Guide to ADR Reporting | ADR Form

The Nigeria Pharmacovigilance Programme is coordinated by the National Pharmacovigilance Centre (NPC) which is located in NAFDAC and collaborates with the Uppsala Monitoring Centre (UMC) and other national centers worldwide. NPC is responsible for monitoring the safety of all medicines in Nigeria. The National Pharmacovigilance Centre will be assisted as the case requires by a National Advisory Committee comprising of experts from various fields of healthcare.The National Pharmacovigilance Centre is responsible for providing reporting forms, collecting, evaluating and communicating the findings from ADR reports to the management of NAFDAC, who may communicate same to council for ratification.

NAFDAC uses the findings from the reports for making regulatory decisions on how to prevent or minimise the risk of ADRs in Nigeria. NAFDAC, through the National Pharmacovigilance Centre, may communicate their findings, recommendations and directives to appropriate organisations or individuals. These include, but are not limited to health professionals, pharmaceutical manufacturers, public health programmes within the Federal and State Ministries of Health, other public and private health institutions, the media and the public.

Aims of Pharmacovigilance

• Early detection of inc-reases in frequency of previously unknown adverse reactions and interactions and other noxious drug induced problems.
• Detection of increase in known adverse reactions.
• Identification of predi-sposing risk factors and possible mechani-sms underlying adver-se reactions.
• Estimation of quantit-ative aspects of risk benefits analysis and dissemination of infor-mation needed to imp-rove drug prescribing, use and regulation.

Goals

• To assess and communicate risk and benefits of drugs on the market.
• To promote rational and safe use of medicines.
• Educate and inform the patient.

How Drug Saftey is Assurred

All drugs undergo a significant amount of testing and evaluation before marketing to ensure their effectiveness as well as safety. Marketed drugs undergo trials in animals (pre-clinical testing) and humans (clinical trials) to establish their efficacy, safety, and quality.

Pre-marketing evaluation

Pre-marketing evaluation involves animal studies and clinical trials in humans. Studies in two or more animal species are conducted to test whether the drugs are harmful and whether they may for instance induce cancer, damage an unborn child etc. Once scientists are sure that the drug is safe, they start studies in human beings and these studies are known as Clinical Trials.
Pre-marketing clinical trials take place in three phases – phases I, II and III. These trials are studies of the effects of drugs on humans under rigorously controlled conditions. All clinical trials will assess safety of the drug in question. A brief description of each phase of clinical trial is given below:

• Phase I—Single dose studies in healthy volunteers, using low doses of the drug. Subsequently, larger doses and multiple sequences are evaluated.
• Phase II—Efficacy is the primary objective of phase II trials, but safety is also continuously monitored and evaluated.
• Phase III—Evaluations of safety in groups of patients with the disease.

Each phase involves increasing number of patients and by the end of full pre-marketing clinical trials about 5000 patients would have taken the drug. However, when the drug is marketed millions of people will take the medicine. There is therefore the question of whether clinical trials involving just about 5000 people provide enough information to extrapolate the safety of a new drug to millions of people. Pre-marketing safety evaluations have two significant drawbacks:

• Under-identification of adverse drug reactions: ADRs which occur infrequently are difficult to identify. Statistically, reactions with an incidence of less than 1% are frequently not identified.
• Over-identification of ADRs:Many adverse drug reactions that are identified in pre-clinical studies are not proven to be related to the drug, but are nevertheless listed in the product literature as potentially causing the ADR. This provides some measure of legal protection for the pharmaceutical company but is misleading to practitioners and patients, as many of these reactions are not definitely proven.
• Post-marketing Surveillance (PMS):It is not possible to have identified all of the safety-related problems that may exist with a new drug during pre-market testing and evaluation. After drugs have been released on the market, NAFDAC, the manufacturers/importers and health care professionals are responsible for post-marketing surveillance of these products. Drugs released to the market will be used not only by more people, but also by different categories of people other than those in whom the drug was tested. The marketed drug will be used by older people, those with more serious illness, those from different ethnic groups, pregnant women and also by children in whom drugs are rarely tested. The medicines may also be used under many different dose regimens (not necessarily the correct and approved dose) and they could also be deliberately misused. These circumstances inevitably lead to a potential for more adverse drug reactions. For these reasons, it is obvious that the safety of a drug requires long-term surveillance after marketing.

