Prescrire Int [JOURNAL]
Sun
200 papers
Drug packaging in 2015: risky industry choices and lax regulation.
Prescrire Int · 2016 Jun · PMID 27486651
Prescrire examined the packaging quality of 240 drugs in 2015. No new advances were identified, but drug packaging continues to expose patients to a variety of dangers. Some past advances persist: for example, INNs are o...
Prescrire examined the packaging quality of 240 drugs in 2015. No new advances were identified, but drug packaging continues to expose patients to a variety of dangers. Some past advances persist: for example, INNs are often more legible, and recent patient leaflets tend to be clearer and more informative. But these measures are not applied to all drugs, and are rarely applied retroactively to older drugs. The overall picture in 2015 is that many drugs are difficult to identify, risky or downright dangerous to prepare, or supplied with patient leaflets that fail to correctly inform patients about their medication. And measures to prevent drug poisoning in children need to be completely rethought. It is high time for regulators and policy makers to take the issue of drug packaging seriously, so blatant are the signs of their failure to do so: the increasing use of bulk bottles for new drugs; failure to implement guidelines on safe drug packaging (unit-dose presentations, appropriate dosing devices, etc.); and expanding umbrella brands which, given the dangers they pose to patients, should be banned instead. All things considered, healthcare professionals and patients must remain vigilant and report any dangers they identify. A major European initiative on drug packaging is becoming increasingly necessary.
Pulmonary embolism and thrombolysis.
Prescrire Int · 2016 Jun · PMID 27486650
A meta-analysis of studies including about 2000 patients with pulmonary embolism suggests that thrombolysis slightly reduces overall mortality at one month in patients under 65 but increases the number of major bleeding...
A meta-analysis of studies including about 2000 patients with pulmonary embolism suggests that thrombolysis slightly reduces overall mortality at one month in patients under 65 but increases the number of major bleeding events, including intracranial haemorrhage.
Pneumococcal conjugate vaccine: do not routinely vaccinate adults aged 65 years and older.
Prescrire Int · 2016 Jun · PMID 27486649
A randomised placebo-controlled trial of 13-valent pneumococcal conjugate vaccine was conducted in about 84 500 adults aged 65 years and older, with no particular risk factors. Four years on average after vaccination, th...
A randomised placebo-controlled trial of 13-valent pneumococcal conjugate vaccine was conducted in about 84 500 adults aged 65 years and older, with no particular risk factors. Four years on average after vaccination, there was no reduction in either mortality or the overall incidence of community-acquired pneumonia. It was necessary to vaccinate about 1000 individuals in order to prevent one case of vaccine-type pneumococcal pneumonia during the 4-year follow-up period.
Oral mucositis associated with cancer therapy. Guide to first-choice treatments.
Prescrire Int · 2016 Jun · PMID 27486648
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Bisphosphonates: osteonecrosis of the external auditory canal.
Prescrire Int · 2016 Jun · PMID 27486647
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Sofosbuvir: bradycardia.
Prescrire Int · 2016 Jun · PMID 27486646
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Azithromycin: pyloric stenosis in neonates.
Prescrire Int · 2016 Jun · PMID 27486645
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Sympathomimetic decongestants during pregnancy: risks for the unborn child.
Prescrire Int · 2016 Jun · PMID 27486644
In addition to the risk of cardiovascular events and neurological disorders, sympathomimetic decongestants have teratogenic potential, albeit weak, when taken during the first trimester of pregnancy, probably through dis...
In addition to the risk of cardiovascular events and neurological disorders, sympathomimetic decongestants have teratogenic potential, albeit weak, when taken during the first trimester of pregnancy, probably through disruption of the vascular system of the embryo and the pregnant woman. In the second and third trimesters of pregnancy, the fetus is exposed to the same adverse effects as the mother.
COMMON STEM. -astine.
Prescrire Int · 2016 Jun · PMID 27486643
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Efavirenz in children. Minimal evaluation.
Prescrire Int · 2016 Jun · PMID 27486642
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Apremilast (Otezla). No progress in plaque psoriasis or psoriatic arthritis.
Prescrire Int · 2016 Jun · PMID 27486641
When PUVA therapy and immunosuppressants such as methotrexate are ineffective, TNF alpha antagonists are an option for patients with severe plaque psoriasis, in the absence of a better alternative. This is also the case...
