DOCTORS - NURSES - Non Medical Prescribers IMPORTANT INFORMATION
Anyone interested in official reports of DRUG SAFETY ALERTS & RECALLS can sign up for emails from the regulatory agency in your country.
Warnings about risks may be seen in one country but not shared in others, so be alert to up to date information about the drugs you are offering.
Many issues occur long after a drug is licensed. In the words of eminent professor of Clinical Pharmacology the late Dr Andrew Herxheimer
" It can take at least 10 years before harms are discovered affecting many lives."
In the UK we have pharmacists who regularly report on findings from ADR Yellow Card Reports and you can read their Re:action data here: http://yccwm.org.uk/index.php/reaction/
They are based at the
Yellow Card Centre West Midlands
The West Midlands Centre for Adverse Drug Reactions
The MHRA Head Office have diminished some of the independence of the West Midlands and other UK branches of the MHRA
but not before the WM were able to publish:
Prescribed Drug Induced Depression
Prescribed Drug Induced Hallucinations
European Independent pharmacists produce A THERAPEUTIC BULLETIN:
PRÉSCRIRE with valuable information about medicines safety and warnings
The journal has an English version:
An article Préscrire published in both journals explains the patients perspective on safety and harm of medicines
USEFUL BOOKS with extra information about psychiatric ADRs - to everyday medicines,
not just those prescribed for mental health issues.
PSYCHIATRIC SIDE EFFECTS OF PRESCRIPTION AND OVER THE COUNTER MEDICATION
An American Psychiatric Association publication written by Stodemire and Brown - free examples of content on line
DRUG SAFETY UPDATE FROM THE MHRA about erectile dysfunction and loss of libido linked to acne drug isotretinoin known as Roaccutane and many other generic names.
For Doctors and prescribers important information that may reduce iatrogenic illness and prevent further complications and a downward spiral in the health of your patient.
Current Drug regulator Safety Communications,
Refer to updates on data about Adverse Reactions (ADRs) on the Electronic Medicines Compendium
FDA Warnings and Alerts Index to drug specific information
MHRA general Drug safety updates issued by Medicines Healthcare Products Regulatory Agency
More information for Prescribers here
For a quick check of possible neuropsychiatric adverse effects refer to :British Journal of Psychiatry Published bimonthly by The Royal College of Psychiatrists,
BJPsych Advances offers a distillation of current clinical knowledge, written by expert clinicians to meet the CPD needs of consultant psychiatrists.
Nora Turjanski, Geoffrey G. Lloyd
Advances in Psychiatric Treatment Jan 2005, 11 (1) 58-70; DOI: 10.1192/apt.11.1.58
The journal includes treatment of psychiatric side-effects
Abstract
Medications often induce neuropsychiatric side-effects. This article reviews psychiatric side-effects that are well known and describes those induced by recently developed medications. Therapeutic innovations have been prominent in the treatment of HIV infection, Parkinson’s disease and epilepsy and therefore psychiatric side-effects caused by these agents are described in more detail.
Medications and herbal remedies are often implicated in the development of neuropsychiatric symptoms. Although the side-effects of established medications are well recognised, numerous new agents have been incorporated into the formulary during the past decade. For some of these drugs, neuropsychiatric side-effects were anticipated as they act by modifying neurotransmitter systems, but for others side-effects were unexpected and are still only partially understood. Toxicity may be increased by the synergistic action of drugs administered concurrently. Thus, the list of medications implicated in inducing neuropsychiatric syndromes is steadily increasing.
In this article we describe psychiatric side-effects induced by commonly used medications other than psychotropics, with emphasis on newer agents. Certain drugs are well recognised for inducing psychiatric side-effects, and we summarise them in Tables 4⇓, 5⇓ and 6⇓. Those interested to further their knowledge could refer to Brown & Stoudemiere (1998). We pay special attention to medications used to treat HIV infection, Parkinson’s disease and epilepsy. These disorders may present with psychiatric symptoms that can also be caused by the medications used to ameliorate them. The treatment of HIV infection in particular is changing rapidly and it is necessary for clinicians to keep apace with therapeutic innovations.
ADR statistics
Hospital A & E admissions showed a shocking increase over ten years. Imperial College researchers found from 1999, ADR emergency admissions to hospital, rose by 76.8%
Professor Munir Pirmohamed's studies Liverpool study of Hospital admissions due to ADRs. 80% of admissions to hospital, in this study, were due to ADRs
Psychotropic drugs have many neuropsychiatric and physical adverse effects including seizures and akathisia.
