PCN Requirements For New Community Pharmacy Location Approval And Facility Inspection

To open a community pharmacy, it must be registered with the corporate affairs commission (CAC) and the Pharmacists Council of Nigeria (PCN). PCN is the body responsible for the regulation and operation of pharmacy in Nigeria. Before a community pharmacy must be approved, it must meet PCN regulatory requirements.

Location approval and facility inspection

Pharmacy Inspection Checklist

There are two inspections done by PCN for a new community pharmacy. They are the location approval popularly known as site approval and facility inspection known as second inspection.

Location Approval (First Inspection)

A new community pharmacy must apply to PCN for location inspection. There is a prescribed inspection and registration fee that is to be paid as a bank draft. The bank draft is given to the applicant with account details already printed, which is to be submitted back to PCN after making payment. Go to the PCN account office to convert the bank draft to receipt which is to be submitted with the other documents. Submission of Form J with a photocopy of annual license to practice and application for the retention of a name in the pharmaceutical register with a passport size photograph. This is given to the pharmacy inspector at their office. Forms to be given include job declaration, directors understanding form and ownership form.

After some months, maybe 1-6 months, they come to check if the community pharmacy is more than 200 meters in radius from any other community pharmacy. They are not interested in the shop design, structure and layout. If the location meets the distance standard from other community pharmacy, it will be approved. They will will come.with a measuring device. Within some few minutes, they are done. Most community pharmacies scale through this stage without stress. The licence last for six months. If you fail to apply for facility inspection within six months, it will be revoke. And that location is up for another competition. You can apply for extension only once for another six months. You must also pay for the second location approval.

Facility Inspection (Second Inspection)

After location approval, you will then apply for facility inspection. Submit all the necessary forms at PCN. Pay inspection fee following the first process of using bank draft. They will come after about eight months from the day of application. Meanwhile, you can start construction and design of the facility including practice. That is when they will know if you are ready.

This is when they focus on the premises itself. They include patient care, security, equipment, reference books, employee strength and qualifications, additional items and Covid-19 protocol.

When they enter the community pharmacy, they will introduce themselves with their identification card and give the reason they are around. Of course, you as the pharmacist will be informed within 24 hours they are coming. They will gather and record evidence using multiple approach including;

a. Looking at written or documentary evidence such as standard operating procedures (SOP), policy, processes, etc.

b. Observing interactions between pharmacy personnel and patients

c. Testing system processes and procedures

d. Questioning opposing scenarios to staffs

After introduction, they will first verify the name of the superintendent pharmacist on their record and the pharmacist on duty. The superintendent pharmacist should be available in the pharmacy at all times the pharmacy is open to the public. But since this is not possible because the daily hours a superintendent pharmacist should work is 8 hours and the pharmacy operates more than that, there is room for other registered pharmacists to work. The other registered pharmacist can work for the remaining hours of the day. But the superintendent pharmacist is not in seat for the remaining hours the pharmacy is open, other support staff can operate over the counter drugs (OTC) and avoid prescription drugs.

The pharmacy should be at least 50 square metres in size. This will gradually erode the previous 30 square metre. Also, the current licence of the superintendent pharmacist, the pharmacy director current license, other pharmacists current license and the CAC registration license must be displayed in place easily seen by the inspector team. Specifically, at the wall facing the entrance so that even patients can see it. The tag pharmacy open and close should be displayed at the entrance with the open facing the public during open hours.

The dressing of the superintendent pharmacist must be professional. By professional, it means professional outlook. It is generally accepted that Mondays through Thursdays are long sleeve shirts and trousers with ties. A white clean well iron long sleeve laboratory apron or coat required. The name of the pharmacist should be in the laboratory apron. Then Fridays are for native. The weekends are for cleaning some clothes like jeans.

The attire of the support staff should be decent and moderate to benefit the pharmacy. Pharmacy technicians should in addition to their professional attire wear a clean well iron short sleeve laboratory apron or coat with blue collar. Other states should wear befitting clothing.

The drugs should be well arranged and neatly organised. There should be a formula for the organisation and arrangements of the drugs. Syrups, tablets, antibiotics, pediatrics, etc. You can use a combination of two or more. The bottom line is that it is well organised.

There should be proper ventilation and lighting. There should be an air conditioner. There is no law on the number or size. They will check out the fridge and the thermostat if it is working properly for cold storage drugs. In Nigeria, a standby electric generating set is required. Install standing fans when needed. When using ceiling fans, it should be those types that have protection for the blades and not the regular ceiling fans in which the blades can cut anybody that raises the hands. PCN doesn't accept that.

They will look at the control drugs compartment if it is under lock and key insert the control of the superintendent pharmacist only. A look at the poison book and its record to see if control drugs are sold with prescription. Ensure there is at least one reference book such as emdex in the office of the pharmacist not minding the year the book was released.

The pharmacist office should be separated from the dispensing dormxonsuktatil and counselling. Books for documentation or computer systems should be in place. It should be strahmywgixally located so that it can easily be accessed by both the superintendent pharmacist, patients and other support staff. It should be connected to the dispensing area to facilitate easy communication with customers. It should be constructed in such a way as to avoid eavesdropping by staff and others during counseling.

The office should be fitted with a computer, a telephone, desk, chair, drawer, etc. It is recommended that the poson cupboard should be in the pharmacist office. In some countries, a bee is even required.

There should be a waiting area equipped with reading materials. The materials should be health magazines, fliers, etc to add to the health knowledge of the patient and guidance. A television with video playing capacity for health talks and shows can be included. Toys for children. The waiting area should be close to the dispensing and counselling unit where the rhenkharmaxist office is. The compounding area has both hot and cold running water. Disposal equipment and designated area for medication and sharps. Background checks for all pharmacy employees are completed before the employee’s first shift.

Pharmacy employees’ education/certificates are up-to-date and displayed when necessary. Medication is regularly rotated and expiry dates checked.

They will go outside to look at the environment if it befits a community pharmacy setting. It must not be located in open market, motor parkskr clustered areas in order to preserve the dignity of the profession. They will look out for an approved PCN sign post with the name of the pharmacy well displayed. The entrance of the pharmacy should clearly indicate what is done there to differentiate it from others. PCN actually requires the registration number to be displayed on the sign post too. And it should be clean.

Employees should be aware of Covid-19 prevention protocol. Covid-19 symptoms information is posted and accessible to all employees. Employees understand reporting procedures in case of presentation of a patient with Covid-19 symptoms. All employees understand procedures should they present with Covid-19 symptoms. Employees are following proper hand washing protocol including frequency and duration. Common and employee areas are regularly disinfected. Pharmacy has made scheduling adjustments to allow for additional disinfecting procedures.

The superintendent pharmacist will be asked some questions as to how they meet the standards of pharmacy practice. His response is used to assess how the premises function to capacity.

The facility inspection should an average of two hours. Just an advice, you can entertain your guest. A bottle of cold fruit juice is not out of place.

If the facility inspection falls below standard, they will show the areas that need to be worked on. If the inspection indicate a major infarction, the shop will be closed down. Infarction such as no superintendent pharmacist on seat, sales of unregistered drugs, expired drugs, sales of expired drugs, etc.

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