an adverse reaction to it in the past.
CASE SERIES
Case
series are collections of patients, all of whom have a
single exposure, whose clinical outcomes are then evaluated and described.
Often they are
from a single hospital or medical practice. Alternatively, case series can be
collections of patients with a single outcome, looking at their antecedent
exposures. For example, one might observe 100 consecutive women under the age of
50 who suffer from a pulmonary embolism, and note that 30 of them had been taking
oral contraceptives.
After drug
marketing, case series are most useful for two related purposes.
They
can be useful for quantifying the incidence of an adverse reaction.
They can be useful for being certain that any
particular adverse effect of concern does not occur when observed in a
population which is larger than that studied prior to drug marketing.The
so-called “Phase IV” post marketing surveillance study of prazosin was conducted
for the former reason, to quantitate the incidence of first-dose syncope from
prazosin. The“Phase IV” post marketing surveillance study of cimetidine was
conducted for the latter reason.
Metiamide was an
H-2 blocker, which was withdrawn after marketing outside the US because it
caused agranulocytosis. Since cimetidineis chemically related to metiamide
there was a concern that cimetidine might also cause agranulocytosis. In both examples,
the manufacturer asked its sales representatives to recruit physicians to
participate in the study. Each participating physician then enrolled the next
series of patients for whom the drug was prescribed.
In this type of
study, one can be more certain that the patients are probably typical of those
with the exposure or with the disease, depending on the focus of the study.
However, in the
absence of a control group, one cannot be certain which features in the
description of the patients are unique to the exposure, or outcome. As an
example,one might have a case series from a particular hospital of 100
individuals with a certain disease, and note that all were men over the age of
60. This might lead one to conclude that this disease seems to be associated
with being a man over the age of 60.
However, it would be clear that this would be
an incorrect conclusion once one noted that the hospital this case series was
drawn from was a Veterans Administration hospital, where most patients are
men over the age of 60.
In the previous example of pulmonary embolism
and oral contraceptives, 30% of the women with pulmonary embolism had been using
oral contraceptives.However, this information is not sufficient to
determine whether this is higher, the same as, or even lower than would have been
expected. For this reason, case series are also not very useful in determining
causation, but provide clinical descriptions of a disease or of patients who
receive an exposure.
CASE–CONTROL STUDIES
Case–control
studies are studies that compare cases with a disease to
controls without the disease, looking
for differences in antecedent exposures.
As an example,
one could select cases of young women with venous thromboembolism and compare
them to controls without venous thromboembolism, looking for differences in
antecedent oral contraceptive use. Several such studies have been
performed,generally demonstrating a strong association between the use of oral
contraceptives and venous thromboembolism.
Case–control
studies can be particularly useful when one wants to study multiple possible
causes of a single disease,as one can use the same cases and controls to
examine any number of exposures as potential risk factors.
This design is
also particularly useful when one is studying a relatively rare disease, as it
guarantees a sufficient number of cases with the disease.
Using case–control studies, one can study rare
diseases with markedly smaller sample sizes than those needed for cohort studies.
For example, the classic study of
diethylstilbestrol and clear cell vaginal adenocarcinoma required only 8 cases
and 40 controls, rather than the many thousands of exposed subjects that would
have been required for a cohort study of this question. Case–control studies
generally obtain their information on exposures retrospectively, i.e., by
recreating events that happened in the past. Information on past exposure to
potential risk factors is generally obtained by abstracting medical records or by
administering questionnaires or interviews.
As such,
case–control studies are subject to limitations in the validity of
retrospectively collected exposure information.In addition, the proper
selection of controls can be a challenging task, and inappropriate control
selection can lead to a selection bias, which may lead to incorrect
conclusions.Nevertheless, when case–control studies are done well, subsequent
well-done cohort studies or randomized clinical trials, if any, will generally
confirm their results. As such, the case–control design is a very useful
approach for pharmacoepidemiology studies.
A cross sectional study measures the prevalence of health
outcomes or determinants of health, or both, in a population at a point in time
or over a short period.
They are usually done through surveys, chart reviews, or
database analyses.
They provide a view of the state of affairs at that time,
and provide an estimate of the prevalence of utilization and of outcomes.
Such information can be used to explore aetiology - for
example, the relation between cataract and vitamin status has been examined in
cross sectional surveys.
These types of studies have been used to compare drug
use between countries or regions within a country. Very large differences
suggest that reasons for those differences should be investigated and policies
examined to determine whether outcomes and costs also differ and whether
changes should be made.
However, associations must be interpreted with caution. Bias
may arise because of selection into or out of the study population.
A cross sectional
survey of asthma in an occupational group of animal handlers would
underestimate risk if the development of respiratory symptoms led people to
seek alternative employment and therefore to be excluded from the study. A
cross sectional design may also make it difficult to establish what is cause and
what is effect.
Tuesday, April 29, 2014
RECOMMENDED IMMUNIZATION SCHEDULE FOLLOWED IN INDIA
Sl No.
|
Age
|
Disease
|
Vaccination
|
Remarks
|
1
|
AT BIRTH
|
HEPATITIS B
|
HEP B VACCINE -I
| |
2
|
AT BIRTH
|
POLIO
|
ORAL PV 0 DOSE
| |
3
|
BIRTH TO 6 WK
|
TUBERCULOSIS
|
BCG
| |
4
|
4 -6 WEEKS
|
HEPATITIS B
|
HEP B VACCINE -II
| |
5
|
6 WEEKS
|
DIPHTHERIA PERTUSIS TETANUS POLIO
|
DPT-I OPV -I
| |
6
|
10 WK
|
DIPHTHERIA PERTUSIS TETANUS POLIO HEPATITIS B
|
DPT-II OPV-II HEP B VACCINE III*
|
*DELHI GOVT RECOMMENDATION
|
7
|
14 WEEKS
|
DIPHTHERIA PERTUSIS TETANUS POLIO
|
DPT-III OPV- III HEP B VACCINE IV*
|
*DELHI GOVT RECOMMENDATION
|
8
|
24 WEEKS
|
HEPATITIS B
|
HEP B VACCINE III*
|
*IAP RECOMMENDATION
|
9
|
9 -12MTHS
|
POLIO MEASLES
|
OPV-IV MEASLES
| |
10
|
15-18 MTHS
|
MUMPS MEASELES RUBELLA
|
MMR*
| |
11
|
18 MTHS
|
DIPHTHERIA PERTUSIS TETANUS POLIO
|
DPT –BOOSTER I OPV –V
|
*RECOMMENDED BY DELHI GOVT & IAP ONLY
|
12
|
24 MTHS
|
TYPHOID
|
TYPHOID*
|
*IAP RECOMMENDATION
|
13
|
4-5 YR
|
DIPHTHERIA PERTUSIS TETANUS POLIO
|
DPT BOOSTER – II OPV -VI
|
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