This study surveyed 5,000 patients seen by 100 French general practitioners to compare suitability of over-the-counter ibuprofen and paracetamol. It found 49.9% of patients had at least one contraindication or warning for ibuprofen use listed on the drug label, compared to only 6.8% for paracetamol. Specifically, 12.3% of patients had an ibuprofen contraindication and 37.6% should consult a doctor before use, versus 0.7% and 6.1% respectively for paracetamol. The results suggest paracetamol is more suitable for the general population than ibuprofen due to fewer restrictions on its
When a psychiatric patient is diagnosed, the practitioner selects a medication therapy from a variety of therapeutic approaches and according to the severity and condition of a patient; through peer evaluation. This requires the writing of a prescription. Prescribing accounts for a large proportion of errors [1]: Medication errors, problems related to strength and frequency of medication, quantity per dose, instructions for use, total quantity to be dispensed, dosage form etc; if absent, can cause great deal of patients’ harm. Medicines are a key component of healthcare and errors relating to medication, may impact on patient’s safety [1-4].
Human errors can be understood through a lot of suggested models and frameworks but the findings vary from country to country [5,6]. Prescribing errors are harmful to the patients and in worst cases they may lead to fatality. To avoid errors in prescriptions and its amelioration at the time of writing; is the easiest way of prevention of prescription errors [6-10]
Theories of human error states that, “a series of planned actions may fail to achieve their desired outcome because the plan itself was inadequate or because the actions did not go as planned. The definition reflects this distinction, including failures both in the prescribing decision and the prescription writing process” [5]. In 2005, Department of Health in the United Kingdom planned to reduce prescribing errors by 40% [10]. Such initiatives are also required in a developing country like Pakistan. Apparently, psychiatrists know a little about prescribing errors. Irrational drug therapy can cause patient’s harm by exacerbation or prolongation of illness, distress and higher costs [8] in some cases. Irrational prescribing is a global problem and may also be regarded as "pathological" prescribing [9].
All prescriptions must include the name, address, specialty and signature of the prescriber as well as the name, sex, and age of the patient and the strength, quantity, dose, frequency, dosage form and instructions for use of the medication [11–15]. The dispensing system of Pakistan is different than some other countries. The medication is available in already packed in containers etc by the pharmaceutical industries, to be dispensed. There is no option of refill instructions to the pharmacist etc. Adherence by the physician to good quality prescribing will minimize errors and ultimately improve patient’s care. Prescribing errors can occur as a result of errors in haste, poor concentration to the patient or attendant (in case the patient is unable to deliver the correct information), decision-making or the prescription-writing process. Incorrect prescribing habits are common unfortunately [16-20].
The purpose of this study was to investigate drug prescriptions of Psychiatry for the essential elements of prescriptions mentioned above, and to study the prescribing trends in psychiatric practice in Peshawar area, Pakistan.
When a psychiatric patient is diagnosed, the practitioner selects a medication therapy from a variety of therapeutic approaches and according to the severity and condition of a patient; through peer evaluation. This requires the writing of a prescription. Prescribing accounts for a large proportion of errors [1]: Medication errors, problems related to strength and frequency of medication, quantity per dose, instructions for use, total quantity to be dispensed, dosage form etc; if absent, can cause great deal of patients’ harm. Medicines are a key component of healthcare and errors relating to medication, may impact on patient’s safety [1-4].
Human errors can be understood through a lot of suggested models and frameworks but the findings vary from country to country [5,6]. Prescribing errors are harmful to the patients and in worst cases they may lead to fatality. To avoid errors in prescriptions and its amelioration at the time of writing; is the easiest way of prevention of prescription errors [6-10]
Theories of human error states that, “a series of planned actions may fail to achieve their desired outcome because the plan itself was inadequate or because the actions did not go as planned. The definition reflects this distinction, including failures both in the prescribing decision and the prescription writing process” [5]. In 2005, Department of Health in the United Kingdom planned to reduce prescribing errors by 40% [10]. Such initiatives are also required in a developing country like Pakistan. Apparently, psychiatrists know a little about prescribing errors. Irrational drug therapy can cause patient’s harm by exacerbation or prolongation of illness, distress and higher costs [8] in some cases. Irrational prescribing is a global problem and may also be regarded as "pathological" prescribing [9].