When PUVA therapy and immunosuppressants such as methotrexate are ineffective, TNF alpha antagonists are an option for patients with severe plaque psoriasis, in the absence of a better alternative. This is also the case for patients with psoriatic arthritis after failure of a "disease-modifying" antirheumatic drug. Apremilast, an oral immunosuppressant that inhibits phosphodiesterase type 4, has been authorised in the European Union for use in these settings. In patients with plaque psoriasis, oral apremilast was compared with subcutaneous etanercept, aTNF alpha antagonist, in a randomised, doubleblind, placebo-controlled trial lasting 16 weeks and involving 250 patients in whom other treatments had failed or were inappropriate. This trial failed to show that apremilast was more effective than etanercept. And about one-quarter more patients experienced symptom relief compared with placebo. In patients with psoriatic arthritis, there are no clinical trials comparing apremilast with TNF alpha antagonists, and no interpretable trials of apremilast after failure of a TNF alpha antagonist. In three randomised, double-blind trials including a total of 1493 patients treated for 16 weeks, at least a modest improvement in joint status was reported in about 35% of patients treated with apremilast versus 19% with placebo. This would suggest that apremilast is less effective than a TNF alpha antagonist. In the trial versus etanercept, serious adverse events occurred in 3.6% of patients treated with apremilast versus 1.2% of those treated with the TNF alpha antagonist. The main adverse effects of apremilast are diarrhoea, nausea and vomiting, headache, sometimes marked weight loss, and infections. A risk of depression and cardiac arrhythmia must also be taken into account. A risk of cancer in the long-term is likely, given the immunosuppressive action of apremilast. Apremilast is a substrate of cytochrome P450 isoenzyme 3A4 and accumulates in patients with renal failure. This creates a risk of multiple pharmacokinetic interactions.
Empagliflozin (Jardiance). Type 2 diabetes: no rush to use this drug.
Prescrire Int · 2016 Jun · PMID 27486640
* In early 2016, metformin monotherapy remains the treatment of choice for most patients with type 2 diabetes. There are several alternatives for patients in whom metformin is poorly tolerated or ineffective. However, da...
* In early 2016, metformin monotherapy remains the treatment of choice for most patients with type 2 diabetes. There are several alternatives for patients in whom metformin is poorly tolerated or ineffective. However, dapagliflozin and canagiflozin have an unfavourable harm-benefit balance and should not be used to enhance the action of metformin. Empagliflozin is the third glifozin to be authorised in the European Union for the treatment of type 2 diabetes. A randomised, double-blind, placebo-controlled trial of empaglifloznin, in combination with other glucose-lowering drugs, involved 7020 patients with type 2 diabetes, an average glycated haemoglobin (HbA1c) concentration of about 8%, and a history of at least one cardiovascular event. After about 3 years of follow-up, overall mortality was lower with empagliflozin (5.7% versus 8.3%, p < 0.001), mainly due to a reduction in cardiovascular mortality, particularly due to heart failure. This benefit does not seem due to efficacy in preventing the cardiovascular complications of diabetes, as there was no difference between the groups in terms of myocardial infarction or stroke. The most likely explanation is an effect in preventing other cardiovascular disorders, such as heart failure, in patients with a history of cardiovascular disorders. This is consistent with the diuretic effect of empagliflozin and its rapid impact on mortality (within a matter of months in the trial), as well as with lower exposure to cardiovascular drugs and reduction in the risk of hospital admission for heart failure. In seven comparative trials, empagliflozin had only a moderate glucose-lowering action: among patients with an average baseline HbA1c of about 8%, the HbA1c fell by about 0.5% more with empagliflozin than with placebo. An even smaller effect was reported in patients with renal impairment. Empagliflozin shares the adverse effects of other gliflozins, including genital infections, kidney failure, and diabetic ketoacidosis. Empagliflozin may also be hepatotoxic. A risk of cancer (especially bladder cancer) cannot be ruled out. Empagliflozin interacts with nephrotoxic drugs, which aggravate its adverse effects and decrease its hypoglycaemic potency. The diuretic action of empagliflozin can lead to volume depletion and a fail in blood pressure, especially during co-administration with other diuretics or antihypertensive drugs. In practice, empagliflozin was found to reduce mortality in a clinical trial involving patients with type 2 diabetes and significant cardiovascular risk factors. This benefit does not seem to be related to the hypoglycaemic effect of empagliflozin or to prevention of the cardiovascular complications of diabetes, but rather to prevention of heart failure in patients with history of cardiovascular disease. In early 2016, it is unclear which patients are most likely to derive a concrete benefit from empagliflozin therapy. Comparative evaluation must continue, especially in patients with heart failure.
