Ethically bound by the pharmaceutical code of conduct, pharmaceutical industry and hence the pharmacists are morally committed to provide standard, safe and effective medicines to the patients. Apart from the humanitarian ground it is also necessary as the drugs have direct impact on the lives of patients and no compromise is possible over the issue. Though the Indian pharmaceutical industry has got sound systems and procedures for quality management for the manufactured drug, yet in some cases, the consumer has certain apprehensions and misconceptions about safety and efficacy, especially about new drugs. Non - adherence to safety safeguards during clinical trials, off-label use of drugs and reports about prevalence of spurious drugs in the market are accountable for the distrust and misconceptions in the mind of the consumers and significantly contribute to the existing scenario.
The remedial measures to overcome such misconceptions and distrust may include the provision of effective drug regulations updated regularly and regulatory mechanisms to ensure proper screening of new drugs, continuous monitoring at manufacturer's level and in distribution network, post marketing surveillance, ADR reporting system, sampling etc. But above all the due emphasis should be there to build the trust and faith of the patients with regard to the quality, safety and efficacy of the drugs.
The issue is relevant and contemporary and is quite vital from the pharmacists’ point of view. A pharmacist may be the most ideal person to serve as a link between the patient and rest of the health care providers to build the trust in patient’s mind with regard to the safety and efficacy of the drug.
The Indian Pharmaceutical Congress organizers have continued to maintain the tradition of raising issues directly related to the well-being of patients-the ultimate target of drug therapy. This ideology is reflected by the selected theme of forthcoming 61st IPC i.e. “Pharma Vision 2020 - Building Trust in Safety and Efficacy of Medicines” which is not only appropriate and relevant but also the most contemporary topic. A drug may be ideally suited for a patient if it fulfils all necessary criteria as well as is up to the expectations of the patients. The patient may be more comfortable during treatment when he is made to believe that the particular drug is quite safe and effective for him. Health care providers, especially pharmacists, may work as a vital link to serve the purpose. It is the prime and foremost responsibility of a pharmacist to ensure that a genuine trust has been developed in patient’s mind with regard to the safety and efficacy of medicines. One should not forget that a firm belief in the minds of patients may sometimes lead to miracles also. After all it is matter of human life and its well being. We pharmacists can play a significant role in ensuring the standard, safety and efficacy of the drug as well as their rational use by focusing attention on building trust within the system comprising the patients and the rest of health care providers.
The threat of substandard drugs
The use of ineffective, poor quality, harmful medicines can result in therapeutic failure, exacerbation of disease, resistance to medicines and sometimes death. It also undermines confidence in health systems, health professionals, pharmaceutical manufacturers and distributors. Money spent on ineffective, poor quality medicines is a waste for consumers. Another major problem is that medicines are traded through several intermediaries and are sometimes repackaged and relabelled to hide their true source or identity, which can lead to the circulation of counterfeit medicines. The reality is that many low-income countries cannot ensure the safety; efficacy and quality of medicines circulating on their markets because of ineffective regulation of medicines. Treating patients with poor quality medicines results in low bioavailability and drug under-dosage, so promoting the development of resistance – one of the major threats to public health. In some countries, illegal manufacturing, distribution and smuggling of medicines are widespread.
In addition to this, there exists an ‘information asymmetry’ or ‘ lack of proper communication’ between those who manufacture the drugs and the patients who are not equipped to make independent assessments of the quality, safety or efficacy of medicines being purchased or used by them. Desperate patients may buy ineffective or even toxic medicines in order to get quick relief leading to unwanted consequences.
Quality drugs, need of the hour
In this rapidly changing global scenario, there is an immense need to focus on such issues that lead us to have safe and effective drugs which is also significant from the point of view of well being of the patients. The ultimate aim of all health care providers must be the availability of safe drugs for the patients to protect and promote the public health. The target may be achieved by ensuring the appropriateness of drug information provided to the public by health professionals. Most importantly there exists a global competition among the pharmaceutical giants to hold the market and hence there are also fare chances to have compromise over the quality and safety of the drugs.
Secondly, it is a hard truth that `trust’ factor for the drugs used by patients has been continuously being given less weightage by health care providers as it should have been. In the 21st century, the pharmaceutical industry has been posed as service marketing sector where sufficient marketing efforts should be there to cater the needs of the customer (here patient). Providing safe, efficacious and quality drugs and thereby building trust among the patients should be an integral part of the noble mission to serve the society. It can be undoubtedly said that once the customer is satisfied no one can stop the product and service to become customer friendly.
Lack of trust,the root cause
Following factors may be responsible for the distrust of patients with regard to the safety and efficacy of the drugs:
● The patients are now more aware, alert and well-informed about what is being administered to them in the form of medicines. This may be due to the increased level of literacy among them. However in India, this factor is still less contributory.
● Up-to-date drug literature is available now-a-days due to the internet and other facilities of similar nature.
● Some drug manufacturers are in the habit of making false or exaggerated claims about the drugs being manufactured by them.