All prescriptions must include the name, address, specialty and signature of the prescriber as well as the name, sex, and age of the patient and the strength, quantity, dose, frequency, dosage form and instructions for use of the medication [11–15]. The dispensing system of Pakistan is different than some other countries. The medication is available in already packed in containers etc by the pharmaceutical industries, to be dispensed. There is no option of refill instructions to the pharmacist etc. Adherence by the physician to good quality prescribing will minimize errors and ultimately improve patient’s care. Prescribing errors can occur as a result of errors in haste, poor concentration to the patient or attendant (in case the patient is unable to deliver the correct information), decision-making or the prescription-writing process. Incorrect prescribing habits are common unfortunately [16-20].
The purpose of this study was to investigate drug prescriptions of Psychiatry for the essential elements of prescriptions mentioned above, and to study the prescribing trends in psychiatric practice in Peshawar area, Pakistan.
Hello members...this powerpoint deals with A journal presentation, that aims at highlighting the "Efficacy & safety of Lacosamide in painful diabetic neuropathy patients".
This also elucidates a model of "Journal club presentation" for interested students.
Happy reading!!
:)
Journal Club - EMS - "Effect of adrenaline on survival in out-of-hospital car...Farooq Khan
Summary and Critical Appraisal of:
Jacobs et al,"Effect of adrenaline on survival in out-of-hospital cardiac arrest: A randomised double-blind placebo-controlled trial" Resuscitation 82 (2011) 1138– 1143
pharmacoepidemiology is the study of use and effect of drugs in large number of population.
pharmacoepidemiology enhances or supplements the information from the preclinical studies.
Hello members...this powerpoint deals with A journal presentation, that aims at highlighting the "Efficacy & safety of Lacosamide in painful diabetic neuropathy patients".
This also elucidates a model of "Journal club presentation" for interested students.
Happy reading!!
:)
Journal Club - EMS - "Effect of adrenaline on survival in out-of-hospital car...Farooq Khan
Summary and Critical Appraisal of:
Jacobs et al,"Effect of adrenaline on survival in out-of-hospital cardiac arrest: A randomised double-blind placebo-controlled trial" Resuscitation 82 (2011) 1138– 1143
pharmacoepidemiology is the study of use and effect of drugs in large number of population.
pharmacoepidemiology enhances or supplements the information from the preclinical studies.
Journal Article Analysis: Medication Errors in Overweight and Obese Pediatric...Paul Pasco
A journal article analysis ("journal club") I completed during an internship/Advanced Pharmacy Practice Experience (APPE) in medication safety at a hospital.
FACTORS ASSOCIATED WITH UNNECESSARY DRUG THERAPY AND INAPPROPRIATE DOSAGE IN ...Jing Zang
To assess factors associated with unnecessary drug therapy and inappropriate dosage in hospitalized patients. A hospital based cross-sectional study design was employed. The study was conducted in Jimma University Specialized Hospital, Jimma, which is 345 Km from South west of Addis Ababa. All patients who were admitted to medical ward from February 5 – March 21, 2011 were included in the study. Data on socio-demographic variables, past medical history, past medication history, current diagnosis, current medications, vital signs and relevant laboratory data were collected by using bed side patient interview guided semi-structured questionnaire and data abstraction formats for card review. The data were analysed by using SPSS version 16 for windows. Descriptive statistics, cross-tabs, chi-square and logistic regression were done. Out of 257 study participants 140(54.5%) had unnecessary drug therapy or inappropriate dosage. The only independent factors which predicted the unnecessary drug therapy in study population was polypharmacy while not considering organ function test, polypharmacy and clinically significant potential drug-drug interaction were independent factors associated with inappropriate dosage . The prevalence of unnecessary drug therapy or inappropriate dosage is significantly high.
Scope on medicatio error in a sample of iraqi two cities samawa and diwania.Ali Al Samawy
Summery
Introduction:
The pregnancy is sensitive period and administration of drugs may lead to threating of fetus life or cause malformations and teratogenicity etc.
Methodology:
A cross-sectional study of medication errors of 100 prescriptions dispensed to a pregnant women in a sample of Iraqi two cities (Al Sammawah & Al Diwania) during October, 2016.
