The New Straits Times, October 11, 1999
QUALITY, safety and efficacy (QSE) are three keywords when it comes to medicinal drug therapy. In fact, they permeate through the whole pharmaceutical process.
Some 15 years ago, the principle based on QSE was firmly entrenched in the Malaysian pharmaceutical sector when the Drug and Cosmetic Regulations 1984 was promulgated.
Beginning in 1985, medicinal drug substances- poisons,non-poisons, traditional medicines and even cosmetics- were registered with the Ministry of Health.
Various systems of evaluation and testing were set up to ensure the QSE criteria complied with acceptable international standards.
As a result, the local pharmaceutical market has never been safer for ordinary consumers. The selection of products available in the country was reduced to almost half in favour of those with QSE benchmarks. Adequate monitoring and enforcement procedures were implemented to ensure that the market was well-regulated. This development is important in ensuring greater protection of public health interest.
With such assurances that only "good" drugs are available, it is time to examine another scenario, "irrational drug use". After all, quality drug protection and safe drug use belong to one continuum, with the latter being the ultimate objective. Moreover, it is now well-documented that "good" drugs can and have been badly used.
The phenomenon borders on the question of the safety of drug use. The impact could range from the occurrence of unwarranted side-effects to life-threatening mishaps leading to death. Most susceptible are children and the elderly whose physiological systems are vulnerable and fragile.
Despite the claims of competencies by many parties, irrational drug use leading to a number of drug misadventures and wastages is not as uncommon as it seems.
The strength of this view is borne out in a 1997 public opinion survey on patient safety conducted by the US National Patient Safety Foundation. The survey identified carelessness, negligence and incompetence of professional staff as the main causes of medical mistakes. Other studies also reported that millions of dollars were being wasted when drugs were improperly used, at the same putting patients at risk.
Assuming that drug-related safety practices in Malaysia are as rigorous and as responsible as that in the US, there are still avenues for mistakes.
A Penang-based cross-sectional study carried out by the National Poison Centre seems to mirror such concern. As competitiveness in health trade and practices increase, it can be assumed that the probability of irrational practices too would increase.
To quote one observation in the US from the 1940s to the 1970s, "... it was clear that harms associated with medical care were often attributable to new pharmaceuticals and to infectious agents in hospitals ...".
Therefore, regulations on safety issues related to medicinal drug products must now extend to the other end of the spectrum, namely, to ensure that "good" drugs are not badly used, misused or even abused; to reduce errors that could result in morbidity, mortality and accidents associated with drug use. In other words, to promote the rational use of drugs.
This has been an important topic of discussion that has spanned more than a decade under the auspices of the World Health Organisation.
Today, the concept of rational drug use is regarded as one of the pillars of safe drug therapy. Closely associated with this is the WHO concept of essential drugs that Malaysia is in the process of adopting as announced by the Minister of Health a few years ago. The implementation of such concepts will undoubtedly buttress public safety, and therefore should be expedited.
Then there is the Patients' Charter agreed to by the national medical, dental and pharmaceutical associations of Malaysia and Fomca. The charter must be given the rightful place in the mainstream of health care practices, and not fall into oblivion. If need be there should be legislation to back all these measures for the greater benefit of patients.
Such demonstration of political will can go a long way towards making patients and consumers into active partners of health care, who will take responsibility for their own health and are able to make informed decisions on the use of medicinal drug products. Health care professionals are an important support system.
As suggested by Ivan Illich in his book Medical Nemesis, in order to regain our health, we must regain the control now held by health professionals and medical institutions. This is the reality of health care in the new millennium as Malaysia steps into the realm of telemedicine.
