Modern medicines have changed the way in which diseases are managed and controlled. However, despite all their benefits, evidence continues to mount that adverse reactions to medicines are a common, yet often preventable, cause of illness, disability and even death. In some countries, adverse drug reactions (ADRs) rank among the top 10 leading causes of mortality. Aside from the intrinsic dangers associated with the products themselves, individual patients may exhibit particular and unpredictable sensitivities to certain medicines. In addition, if more than one medicine is prescribed, there is always a risk of negative interactions.
This is where the science of detection, assessment, understanding and prevention of ADRs which is popularly known as Pharmacovigilance aka PV, pitches in.
Within the last decade, there has been a growing awareness that the scope of pharmacovigilance should be extended beyond the strict confines of detecting new signals of safety concerns. Globalization, consumerism, the explosion in free trade and communication across borders, and increasing use of the Internet have resulted in a change in access to all medicinal products and information on them. These changes have
given rise to new kinds of safety concerns such as(1)
- Illegal sale of medicines and drugs of abuse over the Internet
- Increasing self-medication practices
- Irrational and potentially unsafe drug donation practices
- Widespread manufacture and sale of counterfeit and substandard medicines
- Increasing use of traditional medicines outside the confines of the traditional culture
- Increasing use of traditional medicines and herbal medicines with other medicine with
potential for adverse interactions.
WHO defines sets of practices for safe use of medications to prevent ADRs. They are very widely known as 5Rs. The 5Rs are:
- The right dose
- The right medication
- The right patient
- The right route
- The right time
It is a good practice to write down the new medication when the doctor starts a new one. Any additional instructions being directed may also be worthwhile to note. This avoids the chances of patient mistaking the old drug for the new one.It may be worthwhile to even check the dose, strength are the same as defined in the prescription.
Some medications have specific storage requirements to preserve their effectiveness. Insulin, some liquid antibiotics, and several other medications need to be refrigerated. Any type of medication in the form of a suppository will need to be stored in a cool place to keep them from getting too soft. Nitroglycerin needs to be protected from sunlight. It is also very important to store all the medications in their original containers. Pill cases seem like they would be convenient, and probably are, but once they are filled up it can be confusing to tell the medications apart. It is just much safer, if a little less convenient, to keep all the medicines in their own bottles.
If a medication is ordered to be given orally, that means patient will need to swallow it. If swallowing pills is a problem for patient it may requested to be prescribed in a liquid form. It is not an advisable practice to crush a medication and put it in something, like applesauce, unless the doctor, nurse, or pharmacist confirms that it is fine.. Some medications are extended release, meaning that they give a set dose of medication at regular intervals throughout the day. Crushing these types of pills would allow a large dose of medication to be delivered all at once.
It is very important the duration and frequency patterns that are defined by the clinicians are adhered to. Duration of a prescribed drug should always be stuck to, for example, antibiotics require a course to be completed for the treatment to be effective. Similarly if a drug is prescribed to be taken in the morning and in the night, care should be taken to stick to the times since the nature of drug may require the interval between the two doses.
Earlier the purview of concern was only around the allopathic medicines. Recently, its concerns have been widened to include: (2)
- Traditional and complementary medicines
- Blood products
- Medical devices
It is very crucial to report any Adverse Drug Reactions(ADRs) to the clinician immediately so that a replacement or substitute drug may be prescribed and the same may be avoided in the future. Here Pharmacovigilance has an essential role to play.
Safety monitoring of medicines in common use should be an integral part of clinical practice. The degree to which clinicians are informed about the principles of pharmacovigilance, and practice according to them, has a large impact on the quality of health care. Education and training of health professionals in medicine safety, exchange of information between national pharmacovigilance centres, the coordination of such exchange, and the linking of clinical experience of medicine safety with research and health policy, all serve to enhance effective patient care. A regular flow and exchange of information in this way means that national Pharmacovigilance programs are ideally placed to identify gaps in our understanding of medicine-induced diseases.
1. WHO Library Cataloguing-in-Publication Data
2. Meyboom RHB, Egberts ACG, Gribnau FWJ, Hekster YA. Pharmacovigilance in perspective. Drug Safety 1999; 21(6): 429-447. Abbing HDCR. Legal aspects of medical devices: Study on regulatory mechanisms for safety control. Health Services Research. IOS Press 1993: 358-361. Fracchia GN, Theofilatou M (eds); Mehta U,
Milstien JB, Duclos P, and Folb PI. Developing a national system for dealing with adverse events following immunization. Bulletin of the World Health Organization 2000, 78(2), 170-177. Craven BM, Stewart GT, Khan M. Chan TYK. Monitoring the safety of herbal medicines. Drug Safety 1997; 17(4): 209-215.