Introduction
A case study can be defined as ‘ an intensive study about a person, a group of people or unite, which is aimed to generalize over several Unite. Procedural Violation (When procedure are purposefully deviated from or bypassed) are known to occur in a range are sometimes made with explicitly good intentions, violations, violations have been notes as a potential threat to patient safety. Individuals within a work system have often been judged as liabilities whose behavior may lead to accident.
The provision of detailed rules is often intended to minimize opportunity human error by limiting the freedom of choice is responding to a given situation, Violations from this prescription represent a deviation from the “Correct” way of working and introduce an element of risk to practice.
Objective
Procedural violation are known to occur in a range of work settings and are an important topic of interest with regard to safety management. A safety-I perspective see violations as undesirable digression from standardized procedures while a safety-II perspective see violations as adaptation to a complex work system. This study aimed to apply both perspectives to examination of violations in Community Pharmacists.
Case Study 1: Illegal Online Pharmacy Operations
Violation: Operating an online pharmacy without proper licenses, prescriptions, or adherence to regulatory guidelines.
Background:
In recent years, the proliferation of internet-based commerce has led to the emergence of numerous online pharmacies offering a wide range of prescription and non-prescription medications. While some online pharmacies operate legitimately, providing convenient access to medications for patients, others engage in illicit practices, including the sale of counterfeit, substandard, or unapproved drugs without the necessary regulatory oversight.
Case Details:
1. Investigation and Discovery:
Regulatory authorities received reports and complaints regarding suspicious online pharmacy websites selling prescription medications without requiring valid prescriptions or proper authorization. Initial investigations revealed that these websites were operating outside the boundaries of legal and regulatory frameworks governing pharmaceutical sales and distribution.
2. Identification of Violations:
Upon further investigation, it was determined that the online pharmacies were violating several key regulations and laws related to pharmacy operations, including:
- Selling prescription medications without requiring valid prescriptions from licensed healthcare professionals.
- Failing to obtain necessary licenses, permits, or approvals from regulatory authorities to operate as pharmacies or drug distributors.
- Disregarding patient safety by offering medications of dubious quality, potency, or authenticity without adequate quality control measures in place.
3. Collaborative Efforts:
Regulatory agencies collaborated with law enforcement authorities, internet service providers, and international agencies to identify the individuals and entities behind the illegal online pharmacy operations. This involved tracing the ownership, domain registration details, and financial transactions associated with the illicit websites.
4. Enforcement Actions:
Once the perpetrators were identified, regulatory agencies took swift and decisive enforcement actions to shut down the illegal online pharmacy operations. These actions included:
- Issuing cease and desist orders to the operators of the websites, directing them to immediately cease all unauthorized pharmaceutical sales activities.
- Collaborating with internet service providers to disable or block access to the illicit websites to prevent further dissemination of harmful products.
- Seizing assets, domain names, and financial accounts associated with the illegal online pharmacies to disrupt their operations and deter future violations.
5. Prosecution and Legal Consequences:
Individuals and entities involved in the illegal online pharmacy operations were subjected to legal proceedings and criminal prosecution. Charges were filed against them for violating pharmacy laws, consumer protection regulations, and other applicable statutes. Legal consequences included fines, penalties, asset forfeiture, and potential imprisonment for the most egregious offenders.
6. Public Awareness and Education:
Regulatory agencies launched public awareness campaigns to educate consumers about the risks associated with purchasing medications from unverified online sources. These campaigns emphasized the importance of obtaining prescriptions from licensed healthcare providers and purchasing medications only from reputable pharmacies with proper regulatory oversight.
Conclusion:
The case of illegal online pharmacy operations highlights the challenges posed by the digitalization of pharmaceutical commerce and the importance of robust regulatory enforcement to protect public health and safety. By taking decisive enforcement actions, collaborating across jurisdictions, and raising public awareness, regulatory authorities can mitigate the risks posed by illicit online pharmacies and safeguard the integrity of the pharmaceutical supply chain.