The drug pricing racket.
Prescrire Int · 2016 Jun · PMID 27486639
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Andrew Herxheimer: his life's work, to be continued.
Bardelay D, Bardelay G
Prescrire Int · 2016 Jun · PMID 27483737
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Student action reduces industry influence in US medical schools.
Prescrire Int · 2016 Jul · PMID 30730655
Relationships with drug companies influence the practices of medical stu- dents and healthcare professionals. To ensure that medical education remains patient-focused, the American Medical Student Association (AMSA) is c...
Relationships with drug companies influence the practices of medical stu- dents and healthcare professionals. To ensure that medical education remains patient-focused, the American Medical Student Association (AMSA) is calling for medical schools to establish stringent rules governing their relationships with industry. Since 2007, AMSA has been rating medical schools according to the rules they have established to mini- mise conflicts of interest. The score is based on a list of 14 criteria designed to prevent conflicts of interest, and it is used each year to rate American medical schools. The 14 criteria include gifts and meals, for example, but also pharmaceutical sales representative access to campus, industry funding of talks and presentations, and education on conflicts of interest. The 2014 AMSA scorecard showed that more than two-thirds of US med- ical schools had established excellent or robust rules governing students' relationships with industry.Their num- ber is growing from year to year, as reflected by the steady increase in the number of schools that ban pharma- ceutical reps from visiting students. In 2014, AMSA also began to score teaching hospitals, and found that two-thirds of them had implemented robust rules for avoiding conflicts of interest among their students. The AMSA scorecard is backed up by actions intended to promote stu- dent awareness of conflicts of inter- est, including an AMSA guide laying out the desired content of the conflict-of-interest curriculum.
Electronic prescribing: errors due to multiple causes.
Prescrire Int · 2016 Jul · PMID 30730654
It takes longer to create an elec- tronic prescription than to handwrite a prescription, and the extra workload varies depending on the software used. Bugs, crashes, unreliable access and sluggish response times can caus...
It takes longer to create an elec- tronic prescription than to handwrite a prescription, and the extra workload varies depending on the software used. Bugs, crashes, unreliable access and sluggish response times can cause errors and data loss. Screens that contain too much or poorly displayed information can gen- erate errors through cognitive overload. Information entered in a free-text field, often in order to bypass a problem, can result in conflicting instructions that are missed by inbuilt safeguards. The propagation of default values in input fields can cause errors, including dosing errors, administration errors and premature treatment cessation. Medication errors and adverse effects attributed to electronic pre- scribing can result from a combination of factors. These contributory factors include: incomplete knowledge of how the software works; unclear display of information on the screen; confusing presentation of successive prescrip- tions in the patient's medication history; failure to verify the patient's iden- tity; having several patients' records open at the same time; prescribing from a location other than the unit in which the patient is hospitalised; inappropriate configuration of the drug database; rushed implementation of healthcare information technology; and communication failures between different programmes. There is a tendency to place too much faith in electronic prescribing. Health professionals must carefully check the prescriptions generated and recorded, and the patient's various recent prescriptions. They must take into account situations at increased risk of error, such as prescribing from a remote location that precludes veri- fication with the patient.
Progestogens and prevention of preterm birth in women at risk.
Prescrire Int · 2016 Jul · PMID 30730653
The natural hormone progesterone and the progesterone derivative hydroxyprogesterone have been pro- posed for the prevention of preterm birth in pregnant women considered at high risk due to a history of prior preterm bi...
