Most patients have inadequate pain relief because of inappropriate dose or quality of the drug is not good


 Public Awareness Session by MKMS/Jang Group and Novartis Pharma

Most patients have inadequate pain relief because of
inappropriate dose or quality of the drug is not good

Pain relief will improve sleep, mobility and functions-Dr. Amin Chinoy

Expert’s panel supports the availability of cost effective
quality drugs to ease human sufferings

KARACHI: Mir Khalilur Rehamn Memorial Society and Jang Group of Newspapers in collaboration with Novartis Pharma organized a public awareness session on “Role of quality and originalMedicines in healthcare Practices” at Karachi on January 29th 2016. Dr. Qaiser Mahmood Chief Drug Inspector of Sindh was the chief guest on this occasion while the main invited guest speaker was Prof. Amin Chinoy consultant orthopaedic surgeon at Indus Hospital, Karachi who is also President of Pakistan Orthopaedic Association. Experts panel consisted of Prof. Noorul Haque from Dept. of Anesthesia, Pain Management from Karachi Medical and Dental College, Prof. Pervez Anjum former President of Pakistan Orthopaedic Association, Dr. Asher Afaq from Dow Int. Dental College, Dr. Sarwar Jamil Siddiqui consultant neurologist from Aga Khan University Karachi, Dr. Sughra Parveen Consultant Surgeon from JPMC, Dr.Samir Qureshi ENT Surgeon from Jinnah Sindh Medical University and Dr.Sumbal Sohail Obstetrician and Gynaecologist from Karachi Medical& Dental College, Karachi.

Mr. Asif Nagi Moderator of the session in his introductory remakes said that role of quality drugs is important in healthcare.  Doctors, Patients and the Drugs are part of a triangle and if the healthcare professionals prescribe potent and effective drugs, only then the human sufferings can be effectively controlled and patients will benefit. In Pakistan we have a very low literacy rate hence general public cannot differentiate between quality drugs and sub-standard medications. Hence it is important to create awareness among the public on this issue. That is why Mir Khalilur Rehman Memorial Society and Jang Group of Publications have organized this meeting in collaboration with Novartis Pharma.

Mr. Mansoor Jafary from Novartis speaking at public awareness session on “Role of quality and original
Medicines in healthcare Practices”. It was organized by Mir Khalilur Rehamn Memorial Society and Jang
Group of Newspapers in collaboration with Novartis Pharma at Karachi on January 29th 2016. Picture
also shows members of the expert panel including guest speaker Dr. Ameen Chinoy sitting on the dais.

Dr. Amin Chinoy’s presentation was on “Current therapy in chronic pain management: Physician’s perspective”.  To begin with, he said that he was a member of the consultant’s team at Indus Hospital which gives too much emphasis to quality of care. It is a pleasure to be elected as President of Pakistan OrthopaedicAssociation. and now we have also become member of Asia-Pacific Orthopaedic Association. It will provide trainingopportunities to the young orthopaedic surgeons, he added.

Chronic pain, he said is defined as moderate to severe intensity pain lasting for more than three months. One in five persons will suffer from pain in their life time. Pain has most negative impact on daily living, healthcare use, quality of life and cost. The various disabilities it causes include low back pain, neck pain, osteoarthritis and migraine.  Most of the patients have inadequate pain relief because either the dose of the drug is inappropriate or quality of the drug is not good. This results in significant increase in the cost of healthcare.

Dr. Amin Chinoy then spoke at length on whypatients do not respond to drugs, how much pain relief is considered well, how well pain is treated, risk and benefit of prescription drugs and their side effects. After twelve weeks therapy almost 50% of patients suffering from acute pain do get relief. Response to the Non-Steroidal Anti-Inflammatory Agents, (NSAIUDs) is very good and very poor. In some patients pain relief in neuropathic pain is not so good. Musculoskeletal  disorders are most common.  Pain relief will improve sleep, mobility and functions. The drugs used for pain relief include analgesics/Paracetamol, NSAIDs and Opioids. NSAIDs have the disadvantage of side effects like GI bleeding, fractures, but they are very effective in pain relief as compared to other drugs.

