The recent recommendation of the Drugs Technical Advisory Board (DTAB) (as reported in Chronicle Pharmabiz June 5, 2003), for inclusion of all prescription drugs in Schedule H to check their OTC sales is a late thought of action. It is a positive step, but it needs to be analyzed how really effective this step will be.
What is slightly baffling is, what difference does it make whether the drug is listed in the Schedule H or not? As long as the words: "Warning: To be sold on retail on the prescription of a Registered Medical Practitioner only" appear on the label of the medication, it is clear that selling the medicine without a prescription is a violation of the law. What curtails the drug authorities to prosecute such violations is again baffling.
Regardless of this confusion, the problem remains to be addressed: "How and when will the drug authorities prosecute violations of law even after the drugs are included in the Schedule H?" This law is violated in India almost every minute by almost every retail chemist in this country. Because no precautions/checks have been maintained for the past few decades, the situation now has degraded to almost beyond repair. Today, if any chemist were told to strictly stop selling prescription medicines, unless the customer produces a genuine prescription, he would probably have to/prefer to close his shop. There are a multitude of reasons why such a situation has arisen in our country. Let us try to analyse them one by one, and suggest some measures how the problem could be reduced (if not completely overcome), slowly and steadily.
Reasons leading to prescription medicines being sold without a prescription
FDA:
· Lax implementation of laws
· Corruption & misuse of powers
· Shortage of staff (Drug Inspectors)
· Political interference/compulsions
· Grant of retail drug licences without considering availability of pharmacists, number of retail licences in the vicinity, background of the applicant/owners.
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(The skeletons tumbling out of the cupboards of Karnataka FDA could be fair a representation of what is happening in many FDAs all over the country)
Possible solutions to reduce the problem
· Political interference has to be minimized.
· Corruption has to be tackled effectively.
· Allocation of funds for increasing field force
· Rationalizing of the process of granting new retail licences.
Proper implementation of the Drug Laws to ensure presence of pharmacist, and sale of medicines only against a prescription
PHARMACY OWNERS:
· Non-pharmacy owners are numerous. They often may not have too much consideration for observing laws or ethics.
· Some may not have a desire to appoint a pharmacist
· Pharmacists are often not present in pharmacies
Selling prescription medicines without a prescription, often forces other pharmacies to follow suit out of helplessness.
Possible solutions to reduce the problem
· Ensure presence of pharmacists throughout working hours of the pharmacy
Hold both the owner & pharmacist responsible for deficiencies/anomalies in the pharmacy functioning
UNQUALIFIED DOCTORS (QUACKS)
· They are present in abundance all over the country.
· Selling medicines against the prescription of an unqualified person/quack also amounts to selling without a prescription
Quacks are proliferating and their practices go on unchecked.
Possible solutions to reduce the problem
· Ensure better education & knowledge among pharmacists.
· Professionalize the pharmacists
· Elevate their status
· Take strict action against defaulters of the law.
· Eradicate quackery
Pharmacy associations should step up involvement to solve the problems.
DOCTORS :
· Careless prescribing, incomplete prescriptions
· Often don't use a prescription pad.
· Do not specify clearly for how many days a medicine is to be taken. Do not give "Refill" or "Do not Refill" instructions.
· Fees charged are often too high
Influenced by pharma industry for unnecessary prescribing
Possible solutions to reduce the problem
· Have uniform & compulsory format for prescriptions all over the country.
· Educate doctors about prescription writing, and rational prescribing.
· Improve Government health care services.
Put a check on unethical linkages of doctors with pharma industry.
PHARMA INDUSTRY:
· Puts too much pressure on their field force to sell. In turn, there is heavy, but often unethical promotion.
· Some prescription drugs are advertised through media, directly to consumer.
Heavy & unethical promotions to doctors and pharmacies to push drugs
Possible solutions to reduce the problem
· Have close supervision on advertising and unethical promotions of pharma industry.
Discounts & schemes & gifts on medicines should be thoroughly scrutinized.
PATIENTS/PUBLIC
· Prefer not to go to a doctor for various reasons: high fees, prescribe too many & costly medicines, unfriendly attitude, long queues, etc.
· Some don't mind taking the risk of self-medication
· Many are not aware of the dangers of self-medication.
Insist that they be given medicines without a prescription for various reasons: no time to go to a doctor, doctor not affordable, doctor had prescribed the same medicine the last time, do not want to believe that most medicines are prescription medicines, think it foolish to go to a doctor every time when they know what the medicine is for, etc.
Possible solutions to reduce the problem
· Systematic, planned & comprehensive campaign is necessary for public education about prescription medicines and their potential dangers, and need for careful use.
Involvement & use of media for public education
What it needs to change such a horribly wrong system prevailing in our country is a `Will'! A political will, and a will from the Drug Control authorities, all over the country. Raiding a few pharmacies and suspending their licences for selling prescription medicines without a prescription will not serve the purpose. On the contrary it will generate tremendous hostility from the public as well as the chemists. What it needs is a multi-pronged strategy, including widespread, concerted education of the public, wiping out quackery, promoting rational prescribing, strict supervision of advertisements of medicines, control on the promotions to doctors & pharmacies, cleaning up the corruption in the system, ensuring presence of pharmacists in the pharmacies, curbing irrational granting of new retail licences, suitable modification in the Drug Laws, and then finally, strict implementation of the Drug Laws.
These could be possible ways to restore sanity in the existing chaos in selling medicines today. If the will is there, and immediate planning & implementation follows, it would take at least a couple of years for the effects to be seen. It is time that India too joined other countries in ensuring that no prescription medicine is sold without a proper & genuine prescription of a doctor!
Will the health ministry and the Food and Drug Administration ever consider implementation of such a multi-pronged strategy? If these authorities are really concerned about the health of the people of this nation, it should not waste any more time, and start taking effective steps towards bringing about the changes. Until then, health care in India will continue to be in tatters.
-- The author is a Panaji-based community Pharmacist