A formal was used to collect data included the name of pregnant, age, trimester, doctor diagnosis, the drug dispensed and their dose, rout, duration, frequency, strength and notes section. The formal filled during visits of the research team to pharmacies that most of the prescriptions they dispense are for pregnant women prescribed by a nearby gynecology &obstruct doctors.
Then the data analyzed to identify the medication errors that includes; inappropriate and irrational, ineffective, over and under prescribing and drug interactions using available literature and drugs.com drug interaction checker.
Result:
Total number of prescriptions involved in the study is 100 prescriptions, they contain 487 medication dispensed to the patients. The total number of medication errors identified were 364(74.7%), included 110 irrational & inappropriate prescribing, 47 over prescribing. 19 under prescribing, and 8 ineffective prescribing. The drug interactions were classified to drug-drug interactions 126 interactions identified and drug food interactions 54 interactions were recorded. 0.8 % of all drug-drug interactions were major, 76 % moderate and 23% mild. Phenobarbital (luminal) is the drug that caused the most of medication error that identified as it dispensed 23 times but in all of these patient luminal was irrational and inappropriate and it caused the most of interactions recorded as 44 interactions were caused by luminal.
While Dydrogesterone was prescribed as a tocolytic 21 times, and this considered as irrational & inappropriate prescribing. Isoxsuprine prescribed irrationally 17 times. The parenteral iron administered without calculating the dose depending on the body weight and blood Hb. Most of antibiotics and antifungal prescribed for incorrect duration or dose. The other errors were related to other drugs duration, dose, and indication errors.
Conclusion:
Percentage of medication errors was high. Types of medication errors were mostly drug-drug interaction, irrational and inappropriate use. The impact of these medication errors may include teratogenic effect.
Recommendations:
Adherence to the treatment guidelines and further studies to assess the impact of medications errors on pregnant women and her fetus.
Because of such a high consumption level, any risky impact of these pills on public health would be important. The present study aimed to determine the relationship between consumption of OCPs and hypertension. Method: In this retrospective, cross-sectional study, 165women below 40 years of age who used OCPs were selected by convenience sampling. Necessary information was obtained by a checklist containing demographic information, obstetric history, and OCPs use history based on the subjects’ medical records. Besides, blood pressure and weight were measured at the beginning of OCPs consumption as well as 6 months and one year after that. Results: The results showed a significant difference between the subjects’ mean systolic blood pressure one year after OCPs consumption compared to the beginning (P=0.03). Moreover, this difference was related to the type of pills, such a way that it was significant in the patients who took Low Dose (LD) OCPs compared to those who used Triphasic pills (P=0.01). Conclusion: Consuming the currently available OCPs that contain lower estrogen content had an insignificant effect on blood pressure. However, it is recommended to take care of blood pressure in order to identify the unique occasional responses.
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
HOT NEW PRODUCT! BIG SALES FAST SHIPPING NOW FROM CHINA!! EU KU DB BK substit...GL Anaacs
Contact us if you are interested:
Email / Skype : kefaya1771@gmail.com
Threema: PXHY5PDH
New BATCH Ku !!! MUCH IN DEMAND FAST SALE EVERY BATCH HAPPY GOOD EFFECT BIG BATCH !
Contact me on Threema or skype to start big business!!
Hot-sale products:
NEW HOT EUTYLONE WHITE CRYSTAL!!
5cl-adba precursor (semi finished )
5cl-adba raw materials
ADBB precursor (semi finished )
ADBB raw materials
APVP powder
5fadb/4f-adb
Jwh018 / Jwh210
Eutylone crystal
Protonitazene (hydrochloride) CAS: 119276-01-6
Flubrotizolam CAS: 57801-95-3
Metonitazene CAS: 14680-51-4
Payment terms: Western Union,MoneyGram,Bitcoin or USDT.
Deliver Time: Usually 7-15days
Shipping method: FedEx, TNT, DHL,UPS etc.Our deliveries are 100% safe, fast, reliable and discreet.
Samples will be sent for your evaluation!If you are interested in, please contact me, let's talk details.