He then highlighted the salient features from Network Meta-Analysis which has showed that Diclofenac is the most effective drug in pain relief. In different studies Diclofenac 150mg was compared with Celecoxib 200mg and the withdrawal of therapy due to some adverse events was greater in celecoxib group. In another study Diclofenac 150mg was compared with Ibuprofen 2400mg. Safety was better in diclofenac group. He emphasized the fact that one has to use the therapeutic dose to get some results in pain relief. Diclofenac was also compared with Naproxyn and both were quite safe and effective. Opioids are also quite effective and it is recommended that they should be used but they have certain risks like dizziness etc.

Continuing Dr. Amin Chinoy said that pain relief was the most unmet need of the patients. Management of pain should be undertaken with effective drugs. He suggested individualized and personalized management of pain in patients to get good results as no single drug or therapy will be found effective in all the patients.

Dr. Suhaib Ahmad Jafri Medical Advisor from Novartis was the next speaker who talked about Pharmacovigilance, availability, cost effectiveness, efficacy and quality of drugs. He pointed out that it takes ten to fifteen years of research to find a molecule which can be marketed. There are different stages of drug trials i.e. Stage 1,2,3 and four and billions of dollars are spent by the research oriented pharmaceutical companies to find out and market an innovative safe and effective molecule. That is why they are given some protection in the shape of patent rights so that they can recover their investment. On one side we have research molecules and on the other hand we have Bioequivalence Generics. Some of the national pharmaceutical companies, he alleged, market generics without conducting any bioequivalence studies. He also referred to the Thalidomide tragedy wherein use of a drug meant for insomnia was used for off label indications to treat early morning sickness by pregnant women in the early three months in Europe. It resulted in birth of thousands of babies with congenital malformations. Limbs of these babies were missing or were not fully developed. While this drug was used in Europe for morning sickness, it was not approved, not registered and used in USA hence the population there were saved.  As a result the lady in FDA who despite lot of pressure did not give approval for its marketing in American Market was honoured by President John F. Kennedy. He also referred to the tragedy of Punjab Institute of Cardiology which resulted in the death of over one hundred fifty precious lives because of mix up of anti-malarial raw material with another drug used in cardiovascular diseases.

The drugs Dr. Suhaib said can be divided in to Research Molecules, Bioequivalence Generics, Sub-standard Generics and Counterfeit drugs.  The latter two are the worst as they may not contain drug at all. In Novartis, we have started Pharmacovigilance and Adverse Drug Reporting and physicians, patients are encouraged to inform of any adverse events with the use of Novartis drugs, he added.

Dr. Qaiser Mahmood in his brief presentation said that we have quality control laboratories which are functioning in all the provinces which ensure quality of the drugs before they are marketed. The number of drug manufacturers was just seven hundred and fifty and not nine thousand as stated by Mr. Asif Nagi and now all the drug manufacturers are located in industrial areas and not residential areas. Furthermore drug inspectors are also doing their job, Pharmacovigilance work is also going on and a Directorate of Pharmacy has been established in Sindh province, he added.

Dr. SughraParveen said that we have too many “me too” drugs but while prescribing quality drugs should be preferred. In order to ensure patient safety and adequate relief, quality of drugs should always be kept in mind while writing a prescription. Prof. Pervez Anjum from ASH and KM&DC remarked that patients should be advised to buy drugs from a reputable pharmacy rather than drug stores set up everywhere. Dr. Sarwar Jamil Siddiqui consultant neurologist from Aga Khan University opined that price of the drug also matters.  Generics are very cheap as compared to branded drugs that is why people and the healthcare professionals prefer them because they are affordable. It is the responsibility of the government laboratories to ensure that all the drugs marketed are potent and of quality. It should also ensure that sub-standard and counterfeit drugs are not available in the market. Responding to a question from the audience Dr. Suhaib Ahmad Jafri said that since people want cost effective quality drugs, hence some of the Multinationals have also started marketing Generics which are comparatively cheap but they do ensure bioequivalence studies of these generics before they are marketed. Dr.Sumbal Sohail Obstetrician & Gynaecologist from Abbasi Shaheed Hospital remarked that previously women used to suffer from more pain after menopause but now they have pain much earlier and it is quite common due to various reasons. We must ensure that the patient is satisfied with the treatment. Diclofenac is a good drug as regards pain relief, it has minimal side effects and least adverse events. We give patients its suppositories for local use to get pain relief in post-delivery pain and thepatients get lot of relief. First they are reluctant to use these suppositories but once convinced, they get lot of relief. Health Reporters from Jang Group of Newspapers participating in the discussion referred to the high cost of drugs and inadequate training of the junior doctors. They also pointed out the huge difference in the price of Interferon used for the treatment of Hepatitis-C. While the interferon injection marketed by national companies cost about three thousand rupees or less, the multinationals are selling the same at a much higher price of eight to ten thousand rupees or even more for which there was no justification.