"Mostly seizure associated with antidepressant therapy is seen after an acute overdose. Doseâ€dependent seizure activity has been well recognized with imipramine, amitriptyline, clomipramine and maprotiline. Less commonly, seizures can occur at therapeutic doses and there are two case reports of seizure associated with fluoxetine at a dose of 20 mg.5,6"
1.A Oke, Adhiyaman V, Aziz K and Ross A.
Dose-depen-dent seizure activity associated with fluoxetine therapy. accessed October 2017
QJM: Monthly Journal of the Association of Physicians
2001;94:113–14.
http://qjmed.oxfordjournals.org/cgi/content/full/94/2/113
"Psychotropic drugs, especially antidepressants and antipsychotics, may give rise to some concern in clinical practice because of their known ability to reduce seizure threshold and to provoke epileptic seizures"
Effects of psychotropic drugs on seizure threshold.
Suicide risk link to prescribed medicines
In September 2010, the United States Food and Drug Administration (FDA) issued an initial draft guidance requiring prospective assessment of suicidal ideation and behavior (SIB) in clinical trials of central nervous system (CNS) active compounds under development for psychiatric and neurologic indications and in certain other conditions (e.g., obesity, smoking cessation).1 A further draft was issued in August 2012.
A review of Industry responses by the Pharmaceutical Industry
Prospective Assessment of Suicidal Ideation and Behavior: An Internet Survey of Pharmaceutical Sponsor Practices
concluded:
" results suggest that inconsistent reports of suicidal ideation and behavior within study datasets may occur and that integration of data across studies remains a concern."
Electronic Medicines Compendium contains the data sheets for all drugs licensed in the UK - insert name and look at the PIL - patient information leaflet or the SPC - Summary of Product Characteristics, which should list all adverse drug reactions (ADRs) encountered during Clinical Trials of the drug.
Pre-licensing the drug may have only been tested on men and would not cover all ethnic groups, people of different ages, or those in poor health.
Post Licensing adverse drug reactions (ADRs) data
(less than 10% of serious ADRs are reported)
Interactive Drug Analysis Profiles (iDAPs) on the Yellow Card MHRA website.
. iDAPs are provided for all licensed drugs for which we have received reports of suspected adverse reactions.
About iDAPs
Each iDAP contains complete data for all spontaneous suspected adverse drug reactions, or side effects, which have been reported on that drug substance to the MHRA, via the Yellow Card Scheme from healthcare professionals and members of the public. They also include reports from pharmaceutical companies.
iDAPs enable you to interact with the data so you can understand more about the types of reactions that have been reported, and at a high level about who experienced the side effects. Medicines are listed alphabetically by the name of the active ingredient, not by the brand name. To find the name of the active substance in your medicine, look at the patient information leaflet that was supplied with it.
DPWG Dutch Pharmacogenetics Working Group
established in 2005 by the Royal Dutch Pharmacist's Association (KNMP). The DPWG is multidisciplinary and includes clinical pharmacists, physicians, clinical pharmacologists, clinical chemists, epidemiologists, and toxicologists.
The objectives of the DPWG are:
- To develop pharmacogenetics-based therapeutic (dose) recommendations.
- To assist drug prescribers and pharmacists by integrating the recommendations into computerized systems for drug prescription and automated medication surveillance
The DPWG is funded by the KNMP.The Royal Dutch Pharmacists Association
Prescrire - an independent therapeutics journal on line run by pharmacisits and subscribed to by thousands of doctors Reliable, rigorously independent information on treatments and healthcare strategies,
to enable fully informed decision-making. Prescrire is financed by its subscribers.
No grants, no advertising. No shareholders, no sponsors
The Therapeutics Initiative UBC
The Therapeutics Initiative (TI) was established in 1994 by the Department of Pharmacology and Therapeutics in cooperation with the Department of Family Practice at The University of British Columbia with its mission to provide physicians and pharmacists with up-to-date, evidence-based, practical information on prescription drug therapy.
To reduce bias as much as possible the TI is an independent organization, separate from government, pharmaceutical industry and other vested interest groups. We strongly believe in the need for independent assessments of evidence on drug therapy to balance the drug industry sponsored information sources.
Less than 10% of serious suspected ADRs are reported - please take time to report.
Page is still in preparation.