Monday, April 2, 2018

The Prescription


The Prescription        
Dr. R. S. Thakur
President
Federation of Indian Pharmacists' Organisations
New Delhi

The Medical Council of India has amended Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 with effect from October 8, 2016 vide notification in the Gazette of India: Extraordinary, Part III, Section 4, No. 366 dated  October 8, 2016. This notification has substituted clause 1.5 in Chapter 1-B-Duties and responsibilities of the Physician in general, under the heading – Use of Generic names of drugs, by the following: -
“Every physician should prescribe drugs with generic names legibly and preferably in capital letters and he/she shall ensure that there is a rational prescription and use of drugs”

Importance
This amendment is very important and a useful tool to curb medication error and ensure safe, effective and economic therapy. How this amendment will ensure all the four aspects mentioned above can be illucidated  by its detail implication on public health. The amendment has three distinct parts.

1. Every physician should prescribe drugs with generic names legibly and preferably in capital letters;
2. he/she(Every physician) shall ensure that there is a rational prescription; and
3. he/she(Every physician) shall ensure that there is a rational use of drugs.

Implication
First, while writing a prescription every physician has to follow all the three aspects stipulated in the notification. While dispensing the prescription every Pharmacists must satisfy herself/himself that generic name and capital letters are used in the prescription and it is completely legible to identify the prescribed medicine, the dose, frequency and route of administration and duration of therapy. This will lead to precise and accurate dispensing of the prescription.
As regards writing of prescription in capital letters, Mr. Chilukuri Parmathma of Nalgoda district of the then Andhra Pradesh(now in Telangana State) took up this very genuine and serious issue of larger public interest for writing prescription in capital letters so that patient or her/his attendant is sure that what is prescribed is actually dispensed or sold to her/him. Illegible prescription leads to wrong dispensing, wrong medication and toxicities, claims lives or affects health and huge monetary loss also ensue.

Research in this field revealed that a deposition by patient safety officials at the US Senate hearing on July 17, 2014 reported “Preventable medical errors persist as the No. 3 killer in the U.S. – third only to heart disease and cancer – claiming the lives of some 400,000 people each year. … not only the devastating loss of human but these also cost the nation a colossal $1 trillion each year.”

Mr. Paramathma compiled an exhaustive list of 54 pairs of trade name of medicines which look alike and sound alike, but have entirely different composition and indication for use. He approached various authorities at appropriate levels in Andhra Pradesh Government, but to no avail. He then approached Andhra Pradesh High Court in PIL No.45 of 2014 praying that doctors should prescribe medicines in capital letters.

 The Hon’ble Chief Justice of the High Court of Judicature of Andhra Pradesh in Order dated 24.2.2014 observed:

“We feel that the cause is genuine. ….we direct the Indian Medical Council to look into this aspect and whether this problem can be redressed or not. We desire and hope that the appropriate Legislature may take up the issue if necessary.”

Mr. Paramathama continued pursuing with Ministry of Health & Family Welfare, Government of India as also Medical Council of India and finally the notification has been published by MCI on 8.10.2016.

This aspect of the notification will prevent wrong dispensing, medication error and ensure patient compliance.  Prescriptions written with generic name, legibly and preferably in capital letters will reduce dangers to public health because of medication errors. Illegible prescriptions often lead to wrong medication which claims lives, affects health and cause huge monetary loss on follow up treatments as well as hospitalisation. When medicines are prescribed in capital letters every literate person can read it and it no more remain secret between prescriber and medicine seller. Patient and/or her/his attendant can make sure that right medicine has been dispensed. There will be no chance of confusion. This is highly important because medicine affects life of living people as also the fetus in the womb. Thus, this medical reform is useful for the society and for future generation also. Its impact is beyond imagination.


Second aspect of the notification is ensuring rational prescription. This demands application of pharmacotherapeutics, clinical pharmacology and WHO manual (WHO/DAP 1994) on principles of rational prescribing. The prescriber decides a set of first-choice medicines and on the basis of six steps ensures rational prescribing
(1) patient problem;
(2) therapeutic objective;
(3) suitability of first-choice medicine;
(4) writing prescription;
(5) informing and instructing the patient; and
(6) monitor and/or stop the treatment.

Arriving at the first-choice medicines is very crucial and it should not be based on irrational grounds like prescribing behaviour of other successful consultants without actually considering all alternatives to reach at most appropriate choice in every individual patient, including the dose, dosage form, dosage schedule, and duration of treatment.
Besides Pharmacotherapeutics, Pharmacovigilance and Pharmacoeconomics are also important for rational prescribing to ensure safe, effective and economic therapy. Safety of medicaion is ensured by avoiding drug interactions, adverse drug reactions and  precautions to be taken during therapy. These are very important for sucessful treatment and avoiding iatrogenic or drug induced diseases.   

Finally the physician has to ensure rational use of drug. WHO in its document WHO/EMP/MAR/2012.3 reported that irrational use of medicines is a major problem worldwide. WHO estimated that more than half of all medicines are prescribed, dispensed or sold inappropriately, and that half of all patients fail to take them correctly. The overuse, underuse or misuse of medicines results in wastage of resources and widespread health hazards. For example use of too many medicines(poly pharmacy), inappropriate use of antibiotics, inadequate dose and duration of therapy and even prescribing antibiotics in non-bacterial infections, indiscriminate use of injection when oral products are appropriate are few examples of irrational use of drugs.
WHO advocates 12 key interventions to promote more rational use of medicines:

1. Establishment of a multidisciplinary national body to coordinate policies on medicine use.
2. Use of clinical guidelines.
3. Development and use of national essential medicines list.
4. Establishment of drug and therapeutics committees in districts and hospitals.
5. Inclusion of problem based pharmacotherapy training to doctors and pharmacists.
6. Continuing in service medical education for doctors and pharmacists.
7. Prescription audits and feed backs.
8. Use of independent information on medicines(Drug information centre) not the sponsored sources like Medical representatives.  
9. Public education about medicines through counselling by pharmacists.
10. Avoidance of perversefinancial incentives.
11. Stringent implementation of Drugs Act and Pharmacy Act.
12. Appropriate government machinery to ensure availability of medicines and staff.

Conclusion
Once these three aspect of prescription are seriously met, the therapeutic scenario will completely change. People will enjoy better health, crowd in hospitals both in-patient and out-patient will reduce and health needs of more and more people can be easily met.

However monitoring these three aspects of prescription is crucial. Pharmacists are the ultimate professional in the health care set up whom the patient calls at last. Once the prescription is written, it is presented to the Pharmacist for dispensing. The pharmacist must examine every prescription in light of the notification and satisfy herself/himself that  all the three aspects of notification i.e. generic name written legibly and preferably in capital letters, rational prescribing, and rational use of medicine are ensured. Only then it should be dispesed. Any defect or deficiency in prescription must be corrected by the prescriber before dispensing in the greater interest of health and life of patients.


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