We specializes in exporting high quality Research chemical, medical intermediate, Pharmaceutical chemicals and so on. Products are exported to USA, Canada, France, Korea, Japan,Russia, Southeast Asia and other countries.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
263778731218 Abortion Clinic /Pills In Harare ,sisternakatoto
263778731218 Abortion Clinic /Pills In Harare ,ABORTION WOMEN’S CLINIC +27730423979 IN women clinic we believe that every woman should be able to make choices in her pregnancy. Our job is to provide compassionate care, safety,affordable and confidential services. That’s why we have won the trust from all generations of women all over the world. we use non surgical method(Abortion pills) to terminate…Dr.LISA +27730423979women Clinic is committed to providing the highest quality of obstetrical and gynecological care to women of all ages. Our dedicated staff aim to treat each patient and her health concerns with compassion and respect.Our dedicated group ABORTION WOMEN’S CLINIC +27730423979 IN women clinic we believe that every woman should be able to make choices in her pregnancy. Our job is to provide compassionate care, safety,affordable and confidential services. That’s why we have won the trust from all generations of women all over the world. we use non surgical method(Abortion pills) to terminate…Dr.LISA +27730423979women Clinic is committed to providing the highest quality of obstetrical and gynecological care to women of all ages. Our dedicated staff aim to treat each patient and her health concerns with compassion and respect.Our dedicated group of receptionists, nurses, and physicians have worked together as a teamof receptionists, nurses, and physicians have worked together as a team wwww.lisywomensclinic.co.za/
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...
Pain survey : A Prospective Survey to Compare the Suitability Profiles of Over the Counter Ibuprofen
1. PIERRE PIGEON, ERIC ROBILLARD, GEOFFREY D.
CLARKE, IAN BURNETT
A PROSPECTIVE SURVEY TO COMPARE THE
SUITABILITY PROFILES OF OVER-THE-COUNTER
IBUPROFEN AND PARACETAMOL USE IN A
FRENCH GENERAL PRACTITIONER-CONTROLLED
POPULATION
2. BACKGROUND & OBJECTIVES
The PAIN (Paracetamol, Aspirin and Ibuprofen New tolerability) study published in 1999
assessed the tolerability of over-the- counter (OTC) analgesics in a French general practitioner
(GP)-controlled population and found no apparent difference between the tolerability of
ibuprofen and paracetamol (acetaminophen). However, patient selection in that study could
cast doubt over the relevance of the results to a more generalized OTC population.
The aim of our survey was to prospectively determine what proportion of a French GP-
controlled population is able to take ibuprofen and paracetamol in order to allow appropriate
interpretation of the PAIN study.
Page 2
3. METHODS
This was a prospective survey to identify all contraindications/warnings on product
labelling for ibuprofen and paracetamol in 5000 patients aged 18-75 years. 100 French
GPs each collected anonymized data on 50 patients over a 1-week period using a
standardized form.
GPs were stratified by geographical location and size of practice.
Demographic data for patients were summarized.
Contraindications/warnings for ibuprofen and paracetamol were summarized overall and
by individual criterion.
Page 3
4. RESULTS
The mean age of patients was 45.8 (± 16.5) years; 42% were males and 58% females.
Of these patients, 49.9% would have been ineligible for the PAIN study because of at
least one contraindication/warning for ibuprofen, whereas only 6.8% would have been
ineligible because of at least one contraindication/warning for paracetamol.
More specifically, contraindications to use of ibuprofen was noted in 12.3% of patients
and 37.6% of patients should have consulted a doctor before use of this drug.
In contrast, contraindications to use of paracetamol were noted in only 0.7% of patients
and only 6.1% should have consulted a doctor before use of this drug.
Page 4
5. CONCLUSIONS I
Our survey demonstrates how careful patient selection can limit the generalizability of a study. The
PAIN study excluded individuals 'at-risk' from ibuprofen and the tolerability results of this study
should therefore be interpreted with extreme caution because the patient population may not be
representative of unsupervised OTC analgesic users.
Pain and discomfort are often treated with over-the-counter (OTC) analgesic medications; it has been
estimated that up to 70% of the population in Western countries use such medications regularly.
