AN adverse drug reaction (ADR) is an unintended and noxious effect experienced after the consumption or administration of a drug or substance for an ailment or disease. All drugs have side effects but are only recommended when the benefits outweigh the risks. Most times pronounced ADR effects are picked up only after a hospital admission or forensic report in the event of a fatality.

However there are numerous milder incidences which are unreported and undocumented since the framework for pharmacovigilance is not reinforced. Although the relevant institutions exist, the collaboration among agencies and the mandatory annual reports and reviews on ADR are overlooked. A show of hands would indicate how many, if any, ADR reports have been routinely submitted to the regulatory authorities by health professionals during their years of practice.

The COVID-19 vaccine administration activity gave us a glimpse of observation for adverse events, 15 minutes after administration. However shortage of health care professionals during this observational period hindered efficient official documentation. Noteworthy, in the more developed countries these ADR reports were mandatory to complete the process, where vaccines were administered by pharmacists.

The pharmacovigilance authorities, councils, committees and associations not only supposed to play an integral role in making effective and safe medicines available to the general public but are supposed to make official submissions to the regulatory agency. Those tasked with such responsibilities are the Drug Manufacturers, Licence Holders, Importers and Distributors, Pharmacovigilance Center, Pharmacy and Therapeutics Committee, Regulatory Authority, Professional Associations and Councils, Bureau of Standards, Consumer Association and the Media.

Accountability and transparency were the watchwords for the good constituency of statutory membership for these agencies so that informed, documented and signed off decisions made on drug rationalisation and the banned list of drugs must be traceable and archived for any future references. This list should be publicised for all the players in the health profession and the general public where the relevant information should be posted on the regulatory website. In this way pharmacovigilance management can be enhanced by both top down and bottom up approaches.

In the UK there is a yellow card reporting system which has been instituted since 1964. It was monitored by the Commission on Human Medicines (CHM) but now by the Medicines and Healthcare products Regulatory Agency (MHRA). ADR reporting is monitored in Europe by the European Medicine Agency (EMA) under EudraVigilance operational plan using an electronic system whilst still maintaining patient confidentiality.

In those countries where pharmacovigilance is observed there are various types of reports submitted:
* Anecdotal reporting which is usually initiated by the doctor when the patient suffers an effect.
* Impulsive reporting which is most efficient since it is spontaneous and highlights unusual and acute ADR.
* Intensive monitoring studies which are designed for a selected patient group to continuously watch and screen for ADR; special investigations can be performed if statistical screening is incorporated.
* Other types of reporting are contingent studies, case-control studies (retrospective studies), case cohort studies, record linkage, meta-analysis and utilisation of resident’s statistics.
Apart from budgetary implications there are some additional benefits of ADR reporting:
* It measures those predictable ADR and may help prevent some of the ADR.
* It heightens ADR awareness among all levels of health care professionals
* It establishes a risk-management plan or protocol.
* It assures quality and safety.
* It enhances acceptance to treatment protocol because the patient feels that his/her concerns are validated; for example the numerous queries on vaccines for COVID-19.

ADR can be reported on all categories of drugs such as prescription only medicines (POM), over the counter (OTC), vaccines, natural or complimentary products. There are various ADR categories to be considered namely:
* Children
* Elderly
* Medication efficacy
* Concomitant use with complimentary or natural medicines
* Delayed drug effects
* Interactions
* Medication Errors
* Overdose
* Related effects in pregnancy and breast feeding
* Serious adverse effects
* Product Quality Assurance
* Teratogenicity and congenital anomalies

You are encouraged to report all ADR especially in children, pregnancy and the elderly.
The following details are required:
* Patient information such as the patient’s initials, a traceable unique identifier to the patient from the treating institution but anonymous otherwise (such as a hospital number or a file number), gender, age and weight of the patient.
* The details of the medicine in question such as the name, dose, therapy date, indication, batch or lot number and expiration date.
* The reaction that has occurred i.e. a full description of the reaction, onset date of the reaction, the reaction outcome after medication was reduced or stopped and any episode due to repeated exposure.
* Information on the reporter such as the name or initials, email or telephone contact, occupation and name of health institution or health facility

With the current information age, such available templates can be modified for the relevant information requests in our local setting. The amended version could be adopted and piloted in a small sample size before rolling out for official use.

Documentation is key for change to occur in the system. Who are the front line healthcare professionals who are obligated to report such incidences? They are the doctors, pharmacists, nurses, other health care workers involved in the dispensation or administration of medicines and the consumers. Their responsibility include documentation of any pronounced side effect or suspected side effect in details and immediately forwarded to the relevant agencies for data collation, evaluation, casualty analysis and risk determination by the regulatory authorities.

A track and trace system with batch or lot number for each product, starting from the manufacturer and supplier and down the supply chain to the individual patient, is vital especially in the event of a drug recall.
For a legally registered drug, there is an expected side effect profile that is established during the clinical trials. On the other hand, their counterfeit equivalent and substandard medications containing all kinds of adulterated substances sometimes toxic, such as chalk, paint, brick dust, sheetrock and flour may cause other undocumented problems, hence the need to report.

For further pharmacological guidance, contact the pharmacist of Medicine Express PHARMACY located at 223 Camp Street, between Lamaha and New Market Streets. If you have any queries, comments or further information on the above topic kindly forward them to medicine.express@gmail.com or send them to 223 Camp Street, N/burg. Tel #225-5142.