Quality pharmaceuticals and quality patient care are a sine qua non in the healthcare landscape of a nation. In both these aspects, a pharmacist plays a pivotal role and the pharmacy profession is indispensable in healthcare.
India has made a mark in the global arena by producing medicines with high quality standards. The fact that our nation has the highest number of USFDA plants and every third drug consumed by a patient globally is from India is a testimony to this. However, in the second aspect in healthcare which is giving the best in patient care, we are lagging. Now efforts are on to spruce up this front too.
In this context the theme of the 68th Indian Pharmaceutical Congress , 'Quality pharmaceuticals and patient welfare’ is quite relevant since it reinforces the indisputable fact that quality pharmaceuticals is an absolute necessity for patient welfare.
According to Dr. Rao V S V Vadlamudi, President, Indian Pharmaceutical Association and Director, St. Peter's Institute of Pharmaceutical Sciences, the scientific program developed for the 68th IPC emphasizes this view as well as a few other important aspects that play a major role in transforming the quality of pharmaceuticals in patient welfare.
“First and foremost is the intervention by a pharmacist, which is necessary to ensure that quality pharmaceuticals generate the expected outcome in the patients without producing adverse drug reactions (ADRs) or drug-drug or drug-food interactions or even fail to produce required efficacy due to improper or insufficient adherence to the dosage regimen. The second aspect could be that the quality pharmaceutical might not be the right drug of choice for the treatment and also that it might not be delivering the drug to the patient in an expected way thereby creating bioavailability issues. These issues can be addressed through understanding API-excipient interactions and designing the formulation better or deliver the drug in a specific way in small groups of patients to create patient-centric delivery,” Dr. Rao told Pharmabiz.
“At times, the drug/formulation employed is not appropriate for the disease condition due to lack of proper diagnosis or lack of access to diagnostic tools and devices. There have been cases where most of the conditions necessary for the quality pharmaceuticals to generate expected responses have been met with but the responses in patients could not be estimated due to lack of proper research methods to measure patient outcomes. All the above impact the ability of a quality pharmaceutical to produce the required quality outcome in a patient, said Dr Rao.
Indian pharmaceutical industry is on a growth curve. All generic pharma companies are expanding their business in bio-pharma looking at the future of global market. India can augment its growth in biopharmaceutical sector through R&D and innovation. The industry has witnessed a robust growth with revenues of US$ 36.7 billion in 2016 and is expected to expand at a CAGR of 15.92 per cent to US$ 55 billion by 2020. Pharmaceuticals including bulk drugs, Ayush & herbals and surgicals under the purview of Pharmexcil, has contributed 6.44 per cent to the total exports of India during financial year 2016.
Quality capability
By 2020, India is likely to be among the top three pharmaceutical markets by incremental growth and sixth largest market globally in absolute size. India’s cost of production is significantly lower than that of the US and almost half of that of Europe. It gives a competitive edge to India over others.
The country now ranks third world wide by volume of production and 14th by value, thereby accounting for around 10 per cent of the total world production and three percent by value. Globally the country ranks fourth in terms of production in terms of generic drugs and 17th in terms of total production of bulk actives and dosage forms. The exports are shipped to over 200 countries including the regulated markets of US, EU, Japan and Australia.
India has shown tremendous progress in terms of infrastructure development, technology base creation and new product development. It has now established its presence and is determined to flourish in the changing environment. The industry now manufactures bulk drugs of all therapeutic groups requiring complicated manufacturing technologies. Formulations in various dosage forms are being produced in good manufacturing practice (GMP) compliant facilities. Strong technical manpower and pioneering work done in process development has made it possible.
India with 30,000 brands and 14,000 medical devices has proved its capability in drug production and also an enabler for healthcare. With rising domestic demand and growing exports, the industry is poised for exponential growth in the near future. Presently, over 80 per cent of the antiretroviral drugs used globally to combat AIDS (Acquired Immuno Deficiency Syndrome) are supplied by Indian pharmaceutical firms.
“Branded generics dominate the pharmaceuticals market, constituting nearly 70 per cent of the market. Over-the-Counter (OTC) medicines and patented drugs constitute 21 per cent and nine per cent, respectively, of total market revenues of US$ 20 billion export to 200 countries. India is the largest provider of generic drugs globally accounting for 20 per cent of global exports in terms of volume. It enjoys an important position in the global pharmaceuticals sector. The country also has a large pool of scientists and engineers who have the potential to steer the industry ahead to an even higher level, according to the Equity Report.
Our country already has the highest number of USFDA plants and every third drug consumed by a patient globally is from India. But now it is high time that India moves to adopt 3Ds too. These are drug discovery, development of bulk drugs and medical devices. The government is making every effort to develop pharma parks and clusters to ensure that it could enable policies for taxation, infrastructure among other incentives, said Union Minister of Chemicals and Fertilisers , Ananth Kumar.
