Editing Adverse effect (section)

==Reporting systems==
In many countries, adverse effects are required by law to be reported, researched in [[clinical trial]]s and included into the patient information accompanying [[medical device]]s and [[drug]]s for sale to the public. Investigators in human clinical trials are obligated to report these events in [[clinical study report]]s.<ref>{{cite web | author=Expert working group (efficacy) of the international conference on harmonization of technical requirements for registration of pharmaceuticals for human use | title=Guideline for Industry Structure and Content of Clinical Study Reports. | url=https://www.fda.gov/cder/guidance/iche3.pdf | date=August 25, 2007 | publisher=FDA Center for Drug Evaluation and Research | url-status=dead | archive-url=https://web.archive.org/web/20090525082254/https://www.fda.gov/cder/guidance/iche3.pdf | archive-date=May 25, 2009 }}</ref> Research suggests that these events are often inadequately reported in publicly available reports.<ref>{{cite journal | vauthors = Ioannidis JP, Lau J | title = Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas | journal = JAMA | volume = 285 | issue = 4 | pages = 437–43 | year = 2001 | pmid = 11242428 | doi = 10.1001/jama.285.4.437 | s2cid = 14529735 | doi-access =  }}</ref> Because of the lack of these data and uncertainty about methods for synthesising them, individuals conducting [[systematic review]]s and meta-analyses of therapeutic interventions often unknowingly overemphasise health benefit.<ref>{{cite journal | vauthors = Chou R, Helfand M | title = Challenges in systematic reviews that assess treatment harms | journal = Annals of Internal Medicine | volume = 142 | issue = 12 Pt 2 | pages = 1090–9 | date = June 2005 | pmid = 15968034 | doi = 10.7326/0003-4819-142-12_part_2-200506211-00009 | s2cid = 22188119 | doi-access =  }}</ref> To balance the overemphasis on benefit, scholars have called for more complete reporting of harm from clinical trials.<ref>{{cite journal | vauthors = Ioannidis JP, Evans SJ, Gøtzsche PC, O'Neill RT, Altman DG, Schulz K, Moher D | title = Better reporting of harms in randomized trials: an extension of the CONSORT statement | journal = Annals of Internal Medicine | volume = 141 | issue = 10 | pages = 781–8 | date = November 2004 | pmid = 15545678 | doi = 10.7326/0003-4819-141-10-200411160-00009 | s2cid = 17032571 | author3-link = Peter C. Gøtzsche }}</ref>

===United Kingdom===
The [[Yellow Card Scheme]] is a [[United Kingdom]] initiative run by the [[Medicines and Healthcare products Regulatory Agency|Medicines and Healthcare products Regulatory Agency (MHRA)]] and the [[Committee on Safety of Medicines|Commission on Human Medicines (CHM)]] to gather information on adverse effects to [[Pharmaceutical drug|medicines]]. This includes all licensed medicines, from medicines issued on [[prescription drug|prescription]] to medicines bought [[over-the-counter drug|over the counter]] from a supermarket. The scheme also includes all [[herbalism|herbal supplement]]s and unlicensed medicines found in cosmetic treatments. Adverse drug reactions (ADRs) can be reported by a number of health care professionals including [[physician]]s, [[pharmacist]]s and [[nurse]]s, as well as [[patient]]s.

===United States===
In the [[United States]] several reporting systems have been built, such as the [[Vaccine Adverse Event Reporting System]] (VAERS), the Manufacturer and User Facility Device Experience Database (MAUDE) and the Special Nutritionals Adverse Event Monitoring System. [[MedWatch]] is the main reporting center, operated by the [[Food and Drug Administration (United States)|Food and Drug Administration]].

===Australia===
In [[Australia]], adverse effect reporting is administered by the [[Adverse Drug Reactions Advisory Committee]] (ADRAC), a subcommittee of the [[Australian Drug Evaluation Committee]] (ADEC). Reporting is voluntary, and ADRAC requests healthcare professionals to report all adverse reactions to its current drugs of interest, and serious adverse reactions to any drug. ADRAC publishes the Australian Adverse Drug Reactions Bulletin every two months. The Government's [[Quality Use of Medicines]] program is tasked with acting on this reporting to reduce and minimize the number of preventable adverse effects each year.

===New Zealand===
Adverse reaction reporting is an important component of New Zealand's [[pharmacovigilance]] activities. The [https://nzphvc.otago.ac.nz/carm/ Centre for Adverse Reactions Monitoring (CARM)] in Dunedin is New Zealand's national monitoring centre for adverse reactions. It collects and evaluates spontaneous reports of adverse reactions to medicines, vaccines, herbal products and dietary supplements from health professionals in New Zealand. Currently the CARM database holds over 80,000 reports and provides New Zealand-specific information on adverse reactions to these products, and serves to support clinical decision making when unusual symptoms are thought to be therapy related

===Canada===
In Canada, adverse reaction reporting is an important component of the surveillance of marketed health products conducted by the Health Products and Food Branch (HPFB) of Health Canada. Within HPFB, the Marketed Health Products Directorate leads the coordination and implementation of consistent monitoring practices with regards to assessment of signals and safety trends, and risk communications concerning regulated marketed health products.

MHPD also works closely with international organizations to facilitate the sharing of information.  Adverse reaction reporting is mandatory for the industry and voluntary for consumers and health professionals.

===Limitations===
In principle, medical professionals are required to report all adverse effects related to a specific form of therapy. In practice, it is at the discretion of the professional to determine whether a medical event is at all related to the therapy. As a result, routine adverse effects reporting often may not include long-term and subtle effects that may ultimately be attributed to a therapy.<ref>{{cite journal |last1=Bailey |first1=C |last2=Peddie |first2=D |last3=Wickham |first3=ME |last4=Badke |first4=K |last5=Small |first5=SS |last6=Doyle-Waters |first6=MM |last7=Balka |first7=E |last8=Hohl |first8=CM |title=Adverse drug event reporting systems: a systematic review |journal=British Journal of Clinical Pharmacology |date=July 2016 |volume=82 |issue=1 |pages=17–29 |doi=10.1111/bcp.12944 |pmid=27016266 |pmc=4917803}}</ref>

Part of the difficulty is identifying the source of a complaint. A headache in a patient taking medication for [[influenza]] may be caused by the underlying disease or may be an adverse effect of the treatment. In patients with end-stage [[cancer]], death is a very likely outcome and whether the drug is the cause or a bystander is often difficult to discern.{{Citation needed|date=February 2011}}