● Increased advertisement and publicity of drugs have made patients suspicious about what is being administered on them.
● Increased interaction between health care providers and the patients may also raise some doubts in the mind of patients.
● Health- related articles and drug- related news published in news papers and magazines may also contribute to the doubts of the patients.
Building trust among patients
When it comes to the remedial measures, the role of health care providers becomes crucial. These are the persons having great influence on patients, the ultimate consumers of the drugs. Some suggested remedial measures to build trust among patients with regard to the quality, safety and efficacy of drugs are:
● A collective and massive approach to provide appropriate and more importantly accurate drug information to the patients keeping in mind the point that the patient should not be overloaded with the drug information to make him more confused. Only relevant drug information is needed to be given.
● Multiple and combination drug therapy should be prescribed less frequently and only where it is unavoidable. So many drugs in one prescription may add to the confusion in patient’s mind.
● Patient should not be made a part of the war between the giant competitors of pharmaceutical industry. The same thing is applicable also to the other members of the health care providers.
● Efforts should be directed to have a strong quality management system to ensure the safety and efficacy of the drugs at various levels of their development.
● The government might play an important role in achieving the target by effectively controlling and implementing various drug regulations, laws and legislations leading to the assurance of safety and efficacy of the drugs.
● Appropriate campaigns may be launched on continuous basis to educate and counsel the patients which will help in clarifying their doubts and queries.
● Tying themselves once again in the holy bond of the code of conduct and professional ethics may help the health care providers to serve the purpose. Moral commitment and dedication towards discharging the duties honestly will be helpful in this regard.
Drug regulation, a significant tool
Effective drug regulation is the backbone of the procedure to ensure the development of safe and effective drugs. The regulation should ensure that appropriate practices are followed in the development, production, supply and disposal of medicines, and that any problems are met with a quick, effective and appropriate response.
Following check points should be kept in mind for effective drug regulation:
● It should be consistent with the potential benefits and risks for the community and an appropriate risk-assessment should
be carried out before deciding about the level of regulation.
● The medicines may be subjected to pre-marketing analysis to ensure their safety and efficacy.
● An effective post-market monitoring system may be helpful to ensure ongoing assessment of safety.
● There is a need of harmonization among international rules and regulations prevailing in various countries to make the regulations more effective.
● There should be a proper understanding between pharmaceutical industry and the regulatory agency.
The role of pharmacists
A pharmacist is the core member of the healthcare provider team who has direct interaction with the patient and is the most important person to disseminate the relevant drug information to the patient to ensure the safety and efficacy of the drugs. He should shoulder the responsibility of generating trust in a patients’ mind. The significance of pharmacist in this regard is supplemented by the fact that he plays a variety of roles for the patients such as community pharmacist, hospital pharmacist, family pharmacist etc. The most important thing is that he is the most informed and knowledgeable person as far as medicines are concerned. Certain useful tips for the pharmacists in this regard may be as under:
● Establishment of drug information centres having specialization with regard to the toxic and side effects of drugs may be one good strategy to serve the purpose.
● Patients may be motivated to have consultation and counselling sessions with the pharmacists to know the genuine and hidden facts about the drug .
● Pharmacists should organize on a regular basis, awareness programmes such as seminars, symposia, conferences, exhibitions etc about drugs for the general public
● There should be a regular distribution of drug literature of some of the commonly used drugs by the patients.
● Pharmacists should emphasise on developing a quality management system strong enough to ensure the quality, safety and efficacy of the drugs.
● Academics pharmacists can play a vital role in building trust among the patients by frequently visiting the nearby localities and clarifying the doubts and queries about drugs . Students may also take part in such activities.
● Pharmacist may also contribute in this mission by publishing general as well as specific articles highlighting the adverse effects of the drugs and the remedies which may be used to overcome it.
● Retail outlet is the most appropriate place where the pharmacists may provide drug information to the patient if requested.
● The industry should try to provide information on regular basis about the novel drug delivery systems being developed by them.
● Family pharmacists should encourage the patients to have consultation with them before opting for a new drug.
● Newer branches like pharmacovigilence should be promoted and pharmacists should try to gain knowledge about this discipline.
Conclusion
The organizers of forthcoming 61st IPC deserve kudos for selecting the most appropriate and contemporary theme “Building Trust in Safety and Efficacy of Medicines” for the congress especially in the context of 21st century. Patients are the ultimate target of any drug therapy and building trust in their mind about the safety and efficacy of the drugs becomes almost mandatory. A pharmacist is the most appropriate member of the health care providing team to accomplish this herculean task. Judicious application of mind coupled with the subject knowledge and scholastic wisdom may be employed by the pharmacists for educating patients. This will help in building trust among patients in the safety and efficacy of drugs.
- The first 5 authors are faculty, D J College of Pharmacy, UP & Kamal Dua is faculty, Dept. of Pharmaceutical Technology, KL, Malaysia.