However, because of the relatively unrestricted access to these drugs, many consumers believe that
such medications are innocuous and often do not inform their doctors when they use them. As a
consequence, consumers may purchase and use OTC analgesics without due consideration of their
contraindications, precautions and drug interactions.
In the prescription setting, adverse effects of NSAIDs, including gastrointestinal (GI)
bleeding, cardiovascular complications and renal toxicity, are widely documented and their use
requires careful assessment of the risks and benefits. These NSAID-related adverse effects are drug
and dose dependent with the risk of GI bleeding increasing with dose.
Page 5
6. CONCLUSIONS II
The widespread use of OTC analgesics means that any adverse event associated with the use of these products can
present a significant public health concern. For example, the American College of Gastroenterology Bleeding Registry
has indicated that OTC NSAIDs are used significantly more often in patients with GI bleeding (48%) than in matched
controls (19%). Recent data from the US indicate that some 23 million Americans are using OTC NSAIDs daily, and that
one in four users exceeds the recommended dose of OTC medications.
Paracetamol (acetaminophen) has been regarded as a first-line analgesic of choice for many years, and there is a
general consensus that based on its excellent risk-benefit profile at therapeutic doses, paracetamol should be
continued to be regarded as such, particularly in those patients at increased risk of GI, cardiovascular or renal
complications associated with NSAIDs. In addition, and in contrast to NSAIDs, there are very few clinically significant
drug interactions with paracetamol.
Many of the data pertaining to the relative safety profiles of OTC paracetamol and ibuprofen are derived from patient
populations and conditions that are not necessarily reflective of the general OTC analgesic-using population. In
recognition of this, the PAIN (Paracetamol, Aspirin and Ibuprofen New tolerability) study was an attempt to compare
directly the tolerability of aspirin, paracetamol and ibuprofen in situations that mimicked everyday use at OTC doses
and durations in common, mild to moderate acute pain states.
Page 6
7. CONCLUSIONS III
This large study involved 8677 patients recruited by 1108 French general practitioners (GPs). The results appeared to
support equal tolerability for ibuprofen and paracetamol, leading the investigators to suggest that a reassessment of
the use of these analgesics could be warranted, with ibuprofen replacing paracetamol as the first-line analgesic of
choice.
Concerns have since been raised about methodological deficiencies in the original published research that may have
adversely impacted on interpretation of the results. In particular, there are no data describing patient disposition from
screening through to randomization, making it difficult to draw conclusions regarding the applicability of the data to
the general population of OTC analgesic users. The present research was therefore designed to compare the suitability
profiles of OTC ibuprofen and paracetamol in a population of patients screened through a French GP database network
in order to allow appropriate interpretation of the PAIN study results. The objective of the survey was to determine the
relative incidence rates of contraindications to and/or warnings relating to the use of OTC ibuprofen and
paracetamol, with the primary hypothesis being that the rate would be higher with ibuprofen than with paracetamol.
This was a prospective survey of 5000 patients aged 18-75 years aimed at identifying contraindications and warnings as
listed on the Summary of Product Characteristics (SmPC) for OTC paracetamol and ibuprofen. A total of 100 GPs were
enrolled into the audit, with each GP completing 50 patient records over a 1-week period using a standardized form.
Page 7
8. CONCLUSIONS IV
Physicians were recruited into the survey based on a quota approach to ensure stratification by geographical location and size of
practice. A total of 100 GPs were recruited into the survey, 65% of whom were male and 35% of whom were female.
The only patient inclusion criterion employed in this research was age between 18 and 75 years inclusive. GPs were required to
collect data for every patient who met the age criterion, up to a total of 50 patients, regardless of the purpose of their visit to the
GP.
The primary outcome measure was the overall screening failure rate for ibuprofen and for paracetamol (i.e. the percentage of
patients presenting with at least one contraindication or warning related to use of ibuprofen or paracetamol). Secondary
outcome measures included quantification of the screening failure rate by individual criterion and by age group.
This survey tested the primary hypothesis that there would be a difference in screening failure rate between ibuprofen and
paracetamol. The demographic profile of the audit population was summarized by age and sex. The number of patients failing
screening (overall and by individual exclusion criterion) was summarized descriptively for ibuprofen and paracetamol. The overall
screening failure rates for ibuprofen and paracetamol were compared using a chi-squared (χ2) test to establish whether there was
a statistically significant difference between the two groups.
