Urgent attention needed in tablet/capsule strip cutting despair
Very recently, Maharashtra Food and Drug Administration (FDA) suspended licenses of few retail chemists for refusal to dispense medicines by cutting the strip of a specified medicine. The All India chemist fraternity has fervently opposed the action terming it unjustified and impractical to follow. FDA had issued a circular a month ago stating that retail chemists not dispensing medicines in cut strips as per physician's prescription and instead dispensing the entire strip is in contravention to Rule 65 (11) of Drugs and Cosmetics (D&C) Rules.
Chemists, however, have argued that practice is abounding with practical problems which is inherent as a part of dispensing cut strips. The problem of strip cutting is a constant nightmare to all retail chemists. The simple fact is that no chemist like to cut a strip. Yet, he is forced to, for various reasons:
First and fore most for the Doctor who if prescribes a dose which is other than the strip size:
a) Out of ignorance of strip size
b) Wrong dose
c) Prescribing dose according to the age/weight and extent of illness of the patient
d) Different companies having different pack sizes for the same drug/strength, which makes it impossible for the doctor to remember which company product has what pack size.
f) The pack size keeps changing, with no prior or post intimation to the doctor.
g) Sometimes, Doctors provide few samples of the tab/cap, and tells the patient to buy the remaining medicines from the pharmacy.
Secondly due to Patients. Patients do not have enough money to buy the whole strip/dose, due to various reasons:
a) Poverty (cannot arrange for the money now or late
b) Has not carried enough money with him/her while he/she went to purchase those medicines.
c) Sometimes, experimenting Medicine with shorter dosage schedule, testing its efficacy and not abiding by the prescribed dosage.
d) Patients asking for medicines for self-medication, insisting on giving just a few and not the whole strip.
For all of the above-mentioned reasons, the pharmacist is left with no option but to cut strips, strictly against own wishes.
But the consequences of strip cutting enhances rise of more discrepancies and unavoidable problems in future. Strip cutting are risky, dangerous, and loss making, both monetary, as well as to life.
Many a times, the problems that generally occur and brings in bigger mis-happenings and losses. Generally they are:-
A) Chemists may push some expired tablets or even physician samples (without any batch details) along with genuine tablets. Expired strips and physician’s samples can be cut into appropriate pieces so as to dislodge the part carrying the batch details. This becomes even more convenient for blister packs, where the batch details are printed only on one side of the strip, consequently, the rest of the tablets can be sold long after their expiry.
B) Cut pieces of strips/loose tablets often migrate in the mess and rush of customers. There are chances, that by mistake the pharmacy may give pieces of a strip of other tablets along with the correct ones (for similar looking tablets/strip packings).
C) When cut tablet strips are given to patients, often with no name behind, the patient may get mixed up if two similar looking (but different) drugs packed in the same prescription. He may end up taking a double dose of one drug, and not take the other drug the first few days, and then take only the second drug for the rest of the days.
Moreover, in dispensaries, cut tablets are often not identifiable because the name of the drug may not appear on every part of the strip/foil, and as embossing on the tablet, and are a potential loss ---- when the batch number, expiry, price details get cut off, as generally they are placed in corner of a strip by the manufacturer and thereby strip medicines lose their integrity.
The drawbacks which are pulling in more of the strip cutting owes of medicine in India are that:-
• The Drugs & Cosmetics Act has not yet brought in some strict amendments regulations regarding the cause.
• Every individual company, as per their wishes, and marketing strategies, determines the size of the strip. Only meager per cent of the drugs in the market today are governed by mandatory pack size fixation.
• Even if there is some rationale in having a particular strip size as per the dose, there is no rationale amongst the doctors, and quacks, who have their own dosing regimens, making ’fixing’ of the size of the strip pointless, forcing it to be cut.
• Cut strips and loose tablets which are not sold, or are expired, are a tremendous loss to economy and business of pharmaceuticals.
As, Strip cutting has been a continuous serious problem, which neither the lawmakers, nor the FDA, nor the pharmaceutical industry has tried to amend and justify, it has been seen that finally it is the customers and the retail pharmacist who have to face the brunt of losses as well as conflicts with each other.
Therefore, there should be few viable solutions to take care of most of the shortcomings of the present system of pack sizes & problem of strip cutting. For this, examples from other FDA’s can also be sought out and accordingly laws made in benefit of both retailers and customers. In few cases standard sizes, dosage regimen and strict buying of them should be made mandatory as for drugs like antibiotics, antimicrobials, incomplete dosage regimen can cause bigger complications like drug resistant infections.
For expensive drugs/formulations, the strip size can be small and also for habit forming drugs, smaller pack sizes may be recommended.
The authorities must undertake sufficient campaigns to make the new pack sizes be known to all doctors, pharmacies, and the public, and make them aware of the reasons and the rationale for having these new pack sizes. Though initially, this may create problems, but in the long run it shall be beneficial for patients, retailers, pharmacist and also manufacturers.
In today’s world, where innovations are a regular occurrence, such primitive problems should diminish in co-operation with all stakeholders of Pharmaceuticals with better approaches and modern patient- centric / consumer-friendly methods.
Information collected from various sources and also by communicating with pharmacist, patients, manufacturers etc.