One of the most common methods of PMS is Spontaneous Reporting using approved forms. In Nigeria, the NPC issues Spontaneous Reporting Forms which health care professionals should use to report any suspected adverse drug reaction. Copies of the form can be obtained directly from any health institution, NAFDAC offices nationwide or directly from the National Pharmacovigilance Centre, NAFDAC Headquarters, Abuja.

Definition of Terms

• Drug or Medicine: A pharmaceutical product, used in or on the human body for the prevention (prophylaxis), mitigation, diagnosis and/or treatment of disease, or for the modification of physiological function. This definition includes prescribed medicines, over-the-counter medicines, vaccines, herbal medicines, traditional medicines and Biologicals including blood and blood-related products e.g. sera, plasma etc.
• WHO's Definition for ADR: “a response to a medicine which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function”.What is important in this definition is that a patient experiences an unwanted and/or harmful (noxious) reaction following drug therapy. Individual factors may play an important role but the key point is that the phenomenon experienced is noxious. An ADR is essentially a “bad” reaction suffered by the patient and differs from “side effect” which is essentially an unexpected therapeutic response – which is related to the pharmacological properties of the drug and may be “good” or “bad”.
• Unexpected Adverse Reaction: ‘an adverse reaction, the nature or severity of which is not consistent with domestic labelling or market authorisation, or expected from characteristics of the drug’.
• Adverse Event: Any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with this treatment.
  The basic point here is that an unwanted event occurs during or after the use of a drug. The term “adverse event” is a broad one encompassing “adverse drug reactions”, caused by the drug; and other unwanted reactions, the time of occurrence of which may be related to the use of the drug but are not caused by the drug.
• A Serious Adverse Experience: any untoward medical occurrence that at any dose:
  • results in death,
  • is life-threatening,
  • requires patient hospitalisation or prolongation of existing hospitalisation,
  • results in persistent or significant disability/incapacity,
  • causes a congenital anomaly or birth defect,
  • requires an intervention to prevent permanent impairment or damage.
• Side Effect: Any unintended effect of a pharmaceutical product occurring at doses normally used in humans, which is related to the pharmacological properties of the drug.Such effects may or may not be beneficial. Side effects are related to the known properties of the drug and can often be predicted. It must be stressed that in Pharmacovigilance we are interested in all drug related reactions – this includes side effects and suspected adverse drug reactions. Health professionals must therefore report all drug related problems to the National Pharmacovigilance Centre.
• ADR Case Report: A case report in Pharmacovigilance is a notification relating to a patient with an adverse medical event or laboratory test abnormality suspected to be induced by a medicine. It is important to stress that healthcare workers should send reports of ADRs even if they do not have all the information required.
• Signal: A SIGNAL refers to “Reported information on a possible causal relationship between an adverse event and a drug; the relationship being known or incompletely documented previously.” Usually more than a single report is required to generate a signal, depending upon the seriousness of the event and the quality of the information.
• Pharmacovigilance: Pharmacovigilance is the science and activities relating to the knowledge, detection, assessment and prevention of adverse effects or any drug-related problem.

Rationale for Pharmacovigilance

Drug safety monitoring gained world-wide attention following the thalidomide incident in the 1960s. Thalidomide was a drug given to pregnant women to prevent “morning sickness”. The babies born to some of these women were badly deformed and it took a while before the link between the deformed babies and the drug was made. Once this link was established the drug was banned and regulatory authorities all over the world became aware of the fact that seemingly safe drugs could have potentially serious adverse effects. The WHO therefore called for closer monitoring of the adverse effects of all drugs.
By continuously monitoring all drugs used in Nigeria, it is possible to detect any drugs causing unwanted ADRs and to control them. This can only be done effectively if health care professionals report all suspected ADRs to the National Pharmacovigilance Center.
The effectiveness of any Pharmacovigilance activity is dependent on the active participation of all health professionals. Health professionals are in the best position to report suspected ADRs observed in their every day patient care. All health care professionals should report suspected ADRs as part of their professional responsibility, even if they are doubtful about the precise relationship between the reaction and the given medication. NAFDAC on its part assures the safety of all products before registration. However, some safety issues only come up after registration when the product is in use. There is therefore need for continuous monitoring for further safety assurance.