Five thousand patients were recruited into the study, 42.3% of whom were male and 57.7% female. The mean age of these
patients was 45.8 (± 16.5) years; age was evenly distributed throughout the audit population.
Page 8
9. CONCLUSIONS V
Statistically significantly more patients were found to have at least one contraindication/warning for ibuprofen
compared with paracetamol (2494 [49.9%] vs 340 [6.8%], p = 0.005, figure 1). This confirmed the primary hypothesis
that a higher proportion of this French GP-controlled population should exercise caution before using OTC ibuprofen
compared with paracetamol
Overall screening failure rate (proportion of patients with at least one contraindication to or warning related to use of
either ibuprofen or paracetamol [acetaminophen]).
More specifically, use of ibuprofen was contraindicated in 12.3% of patients. In contrast, use of paracetamol was
contraindicated in only 0.7% of patients. The details of patients with contraindications are presented more fully in
Table III . Additionally, 37.6% of the patients assessed should have consulted a doctor before using ibuprofen because
of warnings on the product labelling. Again, this was in stark contrast to paracetamol: only 6.1% of patients should
have consulted a doctor before using this drug.
There were differences with respect to patient age, with the data showing a positive upwards trend between
increasing age and more patients presenting with at least one contraindication or warning.
Overall screening failure rate (proportion of patients with at least one contraindication to or warning related to use of
either ibuprofen or paracetamol [acetaminophen]).
Page 9
10. CONCLUSIONS VI
This prospective survey of 5000 patients in general practice has shown that, based on an evaluation of the SmPC
contraindications and warnings, OTC paracetamol is suitable for use by many more people than is OTC ibuprofen.
Importantly, these results may have implications with regard to the use and safety perceptions of OTC analgesics.
The primary outcome results were as expected. Given that the product labelling for ibuprofen carries substantially
more contraindications, warnings and precautions than does that for paracetamol, it is not surprising that a higher
proportion of patients would be excluded from using OTC ibuprofen on this basis alone. Our study findings indicate
that particular care needs to be taken in the community to ensure that the labelled instructions are properly followed
so as to limit the possibility of inappropriate use.
Our results provide interesting data on the relative suitability profiles of two commonly used OTC analgesics. In
addition, they provide further insight into the interpretation of the PAIN study,and subsequent re-analyses of these
data. The PAIN study was a blinded, multicenter study that evaluated a French GP-based population of almost 9000
patients in an attempt to mimic the everyday use of aspirin, paracetamol and ibuprofen at OTC doses and durations.
Participants received up to 7 days' treatment with aspirin (3000mg daily), paracetamol (3000mg daily) or ibuprofen
(1200mg daily) for the symptomatic relief of common painful conditions, including musculoskeletal or back pain
(48%), sore throat, the common cold and flu (31%).
Page
10
11. CONCLUSIONS VII
The main outcome measure was the rate of significant (serious, severe or moderate) adverse events resulting in
treatment discontinuation or a visit to a doctor. The rate of significant adverse events for ibuprofen was reported to be
statistically equivalent to that of paracetamol, with both drugs being significantly better tolerated than aspirin.
Our data show that the patient population evaluated in the PAIN study may not have been representative of the
general adult population of OTC analgesic users. Based on our analysis, almost 50% of patients aged 18-75 years
presenting to their GP may have been excluded from the PAIN study because of contraindications, warnings or
precautions listed in the SmPC for ibuprofen. This would go some way to explaining why it took 1108 GPs just over 6
months to recruit 8677 patients in the PAIN study (i.e. a recruitment rate of only 1.3 patients per GP per month).
Hence, the claimed result of equal tolerability for ibuprofen and paracetamol should be interpreted with caution when
applied to an OTC user population rather than a GP-controlled population.
While OTC analgesics are substantially safe for the vast majority of the population, our research has demonstrated that
contraindications, warnings and precautions to OTC ibuprofen apply to 49.9% of the French adult audit population. In
contrast, such exclusions to OTC paracetamol apply to only 6.8% of this population. Therefore, OTC paracetamol is
more suitable for use by a wider proportion of the general population than is OTC ibuprofen.
Page
11