The natural hormone progesterone and the progesterone derivative hydroxyprogesterone have been pro- posed for the prevention of preterm birth in pregnant women considered at high risk due to a history of prior preterm birth or a short cervix on ultrasound examination. What are the results of the evalu- ation of these progestogens in the prevention of preterm birth in women at high risk? And what are the adverse effects on the mother and the unborn child? We identified a Cochrane systematic review and searched the literature for more recent data. Four randomised trials evaluated the administration of intramuscular hydroxyprogesterone, beginning in the second trimester of pregnancy, in about 650 women with a history of preterm birth. The data on perinatal mortality and on the incidence of preterm birth were uninterpretable due to heterogeneity between the pla- cebo groups. Seven randomised placebo- controlled trials evaluated oral or vaginal progesterone in about 1300 women with a history of preterm birth. Delivery before 34 weeks' gestation was less frequent with pro- gesterone (10% of births versus 26% with placebo), with no impact on perinatal mortality. The results on neo- natal health outcomes are undermined by reporting bias. In five randomised trials in women found to have a short cervix midway through pregnancy, there was no firm evidence that either vaginal progester- one or intramuscular hydroxyproges- terone reduce the incidence of preterm birth before 37 weeks. Progesterone and hydroxyproges- terone were evaluated in 16 randomised trials in women with a multiple pregnancy, with no evidence of a reduction in the risk of preterm birth. At the doses evaluated, the adverse effects of these progestogens are moderate for the mother, although women at risk for deep vein thrombosis were excluded from several trials. Exposure to progesterone or hydroxy- progesterone after the first trimester of pregnancy does not appear to increase the risk of congenital defects in the newborn. The long-term effects of these progestogens are unknown. In practice, the efficacy of progesterone and hydroxyprogesterone administered from the second trimester of pregnancy for the prevention of preterm birth is highly uncertain. As of early 2016, the evaluation results are not sufficiently convincing to justify progestogen exposure as soon as the risk of preterm birth appears high. They do, however, justify continued evaluation of progesterone in clinical trials for women with a history of recurrent preterm birth with no iden- tified cause.
Fluoroquinolones: aortic aneurysm and dissection?
Prescrire Int · 2016 Jul · PMID 30730652
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Zidovudine, tenofovir or abacavir? Different adverse effect profiles.
Prescrire Int · 2016 Jul · PMID 30730651
Current guidelines on first-line treatment of HIV infection recommend a combination of at least three antiretroviral drugs from two different pharmacological classes: at least two nucleoside or nucleotide reverse transcr...
Current guidelines on first-line treatment of HIV infection recommend a combination of at least three antiretroviral drugs from two different pharmacological classes: at least two nucleoside or nucleotide reverse transcriptase inhibitors plus either a protease inhibitor or a non-nucleoside reverse transcriptase inhibitor. Among the available nucleoside or nucleotide inhibitors, some guidelines recommend the tenofovir + emtricitabine combination for adults. The abacavir + lamivudine and zidovudine + lamivudine combinations have similar efficacy but are only considered alternative options. What is known of the differences in adverse effects between zidovudine, tenofovir and abacavir? How should their respective adverse effect profiles influence the choice between available combinations? We sought answers to these questions by reviewing the literature using the standard Prescrire methodology. Treatment withdrawals for adverse effects or fear of lipoatrophy are less frequent with tenofovir than with zidovudine. Similarly, treatment withdrawals because of adverse effects are less frequent with abacavir+ lamivudine than with tenofovir + emtricitabine. Zidovudine mainly has haematological adverse effects (anaemia, leukopenia) and also causes lipoatrophy. Tenofovir mainly causes renal disorders (tubulopathy, Fanconi syn- drome), bone disorders (osteoporosis, fractures, osteomalacia) and gastrointestinal disorders. Abacavircan cause life-threatening hypersensitivity reactions, even (al- beit less frequently) in patients who do not carry the HLA-B*5701 allele. It probably also has cardiovascular adverse effects, including myocardial infarction. In practice, the choice between the tenofovir + emtricitabine, abacavir + lamivudine or zidovudine + lamivudine combinations should be made on a case-by-case basis, taking into account the patient's renal function, hepatitis B virus serostatus, and other ongoing treatments, as well as poten- tial adverse effects, treatment moni- toring, and convenience.
INN Common stem: -vastatin.
Prescrire Int · 2016 Jul · PMID 30730650
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