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Precription of Drugs having Misuse Potential : Guidelines

Precription of Drugs having Misuse Potential : Guidelines

Prescription of drugs having Misuse/Abuse Potential are a tricky affair for any medical practitioner. Not only does a doctor have an ethical obligation towards the rational use of these medicines and prevention of their misuse, there is also a legal implication, should these drugs be subjected to abose

The Voluntary Health Association Goa came out Prescription Guideline For Medicines. Following are its major recommendations for Medicines, Drugs Having Misuse,Abuse Potential

Recommendations

Extra special care needs to be taken for prescribing, handling, storage, and dispensing such drugs. Examples of such drugs are:

BENZODIAZEPINES

i.            Diazepam containing products

ii.            Alprazolam containing products

iii.            Lorazepam

iv.            Nitrazepam

v.            Flurazepam

vi.            Midazolam

vii.            Clonazepam

viii.            Clobazam

ix.            Chlordiazepoxide containing products

NON BENZODIAZEPINES

i.            Zopiclone

ii.            Zolpidem

iii.            Eszopiclone

iv.            Etizolam

v.            Phenobarbitone

vi.            Pentobarbitone

OTHERS

i.            Morphine*

ii.            Pethidine*

iii.            Pentazocine

iv.            Buprenorphine

v.            Propoxyphene (Dextropropoxyphene)

OTHER DRUGS WHICH HAVE HABIT FO R M I N G /A B U S E /A D I C T I O N POTENTIAL or could be MISUSED OR HARMFUL :

i.            Codeine containing products

ii.            Tramadol containing products

iii.            Modafinil

iv.            Misoprostol

v.            Mifepristone

vi.            Sildenafil citrate

vii.            Ketamine

* Pethidine can be purchased, stocked and dispensed/sold only by a Retailer having a valid drug license under the Narcotics Drugs & Psychotropic Substances (NDPS) Act.

It is mandatory under law that the prescription should be complete, written by an authorized R.M.P. and be retained by the Pharmacy. A written record of the prescription, along with batch no., expiry date, and quantity purchased and sold, name of R.M.P., and name of patient needs to be maintained.

A quarterly report in the specified format needs to be submitted to the FDA (stating quantities of sale and purchase).

*. Morphine can be stocked only by a stockist who is having a valid drug license under the NDPS Act, and sold directly to the patient. Moreover, it can be sold only against a valid permit issued by the State FDA containing the quantity of Morphine to be dispensed.

The Permit can be obtained by the patient from the FDA against submission of a proper, complete prescription for Morphine, written by a R.M.P.

A. Guidelines for doctors :

Besides all the instructions/guidelines for prescription medicines, additional care needs to be taken in prescribing the above listed medicines:

  1. For safety, and to avoid misuse, use a separate prescription for such drugs; and it is preferable NOT to give a computerized or typed prescriptions.
  2. Ensure that the exact quantity to be dispensed is written, along with the dosing, and the number of days – this in order to deter/prevent the patient from manipulating the quantity by writing additional numbers before or after the quantity prescribed.
  3. Do not write such words as “Continue…..”, or “for long term use”, etc. for such medicines – as this gives no finite quantity, and can be misused by some patients to go on accumulating large quantities of the medicines.
  4. Strictly avoid overwriting. If at all there is a need for any, strike out the wrong word/quantity, write it afresh and countersign it.
  5. The medicines listed above should not be prescribed/recommended/advised to patients or pharmacy over the telephone, though text messages (SMS), or through Email/internet. Pharmacies are not authorized to dispense these drugs against such orders and have the right to refuse to dispense.
  6. Quantities prescribed for such types of drugs should be reasonable. It is advisable to give due justification for large quantities of a particular drug prescribed. If any doctor misuses his powers to indiscriminately prescribe large quantities other than for justifiable medical use, the Medical Council has the powers to take action against the doctor. Pharmacies are authorized to refuse to dispense such prescriptions if they suspect any misuse.

B. Guidelines for the Pharmacy :

PURCHASE & STORAGE:

The Pharmacy owner and Pharmacist should ensure that all the staff members are provided information and given training in handling of such medicines, and the need for such careful handling.

  1. Only minimum quantities should be ordered, as required, from authorized distributors/wholesaler/supplier, having a proper wholesale drug license. Avoid over stocking. Pharmacies should opt to stock reputed brands only.
  2. These drugs should be checked as soon as they are received from the wholesaler. One must tally the quantity, batch and expiry date on the medicine received with that on the invoice of the supplier. If any of these do not tally, please bring it to the notice of the supplier, and get it rectified from them immediately – either as a new corrected invoice, or corrections done in pen and countersigned by the Qualified Person and rubber stamped. Please do not make the changes/corrections on the invoice yourself.
  3. Once checked, these drugs should be immediately transferred to a specially designated cupboard, meant to stock only such drugs, and always kept under lock & key. The key should be with a responsible person.
  4. As a matter of caution it is advisable to check and tally these drugs from time to time to ensure that there is no pilferage, or errors in handling.