Case Study 2: Medical Termination of Pregnency
Introduction: Declining sex ratio is major concern in present time according to censes 2011 sex ratio in district Gwalior was 848 per male and in year 2011 it was 862 through there was marginal hike in sex ratio still district Gwalior is in bottom five district of lowest sex ratio.
Methodology
District adopted two prong approaches for deciling sex ratio, place where sex determination is being done is covered by active tracking devices along with online portal and the place where actual termination of pregnancy take place i.e. MTP centers are being guided by active monitoring this also included development of information system from these centers. Actively, secretly, promptly taking action on any information regarding female feticide was also a key to success.
Action taken
On date 26.11.2012 an information regarding MTP of more duration then permission to that particular center came in notice. After receiving such information an inspection team was formed in leadership of City Magistrate and C.M.H.O. Gwalior. This team suddenly inspected Shantikunj Nursing Home, at Gande wali Sadak own by Dr. K.K. Sharma. During inspection a pregnant female named Smt. Anju Sharma w/o Sh. Smuit Shamra age 28 yrs R/o Vadho wali gali Datia found admitted in this hospital.
During inspection it was found that MTP procedure namely catheter was inserted inside her uterus and no consent form of that pregnant lady was there in his hospital. During inspection Dr. K.K. Sharma told duration of pregnancy of 11 weeks but he cou’d not produce any of aunthetic document such as the referral form, Usg report, consent form or any other form in accordance to MTP act. During medical checkup of the pregnant female no such cause for MTP according to the act was found.
Inspection team decided to call 108 ambulance and shifted to that patient to medical college hospital where evacuation of uterus was done as Dr. K.K. Sharma has already inserted the medicine for abortion.
You May Like: Overview of Pharma marketing practices
Postmortem of the fetus was done and age of fetus came out to be 16 weeks and 4 days and the fetus was a FEMALE FETUS. Medical college hospital also informed the same to Police station kampoo, gwalior. Shanti kunj Nursing home and Dr. K.K. Sharma were registered MTP practitioner there registration no. 64 dt. 6.7.2010 but he was having permission of MTP less than 12 weeks because that center was found and caught red handed for conducting an MTP more than 12 week without consent of patient. So case was registered at police station Indarganj under IPC act. Section 312 and MTP act section 3,4,5 for violation of MTP Act . FIR no. was 629/2012.
You May Like: Drug Testing Labs in India
As soon as this information came in local newspaper another female smt. Kirti Pathak w/o Deepak Singhal R/o Guda Gudi ka naka lashkar gwalior informed on telephone that her abortion more than 5 month was also conducted on the same Shantikunj Nursing home without her consent and his parents have kept her locked in her house. As soon as this information came to the administrative authorities they send the team to her house along with police and rescued her from her home. That female lodged an FIR against Dr. K.K Sharma under section 312,313 of IPC and section 3,4,5 of MTP act at police station indarganj.
For the first time in MP first case for violation of MTP act was filed in District Gwalior and registration of his Nursing Home and MTP registration was cancelled with immediate effect. This is a excellent example of quick action of distt.administration and due to this quick action awareness doveloped in pulbic in form of Smt.Kirti Pathak.
Conclusion and Advice
This is a known fact that female feticide is conducted by mutual coordination between USG Center and MTP Centers. To stop the female feticide both the centers should be monitored regularly, strictly and also sudden inspection should be conducted along with development of information system in the district regarding illegal abortion.
There should also be some cash prize reward as in PC& PNDT act for information of illegal abortion. very MTP Center should also keep an USG report before MTP so that specialist opinion about the age of fetus and cause for MTP can be justify.
Pregnancy due to failures of contraceptive method should be allowed till seven weeks only and such MTP should be done in only Govt. hospitals so that permanent methods of Family planning can be promoted and misuse of the act can be prevented. In presence scenario sex determination is a crime in PC&PNDT act but MTP act does not have any provision for female feticide.
To stop the female feticide we need an effective act including provision of MTP and PC&PNDT act both so that culprit doctors can be prosecuted and punished.