Mr. Shaukat Ali Jawaid Chief Editor of Pulse Internationalparticipating in the discussion first commended the initiative taken by Mir Khalilur Rehman Society/Jang Group of Newspapers in collaborating with Novartis to organize a public awareness session to highlight the importance of quality of drugs in healthcare.  Referring to the excellent presentation by Dr. Amin Chinoy, he however felt that it would have been much better had the speaker included some local studies as well. Pain relief is such a common and important topic and there have been quite a few studies from Pakistan which could have been included after proper literature search. As regards Adverse Drug Reporting, he pointed out that this culture has not yet developed in Pakistan. Federal Ministry of Health tried twice and College of Physicians & Surgeons Pakistan had also made an attempt to establish ADR Center under the supervision of Prof. Akhlaq-un-Nabi but it never worked. The reason being the cozy relationship between the doctors and the pharmaceutical industry. Even the multinationals do not like these ADRs to be reported. However, it is commendable that Novartis was encouraging the healthcare professionals and public to report ADRs related to their drugs.

He also referred to the unethical marketing practices indulged by the pharmaceutical industry and Novartis was no exception. It also marketed and promoted a drug for the management of Irritable Bowel Syndrome. The method adopted to promote this drug was highly unethical and eventually this drug hade to be withdrawn. If the doctors start practicing ethical medicine, such incidents won’t occur. He also stated that NationalBioethics Committee of which he was one of the Founder Members and has now retired after completing two terms, has published Guidelines on Physicians Interaction with Pharmaceutical industry. This most comprehensive document covers everything starting from CME programmes to medical conferences, sponsored meetings and travel within the country and abroad. It has been approved by the Government and PM&DC but as usual its implementation was yet awaited. Once it is implemented in its letter and spirit, most of the unethical medical practices by the doctors an unethical marketing practices by the Pharma industry can be effectively checked and eliminated.Healthcare Committee of NBC has now finalized the curriculum for teaching, examining and assessing the medical and dental graduates in biomedical ethics. It is waiting PM&DC approval before it can be implemented. Pharmacy educaiotn also needs to be improved and the knowledge, training of the Drugs Inspectors leaves much to be desired, he added.   There was a consensus among the participants that scientifically based treatment should be promoted.

Earlier Mr. Mansoor Jafary from Novartis Pharma in his welcome address said that Novartis was a leading organization in the field of pharmaceuticals. It is a research oriented company and almost 19% of its turnover is spent on Drug Research and Development. We have at present the largest pipeline of new drugs which we expect to market in the days to come. He further stated that it is only one out of thousands of molecules which is found to be marketable and all this research costs lot of money.

In the coming days Novartis will market a number of new innovative drugs in the field of oncology, rheumatology, dermatology, Hypertension, Diabetes and pain managements and all these are research molecules. We are marketing innovative drugs to ease human sufferings. When we launched diclofenac in 1974 in Pakistan, it was also an innovative product at that time. We are market leaders in oncology and have a substantial share of market in different other segments as well. Quality of the drugs, he further stated, is extremely important. As such we ensure quality right from the purchase of raw material to the production and finished product. We also monitor adverse events of the drugs to ensure continuous quality. When generics are marketed, it is essential that they have bioequivalence studies before these drugs are marketed to ensure quality but unfortunately it is rarely done in Pakistan. Quality of life of the patients is important which is only possible by minimizing their sufferings, he remarked.