According to Dr. Mahesh Burande, ex-president, APTI, pharma consultant and Hon. Director, Institute of Pharmaceutical Education and Research , the pharmacy profession is related to healthcare. In healthcare, it is essential that one should manufacture medicines of high quality standards. On this front, India is already making a huge contribution. On the second aspect in healthcare ie to give the best in patient care, we are lacking. However, efforts are on to spruce up on this front too.
“We have started a six year Pharm D programme in 2008. Now these Pharm D students will contribute in this area by giving patient counselling, identifying the drug-drug interactions, carrying out therapeutic drug monitoring in the hospitals, going for rounds along with the doctors and discussing with them to increase or decrease the dose, identify the toxicities. These candidates will also conduct research in this area on drug-drug interactions and drug-food interactions so that the right brand is advised as all these pharmacists are working in healthcare besides put-forth suggestions to the doctor on the best therapeutic outcome, noted Dr. Burande.
According to PS Bhagavan, former registrar, KSPC and former deputy director, pharmacy, HFW Karnataka, the presence of a pharmacist in patient care is critical for therapy management . Now therapy management is an expertise in medication management. This is very much lacking in Indian hospitals. The face-to-face contact time between the doctor and patient on an average is hardly three to five minutes where as the duration of could extend from one day to several months.
The patient is left to fend himself to manage his therapy with whatever he has understood during the said 3-5 minutes of interaction.
It is difficult for the doctor also to spend time to explain and train to the full level of understanding of the patients Even the nurses are mechanically administering the drugs to the patients. It is a wonder how the system is running without complaints and without any alarming incidents said Bhagavan adding that with no record or document and channel to communicate , the patient-doctor interaction system is in mute mode where the problems continue to exist as an undercurrent.
“This being the reality one can understand why over 60 to 70 per cent of the patients are discontinuing medication midway, modify medicines on their own, changing the doctors and even coming to terms that their sickness just continues. An alarming fact is developing drug resistance which could lead to a serious complication. This is where a qualified pharmacist is much wanted because it is his domain to tackle the situation along with a medical professional, said Bhagavan.
Challenges in patient care
One of the most important challenges in the hospitals today is the need for a doctor to acknowledge a pharmacist’s sound knowledge on drugs. Once it becomes an accepted fact , the pharmacist will not be competing but co-ordinating with the medical experts in contributing to the patient care. This confidence needs to be built into the medical professionals by the doctors. Initially, there will be resistance. In India, doctors in hospitals are only perceived as the ultimate point to discuss about medication management . There is a need to ensure the acceptance of the valuable inputs provided by the pharmacists in medication management. Once hospitals recognise the role of pharmacists and experience perceivable positive patient outcomes in recovery, then patients will also be able to comprehend their expertise. Once general awareness is created in this new role, automatically posts will be created and competent candidates will be selected. Now this will make the general public prefer community pharmacy services instead of going to the hospitals on similar lines that of the developed world. In fact such initiatives have started, noted Bhagavan.
Role of D Pharm
“The diploma in pharmacy is a two-year programme. We are actually working to increase the pharmacists knowledge and hone their skills in patient welfare. While India’s population is 1.3 billion, only eight lakh pharmacists are working in the community pharmacy. Now these D Pharm qualified candidates have not been able to discharge duties like that of a Pharm D person. It will take another 10 to 15 years to get the necessary skills in patient care. We do see that a D Pharm candidate could contribute to fill the current gap of professionals in Pharm D. The diploma holders need to get the opportunity to develop such skills. They can also contribute to patient care even if they are employed at retail pharmacy outlets. There is a huge need for patient welfare and it is critical for the D Pharm candidates to be provided the adequate training,” said the former APTI president.
“Considerable efforts are made by the Pharmacy Council of India for this. In addition, many state pharmacy councils are also organising training sessions for D Pharm candidates. But the number is less and there is still a long way to reach the masses,” said Dr. Burande.
“The job of the pharmacist does not end with dispensing or selling medicine. It covers looking carefully at the prescription, viewing the patient lab report, preparing a patient profile and advisory on medication management. This should be followed up with patient counselling which has popularised community pharmacy. Besides, pharmacists role in preventive care, emergency and in disaster management are of utmost importance. Even the mandate of Pharmacy Practice Regulation 2015 is the updation of skill development , noted Bhagavan.
Global scenario
“India is no way comparable with the developed countries like the US, EU, Japan and Australia. We lag behind in community pharmacy services and lot of improvement is required. We need enter into the one in 50 rank in the next five years. By the next 15-20 years, India should try to be among the first 10 countries in community pharmacy services,” stated Dr. Burande.