Why Are Pharmacies Subject To Compliance Obligations?

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Why Are Pharmacies Subject To Compliance Obligations? Pharmacies across the country are subject to strict compliance regulations. If you are running a pharmacy, you know that noncompliance can create a lot of legal hurdles for your business. Compliance is necessary for all pharmacies whether they are billing federal healthcare programs or not. No pharmacy can escape these compliance obligations irrespective of its location and the number of customers it is serving. Federal agencies like CMS and DEA keep a strict vigil on the functioning of pharmacies and deal strictly with any incident of noncompliance.

Why Are Pharmacies Subject To Compliance Obligations?

Pharmacies Under Duress Because Of Compliance Obligations

Compliance has become a big issue among pharmacies operating around the country. These pharmacy compliance obligations apply to everything from the purchase of medicines from manufacturers to the stocks in the pharmacy to finally the sale of medicines on prescriptions provided by the customers. Often, pharmacies have to deal with overlapping federal and state compliance obligations. There is no excuse for non-compliance from the authorities and pharmacies have to pay dearly for even oversight of these obligations on their part. Many pharmacies hire services of law firms to fight their cases in law courts whenever they are caught in the legal wrangle on the issue of non-compliance.

Compliance Only Way To Deal With Prescription Drug Abuse

The federal government, after a wave of incidents of prescription drug abuse and deaths caused by such abuse, acted swiftly and announced a slew of measures to prevent drug abuse. These efforts of the government became apparent in the form of compliance obligations for pharmacies operating across the nation.  The substance which the government feels is being abused by the people is HCP (Hydrocodone combination products) and the drugs using HCP are Lortab, Lorcet, and Vicodin. There have been thousands of cases of HCP drug abuse and deaths across the length and breadth of the country. Alarmed by increasing numbers of opioid drug abuse and deaths, the federal government issued strict compliance obligations and asked pharmacies around the country to be partners in the fight against opioid drug abuse.

If one looks at the prescriptions filled by pharmacies in the country every year, he finds that this number exceeds 4 billion. To comply with the obligations requested by the government, pharmacies need to have a highly efficient and scientific method of purchase and sale of medications. In the last six months alone, pharmacies across the country have been slapped with penalties and fines amounting to billions of dollars. These fines have been collected on account of non-compliance with the obligations issued by the federal government.

What Are These Compliance Obligations?

Ordering Prescription Drugs

Pharmacies are required to use DEA form no 222 in a correct manner while ordering prescription drugs. The form needs to be filled up properly, and all documentation must be kept safely during placement and receipt of prescription drug orders.

Inventory Management Of Prescription Drugs

During inspections and audits carried out by DEA, the primary focus remains on compliance with inventory management. Pharmacies are required to keep an up-to-date record of their stocks, and this record should date back to two years.

Fraud Monitoring And Prescription Management Compliance

The federal government is of the view that it is during prescription filling that pharmacies must remain extra vigilant. They must remain alert to the possibility of customers using fake and invalid prescriptions. Pharmacies must have efficient processes in place to prevent customers from obtaining prescription drugs on invalid prescriptions.

Compliance With Security Of Prescription Drugs

There have been increasing incidents of theft of prescription drugs during transit and also from the pharmacies. Compliance obligations touching on this subject require pharmacies to put in place strict security measures to prevent theft of such drugs. If it is found that the pharmacy did not follow security guidelines issued by the authorities, it shall be deemed as being complicit in the theft of prescription drugs.

Prescription Drugs Disposal And Transfer

There are many compliance obligations for pharmacies when it comes to the disposal and transfer of prescription drugs. To get away from these obligations, pharmacies take the recourse of outsourcing. DEA has now made it clear that by outsourcing the responsibility of disposal and transfer of prescription drugs, pharmacies will not be able to shift their obligations.

Record Keeping Practices Of Pharmacies

Pharmacies all over the country are subject to a comprehensive set of guidelines related to record-keeping. All pharmacies are required to quickly produce all such records during inspections and audits carried out by DEA. They should also be reasonably confident in compliance with record-keeping obligations.

Prescription Drug Diversion Control

The activity of diversion of prescription drugs is under the watchful eyes of the DEA. In light of the increasing incidents of opioid drug abuse and deaths across the country, authorities have the right to slap severe penalties against pharmacies accused of diversion of opioid drugs.

With such tight compliance obligations in place, it is clear that pharmacies all over the nation need to be on their toes to ensure full compliance. They cannot get away with the excuse of being overburdened with high demand from customers. These pharmacies cannot get away from the scrutiny of the DEA if their compliance efforts are not found to be satisfactory during inspections and audits. On the other hand, these pharmacies can remain protected if they are seen adopting a proactive approach towards compliance.

In the light of increasing incidences of prescription drug abuse and deaths, it is only right that the federal government has put in place so many compliance obligations for the pharmacies across the nation. It is a fact that pharmacies are crying foul for being slapped with such huge amounts of penalties. But even these pharmacies know that by being a little more proactive and detail-oriented, they can not only avoid penalties but also play their role in the fight against opioid drug abuse and related deaths. One way of achieving the goals of full compliance is to provide training to pharmacy employees and to appoint compliance officers to look into all the related matters.



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