DISPENSING:

  1. At the pharmacy, such prescriptions should be carefully scrutinized by Pharmacists who should read it with extra care and caution. One needs to ensure that the prescription is genuine, prescribed by an authorized doctor, and complete in all aspects, and that there is no manipulation/overwriting in the prescription, etc.
  2. To ensure that there is no misuse/repeat buying by the patient, the pharmacy must put a “Dispensed” stamp without fail on the prescription.
  3. The quantity sold against such orders must not be more than that ordered.
  4. Do not allow these medicines to lie around – promptly put them back in the separate shelf reserved for them, under lock and key.
  5. Strictly, no verbal orders from a doctor/hospital should be entertained for such drugs.
  6. Sale of such drugs to doctors/hospitals must be strictly against a written order on a letterhead with all the doctor’s details, signature and date. If from a hospital, the order must be from the hospital pharmacist countersigned by the administrator or by a qualified doctor, on a letterhead of the doctor or the hospital, bearing all the details as per Guidelines. The doctor must be an authorized, qualified allopathic doctor (R.M.P. – Registered Medical Practitioner). Dispensing/sale of such medicines strictly cannot be done to or against the prescription of doctors of other systems of medicines or unqualified persons/quacks. Pharmacists or nurses strictly cannot recommend/ prescribe such medicines.
  7. The invoice/cash memo should be complete with respect to name and address of the doctor/hospital or the pharmacy to whom the drug is sold, drug license number, name of the drug, quantity, batch number, expiry date, Schedule, price, and the signature of the Pharmacist.
  8. The Pharmacist must ensure that the quantity, batch and expiry of the drug dispensed actually tallies with that on the invoice.
  9. Such drugs must be dispensed only under the personal supervision of the Pharmacist.
  10. Owners must strictly ensure that such drugs are not sold in absence of a Pharmacist.
  11. The Pharmacy must be able to produce the records of purchase and sale of all such drugs.

C. Guidelines for Wholesaler/Stockist :

The owner should ensure that all the staff members are provided with information and given training in handling of such drugs, and the need for very careful handling.

  1. Only minimum quantities required should be ordered, as required, from authorized distributors/suppliers/C&F agents or manufacturers, having a proper wholesale drug license. One should preferably stock reputed brands only, and avoid over stocking.
  2. These medicines should be checked as soon as they are received from the Superstockist/C&F/Company/Suppliers – One must tally the quantity, batch and expiry date on the medicine received with that on the invoice of the supplier. If it does not tally, bring it to the notice of the supplier/manufacturer, and get it rectified from them immediately – either as a new corrected invoice, or corrections done in pen and countersigned by the Qualified Person and rubber stamped. Please do not do the changes/corrections on the invoice yourself.
  3. Once checked, these should be immediately transferred to a specially designated shelf/cupboard, meant to stock only such drugs, and under lock & key. The key should be with a responsible person.

Sale by Wholesalers:

  1. Wholesalers must “sell” only to those retailers who have a valid retail drug license under Drugs & Cosmetics Act to stock such medicines.
  2. Wholesalers should be doubly careful if any retailer asks for what looks like excess/unreasonable quantities of such medicines. One should deal with such matters on a case to case basis.
  3. Orders for such medicines from Retailers must be on the letterhead of the retailer, rubber stamped and signed by the Pharmacist.
  4. It is advisable to make separate bills/invoice for any such drugs; and to receive payments for such invoices by crossed cheque of the pharmacy/retailer only, and not by cash.
  5. Sale of such medicines to doctors/hospitals must be strictly against a written order on a letterhead with all the doctors’ details, signature and date. If from a hospital, the order must be from the hospital pharmacist countersigned by the administrator or by a qualified doctor; on a letterhead of the doctor or the hospital, bearing all the details as per Guidelines. The doctor must be an authorized, qualified R.M.P. Such sale cannot be executed against the prescription of doctors of other systems of medicines or unqualified persons/quacks.
  6. The record of receipt and sale of such medicines must be conveyed to the FDA th before the 5 of every month.
  7. . The wholesaler must keep a hard copy of all the orders received from doctors/hospitals and retailers, and retain the same for at least 2 years.
  8. The quantity sold against such orders must not be more than that ordered.
  9. The invoice should be complete with respect to name and address of the doctor/hospital or the pharmacy to whom sold, drug license number, name of the drug, quantity, batch number, expiry date, Schedule, price, and the signature of the competent person.
  10. The Competent Person must ensure that the quantity, batch and expiry of the medicine dispensed actually tallies with that on the invoice.
  11. Such drugs must be dispensed only under the personal supervision of the Competent Person. Owners must ensure that such drugs are not sold in absence of Competent Person.
  12. The wholesaler must be able to produce the records of purchase and sale of all such medicines.

You can read the full Guideline by clicking on the link :

http://www.dfda.goa.gov.in/images/uploads/prescription_guidelines_booklet_for_doctors_pharmacists.pdf

Read Also : Writing a Prescription: Guidelines

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