The magnitude of the problem

It has been demonstrated by a number of studies that medicine induced morbidity and mortality is a major problem of which health professionals and the general public are becoming increasingly aware. It has been estimated that ADRs are the 4th to 6th largest cause of death in the USA.1 Studies conducted in developed countries have consistently shown that approximately 5% of hospitalised patients are admitted into hospital as a result of an ADR while 6-10% of in-patients will experience a serious ADR during hospitalisation. ADRs cause the death of several thousand patients each year. The percentage of hospital admissions due to ADRs in some countries is about or more than 10%.2,3,4

• Norway 11.5%
• France 13.0%
• UK 16.0%

Even these startling figures do not represent the whole picture. These studies generally excluded ADRs caused by other drug related problems such as, overdose, drug abuse, misuse, poisoning, medication errors and therapeutic failures.
In addition, treatment of ADRs imposes a high financial burden on health care. Some countries spend up to 15-20% of their hospital budget dealing with drug complications.5

What is the Size or Severity of the ADR Problem in Nigeria?

While no studies have comprehensively assessed the burden of adverse drug reactions on health care, it is likely that the problem is considerable in Nigeria. There is very limited information available on ADRs. However, the National Drug Policy recognises the need for a pharmacovigilance programme in Nigeria, to deal with widespread irrational drug use, including, preference for injections, misuse of antibiotics and other prescription drugs, unstandardized use of orthodox and traditional/herbal medicines and extensive self medication.

The circulation of substandard and counterfeit medicines in Nigerian, lack of independent information on drugs other than that from the pharmaceutical industry and the irrational use of drugs, compound the likelihood of a higher incidence of ADRs.
Effective pharmacovigilance activity will enable Nigeria to develop a good record keeping habit and build a useful safety information database that will improve the quality of health care offered to the patient.

Why is Pharmacovigilance (PV) needed in Nigeria?

The information which we receive on adverse effects of drugs in other countries may not be relevant or applicable to Nigeria due to various differences that may influence patient’s response including;

• Diseases and prescribing practices
• Treatment seeking behaviour e.g. self medication
• Genetics, diet, traditions of the people e.g. high carbohydrate,fat, etc diet, kola nut consumption etc
• Drug manufacturing processes used which influence pharmaceutical, quality and composition
• Drug distribution and use including indications, dose, storage and availability
• The use of traditional and complementary drugs (e.g. herbal remedies) which may pose specific toxicological problems, when used alone or in combination with other drugs
• Racial differences

Data derived from within the country may have greater relevance and educational value and can assist NAFDAC to make evidence-based decisions. Information obtained in one country (e.g. the country of origin of the drug) may not be relevant to other parts of the world, where circumstances may differ.
ADR monitoring is to help ensure that patients obtain safe and efficacious drugs and other pharmaceutical products. Drug monitoring while being of tremendous value as a tool for detecting ADRs is specifically important in relation to detection and prevention of counterfeit and substandard products in clinical practice.

It is essential that a monitoring system for the safety of medicines in Nigeria is supported by doctors, pharmacists, nurses and other health professionals in order to prevent unnecessary suffering, and decrease the financial loss sustained by the patient due to ADRs and inappropriate or unsafe use of medicines.

NAFDAC is committed to improving drug safety through adverse drug reaction monitoring in Nigeria. The National Pharmacovigilance Centre (NPC) in NAFDAC shall make, the Spontaneous Report Form available at all times. Health professionals are expected to report adverse reactions, lack of effectsand other drug problems on a daily basis as a professional and moral obligation.

The National Pharmacovigilance (Drug Safety Monitoring) Centre (NPC), NAFDAC, Nigeria will be grateful to receive your comments and suggestions on how to further make this website more useful. Please email us @ nafdac_npc@yahoo.com

Contact Information

The National Coordinator,
National Pharmacovigilance Centre (NPC)
National Agency for Food and Drug Administration and Control
Plot 2032 Olusegun Obasanjo Way, Wuse Zone 7, Abuja,
PMB 5032 Wuse Abuja
Telephones: +234-(0)9-6702823; +234-(0)8037863048
Fax: +234-(0)9-5241108
E-mail: nafdac_npc@yahoo.com
Web Site http://www.nafdacnigeria.org/pharmacovigilance.html