New rules a bitter pill for pharmacies
Pharmacy owners say many will have to shut up shop if forced to follow new National Medicinal Regulatory Authority (NMRA) guidelines, claiming the rules – aimed at better service for customers – are based on foreign norms and are unworkable here.
About 9 out of 10 pharmacies operate in urban areas where the regulations are particularly inoperable, they said.
New minimum standards for setting up pharmacies stipulate that the premises have ample space, with an area of at least 180 square feet, air-conditioning, refrigerators, wheelchair accessibility and parking for customers.
The NMRA says the new guidelines will create and maintain the right environment for safe and effective pharmacy practice. It will give existing businesses time to adjust to the new rules.
Conditions include a waiting area of at least 60 square feet and a separate lockable area for storage of Schedule II and Schedule III medicines – the latter regulation having to be obeyed by the end of this year.
The President of the Pharmaceutical Society of Sri Lanka, K.S.L. Hewage, had no comment on the guidelines, excusing himself on grounds that he was new to the position, but society members were ready to voice concerns.
A leading pharmacist in Colombo, while welcoming the move to regulate pharmacies, said it was unfair to hold all outlets to a universal standard.
The regulations on space, parking, seating capacity and wheelchair access would be impossible to follow, he added.
He acknowledged, however, that the distance specified between pharmacies was fair and would prevent clustering of businesses and ensure ready availability of pharmaceutical drugs to patients.
The guidelines specify that pharmacies in urban areas must be sited at least 250m from each other and, in rural areas, 750m apart.
Pharmacists argue that most outlets in Colombo operate in congested space – paying huge sums in rent – and that spacious premises with parking areas were not available in urban areas and were, moreover, unaffordable for small businesses.
The guidelines, they said, toe international standards that could not be followed in Sri Lanka.
Another concerned member said the NMRA had failed to pursue pharmacies that operate without a pharmacist present on the premises. He said most pharmacies operate only with photograph of the pharmacist and a carefully-framed licence hanging on the wall.
It is learned that such pharmacists receive a monthly payment of Rs. 15,00020,000 from the owner for his or her virtual presence while drugs are dispensed by experienced sales assistants.
The NMRA Act requires that a superintending pharmacist registered with the Sri Lanka Medical Council be present when dispensing drugs.
The new guidelines demand the physical presence of the pharmacist who must oversee staff dispensing medicines.
Pointing out that many outlets flout this requirement, the pharmacist said, “The NMRA knows this. Doctors prescribing drugs also know of this practice but are unconcerned.”
NMRA CEO Kamal Jayasinghe said the new guidelines would be strictly enforced but acknowledged there were regional difficulties with running adequately-managed outlets: “There is a shortage of pharmacies in the north and east because of the war and the lack of qualified pharmacists to operate the businesses,” he said.
Mr. Jayasinghe said applications for new pharmacies would have to be framed around all the new regulations.
Applications would need recommendation by the Regional Director of Health and be reviewed by a committee before registration was granted. Future businesses would be strictly monitored.
Mr. Jayasinghe said established pharmacies would be exempted from some conditions and would be given three years from 1 January 2018 to update their premises.
On the issue of pharmacies operating without a pharmacist present, Mr. Jayasinghe asked patients to be aware of their rights. “They should insist on the presence of a qualified pharmacist when buying drugs,” he said. Pharmacies without a full-time pharmacist should have a sign indicating what time the pharmacist would be on duty and able to dispense drugs, he added.
If these rules were not being followed the public should complain to the NMRA: “We will take up the complaints seriously,” Mr. Jayasinghe said, adding that the authority, in collaboration with the Consumer Affairs Authority and police, had raided several outlets in response to complaints.
The NMRA registry has 3597 registered pharmacies with 2919 retail outlets and 678 pharmaceutical wholesalers.
Pharmacy owners noted that even pharmacies run by the state do not currently conform to the new guidelines, with limited space, no wheelchair access or parking. When drugs are dispensed there is little or no patient education on drug storage, identification of counterfeit drugs, safety and contra-indications, they said.
New minimum standards for setting up pharmacies stipulate that the premises have ample space, with an area of at least 180 square feet, air-conditioning, refrigerators, wheelchair accessibility and parking for customers.